Clinical trial NCT02923349
Conditions: Advanced Malignancies Metastatic Cancer
Keywords: Solid tumor adenocarcinoma of the endometrium ovarian cancer renal cell carcinoma melanoma non-small cell lung cancer OX40 immunoglobulin G monoclonal antibody
Sponsor: Incyte Biosciences International Sàrl
Start date: 2016-10-31; Completion date: 2019-03-26
Enrollment: 87 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the safety and tolerability and assess preliminary efficacy of INCAGN01949 in subjects with advanced or metastatic solid tumors.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: INCAGN01949
Intervention descriptions: intervention 1: Initial cohort dose of INCAGN01949 monotherapy at the protocol-defined starting dose, with subsequent cohort escalations based on protocol-specific criteria. The recommended dose will be taken forward into expansion cohorts.

Protocol documents:
Prot_001.pdf: 
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Clinical Study Protocol 
INCAGN 1949-101 / NCT02923349
A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability 
Study of INCAGN01949 in Subjects With Advanced or Metastatic 
Solid Tumors 
Product: 
INCAGN01949 
IND Number: 
129,838 
EudraCT Number: 
2016-002079-93 
Phase of Study: 
1/2 
Sponsor: 
Incyte Biosciences International Sàrl 
Route de la Corniche 1 
1066 Epalinges, Switzerland 
Date of Protocol: 
07 JUN 2016 
Date of Amendment 1: 
26 APR 2017 
Date of Amendment 2: 
15 AUG 2017 
This study will be performed in accordance with ethical principles that have their origin in the Declaration of 
Helsinki and conducted in adherence to the study Protocol, Good Clinical Practices as defined in Title 21 of the 
US Code of Federal Regulations Parts 11, 50, 54, 56, and 312, as well as ICH GCP consolidated guidelines (E6) and 
applicable regulatory requirements. 
The information in this document is confidential.  No part of this information may be duplicated, referenced, or 
transmitted in any form or by any means (electronic, mechanical, photocopy, recording, or otherwise) without the prior 
written consent of Incyte Biosciences International Sàrl. 


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INVESTIGATOR'S AGREEMENT 
I have read the INCAGN 1949-101 Protocol Amendment 2 (dated 15 AUG 2017) and agree to 
conduct the study as outlined.  I agree to maintain the confidentiality of all information received 
or developed in connection with this Protocol. 
 
 
 
 
 
(Printed Name of Investigator) 
 
 
 
 
 
 
 
 
(Signature of Investigator) 
 
(Date) 


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SYNOPSIS 
Name of Investigational Product:  INCAGN01949 
Title of Study:  A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of 
INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors 
Protocol Number:  INCAGN 1949-101 
Study Phase:  1/2 
Indication: 
Part 1:  advanced or metastatic solid tumors 
Part 2:  advanced or metastatic adenocarcinoma of the endometrium, ovarian cancer, renal cell carcinoma 
(RCC), melanoma, and non–small cell lung cancer (NSCLC) 
Primary Objective:   
• To evaluate the safety, tolerability, and dose-limiting toxicities (DLTs) of INCAGN01949 and to define 
a maximum tolerated dose (MTD) or pharmacologically active dose (PAD) of INCAGN01949 in 
subjects with metastatic or advanced solid tumors. 
Secondary Objectives:   
• To evaluate the pharmacokinetics (PK) of INCAGN01949 in subjects with advanced or metastatic solid 
tumors. 
• To evaluate the preliminary efficacy of INCAGN01949 by assessing the objective response rate, 
duration of response, progression-free survival, and duration of disease control per RECIST v1.1 and 
modified RECIST v1.1 (mRECIST v1.1). 
Primary Endpoint:   
• Safety and tolerability will be assessed by monitoring the frequency, duration, and severity of adverse 
events (AEs). 
Secondary Endpoints:   
• The PK of INCAGN01949, including Cmax, Tmax, Cmin, and AUC0-t for subjects in Parts 1 and 2 will be 
summarized. 
• Objective response rate, defined as the percentage of subjects having complete response (CR) or partial 
response (PR), will be determined by investigator assessment of radiographic disease per RECIST v1.1 
and mRECIST v1.1. 
• Duration of response, defined as the time from earliest date of disease response (CR or PR) until earliest 
date of disease progression, will be determined by investigator assessment of radiographic disease per 
RECIST v1.1 and mRECIST v1.1, or death from any cause, if occurring sooner than progression. 
• Progression-free survival, defined as the time from date of first dose of study drug until the earliest date 
of disease progression, as determined by investigator assessment of objective radiographic disease per 
RECIST v1.1 and mRECIST v1.1, or death from any cause if occurring sooner than progression.  


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• Duration of disease control (CR, PR, and stable disease [SD]) as measured from first report of SD or 
better until disease progression, will be determined by investigator assessment of radiographic disease 
per RECIST v1.1 and mRECIST v1.1, or death from any cause, if occurring sooner than progression. 
Overall Study Design:   
This is an open-label, nonrandomized, Phase 1/2 study to determine the safety and tolerability, define the 
MTD or PAD, and assess the preliminary efficacy of INCAGN01949 in subjects with advanced or 
metastatic solid tumors.  Subjects will receive INCAGN01949 on Day 1 of each cycle.  Part 1 of the study 
will begin with 14-day cycles; however, alternate dose administration schedules may also be explored 
depending on PK, 
, and safety results.  The study will be conducted in 
2 parts: 
• Part 1 – Dose Escalation and Safety Expansion will determine the PAD, defined as a dose that provides 
a maximal biochemical effect, or an increase in 
 immune activity, and/or the MTD of 
INCAGN01949, which includes defining the optimal dose administration schedule and the maximum 
number of tolerated doses (MNTD). 
• Part 2 – Dose Expansion will evaluate the recommended dose and administration schedule determined 
in Part 1 in subjects with select tumor types
 
 including adenocarcinoma of 
endometrium, ovarian cancer, RCC, melanoma, and NSCLC. 
Part 1 
In Part 1, subjects with advanced or metastatic solid tumors who progressed after treatment with available 
therapies that are known to confer clinical benefit, who are intolerant to treatment, or refuse standard 
treatment will be enrolled. 
Dose Escalation 
A 3 + 3 design will be utilized to determine the MTD or PAD of INCAGN01949.  A minimum of 
3 evaluable subjects will be enrolled in each cohort beginning with Cohort 1 (7 mg; starting dose).  There 
will be a waiting period of 48 hours between dose administration to the first subject and second subject of 
each dose cohort.  The first 3 subjects enrolled within a cohort will be observed for a DLT observation 
period of 28 days before the next cohort begins enrollment.  The dose will be escalated if 0 of the first 
3 evaluable subjects enrolled has a DLT.  If 1 of the first 3 evaluable subjects enrolled has a DLT, then 
the cohort will be expanded to include 3 additional evaluable subjects, and if no DLT occurs in the 
additional 3 subjects, then the dose will be escalated.  If a DLT occurs in one-third or more of the 


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expanded cohort, then the MTD will be deemed to be exceeded, and the previous dose level will be 
considered the MTD.  If only 3 subjects were treated at the MTD or PAD, then a minimum of 3 additional 
subjects will be enrolled before this dose is administered in Part 2 of the study. 
If Cohort 1 (7 mg; starting dose) exceeds the MTD, then the sponsor and investigators will consider 
administering INCAGN01949 at 2 mg (Cohort -1) and/or investigate 7 mg at alternate dose schedules (eg, 
every 3 weeks administration), based on available safety, PK, 
 data.  If an alternate 
schedule is tested and determined to be safe, re-escalation of INCAGN01949 will proceed according to 
the table below. 
Throughout the treatment period, if > 33% of subjects (a minimum of 6 subjects) experience a ≥ Grade 3 
toxicity related to study drug after completing ≥ 4 cycles, then dose administration will be stopped, and 
the MNTD will be determined in conjunction with the investigators and sponsor based on all available 
safety data. 
Additional subjects will be enrolled in a cohort to achieve the minimum of 3 evaluable subjects.  Subjects 
who drop out for reasons other than a DLT (eg, events clearly associated with the underlying disease, 
disease progression, concomitant medication, or comorbidity) during the 28-day DLT observation period 
will be considered nonevaluable and will be replaced.  Dose modifications should not be made during the 
DLT observation period without discussion with the medical monitor.  Intrasubject dose escalation is not 
permitted; however, once the recommended dose has been determined, ongoing subjects in Part 1 may be 
permitted to escalate the dose to the recommended level with approval of the medical monitor.  The 
cohorts and dose levels are shown in the table below. 
Cohort 
Dose of INCAGN01949a 
-1 
2 mgb 
1 (starting dose) 
7 mg 
2 
20 mg 
3 
70 mg 
4 
200 mg 
5 
350 mg 
6 
700 mg 
7 
1400 mgc 
a  Additional dose schedules may be explored that would depend on PK, 
, and safety results. 
b  Subjects who require a dose reduction below 2 mg should be discontinued from study drug. 
c Cohort 7 may be evaluated if the MTD has not been established and translational data indicate that a higher dose of 
INCAGN01949 may be necessary to confirm the optimal PAD.   
Safety Expansion 
In order to evaluate additional 
 activity of INCAGN01949 and confirm the preliminary safety of the 
dose-escalation cohorts, Part 1 of the study may include safety expansion cohorts evaluating doses and 
schedules equivalent to or lower than the highest dose levels determined to be safe and/or doses 
determined to be pharmacologically active.  The alternative dose administration schedules and fixed doses 
(equivalent to or less than the MTD determined during dose escalation) that may be explored during the 
safety expansion would depend on PK, 
, and safety results. 
A maximum of 36 subjects will be enrolled into the Part 1 safety expansion, and each Part 1 safety 
expansion cohort will enroll up to 9 evaluable subjects.  If < 3 of 9 evaluable subjects have a DLT, then 
the cohort will be deemed safe.  If > 1 safety expansion cohort is deemed safe, then a recommended dose 
and schedule will be determined in conjunction with the investigators and sponsor based on all available 
safety, PK, 
 results.  The safety expansion cohorts may be run in parallel to Part 2 and 
may be limited by the sponsor to subjects with specific tumor types to achieve a balance across cohorts. 
 


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Part 2 
Part 2 of the study will further evaluate the safety, tolerability, preliminary efficacy, PK, and 
pharmacologic activity of the recommended dose of INCAGN01949 in subjects with advanced or 
metastatic adenocarcinoma of the endometrium, ovarian cancer, RCC, melanoma, and NSCLC (squamous 
and nonsquamous).  Each cohort will consist of an individual tumor type.  A Simon 2-stage design will be 
used with a stopping rule to allow for early termination of a particular cohort at the end of Stage 1 if there 
are insufficient responses observed.  During Stage 1, 9 subjects will be enrolled into each cohort; if no 
responses are observed within a cohort, then the cohort will be discontinued.  If at least 1 response is 
observed, then 8 additional subjects will be enrolled into that cohort (Stage 2), for a maximum of 
17 subjects per cohort.   
Subjects will continue to receive INCAGN01949 until Protocol-defined withdrawal criteria are met.  
Continuous evaluation of toxicity events will be performed throughout enrollment in Part 2 of the study.  
If the cumulative incidence of DLTs occurs in > 33% of subjects after 6 subjects have been observed for 
at least 28 days, further enrollment may be interrupted until the sponsor has determined the appropriate 
course of action (eg, the MNTD may be determined).  All AEs, regardless of the time of occurrence on 
study, may be considered in determining of the appropriate dose, schedule, and MNTD.   
Toxicity will continue to be monitored throughout the treatment period.  If > 33% of subjects (minimum 
of 6 subjects) experience a Grade ≥ 3 toxicity related to study drug after completing ≥ 4 cycles, then the 
MNTD will be determined in conjunction with the investigators and sponsor based on all available safety 
data. 
Study Population:  Enrollment in Part 1 will include subjects with advanced or metastatic solid tumors 
who have disease progression after prior treatment.  Enrollment in Part 2 will be limited to subjects with 
advanced or metastatic adenocarcinoma of the endometrium, ovarian cancer, RCC, melanoma, and 
NSCLC (squamous and nonsquamous). 
Key Inclusion Criteria: 
• Men and women, aged 18 or older. 
• Willingness to provide written informed consent for the study. 
• Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection 
with curative intent. 
• Subjects who have disease progression after treatment with available therapies that are known to confer 
clinical benefit, or who are intolerant to treatment, or who refuse standard treatment.  There is no limit 
to the number of prior treatment regimens. 
• Part 1:  Subjects with advanced or metastatic solid tumors. 
• Part 2:  Subjects with advanced or metastatic adenocarcinoma of the endometrium, ovarian cancer, 
RCC, melanoma, and NSCLC. 
- For subjects with adenocarcinoma of the endometrium:  should have documented microsatellite 
instability (MSI) status (eg, MSI-high, MSI-low, microsatellite stable), or consent to MSI status 
testing during the screening period. 
Note:  MSI-high is defined by instability in ≥ 30% of examined microsatellites.  MSI-low is defined 
by instability of < 30% of examined microsatellites.  Microsatellite stable is defined by no instability. 
- For subjects with ovarian cancer:  histologically confirmed diagnosis of ovarian, fallopian, or 
primary peritoneal carcinoma of epithelial origin.   
- For subjects with NSCLC (squamous and nonsquamous):  should have documentation of driver 
mutation testing for anaplastic lymphoma kinase, epidermal growth factor receptor status, BRAF 
mutation status, or consent to testing for these markers during the screening period. 
- For subjects with RCC:  must have histologically confirmed diagnosis of RCC that is predominantly 
clear cell histology. 


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- For subjects with melanoma:  mucosal or cutaneous melanoma is acceptable; however, subjects 
with ocular melanoma are excluded.  Subjects should have documented BRAF mutation status or 
consent to BRAF mutation testing during the screening period. 
Note: BRAF mutation status determined as part of a panel of genetic tests performed in a gene 
expression analysis will also satisfy the inclusion criterion for BRAF mutation testing. 
• Presence of measureable disease based on RECIST v1.1.  Tumor lesions situated in a previously 
irradiated area, or in an area subjected to other locoregional therapy, are not considered measureable 
unless there has been demonstrated progression in the lesion. 
• Part 1 Safety Expansion and Part 2:  Willingness to undergo pretreatment and on-treatment tumor 
biopsies (core or excisional). 
Note:  A baseline biopsy obtained for other purposes (ie, not a protocol-defined procedure) before 
signing consent may be utilized if the subject has not had any intervening systemic therapy from the 
time of the biopsy to the start of treatment (ie, Cycle 1 Day 1), and if a minimum of 20 slides or 
preferably 1 tissue block can be submitted. 
Note:  If a subject is scheduled to have a tumor biopsy for the purposes of this study and it is 
subsequently determined that tumor tissue cannot safely be obtained, then the subject may still enroll on 
the study.  The subject may be replaced within the cohort. 
Note:  For Part 1 Dose Escalation, pretreatment tumor biopsies are optional. 
• ECOG performance status 0 or 1. 
Key Exclusion Criteria (refer to full Protocol for full exclusion criteria):   
• Laboratory and medical history parameters not within the Protocol-defined range.  If the screening 
laboratory tests below were conducted > 7 days before treatment initiation, they will need to be repeated 
on Day 1 before initiation of treatment. 
- Absolute neutrophil count < 1.5 × 109/L. 
- Platelets < 100 × 109/L. 
- Hemoglobin < 9 g/dL or < 5.6 mmol/L. 
- Serum creatinine > 1.5 × institutional upper limit of normal (ULN), OR measured or calculated 
creatinine clearance (glomerular filtration rate can also be used in place of creatinine or creatinine 
clearance) < 50 mL/min for subjects with creatinine levels > 1.5 × ULN. 
- Aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase ≥ 2.5 × ULN. 
Note: Subjects with 1) bone metastases and 2) no hepatic parenchymal metastases on screening 
radiographic examinations may enroll if the alkaline phosphatase ≤ 5 × ULN.  Subjects with 1) bone 
metastases and/or 2) hepatic parenchymal metastases on screening radiographic examinations may 
enroll if the alkaline phosphatase is ≤ 5 × ULN only with medical monitor approval. 
- Total bilirubin ≥ 1.2 × ULN unless conjugated bilirubin ≤ ULN (conjugated bilirubin only needs to be 
tested if total bilirubin exceeds ULN).  If there is no institutional ULN, then direct bilirubin must be 
< 40% of total bilirubin. 
- International normalized ratio, prothrombin time, or activated partial thromboplastin time 
> 1.5 × ULN. 
• Transfusion of blood products (including platelets or red blood cells) or administration of colony 
stimulating factors (including granulocyte colony–stimulating factor, granulocyte macrophage colony–
stimulating factor, or recombinant erythropoietin) within 14 days before study Day 1. 
• Receipt of anticancer medications or investigational drugs within the following intervals before the first 
administration of study drug: 
- ≤ 14 days for chemotherapy, targeted small molecule therapy, or radiation therapy.  Subjects must 
also not require chronic use of corticosteroids and must not have had radiation pneumonitis as a result 
of treatment.  A 1-week washout is permitted for palliative radiation to non–central nervous system 
(CNS) disease with sponsor approval. 


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Note:  There is no washout period required between radiation therapy and the first administration of 
study drug in Part 2 of the study. 
Note:  Bisphosphonates and denosumab are permitted concomitant medications. 
- ≤ 28 days for prior immunotherapy or persistence of active cellular therapy (ie, chimeric antigen 
receptor T-cell therapy; other cellular therapies must be discussed with medical monitor to determine 
eligibility). 
- ≤ 28 days for a prior monoclonal antibody used for anticancer therapy with the exception of 
denosumab. 
- ≤ 7 days for immune-suppressive–based treatment for any reason. 
Note:  Use of inhaled or topical steroids or corticosteroid use for radiographic procedures is 
permitted. 
Note:  The use of physiologic corticosteroid replacement therapy may be approved after consultation 
with the medical monitor. 
- ≤ 28 days or 5 half-lives (whichever is longer) before the first dose for all other investigational agents 
or devices.  For investigational agents with long half-lives (eg, > 5 days), enrollment before the fifth 
half-life requires medical monitor approval. 
• Has not recovered to ≤ Grade 1 from toxic effects of prior therapy (including prior immunotherapy) 
and/or complications from prior surgical intervention before starting therapy. 
Note:  Subjects with stable chronic AEs (≤ Grade 2) not expected to resolve (such as neuropathy and 
alopecia) are exceptions and may enroll. 
Note:  Subjects with a history of any grade immune-related ocular AEs will be excluded. 
Note:  Subjects with a history of a Grade 3 or higher immune-related AE from prior immunotherapies 
are excluded from the dose escalation portion of the study. 
• Receipt of a live vaccine within 30 days of planned start of study drug. 
Note:  Examples of live vaccines include, but are not limited to, the following:  measles, mumps, 
rubella, chicken pox/zoster, yellow fever, rabies, Bacillus Calmette–Guérin, and typhoid vaccine.  
Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, 
intranasal influenza vaccines are live attenuated vaccines and are not allowed. 
• Active autoimmune disease that required systemic treatment in the past (ie, with use of 
disease-modifying agents, corticosteroids, or immunosuppressive drugs). 
Note:  Subjects who have not required systemic treatment in the past 2 years should discuss their case 
with medical monitor to determine eligibility. 
Note:  Subjects with hyper/hypothyroidism are eligible to participate. 
Note:  Replacement and symptomatic therapies (eg, levothyroxine, insulin, or physiologic corticosteroid 
replacement therapy for adrenal or pituitary insufficiency, etc) are not considered a form of systemic 
treatment and are allowed. 
• Known active CNS metastases and/or carcinomatous meningitis. 
Note:  Subjects with previously treated brain metastases may participate provided that they are stable 
(without evidence of progression by imaging for at least 28 days before the first dose of study drug and 
any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain 
metastases or CNS edema, and have not required steroids for at least 14 days before the first dose of 
study drug. 
• Known additional malignancy that is progressing or requires active treatment, or history of other 
malignancy within 2 years of study entry with the exception of cured basal cell or squamous cell 
carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of 
the cervix, or other noninvasive or indolent malignancy, or cancers from which the subject has been 
disease-free for > 1 year, after treatment with curative intent. 
• Evidence of active, noninfectious pneumonitis or history of interstitial lung disease. 


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• History or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is 
clinically meaningful.  Screening QTc interval > 470 milliseconds is excluded (corrected by Fridericia).  
In the event that a single QTc is > 470 milliseconds, the subject may enroll if the average QTc for the 
3 ECGs is < 470 milliseconds.  For subjects with an intraventricular conduction delay (QRS 
interval > 120 milliseconds), the JTc interval may be used in place of the QTc with sponsor approval.  
The JTc must be < 340 milliseconds if JTc is used in place of the QTc.  Subjects with left bundle branch 
block are excluded. 
Note:  QTc prolongation due to pacemaker may enroll if the JTc is normal or with medical monitor 
approval. 
• Active infection requiring systemic therapy. 
• Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation.  
Hepatitis B virus DNA and HCV RNA must be undetectable.  Subjects cannot be positive for HBV 
DNA, HCV RNA, hepatitis B surface antigen, or anti–hepatitis B core antibody, without approval from 
the medical monitor. 
Note:  Subjects with no prior history of hepatitis B infection who have been vaccinated against hepatitis 
B and who have a positive antibody against hepatitis B surface antigen test as the only evidence of prior 
exposure may participate in the study. 
• Known history of human immunodeficiency virus (HIV; HIV 1/2 antibodies). 
• Known allergy or reaction to any component of study drug or formulation components. 
• Prior treatment with an OX40 agonist for any indication. 
• Is a female who is pregnant or breastfeeding, or expecting to conceive children within the projected 
duration of the study, starting with the screening visit through 60 days after the last dose of study drug. 
• Is a male who is expected to father children within the duration of the study, starting with the screening 
visit through 90 days after the last dose of study drug. 
INCAGN01949 Dosage, and Mode of Administration: 
INCAGN01949 will be administered intravenously over a 30-minute period on Day 1 of each cycle.  
Subjects will continue to receive INCAGN01949 as long as the subject is deriving benefit, has not met 
any of the Protocol-defined conditions for treatment withdrawal, or has not exceeded the MNTD.  The 
MNTD will be determined in conjunction with the investigators and sponsor based on all available safety 
data. 
Reference Therapy, Dosage, and Mode of Administration: 
Not applicable. 
Study Schedule/Procedures: 
Subjects will have regularly scheduled study visits at the clinical site on Day 1 of each cycle.  Additional 
study visits may be required during some cycles to monitor for safety, efficacy, or for PK/
 evaluations.  
Study visits are as follows: 
• Screening:  up to 28 days before enrollment.  Screening will begin at the time that the subject signs the 
informed consent and will continue until the date that the subject is enrolled in the study 
(Cycle 1 Day 1). 
• Cycle 1:  Day 1, Day 2, and Day 7 (± 1 day). 
• Cycle 2:  Day 1 (± 1 days) and Day 7 (± 1 day). 
• Cycle 6:  Day 1 (± 3 days), Day 2, and Day 7 (± 1 day). 
• All other treatment cycles:  Day 1 (± 3 days). 
• Efficacy assessments:  Every 8 weeks (± 7 days) for 12 months, and every 12 weeks (± 7 days) 
thereafter until disease progression is determined. 


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• End of treatment:  ± 3 days of withdrawal from study. 
• Safety follow-up:  30 days (+ 7 days) and 60 days (+ 7 days) after end of treatment. 
Safety Assessments: 
Subjects will have regularly scheduled study visits at the clinical site on Day 1 of every cycle where 
targeted physical examinations, vital sign collection, ECOG performance status, collection of concomitant 
medications, and AE assessments will be performed.  A 12-lead ECG will be performed at screening, 
Cycle 1 Day 1, Cycle 2 Day 1, and then Day 1 of every other cycle after Cycle 2 (eg, Cycle 4, Cycle 6, 
Cycle 8).  Triplicate ECG measurements will be performed at screening, Cycle 1 Day 1, and Cycle 6 
Day 1, in conjunction with PK assessments.  Laboratory assessments will be collected on Day 1 of each 
cycle, with more frequent blood sample collection during the first and second cycles (Day 1 and Day 7) to 
evaluate for DLTs.  Toxicities will be monitored continuously and will be graded using the NCI 
CTCAE v4.03 criteria. 
On Day 1 of the first 4 cycles (Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1), 
subjects will be required to stay at the study site for at least 4 hours after infusion of study drug for safety 
observation.  It is recommended that the subject does not leave the site for any reason during the safety 
observation period.  During the safety observation period, subjects will be assessed for the onset of acute 
AEs. 
Regular telephone conferences with study investigators will be scheduled by the sponsor in order to 
review cohort-specific data and overall safety data, agree on dose escalation, adjudicate individual 
high-grade AEs as potentially dose-limiting, and guide other major study decisions. 
Efficacy Assessments: 
Disease assessments will be performed based on RECIST v1.1 and also on mRECIST to account for the 
unique tumor response characteristics seen with immunotherapy.  Modified RECIST will be defined as 
RECIST v1.1 with required confirmation of disease progression in the absence of clinical deterioration.  
The best overall response for subjects will be defined as the best overall response occurring during 
treatment, even if this assessment occurs after an initial assessment of progressive disease. 
Assessment of tumor size (by magnetic resonance imaging or computed tomography scan) will be 
performed at screening or baseline (before beginning therapy) and every 8 weeks for 12 months and then 
every 12 weeks thereafter until disease progression is determined.  Disease progression is defined as 
progression confirmed by a second consecutive assessment at least 4 weeks but no later than 6 weeks 
apart with the option for continuing treatment while awaiting radiographic confirmation of progression 
where feasible, provided that the subject meets the following definition of clinical stability: 
• Absence of clinically significant signs and symptoms (including worsening of laboratory values) 
indicating disease progression. 
• No decline in ECOG performance status. 
• Absence of rapid progression of disease.  
• Absence of progressive tumors at critical anatomical sites (eg, cord compression) requiring urgent 
alternative medical intervention. 
Subjects who discontinue study drug for a reason other than disease progression will continue to be 
assessed for their disease status during the follow-up phase and should continue to have tumor 
assessments every 8 weeks for the first 12 months and then every 12 weeks thereafter until a new cancer 
therapy is started, disease progression, death, or the end of the study, whichever occurs first. 
Pharmacokinetic Assessments: 
Serum PK samples will be obtained at Cycle 1 (Day 1, Day 2, and Day 7), Cycle 2 Day 1, Cycle 3 Day 1, 
Cycle 4 Day 1, Cycle 6 (Day 1, Day 2, and Day 7), and Cycle 7 Day 1. 
 
 
 Adjustments to the timing of blood sample 


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collection after dose administration may be made based on emerging PK data. 
Estimated Duration of Participation: 
Each subject will be expected to participate for up to 14 months. 
Estimated Number of Subjects: 
Up to approximately 163 subjects may be enrolled in the study. 
• Part 1 Dose Escalation – Approximately 18 to 42 evaluable subjects. 
• Part 1 Safety Expansion – Approximately 18 to 36 evaluable subjects. 
• Part 2 – Up to 85 evaluable subjects (up to 45 in Stage 1 and up to 40 in Stage 2). 
Statistical Methods: 
This is an open-label, nonrandomized, multicenter, dose-escalation Phase 1/2 study.  The primary 
objective of Part 1 of the study is to determine the MTD and/or PAD of INCAGN01949.  The total 
number of subjects will depend on the number of dose levels tested before the MTD or PAD is 
established.  Dose escalation will follow a 3 + 3 design algorithm. 
A Simon 2-stage design will be used in Part 2 with a stopping rule to allow early termination of a 
particular cohort at the end of Stage 1 if insufficient response is observed (calculated response rate < 5%), 
while enrolling enough subjects to predict possible target responses (≥ 25%) worthy of cohort expansion 
and potentially further evaluation in future studies.  Part 2 will include 5 cohorts, one for each of the 
tumor types to be studied (ie, adenocarcinoma of the endometrium, ovarian cancer, RCC, melanoma, and 
NSCLC).  The response rates for each tumor type will be estimated with 95% confidence intervals.  Other 
efficacy variables will be summarized with descriptive statistics. 
With a 1-sided Type I error of 0.05 and power of 80%, 9 subjects will initially be enrolled in the first 
stage.  If no responses are observed within a cohort (consistent with a calculated response rate < 5%), the 
cohort will be discontinued.  If at least 1 response is observed within a cohort, then 8 additional subjects 
will be enrolled in the appropriate cohort to a maximum of 17 subjects per cohort.  Investigation of the 
study drug will be considered interesting (predictive of a 25% response rate) if ≥ 3 responses are observed 
in the first 17 subjects. 


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TABLE OF CONTENTS 
SYNOPSIS ......................................................................................................................................3 
LIST OF ABBREVIATIONS ........................................................................................................19 
1. 
INTRODUCTION ......................................................................................................22 
1.1. 
Background .................................................................................................................22 
1.1.1. 
The Role of the Immune System in Cancer ................................................................22 
1.1.2. 
Immune Modulators ....................................................................................................23 
1.1.3. 
OX40 and the Tumor Necrosis Factor Super Family .................................................23 
1.1.4. 
In Vitro and In Vivo Evaluation of OX40 ...................................................................24 
1.1.5. 
Clinical Experience With OX40 Agonists ..................................................................25 
1.2. 
Overview of INCAGN01949 ......................................................................................26 
1.2.1. 
Pharmacology of INCAGN01949 ..............................................................................26 
1.2.2. 
Pharmacokinetics of INCAGN01949 .........................................................................26 
1.2.3. 
Preclinical Safety and Potential Risks of INCAGN01949 .........................................27 
1.3. 
Study Rationale ...........................................................................................................28 
1.3.1. 
Rationale for the Safe Starting Dose of INCAGN01949 ............................................28 
1.3.2. 
Rationale for Subject Population in Part 2 .................................................................30 
1.3.3. 
Rationale for the Study Endpoints ..............................................................................31 
1.3.3.1. 
Efficacy Endpoints ......................................................................................................31 
2. 
STUDY OBJECTIVES AND ENDPOINTS ..............................................................33 
2.1. 
Study Objectives .........................................................................................................33 
2.1.1. 
Primary Objective .......................................................................................................33 
2.1.2. 
Secondary Objectives .................................................................................................33 
 
33 
2.2. 
Study Endpoints ..........................................................................................................33 
2.2.1. 
Primary Endpoint ........................................................................................................33 
2.2.2. 
Secondary Endpoints ..................................................................................................33 
 
34 
3. 
SUBJECT ELIGIBILITY ...........................................................................................35 
3.1. 
Subject Inclusion Criteria ...........................................................................................35 
3.2. 
Subject Exclusion Criteria ..........................................................................................36 
4. 
INVESTIGATIONAL PLAN .....................................................................................39 


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4.1. 
Overall Study Design ..................................................................................................39 
4.1.1. 
Part 1 ...........................................................................................................................40 
4.1.1.1. 
Dose Escalation ..........................................................................................................40 
4.1.1.2. 
Safety Expansion ........................................................................................................41 
4.1.2. 
Part 2 ...........................................................................................................................41 
4.2. 
Measures Taken to Avoid Bias ...................................................................................42 
4.3. 
Number of Subjects ....................................................................................................43 
4.3.1. 
Planned Number of Subjects ......................................................................................43 
4.3.2. 
Replacement of Subjects .............................................................................................43 
4.4. 
Duration of Treatment and Subject Participation .......................................................43 
4.5. 
Overall Study Duration ...............................................................................................43 
4.6. 
Study Termination ......................................................................................................43 
5. 
TREATMENT ............................................................................................................44 
5.1. 
Treatment Assignment ................................................................................................44 
5.1.1. 
Subject Numbering and Treatment Assignment .........................................................44 
5.1.2. 
Randomization and Blinding ......................................................................................44 
5.2. 
INCAGN01949 ...........................................................................................................44 
5.2.1. 
Description and Administration ..................................................................................44 
5.2.2. 
Supply, Packaging, and Labeling ...............................................................................44 
5.2.3. 
Storage ........................................................................................................................45 
5.3. 
Treatment Compliance ................................................................................................45 
5.4. 
Treatment Interruptions and Adjustments ..................................................................45 
5.4.1. 
Dose Modifications .....................................................................................................45 
5.4.2. 
Dose-Limiting Toxicity and Determination of Maximum Tolerated Dose ................45 
5.4.3. 
Management of Dose-Limiting Toxicities or Other Urgent Situations ......................47 
5.4.4. 
Follow-Up of Dose-Limiting Toxicities .....................................................................47 
5.4.5. 
Procedures for Cohort Review and Dose Escalation ..................................................47 
5.4.6. 
Criteria and Procedures for Dose Interruptions and Adjustments of Study 
Drug ............................................................................................................................47 
5.4.7. 
Definition, Procedures, and Supportive Care Guidelines for Immune-Related 
Adverse Events ...........................................................................................................48 
5.4.8. 
Management of Infusion Reactions ............................................................................49 
5.4.9. 
Criteria for Permanent Discontinuation of Study Drug ..............................................51 


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5.4.10. 
Treatment After Initial Evidence of Radiologic Disease Progression ........................51 
5.5. 
Withdrawal of Subjects From Study Treatment .........................................................51 
5.5.1. 
Withdrawal Criteria ....................................................................................................51 
5.5.2. 
Withdrawal Procedures ...............................................................................................52 
5.6. 
Concomitant Medications ...........................................................................................53 
5.6.1. 
Permitted Medications ................................................................................................53 
5.6.2. 
Restricted Medications ...............................................................................................53 
5.6.3. 
Prohibited Medications ...............................................................................................53 
6. 
STUDY ASSESSMENTS ..........................................................................................54 
6.1. 
Screening ....................................................................................................................60 
6.2. 
Treatment ....................................................................................................................60 
6.3. 
End of Treatment ........................................................................................................60 
6.4. 
Follow-Up ...................................................................................................................61 
6.4.1. 
Safety Follow-Up ........................................................................................................61 
6.4.2. 
Disease Status Follow-Up ...........................................................................................61 
6.5. 
End of Study ...............................................................................................................61 
6.6. 
Unscheduled Visits .....................................................................................................61 
7. 
CONDUCT OF STUDY ASSESSMENTS AND PROCEDURES ...........................62 
7.1. 
Administration of Informed Consent Form ................................................................62 
7.2. 
Interactive Response Technology Procedure ..............................................................62 
7.3. 
Demography and Medical History ..............................................................................62 
7.3.1. 
Demographics and General Medical History .............................................................62 
7.3.2. 
Disease Characteristics and Treatment History ..........................................................62 
7.4. 
Prior and Concomitant Medications and Procedures ..................................................63 
7.5. 
Poststudy Anticancer Therapy Status .........................................................................63 
7.6. 
Safety Assessments .....................................................................................................63 
7.6.1. 
Adverse Events ...........................................................................................................63 
7.6.2. 
Physical Examinations ................................................................................................63 
7.6.2.1. 
Comprehensive Physical Examination .......................................................................63 
7.6.2.2. 
Targeted Physical Examination ..................................................................................64 
7.6.3. 
Vital Signs ..................................................................................................................64 
7.6.4. 
Electrocardiograms .....................................................................................................64 
7.6.5. 
Laboratory Assessments .............................................................................................65 


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7.6.5.1. 
Pregnancy Testing ......................................................................................................65 
7.6.5.2. 
Hepatitis Screening Tests ...........................................................................................65 
7.7. 
Efficacy Assessments .................................................................................................66 
7.7.1. 
Modified RECIST v1.1 Assessment of Disease .........................................................66 
7.7.1.1. 
Tumor Imaging ...........................................................................................................67 
7.8. 
Performance and Quality-of-Life Assessments ..........................................................68 
7.9. 
Pharmacokinetic Assessments ....................................................................................68 
7.9.1. 
Blood Sample Collection ............................................................................................68 
7.9.2. 
Pharmacokinetic Analysis ..........................................................................................69 
 
69 
 
70 
 
70 
 
70 
 
71 
 
71 
 
71 
 
71 
 
71 
 
71 
 
73 
7.11. 
Other Study Procedures ..............................................................................................73 
7.11.1. 
Distribution of Subject Reminder Cards .....................................................................73 
8. 
SAFETY MONITORING AND REPORTING .........................................................73 
8.1. 
Adverse Events ...........................................................................................................73 
8.1.1. 
Definitions ..................................................................................................................73 
8.1.2. 
Reporting ....................................................................................................................73 
8.2. 
Laboratory Test Abnormalities ...................................................................................75 
8.3. 
Serious Adverse Events ..............................................................................................75 
8.3.1. 
Definitions ..................................................................................................................75 
8.3.2. 
Reporting ....................................................................................................................76 
8.4. 
Emergency Unblinding of Treatment Assignment .....................................................77 
8.5. 
Pregnancy ...................................................................................................................77 
8.6. 
Warnings and Precautions ..........................................................................................77 


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8.7. 
Data Monitoring Committee .......................................................................................78 
8.8. 
Immune-Related Adverse Events ...............................................................................78 
8.9. 
Product Complaints ....................................................................................................78 
9. 
STATISTICS ..............................................................................................................79 
9.1. 
Study Populations .......................................................................................................79 
9.2. 
Selection of Sample Size ............................................................................................79 
9.2.1. 
Sample Size in Part 1 ..................................................................................................79 
9.2.2. 
Sample Size in Part 2 ..................................................................................................79 
9.3. 
Level of Significance ..................................................................................................79 
9.4. 
Statistical Analyses .....................................................................................................80 
9.4.1. 
Efficacy Analyses .......................................................................................................80 
9.4.1.1. 
Primary Efficacy Analyses .........................................................................................80 
9.4.1.2. 
Secondary Efficacy Analyses .....................................................................................80 
9.4.1.3. 
Other Efficacy Analyses .............................................................................................80 
9.4.2. 
Safety Analyses ..........................................................................................................80 
9.4.2.1. 
Adverse Events ...........................................................................................................80 
9.4.2.2. 
Clinical Laboratory Tests ...........................................................................................81 
9.4.2.3. 
Vital Signs ..................................................................................................................81 
9.4.2.4. 
Electrocardiograms .....................................................................................................81 
9.4.3. 
Pharmacokinetic Analysis ..........................................................................................82 
 
82 
9.5. 
Analyses for the Data Monitoring Committee ............................................................82 
9.6. 
Interim Analysis ..........................................................................................................82 
10. 
ETHICAL CONSIDERATIONS AND ADMINISTRATIVE 
PROCEDURES ..........................................................................................................84 
10.1. 
Investigator Responsibilities .......................................................................................84 
10.2. 
Accountability, Handling, and Disposal of Study Drug .............................................85 
10.3. 
Data Management .......................................................................................................86 
10.4. 
Data Privacy and Confidentiality of Study Records ...................................................86 
10.5. 
Financial Disclosure ...................................................................................................87 
10.6. 
Publication Policy .......................................................................................................87 
11. 
REFERENCES ...........................................................................................................88 


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APPENDIX A. INFORMATION REGARDING EFFECTIVENESS OF 
CONTRACEPTIVE METHODS ...............................................................................92 
APPENDIX B. PROCEDURES AND SUPPORTIVE CARE GUIDELINES FOR 
SUBJECTS EXHIBITING IMMUNE-RELATED ADVERSE EVENTS ................93 
APPENDIX C. EASTERN COOPERATIVE ONCOLOGY GROUP 
PERFORMANCE STATUS .......................................................................................99 
 
LIST OF TABLES 
Table 1: 
Summary of In Vitro Pharmacology Data to Support the Safe Starting Dose 
of INCAGN01949 ......................................................................................................29 
Table 2: 
INCAGN01949 Dose Levels and Cohort ...................................................................41 
Table 3: 
Definition of Dose-Limiting Toxicity ........................................................................46 
Table 4: 
Rules for Interruption and Restarting of Study Drug .................................................48 
Table 5: 
Supportive Care Guidelines for Subjects Exhibiting Immune-Related 
Adverse Events ...........................................................................................................49 
Table 6: 
INCAGN01949 Infusion Reaction Treatment Guidelines .........................................50 
Table 7: 
Schedule of Assessments ............................................................................................55 
Table 8: 
Schedule of Laboratory Assessments .........................................................................57 
Table 9: 
Schedule of Pharmacokinetic 
 Assessments ..........................58 
Table 10: Local Laboratory Tests:  Required Analytes ..............................................................59 
Table 11: Timing of Triplicate Electrocardiograms ...................................................................65 
Table 12: Imaging and Treatment After First Radiologic Evidence of Progressive 
Disease ........................................................................................................................66 
Table 13: Timing of Pharmacokinetic 
 Sample Collection ...................69 
 
 
72 
Table 15: Criteria for Clinically Notable Vital Sign Abnormalities ...........................................81 
Table 16: Criteria for Clinically Notable Electrocardiogram Abnormalities .............................82 
Table 17: Probability of Dose Escalation by DLT Rate for 3 + 3 Design and Safety 
Expansion ...................................................................................................................83 
Table 18: Probability of Early Termination at Stage 1 for Simon 2-Stage Design ....................83 
 


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LIST OF FIGURES 
Figure 1: 
Tumor-Infiltrating Lymphocytes Expression of OX40 ..............................................31 
Figure 2: 
Study Design ...............................................................................................................42 
 


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LIST OF ABBREVIATIONS 
The following abbreviations and special terms are used in this clinical study Protocol. 
Abbreviation 
Definition 
ADA 
antidrug antibody 
ADCC 
antibody-dependent cell-mediated cytotoxicity 
ADCP 
antibody-dependent cell-mediated phagocytosis 
AE 
adverse event 
aPTT 
activated partial thromboplastin time 
CA-125 
cancer antigen 125 
CFR 
Code of Federal Regulations 
CNS 
central nervous system 
CR 
complete response 
CRA 
cytokine release assays 
CRS 
cytokine release syndrome 
CT 
computed tomography 
CTCAE 
Common Terminology Criteria for Adverse Events 
CTLA-4 
cytotoxic T lymphocyte–associated protein 4 
DLT 
dose-limiting toxicity 
DNA 
deoxyribonucleic acid 
ECG 
electrocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
eCRF 
electronic case report form 
EDC 
electronic data capture 
EOT 
end of treatment 
FcγR 
Fc-gamma receptor 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
GI 
gastrointestinal 
GLP 
Good Laboratory Practice 
GM-CSF 
granulocyte macrophage colony–stimulating factor 
HBV 
hepatitis B virus 
HCV 
hepatitis C virus 
HDL 
high-density lipoprotein 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
HIV 
human immunodeficiency virus 
ICF 
informed consent form  


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Abbreviation 
Definition 
ICH 
International Conference on Harmonisation 
IEC 
independent ethics committee 
IFN 
interferon 
IgG 
immunoglobulin G 
IL 
interleukin 
IN 
Investigator Notification 
INR 
international normalized ratio 
irAE 
immune-related adverse event 
IRB 
institutional review board 
IRT 
interactive response technology 
IV 
intravenous 
LDL 
low-density lipoprotein 
mAb 
monoclonal antibody 
MABEL 
minimum anticipated biological effect level 
MedDRA 
Medical Dictionary for Regulatory Activities 
MNTD 
maximum number of tolerated doses 
mRECIST 
modified Response Evaluation Criteria in Solid Tumors 
MRI 
magnetic resonance imaging 
MSI 
microsatellite instability 
MTD 
maximum tolerated dose 
NCCN 
National Comprehensive Cancer Network 
NCI 
National Cancer Institute 
NF-κB 
nuclear factor kappa-light-chain-enhancer of activated B cells 
NK 
natural killer 
NOAEL 
no-observed-adverse-effect level 
NSAID 
nonsteroidal anti-inflammatory drug 
NSCLC 
non–small cell lung cancer 
PAD 
pharmacologically active dose 
PCP 
pneumocystis pneumonia 
 
 
PD-1 
programmed cell death protein 
PFS 
progression-free survival 
PK 
pharmacokinetic 
PR 
partial response 
PT 
prothrombin time 
RCC 
renal cell carcinoma 


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Abbreviation 
Definition 
RECIST 
Response Evaluation Criteria in Solid Tumors 
RNA 
ribonucleic acid 
SAE 
serious adverse event 
SD 
stable disease 
SSD 
safe starting dose 
SUSAR 
suspected unexpected serious adverse reaction 
TCR 
T-cell receptor 
TEAE 
treatment-emergent adverse event 
TNF 
tumor necrosis factor 
TNFR 
tumor necrosis factor receptor 
Treg 
regulatory T cell 
ULN 
upper limit of normal 


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1. 
INTRODUCTION 
This is an open-label, nonrandomized, Phase 1/2 study to determine the safety and tolerability, 
define the maximum tolerated dose (MTD) or pharmacologically active dose (PAD), and assess 
the preliminary efficacy of INCAGN01949.  Part 1 will utilize a 3 + 3 design to determine the 
PAD and/or MTD of INCAGN01949 in subjects with advanced or metastatic solid tumors.  An 
optional safety expansion may also be initiated in Part 1, which would enroll cohorts to evaluate 
dose(s) and schedule(s) equivalent to or less than the highest dose determined to be safe in the 
Part 1 dose escalation.  Part 2 will further evaluate the safety, tolerability, preliminary efficacy, 
pharmacokinetics (PK), and pharmacologic activity of INCAGN01949 in subjects with advanced 
or metastatic adenocarcinoma of the endometrium, ovarian cancer, renal cell carcinoma (RCC), 
melanoma, or non–small cell lung cancer (NSCLC).  A Simon 2-stage design will be used with a 
stopping rule to allow for early termination of a particular cohort at the end of Stage 1 if 
insufficient responses observed. 
1.1. 
Background 
1.1.1. 
The Role of the Immune System in Cancer 
The immune system comprises diverse sets of cells designed to protect a host from pathogens 
while distinguishing host from foreign antigens.  This immune response is controlled by a series 
of checks and balances to allow for robust immune responses to pathogens while preventing 
either an excessive inflammatory event or an autoimmune response.  Through immune 
surveillance, the immune system has been shown to recognize, attack, and destroy tumor cells 
(Wolchok and Saenger 2008).  The presence of tumor-infiltrating lymphocytes in cancer tissue 
among various malignancies has been shown to confer a more favorable prognosis (Mei et al 
2014, Salgado et al 2015, Gooden et al 2011, Schreiber et al 2011, Bremnes et al 2011, 
Talmadge 2011, Shirabe et al 2010, Nosho et al 2010, Bellati et al 2009, Oble et al 2009, 
Uppaluri et al 2008).  Detailed analysis of CD8+ T cells and the ratio of CD8+ effector T 
cells/forkhead box P3 (FoxP3)+ regulatory T cells (Tregs) seem to correlate with improved 
prognosis and long-term survival in many solid tumors (Nosho et al 2010, Chang et al 2014, 
Preston et al 2013, Yoon et al 2012, Kim et al 2013, Mathai et al 2012, Liu et al 2011, 
Kirk 2010).  Although the immune system has been shown to recognize and reject a tumor, 
many tumors evade immune surveillance or develop mechanisms of resistance. 
Histologic evaluation of multiple human cancers show extensive infiltration by inflammatory 
and immune cells (Galon et al 2006), suggesting that the immune system responds less 
effectively to malignancy.  As tumors grow, an "equilibrium" is reached where tumor growth is 
matched by immune-mediated tumor destruction.  Eventually, malignant cells either accumulate 
mutations, making them nonimmunogenic, or immunosuppressive pathways become activated, 
allowing the tumor to escape immune recognition (DuPage et al 2012, Schreiber et al 2011, 
Dunn et al 2002, Matsushita et al 2012).  The accumulation of suppressive cells and an inhibitory 
cytokine milieu in and around a tumor can form an immunosuppressive environment that 
prevents successful T-cell–mediated destruction of malignant cells (Schaer et al 2011).  
Overcoming tumor resistance to immune surveillance either through stimulating the immune 
response or preventing inhibition is the basic rationale for the development of immunotherapies. 


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Targeting the immune system is a proven and effective approach for cancer therapies.  Food and 
Drug Administration– and EU-approved checkpoint inhibitors, such as ipilimumab, nivolumab, 
and pembrolizumab, allow for the immune response to continue to proliferate in spite of 
inhibitory signals.  The activation of costimulatory pathways through OX40 is another promising 
treatment approach and is the focus of this clinical trial. 
1.1.2. 
Immune Modulators 
Immune cell receptors known as checkpoint modulators (collectively known as immune 
modulators) provide a critical mechanism for the regulation of an immune response.  Checkpoint 
modulation can either diminish an inflammatory process or escalate an immune response.  
Modulation of coinhibitory and costimulatory receptors of the immune system has become a 
proven approach for the immunotherapy of cancer (Chen and Mellman 2013). 
The development of fully human antibodies that target and modulate immune receptors in 
humans have led to the discovery of multiple validated targets for the immunotherapy of cancer 
(Chen and Mellman 2013, Leach et al 1996).  Antibodies that engage the various checkpoint 
modulators can broadly be classified into 2 categories based on mechanism of 
action:  antagonists (blocking the interaction between receptor and cognate ligand[s]), and 
agonists (inducing or facilitating receptor-forward signaling).  Clinical testing of therapeutic 
antibodies has demonstrated their ability to influence the direction and magnitude of the immune 
responses, leading to tumor eradication (Yao et al 2013).  The blocking of coinhibitory receptors 
such as cytotoxic T lymphocyte–associated protein 4 (CTLA-4) or programmed cell death 
protein 1 (PD-1) blockade are the basis of FDA-approved therapies to augment an antitumor 
immune response.  Clinical and preclinical research has demonstrated a rationale for targeting 
costimulatory receptors within the tumor necrosis factor super family (Schaer et al 2013). 
1.1.3. 
OX40 and the Tumor Necrosis Factor Super Family 
OX40 (CD134) is a member of the tumor necrosis factor receptor (TNFR) superfamily.  Other 
members of the TNFR superfamily include CD40, CD27, FAS, DR3, GITR, and 4-1BB.  The 
regulation of the activation, proliferation, or apoptosis of lymphocytes is a common function of 
members of this family (Weinberg et al 2000).   
OX40 is a 227 amino acid protein that has a cytoplasmic tail, a transmembrane domain, and an 
extracellular region that contains 3 complete and 1 truncated cysteine-rich domains (Jensen et al 
2010, Croft et al 2010).  OX40L (also known as CD252) is thought to be the only ligand for 
OX40 and is thought to only bind to OX40 (Croft et al 2010). 
Expression of OX40 has been observed on activated T cells, including CD4+ T cells, CD8+ T 
cells, and Tregs (Weinberg et al 2011).  OX40 expression is up-regulated on the surface of T 
cells after T-cell receptor (TCR) engagement and costimulation through CD28 or the presence of 
inflammatory cytokines, including interleukin (IL) 1, IL-2, and tumor necrosis factor (TNF)-α 
(Weinberg et al 2000, Jensen et al 2010).  Following antigen activation of naive T cells, OX40 
expression occurs between 24 hours and 4 to 5 days following TCR engagement.  The 
upregulation of OX40 on memory T cells after the rechallenge of antigen occurs much more 
rapidly (within 4 hours) compared to naive T cells (Jensen et al 2010, Croft et al 2009, 
Gramaglia et al 1998).   


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Several groups have demonstrated that OX40 is expressed on T cells in the tumor 
microenvironment.  In samples surgically obtained from patients with breast cancer, OX40 
expressing T cells were observed in areas surrounding tumor cells, and those cells were thought 
to be tumor-specific T cells (Weinberg et al 2000).  Other groups have shown that OX40+ T cells 
are present in samples from patients with melanoma, head and neck cancer, breast cancer, and 
colon cancer (Petty et al 2002, Ladányi et al 2004, Weinberg et al 2000, Vetto et al 1997).  In 
addition, it is thought that the proportion of OX40+ T cells may correlate with improved survival 
(Petty et al 2002, Ladányi et al 2004).   
OX40L is mainly expressed on antigen presenting cells that include B cells, dendritic cells, 
endothelial cells, and macrophages (Weinberg et al 2000).  OX40L is not expressed at high 
levels in noninflamed tissues, but is observed at sites of active autoimmune disease.  To date, 
OX40L has not been identified within the tumor microenvironment (Gough et al 2008, 
Weinberg et al 2011). 
Given its role in immune activation, targeting OX40 with an agonistic antibody would be 
expected to enhance the response of memory and effector T cells to tumor-specific antigens.  The 
use of an antibody with antibody-dependent cell-mediated cytotoxicity (ADCC) capabilities may 
also selectively deplete Tregs (Gonzalez et al 2016, Bulliard et al 2013).  Therefore the use of an 
anti-OX40 monoclonal antibody (mAb) with both agonistic and ADCC properties may be 
beneficial in boosting the immune response to malignant cells within the body.  This hypothesis 
will be tested in this study. 
1.1.4. 
In Vitro and In Vivo Evaluation of OX40 
Several groups have explored the function of OX40 using both in vitro and in vivo models.  
OX40 signaling has been shown to promote T cell division and survival, suppress the 
differentiation of Tregs, and modulate cytokine production and signaling.  One way this is 
thought to occur is that OX40L binding to the OX40 receptor results in intracellular recruitment 
of TNFR-associated molecules which then activates the nuclear factor 
kappa-light-chain-enhancer of activated B cells (NF-κB) pathway known to be important in cell 
survival (Jensen et al 2010).  This is consistent with the observation that OX40 receptor 
engagement has been shown to increase survival, cytokine production, and migration of CD4+ T 
cells, increase granzyme B, interferon (IFN) γ, perforin production of CD8+ T cells, and increase 
proliferation and overcome the anergic state in both CD4+ and CD8+ T cells (Moran et al 2013, 
Weinberg et al 2000). 
Murine studies have shown that OX40 agonists promote tumor-specific memory T-cell 
expansion leading to rejection of tumor growth after inoculation with 4 different tumor cell lines   
(Weinberg et al 2000).  Subsequent experiments performed in mice with established tumors 
showed that administration of an OX40 agonist led to an increase in the number of CD8+ T cells 
at the tumor site (Gough et al 2008).  This combined with the lack of OX40L expression in the 
tumor environment indicates that there is a lack of OX40 signaling in the tumor 
microenvironment and provides additional rationale for OX40 agonist therapy in cancer. 
While a contributing factor to the improved proportion of CD8+ T cells to Tregs is likely the 
activation and proliferation of CD8+ T cells after OX40 engagement, the role of Treg depletion 
must also be considered.  Several studies have shown that OX40 expression is highest in the 
population of Treg cells within a tumor (Bulliard et al 2014, Marabelle et al 2013).  OX40 has 


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been shown to inhibit the suppressing ability of Tregs (Kroemer et al 2007, Valzasina et al 
2005).  OX40 has been shown to suppress Treg development and function in vitro and in in vivo 
studies the population of CD4+CD25+FoxP3+ Treg cells was decreased following treatment 
with an OX40 agonist (Gough et al 2008).  Bulliard et al (2014) demonstrated that the 
administration of an agonistic anti-OX40 mAb induced the depletion of Tregs via an Fc gamma 
receptor (FcγR)-mediated ADCC/antibody-dependent cell-mediated phagocytosis (ADCP) 
manner.  Experiments performed in mice showed that this mechanism contributed to the control 
of tumor growth in mice (Bulliard et al 2014).   
1.1.5. 
Clinical Experience With OX40 Agonists 
Curti et al (2013) developed a 9B12 murine anti-human OX40 mAb and tested this antibody in a 
Phase 1 dose-escalation study.  Thirty subjects with metastatic solid tumors that were refractory 
to conventional therapy were enrolled and administered doses of anti-OX40 mAb at 0.1 mg/kg, 
0.4 mg/kg, or 2 mg/kg on Days 1, 3, and 5 of the study.  The murine origin of the antibody 
precluded further administration of this agent.  Results of this study showed that the OX40 
agonist was well-tolerated, with observed toxicities mostly Grade 1 or Grade 2.  Events of 
Grade 3 and Grade 4 lymphopenia were observed; however, the lymphopenia that was seen 
typically resolved by Day 15 or Day 28 in a dose-dependent manner.  The most common adverse 
events (AEs) reported were lymphopenia, fatigue, rash, and flu-like symptoms with fever and 
chills.  The MTD was not reached for this mAb.  Tumor shrinkage or stable disease (SD) was 
seen in subjects with melanoma, renal cell cancer, squamous cell carcinoma of the urethra, 
prostate cancer, and cholangiocarcinoma, including 1 subject with renal cell cancer that had SD 
for 470 days. 
Correlative studies used Ki-67 to identify proliferating T cells after treatment with the OX40 
mAb.  Following treatment, the percentage of Ki-67+CD4+ T cells increased by Day 8 and 
Ki-67+CD8+ T cells increased by Day 15.  Compared with the controls, numbers of 
CD4+/FoxP3- T cells, CD8+ T cells, and CD3-/natural killer (NK) cells were significantly 
increased; however, the number of CD4+/FoxP3+ Treg was unchanged.  Additional studies 
showed that treatment with the OX40 mAb increased proliferation and activation of CD8+ 
T cells.  The T cell population of subjects who had some benefit (an initial decrease or 
stabilization of their disease) were compared with those considered initial progressors, and an 
increase was seen in Ki-67+ CD4+/FoxP3- and CD8+ T lymphocytes of those subjects who 
benefited from this treatment.  This study shows evidence that OX40 agonists may provide 
benefit to subjects with late stage metastatic disease and that treatment with these agents may 
have long term effects on the T cell population (Curti et al 2013).  
Clinical data of a humanized IgG1 anti-OX40 agonistic mAb (MOXR0916) were described at 
the AACR annual meeting (Hansen et al 2016).  MOXR0916 was administered to 70 subjects 
with a variety of solid tumors within a dose-escalation study (standard 3 + 3 design with doses 
ranging from 0.2 to 1200 mg).  No dose-limiting toxicities (DLTs) were observed; there were no 
study-related deaths, and there were no drug-related Grade 4 AEs.  On-study paired biopsies 
evaluating the tumor microenvironment pre- and post-treatment revealed increases in CD8 T-cell 
infiltration, upregulation in gene expression of T effector cells, and increased PD-L1 expression 
in some subjects, which may reflect an increase in IFN-γ.  Two objective responses were 
reported, both in subjects with previously treated RCC. 


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1.2. 
Overview of INCAGN01949 
1.2.1. 
Pharmacology of INCAGN01949 
INCAGN01949 is a fully human IgG1κ mAb being developed for the treatment of advanced 
malignancies.  INCAGN01949 binds selectively to the extracellular domain of human OX40 
with an estimated affinity (KD) of 0.12 nM and does not bind to related TNFR super family 
members.  INCAGN01949 functions as an OX40 agonist antibody in human cells, activating 
NF-κB signaling, and providing T-cell costimulation in the context of suboptimal TCR 
activation.  Similar to its effects on human T cells, INCAGN01949 binds to cynomolgus monkey 
OX40 with less than 2-fold difference in relative affinity and enhances cynomolgus monkey 
T-cell function under suboptimal TCR stimulatory conditions in cell-based assays.  
INCAGN01949 does not cross-react with rodent OX40.  Therefore, the cynomolgus monkey 
nonhuman primate was considered a relevant species to evaluate the pharmacological and 
toxicological impact of INCAGN01949. 
Consistent with a human IgG1κ Fc region, INCAGN01949 binds to both recombinant and 
cell-expressed FcγRs. Co-engagement of FcγRs by INCAGN01949-labeled target cells triggers 
FcγRIIA and FcγRIIIA signaling and results in FcγR-mediated effector cell activity by a NK cell 
line, as measured by antibody-dependent cellular cytotoxicity.  Also consistent with an IgG1κ Fc 
region, INCAGN01949 binds to recombinant C1q, the first subcomponent of the C1 complex of 
the classical pathway of complement activation and shows evidence of complement-dependent 
cytotoxicity of OX40-expressing target cells.  A fresh human whole blood cytokine release assay 
(CRA) was used to evaluate the potential risk of INCAGN01949 eliciting adverse 
proinflammatory infusion reactions in soluble and complexed (plate-bound) formats.  At 
concentrations up to 100 μg/mL, INCAGN01949 demonstrates only modest induction of IL-6 
and does not induce other cytokines in whole blood that in vivo would be predictive of cytokine 
release syndrome (CRS) in patients.  Taken together, the pharmacologic properties of 
INCAGN01949 illustrate its suitability for clinical development in patients with advanced 
malignancies. 
1.2.2. 
Pharmacokinetics of INCAGN01949 
The PK of INCAGN01949 was characterized in cynomolgus monkeys after intravenous (IV) 
administration.  Following a single IV dose, the mean estimated terminal half-life was estimated 
to be 11.4 days; the mean clearance was estimated to be 0.23 mL/h/kg, and the mean volume of 
distribution was estimated to be 90.3 mL/kg.  In monkeys, exposures (AUC and Cmax) 
demonstrated a linear and dose-proportional increase.  No sex differences in the PK of 
INCAGN01949 were noted.  
Following weekly repeat dose administration from 0.5 to 100 mg/kg in monkeys, the mean Cmax 
and AUC values after the fourth dose were higher than after the first dose, reflecting 
accumulation of INCAGN01949.  The observed incidence of immunogenicity was low, with 
5 out of 46 monkeys with confirmed antidrug antibodies (ADA).  Monkeys with confirmed ADA 
exhibited decreased systemic exposures after repeated dosing.  However, the high plasma 
concentrations of INCAGN01949, especially at the higher dose levels, may have confounded the 
detection of ADA. 


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1.2.3. 
Preclinical Safety and Potential Risks of INCAGN01949 
A non-GLP repeated dose range finding toxicity study was conducted in cynomolgus monkeys 
(1 male/1 female) given weekly IV doses of INCAGN01949 (0 mg/kg, 0.5 mg/kg, 5 mg/kg, 
20 mg/kg, or 100 mg/kg) for 4 weeks (29 days).  There were no adverse treatment-related 
changes in clinical observations, body weight, food consumption, serum proinflammatory 
cytokines, peripheral blood immunophenotypes, immune cell activation markers, or clinical or 
anatomic pathology.  Thus, the no-observed-adverse-effect level (NOAEL) for this non-GLP 
dose range finding study was determined to be 100 mg/kg. 
A GLP repeat-dose toxicity study was conducted in cynomolgus monkeys that received an IV 
bolus injection of vehicle control or 1 of the 4 levels (0.5 mg/kg, 5 mg/kg, 20 mg/kg, or 
100 mg/kg) of INCAGN01949 once per week for 5 weeks followed by a 4-week recovery period 
(except for 0.5 mg/kg group).  There were no adverse treatment-related changes in physical 
examinations, ophthalmologic examinations, clinical observations, neurologic examinations, 
body weights, food consumption, electrocardiogram (ECG), clinical pathology (hematology, 
clinical chemistry, and urinalysis) serum proinflammatory cytokines, peripheral blood 
immunophenotypes, immune cell activation markers, or anatomic pathology. 
The NOAEL for this 4-week GLP repeat dose study with a 4-week recovery period was 
determined to be 100 mg/kg per dose.  This dose level corresponded to mean Cmax and AUC0-168h 
values of 2980 µg/mL and 221,000 µg·hr/mL, respectively, after the first dose in this study; and 
Cmax and AUC values of 4360 µg/mL and 457,000 µg·hr/mL, respectively, following the 
fourth dose (Day 22).  The estimated half-life was approximately 15 days. 
Antidrug antibodies were detected in 5 of 46 treated monkeys.  However, the high circulating 
plasma concentrations of INCAGN01949 at the time of the collection of the ADA samples may 
have confounded detection of ADA, as the bridging ELISA method had a plasma drug tolerance 
limit of 200 μg/mL.  Consequently, the negative ADA results at the higher INCAGN01949 dose 
levels (20 and 100 mg/kg) should be considered inconclusive. 
In a GLP tissue cross-reactivity study of the INCAGN01949 mAb, expected cell membrane and 
cytoplasmic staining was observed in resident, migrating, and/or infiltrating mononuclear cells in 
colon, esophagus, spleen, thymus, tonsil, ureter, and cervix. 
In summary, in the pivotal toxicity study, treatment of cynomolgus monkeys with 5 weekly 
doses of INCAGN01949 (at 0.5 mg/kg, 5 mg/kg, 20 mg/kg, or 100 mg/kg) was well-tolerated 
and did not reveal any relevant treatment-related effects up to the highest dose level (100 mg/kg), 
at the end of the 5-week treatment period, or after the 4-week recovery period.  Although not 
observed in the preclinical toxicology studies,  INCAGN01949 is a potential moderator of the 
immune system, and although no immune-related adverse events (irAEs) were observed in 
preclinical toxicology studies, investigative sites will be instructed to monitor for irAEs, which 
have been previously observed with other immunotherapies (see Section 5.4.7, Section 5.4.8, and 
Appendix B). 
In in vitro CRA, INCAGN01949 at concentrations up to 100 μg/mL did not induce the classic 
signature of CRS, which consists of the proinflammatory cytokines TNF-α, IFN-γ, and IL-6.  
Only modest increases in median IL-6 levels were observed at the highest concentrations of 
INCAGN01949 tested.  Interleukin 4, which has not been associated with CRS, was also 
modestly increased (median levels) but not related to dose.  These effects demonstrated 


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donor-to-donor variability, and the levels were lower than the comparator antibody 
alemtuzumab, an antibody previously associated with CRS in patients, suggesting that the 
changes may have limited value in predicting a potential safety risk for patients.  Increases in 
IL-8, IL-10, IFN-γ and TNF-α occurred in only a subset of donors (median values were 0) and 
were not related to dose; and thus, these too were considered to have limited value in predicting a 
potential safety risk for patients.  Given the variability in human donor-to-donor response in the 
CRA, these data must be interpreted with caution and may not be representative of CRS in 
patients administered INCAGN01949. 
Safety pharmacology assessments were incorporated into the 4-week GLP toxicity study in 
cynomolgus monkeys.  There were no INCAGN01949-related effects on clinical observations; 
physical examinations (abdominal palpation, observation of the integument, body temperature, 
heart rate, and respiratory rate); or neurologic (behavior, evaluation of motor function, cranial 
nerves, proprioception, postural reactions, and spinal nerves), ophthalmologic, or ECG 
parameters. 
1.3. 
Study Rationale 
1.3.1. 
Rationale for the Safe Starting Dose of INCAGN01949 
INCAGN01949 was characterized in a series of in vitro pharmacology assays.  The assays 
considered most physiologically relevant in the assessment of potential safety signals in humans, 
and to the determination of the safe starting dose (SSD), were those that assessed the impact of 
INCAGN01949 agonist activity using primary human T cells.  Similarly, the assays that 
evaluated the potential of INCAGN01949 to enhance T-cell cytokine modulation were 
considered to be most relevant to the assessment of proinflammatory cytokines in relation to 
potential CRS (Table 1). 
A minimum anticipated biological effect level (MABEL)-based approach is the basis for the 
determination of the SSD, and the EC30 closely approximates the MABEL.  Using the potency 
values obtained experimentally in the cytokine assays shown (Table 1), the mean EC30 is 
calculated to be 1.7 μg/mL. 
 
 


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Table 1: 
Summary of In Vitro Pharmacology Data to Support the Safe Starting Dose 
of INCAGN01949 
Assays 
n 
EC50 
(μg/mL) 
INCAGN01949-induced IL-2 secretion (with SEA antigen) 
5 
2.9 
INCAGN01949-induced human T cell IFN-γ and/or TNF-α production (with TCR) 
14 
6.1 
INCAGN01949-induced human TNF-β (supernatant; with TCR) 
9 
2.0 
INCAGN01949-induced human IL-2 (supernatant; with TCR) 
9 
6.7 
INCAGN01949-induced human GM-CSF (supernatant; with TCR) 
9 
2.0 
   
Average 
3.9 
Standard 
Deviation 
2.3 
Calculated EC30 (assuming slope of 1)a 
 
1.7 
EC30 value converted to dose (mg/kg) 
 
0.13 
GM-CSF = granulocyte macrophage colony–stimulating factor. 
a Based on TK (Cave) from 4-week study in cynomolgus monkeys - Steady state AUC0-168h (Day 22) = 
1120 μg∙hr/mL at 0.5 mg/kg (male); average concentration (Cave) = 1120 / (7 × 24 h) = 6.67 μg/mL.  Calculation 
based on male AUC only due to the impact of high ADA in females at 0.5 mg/kg (low AUC). 
The MABEL-based SSD of 0.1 mg/kg is approximately 300-fold lower than the NOAEL 
determined for the cynomolgus monkey and approximately 4.4-fold lower than an estimated 
PAD of 0.44 mg/kg (based on a mean EC50 for cytokine release of 3.9 µg/mL). 
The proposed SSD attempts to balance potential safety risks with the recognized obligation to 
provide an effective therapeutic dose to a patient with advanced malignancy.  This proposed SSD 
is expected to pose a low safety risk to humans based on the following key observations: 
• An absence of target organ toxicity, cytokine release or changes in immune cell 
populations in the 4-week GLP toxicity study in cynomolgus monkeys. 
• Absence of evidence for potential infusion reactions; assay of cytokine release 
without T-cell activation. 
• Absence of evidence for specific off-target tissue cross-reactivity in human tissues. 
• OX40 expression is restricted to activated T cells, with minimal to no detectable 
expression on peripheral T cell subsets.  Related to this, INCAGN01949 modulates 
T-cell function (e.g. cytokine responses) only in the context of TCR stimulation. 
Fixed dosing has several advantages over weight-based dosing, including convenience of 
preparation and administration, reducing errors in preparation calculations, and minimization of 
drug waste.  Body size–based dosing and fixed dosing of monoclonal antibodies have been 
evaluated with the 2 dosing approaches performing similarly, with body size–based dosing not 
always offering an advantage in reducing variability of exposure.  The authors of these studies 
concluded that either approach may be used in first-in-human studies and that fixed dosing is 
recommended in these studies due to the advantages discussed above (Wang et al 2009, 


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Bai et al 2012).  An average adult weight of 70 kg was used to convert weight-based dose levels 
to fixed doses.  The MABEL-based SSD of 0.13 mg/kg is rounded down to 0.1 mg/kg to achieve 
a starting dose of 7 mg (0.1mg/kg · 70 kg = 7 mg). 
1.3.2. 
Rationale for Subject Population in Part 2 
To further elucidate the effects of INCAGN01949, 5 different tumor types have been selected for 
investigation in Part 2.  Melanoma and NSCLC will be evaluated, because they are both 
immunogenic histologies that have been proven to respond to checkpoint inhibitors (CTLA-4 
and PD-1).  Experiments looked at the expression of OX40 on T effector cells and Tregs in 
samples from patients with endometrial cancer, RCC, ovarian cancer, and NSCLC.  Intratumoral 
Tregs had elevated OX40 expression, and to a lesser extent, T effector cells had elevated OX40 
expression as well.  Dissociated (frozen) primary tumor samples were analyzed by flow 
cytometry.  After gating on either CD4+CD25-Foxp3- (T effector cells) and 
CD4+CD25+Foxp3+ (Tregs), OX40 expression was analyzed, and a few representative 
experiments are shown in Figure 1. 
Based on these data, ovarian cancer, endometrial cancer, RCC, NSCLC, and melanoma will be 
further evaluated in disease-specific cohorts in Part 2 of this study.  A Simon 2-stage design will 
be used with a stopping rule to allow early termination of a particular cohort at the end of Stage 1 
if insufficient response is observed, and enough subjects will be enrolled to predict possible 
target responses (≥ 25%) worthy of cohort expansion and potentially for further evaluation in 
future studies (see Section 9.2.2). 


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Figure 1: 
Tumor-Infiltrating Lymphocytes Expression of OX40 
 
1.3.3. 
Rationale for the Study Endpoints 
1.3.3.1. 
Efficacy Endpoints 
Efficacy endpoints of this study are secondary and include objective response rate, duration of 
response, duration of disease control, and progression-free survival (PFS) by investigator 
assessment based on RECIST v1.1 and modified RECIST (mRECIST). 
1.3.3.1.1. Modified RECIST 
RECIST v1.1 will be adapted to account for the unique tumor response characteristics seen with 
immunotherapy (Chiou and Burotto 2015).  Immunotherapeutic agents may produce antitumor 
effects by potentiating endogenous cancer-specific immune responses.  The response patterns 
seen with such an approach may extend beyond the typical time course of responses seen with 
cytotoxic agents and can manifest a clinical response after an initial increase in tumor burden or 
even the appearance of new lesions.  Standard RECIST may not provide an accurate response 


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assessment of immunotherapeutic agents.  Therefore, RECIST v1.1 will be used with the 
following adaptations: 
If radiologic imaging shows initial progressive disease, then tumor assessment should be 
repeated at least 4 weeks but no later than 6 weeks later in order to confirm disease progression 
with the option of continuing treatment while awaiting radiologic confirmation of progression.   
In subjects who have initial evidence of radiological progression but are clinically stable as 
defined below, it is at the discretion of the treating physician whether to continue a subject on 
study drug until repeat imaging is obtained.  This clinical judgment decision should be based on 
the subject's overall clinical condition, including performance status, clinical symptoms, and 
laboratory data.  Subjects may receive treatment while waiting for confirmation of disease 
progression if they are clinically stable as defined by the following criteria: 
• Absence of clinically significant signs and symptoms indicating disease progression. 
• No decline in ECOG performance status. 
• Absence of rapid progression of disease. 
• Absence of progressive tumor at critical anatomical sites (eg, cord compression) 
requiring urgent alternative medical intervention. 
If repeat imaging shows < 20% tumor burden compared with nadir, stable or improved previous 
new lesion (if identified as cause for initial disease progression), and stable/improved nontarget 
disease (if identified as cause for initial disease progression), then treatment may be continued or 
resumed.  If repeat imaging confirms disease progression due to any of the scenarios listed 
below, then subjects will be discontinued from study therapy.  However, if a subject has 
confirmed radiographic progression (ie, 2 scans at least 4 weeks but no later than 6 weeks apart 
demonstrating progression) per mRECIST, but the subject is achieving a clinically meaningful 
benefit, then an exception to continue treatment may be considered after consultation with the 
medical monitor.  Clinically stable subjects at the confirmatory scan should also have no further 
increase in the target lesions, no unequivocal increase in nontarget lesions, and no additional new 
lesions develop (nonworsening disease progression) to continue study treatment (see 
Section 7.7.1). 
In determining whether or not the tumor burden has increased or decreased, site study teams 
should consider all target lesions as well as nontarget lesions (refer to RECIST v1.1 guidelines). 
Scenarios where disease progression is confirmed at repeat imaging include the following: 
• Tumor burden remains ≥ 20% and at least 5 mm absolute increase compared with 
nadir. 
• Nontarget disease resulting in initial disease progression is worse (qualitative). 
• New lesion resulting in initial disease progression is worse (qualitative). 
• Additional new lesion(s) are found since last evaluation. 
When feasible, subjects should not be discontinued until progression is confirmed.  This 
allowance to continue treatment despite initial radiologic progression takes into account the 
observation that some subjects can have a transient tumor flare in the first few months after the 


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start of immunotherapy, but with subsequent disease response.  Subjects who are deemed 
clinically unstable are not required to have repeat imaging for confirmation of disease 
progression. 
2. 
STUDY OBJECTIVES AND ENDPOINTS 
2.1. 
Study Objectives 
2.1.1. 
Primary Objective 
• To evaluate the safety, tolerability, and DLTs of INCAGN01949 and to define a 
MTD or PAD of INCAGN01949 in subjects with metastatic or advanced solid 
tumors. 
2.1.2. 
Secondary Objectives 
• To evaluate the PK of INCAGN01949 in subjects with advanced or metastatic solid 
tumors. 
• To evaluate the preliminary efficacy of INCAGN01949 by assessing the objective 
response rate, duration of response, PFS, and duration of disease control per RECIST 
v1.1 and mRECIST v1.1. 
2.2. 
Study Endpoints 
2.2.1. 
Primary Endpoint 
• Safety and tolerability will be assessed by monitoring the frequency, duration, and 
severity of AEs. 
2.2.2. 
Secondary Endpoints 
• The PK of INCAGN01949, including Cmax, Tmax, Cmin, and AUC0-t for subjects in 
Parts 1 and 2 will be summarized. 
• Objective response rate, defined as the percentage of subjects having complete 
response (CR) or PR, will be determined by investigator assessment of radiographic 
disease per RECIST v1.1 and mRECIST v1.1. 


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• Duration of response, defined as the time from earliest date of disease response (CR 
or PR) until earliest date of disease progression, will be determined by investigator 
assessment of radiographic disease per RECIST v1.1 and mRECIST v1.1, or death 
from any cause, if occurring sooner than progression. 
• Progression-free survival, defined as the time from date of first dose of study drug 
until the earliest date of disease progression, as determined by investigator assessment 
of objective radiographic disease per RECIST v1.1 and mRECIST v1.1, or death 
from any cause if occurring sooner than progression. 
• Duration of disease control, (CR, PR, and SD), as measured from first report of SD or 
better until disease progression, will be determined by investigator assessment of 
radiographic disease per RECIST v1.1 and mRECIST v1.1, or death from any cause, 
if occurring sooner than progression. 


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3. 
SUBJECT ELIGIBILITY 
Deviations from eligibility criteria are not allowed because they can potentially jeopardize the 
scientific integrity of the study, regulatory acceptability, and/or subject safety.  Therefore, 
adherence to the criteria as specified in the Protocol is essential. 
3.1. 
Subject Inclusion Criteria 
A subject who meets all of the following criteria may be included in the study: 
1. Men and women, aged 18 or older. 
2. Willingness to provide written informed consent for the study. 
3. Locally advanced or metastatic disease; locally advanced disease must not be amenable 
to resection with curative intent. 
4. Subjects who have disease progression after treatment with available therapies that are 
known to confer clinical benefit, or who are intolerant to treatment, or who refuse 
standard treatment.  There is no limit to the number of prior treatment regimens. 
5. Part 1:  Subjects with advanced or metastatic solid tumors. 
6. Part 2:  Subjects with advanced or metastatic adenocarcinoma of the endometrium, 
ovarian cancer, RCC, melanoma, and NSCLC. 
a. For subjects with adenocarcinoma of the endometrium:  should have documented 
microsatellite instability (MSI) status (eg, MSI-high, MSI-low, microsatellite stable), 
or consent to MSI status testing during the screening period.   
Note:  MSI-high is defined by instability in ≥ 30% of examined microsatellites.  
MSI-low is defined by instability of < 30% of examined microsatellites.  
Microsatellite stable is defined by no instability. 
b. For subjects with ovarian cancer:  histologically confirmed diagnosis of ovarian, 
fallopian, or primary peritoneal carcinoma of epithelial origin. 
c. For subjects with NSCLC (squamous and nonsquamous):  should have documentation 
of driver mutation testing for anaplastic lymphoma kinase, epidermal growth factor 
receptor status, BRAF mutation status, or consent to testing for these markers during 
the screening period. 
d. For subjects with RCC:  must have histologically confirmed diagnosis of RCC that is 
predominantly clear cell histology. 
e. For subjects with melanoma:  mucosal or cutaneous melanoma is acceptable; 
however, subjects with ocular melanoma are excluded.  Subjects should have 
documented BRAF mutation status or consent to BRAF mutation testing during the 
screening period. 
Note:  BRAF mutation status determined as part of a panel of genetic tests performed 
in a gene expression analysis will also satisfy the inclusion criterion for BRAF 
mutation testing. 


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7. Presence of measureable disease based on RECIST v1.1.  Tumor lesions situated in a 
previously irradiated area, or in an area subjected to other locoregional therapy, are not 
considered measureable unless there has been demonstrated progression in the lesion. 
8. Part 1 Safety Expansion and Part 2:  Willingness to undergo pretreatment and 
on-treatment tumor biopsies (core or excisional).   
Note:  A baseline biopsy obtained for other purposes (ie, not a Protocol-defined 
procedure) before signing consent may be utilized if the subject has not had any 
intervening systemic therapy from the time of the biopsy to the start of treatment (ie, 
Cycle 1 Day 1), and if a minimum of 20 slides or preferably 1 tissue block can be 
submitted. 
Note:  If a subject is scheduled to have a tumor biopsy for the purposes of this study and 
it is subsequently determined that tumor tissue cannot safely be obtained, then the subject 
may still enroll on the study.  The subject may be replaced within the cohort. 
Note:  For Part 1 Dose Escalation, pretreatment tumor biopsies are optional. 
9. ECOG performance status 0 or 1. 
10. Female subjects of childbearing potential (defined as women who have not undergone 
surgical sterilization with a hysterectomy and/or bilateral oophorectomy and are not 
postmenopausal, defined as ≥ 12 months of amenorrhea) must have a negative serum 
pregnancy test at screening.  All female subjects of childbearing potential must agree to 
take appropriate precautions to avoid pregnancy (with at least 99% certainty) from 
screening through 60 days after the last dose of study drug.  All male subjects must agree 
to take appropriate precautions to avoid pregnancy with a partner (with at least 99% 
certainty) from screening through 90 days after the last dose of study drug.  Permitted 
methods that are at least 99% effective in preventing pregnancy (see  
Appendix A) should be communicated to the subjects and their understanding confirmed. 
3.2. 
Subject Exclusion Criteria 
A subject who meets any of the following criteria will be excluded from the study: 
1. Laboratory and medical history parameters not within the Protocol-defined range.  If the 
screening laboratory tests below were conducted > 7 days before treatment initiation, 
they will need to be repeated on Day 1 before initiation of treatment. 
a. Absolute neutrophil count < 1.5 × 109/L. 
b. Platelets < 100 × 109/L. 
c. Hemoglobin < 9 g/dL or < 5.6 mmol/L. 
d. Serum creatinine > 1.5 × institutional upper limit of normal (ULN), OR measured or 
calculated creatinine clearance (glomerular filtration rate can also be used in place of 
creatinine or creatinine clearance) < 50 mL/min for subjects with creatinine levels 
> 1.5 × ULN. 
e. Aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase 
≥ 2.5 × ULN. 
Note: Subjects with 1) bone metastases and 2) no hepatic parenchymal metastases on 
screening radiographic examinations may enroll if the alkaline phosphatase 
≤ 5 × ULN.  Subjects with 1) bone metastases and/or 2) hepatic parenchymal 


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metastases on screening radiographic examinations may enroll if the alkaline 
phosphatase is ≤ 5 × ULN only with medical monitor approval. 
f. Total bilirubin ≥ 1.2 × ULN unless conjugated bilirubin ≤ ULN (conjugated bilirubin 
only needs to be tested if total bilirubin exceeds ULN).  If there is no institutional 
ULN, then direct bilirubin must be < 40% of total bilirubin. 
g. International normalized ratio, prothrombin time (PT), or activated partial 
thromboplastin time > 1.5 × ULN. 
2. Transfusion of blood products (including platelets or red blood cells) or administration of 
colony-stimulating factors (including granulocyte colony–stimulating factor, granulocyte 
macrophage colony–stimulating factor, or recombinant erythropoietin) within 14 days 
before study Day 1. 
3. Receipt of anticancer medications or investigational drugs within the following intervals 
before the first administration of study drug: 
a. ≤ 14 days for chemotherapy, targeted small molecule therapy, or radiation therapy.  
Subjects must also not require chronic use of corticosteroids and must not have had 
radiation pneumonitis as a result of treatment.  A 1-week washout is permitted for 
palliative radiation to non–central nervous system (CNS) disease with sponsor 
approval. 
Note:  There is no washout period required between radiation therapy and the first 
administration of study drug in Part 2 of the study. 
Note:  Bisphosphonates and denosumab are permitted concomitant medications. 
b. ≤ 28 days for prior immunotherapy or persistence of active cellular therapy (ie, 
chimeric antigen receptor T-cell therapy; other cellular therapies must be discussed 
with medical monitor to determine eligibility). 
c. ≤ 28 days for a prior mAb used for anticancer therapy with the exception of 
denosumab. 
d. ≤ 7 days for immune-suppressive–based treatment for any reason. 
Note:  Use of inhaled or topical steroids or corticosteroid use for radiographic 
procedures is permitted. 
Note:  The use of physiologic corticosteroid replacement therapy may be approved 
after consultation with the medical monitor. 
e. ≤ 28 days or 5 half-lives (whichever is longer) before the first dose for all other 
investigational agents or devices.  For investigational agents with long half-lives (eg, 
> 5 days), enrollment before the fifth half-life requires medical monitor approval. 
4. Has not recovered to ≤ Grade 1 from toxic effects of prior therapy (including prior 
immunotherapy) and/or complications from prior surgical intervention before starting 
therapy. 
Note:  Subjects with stable chronic AEs (≤ Grade 2) not expected to resolve (such as 
neuropathy and alopecia) are exceptions and may enroll. 
Note:  Subjects with a history of any grade immune-related ocular AE will be excluded. 
Note:  Subjects with a history of a Grade 3 or higher irAE from prior immunotherapies 
are excluded from the dose escalation portion of the study. 


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5. Receipt of a live vaccine within 30 days of planned start of study drug. 
Note:  Examples of live vaccines include, but are not limited to, the following:  measles, 
mumps, rubella, chicken pox/zoster, yellow fever, rabies, Bacillus Calmette–Guérin, and 
typhoid vaccine.  Seasonal influenza vaccines for injection are generally killed virus 
vaccines and are allowed; however, intranasal influenza vaccines are live-attenuated 
vaccines and are not allowed. 
6. Active autoimmune disease that required systemic treatment in the past (ie, with use of 
disease-modifying agents, corticosteroids, or immunosuppressive drugs).   
Note:  For subjects who have not required systemic treatment in the past 2 years, the 
investigator should discuss the case with medical monitor to determine eligibility. 
Note:  Subjects with hyper/hypothyroidism are eligible to participate. 
Note:  Replacement and symptomatic therapies (eg, levothyroxine, insulin, or 
physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) 
are not considered a form of systemic treatment and are allowed. 
7. Known active CNS metastases and/or carcinomatous meningitis. 
Note:  Subjects with previously treated brain metastases may participate provided that 
they are stable (without evidence of progression by imaging for at least 28 days before 
the first dose of study drug and any neurologic symptoms have returned to baseline), 
have no evidence of new or enlarging brain metastases or CNS edema, and have not 
required steroids for at least 14 days before the first dose of study drug. 
8. Known additional malignancy that is progressing or requires active treatment, or history 
of other malignancy within 2 years of study entry with the exception of cured basal cell 
or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial 
neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy, 
or cancers from which the subject has been disease-free for > 1 year, after treatment with 
curative intent. 
9. Evidence of active, noninfectious pneumonitis or history of interstitial lung disease. 
10. History or presence of an abnormal ECG that, in the investigator's opinion, is clinically 
meaningful.  Screening QTc interval > 470 milliseconds is excluded (corrected by 
Fridericia).  In the event that a single QTc is > 470 milliseconds, the subject may enroll if 
the average QTc for the 3 ECGs is < 470 milliseconds.  For subjects with an 
intraventricular conduction delay (QRS interval > 120 milliseconds), the JTc interval may 
be used in place of the QTc with sponsor approval.  The JTc must be < 340 milliseconds 
if JTc is used in place of the QTc.  Subjects with left bundle branch block are excluded. 
Note:  QTc prolongation due to pacemaker may enroll if the JTc is normal or with 
medical monitor approval. 
11. Active infection requiring systemic therapy. 


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12. Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of 
reactivation.  Hepatitis B virus DNA and HCV RNA must be undetectable.  Subjects 
cannot be positive for HBV DNA, HCV RNA, hepatitis B surface antigen, or  
anti–hepatitis B core antibody, without approval from the medical monitor. 
Note:  Subjects with no prior history of hepatitis B infection who have been vaccinated 
against hepatitis B and who have a positive antibody against hepatitis B surface antigen 
test as the only evidence of prior exposure may participate in the study. 
13. Known history of human immunodeficiency virus (HIV; HIV 1/2 antibodies). 
14. Known allergy or reaction to any component of study drug or formulation components. 
15. Prior treatment with an OX40 agonist for any indication. 
16. Is a female who is pregnant or breastfeeding, or expecting to conceive children within the 
projected duration of the study, starting with the screening visit through 60 days after the 
last dose of study drug OR is a male who is expected to father children within the 
duration of the study, starting with the screening visit through 90 days after the last dose 
of study drug. 
17. Any condition that would, in the investigator's judgment, interfere with full participation 
in the study, including administration of study drug and attending required study visits; 
pose a significant risk to the subject; or interfere with interpretation of study. 
18. Inability to comprehend or unwillingness to sign the informed consent form (ICF). 
4. 
INVESTIGATIONAL PLAN 
4.1. 
Overall Study Design 
This is an open-label, nonrandomized, Phase 1/2 study to determine the safety and tolerability, 
define the MTD or PAD, and assess the preliminary efficacy of INCAGN01949 in subjects with 
advanced or metastatic solid tumors.  Subjects will receive INCAGN01949 on Day 1 of each 
cycle.  Part 1 of the study will begin with 14-day cycles; however, alternate dose administration 
schedules may also be explored depending on PK, 
, and 
safety results.  The study will be conducted in 2 parts: 
• Part 1 – Dose Escalation and Safety Expansion will determine the PAD, defined as a 
dose that provides a maximal biochemical effect 
 
, and/or the MTD of INCAGN01949, which includes defining the 
optimal dose administration schedule and the maximum number of tolerated doses 
(MNTD). 
• Part 2 – Dose Expansion will evaluate the recommended dose and administration 
schedule determined in Part 1 in subjects with select tumor types 
 
 
 including adenocarcinoma of the endometrium, ovarian cancer, 
RCC, melanoma, and NSCLC. 
See Figure 2 for overall study design. 


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4.1.1. 
Part 1 
In Part 1, subjects with advanced or metastatic solid tumors who progressed after treatment with 
available therapies that are known to confer clinical benefit, who are intolerant to treatment, or 
who refuse standard treatment will be enrolled. 
4.1.1.1. 
Dose Escalation 
In the dose-escalation part of the study, a 3 + 3 design will be utilized to determine the MTD or 
PAD of INCAGN01949.  A minimum of 3 evaluable subjects will be enrolled in each cohort 
beginning with Cohort 1 (7 mg; starting dose).  There will be a waiting period of 48 hours 
between dose administration to the first subject and second subject of each dose cohort.  The first 
3 subjects enrolled within a cohort will be observed for a DLT observation period of 28 days 
before the next cohort begins enrollment.  The dose will be escalated if 0 of the first 3 evaluable 
subjects enrolled has a DLT.  If 1 of the first 3 evaluable subjects enrolled has a DLT, then the 
cohort will be expanded to include 3 additional evaluable subjects, and if no DLT occurs in the 
additional 3 subjects, then the dose will be escalated.  If a DLT occurs in one-third or more of the 
expanded cohort, then the MTD will be deemed to be exceeded, and the previous dose level will 
be considered the MTD.  If only 3 subjects were treated at the MTD or PAD, then a minimum of 
3 additional subjects will be enrolled before this dose is administered in Part 2 of the study. 
If Cohort 1 (7 mg; starting dose) exceeds the MTD, then the sponsor and investigators will 
consider administering INCAGN01949 at 2 mg (Cohort -1) and/or investigate 7 mg at alternate 
dose schedules (eg, every 3 week administration), based on available safety, PK, 
 
 data.  If an alternate schedule is tested and determined to be safe, then re-escalation of 
INCAGN01949 will proceed according to Table 2. 
Throughout the treatment period, if > 33% of subjects (a minimum of 6 subjects) experience a 
Grade ≥ 3 toxicity related to study drug after completing ≥ 4 cycles, then dose administration 
will be stopped, and the MNTD will be determined in conjunction with the investigators and 
sponsor based on all available safety data. 
Additional subjects will be enrolled in a cohort to achieve the minimum of 3 evaluable subjects.  
Subjects who drop out for reasons other than a DLT (eg, events clearly associated with the 
underlying disease, disease progression, concomitant medication, or comorbidity) during the 
28-day DLT observation period will be considered nonevaluable and will be replaced.  Dose 
modifications should not be made during the DLT observation period without discussion with 
the medical monitor.  Intrasubject dose escalation is not permitted; however, once the 
recommended dose has been determined, ongoing subjects in Part 1 may be permitted to escalate 
the dose to the recommended level with approval of the medical monitor.  The cohorts and dose 
levels are shown in Table 2.   


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Table 2: 
INCAGN01949 Dose Levels and Cohort 
Cohort 
Dose of INCAGN01949a 
-1 
2 mgb 
1 (starting dose) 
7 mg 
2 
20 mg 
3 
70 mg 
4 
200 mg 
5 
350 mg 
6 
700 mg 
7 
1400 mgc 
a Additional dose schedules may be explored that would depend on PK, 
, and safety results. 
b Subjects who require a dose reduction below 2 mg should be discontinued from study drug. 
c Cohort 7 may be evaluated if the MTD has not been established and translational data indicate that a higher dose 
of INCAGN01949 may be necessary to confirm the optimal PAD.   
4.1.1.2. 
Safety Expansion 
In order to evaluate additional 
 activity of INCAGN01949 and confirm the preliminary safety 
of the dose-escalation cohorts, Part 1 of the study may include safety expansion cohorts 
evaluating doses and schedules equivalent to or lower than the highest dose levels determined to 
be safe and/or doses determined to be pharmacologically active.  The alternative dose 
administration schedules and fixed doses (equivalent to or less than the MTD determined during 
dose escalation) that may be explored during the safety expansion would depend on PK, 
 
 and safety results. 
A maximum of 36 subjects will be enrolled into the Part 1 safety expansion, and each Part 1 
safety expansion cohort will enroll up to 9 evaluable subjects.  If < 3 of 9 evaluable subjects have 
a DLT, then the cohort will be deemed safe.  If > 1 safety expansion cohort is deemed safe, then 
a recommended dose and schedule will be determined in conjunction with the investigators and 
sponsor based on all available safety, PK, 
 results.  The safety expansion 
cohorts may be run in parallel to Part 2 and may be limited by the sponsor to subjects with 
specific tumor types to achieve a balance across cohorts. 
4.1.2. 
Part 2 
Part 2 of the study will further evaluate the safety, tolerability, preliminary efficacy, PK, and 
pharmacologic activity of the recommended dose of INCAGN01949 in subjects with advanced 
or metastatic adenocarcinoma of the endometrium, ovarian cancer, RCC, melanoma, and 
NSCLC (squamous and nonsquamous).  Each cohort will consist of an individual tumor type.  A 
Simon 2-stage design will be used with a stopping rule to allow for early termination of a 
particular cohort at the end of Stage 1 if there are insufficient responses observed.  During 
Stage 1, 9 subjects will be enrolled into each cohort; if no responses are observed within a 
cohort, then the cohort will be discontinued.  If at least 1 response is observed, then 8 additional 
subjects will be enrolled into that cohort (Stage 2), for a maximum of 17 subjects per cohort.   
Subjects will continue to receive INCAGN01949 until Protocol-defined withdrawal criteria are 
met.  Continuous evaluation of toxicity events will be performed throughout enrollment in Part 2 


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of the study.  If the cumulative incidence of DLTs occurs in > 33% of subjects after 6 subjects 
have been observed for at least 28 days, then further enrollment may be interrupted until the 
sponsor has determined the appropriate course of action (eg, the MNTD may be determined).  
All AEs, regardless of the time of occurrence on study, may be considered in determining the 
appropriate dose, schedule, and MNTD.   
Toxicity will continue to be monitored throughout the treatment period.  If > 33% of subjects 
(minimum of 6 subjects) experience a Grade ≥ 3 toxicity related to study drug after completing 
≥ 4 cycles, then the MNTD will be determined in conjunction with the investigators and sponsor 
based on all available safety data. 
Figure 2: 
Study Design 
 
4.2. 
Measures Taken to Avoid Bias 
This is an open-label study; no formal comparisons will be made between subjects or against 
historical controls.  Measurements of safety and efficacy are objective measurements, and only 
comparisons to pretreatment conditions will be made. 


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4.3. 
Number of Subjects 
4.3.1. 
Planned Number of Subjects 
Up to approximately 163 subjects may be enrolled in the study: 
• Part 1 Dose Escalation – Approximately 18 to 42 evaluable subjects. 
• Part 1 Safety Expansion – Approximately 18 to 36 evaluable subjects. 
• Part 2 – Up to 85 evaluable subjects (up to 45 in Stage 1 and up to 40 in Stage 2). 
4.3.2. 
Replacement of Subjects 
Subjects may be replaced for any of the following reasons: 
• Subject is not evaluable for DLTs (see Section 5.4.2). 
• In Part 1 Safety Expansion and Part 2, subject has not met the biopsy requirements for 
the study (ie, pre- and on-treatment samples). 
• Subject does not meet the eligibility requirements of the study (eg, accidental 
enrollment). 
4.4. 
Duration of Treatment and Subject Participation 
After signing the ICF, screening assessments may be completed over a period of up to 28 days.  
Each subject enrolled in the study may continue to receive INCAGN01949 as long as the subject 
is deriving benefit and has not met any of the Protocol-defined conditions for treatment 
withdrawal (see Section 5.5).  If the subject discontinues treatment with INCAGN01949, then 
the treatment period will end, and the subject will enter the follow-up period (see Section 6.4).  
Subjects are expected to participate in the study for a maximum of 14 months. 
4.5. 
Overall Study Duration 
The study begins when the first subject signs the ICF.  The end of the study will occur when all 
subjects have completed the last study follow-up visit or have discontinued study drug and have 
completed applicable follow-up assessments. 
4.6. 
Study Termination 
The investigator retains the right to terminate study participation at any time, according to the 
terms specified in the study contract.  The investigator is to notify the institutional review board 
(IRB)/independent ethics committee (IEC) in writing of the study's completion or early 
termination, send a copy of the notification to the sponsor or sponsor's designee, and retain 
1 copy for the site study regulatory file. 
The sponsor may terminate the study electively, if required by regulatory decision, or upon 
review of emerging data.  If the study is terminated prematurely, then the sponsor or designee 
will notify the investigators, the IRBs and IECs, and regulatory bodies of the decision and reason 
for termination of the study.   


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5. 
TREATMENT 
5.1. 
Treatment Assignment 
5.1.1. 
Subject Numbering and Treatment Assignment 
All subject numbers will be 6 digits; the first 3 digits will be the site number, and the last 3 digits 
will be the subject's number.  This subject number will be maintained throughout the study and 
will not be reassigned.  Subjects who withdraw consent or discontinue from the study after being 
assigned a subject number will retain their number. 
This is a nonrandomized study, in which subjects will be enrolled into either Part 1 or Part 2 as 
described previously, with all subjects receiving INCAGN01949 (herein referred to as study 
drug).  Site staff will contact the interactive response technology (IRT) at the time of screening, 
when enrolling subjects, and when ordering study drug for all treatment cycles, as well as to 
discontinue subjects from treatment.  Refer to the IRT manual for detailed information. 
5.1.2. 
Randomization and Blinding 
This is an open-label nonrandomized study; therefore, randomization and blinding do not apply. 
5.2. 
INCAGN01949 
5.2.1. 
Description and Administration 
The study drug (INCAGN01949) is in liquid form in the formulation buffer of 20 mM histidine, 
250 mM sorbitol, pH 6.5 at a strength of 10 mg/mL to be used for IV infusion.  The infusion site 
should not be used for blood sampling.   
Study drug will be diluted in 0.9% normal saline or acceptable admixture as outlined in the 
Pharmacy Manual and will be administered by qualified personnel as an IV infusion over 
30 minutes (-5/+10 minutes) on Day 1 of each cycle.  In Part 1, subjects will be administered 
study drug, according to cohort enrollment (Table 2).  In Part 2, subjects will be administered 
study drug at the recommended dose and schedule.  Subjects will continue to receive 
INCAGN01949 as long as the subject is deriving benefit and has not met any of the Protocol-
defined conditions for treatment withdrawal (see Section 5.5). 
The Pharmacy Manual contains additional information and instructions for study drug 
preparation and infusion. 
5.2.2. 
Supply, Packaging, and Labeling 
Study drug will be supplied as 5 mL of aqueous solution in 10 mL glass vials with 10 mg/mL of 
INCAGN01949.  Study drug will be packaged as open-labeled supplies, and each vial will be 
labeled and placed in protective packaging.  The Pharmacy Manual contains additional 
information regarding supply, packaging, and labeling of study drug. 
The investigator will take responsibility for and take all steps to maintain appropriate records and 
ensure appropriate supply, storage, handling, distribution, and usage of study drug in accordance 
with the Protocol and any applicable laws and regulations.   


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All Incyte investigational product labels will be in the local language and will comply with the 
legal requirements of each country. 
5.2.3. 
Storage 
Study drug must be stored refrigerated (2°C-8°C) and protected from light in a secure, 
limited-access location.  Receipt and dispensing of study drug must be recorded by an authorized 
person at the study site.  Study drug may not be used for any purpose other than that stated in the 
Protocol.  The Pharmacy Manual contains additional information regarding storage of study 
drug. 
5.3. 
Treatment Compliance 
INCAGN01949 is administered as an IV infusion by site personnel.  Receipt of infusions will be 
documented by the site staff and monitored by the sponsor/designee. 
5.4. 
Treatment Interruptions and Adjustments 
5.4.1. 
Dose Modifications 
Selections and modifications to the study drug regimen are planned for dose-escalation cohorts.  
Dose interruptions and modifications also may occur for individual study subjects.  The 
identification of DLTs will define the doses used in planned cohorts (see Section 5.4.2).  Further, 
the occurrence of DLTs and other toxicities (related or unrelated to study drug) will guide 
decisions for treatment interruptions and discontinuation for individual subjects. 
Intrasubject dose escalation is not permitted; however, once the recommended dose has been 
determined, ongoing subjects in Part 1 may be permitted to dose escalate to the recommended 
dose and schedule with approval of the medical monitor.   
5.4.2. 
Dose-Limiting Toxicity and Determination of Maximum Tolerated Dose 
The evaluation period for DLTs will begin on Cycle 1 Day 1 and will continue up to and 
including study Day 28.  All DLTs will be assessed by the investigator using CTCAE v4.03.  A 
DLT will be defined as the occurrence of any toxicity in Table 3, with the exception of events 
clearly associated with the underlying disease, disease progression, a concomitant medication, or 
comorbidity. 
Individual subject dose reductions may be made based on events observed at any time during 
treatment with study drug; however, for the purposes of dose cohort escalation/de-escalation, 
expanding a dose cohort, and determining the MTD/PAD of study drug, decisions will be made 
based on events that are observed from the first day of study drug administration through and 
including study Day 28.  A lower MTD may subsequently be determined based on relevant 
toxicities that become evident after Day 28. 


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Table 3: 
Definition of Dose-Limiting Toxicity 
Nonhematologic toxicity 
• Any ≥ Grade 3 nonhematologic toxicity EXCEPT the following: 
− Transient (≤ 72 hours) abnormal laboratory values without associated clinically significant signs or symptoms. 
− Nausea, vomiting, and diarrhea adequately controlled with supportive care within 48 hours. 
− Changes in cholesterol and triglycerides. 
− An event clearly associated with the underlying disease, disease progression, a concomitant medication, or 
comorbidity. 
− Asymptomatic changes in lipid profiles. 
− Asymptomatic changes in amylase and lipase. 
− Singular or nonfasting elevations in blood glucose (ie, blood glucose excursions will be considered toxicities if 
fasting blood glucose is elevated on 2 separate occasions). 
Hematologic toxicity 
• Grade 3 thrombocytopenia with clinically significant bleeding (ie, requires hospitalization, transfusion of blood 
products, or other urgent medical intervention). 
• Grade 4 thrombocytopenia. 
• ≥ Grade 3 febrile neutropenia (absolute neutrophil count < 1.0 × 109/L and fever > 101°F/38.3°C). 
• Grade 4 neutropenia that does not recover to ≤ Grade 2 in ≤ 3 days after interrupting study drug. 
• Grade 4 anemia not explained by underlying disease or some other concomitant disorder. 
Immune-related toxicitya 
• ≥ Grade 2 ocular irAEs will be considered a DLT. 
• Grade 3 irAEs that do not improve to baseline or at least Grade 1 in < 5 days with appropriate care or with 
corticosteroid therapy will be considered a DLT. 
• Grade 4 irAEs will be considered a DLT regardless of duration. 
General 
• Inability to receive the planned number of doses within the 28-day DLT period due to toxicity, regardless of 
grade, will be considered a DLT. 
MTD  
• In Part 1 of the study, the MTD will be defined as 1 dose level below that at which ≥ one-third of subjects in a 
particular cohort have DLTs. 
• In Part 2 of the study, toxicities will continue to be monitored.  If the cumulative incidence of DLTs occurs in 
≥ 33% of subjects after 6 subjects have been observed for at least 28 days, further enrollment may be interrupted, 
and the investigators and sponsor will meet and reassess the MTD.  All AEs, regardless of the time of occurrence 
on study, may be considered in DLT determination purposes. 
MNTD 
• For each dose and schedule explored, if > 33% of subjects (minimum of 6 subjects) experience a ≥ Grade 3 
toxicity related to study drug after completing ≥ 4 cycles, then treatment will be stopped, and the MNTDs will be 
determined in conjunction with the investigators and sponsor based on all available safety data.  All AEs, 
regardless of the time of occurrence on study, may be considered in DLT determination decisions. 
Note:  Transient (≤ 72 hours) abnormal laboratory values without associated clinically significant signs or symptoms based on 
investigator determination will not be considered DLTs. 
a Immune-related AEs are a diagnosis of exclusion, after alternative etiologies have been ruled out. 


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5.4.3. 
Management of Dose-Limiting Toxicities or Other Urgent Situations 
In all cases, investigators may employ any measures or concomitant medications, after 
discussion with the sponsor (whenever possible), necessary to optimally treat the subject. 
5.4.4. 
Follow-Up of Dose-Limiting Toxicities 
Any DLT should be followed until it resolves to baseline or appears to have stabilized for a 
minimum of 4 weeks (ie, 28 days).  During follow-up, subjects should be seen as often as 
medically indicated to assure safety. 
5.4.5. 
Procedures for Cohort Review and Dose Escalation 
Telephone conferences will be scheduled by the sponsor with study investigators in order to 
review cohort-specific data and overall safety data, agree on dose escalation, adjudicate 
individual high-grade AEs as potentially dose-limiting, and guide other major study decisions. 
5.4.6. 
Criteria and Procedures for Dose Interruptions and Adjustments of Study Drug 
Treatment with study drug may be delayed to allow for resolution of toxicity.  Subjects may 
resume treatment if no medical condition or other circumstance exists that, in the opinion of the 
investigator, would make the subject unsuitable for further participation in the study.  For 
toxicities that occur outside of the 28-day DLT period, the treating investigator should contact 
the medical monitor to discuss the case of any subject whose treatment has been delayed for 
more than 4 weeks (28 days) before restarting treatment with study drug. 
Instructions for dose modifications and interruptions are outlined in Table 4.  Individual 
decisions regarding dose interruptions and reductions should be made using appropriate clinical 
judgment in consultation with the medical monitor, taking into account relatedness of the AE to 
the study drug and the subject's underlying condition.  Adverse events that have a clear 
alternative explanation, or transient (≤ 72 hours) abnormal laboratory values without associated 
clinically significant signs or symptoms, may be exempt from dose-reduction rules.  Dose 
interruptions are permitted in the case of medical/surgical events or logistical reasons not related 
to study therapy (eg, elective surgery, unrelated medical events, subject vacation, holidays).  
Subjects should be placed back on study therapy within 4 weeks (28 days) of the scheduled 
interruption, unless otherwise discussed with the sponsor.  The reason for interruption should be 
documented in the subject's study record. 


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Table 4: 
Rules for Interruption and Restarting of Study Drug 
CTCAE Grade or 
Severity 
Timing for Restarting 
Treatment 
Dose Level for 
Restarting Treatment 
Treatment 
 Discontinuationa 
1-2 (mild-moderate) 
Continue treatment at the 
discretion of the investigator. 
N/A 
N/A 
3 (severe) 
Toxicity resolves to Grade 0-1. 
Reduce by 1 dose level.b 
Toxicity does not resolve within 
4 weeks (28 days) of last dose, 
except by approval of the 
medical monitor. 
OR 
Second occurrence of previously 
resolved Grade 3 AE. 
4 (life-threatening) 
Permanently discontinue. 
N/A 
Permanently discontinue. 
a Permanently discontinue for any severe or Grade 3 AE that recurs or any life-threatening event. 
b No more than 2 dose reductions of study drug are permitted, or 1 dose reduction of study drug if the starting dose is 7 mg (see 
Table 2).  Subject should be permanently discontinued from study drug if they have AEs requiring more than 2 dose reductions 
of study drug. 
5.4.7. 
Definition, Procedures, and Supportive Care Guidelines for Immune-Related 
Adverse Events 
INCAGN01949 is an immune modulator, and although no toxicities were identified in 
preclinical models, it is possible that irAEs (both nonserious and serious) similar to those 
described with approved immunotherapies may occur.  Adverse events of a potential 
immunologic etiology or irAEs may be defined as an AE consistent with an immune 
phenomenon associated with drug exposure after all other etiologies have been eliminated (see 
Section 8.8).  Immune-related AEs may be expected based on the nature of INCAGN01949, its 
mechanism of action, and reported experience with other immunotherapies.  Special attention 
should be paid to AEs that may be suggestive of potential irAEs.  An irAE can occur shortly 
after the first dose or several months after the last dose of treatment.  Suspected irAEs should be 
discussed with the medical monitor when possible. 
Subjects should receive appropriate supportive care measures as deemed necessary by the 
treating investigator.  Suggested supportive care measures for the management of drug-related 
AEs with potential immunologic etiology are outlined in Table 5.  Detailed supportive care 
guidelines for specific irAEs can be in found in Appendix B.  For each AE, attempts should be 
made to rule out other causes including, but not limited, to metastatic disease or bacterial or viral 
infection, which might require specific supportive care. 


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Table 5: 
Supportive Care Guidelines for Subjects Exhibiting Immune-Related 
Adverse Events 
CTCAE Grade/Severity 
Supportive Carea 
Grade 1 (mild) 
• Monitor symptoms and provide symptomatic treatment. 
Grade 2 (moderate) 
• Monitor symptoms and provide symptomatic treatment. 
• Consider consultation with specialists as necessary. 
• Consider systemic corticosteroids per institutional standard of care. 
Grade 3-4  
(severe–life-threatening) 
• Monitor symptoms and provide symptomatic treatment. 
• Consider consultation with specialists as necessary. 
• Administer corticosteroids per institutional standard of care. 
• More potent immunosuppressive therapies should be considered for events not 
responding to systemic steroids after discussing with the medical monitor. 
• Study drug should be permanently discontinued for clinically significant or 
severe irAEs or for events where steroid course cannot be tapered below 
7.5 mg/day prednisone or equivalent to manage symptoms. 
a Detailed supportive care guidelines for specific irAEs can be found in Appendix B. 
5.4.8. 
Management of Infusion Reactions 
Table 6 shows treatment guidelines for subjects who experience an infusion reaction associated 
with study drug administrative procedures.  Signs and symptoms usually develop during or 
shortly after drug infusion and generally resolve completely within 24 hours of completion of 
infusion. 


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Table 6: 
INCAGN01949 Infusion Reaction Treatment Guidelines 
CTCAE Grade 
Treatment 
Premedication at  
Subsequent Dose Administration 
Grade 1: 
Mild reaction; infusion 
interruption not indicated; 
intervention not indicated. 
Increase monitoring of vital signs as 
medically indicated until the subject is 
deemed medically stable in the opinion of the 
investigator. 
None. 
Grade 2: 
Requires infusion interruption 
but responds promptly to 
symptomatic treatment  
(eg, antihistamines, NSAIDs, 
narcotics, IV fluids); 
prophylactic medications 
indicated for ≤ 24 hours. 
Stop infusion and monitor symptoms. 
Additional appropriate medical therapy may 
include but is not limited to the following: 
• IV fluids 
• Antihistamines 
• NSAIDs 
• Acetaminophen 
• Narcotics 
Increase monitoring of vital signs as 
medically indicated until the subject is 
deemed medically stable in the opinion of the 
investigator. 
If symptoms resolve within 1 hour of 
stopping drug infusion, the infusion may be 
restarted at 50% of the original infusion rate.  
Otherwise, dose administration will be 
interrupted until symptoms resolve, and the 
subject should be premedicated for the next 
scheduled dose. 
Subjects who develop Grade 2 toxicity 
despite adequate premedication should be 
permanently discontinued from further study 
drug administration. 
Subject may be premedicated 1.5 h 
(± 30 min) before infusion with 
the following: 
• Diphenhydramine 50 mg orally 
(or equivalent dose of 
antihistamine). 
• Acetaminophen 500-1000 mg 
orally (or equivalent dose of 
antipyretic). 
Grade 3: 
Prolonged (ie, not rapidly 
responsive to symptomatic 
medication and/or brief 
interruption of infusion); 
recurrence of symptoms 
following initial improvement; 
hospitalization indicated for 
other clinical sequelae (eg, 
renal impairment, pulmonary 
infiltrates). 
Stop infusion. 
Additional appropriate medical therapy may 
include but not be limited to the following: 
• IV fluids 
• Antihistamines 
• NSAIDs 
• Acetaminophen 
• Narcotics 
• Oxygen 
• Pressors 
• Corticosteroids 
• Epinephrine 
Increase monitoring of vital signs as 
medically indicated until the subject is 
deemed medically stable in the opinion of the 
investigator. 
Hospitalization may be indicated. 
Subject is permanently discontinued from 
further study drug administration. 
No subsequent dose. 
Grade 4: 
Life-threatening; pressor or 
ventilatory support indicated. 
NSAID = nonsteroidal anti-inflammatory drug. 
Note:  Appropriate resuscitation equipment should be available in the room and a physician readily available during study drug 
infusion. 


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5.4.9. 
Criteria for Permanent Discontinuation of Study Drug 
The occurrence of unacceptable toxicity not caused by the underlying malignancy will be 
presumed to be related to study drug treatment and will require that the study drug be 
permanently discontinued.  Unacceptable toxicity is defined as follows: 
• Grade 4 or life-threatening AEs (see Table 4 and Table 6). 
• ≥ Grade 2 ocular irAE. 
• Occurrence of an AE that is related to treatment with the study drug that, in the 
judgment of the investigator or the sponsor's medical monitor, compromises the 
subject's ability to continue study-specific procedures or is considered to not be in the 
subject's best interest. 
• An AE requiring more than 2 dose reductions of study drug, or more than 1 dose 
reduction if the starting dose is 7 mg (see Table 2). 
• Persistent AE requiring a delay of therapy for more than 4 weeks (28 days), unless a 
greater delay has been approved by the sponsor. 
5.4.10. 
Treatment After Initial Evidence of Radiologic Disease Progression 
Immunotherapeutic agents may produce antitumor effects by potentiating endogenous 
cancer-specific immune responses.  The response patterns seen with such an approach may 
extend beyond the typical time course of responses seen with cytotoxic agents and may manifest 
as a clinical response after an initial increase in tumor burden or even the appearance of new 
lesions. 
If radiologic imaging shows disease progression, then subjects have the option to continue 
treatment while awaiting radiographic confirmation of progression as outlined in Section 7.7.1. 
5.5. 
Withdrawal of Subjects From Study Treatment 
5.5.1. 
Withdrawal Criteria 
A subject may choose to withdraw from the study at any time or be withdrawn by the 
investigator or sponsor, if the subject is noncompliant with the study requirements.  Subjects may 
also be withdrawn at the discretion of the FDA or health authorities.  If a subject is withdrawn, 
then every reasonable effort should be made to determine the reason for withdrawal, and this 
information should be recorded in the electronic case report form (eCRF).   
Subjects must be withdrawn from study drug for the following reasons: 
• The subject becomes pregnant. 
• Consent is withdrawn.  Subjects may choose to withdraw from the study at any time 
without penalty of jeopardizing their health care or loss of benefits to which the 
subject is otherwise entitled.   
• Further participation would be injurious to the subject's health or well-being, in the 
investigator's medical judgment. 
• The subject is lost to follow-up. 


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• Unacceptable toxicity (see Section 5.4).  Subjects with unacceptable toxicities must 
be withdrawn from study drug but will continue to be followed during the safety 
follow-up visits as specified in Section 6.4. 
• The study is terminated by the sponsor. 
• The study is terminated by the local health authority, IRB, or IEC. 
A subject may be discontinued from study treatment as follows: 
• Confirmed radiographic progression of disease per mRECIST v1.1.  See 
Section 7.7.1. 
Note:  For unconfirmed progression, see Section 7.7.1. 
Note:  A subject may be granted an exception to continue on treatment with 
confirmed radiographic progression if clinically stable or clinically improved.  See 
Section 7.7.1. 
• If, during the course of the study, a subject is found not to have met eligibility criteria 
(see Section 3), then the medical monitor, in collaboration with the investigator, will 
determine whether the subject should be withdrawn from the study. 
• If a subject is noncompliant with study procedures or study drug administration in the 
investigator's opinion, then the sponsor should be consulted for instruction on 
handling the subject. 
5.5.2. 
Withdrawal Procedures 
In the event that the decision is made to permanently discontinue the study drug, the subject will 
be withdrawn from the study, and the end-of-treatment (EOT) visit should be conducted.  
Reasonable efforts should be made to have the subject return for follow-up visits.  These visits 
are described in Section 6.  The last date of the last dose of study drug and the reason for subject 
withdrawal will be recorded in the eCRF. 
If a subject is withdrawn from the study: 
• The study monitor or sponsor must be notified. 
• The reason(s) for withdrawal must be documented in the subject's medical record and 
in the eCRF. 
• The EOT visit should be performed. 
• The date of the EOT visit should be recorded in the IRT. 
• Subjects must be followed for safety until the time of the follow-up visit or until 
study drug–related toxicities resolve, return to baseline, or are deemed irreversible, 
whichever is longest. 
If the subject discontinues study treatment and actively withdraws consent for collection of 
follow-up data (safety follow-up or disease assessment), then no additional data collection 
should occur; however, subjects will have the option of withdrawing consent for study treatment 
but continuing in the follow-up period of the study for safety/efficacy assessments. 


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5.6. 
Concomitant Medications 
All concomitant medications and treatments must be recorded in the eCRF.  Any prior 
medication received up to 28 days before the first dose of study drug and 60 days after the last 
dose of study drug will be recorded in the eCRF.  Any addition, deletion, or change in the dose 
of these medications will also be recorded.  Concomitant medications administered after 60 days 
after the last dose of study drug should be recorded for serious adverse events (SAEs) as defined 
in Section 8.  Concomitant treatments/procedures that are required to manage a subject's medical 
condition during the study will also be recorded in the eCRF. 
5.6.1. 
Permitted Medications 
All treatments that the investigator considers necessary for a subject's welfare may be 
administered at the discretion of the investigator in keeping with the community standards of 
medical care.  All concomitant medications will be recorded on the eCRF, including all 
prescription and over-the-counter medications, herbal supplements, and IV medications and 
fluids.  If changes occur during the study period, then documentation of drug regimen, 
frequency, route, and date may also be included on the eCRF.  Note:  The use of 
bisphosphonates and denosumab are permitted in this study. 
5.6.2. 
Restricted Medications 
Use of systemic glucocorticoids is restricted to prophylaxis for contrast allergies for radiographic 
procedures or to modulate symptoms or treat an AE of suspected immunologic etiology.  The use 
of physiologic corticosteroid replacement therapy may be approved after consultation with the 
sponsor. 
Note:  Inhaled and topical steroids are allowed.  A short course of steroids (prednisone or 
equivalent) ≤ 10 mg/day may be permitted with sponsor approval. 
5.6.3. 
Prohibited Medications 
Medications or vaccinations specifically prohibited in the exclusion criteria (see Section 3.2) are 
not allowed during the ongoing study.  If there is a clinical indication for one of these 
medications or vaccinations specifically prohibited during the study, discontinuation from study 
drug or vaccination may be required.  The investigator should discuss any questions regarding 
this with the sponsor.  The final decision on any supportive therapy or vaccination rests with the 
investigator and/or the subject's primary physician.  However, the decision to continue the 
subject on study drug or vaccination schedule requires the mutual agreement of the investigator, 
the sponsor, and the subject. 


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Subjects are prohibited from receiving the following therapies during the screening and treatment 
periods of this study: 
• Any anticancer medications, including chemotherapy or biologic therapy other than 
the study drug. 
• Any immunological-based treatment for any reason from screening through follow-up 
visit. 
Note:  Completed adjuvant therapy (eg, vaccines) with medical monitor approval, 
inhaled or topical steroids, systemic steroids at doses ≤ 10 mg/day prednisone or 
equivalents, and immune suppressants are allowed for treatment of immune toxicities 
as described in Section 5.4.7 and Appendix B. 
Note:  Allergy shots may be permitted after consultation with the medical monitor. 
• Investigational agents other than the study drug from screening through the follow-up 
visit. 
• Concomitant radiation therapy. 
Note:  Radiation therapy to a symptomatic solitary lesion or to the brain may be 
considered on a case-by-case basis after consultation with the medical monitor.  The 
subject must have clear measurable disease outside the radiated field.  Administration 
of palliative radiation therapy will be considered clinical progression for the purposes 
of determining PFS. 
• Live vaccines within 30 days before the first dose of study drug and while 
participating in the study.  Examples of live vaccines include, but are not limited to, 
measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette–
Guérin, and typhoid (oral) vaccine.  Seasonal influenza vaccines for injection are 
generally killed virus vaccines and are allowed.  However, intranasal influenza 
vaccines are live attenuated vaccines and are not allowed. 
Subjects who, in the assessment by the investigator, require the use of any of the aforementioned 
treatments for clinical management should be removed from the study.  Subjects may receive 
other medications that the investigator deems to be medically necessary.  The exclusion criteria 
describe other medications that are prohibited in this study.  There are no prohibited therapies 
during the post-treatment follow-up period. 
6. 
STUDY ASSESSMENTS 
All study assessments will be performed as indicated in the schedule of assessments (Table 7), 
and all laboratory assessments will be performed as indicated in Table 8 and Table 9.  Table 10 
presents a summary of clinical laboratory analytes to be assessed.  The order of assessments is 
suggested by the order of mention within the schedule.  See Section 7 for instructions on each 
assessment.  Further details of study procedures and assessments can be found in the study 
reference manual or applicable procedural documentation. 


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Table 7: 
Schedule of Assessments 
Visit Day (Range) 
Protocol 
Section 
Screening 
Treatmenta 
Post-Treatmentb 
C1 and C2 
All 
Subsequent 
Cycles 
Every 
8 weeks 
EOT 
Safety 
Follow-Up Visit 1 
Safety 
Follow-Up Visit 2 
D1 
D7 
D1 
Disease Status 
Evaluation/Window 
 
Day -28 
to -1 
 
± 1 day 
± 3 days 
± 7 days 
± 3 days 
30 days 
(+ 7 days) 
60 days 
(+ 7 days) 
Administrative procedures 
Informed consent 
7.1 
X 
 
 
 
 
 
 
 
Inclusion/exclusion criteria 
3.1, 3.2 
X 
X 
 
 
 
 
 
 
Contact IRT 
7.2 
X 
X 
 
X 
 
X 
 
 
Medical and cancer history 
7.3  
X 
 
 
 
 
 
 
 
Prior/concomitant 
medications 
7.4  
X 
X 
X 
X 
 
X 
X 
X 
Administer INCAGN01949 
5.2.1 
 
X 
 
X 
 
 
 
 
Poststudy anticancer therapy 
status 
7.5  
 
 
 
 
 
 
X 
X 
Clinical procedures/assessments  
Comprehensive physical 
examination including height 
7.6.2.1 
X 
 
 
 
 
 
 
 
Targeted physical assessment 
7.6.2.2 
 
X 
X 
X 
 
X 
X 
X 
Vital signs and weight  
7.6.3 
X 
Xc 
X 
Xc 
 
X 
X 
X 
ECOG performance status 
7.8 
X 
X 
X 
X 
 
X 
X 
X 
Laboratory assessments 
7.6.5 
X 
Xd 
X 
X 
 
X 
X 
X 
12-lead ECGe 
7.6.4 
Xf,g 
Xg 
 
Xg,h 
 
X 
X 
 
AE assessment 
7.6.1 
X 
X 
X 
X 
 
X 
X 
X 
Efficacy measurements 
 
Radiologic tumor assessments 
7.7  
Xi 
 
 
 
Xj 
Xk 
Xk 
a Treatment cycles will begin every 14 days (± 3 days).  Alternate dose schedules may also be explored based on emerging safety, PK, 
 data. 
b The mandatory safety follow-up visits should be conducted approximately 30 days and 60 days after the last dose of study drug or before the initiation of a new anticancer 
treatment, whichever comes first. 
c On Day 1 of the first 4 cycles (C1D1, C2D1, C3D1, and C4D1), subjects will be required to stay at the study site for safety observation for up to 4 hours postinfusion.  It is 
recommended that the subject does not leave the site for any reason during the safety observation period.  During the safety observation period, vital signs (blood pressure, pulse, 
respiratory rate, and body temperature) will be assessed every 60 minutes ± 10 minutes (eg, 1 hour postinfusion, 2 hours postinfusion, 3 hours postinfusion, and 4 hours 
postinfusion).  Subjects will also be assessed for the onset of acute AEs. 
d Laboratory assessments may also be required on additional visit days as described in Table 8 and Table 9. 


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e All 12-lead ECGs will be performed with the subject in a recumbent or semirecumbent position after 5 minutes of rest and should not be performed within 15 minutes after a 
blood collection. 
f In the event that a single QTc is > 470 milliseconds, the subject may enroll if the average QTc for the 3 ECGs is < 470 milliseconds. 
g Triplicate ECG measurements are required at screening, C1D1 (in conjunction with PK samples), and C6D1 (in conjunction with PK samples).  Other ECGs only need 
to be performed in triplicate if there has been a QT prolongation on study or if the ECG shows a clinically significant abnormality not present at baseline.  Triplicate ECG 
measurements should be performed predose and within 1 hour postdose.  Measurements should be taken in triplicate (separated by 5 minutes ± 5 minutes). 
h A 12-lead ECG should be performed on Day 1 of every other cycle after C2 (eg, C4, C6, C8, C10). 
i The initial tumor imaging will be performed within 28 days before the first dose of study drug.  Scans performed as part of routine clinical management are acceptable for use as 
the screening scan if they are of diagnostic quality and performed within 28 days before the first dose of study drug.  The same imaging technique should be used for a subject 
throughout the study.  Local reading (investigator assessment with site radiology reading) will be used to determine eligibility and for subject management. 
j On-study imaging will be performed at Week 8, every 8 weeks (± 7 days) for the first 12 months, and then every 12 weeks (± 7 days) thereafter.  Imaging should follow calendar 
days and should NOT be adjusted for delays in cycle starts.  If imaging shows disease progression, then another imaging assessment should be performed at a minimum of 
4 weeks but no later than 6 weeks later to confirm progression per mRECIST. 
k If scan was obtained within 4 weeks before the date of discontinuation, then a scan at treatment discontinuation (EOT) is not mandatory.  For subjects who discontinue study 
therapy without confirmed disease progression, a radiologic evaluation should be repeated at the time of treatment discontinuation (ie, date of discontinuation ± 4 week window).  
For subjects who discontinue treatment for reasons other than disease progression, every effort should be made to continue monitoring their disease status every 8 weeks 
(± 7 days) by radiographic imaging until 1) start of new cancer therapy, 2) documented disease progression, 3) death, 4) withdrawal of consent or 5) the end of the study, 
whichever occurs first. 


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Table 8: 
Schedule of Laboratory Assessments 
 
 
 
Treatment 
Post-Treatment 
Visit Day (Range) 
Protocol 
Section 
Screening 
C1 and C2 
Odd Numbered Cycles 
(C3, C5, C7, etc) 
Even Numbered Cycles 
(C4, C6, C8, etc) 
EOT 
Safety 
Follow-Up 
Visit 1 
Safety 
Follow-Up 
Visit 2 
D1 
D7 
D1  
D1 
Evaluation/Window 
 
Day 
-28 to -1 
Predose 
± 1 day 
± 3 days 
± 3 days 
± 3 days 
30 days  
(+ 7 days) 
60 days  
(+ 7 days) 
Local laboratory testsa 
Comprehensive serum chemistriesb 
and lipid panel 
7.6.5 
Xc 
Xd 
X 
X 
X 
X 
X 
X 
Hematology with differential 
7.6.5 
Xc 
Xd 
X 
X 
X 
X 
X 
X 
Coagulation panel  
7.6.5 
Xc 
Xd 
X 
X 
 
X 
X 
X 
Urinalysis 
7.6.5 
X 
Xd 
X 
X 
 
X 
 
 
Endocrine function tests 
7.6.5 
Xc 
Xd 
X 
X 
 
X 
X 
X 
Hepatitis B and C 
7.6.5.2 
X 
 
 
 
 
 
 
 
Serum pregnancy test 
(childbearing females only)e 
7.6.5.1 
X 
 
 
 
 
X 
 
 
Urine pregnancy test (childbearing 
females only)f 
7.6.5.1 
 
 
 
X 
X 
 
 
 
CA-125 (subjects with ovarian 
cancer only) 
 
 
Xg 
 
 
Xg 
X 
 
 
a All safety laboratory assessments will be performed locally. 
b If liver chemistry tests are abnormal (eg, change in grade from baseline), then liver chemistry monitoring should increase to once per week until resolved to baseline.  Liver 
chemistry does not need to be monitored once per week indefinitely for persistent low grade abnormalities.  Appropriate liver chemistry monitoring intervals should be discussed 
with the medical monitor for those circumstances. 
c Screening laboratory tests must be performed within 7 days of Cycle 1 Day 1.  If performed more than 7 days before Cycle 1 Day 1, then the tests must be repeated and 
eligibility confirmed before study drug administration on Cycle 1 Day 1. 
d Only required to be performed at Cycle 1 Day 1 if the screening assessment was not performed within 7 days. 
e A serum pregnancy test will be required for all women of childbearing potential during screening and must be performed within 72 hours before the first dose of study drug. 
f Urine pregnancy tests will be conducted as medically indicated or per country-specific requirements. 
g CA-125 should be performed at Cycle 1 Day 1 and with the radiographic tumor assessment (± 7 days). 


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Table 9: 
Schedule of Pharmacokinetic and Pharmacodynamic Assessments 
Visit Day (Range) 
Protocol 
Section 
Timing of 
Assessment 
Screening 
Treatment 
Post-Treatment 
C1 
C2 
C3 
C4 
C6 
C7 
C8 and C12 
EOT 
Safety 
Follow-Up 
Visit 1 
D1 
D2 
D7 
D1 
D1 
D1 
D1 
D2 
D7 
D1  
D1 
Evaluation/Window 
 
 
Day 
-28 to -1 
 
 
± 1 
day 
± 1 
day 
± 3 
days 
± 3 
days 
± 3 
days 
 
± 1 
day 
± 3 
days 
± 3 days 
 
30 days  
(+ 7 days) 
Pharmacokinetics Assessmentsa 
Serum sample for PKb 
7.9 
Table 13 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
a All PK 
 assessments will be performed by a central laboratory.  Details regarding PK 
 samples including specimen handling, processing, and shipping will be 
outlined in the laboratory manual. 
b Adjustments to the time of PK 
 blood sampling postdose may be made based on emerging PK data; however, no additional postdose timepoints will be used, and the 
maximum scheduled timepoints will be not greater than 6 hours postdose on the day of infusion. 
 
 
 
 
 
 
 
 
 
 
 


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Table 10: 
Local Laboratory Tests:  Required Analytes 
Serum Chemistries 
Hematology 
Urinalysis 
Hepatitis Screening 
Coagulation 
Albumin 
Alkaline phosphatase 
Alanine aminotransferase 
Aspartate aminotransferase  
Bicarbonate 
Blood urea nitrogen  
Calcium 
Chloride  
Creatinine 
Glucose 
Lactate dehydrogenase 
Phosphorus 
Potassium 
Sodium 
Total bilirubin 
Direct bilirubin (if total bilirubin is 
elevated above ULN) 
Total protein 
Uric acid 
Amylase 
Lipase 
Complete blood count, 
including: 
Hemoglobin 
Hematocrit 
Platelet count 
Red blood cell count 
White blood cell count 
Mean corpuscular volume 
 
Differential count, including: 
Basophils 
Eosinophils 
Lymphocytes 
Monocytes 
Neutrophils 
 
Absolute values must be 
provided for the following 
WBC differential laboratory 
results: 
White blood cells 
Lymphocytes 
Neutrophils 
Color and appearance 
pH and specific gravity 
Bilirubin 
Glucose 
Ketones 
Leukocytes 
Nitrite 
Occult blood 
Protein 
Urobilinogen 
Hepatitis B surface antigen 
Hepatitis B core antibody 
HBV-DNA 
HCV antibody 
HCV-RNA 
PT 
aPTT 
INR 
Lipid Panel 
Endocrine Monitoring 
Pregnancy Testinga 
Total Cholesterol 
Triglycerides 
LDL 
HDL 
Thyroid-stimulating hormone 
Free thyroxine 
Total triiodothyronine/free 
triiodothyronineb 
Female subjects of 
childbearing potential 
only require a serum test 
at screening.  
Pregnancy tests (serum or 
urine) should be repeated 
if required by local 
regulations. 
aPTT = activated partial thromboplastin time; HDL = high-density lipoprotein; INR = international normalized ratio; LDL = low-density lipoprotein. 
Note:  Additional tests may be required, as agreed by investigator and sponsor, based on emerging safety data. 
a Urine pregnancy tests are only required if medically indicated or a country-specific requirement. 
b If considered standard depending on region.


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6.1. 
Screening 
Screening is the interval between signing the ICF and the day that the subject is enrolled in the 
study (eg, Cycle 1 Day 1).  Screening may not exceed 28 days.  Assessments that are required to 
demonstrate eligibility may be performed over the course of 1 or more days during the screening 
process. 
Procedures conducted as part of the subject's routine clinical management (eg, blood count, 
imaging study) and obtained before signing of informed consent may be used for screening or 
baseline purposes provided that the procedure meets the Protocol-defined criteria and has been 
performed in the timeframe of the study.  All information associated with eligibility requirements 
must be entered into the appropriate eCRF pages. 
Tests with results that fail eligibility requirements may be repeated once during screening if the 
investigator believes the results to be in error.  For screening assessments that are repeated, the 
most recent available result before enrollment will be used to determine subject eligibility.  
Additionally, a subject who fails screening may repeat the screening process 1 time if the 
investigator believes there has been a change in eligibility status (eg, after recovery from an 
infection).  Treatment should start as soon as possible after the date of enrollment. 
6.2. 
Treatment 
The treatment period begins on the day that the subject receives the first dose of study drug 
(Cycle 1 Day 1) through the point at which the investigator determines that the subject will be 
permanently discontinued from study drug.  Cycle 1 Day 1 must be no more than 28 days after 
the subject has signed the ICF. 
Subjects will have regularly scheduled study visits on Day 1 of every cycle ± 3 days.  Additional 
visits will be required on Day 7 of Cycles 1 and 2.  During study visits, the subject will have 
clinical and laboratory assessments as outlined in Table 7 and Table 8.  At certain study visits as 
indicated in Section 7.9 and Section 7.10, subjects will have PK, 
 samples 
obtained (see Table 9).  Toxicities will be monitored continuously and will be graded using the 
National Cancer Institute (NCI) CTCAE v4.03 criteria. 
One Day 1 of the first 4 cycles (Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 
Day 1), subjects will be required to stay at the study site for safety observation for up to 
4 hours postinfusion.  It is recommended that the subject does not leave the site for any reason 
during the safety observation period.  During the safety observation period, subjects will be 
assessed for the onset of acute AEs. 
6.3. 
End of Treatment 
When the subject permanently discontinues study drug, the EOT visit should be conducted.  If 
the EOT visit coincides with a regular study visit, then the EOT evaluations will supersede those 
of that scheduled visit, and the data should be entered in the EOT visit in the eCRF.  The subject 
should be encouraged to return for the follow-up visit(s). 


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6.4. 
Follow-Up 
6.4.1. 
Safety Follow-Up 
The safety follow-up period is the interval between the EOT visit and the scheduled follow-up 
visit, which should occur 30 days (+ 7 days) and 60 days (+ 7 days) after the EOT visit (or after 
the last dose of study drug if the EOT visit was not performed).  Adverse events and SAEs must 
be reported up until at least 60 days after the last dose of study drug, the date of the follow-up 
visit, or until toxicities resolve, return to baseline, or are deemed irreversible, whichever is 
longer.  If a subject is scheduled to begin a new anticancer therapy before the end of the 30-day 
or the 60-day safety follow-up period, then the safety follow-up visit should be performed before 
new anticancer therapy is started. 
6.4.2. 
Disease Status Follow-Up 
Subjects who discontinue study treatment for a reason other than disease progression will move 
into the disease status follow-up period and should continue to be assessed every 8 weeks 
(± 7 days) for the first 12 months and then every 12 weeks thereafter by radiologic imaging to 
monitor disease status.  Every effort should be made to collect information regarding disease 
status until the earliest of the following: 
• The start of new antineoplastic therapy. 
• Disease progression. 
• Death. 
• The end of the study. 
6.5. 
End of Study 
The end of the study will occur when all subjects have completed the last study follow-up visit or 
have discontinued study drug and have completed applicable follow-up assessments.  
Additionally, subjects will be considered as having completed the study if they meet any of the 
following criteria: 
• Subject dies and a date of death is available. 
• Subject is known to have died; however, the date of death cannot be obtained.  
(NOTE:  Every effort must be made to obtain the date of death.) 
• Consent is withdrawn for any further contact related to this study. 
− Every reasonable effort should be made to determine the reason a subject 
withdraws prematurely, and this information should be recorded in the eCRF. 
• The study is terminated by the sponsor. 
• The study is terminated by the local health authority or IRB or IEC. 
6.6. 
Unscheduled Visits 
Unscheduled study visits may occur at any time if medically warranted.  Any assessments 
performed at those visits should be recorded in the eCRF. 


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7. 
CONDUCT OF STUDY ASSESSMENTS AND PROCEDURES 
Individual study procedures are described in detail below.  It may be necessary to perform these 
procedures at unscheduled timepoints if deemed clinically necessary by the investigator.  
Furthermore, additional evaluations/testing may be deemed necessary for reasons related to 
subject safety.  In some cases, such evaluation/testing may be potentially sensitive in nature 
(eg, HIV, HCV), and thus local regulations may require that additional informed consent be 
obtained from the subject.  In these cases, such evaluations/testing will be performed in 
accordance with those regulations.  Subjects of childbearing potential must agree to take 
appropriate measures to avoid pregnancy in order to participate in the study (Appendix A). 
7.1. 
Administration of Informed Consent Form 
Valid informed consent must be obtained from the study subject before conducting any 
study-specific procedures using an ICF approved by the local IRB/IEC that contains all elements 
required by ICH E6 and describes the nature, scope, and possible consequences of the study in a 
form understandable to the study subject.  Local and institutional guidelines for ICF content and 
administration must be followed; the original signed ICF must be retained by the investigator, 
and a copy of the signed ICF must be provided to the study subject.  The informed consent 
process for each subject must be documented in writing within the subject source documentation. 
7.2. 
Interactive Response Technology Procedure 
The investigator or designee will assign a subject number when a subject enters the screening 
phase (see Section 5.1.1).  Upon determining that the subject is eligible for study entry (see 
Section 3), the subject will be entered into the IRT.  Additionally, the IRT will be contacted to 
update the subject's status and for study drug supply.  Refer to the IRT manual for detailed 
instructions. 
7.3. 
Demography and Medical History 
7.3.1. 
Demographics and General Medical History 
Demographic data and general medical history will be collected at screening by the investigator 
or qualified designee and will include date of birth, race, ethnicity, medical and surgical history, 
and current illness.  Medical history will include relevant medical or surgical treatment within 
the last 10 years that are considered to be clinically significant by the investigator. 
7.3.2. 
Disease Characteristics and Treatment History 
A disease-targeted medical and medication history will be collected at screening.  Details 
regarding the subject's malignancy under study including date of diagnosis, initial and current 
cancer stage, primary tumor histology, and prior treatments including systemic, radiation, and 
surgical procedures will be recorded. 


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7.4. 
Prior and Concomitant Medications and Procedures 
Prior and concomitant medications and procedures will be reviewed to determine subject 
eligibility.  All concomitant medications and measures must be recorded in the eCRF, and any 
medication received or procedure performed within 28 days before the first dose of study drug 
and up to the end of the safety follow-up phase of the study will be recorded in the eCRF.  The 
medication record will be maintained after signing the ICF to document concomitant 
medications, including any changes to the dose or regimen.  Concomitant medications include 
any prescription, over-the-counter, or natural/herbal preparations taken or administered during 
the study period.  Concomitant treatments and/or procedures that are required to manage a 
subject's medical condition during the study will also be recorded in the eCRF.  See Section 5.6 
for details regarding restricted and prohibited medications. 
7.5. 
Poststudy Anticancer Therapy Status 
The investigator or qualified designee will review all new anticancer therapy initiated after the 
last dose of study drug.  If a subject initiates a new anticancer therapy within 30 to 60 days after 
the last dose of study drug, the 30-day or 60-day safety follow-up visit should occur before the 
first dose of the new anticancer therapy. 
7.6. 
Safety Assessments 
7.6.1. 
Adverse Events 
Adverse events will be monitored from the time the subject signs the ICF.  Subjects will be 
instructed to report all AEs during the study and will be assessed for the occurrence of AEs 
throughout the study.  In order to avoid bias in eliciting AEs, subjects will be asked general, 
nonleading questions such as "How are you feeling?"  All AEs (serious and nonserious) must be 
recorded on the source documents and eCRFs regardless of the assumption of a causal 
relationship with the study drug.  The definition, reporting, and recording requirements for AEs 
are described in Section 8. 
7.6.2. 
Physical Examinations 
7.6.2.1. 
Comprehensive Physical Examination 
Physical examinations must be performed by a medically qualified individual such as a licensed 
physician, physician's assistant, or an advanced registered nurse practitioner, as local law 
permits. 
The comprehensive physical examination will include assessment(s) of the following organ or 
body systems:  skin; head, eyes, ears, nose, and throat; thyroid; lungs; cardiovascular system; 
abdomen (liver, spleen); extremities; and lymph nodes, as well as a brief neurological 
examination.  The screening physical examination should also include a measurement of height.  
Clinically notable abnormalities that are considered clinically significant in the judgement of the 
investigator are to be reported as AEs. 


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7.6.2.2. 
Targeted Physical Examination 
The targeted physical examination will be a symptom-directed evaluation conducted by the 
investigator or medically qualified designee.  The targeted physical examination will include 
assessment(s) of the body systems or organs, as indicated by subject symptoms, AEs, or other 
findings.  Clinically notable abnormalities that are considered clinically significant in the 
judgement of the investigator are to be reported as AEs. 
7.6.3. 
Vital Signs 
Vital sign measurements include blood pressure, pulse, respiratory rate, and body temperature.  
Blood pressure and pulse will be taken with the subject in the recumbent, semirecumbent, or 
sitting position after 5 minutes of rest.  Weight will also be assessed at each study visit.  
Clinically notable abnormalities that are considered clinically significant in the judgment of the 
investigator are to be reported as AEs. 
7.6.4. 
Electrocardiograms 
All 12-lead ECGs will be performed with the subject in a recumbent or semirecumbent position 
after 5 minutes of rest and should not be performed within 15 minutes of a blood collection.  All 
12-lead ECGs will be acquired using an ECG analysis system with analysis and printing 
capabilities, as well as digital transmission capabilities to a central capture module at the central 
ECG laboratory. 
Timed triplicate ECGs (separated by 5 minutes ± 5 minutes) will be conducted at screening and 
in conjunction with the pre- and postinfusion PK timepoints on C1D1 and C6D1 (see Table 11).  
The specified postdose timepoint may be adjusted based on emerging PK data. 
A 12-lead ECG should be performed on Day 1 of every other cycle after Cycle 2 (eg, Cycle 4, 
Cycle 6, Cycle 8, Cycle 10).  Subsequent ECGs only need to be performed in triplicate if there 
has been a QT prolongation on study or the ECG shows a clinically significant abnormality not 
present at baseline. 
The 12-lead ECGs will be interpreted by the investigator or qualified designee at the site to be 
used for immediate subject management.  The decision to include, exclude, or withdraw a 
subject from the study based on an ECG flagged as "Abnormal, Clinically Significant" is the 
responsibility of the investigator, in consultation with the medical monitor, as appropriate.  
Clinically significant abnormal findings before signing consent should be recorded as medical 
history.  Clinically significant abnormal findings after signing consent should be recorded as an 
AE.  In the event that a single QTc is > 470 milliseconds at screening, the subject may enroll if 
the average QTc for the 3 ECGs is < 470 milliseconds.  For subjects with an intraventricular 
conduction delay (QRS interval > 120 milliseconds) at screening, the JTc interval may be used in 
place of the QTc with sponsor approval.  In addition, the JTc interval should be used for all 
subsequent assessments. 


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Table 11: 
Timing of Triplicate Electrocardiograms 
Study Visit 
Timing of Sample 
Any Time 
Preinfusion 
Postinfusion PK 
Timepoint 
4-Hr 
Postinfusion PK 
Timepoint 
Screening 
X 
 
 
 
C1D1 
 
Xa 
Xb 
Xa 
C6D1 
 
Xa 
Xb 
Xa 
a Electrocardiograms should be conducted before but within 30 minutes of the PK blood draw at the corresponding 
timepoint. 
b Electrocardiograms should be performed 15 to 30 minutes (+ 10 minutes) after corresponding PK sample is drawn. 
7.6.5. 
Laboratory Assessments 
A laboratory local to the study site and subject will perform all clinical laboratory assessments 
for safety (ie, blood chemistries, hematology assessments, coagulation tests, endocrine function, 
and urinalysis).  The investigative site will enter the laboratory results and laboratory normal 
ranges into the eCRF.  All local laboratory assessments should be performed using standard 
procedures on the days indicated in Table 8.  Table 10 lists the specific laboratory analytes 
required for each test.  Additional testing may be required by the sponsor based on emerging 
safety data.  Additional tests may also be performed if clinically indicated. 
Laboratory samples collected on study Day 1 must be performed before study drug 
administration.  After Cycle 1, predose laboratory procedures can be conducted up to 72 hours 
before study drug administration (within the 3-day study window), and results should be 
reviewed by the investigator or qualified designee and found to be acceptable before a new cycle 
of treatment is initiated. 
7.6.5.1. 
Pregnancy Testing 
A local laboratory serum pregnancy test will be required for all women of childbearing potential 
during screening and at the EOT visit.  The serum pregnancy test performed at screening must be 
performed within 72 hours before the first dose of study drug.  Urine pregnancy tests will be 
conducted as outlined in Table 8, as medically indicated, or per country-specific requirement.  
Urine pregnancy tests will be performed locally.  If a urine pregnancy test is positive, then the 
results should be confirmed with a serum pregnancy test. 
If the serum pregnancy test is negative after a urine test was positive, then the investigator will 
assess the potential benefit/risk to the subject and determine whether it is in the subject's best 
interest to resume study drug and continue participation in the study. 
7.6.5.2. 
Hepatitis Screening Tests 
Hepatitis screening assessments will be performed at the screening visit (Table 8) to rule out 
hepatitis infection; required analytes are shown in Table 10.  Generally, hepatitis tests should be 
performed early in the screening process due to the length of time needed to obtain the results.  
Additional tests may be performed in clinically indicated.  


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7.7. 
Efficacy Assessments 
7.7.1. 
Modified RECIST v1.1 Assessment of Disease 
Modified RECIST will be applied by the site as the primary measure for assessment of tumor 
response and as a basis for Protocol guidelines related to disease status (eg, discontinuation of 
study therapy).  Unique tumor responses have been noted with immunotherapy treatment 
(Chiou and Burotto 2015); therefore, RECIST v1.1 has been adapted for use in this study and 
referred to as mRECIST (see Section 1.3.3.1). 
If radiologic imaging shows progressive disease, then tumor assessment should be repeated at a 
minimum of 4 weeks, but no later than 6 weeks later to confirm progression, with the option of 
continuing treatment while awaiting radiologic confirmation of progression.  Table 12 provides 
instructions on how to proceed with treatment based on the subject's clinical status once the 
initial scan showing radiologic evidence of progression is observed. 
Subjects may receive treatment while waiting for confirmation of progression if they are 
clinically stable as defined by the following criteria: 
• Absence of clinically significant signs and symptoms (including worsening of 
laboratory values) indicating disease progression. 
• No decline in ECOG performance status. 
• Absence of rapid progression of disease. 
• Absence of progressive tumor at critical anatomical sites (eg, cord compression) 
requiring urgent alternative medical intervention. 
Table 12: 
Imaging and Treatment After First Radiologic Evidence of Progressive 
Disease 
 
Clinically Stable 
Clinically Unstable 
Tumor Imaging 
Treatment 
Tumor Imaging 
Treatment 
First radiologic 
evidence of 
progression 
Repeat imaging 
4-6 weeks to confirm 
progression 
May continue study 
treatment at the 
investigator's discretion 
while awaiting 
confirmatory tumor 
imaging 
Repeat tumor imaging 
4-6 weeks to confirm 
progression per 
physician discretion 
only 
Discontinue 
treatment 
Repeat scan  
confirms 
progression 
No additional tumor 
imaging required 
Discontinue treatment 
No additional tumor 
imaging required 
N/A 
Repeat scan 
shows SD, PR, 
or CR 
Continue regularly 
scheduled tumor 
imaging assessments 
Continue study 
treatment at the 
investigator's discretion 
Continue regularly 
scheduled tumor 
imaging assessments 
May restart study 
treatment if 
condition has 
improved and/or 
clinically stable 
per investigator's 
discretion 


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As noted above, if disease progression is observed, then the study site may elect to continue 
treatment; repeat imaging at a minimum of 4 weeks, but no later than 6 weeks later; and assess 
tumor response or confirmed progression per mRECIST. 
In determining whether or not the tumor burden has increased or decreased, study site 
investigators should consider all target lesions as well as nontarget lesions.  Subjects that are 
deemed clinically unstable are not required to have repeat tumor imaging for confirmation.  If 
radiologic progression is confirmed by subsequent scan, then the subject should be discontinued 
from study treatment.  If radiologic progression is not confirmed, then the subject should resume 
or continue study treatment and have the next tumor imaging according to the Protocol schedule 
(see Table 7).  If progression is not confirmed and the subject continues on treatment, then the 
next scan that documents disease progression (and is confirmed by a second scan at least 4 weeks 
but no later than 6 weeks later) will be considered the date of disease progression. 
If a subject has confirmed radiographic progression (ie, 2 scans at least 4 weeks, but no later than 
6 weeks apart demonstrating progression) per mRECIST, but the subject is achieving a clinically 
meaningful benefit, an exception to continue treatment may be considered after consultation with 
the medical monitor.  Clinically stable subjects at the confirmatory scan should also have no 
further increase in the target lesions, no unequivocal increase in nontarget lesions, and no 
additional new lesions develop (nonworsening disease progression) to continue study treatment. 
7.7.1.1. 
Tumor Imaging 
The same imaging technique should be used for a subject throughout the study.  The 
baseline scan must be a contrast computed tomography (CT) or magnetic resonance imaging 
(MRI), except in circumstances where there is a contrast allergy or with medical monitor 
approval.  When the CT component of a positron emission tomography/CT uses higher energy 
and thinner slices, it may be acceptable with medical monitor approval.  Images of the chest and 
abdomen are required for all subjects. 
7.7.1.1.1. Tumor Imaging During Screening 
Initial tumor imaging must be performed within 28 days before the first dose of study drug.  The 
site study team must review prestudy images to confirm that the subject has measurable disease 
per RECIST v1.1.  Tumor lesions that are located in a previously irradiated area or in an area 
subjected to other locoregional therapy should not be selected as target lesions.  If a subject only 
has lesions in an area previously irradiated or subjected to locoregional therapy, then the subject 
will be allowed to enroll.  Additionally, it is recommended that tumor lesions selected for biopsy 
not be selected as target lesions. 
Computed tomography or MRI scan of the brain will be performed at screening if there are signs 
or symptoms suggesting that the subject has disease involvement in the CNS.  An MRI of the 
brain will also be required at screening for all subjects with melanoma. 
Scans performed as part of routine clinical management are acceptable for use as the screening 
scan if they are of diagnostic quality and performed within 28 days before the first dose of study 
drug. 


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7.7.1.1.2. Tumor Imaging During the Study 
The first imaging assessment should be performed 8 weeks after the first dose of study drug, 
every 8 weeks (56 days ± 7 days) for 12 months, and then every 12 weeks (84 days ± 7 days) 
thereafter until disease progression is determined.  Imaging assessments may be performed more 
frequently if clinically indicated.  Imaging should not be adjusted for delays in cycle starts. 
Per mRECIST v1.1, response should be confirmed by a repeat radiographic assessment not less 
than 4 weeks from the date that the response was first documented.  The scan for confirmation of 
response may be performed at the earliest of 4 weeks after the first indication of response or at 
the next scheduled scan, whichever is clinically indicated. 
Imaging should continue to be performed until documented disease progression, the start of new 
anticancer treatment, withdrawal of consent, death, or the end of the study, whichever occurs 
first.  Disease progression should be confirmed at least 4 weeks, but no later than 6 weeks after 
the first scan indicating progression in clinically stable subjects.  Subjects who have unconfirmed 
disease progression may continue on treatment until progression is confirmed, provided that they 
have met the conditions detailed in Section 7.7.1.  A central imaging vendor will not be used in 
this study.  
7.7.1.1.3. Imaging During Follow-Up 
If the subject discontinues study drug for reasons other than disease progression, imaging 
assessments should continue at the Protocol-specified interval until documented disease 
progression, the start of new anticancer treatment, withdrawal of consent, death, or the end of the 
study, whichever occurs first. 
7.8. 
Performance and Quality-of-Life Assessments 
Eastern Cooperative Oncology Group performance status (Appendix C) must be assessed by a 
medically qualified individual and recorded in the CRF at visits indicated in Table 7.  
7.9. 
Pharmacokinetic Assessments 
7.9.1. 
Blood Sample Collection 
Pharmacokinetics 
 samples will be obtained at the visits indicated in Table 9.  Timing 
of PK 
 assessments are outlined in Table 13.  After the predose PK sample is drawn, 
subjects will begin the study drug infusion.  Predose is defined as within 24 hours before 
administration of study drug.  Adjustments to the timing of blood sampling may be made based 
on emerging PK data.  The exact dates and times of the PK blood collection will be recorded in 
the eCRF.  Instructions for sample preparation and shipping will be provided in the Laboratory 
Manual. 


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Table 13: 
Timing of Pharmacokinetic 
 Sample Collection 
Study Visit 
Assessment 
Timing of Sample Collection 
Cycle 1 Day 1 
PK 
 
• Preinfusion 
PK 
• Postinfusion (± 10 min) 
• 4 h (± 30 min) postinfusion 
Cycle 1 Day 2 
PK 
• 24 h (± 60 min) postinfusion 
Cycle 1 Day 7 
PK 
• Untimed PK sample 
Cycle 2 Day 1 
PK 
 
• Preinfusion 
Cycle 3 Day 1 
PK 
 
• Preinfusion 
Cycle 4 Day 1 
PK 
• Preinfusion 
Cycle 6 Day 1 
PK 
 
• Preinfusion 
PK 
• Postinfusion (± 10 min) 
• 4 h (± 30 min) postinfusion 
Cycle 6 Day 2 
PK 
• 24 h (± 60 min) postinfusion 
Cycle 6 Day 7 
PK 
• Untimed PK sample 
Cycle 7 Day 1 
PK 
• Preinfusion 
 
 
 
 
7.9.2. 
Pharmacokinetic Analysis 
The PK calculations will be performed, if appropriate, using commercial software such as 
WinNonlin® (Pharsight Corporation, Mountain View, CA).  Nominal times will be used in all 
cases, except when the difference between the actual time and nominal time is greater than 
5 minutes for samples collected up to 4 hours after administration; in these cases, actual times 
will be used for PK analysis.  Additional details of analyses will be described in the Statistical 
Analysis Plan. 


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7.11. 
Other Study Procedures 
7.11.1. 
Distribution of Subject Reminder Cards 
Subjects will be provided with a reminder card at each visit.  The subject reminder cards will 
remind the subject of the date/time of the next visit.   
8. 
SAFETY MONITORING AND REPORTING 
8.1. 
Adverse Events 
8.1.1. 
Definitions 
For the purposes of this Protocol, an adverse event (AE) is defined as any untoward medical 
occurrence associated with the use of a drug in humans, whether or not considered drug related, 
that occurs after a subject provides informed consent.  Abnormal laboratory values or test results 
occurring after informed consent constitute AEs only if they induce clinical signs or symptoms, 
are considered clinically meaningful, require therapy (eg, hematologic abnormality that requires 
transfusion), or require changes in the study drug(s). 
8.1.2. 
Reporting 
Adverse events that begin or worsen after informed consent should be recorded on the Adverse 
Events form of the eCRF.  Conditions that were already present at the time of informed consent 
should be recorded on the Medical History form in the eCRF.  Monitoring for the occurrence of 
new AEs should be continued for at least 60 days after the last dose of study drug or until the 
start of new anticancer therapy, whichever occurs first.  Adverse events (including laboratory 
abnormalities that constitute AEs) should be described using a diagnosis whenever possible 
rather than by individual underlying signs and symptoms.   
The term "disease progression" should be recorded as an AE/SAE only if there are no other 
identifiable AEs/SAEs associated with the disease progression at the time of reporting.  For 
events associated with disease progression, the relevant signs and symptoms should be reported 
using a diagnosis whenever possible rather than individual underlying signs and symptoms.  
When a clear diagnosis cannot be identified, each sign or symptom should be reported as a 
separate AE.  If the events resulting from disease progression meet the criteria for an SAE (eg, 
resulted in hospitalization, a life-threatening event, or death), the specific event(s) should be 
reported as an SAE(s) as described in Section 8.3.2.  In both cases (ie, AEs or SAEs related to 
disease progression), it should be indicated that each event (reported as a diagnosis or as signs 
and symptoms) is related to disease progression on the Adverse Events form of the eCRF. 


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The severity of AEs will be assessed using CTCAE v4.03 Grades 1 through 4.  The CTCAE 
v4.03 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly 
using Grades 1 through 4 and have the outcome noted as fatal.  If an event is not classified by 
CTCAE, the severity of the AE will be graded according to the scale below to estimate the grade 
of severity: 
Grade 1 
Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; 
intervention not indicated. 
Grade 2 
Moderate; minimal, local, or noninvasive intervention indicated; limiting 
age-appropriate activities of daily living. 
Grade 3 
Severe or medically significant but not immediately life-threatening; hospitalization 
or prolongation of hospitalization indicated; disabling; limiting self-care activities of 
daily living. 
Grade 4 
Life-threatening consequences; urgent intervention indicated. 
The occurrence of AEs should be sought by nondirective questioning of the subject during the 
screening process after signing the ICF and at each visit during the study.  Adverse events may 
also be detected when they are volunteered by the subject during the screening process or 
between visits, or through physical examination, laboratory test, or other assessments.  To the 
extent possible, each AE should be evaluated to determine: 
• The severity grade (CTCAE Grade 1 to 4). 
• Whether there is at least a reasonable possibility that the AE is related to the study 
treatment:  suspected (yes) or not suspected (no). 
• The start and end dates, unless unresolved at final follow-up. 
• The action taken with regard to study drug. 
• The event outcome (eg, not recovered/not resolved, recovered/resolved, 
recovering/resolving, recovered/resolved with sequelae, fatal, unknown). 
• The seriousness, as per serious adverse event (SAE) definition provided in 
Section 8.3.1. 
Unlike routine safety assessments, SAEs are monitored continuously and have special reporting 
requirements (see Section 8.3.2). 
All AEs should be treated appropriately.  If an AE is treated with a concomitant medication or 
nondrug therapy, this action should be recorded on Adverse Event form and the treatment should 
be specified on the Prior/Concomitant Medications or Procedures and Non-Drug Therapy form 
in the eCRF. 
Once an AE is detected, it should be followed until it has resolved or until it is judged to be 
permanent; assessment should be made at each visit (or more frequently if necessary) of any 
changes in severity, the suspected relationship to the study drug, the interventions required to 
treat the event, and the outcome. 
When the severity of an AE changes over time for a reporting period (eg, between visits), each 
change in severity will be reported as a separate AE until the event resolves.  For example, 
2 separate AEs will be reported if a subject has Grade 1 diarrhea, meeting the definition of an 


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AE, that lasts for 3 days before worsening to a Grade 3 severity.  The Grade 1 event will be 
reported as an AE with a start date equal to the day the event met the Grade 1 AE definition and 
a stop date equal to the day that the event increased in severity from Grade 1 to Grade 3.  The 
Grade 3 event will also be reported as an AE, with the start date equal to the day the event 
changed in intensity from Grade 1 to Grade 3 and a stop date equal to the day that the event 
either changed severity again or resolved. 
8.2. 
Laboratory Test Abnormalities 
Laboratory abnormalities that constitute an AE in their own right (considered clinically 
meaningful, induce clinical signs or symptoms, require concomitant therapy, or require changes 
in study drug) should be recorded on the Adverse Event form in the eCRF.  Whenever possible, a 
diagnosis rather than a symptom should be provided (eg, "anemia" instead of "low hemoglobin").  
Laboratory abnormalities that meet the criteria for AEs should be followed until they have 
returned to normal or an adequate explanation of the abnormality is found.  When an abnormal 
laboratory test result corresponds to a sign or symptom of a previously reported AE, it is not 
necessary to separately record the laboratory test result as an additional event. 
Laboratory abnormalities that do not meet the definition of an AE should not be reported as AEs.  
A Grade 3 or 4 (severe) AE does not automatically indicate an SAE unless it meets the definition 
of serious, as defined in Section 8.3.1.  A dose modification for the laboratory abnormality may 
be required (see Section 5.4) and should not contribute to the designation of a laboratory test 
abnormality as an SAE. 
8.3. 
Serious Adverse Events 
8.3.1. 
Definitions 
An SAE is defined as an event that meets at least 1 of the following criteria: 
• Is fatal or life-threatening. 
• Requires inpatient hospitalization or prolongation of existing hospitalization, unless 
hospitalization is a result of: 
− A routine treatment or monitoring of the studied indication not associated with 
any deterioration in condition.   
− An elective surgery or preplanned treatment for a pre-existing condition that is 
unrelated to the indication under study and has not worsened since signing the 
ICF. 
− A treatment on an emergency outpatient basis for an event not fulfilling any of the 
definitions of a SAE and not resulting in hospital admission. 
− Any social reasons and respite care, in the absence of any deterioration in the 
subject's general condition. 
• Results in persistent or significant disability, incapacity, or a substantial disruption of 
a person's ability to conduct normal life functions. 


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• Constitutes a congenital anomaly or birth defect. 
• Is considered to be an important medical event or a medically significant event that 
may not result in death, be immediately life-threatening, or require hospitalization but 
may be considered serious when, based on appropriate medical judgment, the event 
may jeopardize the subject or may require medical or surgical intervention to prevent 
1 of the outcomes listed above. 
8.3.2. 
Reporting 
Every SAE, regardless of suspected causality (eg, relationship to study drug(s) or study 
procedure or disease progression), occurring after the subject has signed the ICF through the last 
study visit (or 60 days after the last dose of study drug, whichever is later) must be reported to 
the sponsor (or designee) within 24 hours of learning of its occurrence, unless otherwise 
specified by the Protocol.  Any SAEs occurring more than 60 days after the last dose of study 
drug should be reported to the sponsor or its designee only if the investigator suspects a causal 
relationship to the study drug.   
Information about all SAEs is collected and recorded on the Adverse Event form of the eCRF.  
The investigator must assess and record the causal relationship of each SAE to the study 
treatment. 
The investigator must also complete the Incyte Serious Adverse Event Report Form, in English, 
and send the completed and signed form to the sponsor or designee within 24 hours of becoming 
aware of the SAE.  The investigator must provide a causality assessment, that is, assess whether 
there is at least a reasonable possibility that the SAE is related to the study treatment:  suspected 
(yes) or not suspected (no).  Refer to the Incyte Reference Guide for Completing the Serious 
Adverse Event Report Form. 
The contact information of the sponsor's study-specific representatives is listed in the 
investigator manual provided to each site.  The original copy of the SAE Report Form and the 
confirmation sheet must be kept at the study site. 
Investigational site personnel must report any new information regarding the SAE within 
24 hours of becoming aware of the information in the same manner that the initial SAE Report 
Form was sent.  Follow-up information is recorded on an amended or new SAE Report Form, 
with an indication that it is follow-up to the previously reported SAE and the date of the original 
report.  The follow-up report should include information that was not provided on the previous 
SAE Report Form, such as the outcome of the event (eg, resolved or ongoing), treatment 
provided, action taken with study drug because of the SAE (eg, dose reduced, interrupted, or 
discontinued), or subject disposition (eg, continued or withdrew from study participation).  Each 
recurrence, complication, or progression of the original event should be reported as follow-up to 
that event, regardless of when it occurs. 
If the SAE is not documented in the IB for the study drug (new occurrence) and is thought to be 
related to the sponsor's study drug, the sponsor or its designee may urgently require further 
information from the investigator for reporting to health authorities.  The sponsor or its designee 
may need to issue an Investigator Notification (IN) to inform all investigators involved in any 
study with the same drug that this SAE has been reported.  Suspected Unexpected Serious 
Adverse Reactions (SUSARs) will be collected and reported to the competent authorities and 


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relevant ethics committees in accordance with Directive 2001/20/EC, or as per national 
regulatory requirements in participating countries. 
8.4. 
Emergency Unblinding of Treatment Assignment 
Not applicable. 
8.5. 
Pregnancy 
Pregnancy, in and of itself, is not regarded as an AE unless there is suspicion that study drug may 
have interfered with the effectiveness of a contraceptive medication or method.  When a 
pregnancy has been confirmed in a subject during maternal or paternal exposure to study drug, a) 
within 60 days of the last dose of study drug for maternal exposure, b) within 90 days of the last 
dose for paternal exposure, or c) within 30 days after cessation of treatment if the subject 
initiates new anticancer therapy, the following procedures should be followed in order to ensure 
subject safety: 
• The study drug must be discontinued immediately (female subjects only). 
• The investigator must complete and submit the Incyte Clinical Trial Pregnancy form 
to the sponsor or its designee within 24 hours of learning of the pregnancy. 
• A serum pregnancy test must be performed to confirm the urine pregnancy test result.  
If a negative serum test does not confirm the urine pregnancy test result, then: 
− The investigator will use his or her expert judgment, based on an assessment of 
the potential benefit/risk to the subject, to determine whether it is in the subject's 
best interest to resume study drug and continue participation in the study. 
• The EOT visit evaluations must be performed. 
Data on fetal outcome and breastfeeding are collected for regulatory reporting and drug safety 
evaluation.  Follow-up should be conducted for each pregnancy to determine outcome, including 
spontaneous or voluntary termination, details of the birth, and the presence or absence of any 
birth defects, congenital abnormalities, or maternal and/or newborn complications, by following 
until the first well-baby visit.  Pregnancy should be recorded on a Clinical Trial Pregnancy form 
and reported by the investigator to the sponsor or its designee.  Pregnancy follow-up information 
should be recorded on the same form and should include an assessment of the possible causal 
relationship to the sponsor's study drug to any pregnancy outcome, as well as follow-up to the 
first well-baby visit or the duration specified in local regulations, whichever is later.  Refer to the 
Incyte Reference Guide for Completing the Clinical Trial Pregnancy Form. 
Any SAE occurring during pregnancy must be recorded on the SAE report form and 
submitted to the sponsor or designee. 
8.6. 
Warnings and Precautions 
Special warnings or precautions for the study drug, derived from safety information collected by 
the sponsor or its designee, are presented in the Investigator's Brochure (IB).  Additional safety 
information collected between IB updates will be communicated in the form of Investigator 
Notifications (INs).  Any important new safety information should be discussed with the subject 


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during the study, as necessary.  If new significant risks are identified, they will be added to the 
ICF. 
8.7. 
Data Monitoring Committee 
There will be no formal Data Monitoring Committee for this open-label study.  For Part 1, the 
sponsor will conduct telephone conferences with investigators in order to review cohort-specific 
data, to review overall safety data from previous cohorts (if applicable), and to agree on dose 
escalation, de-escalation, and cohort expansion decisions on a regular basis (ie, approximately 
weekly).  For Part 2, safety and tolerability will be carefully monitored throughout the study by 
the sponsor on a regular basis (ie, approximately monthly). 
8.8. 
Immune-Related Adverse Events 
Adverse events of a potential immunologic etiology or irAEs may be defined as an AE consistent 
with an immune phenomenon associated with drug exposure after all other etiologies have been 
eliminated.  Immune-related AEs may be expected based on the nature of INCAGN01949, its 
mechanism of action, and reported experience with other immunotherapies.  Special attention 
should be paid to AEs that may be suggestive of potential irAEs.  An irAE can occur shortly 
after the first dose or several months after the last dose of treatment.  Guidance for the 
assessment, diagnosis, and management of irAEs is provided in Section 5.4.7 and Appendix B.  
Suspected irAEs should be discussed with the medical monitor when possible. 
8.9. 
Product Complaints 
The sponsor collects product complaints on study drugs and drug delivery systems used in 
clinical studies in order to ensure the safety of study participants, monitor quality, and facilitate 
process and product improvements. 
All product complaints associated with material packaged, labeled, and released by the sponsor 
or its designee will be reported to the sponsor.  All product complaints associated with other 
study material will be reported directly to the respective manufacturer. 
The investigator or his/her designee is responsible for reporting a complete description of the 
product complaint via email or other written communication to the sponsor contact or respective 
manufacturer as noted in the packaging information.  Any AE associated with a product 
complaint should be reported as described in Section 8.1.2 of this Protocol. 
If the investigator is asked to return the product for investigation, he/she will return a copy of the 
product complaint communication with the product. 


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9. 
STATISTICS 
9.1. 
Study Populations 
The full analysis set/safety population includes all subjects enrolled in the study who received at 
least 1 dose of study drug (INCAGN01949).  They will be used in the analyses of demographic, 
baseline, safety, study drug administration, and efficacy data. 
The PK/
 evaluable population includes subjects having received at least 1 dose of study drug 
and had at least 1 PK/
 sample collected and analyzed. 
9.2. 
Selection of Sample Size 
9.2.1. 
Sample Size in Part 1 
The primary objective of Part 1 of the study is to determine the PAD or the MTD of 
INCAGN01949.  The total number of subjects will depend on the number of dose levels tested 
before the PAD or MTD is established.  Approximately 18 to 42 subjects (6 subjects per dose 
level for 7 dose levels) will be included based on the dose escalation.  Dose escalation will 
follow the 3 + 3 design algorithm.  Based on this algorithm, a minimum of 3 evaluable subjects 
will be enrolled in each cohort beginning with Cohort 1 (7 mg; starting dose) and a maximum of 
6 subjects for each cohort. 
Part 1 of the study may also include safety expansion cohorts evaluating dose(s) and schedule(s) 
equivalent to or lower than the highest dose levels determined to be safe and/or doses determined 
to be pharmacologically active.  Each safety expansion cohort will enroll 9 evaluable subjects.  
Up to 36 subjects will be enrolled in Part 1 safety expansion.  If < 3 of 9 evaluable subjects 
experience a DLT, then the cohort will be deemed safe.  If more than 1 safety expansion cohort 
is deemed safe, then a recommended dose and schedule will be determined in conjunction with 
the investigators and sponsor based on all available safety, PK, 
 results. 
9.2.2. 
Sample Size in Part 2 
Part 2 of the study will further evaluate the safety, tolerability, preliminary efficacy, PK, and 
pharmacologic activity of the recommended dose of INCAGN01949.  The sample size for each 
tumor type will be guided by the Simon 2-stage design (Simon 1989).  Let 5% be a clinically 
insignificant response rate for all tumor types.  During Stage 1, 9 subjects will be enrolled; if no 
responses are observed, then the cohort will be discontinued.  If at least 1 response is observed, 
then 8 additional subjects will be enrolled (Stage 2), for a maximum of 17 subjects per tumor 
type in Part 2.  The detailed calculation is based on a 1-sided Type I error of 0.05 and power of 
80% to detect a 25% response rate for each of the tumor types. 
9.3. 
Level of Significance 
For the primary efficacy endpoints of objective response rate, the 1-sided Type I error will be 
controlled at 0.05 for each individual cohort expansion.  Note that this level of significance does 
not account for the multiple expansion cohorts.  For other endpoints, confidence intervals will be 
reported at a 95% confidence level. 


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9.4. 
Statistical Analyses 
9.4.1. 
Efficacy Analyses 
9.4.1.1. 
Primary Efficacy Analyses 
In Part 2, the proportion of subjects who meet the objective response criteria (CR + PR) per 
mRECIST v1.1 will be summarized by tumor type. 
If there are no responses with each tumor type out of 9 subjects (consistent with a calculated 
response rate < 5%) at Stage 1, then the study will be stopped for futility, and the null hypothesis 
is not rejected.  Otherwise, in the tumor types in which at least 1 response among the Stage 1 
subjects is observed, 8 additional subjects will be treated in Stage 2.  If there are ≤ 2 responders 
among 17 subjects at the end of Stage 2, then the drug will be declared nonpromising for that 
tumor type, and the null hypothesis is not rejected.  Further investigation of the study drug will 
be considered interesting (predictive of ≥ 25% response rate) if ≥ 3 responses are observed in the 
first 17 subjects.  For the hypothesis test in the Simon 2-stage design, the null response rate is 5% 
and alternative response rate is 25%. 
9.4.1.2. 
Secondary Efficacy Analyses 
The PK of INCAGN01949 will be summarized.  
The proportion of subjects who have disease control (CR + PR + SD), as per RECIST v1.1 and 
mRECIST v1.1 will be summarized. 
Progression-free survival and duration of response will be estimated using the Kaplan-Meier 
method as per RECIST v1.1 and mRECIST v1.1. 
9.4.2. 
Safety Analyses 
9.4.2.1. 
Adverse Events 
A treatment-emergent adverse event (TEAE) is any AE either reported for the first time or 
worsening of a pre-existing event after the first dose of study drug.  Analysis of AEs will be 
limited to TEAEs, but data listings will include all AEs regardless of their timing in relation to 
study drug administration.  Adverse events will be tabulated by the MedDRA preferred term and 
system organ class.  Severity of AEs will be based on the NCI CTCAE v4.03 using Grades 1 
through 4. 
The subset of AEs considered by the investigator to have a relationship to study drug will be 
considered to be treatment-related AEs.  If the investigator does not specify the relationship of 
the AE to study drug, then the AE will be considered treatment-related.  The incidence of AEs 
and treatment-related AEs will be tabulated. 


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9.4.2.2. 
Clinical Laboratory Tests 
Laboratory test values outside of the normal range will be assessed for severity based on the 
normal ranges for the clinical reference laboratory.  The incidence of abnormal laboratory values 
and shift tables relative to baseline will be tabulated. 
Laboratory data will be classified into Grades 1 through 4 using CTCAE v4.03.  The following 
summaries will be produced for the laboratory data: 
• Number and percentage of subjects with worst postbaseline CTCAE grade (regardless 
of baseline value).  Each subject will be counted only for the worst grade observed 
postbaseline. 
• Shift tables from baseline to the worst postbaseline value using CTCAE grade. 
• For laboratory parameters where CTCAE grades are not defined, shift tables to the 
worst postbaseline value using the low/normal/high classifications based on 
laboratory reference ranges. 
9.4.2.3. 
Vital Signs 
Descriptive statistics and mean change from baseline will be determined for vital signs (blood 
pressure, pulse, respiratory rate, and body temperature) at each assessment time.  Vital sign 
results will be reviewed for clinically notable abnormalities (see Table 15), and subjects 
exhibiting clinically notable vital sign abnormalities will be listed.  A value will be considered an 
"alert" value if it is outside the established range and shows a > 25% change from baseline. 
Table 15: 
Criteria for Clinically Notable Vital Sign Abnormalities 
Parameter 
High Threshold 
Low Threshold 
Systolic blood pressure 
> 155 mmHg 
< 85 mmHg 
Diastolic blood pressure 
> 100 mmHg 
< 40 mmHg 
Pulse 
> 100 bpm 
< 45 bpm 
Temperature 
> 38ºC 
< 35.5ºC 
Respiratory rate 
> 24/min 
< 8/min 
9.4.2.4. 
Electrocardiograms 
Descriptive statistics and mean change from baseline will be determined for each ECG parameter 
at each assessment time.  Electrocardiogram results will be reviewed for clinically notable 
abnormalities according to predefined criteria (Table 16).  Subjects exhibiting clinically notable 
ECG abnormalities will be listed. 


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Table 16: 
Criteria for Clinically Notable Electrocardiogram Abnormalities 
Parameter 
High Threshold 
Low Threshold 
QTcF 
> 460 msec 
< 295 msec 
PR 
> 220 msec 
< 75 msec 
QRS 
> 120 msec 
< 50 msec 
QT 
> 500 msec 
< 300 msec 
RR 
> 1330 msec 
< 600 msec 
QTcF = Fridericia correction. 
9.4.3. 
Pharmacokinetic Analysis 
The PK parameters of Cmax, Tmax, Cmin, and AUC0-t (INCAGN01949) will be summarized by 
part, dose, and study cycle.  The log-transformed PK parameters will be compared among dose 
levels by using a 1-factor analysis of variance.  Dose-dependent parameters (Cmax and AUC) will 
be normalized to the lowest common dose before statistical comparisons.  Additionally, if 
sufficient data are available, then the dose proportionality of INCAGN01949 Cmax and AUC will 
be evaluated statistically by using a power model (eg, AUC = α ∙ [doseβ]) or equivalently log 
(AUC) = log(α) + β∙log (dose), where linear dose proportionality is accepted if β is not 
significantly different from 1). 
If there is a sufficient amount of plasma concentration data from this study, then the data will be 
analyzed by standard population PK methods using appropriate software (eg, NONMEM). 
9.5. 
Analyses for the Data Monitoring Committee 
Not applicable. 
9.6. 
Interim Analysis 
Part 1 of the study will use a standard 3 + 3 dose-escalation design.  Each Part 1 safety expansion 
cohort will enroll up to 9 additional evaluable subjects.  If < 3 of 9 additional evaluable subjects 
has a DLT, then the cohort will be deemed safe.  If more than 1 safety expansion cohort is 
deemed safe, then a recommended dose and schedule will be determined in conjunction with the 
investigators and sponsor based on all available safety, PK, 
 results.  The 
probability of declaring a dose cohort as safe for various DLT rates in the 3 + 3 and the safety 
expansion is summarized in Table 17. 


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Table 17: 
Probability of Dose Escalation by DLT Rate for 3 + 3 Design and Safety 
Expansion 
True DLT Rate 
Probability of Declaring Dose Cohort as Safe 
3 + 3 Design 
In BOTH 3 + 3 Design and 
Safety Expansion 
10% 
90.6% 
85.8% 
20% 
70.9% 
52.3% 
30% 
49.4% 
22.9% 
40% 
30.9% 
7.2% 
50% 
17.2% 
1.5% 
60% 
8.2% 
0.2% 
In Part 2, the Simon 2-stage design will be applied.  During Stage 1, 9 subjects will be enrolled, 
and if no responses are observed, then the cohort will be discontinued.  The probability of early 
termination for Stage 1 is summarized in Table 18.  If at least 1 response is observed, then 
8 additional subjects will be enrolled (Stage 2). 
Table 18: 
Probability of Early Termination at Stage 1 for Simon 2-Stage Design 
True Response Rate 
Probability of Early Termination at Stage 1 
15% 
23.2% 
20% 
13.4% 
25% 
7.5% 
30% 
4.0% 
35% 
2.1% 
Subjects will continue to receive INCAGN01949 until Protocol-defined withdrawal criteria are 
met.  Continuous evaluation of toxicity events will be performed throughout enrollment in Part 2 
of the study.  If the cumulative incidence of DLTs occurs in ≥ 33% of subjects after 6 subjects 
have been observed for at least 28 days, further enrollment may be interrupted until the sponsor 
has determined the appropriate course of action.  All AEs, regardless of the time of occurrence 
on study may be considered in determination of the appropriate dose, schedule, and MNTD. 
Toxicity will continue to be monitored throughout the treatment period.  If > 33% of subjects 
(minimum of 6 subjects) experience a Grade ≥ 3 toxicity related to study drug after completing 
≥ 4 cycles, then dose administration will be stopped, and the MNTD will be determined in 
conjunction with the investigators and sponsor based on all available safety data. 


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10. 
ETHICAL CONSIDERATIONS AND ADMINISTRATIVE 
PROCEDURES 
10.1. 
Investigator Responsibilities 
This study will be performed in accordance with ethical principles that originate in the 
Declaration of Helsinki and conducted in adherence to the study Protocol; GCPs as defined in 
Title 21 of the US CFR Parts 11, 50, 54, 56, and 312; ICH E6 GCP consolidated guidelines; and 
local regulatory requirements as applicable to the study locations. 
The investigator will be responsible for: 
• Permitting study-related monitoring, sponsor audits, IRB/IEC review, and regulatory 
inspections by providing direct access to source data and other relevant clinical study 
documents. 
− Monitoring:  Qualified representatives of the sponsor or its designee, study 
monitors, will monitor the study according to a predetermined plan.  The 
investigator must allow the study monitors to review any study materials and 
subject records at each monitoring visit. 
− Auditing:  Qualified representatives of the sponsor or its designee may audit the 
clinical study site and study data to evaluate compliance with the Protocol, 
applicable local clinical study regulations, and overall study conduct.  The 
investigator must allow the auditors to review original source records and study 
documentation for all subjects. 
− Regulatory inspection:  Regulatory authorities may conduct an inspection of the 
study and the site at any time during the development of an investigational 
product.  The investigator and staff are expected to cooperate with the inspectors 
and allow access to all source documents supporting the eCRFs and other 
study-related documents.  The investigator must immediately notify the sponsor 
when contacted by any regulatory authority for the purposes of conducting an 
inspection. 
• Obtaining informed consent and ensuring that the study subjects' questions have been 
answered and the subjects fully understand study procedures: 
− Informed consent must be obtained before any study-related procedures are 
conducted, unless otherwise specified by the Protocol. 
− Informed consent must be obtained using the IRB/IEC-approved version in a 
language that is native and understandable to the subject.  A template will be 
provided by the sponsor or its designee.  The sponsor or its designee must review 
and acknowledge the site-specific changes to the ICF template.  The ICF must 
include a statement that the sponsor or its designee and regulatory authorities have 
direct access to subject records. 


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• Obtaining approval from the IRB/IEC before the start of the study and for any 
changes to the clinical study Protocol, important Protocol deviations, routine updates, 
and safety information in accordance with institutional requirements and local law. 
− The investigator is responsible for ensuring that the safety reports provided by the 
sponsor are reviewed and processed in accordance with regulatory requirements 
and with the policies and procedures established by the IRB/IEC. 
• Adhering to the Protocol as described in this document and agreeing that changes to 
the Protocol procedures, with the exception of medical emergencies, must be 
discussed and approved, first, by the sponsor or its designee and, second, by the 
IRB/IEC.  Each investigator is responsible for enrolling subjects who have met the 
specified eligibility criteria. 
• Retaining records in accordance with all local, national, and regulatory laws, but for a 
minimum period of at least 2 years after the last marketing application approval in an 
ICH region and until there are no pending or contemplated marketing applications in 
an ICH region, or if not approved, 2 years after the termination of the test article for 
investigation to ensure the availability of study documentation should it become 
necessary for the sponsor or a regulatory authority to review. 
− The investigator must not destroy any records associated with the study without 
receiving approval from the sponsor.  The investigator must notify the sponsor or 
its designee in the event of accidental loss or destruction of any study records.  If 
the investigator leaves the institution where the study was conducted, the sponsor 
or its designee must be contacted to arrange alternative record storage options. 
− All eCRF data entered by the site (including audit trail), as well as computer 
hardware and software (for accessing the data), will be maintained or made 
available at the site in compliance with applicable record retention regulations.  
The sponsor will retain the original eCRF data and audit trail. 
10.2. 
Accountability, Handling, and Disposal of Study Drug 
The investigator is responsible for drug accountability at the study site; however, some of the 
drug accountability duties may be assigned to an appropriate pharmacist or other designee.  
Inventory and accountability records must be maintained and readily available for inspection by 
the study monitor and are open to inspection at any time by any applicable regulatory authorities.  
The investigator or designee must maintain records that document: 
• Delivery of study drug to the study site. 
• Inventory of study drug at the site. 
• Subject use of the study drug including pill or unit counts from each supply 
dispensed. 
• Return of study drug to the investigator or designee by subjects. 
The investigational product must be used only in accordance with the Protocol.  The investigator 
will also maintain records adequately documenting that the subjects were provided the specified 


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study drug.  These records should include dates, quantities, and any available batch or serial 
numbers or unique code numbers assigned to the investigational product and study subjects. 
Completed accountability records will be archived by the site.  The investigator or designee will 
be expected to collect and retain all used, unused, and partially used containers of study drug 
until verified by the study monitor (unless otherwise agreed to by the sponsor).  At the 
conclusion of the study, the investigator or designee will oversee shipment of any remaining 
study drug back to the sponsor or its designee for destruction according to institutional standard 
operating procedures.  If local procedures mandate on-site destruction of investigational supply, 
the site should (where local procedures allow) maintain the investigational supply until the study 
monitor inspects the accountability records in order to evaluate compliance and accuracy of 
accountability by the investigative site.  At sites where the study drug is destroyed before 
monitor inspection, the monitors rely on documentation of destruction per the site SOP. 
10.3. 
Data Management 
Data management will be performed in a validated database via an Electronic Data Capture 
(EDC) system.  All data entry, verification, and validation will be performed in accordance with 
the current standard operating procedures of the Data Management Department at the sponsor or 
its designee.  The database will be authorized for lock once all defined procedures are completed. 
The investigator will be provided with access to an EDC system so that an eCRF can be 
completed for each subject.  Entries made in the eCRF must be verifiable against source 
documents; if updates to the database are not possible, any discrepancies should be explained 
and documented.  The investigator will be responsible for reviewing all data and eCRF entries, 
and will sign and date the designated forms in each subject's eCRF, verifying that the 
information is true and correct.  The investigator is responsible for the review and approval of all 
query responses. 
Protocol deviations will be identified and recorded in the Protocol Deviation form of the eCRF.  
The study monitor will reference the Monitoring Plan in order to ensure that each issue identified 
is appropriately documented, reported, and resolved in a timely manner in accordance with the 
plan's requirements. 
10.4. 
Data Privacy and Confidentiality of Study Records 
The investigator and the sponsor or its designee must adhere to applicable data privacy laws and 
regulations.  The investigator and the sponsor or its designee are responsible for ensuring that 
sensitive information is handled in accordance with local requirements (eg, HIPAA).  
Appropriate consent and authorizations for use and disclosure and/or transfer (if applicable) of 
protected information must be obtained. 
Subject names will not be supplied to the sponsor or its designee, if applicable.  Only the subject 
number and subject's initials (subject's initials will only be recorded if allowable by local 
regulations) will be recorded in the eCRF, where permitted; if the subject's name appears on any 
other document (eg, laboratory report), it must be obliterated on the copy of the document to be 
supplied to the sponsor or its designee.  Study findings stored on a computer will be stored in 
accordance with local data protection laws.  The subjects will be informed that representatives of 
the sponsor or its designee, IRB or IEC, or regulatory authorities may inspect their medical 


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records to verify the information collected, and that all personal information made available for 
inspection will be handled in strictest confidence and in accordance with local data protection 
laws. 
10.5. 
Financial Disclosure 
Before study initiation, all clinical investigators participating in clinical studies subject to FDA 
Regulation Title 21 Code of Federal Regulations (CFR) Part 54 – Financial Disclosure by 
Clinical Investigators (ie, "covered studies") are required to submit a completed Clinical 
Investigator Financial Disclosure form that sufficiently details any financial interests and 
arrangements that apply.  For the purpose of this regulation, "clinical investigator" is defined as 
any investigator or subinvestigator who is directly involved in the treatment or evaluation of 
research subjects, including the spouse and each dependent child of the clinical investigator or 
subinvestigator.  These requirements apply to both US and foreign clinical investigators 
conducting covered clinical studies. 
Any new clinical investigators added to the covered clinical study during its conduct must also 
submit a completed Investigator Financial Disclosure Form.  During a covered clinical study, 
any changes to the financial information previously reported by a clinical investigator must be 
reported to the sponsor or its designee.  At the conclusion of the covered clinical study, the 
clinical investigators will be reminded of their obligations.  In the event that the clinical 
investigator is not reminded, they nevertheless will remain obligated to report to the sponsor or 
its designee any changes to the financial information previously reported, as well as any changes 
in their financial information for a period of 1 year after completion of the covered clinical study. 
10.6. 
Publication Policy 
By signing the study Protocol, the investigator and his or her institution agree that the results of 
the study may be used by the sponsor, Incyte Biosciences International Sàrl (Incyte), for the 
purposes of national and international registration, publication, and information for medical and 
pharmaceutical professionals.  Study results will be published in accordance with applicable 
local and national regulations.  If necessary, the authorities will be notified of the investigator's 
name, address, qualifications, and extent of involvement.  The terms regarding the publication of 
study results are contained in the agreement signed with the sponsor or its designee.  A signed 
agreement will be retained by the sponsor or its designee. 


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Moran AE, Kovacsovics-Bankowski M, Weinberg AD. The TNFRs OX40, 4-1BB, and CD40 as 
targets for cancer immunotherapy. Curr Opin Immunol 2013;25. 
National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology. 
http://www.nccn.org/professionals/physician_gls/f_guidelines.asp. Accessed May 27, 2014. 
Nosho K, Baba Y, Tanaka N, et al. Tumour-infiltrating T-cell subsets, molecular changes in 
colorectal cancer, and prognosis: cohort study and literature review. J Pathol 2010;222:350-366. 
Oble DA, Loewe R, Yu P, Mihm MC Jr. Focus on TILs: prognostic significance of tumor 
infiltrating lymphocytes in human melanoma. Cancer Immun 2009;9:3. 
Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern 
Cooperative Oncology Group. Am J Clin Oncol 1982;5:649-655. 
Petty JK, He K, Corless CL, Vetto JT, Weinberg AD. Survival in human colorectal cancer 
correlates with expression of the T-cell costimulatory molecule OX-40 (CD134). Am J Surg 
2002;183:512-518. 
Preston CC, Maurer MJ, Oberg AL, et al. The ratios of CD8+ T cells to CD4+CD25+ FOXP3+ 
and FOXP3- T cells correlate with poor clinical outcome in human serous ovarian cancer. PLoS 
One 2013;8:e80063. 
Salgado R, Denkert C, Demaria S, et al. The evaluation of tumor-infiltrating lymphocytes (TILs) 
in breast cancer: recommendations by an International TILs Working Group 2014. Ann Oncol 
2015;26:259-271. 
Schaer DA, Budhu S, Liu C, et al. GITR pathway activation abrogates tumor immune 
suppression through loss of regulatory T cell lineage stability. Cancer Immunol Res 
2013;1:320-331. 
Schaer DA, Li Y, Merghoub T, et al. Detection of intra-tumor self antigen recognition during 
melanoma tumor progression in mice using advanced multimode confocal/two photon 
microscope. PLoS One 2011;6:e21214. 
Schreiber RD, Old LJ, Smyth MJ. Cancer immunoediting: integrating immunity's roles in cancer 
suppression and promotion. Science 2011;331:1565-1570. 
Shirabe K, Motomura T, Muto J, et al. Tumor-infiltrating lymphocytes and hepatocellular 
carcinoma: pathology and clinical management. Int J Clin Oncol 2010;15:552-558. 
Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials 1989;10:1-10. 
Talmadge JE. Immune cell infiltration of primary and metastatic lesions: mechanisms and 
clinical impact. Semin Cancer Biol 2011;21:131-138. 
Uppaluri R, Dunn GP, Lewis JS Jr. Focus on TILs: prognostic significance of tumor infiltrating 
lymphocytes in head and neck cancers. Cancer Immun 2008;8:16. 
Valzasina B, Guiducci C, Dislich H, Killeen N, Weinberg AD, Colombo MP. Triggering of 
OX40 (CD134) on CD4(+)CD25+ T cells blocks their inhibitory activity: a novel regulatory role 
for OX40 and its comparison with GITR. Blood 2005;105:2845-2851. 


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CONFIDENTIAL 
Vetto JT, Lum S, Morris A, et al. Presence of the T-Cell activation marker OX-40 on tumor 
infiltrating lymphocytes and draining lymph node cells from patients with melanoma and head 
and neck cancers. Am J Surg 1997;174:258-265. 
Wang DD, Zhang S, Zhao H, Men AY, Parivar MS. Fixed dosing versus body size-based dosing 
of monoclonal antibodies in adult clinical trials. J Clin Pharmacol 2009;49:1012-1024. 
Weinberg AD, Rivera MM, Prell R, et al. Engagement of the OX-40 receptor in vivo enhances 
antitumor immunity. J Immunol 2000;164:2160-2169. 
Weinberg AD, Morris NP, Kovacsovics-Bankowski M, Urba WJ, Curti BD. Science gone 
translational: the OX40 agonist story. Immunol Rev 2011;244:218-231. 
Wolchok JD, Saenger Y. The mechanism of anti-CTLA-4 activity and the negative regulation of 
T-cell activation. Oncologist 2008;13 Suppl 4:2-9. 
Yao S, Zhu Y, Chen L. Advances in targeting cell surface signalling molecules for immune 
modulation. Nat Rev Drug Discov 2013;12:130-146. 
Yoon HH, Orrock JM, Foster NR, Sargent DJ, Smyrk TC, Sinicrope FA. Prognostic impact of 
FoxP3+ regulatory T cells in relation to CD8+ T lymphocyte density in human colon 
carcinomas. PLoS One 2012;7:e42274. 


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APPENDIX A. INFORMATION REGARDING EFFECTIVENESS OF 
CONTRACEPTIVE METHODS 
For Subjects Participating in the Study: 
The following methods that can achieve a failure rate of less than 1% per year when used 
consistently and correctly are considered as highly effective birth control methods.  
Such methods include: 
• Combined (estrogen and progestogen containing) hormonal contraception associated 
with inhibition of ovulation1 
− oral 
− intravaginal 
− transdermal 
• Progestogen-only hormonal contraception associated with inhibition of ovulation1 
− oral 
− injectable 
− implantable2 
• Intrauterine device (IUD)2 
• Intrauterine hormone-releasing system (IUS)2 
• Bilateral tubal occlusion2 
• Vasectomised partner2,3 
• Sexual abstinence4 
 
1  Hormonal contraception may be susceptible to interaction with the IMP, which may reduce the efficacy of the 
contraception method. 
2  Contraception methods that in the context of this guidance are considered to have low user dependency. 
3  Vasectomised partner is a highly effective method provided of avoiding pregnancy that partner is the sole sexual 
partner of the WOCBP trial participant and that the vasectomised partner has received medical assessment of the 
surgical success.  
4  In the context of this guidance, sexual abstinence is considered a highly effective method only if defined as 
refraining from heterosexual intercourse during the entire period of risk associated with the study treatments.  The 
reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the 
preferred and usual lifestyle of the subject. 
Source:  CTFG 2014. 


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APPENDIX B. PROCEDURES AND SUPPORTIVE CARE GUIDELINES 
FOR SUBJECTS EXHIBITING IMMUNE-RELATED 
ADVERSE EVENTS 
irAE 
Supportive Care 
Pneumonitis 
For Grade 2 (mild to moderate new symptoms):  
• Monitor symptoms daily and consider hospitalization.  
• Promptly start systemic steroids per institutional standard of care. 
• Consider adding prophylactic antibiotics for opportunistic infections in the case 
of prolonged steroid administration. 
• Reimaging as clinically indicated. 
• If no improvement within 3 to 5 days, additional work-up should be considered 
and prompt treatment with IV methylprednisolone should be started. 
• If still no improvement within 3 to 5 days despite IV methylprednisone, consider 
starting immunosuppressive therapy (eg, infliximab), after discussing with the 
medical monitor. 
Caution:  Important to rule out sepsis and refer to infliximab label for general 
guidance before using infliximab.  
• Once improving, gradually taper steroids over ≥ 4 weeks and consider 
prophylactic antibiotics, antifungal, or anti-PCP treatment (refer to current 
NCCN Guidelines for treatment of cancer-related infections 
[Category 2B recommendation]). 
• Consider pulmonary and infectious disease consult.  
For Grade 3 or 4 (severe or new symptoms, new/worsening hypoxia, life 
threatening):  
• Promptly initiate empiric IV methylprednisolone or equivalent.  
• Carefully monitor subject, and institute medical intervention as appropriate for 
the management of symptoms.  Consider obtaining pulmonary and infectious 
disease consult. 
• If no improvement within 3-5 days, additional work-up should be considered and 
prompt treatment with additional immunosuppressive therapy (eg, infliximab), 
after discussing with the medical monitor. 
Caution:  Rule out sepsis and refer to infliximab label for general guidance 
before using infliximab.  
• Once improving, gradually taper steroids over ≥ 4 weeks and consider 
prophylactic antibiotics, antifungals, and in particular, anti-PCP treatment (refer 
to current NCCN Guidelines for treatment of cancer-related infections [Category 
2B recommendation]). 


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irAE 
Supportive Care 
Diarrhea/colitis 
Note: Subjects should be carefully monitored for signs and symptoms of 
enterocolitis (such as diarrhea, abdominal pain, blood or mucus in stool, with or 
without fever) and of bowel perforation (such as peritoneal signs and ileus).   
For Grade 2 (mild to moderate new symptoms):  
• Consider symptomatic treatment, including hydration, electrolyte replacement, 
dietary changes (eg, American Dietetic Association colitis diet), and loperamide 
and/or budesonide. 
• Promptly start systemic steroids per institutional standard of care. 
• If event is not responsive within 3 to 5 days or worsens, GI consult should be 
obtained for consideration of further work-up, and prompt treatment with IV 
methylprednisolone started. 
• If still no improvement within 3 to 5 days, consider starting immunosuppressives 
(eg, infliximab) after discussing with the medical monitor. 
Caution:  Important to rule out bowel perforation and refer to infliximab label 
for general guidance before using infliximab. 
• Consult medical monitor if no resolution to ≤ Grade 1 in 3-4 days. 
• Once improving, gradually taper steroids over ≥ 4 weeks and consider 
prophylactic antibiotics, antifungals, and anti-PCP treatment (refer to current 
NCCN Guidelines for treatment of cancer-related infections [Category 2B 
recommendation]). 
For Grade 3 or 4 (severe or new symptoms, new/worsening diarrhea, life 
threatening): 
• Treatment with systemic corticosteroids should be initiated per institutional 
standard of care. 
• Manage symptoms and consider GI consult for further work-up as appropriate. 
• If still no improvement within 3-5 days, consider starting immunosuppressives 
(eg, infliximab), after discussing with the medical monitor. 
Caution:  Ensure GI consult to rule out bowel perforation and refer to infliximab 
label for general guidance before using infliximab. 
• Once improving, gradually taper steroids over ≥ 4 weeks and consider 
prophylactic antibiotics, antifungals, and anti-PCP treatment (refer to current 
NCCN Guidelines for treatment of cancer-related infections [Category 2B 
recommendation]). 


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irAE 
Supportive Care 
Hepatitis 
For Grade 2 (mild to moderate new symptoms):  
• Observe subject with regular and frequent checking of liver chemistries until 
improving or resolved. 
• Rule out non-irAE etiologies. 
• If event is persistent (> 3-5 days) or worsens, consider starting systemic steroids 
per institutional standard of care. 
• If still no improvement within 3-5 days, consider additional work-up and prompt 
treatment with IV methylprednisolone. 
• If still no improvement within 3-5 days, consider starting immunosuppressives 
(eg, mycophenolate mofetil), after discussing with the medical monitor. 
• Infliximab should NOT be used. 
• Once improving, gradually taper steroids over ≥ 4 weeks and consider 
prophylactic antibiotics, antifungals, and anti-PCP treatment (refer to current 
NCCN Guidelines for treatment of cancer-related infections [Category 2B 
recommendation]). 
For Grade 3 or 4 (severe or new symptoms, new/worsening hepatitis, life 
threatening): 
• Promptly initiate empiric IV methylprednisolone or equivalent. 
• If still no improvement within 3 to 5 days, consider starting treatment with 
immunosuppressive therapy (eg, mycophenolate mofetil), after discussing with 
the medical monitor. 
• Infliximab should NOT be used. 
• Consider hepatology consult for additional work-up, as appropriate. 
• Once improving, gradually taper steroids over ≥ 4 weeks and consider 
prophylactic antibiotics, antifungals, and anti-PCP treatment (refer to current 
NCCN Guidelines for treatment of cancer-related infections [Category 2B 
recommendation]). 


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irAE 
Supportive Care 
Dermatitis 
Note:  Monitor subjects for signs and symptoms of dermatitis such as rash and 
pruritus.  Unless an alternate etiology has been identified, signs or symptoms of 
dermatitis should be considered immune-mediated.  If there is any bullous 
formation, the medical monitor should be contacted, and the study drug should be 
discontinued. 
For Grade 2 (mild to moderate new symptoms):  
• Consider dermatology consult. 
• Consider symptomatic treatment per institutional standard of care. 
• Consider moderate-strength topical steroid. 
• If no improvement of rash/skin lesions occurs within 3 to 5 days or is worsening 
despite symptomatic treatment and/or use of moderate strength topical steroid, 
discuss with medical monitor and promptly start systemic steroids. 
For Grade 3 or 4 (severe or new symptoms, new/worsening dermatitis, life 
threatening): 
• Consider dermatology consult. 
• Promptly initiate empiric IV methylprednisolone or equivalent. 
• Carefully monitor subject, and institute medical intervention as appropriate for 
the management of symptoms.   
• Consider hospitalization. 
• Once improving, gradually taper steroids over ≥ 4 weeks and consider 
prophylactic antibiotics, antifungals, and anti-PCP treatment (refer to current 
NCCN Guidelines for treatment of cancer-related infections [Category 2B 
recommendation]). 
• Discuss with medical monitor. 
Renal failure or 
nephritis 
Note:  Subjects should be monitored for signs and symptoms that may be related to 
changes in renal function.  Subjects should be thoroughly evaluated to rule out any 
alternative etiology.  Steroids should be considered in the absence of clear 
alternative etiology even for low-grade events (Grade 2) in order to prevent 
potential progression to higher grade event. 
For Grades 2 to 4:  
• Carefully monitor subject, and institute medical intervention as appropriate for 
the management of symptoms.  Consider consult with nephrologist, if clinically 
indicated.   
• If event is persistent (> 3-5 days) or worsens, promptly start systemic steroids per 
institutional standard of care. 
• If event is not responsive within 3-5 days or worsens despite steroids, additional 
work-up should be considered, and prompt treatment with IV methylprednisolone 
started. 
• Once improving, gradually taper steroids over ≥ 4 weeks and consider 
prophylactic antibiotics, antifungals, and anti-PCP treatment (refer to current 
NCCN Guidelines for treatment of cancer-related infections [Category 2B 
recommendation]). 


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irAE 
Supportive Care 
Endocrinopathies 
Note:  Subjects should be monitored for clinical signs and symptoms of 
hypophysitis, adrenal insufficiency (including adrenal crisis), and hyper- or 
hypothyroidism.  Subjects may report fatigue, headache, mental status changes, 
abdominal pain, unusual bowel habits, and hypotension or report nonspecific 
symptoms that may resemble other causes, such as brain metastasis or underlying 
disease.  Unless an alternate etiology has been identified, signs or symptoms of 
endocrinopathies should be considered immune-mediated. 
For Grade 2 (mild to moderate new symptoms):  
• In hypophysitis, treat with systemic corticosteroids, per institutional standard of 
care.  When symptoms improve to Grade 1 or less, steroid taper should be started 
and continued over no less than 4 weeks.  Replacement of appropriate hormones 
may be required as the steroid dose is tapered. 
Note:  These suggested supportive care measures also apply to Grade 3 
hypophysitis  
• In hyperthyroidism, nonselective beta-blockers (eg, propranolol) are suggested as 
initial therapy. 
• In hypothyroidism, thyroid hormone replacement therapy, with levothyroxine or 
liothyronine, is indicated per standard of care. 
Note:  Isolated hypothyroidism may be treated with replacement therapy without 
treatment interruption and without corticosteroids. 
• Evaluate endocrine function and, as clinically indicated, consider pituitary scan. 
• For subjects with abnormal endocrine work-up, except for those with isolated 
hypothyroidism, consider short-term, high-dose corticosteroids (eg, 
methylprednisolone or IV equivalent), and initiate appropriate hormone 
replacement therapy. 
• For subjects with normal endocrine work-up (laboratory assessments or MRI), 
repeat laboratory assessments/MRI as clinically indicated. 
• For Grade 3 or 4 (severe or new symptoms, new/worsening endocrinopathies, 
life threatening): 
• Hypothyroidism may be treated with replacement therapy without treatment 
interruption and without corticosteroids. 
• In hyperthyroidism, treat with an initial dose of IV corticosteroid followed by 
oral corticosteroids.  Consider initiation of systemic corticosteroids at a dose of 
1-2 mg/kg per day of prednisone or equivalent, and initiate appropriate hormone 
replacement therapy.  Once improving, gradually taper immunosuppressive 
steroids over ≥ 4 weeks. 
• In hypophysitis, treat with an initial dose of IV corticosteroids followed by oral 
corticosteroids.  When symptoms improve to Grade 1 or less, steroid taper should 
be started and continued over no less than 4 weeks.  Replacement of appropriate 
hormones may be required as the steroid dose is tapered. 
• For adrenal crisis, severe dehydration, hypotension, or shock:  immediately 
initiate IV corticosteroids with mineralocorticoid activity. 
• Consult endocrinologist. 
• Consult medical monitor. 


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irAE 
Supportive Care 
Neuropathies 
Note:  Monitor subjects for symptoms of motor or sensory neuropathy such as 
unilateral or bilateral weakness, sensory alterations, or paresthesia. 
For Grade 2 (mild to moderate new symptoms):  
• Consider systemic corticosteroids per institutional standard of care in addition to 
appropriate symptomatic treatment. 
• If no improvement within 3-5 days, consider additional work-up and consider 
treating with additional immunosuppressive therapy (eg, IV IgG), after 
discussing with the medical monitor. 
For Grade 3 or 4 (severe or new symptoms, new/worsening neuropathies, life 
threatening): 
• Consider initiation of systemic corticosteroids (IV administration should be 
strongly considered) for severe neuropathies. 
• Institute medical intervention as appropriate for management of severe 
neuropathy. 
• If no improvement within 3-5 days despite IV corticosteroids, consider additional 
workup and consider treating with additional immunosuppressants (eg, IV IgG) 
after discussing with the medical monitor. 
• Once stable, gradually taper steroids over ≥ 4 weeks. 
GI = gastrointestinal; IgG = immunoglobulin G; irAE = immune-related adverse event; IV = intravenous; 
MRI = magnetic resonance imaging; NCCN = National Comprehensive Cancer Network; PCP = pneumocystis 
pneumonia. 


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APPENDIX C. EASTERN COOPERATIVE ONCOLOGY GROUP 
PERFORMANCE STATUS 
Grade 
Performance Status 
0 
Fully active, able to carry on all predisease performance without restriction. 
1 
Restricted in physically strenuous activity but ambulatory and able to carry out work of a light 
or sedentary nature, eg, light house work, office work. 
2 
Ambulatory and capable of all self-care but unable to carry out any work activities.  Up and 
about more than 50% of waking hours. 
3 
Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 
4 
Completely disabled.  Cannot carry on any self-care.  Totally confined to bed or chair. 
5 
Dead. 
Source:  Oken et al 1982. 


Signature Manifest
Document Number: IC-DEV-PROT-AMEND-0270
Revision: 0
Title: INCAGN 1949-101 Protocol Amendment 2
All dates and times are in Eastern Standard Time.
APPROVAL: 1949-101 Amendment 2
Approval and Release
Name/Signature
Title
Date
Meaning/Reason
 
17 Aug 2017, 12:46:19 PM
Approved
 
 O 17 Aug 2017, 01:06:13 PM
Approved
 
17 Aug 2017, 01:21:36 PM
Approved
 
17 Aug 2017, 06:10:17 PM
Approved
Page 1 of 1
Signature Manifest
8/17/2017

SAP_000.pdf: 
Incyte Corporation 
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INCAGN 1949-101 Statistical Analysis Plan 
05 JAN 2017 
CONFIDENTIAL 
STATISTICAL ANALYSIS PLAN 
INCAGN 1949-101 / NCT02923349
A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability 
Study of INCAGN01949 in Subjects With Advanced or Metastatic 
Solid Tumors 
IND Number: 
129,838 
EudraCT Number: 
2016-002079-93 
Sponsor: 
Incyte Europe Sàrl 
rue du Pré-de-la-Bichette 1 
1202 Geneva, Switzerland 
Protocol Version: 
Original Protocol dated 07 JUN 2016 
CRF Approval Date: 
26 JUL 2016 
SAP Version: 
Original 
SAP Author: 
, PhD 
 
Date of Plan: 
05 JAN 2017 
This study is being conducted in compliance with good clinical practice, 
including the archiving of essential documents. 


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TABLE OF CONTENTS 
LIST OF ABBREVIATIONS ..........................................................................................................6 
1. 
INTRODUCTION ........................................................................................................8 
2. 
STUDY INFORMATION, OBJECTIVES, AND ENDPOINTS.................................8 
2.1. 
Protocol and Case Report Form Version ......................................................................8 
2.2. 
Study Objectives ...........................................................................................................8 
2.2.1. 
Primary Objective .........................................................................................................8 
2.2.2. 
Secondary Objectives ...................................................................................................8 
 
9 
2.3. 
Study Endpoints ............................................................................................................9 
2.3.1. 
Primary Endpoint ..........................................................................................................9 
2.3.2. 
Secondary Endpoints ....................................................................................................9 
 
9 
3. 
STUDY DESIGN .......................................................................................................10 
3.1. 
Dose Escalation and Expansion ..................................................................................11 
3.1.1. 
Part 1 – Dose Escalation .............................................................................................11 
3.1.2. 
Part 1 – Safety Expansion ...........................................................................................12 
3.1.3. 
Part 2 – Dose Expansion .............................................................................................13 
3.2. 
Randomization ............................................................................................................13 
3.3. 
Control of Type I Error ...............................................................................................13 
3.4. 
Sample Size Considerations .......................................................................................14 
3.4.1. 
Sample Size in Part 1 ..................................................................................................14 
3.4.2. 
Sample Size in Part 2 ..................................................................................................14 
4. 
DATA HANDLING DEFINITIONS AND CONVENTIONS ..................................16 
4.1. 
Scheduled Study Evaluations and Study Periods .......................................................16 
4.1.1. 
Day 1 ...........................................................................................................................16 
4.1.2. 
Study Day ...................................................................................................................16 
4.1.3. 
Baseline Value ............................................................................................................16 
4.1.4. 
Handling of Missing and Incomplete Data .................................................................16 
4.1.5. 
Cycle Length and Duration .........................................................................................17 
4.2. 
Variable Definitions ....................................................................................................18 
4.2.1. 
Derived Variables .......................................................................................................18 


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4.2.1.1. 
MSKCC Criteria for Renal Cell Carcinoma Subjects ................................................18 
4.2.1.2. 
Prior and Concomitant Medication .............................................................................18 
4.2.2. 
Variables to Be Derived Only If Not Provided on Case Report Form .......................19 
5. 
STATISTICAL METHODOLOGY ...........................................................................19 
5.1. 
General Methodology .................................................................................................19 
5.2. 
Treatment Groups .......................................................................................................19 
5.3. 
Analysis Populations ..................................................................................................19 
5.3.1. 
Full Analysis Set Population ......................................................................................19 
5.3.2. 
Part 1 Full Analysis Set Population ............................................................................20 
5.3.3. 
Part 2 Full Analysis Set Population ............................................................................20 
5.3.4. 
Per Protocol Population ..............................................................................................20 
5.3.5. 
Pharmacokinetic 
 Evaluable Populations ...............................20 
5.3.5.1. 
Pharmacokinetic Evaluable Population ......................................................................20 
 
20 
 
21 
6. 
BASELINE, EXPOSURE, AND DISPOSITION VARIABLES AND 
ANALYSES ...............................................................................................................21 
6.1. 
Baseline and Demographics, Physical Characteristics, and Disease History .............21 
6.1.1. 
Demographics .............................................................................................................21 
6.1.2. 
Baseline Disease Characteristics and Disease History ...............................................21 
6.1.3. 
Prior Therapy ..............................................................................................................21 
6.1.4. 
Medical History ..........................................................................................................22 
6.2. 
Disposition of Subjects ...............................................................................................22 
6.3. 
Protocol Deviations and Violations ............................................................................22 
6.4. 
Exposure .....................................................................................................................22 
6.5. 
Prior and Concomitant Medication .............................................................................23 
7. 
EFFICACY .................................................................................................................23 
7.1. 
General Considerations ...............................................................................................23 
7.2. 
Efficacy Hypotheses ...................................................................................................23 
7.3. 
Analysis of the Primary Efficacy Parameter ..............................................................23 
7.4. 
Analysis of the Secondary Efficacy Parameter ..........................................................23 
7.4.1. 
Response Criteria ........................................................................................................23 
7.4.2. 
Objective Response Rates and Best Overall Response ..............................................24 


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7.4.2.1. 
Objective Response Rate by RECIST v1.1 ................................................................24 
7.4.2.2. 
Objective Response Rate by mRECIST v1.1 .............................................................24 
7.4.3. 
Subgroup Analyses of Objective Response Rates ......................................................25 
7.4.4. 
Duration of Response .................................................................................................25 
7.4.4.1. 
Duration of Response by RECIST v1.1 ......................................................................26 
7.4.4.2. 
Duration of Response by mRECIST v1.1 ...................................................................26 
7.4.5. 
Duration of Disease Control .......................................................................................26 
7.4.6. 
Largest Percentage Reduction in Sum of Diameters of Target Lesions .....................26 
7.4.7. 
Percentage Change in Sum of Diameters of Target Lesions Over Time ....................26 
7.4.8. 
Progression-Free Survival ..........................................................................................27 
7.4.8.1. 
Progression-Free Survival by RECIST v1.1 ...............................................................27 
7.4.8.2. 
Progression-Free Survival by mRECIST v1.1 ............................................................28 
 
28 
7.6. 
Pharmacokinetic Analyses ..........................................................................................28 
 
29 
8. 
SAFETY AND TOLERABILITY ..............................................................................29 
8.1. 
General Considerations ...............................................................................................29 
8.2. 
Adverse Events ...........................................................................................................30 
8.2.1. 
Adverse Event Definitions ..........................................................................................30 
8.2.2. 
Dose-Limiting Toxicities ............................................................................................30 
8.2.3. 
Maximum Tolerated Dose ..........................................................................................30 
8.2.4. 
Immune-Related Adverse Events ...............................................................................31 
8.2.5. 
Adverse Event Summaries ..........................................................................................31 
8.3. 
Clinical Laboratory Tests ...........................................................................................32 
8.3.1. 
Laboratory Value Definitions .....................................................................................32 
8.3.2. 
Laboratory Value Summaries .....................................................................................32 
8.4. 
Vital Signs ..................................................................................................................33 
8.5. 
Electrocardiograms .....................................................................................................34 
9. 
INTERIM ANALYSES ..............................................................................................35 
10. 
CHANGES AND MODIFICATIONS TO THE ANALYSIS PLAN ........................36 
11. 
REFERENCES ...........................................................................................................37 
APPENDIX A. PLANNED TABLES AND FIGURES .............................................................38 
 


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LIST OF TABLES 
Table 1: 
INCAGN01949 Dose Levels and Cohort ...................................................................12 
Table 2: 
Probability of Dose Escalation by DLT Rate for 3 + 3 Design and Safety 
Expansion ...................................................................................................................14 
Table 3: 
RECIST Evaluation Criteria for Overall Response:  Measurable Disease at 
Baseline .......................................................................................................................24 
Table 4: 
Rules for Determining PD Event Status After an Unconfirmed PD ..........................25 
Table 5: 
Evaluation and Censoring of Progression-Free Survival ............................................27 
Table 6: 
Criteria for Clinically Notable Vital Sign Abnormalities ...........................................34 
Table 7: 
Criteria for Clinically Notable Electrocardiogram Abnormalities .............................34 
Table 8: 
Probability of Early Termination at Stage 1 for Simon 2-Stage Design ....................35 
Table 9: 
Statistical Analysis Plan Versions ..............................................................................36 
 
LIST OF FIGURES 
Figure 1: 
Study Design ...............................................................................................................11 
Figure 2: 
Power and Type I Error for Simon 2-Stage Design for Various Response 
Rates ...........................................................................................................................15 
Figure 3: 
Probabilities of Early Termination for Futility at the End of Simon Stage 1 
Based on Various Assumed Rates of Response to a Given Dose Level ....................36 
 


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CONFIDENTIAL 
LIST OF ABBREVIATIONS 
Abbreviation 
Term 
 
 
AE 
adverse event 
AUC 
area under the concentration-time curve 
AUC(0-τ) 
AUC from time zero (predose) to time of last observed quantifiable concentration 
within a subject across all treatments 
CI 
confidence interval 
Cmax 
maximum observed concentration 
Cmin 
minimum observed concentration 
CR 
complete response  
CRF 
case report form 
CSR 
Clinical Study Report 
CTCAE 
Common Terminology Criteria for Adverse Events 
DLT 
dose-limiting toxicity 
DOR 
duration of response 
ECG 
electrocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
EOS 
end of study 
EOT 
end of treatment 
FAS 
full analysis set 
FDA 
Food and Drug Administration 
irAE 
immune-related adverse event   
JTc 
corrected JT interval 
KM 
Kaplan-Meier 
MedDRA 
Medical Dictionary for Regulatory Activities  
MNTD 
maximum number of tolerated doses  
MSI 
microsatellite instability 
MSKCC 
Memorial Sloan Kettering Cancer Center 
mRECIST 
modified Response Evaluation Criteria in Solid Tumors 
MTD 
maximum tolerated dose 
NCI 
National Cancer Institute  
NE 
not evaluable 
NSCLC 
non–small cell lung cancer 
ORR 
objective response rate 
PAD 
pharmacologically active dose 


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Abbreviation 
Term 
PD 
progressive disease 
PD-1 
programmed death-1 
PD-L1 
programmed death ligand-1 
PFS 
progression-free survival 
PK 
pharmacokinetic 
PP 
per protocol 
PR 
partial response 
PT 
preferred term 
QTcF 
QT interval corrected using the Fridericia formula 
QRS 
QRS is the combination of three of the graphical deflections on an ECG.  It is 
usually the central and most visually obvious part of the tracing.  It corresponds to 
the depolarization of the right and left ventricles of the human heart. 
RCC 
renal cell carcinoma 
RECIST 
Response Evaluation Criteria in Solid Tumors 
RR 
RR is the interval from the beginning of a QRS complex to the beginning of the next 
QRS complex 
SAE 
serious adverse event 
SAP 
Statistical Analysis Plan 
SD 
stable disease 
SI 
International System of Units 
SOC 
system organ class 
t 
time of last observed quantifiable concentration 
TEAE 
treatment-emergent adverse event 
Tmax 
time of occurrence of Cmax 
WBC 
white blood cell 
WHO 
World Health Organization  


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1. 
INTRODUCTION 
This is a Phase 1/2, open-label, nonrandomized, multicenter, dose-escalation study.  This study 
will be conducted in 2 parts.  Part 1 will utilize a 3 + 3 design to determine the MTD or PAD for 
INCAGN01949 in subjects with advanced or metastatic solid tumors.  Part 2 of the study will 
further evaluate the safety, tolerability, preliminary efficacy, PK, 
 of the 
recommended dose and schedule of INCAGN01949 in subjects with advanced or metastatic 
adenocarcinoma of the endometrium, ovarian cancer, RCC, melanoma, and NSCLC (squamous 
and nonsquamous).  Section 1 of the Protocol provides a detailed description of the 
investigational product, target patient population, rationale for doses to be examined, and 
potential risks and benefits of treatment with INCAGN01949. 
The purpose of this SAP is to provide details of the statistical analyses that have been outlined in 
the Study INCAGN 1949-101 Protocol.  The scope of this plan includes the interim and final 
analyses that are planned and will be executed by the Department of Biostatistics or designee and 
the analyses of PK. 
 
. 
2. 
STUDY INFORMATION, OBJECTIVES, AND ENDPOINTS 
2.1. 
Protocol and Case Report Form Version 
This SAP is based on INCAGN 1949-101 Protocol dated 07 JUN 2016 and CRFs approved 
26 JUL 2016.  Unless superseded by an amendment, this SAP will be effective for all subsequent 
Protocol amendments and CRF versions. 
2.2. 
Study Objectives 
2.2.1. 
Primary Objective 
• To evaluate the safety, tolerability, and DLTs of INCAGN01949, and to define a 
MTD or PAD of INCAGN01949 in subjects with metastatic or advanced solid 
tumors. 
2.2.2. 
Secondary Objectives 
• To evaluate the PK of INCAGN01949 in subjects with advanced or metastatic solid 
tumors. 
• To evaluate the preliminary efficacy of INCAGN01949 by assessing the ORR, DOR, 
PFS, and duration of disease control per RECIST v1.1 and mRECIST v1.1. 


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2.3. 
Study Endpoints 
2.3.1. 
Primary Endpoint 
• Safety and tolerability will be assessed by monitoring the frequency, duration, and 
severity of AEs. 
2.3.2. 
Secondary Endpoints 
• The PK of INCAGN01949, including Cmax, Tmax, Cmin, and AUC0-t for subjects in 
Parts 1 and 2 will be summarized. 
• ORR, defined as the percentage of subjects having CR or PR, will be determined by 
investigator assessment of radiographic disease per RECIST v1.1 and mRECIST 
v1.1. 
• DOR, defined as the time from earliest date of disease response (CR or PR) until 
earliest date of disease progression, will be determined by investigator assessment of 
radiographic disease per RECIST v1.1 and mRECIST v1.1, or death from any cause, 
if occurring sooner than progression. 
• PFS, defined as the time from date of first dose of study drug until the earliest date of 
disease progression, as determined by investigator assessment of objective 
radiographic disease per RECIST v1.1 and mRECIST v1.1, or death from any cause 
if occurring sooner than progression. 
• Duration of disease control (CR, PR, and SD), as measured from first report of SD or 
better until disease progression, will be determined by investigator assessment of 
radiographic disease per RECIST v1.1 and mRECIST v1.1, or death from any cause, 
if occurring sooner than progression.  


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3. 
STUDY DESIGN 
This is an open-label, nonrandomized, Phase 1/2 study to determine the safety and tolerability, 
define the MTD or PAD, and assess the preliminary efficacy of INCAGN01949 in subjects with 
advanced or metastatic solid tumors.  Subjects will receive escalating doses of INCAGN01949 
on Day 1 of each cycle.  Part 1 of the study will begin with 14-day cycles; however, alternate 
dose administration schedules may also be explored depending on PK, 
 
 and safety results.  The study will be conducted in 2 parts: 
• Part 1 – Dose Escalation and Safety Expansion will determine the PAD, defined as 
a dose that provides a maximal biochemical effect, 
 
, and/or the MTD of INCAGN01949, including defining the optimal 
dose administration schedule and the MNTD. 
• Part 2 – Dose Expansion will evaluate the recommended dose and administration 
schedule determined in Part 1 in subjects with select tumor types 
 
 
 including adenocarcinoma of endometrium, ovarian cancer, 
melanoma, NSCLC, and RCC. 
See Figure 1 for overall study design. 


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Figure 1: 
Study Design 
 
3.1. 
Dose Escalation and Expansion 
3.1.1. 
Part 1 – Dose Escalation  
The PAD is defined as a dose that provides a maximal biochemical effect, or an increase in 
biomarkers of immune activity.  
A DLT will be defined as the occurrence of a toxicity, with the exception of events clearly 
associated with the underlying disease, disease progression, a concomitant medication, or 
comorbidity; the list of toxicities that will be designated as dose limiting toxicities are provided 
in Table 3 of the Protocol. 
In Part 1 of the study, the MTD will be defined as 1 dose level below that at which ≥ one-third of 
subjects in a particular cohort have DLTs. 
In Part 1, subjects with advanced or metastatic solid tumors who progressed after treatment with 
available therapies that are known to confer clinical benefit, who are intolerant to treatment, or 
refuse standard treatment will be enrolled. 
In the dose-escalation part of the study, a 3 + 3 design will be used to determine the MTD or 
PAD of INCAGN01949.  A minimum of 3 evaluable subjects will be enrolled in each cohort 
beginning with Cohort 1 (7 mg; starting dose).  There will be a waiting period of 48 hours 
between dose administration of the first subject and second subject of each dose cohort.  The first 
3 subjects enrolled within a cohort will be observed for a DLT observation period of 28 days 


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before the next cohort begins enrollment.  The dose will be escalated if 0 of the first 3 evaluable 
subjects enrolled has a DLT.  If 1 of the first 3 evaluable subjects enrolled has a DLT, then the 
cohort will be expanded to include 3 additional evaluable subjects, and if no DLT occurs in the 
additional 3 subjects, then the dose will be escalated.  If a DLT occurs in one-third or more of the 
expanded cohort, then the MTD will be deemed to be exceeded, and the prior dose level will be 
considered the MTD.  If only 3 subjects were treated at the MTD or PAD, then a minimum of 
3 additional subjects will be enrolled before this dose is administered in Part 2 of the study. 
If Cohort 1 (7 mg; starting dose) exceeds the MTD, the sponsor and investigators will consider 
dosing INCAGN01949 at 2 mg (Cohort -1), and/or investigate 7 mg at alternate dose schedules 
(eg, every 3-week administration), based on available safety, PK, 
 
 data.  If an alternate schedule is tested and determined to be safe, re-escalation of 
INCAGN01949 will proceed according to Table 1. 
Throughout the treatment period, if > 33% of subjects (a minimum of 6 subjects) experience a 
≥ Grade 3 toxicity related to study drug after completing ≥ 4 cycles, then dose administration 
will be stopped, and the MNTD will be determined in conjunction with the investigators and 
sponsor based on all available safety data. 
Additional subjects will be enrolled in a cohort to achieve the minimum of 3 evaluable subjects.  
Subjects who drop out for reasons other than a DLT (eg, events clearly associated with the 
underlying disease, disease progression, concomitant medication, or comorbidity) during the 
28-day DLT observation period will be considered nonevaluable and will be replaced.  Dose 
modifications should not be made during the DLT observation period without discussion with 
the medical monitor.  Intrasubject dose escalation is not permitted; however, once the 
recommended dose and schedule have been determined, ongoing subjects in Part 1 may be 
permitted to escalate the dose to the recommended level with approval of the medical monitor.  
The cohorts and dose levels are shown in Table 1. 
Table 1: 
INCAGN01949 Dose Levels and Cohort 
Cohort 
Dose of INCAGN01949a 
-1 
2 mgb 
1 (starting dose) 
7 mg 
2 
20 mg 
3 
70 mg 
4 
200 mg 
5 
350 mg 
6 
700 mg 
a Additional dose schedules may be explored that would depend on PK, 
, and safety 
results. 
b Subjects who require a dose reduction below 2 mg should be discontinued from study drug. 
3.1.2. 
Part 1 – Safety Expansion 
In order to evaluate additional 
 activity of INCAGN01949 and confirm the 
preliminary safety of the dose escalation cohorts, Part 1 of the study may include safety 
expansion cohorts evaluating doses and schedules equivalent to or lower than the highest dose 


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levels determined to be safe and/or doses determined to be pharmacologically active.  The 
alternative dose administration schedules and fixed doses (equivalent to or less than the MTD 
determined during dose escalation) that may be explored during the safety expansion would 
depend on PK, 
, and safety results. 
A maximum of 36 subjects will be enrolled into the Part 1 safety expansion, and each Part 1 
safety expansion cohort will enroll up to 9 evaluable subjects.  If < 3 of 9 evaluable subjects have 
a DLT, then the cohort will be deemed safe.  If > 1 safety expansion cohort is deemed safe, then 
a recommended dose and schedule will be determined in conjunction with the investigators and 
sponsor based on all available safety, PK, 
 results.  The safety 
expansion cohorts may be run in parallel to Part 2 and may be limited by the sponsor to subjects 
with specific tumor types to achieve a balance across cohorts. 
3.1.3. 
Part 2 – Dose Expansion  
Part 2 of the study will further evaluate the safety, tolerability, preliminary efficacy, PK, and 
pharmacologic activity of the recommended dose of INCAGN01949 in subjects with advanced 
or metastatic adenocarcinoma of the endometrium, melanoma, NSCLC (squamous and 
nonsquamous), and RCC.  Each cohort will comprise an individual tumor type.  A Simon 2-stage 
design (Simon 1989) will be utilized with a stopping rule to allow early termination of a 
particular cohort at the end of Stage 1 if there are insufficient responses observed.  During 
Stage 1, 9 subjects will be enrolled; if no responses are observed in 16 weeks with 2 scans, then 
enrollment in the cohort will be terminated.  If at least 1 response is observed, then 8 additional 
subjects will be enrolled into that cohort (Stage 2), for a maximum of 17 subjects per cohort.   
Subjects will continue to receive INCAGN01949 until Protocol-defined withdrawal criteria are 
met.  Continuous evaluation of toxicity events will be performed throughout enrollment in Part 2 
of the study.  If the cumulative incidence of DLTs occurs in > 33% of subjects after 6 subjects 
are observed for at least 28 days, further enrollment will be interrupted until the sponsor 
determines the appropriate course of action.  All AEs, regardless of the time of occurrence on 
study, may be considered in determining the appropriate dose, schedule, and MNTD.  
Toxicity will continue to be monitored throughout the treatment period. If > 33% of subjects 
(minimum of 6 subjects) experience a Grade ≥ 3 toxicity related to study drug after completing 
≥ 4 cycles, then the MNTD will be determined in conjunction with the investigators and sponsor 
based on all available safety data.  All AEs, regardless of the time of occurrence on study, may 
be considered in DLT determination decisions.   
3.2. 
Randomization 
Not applicable. 
3.3. 
Control of Type I Error 
All statistical analyses are exploratory in nature.  Unless otherwise specified, all CIs provided 
will be at the 95% confidence level.    


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3.4. 
Sample Size Considerations 
3.4.1. 
Sample Size in Part 1 
The primary objective of Part 1 of the study is to determine the PAD or the MTD of 
INCAGN01949.  The total number of subjects will depend on the number of dose levels tested 
before the MTD or PAD is established.  Approximately 18 to 36 subjects (6 subjects per dose 
level for 6 dose levels) will be included based on the dose escalation.  Dose escalation will 
follow the 3 + 3 design algorithm.  Based on this algorithm, a minimum of 3 evaluable subjects 
will be enrolled in each cohort beginning with Cohort 1 (7 mg; starting dose) and a maximum of 
6 evaluable subjects for each cohort.  The probability of declaring a dose cohort as safe for 
various DLT rates in the 3 + 3 and the safety expansion is summarized in Table 2. 
Table 2: 
Probability of Dose Escalation by DLT Rate for 3 + 3 Design and Safety 
Expansion 
True DLT Rate 
Probability of Declaring Dose Cohort as Safe 
3 + 3 Design 
In Both 3 + 3 Design  
and Safety Expansion 
10% 
90.6% 
85.8% 
20% 
70.9% 
52.3% 
30% 
49.4% 
22.9% 
40% 
30.9% 
7.2% 
50% 
17.2% 
1.5% 
60% 
8.2% 
0.2% 
For example, if the true DLT rate is 50% at a given dose level, there is a 17.2% chance that the 
dose would be escalated.  Further, if the true DLT rate is 20%, there is a 70.9% chance that the 
dose would be escalated.  If the MTD is not determined at the highest dose level tested during 
the study, then the MTD is at or above the highest dose level.  The MTD is below the lowest 
dose level of INCAGN01949 if Cohort 1 is not well-tolerated.  The PAD may be used in lieu of 
the MTD and/or prescribed doses may need to be altered in order to determine the MTD. 
Part 1 of the study may also include safety expansion cohorts evaluating doses and schedules 
equivalent to or lower than the highest dose levels determined to be safe and/or doses determined 
to be pharmacologically active.  Each safety expansion cohort will enroll 9 evaluable subjects 
(up to 36 subjects).  If < 3 of 9 evaluable subjects experience a DLT, the cohort will be deemed 
safe.  If more than 1 safety expansion cohort is deemed safe, then the recommended dose will be 
determined in conjunction with the investigators and sponsor based on all available safety, PK, 
 results. 
3.4.2. 
Sample Size in Part 2   
Part 2 of the study will further evaluate the safety, tolerability, preliminary efficacy, PK, and 
pharmacologic activity of the recommended dose of INCAGN01949.  The sample size for each 
tumor type will be guided by the Simon 2-stage design (Simon 1989).  Let P0 = 5% denote a 
clinically insignificant response rate for all tumor types.  In order to determine whether the target 
response rate (25%) is likely, an initial number of evaluable subjects (9 subjects) treated at the 


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MTD or PAD and schedule of INCAGN01949 will be enrolled in a cohort (Stage 1).  If there is 
no response for the cohort, it will be concluded that the true response rate is unlikely to be 
greater than or equal to the target rate, and no more subjects will be enrolled in that tumor type in 
Stage 2.  Due to replacement of subjects for biopsy analysis, additional subjects may be enrolled 
for the biopsy evaluable population; however, the first 9 evaluable subjects in each cohort will be 
used for early stopping at Stage 1.  In the tumor types in which at least 1 response among the 
Stage 1 subjects is observed, 8 additional evaluable subjects will be treated in Stage 2 to estimate 
the response rate.  At the end of Stage 2, if ≤ 2 subjects have responded among the evaluable 
subjects, the drug will be declared nonpromising for that tumor type.  In other words, after the 
study is finished, if there is a sufficient number of responses in the 2 stages combined, the study 
compound is considered promising; otherwise it is considered nonpromising.  The detailed 
calculation is based on a 1-sided Type I error of 0.05 and power of 80% for each of the tumor 
types.  Figure 2 shows the power to reject the null hypothesis for various response rates. 
Figure 2: 
Power and Type I Error for Simon 2-Stage Design for Various Response 
Rates  
 
 


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4. 
DATA HANDLING DEFINITIONS AND CONVENTIONS 
4.1. 
Scheduled Study Evaluations and Study Periods 
4.1.1. 
Day 1 
Day 1 is the date that the first dose of study drug (INCAGN01949) is administered to the 
subjects.  
4.1.2. 
Study Day 
If a visit/reporting date is on or after Day 1, then the study day at the visit/reporting date will be 
calculated as  
Day # = (Visit/Reporting Date – Day 1 date + 1).  
If the visit/reporting date is before Day 1, then the study day at the visit/reporting date will be 
calculated as  
Day # = (Visit/Reporting Date – Day 1 date).  
A study day of -1 indicates 1 day before Day 1. 
4.1.3. 
Baseline Value 
Baseline is the last nonmissing measurement obtained before the first administration of 
INCAGN01949. 
When scheduled assessments and unscheduled assessments occur on the same day and time of 
the assessment or time of first dose is not available, use the following convention to determine 
baseline: 
• If both a scheduled and an unscheduled visit are available on the day of the first dose 
and the time is missing, use the scheduled assessment as baseline. 
• If all scheduled assessments are missing on the day of the first dose and an 
unscheduled assessment is available, use the unscheduled assessment as baseline. 
4.1.4. 
Handling of Missing and Incomplete Data  
In general, values for missing data will not be imputed unless methods for handling missing data 
are specified in this section or relevant sections.  
Partial disease/cancer diagnosis date will be handled as follows:  
• If only the day is missing, then the imputed day will be the first of the month.  
• If both the month and day are missing, then the imputed day and month will be 
01 JAN.  
• No imputation will be done if the date is completely missing.  


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Missing or partial date of last dose will be handled as follows:  
• If only the day is missing, then the imputed date of the last dose will be the earlier 
date of the first day of the month or the date that the subject discontinued treatment.  
• Otherwise, the date that the subject discontinued treatment will be used as the date of 
the last dose.  
For relevant efficacy endpoints, partial death date will be imputed as follows:  
• If mmyyyy for the last contact date = mmyyyy for the death date, then the death date 
will be set to the day after the last contact date.  
• If mmyyyy for the last contact date < mmyyyy for the death date, then the death date 
will be set to the first day of the death month.  
• Otherwise, the partial death date will not be imputed.  
For prior and concomitant medications: 
The start/stop dates recorded in the CRF by the investigator and his or her research staff will be 
used to identify when a concomitant medication was taken during the study.  Any missing start 
date must be queried for resolution.  Unresolved missing start dates will be handled as follows: 
• If the date is completely missing, the medication will be considered both prior and 
concomitant. 
• If only the day is missing, and the last day of the month is before the first dose date 
on Day 1, then the concomitant medication will be considered as starting before 
Day 1, and the incomplete date will be imputed as the last day of the month. 
• If only the day is missing, and the first day of the month is after the first dose date on 
Day 1, then the concomitant medication will be considered as starting after Day 1, 
and the incomplete date will be imputed as the first day of the month. 
• If only the day is missing, and the month is equal to the month of the first dose date 
on Day 1, then the incomplete date will be imputed as the first day of the month. 
• If both the month and day are missing, and the last day of the year is before the first 
dose date on Day 1, then the concomitant medication will be considered as starting 
before Day 1, and the incomplete date will be imputed as if it is the last day of the 
year.  Otherwise, the incomplete date will be imputed as if it is the first day of the 
year. 
4.1.5. 
Cycle Length and Duration 
Cycle 1 Day 1 is the day that the first dose of study drug is administered.  Scheduled cycle length 
is 14 days.  Actual Day 1 of subsequent cycles will correspond with the first day of 
administration of INCAGN01949 in that cycle; thus, treatment cycles may become out of sync 
with the originally planned schedule and cycle length may be different from 14 days.  The date 
of the Day 1 of subsequent cycles recorded on CRF will be used as the Day 1 of the subsequent 
cycles. 


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Note that there leaves flexibility to test different dosing schedules of INCAGN01949 based on 
evolving PK 
 data.  The SAP does not specify all of the dosing schedule 
possibilities. 
4.2. 
Variable Definitions 
4.2.1. 
Derived Variables  
The following variable is provided on the CRF but also derived for analysis purposes.  The 
MSKCC (Motzer et al 2004) criteria will be summarized for both investigator reported and 
derived data for RCC subjects. 
4.2.1.1. 
MSKCC Criteria for Renal Cell Carcinoma Subjects 
The MSKCC (Motzer et al 2004) score will be derived as a prognostic tool for RCC subjects 
enrolled in Parts 1 and 2.  The calculation for the MSKCC score is provided below as the sum of 
5 component "no" vs "yes" (0 vs 1) scores.  For each component, subjects will have a score of 1 
for each criterion they meet.  An MSKCC total score of 0 indicates a prognosis of Good.  A 
MSKCC total score of 1 to 2 indicates an Intermediate prognosis, and a total score of ≥ 3 
indicates a Poor prognosis.  The derivation of MSKCC will use screening data; if screening data 
is not available, then Cycle 1 Day 1 data will be used. 
1. Time from diagnosis to systematic treatment < 1 year 
2. Low hemoglobin 
• Men (normal):  13.5 to 17.5 g/dL 
• Women (normal):  12.0 to 15.5 g/dL 
3. Calcium > 10 mg/dL (> 2.5 mmol/L) 
4. Lactate dehydrogenase > 420 U/L 
5. Performance status:  Karnofsky < 80% or ECOG > 1 
Missing dates for time of first systemic treatment will be handled according to rules for missing 
partial disease/cancer diagnosis date that are given in Section 4.1.4. 
4.2.1.2. 
Prior and Concomitant Medication 
Prior medication is defined as any nonstudy medication started before the first dose of 
INCAGN01949. 
Concomitant medication is defined as any nonstudy medication that is started accordingly:  
• Before the date of first administration of INCAGN01949 and is ongoing throughout 
the study or ends on/after the date of first study drug administration. 
• On/after the date of first administration INCAGN01949 and is ongoing or ends during 
the course of study drug. 
A prior medication could also be classified as "both prior and concomitant medication" if the end 
date is on or after first dose of INCAGN01949.  In the listing, it will be indicated whether a 
medication is prior-only, concomitant-only, or both prior and concomitant medication. 


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For the purposes of analysis, all medications will be considered concomitant medications unless 
the medications can unequivocally be defined as not concomitant. 
4.2.2. 
Variables to Be Derived Only If Not Provided on Case Report Form 
The following variables will only be calculated if not reported on the CRF. 
• Subject age will be calculated as the integer part of the number of years from date of 
birth to the date of signing the informed consent form, using the following formula: 
Age = integer part of (date of informed consent – date of birth + 1) / 365.25 
5. 
STATISTICAL METHODOLOGY 
5.1. 
General Methodology 
Unless otherwise noted, SAS software (SAS Institute Inc, Cary, NC; Version 9 or later) will be 
used for the generation of all tables, graphs, and statistical analyses.  Descriptive summaries for 
continuous variables will include, but not be limited to, the number of observations, mean, 
standard deviation, median, minimum, and maximum.  Descriptive summaries for categorical 
variables will include the number and percentage of subjects in each category. 
Interim analyses are planned for this study as defined in Section 9. 
5.2. 
Treatment Groups 
This is a Phase 1/2, open-label, nonrandomized, multicenter, dose-escalation study.  Up to 
7 doses will be tested.  Data will be summarized overall and by treatment group.  Treatment 
group is defined as the dose regimen initially assigned.  Treatment cycles will begin every 
14 days (± 3 days) but are flexible for different dose schedules based on emerging safety, PK, 
 data. 
• 2 mg 
• 7 mg 
• 20 mg 
• 70 mg 
• 200 mg 
• 350 mg 
• 700 mg 
5.3. 
Analysis Populations 
5.3.1. 
Full Analysis Set Population 
The FAS population includes all subjects enrolled in the study who received at least 1 dose of 
INCAGN01949.  The FAS population will be used for the summary of demographics, baseline 
characteristics, subject disposition, safety, study drug administration, and analyses of all efficacy 
data. 


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5.3.2. 
Part 1 Full Analysis Set Population 
The Part 1 FAS population includes all subjects in the FAS population enrolled in Part 1 of the 
study who received at least 1 dose of INCAGN01949. 
5.3.3. 
Part 2 Full Analysis Set Population 
The Part 2 FAS population includes all subjects in the FAS population enrolled in Part 2 of the 
study who received at least 1 dose of the MTD/PAD of INCAGN01949.  Subjects tested in 
Part 1 (dose escalation and safety expansion) who are treated at the MTD/PAD and in Part 2, are 
of the same tumor type, and who meet inclusion/exclusion criteria used for the tumor type of 
interest in Part 2 will be combined for both safety and efficacy summary purposes. 
Specific analysis populations to be used for evaluating the Simon 2-stage efficacy rules include 
the following subgroups: 
• Part 2 FAS population subjects with adenocarcinoma of endometrium 
• Part 2 FAS population subjects with melanoma 
• Part 2 FAS population subjects with ovarian cancer 
• Part 2 FAS population subjects with NSCLC 
• Part 2 FAS population subjects with RCC 
Table summaries, unless otherwise indicated, will be provided by tumor-specific cohort. 
5.3.4. 
Per Protocol Population 
Subjects in the FAS population who are considered to be sufficiently compliant with the Protocol 
comprise the PP population. 
The following procedures will be performed to identify those subjects who are to be excluded 
from the PP population before the database lock: 
• Clinical review of Protocol deviations/violations 
• Clinical review of concomitant medications (prohibited medications) as defined in 
Section 5.6.3 of the Protocol.  
• Clinical review of the dose administration and drug accountability listing. 
5.3.5. 
Pharmacokinetic 
 Evaluable Populations 
5.3.5.1. 
Pharmacokinetic Evaluable Population 
The PK evaluable population will include all subjects who received at least 1 dose of 
INCAGN01949 and provided at least 1 postdose sample (1 PK measurement).  The study 
pharmacokineticist will review data listings of study drug administration and sample records to 
identify subjects to be excluded from analyses of PK data. 


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6. 
BASELINE, EXPOSURE, AND DISPOSITION VARIABLES AND 
ANALYSES 
Appendix A provides a list of data displays and sample data displays. 
6.1. 
Baseline and Demographics, Physical Characteristics, and Disease 
History 
6.1.1. 
Demographics 
The following demographics will be summarized for the Part 1 FAS population by dose level 
and for the Part 2 FAS population by tumor type:  age, sex, race, ethnicity, and ECOG 
performance status. 
6.1.2. 
Baseline Disease Characteristics and Disease History 
For each type of tumor, primary tumor histology, date of initial diagnosis, stage at initial 
diagnosis, current stage of disease, current site of disease, and tumor markers will be 
summarized for all subjects in the Part 1 FAS population by dose level and Part 2 FAS 
population by tumor type. 
6.1.3. 
Prior Therapy 
Number of prior systemic cancer therapy regimens and prior immunotherapy will be summarized 
for all subjects in the FAS population by dose level in Part 1 and by tumor type in Part 2.  
Regimen name, component drugs, start and stop date, purpose of the regimen, best response, 
reason for discontinuation, and date of relapse/progression will be listed by total number and by 
number of prior systematic cancer therapies taken for both advanced and metastatic disease. 


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Number of subjects who received prior radiation will be summarized for the FAS population.  
Radiotherapy type, body site, start and stop date, total dose, and best response will be listed. 
Number of subjects who had prior surgery or surgical procedure for the malignancies under 
study will be summarized for the FAS population.  Date and description of the surgery/procedure 
will be listed. 
Number of subjects with prior immunotherapy and prior anti–PD-1/PD-L1 therapy will be 
summarized for the Part 1 FAS population by dose level and the Part 2 FAS population by tumor 
type.  Prior immunotherapy type, start and stop date, total dose, and best response will be listed. 
6.1.4. 
Medical History 
For subjects in the Part 1 FAS population by dose level and Part 2 FAS population by tumor 
type, medical history will be summarized by assigned treatment group.  This summation will 
include the number and percentage of subjects with significant medical history for each body 
system/organ class as documented on the CRF. 
6.2. 
Disposition of Subjects 
The number and percentage of subjects who were enrolled, treated, completed the study, 
discontinued study treatment with a primary reason for discontinuation, and discontinued from 
the study with a primary reason for withdrawal will be summarized for the subjects in the Part 1 
FAS population by dose level and Part 2 FAS population by tumor type.  The number of subjects 
enrolled by site will also be provided by treatment group. 
6.3. 
Protocol Deviations and Violations 
Protocol deviations and violations recorded on the CRF will be presented in the subject data 
listings. 
6.4. 
Exposure 
For subjects in the FAS population, exposure to INCAGN01949 will be summarized 
descriptively as the following: 
• Total number of infusions:  Total number of infusions per subject by the time of 
date cutoff will be the total number of infusions per subject with a nonzero dose of 
INCAGN01949.  
• Dose administered per cycle:  The actual dose administered (in mg) per cycle. 
• Total dose administered in mg/kg:  The total actual dose administered (in mg/kg) 
across cycles for each subject will be determined according to the following 
calculation:  
For an infusion i, let Ci be the concentration (in mg/mL) of INCAGN01949 and Vi be 
the total volume administered (in mL) reported on the INCAGN01949 dosing CRF; 
let 𝑊 be the subject's baseline weight (in kg), and N be the total number of infusions 
Total dose administered (in mg/kg) = ∑
𝐶𝑖×𝑉𝑖
𝑊
𝑁
𝑖=1
. 


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• Average dose in mg/kg:  The average dose (in mg/kg) will be the total dose 
administered (in mg/kg) divided by the total number of infusions. 
• Total dose administered in mg:  Total actual dose administered (in mg) across 
cycles for each subject will be determined according to the following calculation: 
For an infusion i, let Ci, Vi, and N be defined as above 
Total dose administered (in mg) =∑
𝐶𝑖× 𝑉𝑖
𝑁
𝑖=1
. 
• Average dose in mg:  The average dose (in mg) will be the total dose administered 
(in mg) divided by the total number of infusions. 
6.5. 
Prior and Concomitant Medication 
Prior medications and concomitant medications will be coded using the WHO Drug Dictionary 
and summarized by WHO drug class and WHO drug term by dose level in the Part 1 FAS 
population and by tumor type in the Part 2 FAS population.  Results will be summarized as 
number and percentage of subjects with prior and concomitant medications by PT and WHO 
drug class. 
7. 
EFFICACY 
Sample data displays are provided in Appendix A. 
7.1. 
General Considerations 
Efficacy endpoints of this study are secondary and include ORR, DOR, duration of disease 
control, and PFS by investigator assessment based on RECIST v1.1 and mRECIST v1.1. 
7.2. 
Efficacy Hypotheses 
Each Simon 2-stage design will test the null hypothesis that the true ORR is less than or equal to 
the clinically insignificant response rate 5% against the alternative hypothesis that the true ORR 
is equal to the target ORR of 25%. 
7.3. 
Analysis of the Primary Efficacy Parameter 
Not applicable. 
7.4. 
Analysis of the Secondary Efficacy Parameter 
7.4.1. 
Response Criteria 
Overall disease status will be categorized using RECIST v1.1 and mRECIST v1.1.  Subjects will 
have their overall response evaluated as CR, PR, SD, PD, or NE at each postbaseline radiological 
assessment based on changes in target lesions, nontarget lesions, and appearance of new lesions. 


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7.4.2. 
Objective Response Rates and Best Overall Response 
A subject is defined as an objective responder if the subject has an overall response of CR or PR 
at any postbaseline visit before first PD.  Objective responders will be assessed based on both 
RECIST v1.1 and mRECIST v1.1. 
Objective response rate is defined as the proportion of subjects with objective responses.  
Objective response rate will be estimated with 95% CIs overall by cohort-specific tumor type.  
Confidence intervals will be calculated based on the method for Simon 2-stage CIs of response 
rates outlined in Koyama and Chen (Koyama and Chen 2008).  Subjects who do not have 
sufficient baseline or on-study response assessment information to be adequately assessed for 
response status will be included in the denominators in the calculation of ORR. 
7.4.2.1. 
Objective Response Rate by RECIST v1.1 
Under RECIST v1.1, the best overall response is determined on subject level using the highest 
overall response achieved postbaseline before and including the first PD, in the order of CR, PR, 
SD, PD, and NE.  Responses of CR, PR, or SD after the first assessment of PD will not be 
considered.  In the case of SD, measurements must meet the SD criteria at least after the date of 
first dose at a minimum of 49 (56-57) days.  Subjects who fail to meet this criterion will have 
best overall response of PD if the next available assessment indicated PD or NE if there is no 
additional assessment available. 
For subjects with measurable disease at baseline, the RECIST v1.1 assessment criteria presented 
in Table 3 can be used to determine the overall disease status at a given timepoint based on the 
target lesion, nontarget lesion, and new lesion assessment. 
Table 3: 
RECIST Evaluation Criteria for Overall Response:  Measurable Disease at 
Baseline 
Target Lesions 
Nontarget Lesions 
New Lesions 
Overall Response 
CR 
CR 
No 
CR 
CR 
Non-CR/non-PD 
No 
PR 
CR 
NE 
No 
PR 
PR 
Non-PD or NE 
No 
PR 
SD 
Non-PD or NE 
No 
SD 
Not all evaluated 
Non-PD 
No 
NE 
PD 
Any 
Yes or No 
PD 
Any 
PD 
Yes or No 
PD 
Any 
Any 
Yes 
PD 
7.4.2.2. 
Objective Response Rate by mRECIST v1.1 
The mRECIST v1.1 instrument was adapted from RECIST v1.1 to include criteria that accounts 
for new lesions that can occur in immuno-oncology subjects before the occurrence of an SD, PR, 
or CR.  Under mRECIST v1.1, if radiologic imaging shows PD, tumor assessment should be 


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repeated at a minimum of 4 weeks but not more than 6 weeks later to confirm the progression.  If 
there is no second PD tumor assessment in the 4- to 6-week follow-up time, the PD will be 
defined as unconfirmed.  Table 4 lists the scenarios that can occur after an unconfirmed PD in at 
least 4 weeks and no more than 6 weeks, and provides rules for determining whether or not the 
unconfirmed PD will be counted as an event in the corresponding scenario. 
Table 4: 
Rules for Determining PD Event Status After an Unconfirmed PD 
Event Occurring After Unconfirmed PD in the 
Confirmation Window (4-6 Weeks) 
PD Event Status 
Subject had EOS/EOT or started new anticancer 
therapy. 
PD will be confirmed as a PD. 
Subject had a confirmed PD. 
PD will be confirmed as a PD. 
Subject had an CR, PR, SD, or NE. 
PD will not be considered as a PD and counted as 
corresponding CR, PR, SD, or NE for the second 
timepoint only. 
7.4.3. 
Subgroup Analyses of Objective Response Rates 
Subgroups will be formed based on the following subject characteristics and baseline variables 
for those subjects whose data are available. 
• PD-L1 expression within tumor type:  high versus negative/low 
• Prior treatment with an anti–PD-1/PD-L1 therapy within tumor type:  Yes/No 
• Number of prior therapies for advanced and metastatic disease within tumor type 
• Subjects with > 1 postbaseline scan within tumor type 
• Tumor-type disease characteristics including the following: 
− Endometrium – MSI status (high, low, stable, unknown) 
− Ovarian – Histology and BRCA status 
− Melanoma – BRAF mutation status (mutated, wild-type, unknown), PD-L1 status 
(positive or negative) 
− NSCLC – Histology (squamous or nonsquamous), PD-L1 status (positive or 
negative) 
− RCC – MSKCC score (Poor, Intermediate, Good), PD-L1 status (positive or 
negative) 
7.4.4. 
Duration of Response 
Duration of response will be assessed with RECIST v1.1 and mRECIST v1.1 criteria. 
Censoring of DOR will follow the same algorithm as the censoring of PFS.  Kaplan-Meier 
curves for DOR will be presented by cohort-specific tumor types.  The KM estimate of median 
DOR will be presented with its 95% CI.  The 95% CI will be calculated using Brookmeyer and 


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Crowley's method (Brookmeyer and Crowley 1982).  A swim plot for DOR will be generated 
under both RECIST v1.1 and mRECIST v1.1 criteria. 
7.4.4.1. 
Duration of Response by RECIST v1.1 
Under RECIST v1.1, for objective responders, DOR is defined as the time from the first overall 
response contributing to an objective response (CR or PR) to the earlier of the subject's death 
from any cause or first assessment of PD. 
7.4.4.2. 
Duration of Response by mRECIST v1.1 
Under mRECIST v1.1, for objective responders, DOR is the time from the first overall response 
contributing to an objective response (CR or PR) to the earlier of the subject's death from any 
cause or first confirmed assessment of PD.  Note that the criteria for the assessment of PD in 
DOR are the same with ORR, which are presented in Section 7.4.2.2. 
7.4.5. 
Duration of Disease Control 
Duration of disease control (CR, PR, and SD) is defined as the time from the first report of SD or 
better until disease progression or death from any cause, if occurring sooner than progression, as 
determined by investigator assessment of radiographic disease per RECIST v1.1 and mRECIST 
v1.1.  Note that the criteria for the assessment of PD in duration of disease control are the same 
with ORR, which are presented in Section 7.4.2.2. 
The duration of disease control will be estimated with 95% CIs overall and by treatment group.  
Confidence intervals will be calculated based on the exact method for binomial distributions.  
Swim plots for duration of disease control will be generated separately for RECIST v1.1 and 
mRECIST v1.1 criteria. 
Subjects who do not have sufficient baseline or on-study response assessment information to be 
adequately assessed for response status will be included in the denominators in the calculation of 
rate of disease control. 
7.4.6. 
Largest Percentage Reduction in Sum of Diameters of Target Lesions 
For each subject in the FAS population with target lesions at baseline, target lesion sizes will be 
measured by sum of diameters.  The best percentage change from baseline, defined as the largest 
decrease in target lesion size for each subject, will be summarized descriptively, and a waterfall 
plot of the best percentage change will be generated. 
Per RECIST criteria, target lesions considered "too small to measure" will be assigned a default 
value of 5 mm for purposes of this analysis.  Likewise, target lesions identified as "not present" 
at postbaseline assessments will be assigned 0 mm for this analysis.  In the event a target lesion 
is unaccounted for in a particular postbaseline timepoint (ie, assessment missing or NE), then the 
overall sum of diameters for target lesions will not be evaluable for that postbaseline timepoint. 
7.4.7. 
Percentage Change in Sum of Diameters of Target Lesions Over Time 
For each subject in the FAS population with target lesions at baseline, target lesion sizes will be 
measured by sum of diameters.  The percentage change in sum of diameter of target lesions over 
time will be listed and a spider plot will be generated. 


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7.4.8. 
Progression-Free Survival 
Progression-free survival is defined as the length of time between the baseline visit (Day 1) and 
the earlier of death or PD as assessed by RECIST v1.1 and mRECIST v1.1.  Date of death will 
be determined using the Death Report CRF. 
Censoring for PFS will follow the algorithm outlined in Table 5, which is based on the FDA 
Guidance for Industry:  Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics 
(FDA 2007). 
Kaplan-Meier curves for PFS will be presented by cohort-specific tumor types.  The KM 
estimate of median PFS will be presented with its 95% CI.  The 95% CI will be calculated using 
the Brookmeyer and Crowley's method (Brookmeyer and Crowley 1982). 
Table 5: 
Evaluation and Censoring of Progression-Free Survival 
Situation 
Outcome 
Date of Progression or Censoring 
No baseline tumor assessments 
Censored 
Date of Day 1  
No valid postbaseline response 
assessments 
Censored 
Date of Day 1  
Progression documented between 
scheduled response assessments 
Progressed 
Date of first overall response of PD 
No progression 
Censored 
Date of last valid radiologic assessment 
(not NE and not missing) 
Study discontinuation for 
undocumented progression 
Censored 
Date of last valid radiologic assessment 
(not NE and not missing) 
Study discontinuation for toxicity 
or other reason 
Censored 
Date of last valid radiologic assessment 
(not NE and not missing) 
New anticancer treatment started 
Censored 
Date of last valid radiologic assessment 
(not NE and not missing) on/before starting 
a new anticancer treatment 
Death before first progressive 
response assessment 
Progressed 
Date of death 
Death between adequate response 
assessments 
Progressed 
Date of death 
Death or progression after more 
than 1 missed assessments 
Censored 
Date of last valid radiologic assessment 
(not NE and not missing) before death 
NE = not evaluable. 
7.4.8.1. 
Progression-Free Survival by RECIST v1.1 
Under RECIST v1.1, PFS is defined as the length of time between the baseline visit (Day 1) and 
the earlier of death or first assessment of PD as assessed by RECIST v1.1. 


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7.4.8.2. 
Progression-Free Survival by mRECIST v1.1 
Under mRECIST v1.1, PFS is defined as the length of time between the baseline visit (Day 1) 
and the earlier of death or first overall confirmed assessment of PD (as described in 
Section 7.4.2.2). 
7.4.8.2.1. Confirmation of Progression per mRECIST v1.1 
Under mRECIST v1.1, the assessment of PD will be confirmed by a second consecutive 
assessment at least 4 weeks but no later than 6 weeks apart with the option for continuing 
treatment while awaiting radiologic confirmation of progression (Table 4). 
• If after the first unconfirmed PD, there is an EOT/EOS or a new treatment is started, 
this unconfirmed PD will be counted as a confirmed PD, and DOR will be defined as 
the time from the first overall response (CR or PR) to this PD, or death from any 
cause if occurring sooner than the PD. 
• If a second PD occurs after the first unconfirmed PD, the first unconfirmed PD will 
be counted as a confirmed PD, and DOR  will be defined as the time from the first 
overall response (CR or PR) to the first PD, or death from any cause if occurring 
sooner than the confirmed PD. 
• If a CR, PR, SD, or NE occurs after the first unconfirmed PD, the unconfirmed PD 
will not be counted as a PD.  If there is no further PD assessment, DOR will be 
censored. 
 
 
 
7.6. 
Pharmacokinetic Analyses 
The PK calculations will be performed, if appropriate, using commercial software such as 
WinNonlin® (Pharsight Corporation, Mountain View, CA).  Nominal times will be used in all 
cases, except when the difference between the actual time and nominal time is greater than 
5 minutes for samples collected up to 4 hours after administration; in these cases, actual time will 
be used for PK analysis. 
The PK parameters of Cmax, tmax, Cmin, and AUC0-t (INCAGN01949) will be summarized by part, 
dose, and study cycle.  The log-transformed PK parameters will be compared among dose levels 
by using a 1-factor analysis of variance.  Dose-dependent parameters (Cmax and AUC) will be 
normalized to the lowest common dose before statistical comparisons.  Additionally, if sufficient 
data are available, the dose proportionality of INCAGN01949 Cmax and AUC will be evaluated 
statistically by using a power model (eg, AUC = α∙(doseβ) or equivalently log (AUC) = log(α) + 
β∙log (dose), where linear dose proportionality is accepted if β is not significantly different 
from 1). 
If there is a sufficient amount of plasma concentration data from this study, then the data will be 
analyzed by standard population PK methods using appropriate software (eg, NONMEM).  The 
effect of covariates on PK parameters will be evaluated.  The covariates will include, but not be 


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limited to, demographics (age, weight, sex, race), clinical laboratory test values, and concomitant 
medications. 
The relationship between plasma concentrations of INCAGN01949 and the baseline-subtracted 
change in QTc interval will be explored graphically and analyzed using a linear mixed-effect 
model. 
8. 
SAFETY AND TOLERABILITY 
Sample data displays are provided in Appendix A. 
8.1. 
General Considerations 
Summary tables may be replaced with listings when appropriate.  For instance, an AE frequency 
table may be replaced with a listing if it only contains a few unique PTs reported on relatively 
few subjects.  Data from the Part 1 portion will be summarized separately where appropriate.  
Additional summaries for specific subgroups may be included on an ad hoc basis. 
Unless otherwise stated, table summaries will be limited to AEs occurring within 60 days of the 
last administration of study drug. 


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8.2. 
Adverse Events 
8.2.1. 
Adverse Event Definitions 
A TEAE is any AE either reported for the first time or worsening of a pre-existing event after 
first dose of study drug.  Analysis of AEs (as discussed below) will be limited to TEAEs, but 
data listings will include all AEs regardless of their timing in relation to study drug 
administration. 
Adverse events will be tabulated by MedDRA PT and SOC.  Severity of AEs will be graded 
using the NCI CTCAE.  The CTCAE version 4.03 is used for this study.  The CTCAE reporting 
guidelines and grading details are available on the Cancer Therapy Evaluation Program website. 
The subset of AEs considered by the investigator to be related to study drug will be considered to 
be treatment-related AEs.  If the investigator does not specify the relationship of the AE to study 
drug, the AE will be considered to be treatment-related.  The incidence of AEs and 
treatment-related AEs will be tabulated.  In addition, SAEs will also be tabulated. 
A grading (severity) scale is provided for each AE term.  If the toxicity is not included in the 
CTCAE v4.03 criteria, it will be rated on a scale of 1 to 4 as follows:  1 = mild, 2 = moderate, 
3 = severe, and 4 = life threatening.  All toxicities will be graded based on the worst level 
reached, not the level they may have reached if they had not been treated.  When the intensity of 
an AE changes over time for a reporting period (eg, between visits), each change in intensity will 
be collected as an AE until the event resolves.  Only the worst grade will be reported in AE 
summaries.  Also, the Grade 3 or higher AEs will be reported in a listing. 
Any missing onset date, causality, or severity must be queried for resolution.  Unresolved 
missing causality and severity will be handled according to the following rules: 
• An unresolved missing causality will be considered treatment-related. 
• An unresolved missing severity will be identified as an unknown severity.  
For purposes of analysis, all AEs will be considered TEAEs unless the AE can unequivocally be 
defined as not treatment-emergent. 
8.2.2. 
Dose-Limiting Toxicities 
The number of subjects with DLTs and the type of DLT will be listed by dose level.  If a dose 
with multiple schedules is tested, the DLTs will be summarized by dose and by schedules. 
8.2.3. 
Maximum Tolerated Dose 
• In Part 1 of the study, the MTD will be defined as 1 dose level below that at which 
≥ one-third of subjects in a particular cohort have DLTs. 
• In Part 2 of the study, toxicities will continue to be monitored.  If the cumulative 
incidence of DLTs occurs in ≥ 33% of subjects after 6 subjects have been observed 
for at least 28 days, further enrollment may be interrupted, and the investigators and 
sponsor will meet and reassess the MTD.  All AEs, regardless of the time of 
occurrence on study, may be considered in DLT determination purposes. 


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8.2.4. 
Immune-Related Adverse Events 
The number of subjects with irAEs and type of irAE will be listed by dose level (and by 
schedules) and by tumor type.  Adverse event terms will be reviewed periodically without 
respect to treatment group by the medical monitor and clinical scientist to determine which AE 
terms correspond to irAEs.  This periodic review may also occur after database lock.  The 
medical monitor and clinical scientist will also review investigator reported AEs to determine if 
they qualify as irAEs.  For example, a rash will be counted as an irAE even if the investigator did 
not report it as an irAE. 
8.2.5. 
Adverse Event Summaries 
An overall summary of AEs by treatment group and by tumor type as applicable will include the 
following: 
• Number (%) of subjects reporting any TEAEs 
• Number (%) of subjects reporting any DLTs 
• Number (%) of subjects reporting any SAEs 
• Number (%) of subjects reporting any Grade 3 or higher TEAEs 
• Number (%) of subjects reporting any TEAEs related to INCAGN01949 
• Number (%) of subjects who dose interrupted INCAGN01949 because of TEAEs 
• Number (%) of subjects who permanently discontinued INCAGN01949 because of 
TEAEs 
• Number (%) of subjects with INCAGN01949 dose reductions because of TEAEs  
• Number (%) of subjects who had a fatal TEAE 
• Number (%) of subjects who withdrew from study because of an TEAE 
The following summaries will be produced by MedDRA term (if 10 or fewer subjects appear in a 
table, a listing may be appropriate): 
• Summary of TEAEs by SOC and PT 
• Summary of TEAEs by PT in decreasing order of frequency 
• Summary of TEAEs by SOC, PT, and highest CTCAE grade/maximum severity 
• Summary of Grade 3 or higher TEAEs by SOC and PT 
• Summary of INCAGN01949 treatment-related AEs by SOC and PT 
• Summary of Grade 3 or higher INCAGN01949 treatment-related AEs by SOC and 
PT 
• Summary of all TEAEs, treatment-related AEs, Grade 3 or 4 TEAEs, and 
treatment-related Grade 3 or 4 TEAEs. 
• Summary of INCAGN01949 treatment-related AEs by SOC, PT, and highest CTCAE 
grade/maximum severity 


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• Summary of TEAEs leading to death by SOC and PT 
• Summary of treatment-emergent SAEs by SOC and PT 
• Summary of treatment-emergent SAEs by PT in descending order of frequency 
• Summary of INCAGN01949 treatment-related SAEs by SOC and PT 
• Summary of TEAEs leading to INCAGN01949 dose reduction by SOC and PT 
• Summary of TEAEs leading to INCAGN01949 dose interruption by SOC and PT 
• Summary of TEAEs leading to discontinuation of INCAGN01949 by SOC and PT 
• Summary of treatment-emergent non-SAE by SOC and PT.   
• Summary of irAEs by SOC and PT. 
• Summary of Grade 3 or higher irAEs by SOC and PT. 
• Number (%) of subjects reporting an immune-related AE (irAE) 
• Number (%) of subjects reporting any Grade 3 or 4 irAE 
• Number (%) of subjects reporting an immune-related treatment-related AE (irAE)  
• Number (%) of subjects reporting an immune-related treatment-related Grade 3 or 4 
AE (irAE) 
A KM analysis of time to first TEAE of Grade 3 or higher will be conducted.  A KM analysis of 
time to first treatment-related irAE of Grade 3 or higher will be conducted. 
8.3. 
Clinical Laboratory Tests 
8.3.1. 
Laboratory Value Definitions 
Laboratory values and change from baseline values will be summarized descriptively by visit.  
Baseline will be determined according to Section 4.1.3.  If there are multiple values that meet the 
criteria for baseline, additional rules may be provided after consultation with the medical monitor 
to delineate which value will be defined as baseline. 
Laboratory test values outside the normal range will be assessed for severity based on CTCAE 
grade or similar criteria where clinical intervention is required for CTCAE grading.  The 
incidence of abnormal laboratory values and shift tables relative to baseline will be tabulated. 
8.3.2. 
Laboratory Value Summaries 
Laboratory values and change from baseline values will be summarized descriptively by visit.  
The baseline value will be determined using the nonmissing values collected before the first 
dose, prioritizing scheduled assessments for baseline identification over unscheduled visits.  The 
last record before administration in the highest priority will be considered the baseline record.  
For baseline laboratory candidates with the same date and time in the same priority category, 
additional rules may be provided after consultation with the medical monitor to delineate which 
value will be defined as baseline. 


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All test results and associated normal ranges from local laboratories will be reported in SI units.  
All tests with numeric values will have a unique unit per test.  Any laboratory test results and 
associated normal ranges from local laboratories will be converted to SI units.  For the limited 
number of cases where the associated normal ranges from a local laboratory cannot be obtained 
despite due diligence, if query is unsuccessful at resolving issue and analysis is mandatory then 
the clinical scientist and medical monitor can provide a suitable normal range to be used in 
determining CTC grading and flags for above and below normal. 
When there are multiple laboratory nonmissing values for a subject's particular test at a 
scheduled visit, the laboratory value with the smallest laboratory sequence number will be used 
in by-visit summaries. 
Numeric laboratory values will be summarized descriptively in SI units, and non-numeric test 
values will be tabulated when necessary.  In addition, line graphs and box-and-whisker plots will 
be provided for hemoglobin, platelet counts, WBC, and neutrophils. 
For test results that will be summarized with available normal ranges, the number and percentage 
of subjects with the laboratory values being low (but never high), normal, high (but never low), 
and both low and high will be calculated for each test.  This shift summary will be produced for 
each test for the safety population.  The denominator for the percentage calculation will use the 
number of subjects in the baseline category (ie, low, high, normal, missing) as the denominator 
for the percentage in each of the categories during the treatment period. 
For all gradable laboratory parameters shift tables will be presented showing change in CTCAE 
grade from baseline to worst grade postbaseline for all treatment-emergent laboratory AEs.  The 
number and percentage of subjects with the laboratory values of Grade 1, 2, 3, or 4 will be 
calculated for each treatment group according to the largest treatment-emergent worsening of 
laboratory grade.  Separate summaries for abnormally high and abnormally low laboratory 
values will be provided when the laboratory parameter has both high and low grading criteria.  
The denominator for the percentage calculation will be the number of subjects in the baseline 
category.   
In cases where differentials of hematology parameters are obtained without corresponding 
absolute count data, efforts will be made to investigate if the conversion to an absolute value will 
lead to additional abnormalities.  This will be discussed with the clinical team regarding 
appropriate documentation and action. 
8.4. 
Vital Signs 
Values at each scheduled visit, change, and percentage change from baseline for vital signs, 
including systolic blood pressure, diastolic blood pressure, pulse, respiratory rate, body 
temperature, and weight will be summarized descriptively.  Change and percentage change from 
baseline will be calculated using the last nonmissing value before first dose of study drug 
(Day 1) as the baseline value. 
Criteria for clinically notable vital sign abnormalities are defined in Table 6.  The abnormal 
values for subjects exhibiting clinically notable vital sign abnormalities will be listed along with 
their assigned treatment group.  Alert vital signs are defined as an absolute value outside the 
defined range and percentage change > 25%.  The abnormal values for subjects exhibiting alert 
vital sign abnormalities will be listed. 


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Table 6: 
Criteria for Clinically Notable Vital Sign Abnormalities 
Parameter 
High Threshold 
Low Threshold 
Systolic blood pressure 
> 155 mmHg 
< 85 mmHg 
Diastolic blood pressure 
> 100 mmHg 
< 40 mmHg 
Pulse 
> 100 bpm 
< 45 bpm 
Temperature 
> 38ºC 
< 35.5ºC 
Respiratory rate 
> 24/min 
< 8/min 
8.5. 
Electrocardiograms 
Timed triplicate ECGs (separated by 5 minutes) will be conducted at screening and in 
conjunction with the pre- and postinfusion PK timepoints on C1D1 and C6D1.  The baseline 
ECG measurement will be the average of the 3 nonmissing triplicate ECGs performed 
preinfusion on C1D1.  
Singleton 12-lead ECGs including heart rate, PR, QRS, QT, RR, QTcF, and JTc intervals (where 
applicable) will be obtained for each subject on Day 1 of every other cycle after Cycle 2 (eg, 
Cycle 4, Cycle 6, Cycle 8, Cycle 10, etc) during the study.  Values at each scheduled visit, 
change, and percentage change from baseline will be summarized for each ECG parameter.  
Separate summaries will be provided for triplicate ECGs and singleton 12-lead ECGs. 
Criteria for clinically notable ECG abnormalities are defined in Table 7.  Subjects exhibiting 
clinically notable ECG abnormalities will be listed with study visit and assigned treatment group.  
Abnormal values for subjects with alert ECG values, defined as both the absolute value and the 
percentage change from baseline being outside normal ranges, will be identified and listed. 
Table 7: 
Criteria for Clinically Notable Electrocardiogram Abnormalities 
Parameter  
High Threshold 
Low Threshold 
QTcF  
> 460 msec 
< 295 msec 
PR  
> 220 msec 
< 75 msec 
QRS  
> 120 msec 
< 50 msec 
QT  
> 500 msec 
< 300 msec 
RR 
> 1330 msec 
< 600 msec 
QTcF = Fridericia correction. 
Electrocardiogram abnormalities, both at baseline and postbaseline visits, will be tabulated by 
treatment group.  Incidences of abnormalities will be listed separately for triplicate and singleton 
ECGs with study visit, assigned treatment group, and a description of the abnormality. 


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CONFIDENTIAL 
9. 
INTERIM ANALYSES 
There will be no planned, formal interim analyses for the Part 1 dose escalation portion of the 
study.  The review of accrued clinical data will be conducted by Incyte and provided to study 
investigators via teleconferences at the end of Part 1 of the study.  Based on review of the most 
current safety data, the sponsor (in consultation with the study investigators and using the 
dose-escalation/de-escalation rules) will determine if and at what dose additional subjects should 
be treated in the study. 
An interim analysis of efficacy will be conducted in Part 2 by applying the Simon 2-stage design.  
During Stage 1, 9 evaluable subjects treated at the recommended dose and schedule will be 
enrolled, and if no responses (CR or PR) are observed by the Week 16 assessment (at least 
2 scans), then the cohort will be discontinued.  The probability of early termination for Stage 1 is 
summarized in Table 8.  If at least 1 response (CR or PR) is observed, then 8 additional subjects 
will be enrolled for Stage 2.  Subject replacement may occur due to the biopsy requirement.  In 
that case, the interim analysis will be conducted with the first 9 evaluable subjects for Stage 1. 
Per mRECIST v.1.1, the tumor response should be confirmed by a repeat radiographic 
assessment not less than 4 weeks from the date that the response was first documented.  Disease 
progression will be confirmed by a second tumor assessment in at least 4 weeks and no later than 
6 weeks after the first scan indicating PD in clinically stable subjects.  The first tumor 
assessment is conducted at the eighth week.  If a CR or PR occurs after an unconfirmed PD in at 
least 4 weeks but no more than 6 weeks, then the tumor assessment will be counted as a 
corresponding CR or PR (Table 4). 
Table 8: 
Probability of Early Termination at Stage 1 for Simon 2-Stage Design 
True Response Rate 
Probability of Early Termination at Stage 1 
15% 
23.2% 
20% 
13.4% 
25% 
7.5% 
30% 
4.0% 
35% 
2.1% 
Figure 3 provides the probabilities of early termination with regard to the efficacy analysis of the 
primary endpoint. 


Incyte Corporation 
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INCAGN 1949-101 Statistical Analysis Plan 
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CONFIDENTIAL 
Figure 3: 
Probabilities of Early Termination for Futility at the End of Simon Stage 1 
Based on Various Assumed Rates of Response to a Given Dose Level 
 
10. 
CHANGES AND MODIFICATIONS TO THE ANALYSIS PLAN 
All versions of the SAP are listed in Table 9. 
Table 9: 
Statistical Analysis Plan Versions 
SAP Version 
Date 
Original 
05 JAN 2017 


Incyte Corporation 
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CONFIDENTIAL 
11. 
REFERENCES 
Brookmeyer R, Crowley J. A confidence interval for the median survival time. Biometrics 
1982;38:29-41. 
Food and Drug Administration (FDA). Guidance for Industry: Clinical Trial Endpoints for the 
Approval of Cancer Drugs and Biologics. 2007. 
http://www.fda.gov/downloads/Drugs/.../Guidances/ucm071590.pdf. Accessed January 4, 2016. 
Koyama T, Chen H. Proper inference from Simon's two-stage designs. Stat Med 
2008;27:3145-3154. 
Lan KK, Wittes J. The B-value: a tool for monitoring data. Biometrics 1988;44:579-585. 
Mosteller RD. Simplified calculation of body surface area. N Engl J Med 1987;317:1098. 
Motzer RJ, Bacik J, Mazumdar M. Prognostic factors for survival of patients with stage IV renal 
cell carcinoma: memorial sloan-kettering cancer center experience. Clin Cancer Res 
2004;10:6302S-6303S. 
Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials 1989;10:1-10. 


Incyte Corporation 
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APPENDIX A. PLANNED TABLES AND FIGURES 
This appendix provides a list of the planned tables and figures for the CSR.  Standard tables will 
follow the conventions in the Standard Safety Tables initial version.  Shells are provided for 
nonstandard tables.  In-text tables are identical in structure and content as appendix tables, but 
follow a Rich Text Format. 
The list of tables, figures, and the shells are to be used as guideline.  Modifications of the list or 
shells that do not otherwise affect the nature of the analysis will not warrant an amendment to the 
SAP. 
Tables 
Table No. 
Title 
Population 
Standard 
In-Text 
Baseline and Demographic Characteristics 
1.1  Disposition 
1.1.1.1 
Analysis Populations  
Part 1 FAS 
Population 
X 
X 
1.1.1.2 
Analysis Populations  
Part 2 FAS 
Population 
X 
X 
1.1.2.1 
Summary of Subject Disposition 
Part 1 FAS 
Population 
X 
X 
1.1.2.2 
Summary of Subject Disposition 
Part 2 FAS 
Population 
X 
X 
1.1.3.1 
Summary of Number of Subjects Enrolled By Site 
Part 1 FAS 
Population 
X 
X 
1.1.3.2 
Summary of Number of Subjects Enrolled By Site 
Part 2 FAS 
Population 
X 
X 
1.2  Demography 
1.2.1 
Summary of Demographics 
Part 1 FAS 
Population 
X 
X 
1.2.2 
Summary of Demographics 
Part 2 FAS 
Population 
X 
X 
1.3  Baseline Characteristics 
1.3.1.1 
Summary of Baseline Disease Characteristics and 
Disease History  
Part 1 FAS 
Population 
X 
X 
1.3.1.2.1 
Summary of Baseline Disease Characteristics and 
Disease History 
Endometrium  
Part 2 FAS 
Population 
X 
X 
1.3.1.2.2 
Summary of Baseline Disease Characteristics and 
Disease History 
Melanoma 
Part 2 FAS 
Population 
X 
X 
1.3.1.2.3 
Summary of Baseline Disease Characteristics and 
Disease History 
NSCLC 
Part 2 FAS 
Population 
X 
X 
1.3.1.2.4 
Summary of Baseline Disease Characteristics and 
Disease History 
Ovarian  
Part 2 FAS 
Population 
X 
X 


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Table No. 
Title 
Population 
Standard 
In-Text 
1.3.1.2.5 
Summary of Baseline Disease Characteristics and 
Disease History 
RCC  
Part 2 FAS 
Population 
X 
X 
1.4  Prior Medication and Concomitant Medication 
1.4.1.1 
Summary of Prior Cancer Therapy 
Part 1 FAS 
Population 
X 
 
1.4.1.2 
Summary of Prior Cancer Therapy 
Part 2 FAS 
Population 
X 
 
1.4.2.1 
Summary of Prior Medications 
Part 1 FAS 
Population 
X 
 
1.4.2.2 
Summary of Prior Medications 
Part 2 FAS 
Population 
X 
 
1.4.3.1 
Summary of Concomitant Medications 
Part 1 FAS 
Population 
X 
 
1.4.3.2 
Summary of Concomitant Medications 
Part 2 FAS 
Population 
X 
 
1.5+  Others 
1.5.1 
Summary of General Medical History 
Part 1 FAS 
Population 
X 
 
1.5.2 
Summary of General Medical History 
Part 2 FAS 
Population 
X 
 
Efficacy 
2.1.1 
Summary of Best Response, Duration of Response, 
and Duration of Disease Control under RECIST v1.1 
Part 1 FAS 
Population 
 
X 
2.1.2 
Summary of Best Response, Duration of Response, 
and Duration of Disease Control under RECIST v1.1 
Part 2 FAS 
Population 
 
X 
2.2.1 
Summary of Best Response, Duration of Response, 
and Duration of Disease Control under mRECIST v1.1 
Part 1 FAS 
Population 
 
X 
2.2.2 
Summary of Best Response, Duration of Response, 
and Duration of Disease Control under mRECIST v1.1 
Part 2 FAS 
Population 
 
X 
2.3.1 
Summary of Progression-Free Survival under RECIST 
v1.1 
Part 1 FAS 
Population 
 
X 
2.3.2 
Summary of Progression-Free Survival under RECIST 
v1.1 
Part 2 FAS 
Population 
 
X 
2.4.1 
Summary of Progression-Free Survival under 
mRECIST v1.1 
Part 1 FAS 
Population 
 
X 
2.4.2 
Summary of Progression-Free Survival under 
mRECIST v1.1 
Part 2 FAS 
Population 
 
X 
2.5 
Summary of PK Parameters 
PK Evaluable 
Population 
 
 
 
 
 
 
 
Safety 
3.1  Dose Exposure 
3.1.1.1 
Summary of Study Drug Exposure  
Part 1 FAS 
Population 
X 
X 
3.1.1.2 
Summary of Study Drug Exposure  
Part 2 FAS 
Population 
X 
X 


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Table No. 
Title 
Population 
Standard 
In-Text 
3.1.2.1 
Summary of Study Drug Exposure by Visit 
Part 1 FAS 
Population 
X 
X 
3.1.2.2 
Summary of Study Drug Exposure by Visit 
Part 2 FAS 
Population 
X 
X 
3.2  Adverse Events 
3.2.1.1 
Overall Summary of Treatment-Emergent Adverse 
Events 
Part 1 FAS 
Population 
X 
X 
3.2.1.2 
Overall Summary of Treatment-Emergent Adverse 
Events 
Part 2 FAS 
Population 
X 
X 
3.2.2.1 
Summary of Treatment-Emergent Adverse Events by 
MedDRA System Organ Class and Preferred Term 
Part 1 FAS 
Population 
X 
 
3.2.2.2 
Summary of Treatment-Emergent Adverse Events by 
MedDRA System Organ Class and Preferred Term 
        Part 2 FAS  
        Population 
X 
 
3.2.3.1 
Summary of Treatment-Emergent Adverse Events by 
MedDRA Preferred Term in Decreasing Order of 
Frequency 
Part 1 FAS 
Population 
X 
X 
3.2.3.2 
Summary of Treatment-Emergent Adverse Events by 
MedDRA Preferred Term in Decreasing Order of 
Frequency 
Part 2 FAS 
Population 
X 
X 
3.2.4.1 
Summary of Grade 3 or Higher Treatment-Emergent 
Adverse Events by MedDRA Preferred Term in 
Decreasing Order of Frequency 
Part 1 FAS 
Population 
X 
X 
3.2.4.2 
Summary of Grade 3 or Higher Treatment-Emergent 
Adverse Events by MedDRA Preferred Term in 
Decreasing Order of Frequency 
Part 2 FAS 
Population 
X 
X 
3.2.5.1 
Summary of Treatment-Emergent Adverse Events by 
MedDRA System Organ Class, Preferred Term, and 
Maximum Severity 
Part 1 FAS 
Population 
X 
 
3.2.5.2 
Summary of Treatment-Emergent Adverse Events by 
MedDRA System Organ Class, Preferred Term, and 
Maximum Severity 
Part 2 FAS 
Population 
X 
 
3.2.6.1 
Summary of Grade 3 or Higher Treatment-Emergent 
Adverse Events by MedDRA System Organ Class and 
Preferred Term 
Part 1 FAS 
Population 
X 
X 
3.2.6.2 
Summary of Grade 3 or Higher Treatment-Emergent 
Adverse Events by MedDRA System Organ Class and 
Preferred Term 
Part 2 FAS 
Population 
X 
X 
3.2.7.1 
Summary of INCAGN01949 Treatment-Related 
Adverse Events by MedDRA System Organ Class and 
Preferred Term 
Part 1 FAS 
Population 
X 
X 
3.2.7.2 
Summary of INCAGN01949 Treatment-Related 
Adverse Events by MedDRA System Organ Class and 
Preferred Term 
Part 2 FAS 
Population 
X 
X 
3.2.8.1 
Summary of Grade 3 or Higher INCAGN01949 
Treatment-Related Adverse Events by MedDRA 
System Organ Class and Preferred Term 
Part 1 FAS 
Population 
X 
 
3.2.8.2 
Summary of Grade 3 or Higher INCAGN01949 
Treatment-Related Adverse Events by MedDRA 
System Organ Class and Preferred Term 
Part 2 FAS 
Population 
X 
 


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Table No. 
Title 
Population 
Standard 
In-Text 
3.2.9.1 
Summary of Grade 3 or Higher INCAGN01949 
Treatment-Related Adverse Events by MedDRA 
Preferred Term in Decreasing Order of Frequency 
Part 1 FAS 
Population 
X 
X 
3.2.9.2 
Summary of Grade 3 or Higher INCAGN01949 
Treatment-Related Adverse Events by MedDRA 
Preferred Term in Decreasing Order of Frequency 
Part 2 FAS 
Population 
X 
X 
3.2.10.1 
Summary of INCAGN01949 Treatment-Related 
Adverse Events by MedDRA System Organ Class, 
Preferred Term, and Maximum Severity 
Part 1 FAS 
Population 
X 
 
3.2.10.2 
Summary of INCAGN01949 Treatment-Related 
Adverse Events by MedDRA System Organ Class, 
Preferred Term, and Maximum Severity 
Part 2 FAS 
Population 
X 
 
3.2.11.1 
Summary of Treatment-Emergent Adverse Events 
With a Fatal Outcome by MedDRA System Organ 
Class and Preferred Term 
Part 1 FAS 
Population 
X 
X 
3.2.11.2 
Summary of Treatment-Emergent Adverse Events 
With a Fatal Outcome by MedDRA System Organ 
Class and Preferred Term 
Part 2 FAS 
Population 
X 
X 
3.2.12.1 
Summary of Serious Treatment-Emergent Adverse 
Events by MedDRA System Organ Class and 
Preferred Term 
Part 1 FAS 
Population 
X 
X 
3.2.12.2 
Summary of Serious Treatment-Emergent Adverse 
Events by MedDRA System Organ Class and 
Preferred Term 
Part 2 FAS 
Population 
X 
X 
3.2.13.1 
Summary of Serious Treatment-Emergent Adverse 
Events by MedDRA Preferred Term in Decreasing 
Order of Frequency 
Part 1 FAS 
Population 
X 
X 
3.2.13.2 
Summary of Serious Treatment-Emergent Adverse 
Events by MedDRA Preferred Term in Decreasing 
Order of Frequency 
Part 2 FAS 
Population 
X 
X 
3.2.14.1 
Summary of Non-Serious Treatment-Emergent 
Adverse Events by MedDRA System Organ Class and 
Preferred Term 
Part 1 FAS 
Population 
X 
 
3.2.14.2 
Summary of Non-Serious Treatment-Emergent 
Adverse Events by MedDRA System Organ Class and 
Preferred Term 
Part 2 FAS 
Population 
X 
 
3.2.15.1 
Summary of INCAGN01949 Treatment-Related 
Serious Adverse Events by MedDRA System Organ 
Class and Preferred Term 
Part 1 FAS 
Population 
X 
X 
3.2.15.2 
Summary of INCAGN01949 Treatment-Related 
Serious Adverse Events by MedDRA System Organ 
Class and Preferred Term 
Part 2 FAS 
Population 
X 
X 
3.2.16.1 
Summary of Treatment-Emergent Adverse Events 
Leading to INCAGN01949 Dose Reduction by 
MedDRA System Organ Class and Preferred Term 
Part 1 FAS 
Population 
X 
 
3.2.16.2 
Summary of Treatment-Emergent Adverse Events 
Leading to INCAGN01949 Dose Reduction by 
MedDRA System Organ Class and Preferred Term 
Part 2 FAS 
Population 
X 
 


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Table No. 
Title 
Population 
Standard 
In-Text 
3.2.17.1 
Summary of Treatment-Emergent Adverse Events 
Leading to INCAGN01949 Dose Interruption by 
MedDRA System Organ Class and Preferred Term 
Part 1 FAS 
Population 
X 
 
3.2.17.2 
Summary of Treatment-Emergent Adverse Events 
Leading to INCAGN01949 Dose Interruption by 
MedDRA System Organ Class and Preferred Term 
Part 2 FAS 
Population 
X 
 
3.2.18.1 
Summary of Treatment-Emergent Adverse Events 
Leading to Discontinuation of INCAGN01949 by 
MedDRA System Organ Class and Preferred Term 
Part 1 FAS 
Population 
X 
X 
3.2.18.2 
Summary of Treatment-Emergent Adverse Events 
Leading to Discontinuation of INCAGN01949 by 
MedDRA System Organ Class and Preferred Term 
Part 2 FAS 
Population 
X 
X 
3.2.19.1 
Summary of Treatment-Emergent Immune-Related 
Adverse Events (Investigator Identified) by MedDRA 
System Organ Class and Preferred Term 
Part 1 FAS 
Population 
 
 
3.2.19.2 
Summary of Treatment-Emergent Immune-Related 
Adverse Events (Investigator Identified) by MedDRA 
System Organ Class and Preferred Term 
Part 2 FAS 
Population 
 
 
3.2.20.1 
Summary of Treatment-Emergent Immune-Related 
Adverse Events (Sponsor Identified) by MedDRA 
System Organ Class and Preferred Term 
Part 1 FAS 
Population 
 
 
3.2.20.2 
Summary of Treatment-Emergent Immune-Related 
Adverse Events (Sponsor Identified) by MedDRA 
System Organ Class and Preferred Term 
Part 2 FAS 
Population 
 
 
3.2.21.1 
Summary of Treatment-Emergent Immune-Related 
Adverse Events by MedDRA System Organ Class, 
Preferred Term, and Maximum Severity  
Part 1 FAS 
Population 
 
 
3.2.21.2 
Summary of Treatment-Emergent Immune-Related 
Adverse Events by MedDRA System Organ Class, 
Preferred Term, and Maximum Severity  
Part 2 FAS 
Population 
 
 
3.2.22.1 
Summary of Grade 3 or Higher Treatment-Emergent 
Immune-Related Adverse Events by MedDRA System 
Organ Class and Preferred Term 
Part 1 FAS 
Population 
 
 
3.2.22.2 
Summary of Grade 3 or Higher Treatment-Emergent 
Immune-Related Adverse Events by MedDRA System 
Organ Class and Preferred Term 
Part 2 FAS 
Population 
 
 
3.2.23 
Life Table Estimate of Time to First Grade 3 or Higher 
Treatment-Emergent Adverse Event 
Part 2 FAS 
Population 
 
 
3.3  Laboratory 
3.3.1 
Summary of Laboratory Values - Hematology 
Part 2 FAS 
Population 
X 
 
3.3.2.1 
Shift Summary of Hematology Laboratory Values in 
CTC Grade - To the Worst Abnormal Value  
Part 1 FAS 
Population 
X 
X 
3.3.2.2 
Shift Summary of Hematology Laboratory Values in 
CTC Grade - To the Worst Abnormal Value  
Part 2 FAS 
Population 
X 
X 
3.3.3 
Summary of Laboratory Values - Chemistry 
Part 2 FAS 
Population 
X 
 
3.3.4.1 
Shift Summary of Chemistry Laboratory Values in 
CTC Grade - To the Worst Abnormal Value 
Part 1 FAS 
Population 
X 
X 


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Table No. 
Title 
Population 
Standard 
In-Text 
3.3.4.2 
Shift Summary of Chemistry Laboratory Values in 
CTC Grade - To the Worst Abnormal Value 
Part 2 FAS 
Population 
X 
X 
3.4  Vital Signs 
3.4.1.1 
Summary of Systolic Blood Pressure (mmHg) 
Part 1 FAS 
Population 
X 
 
3.4.1.2 
Summary of Systolic Blood Pressure (mmHg) 
Part 2 FAS 
Population 
X 
 
3.4.2.1 
Summary of Diastolic Blood Pressure (mmHg)  
Part 1 FAS 
Population 
X 
 
3.4.2.2 
Summary of Diastolic Blood Pressure (mmHg)  
Part 2 FAS 
Population 
X 
 
3.4.3.1 
Summary of Heart Rate (bpm)  
Part 1 FAS 
Population 
X 
 
3.4.3.2 
Summary of Heart Rate (bpm)  
Part 2 FAS 
Population 
X 
 
3.4.4.1 
Summary of Respiration Rate (bpm)  
Part 1 FAS 
Population 
X 
 
3.4.4.2 
Summary of Respiration Rate (bpm)  
Part 2 FAS 
Population 
X 
 
3.4.5.1 
Summary of Body Temperature (ºC) 
Part 1 FAS 
Population 
X 
 
3.4.5.2 
Summary of Body Temperature (ºC) 
Part 2 FAS 
Population 
X 
 
3.4.6.1 
Summary of Body Weight (kg) 
Part 1 FAS 
Population 
X 
 
3.4.6.2 
Summary of Body Weight (kg) 
Part 2 FAS 
Population 
X 
 
3.5  ECG 
3.5.1.1 
Summary of PR Interval (msec) from Central Lab 
12-Lead ECG 
Part 1 FAS 
Population 
X 
 
3.5.1.2 
Summary of PR Interval (msec) from Central Lab 
12-Lead ECG 
Part 2 FAS 
Population 
X 
 
3.5.2.1 
Summary of RR Interval (msec) from Central Lab 
12-Lead ECG 
Part 1 FAS 
Population 
X 
 
3.5.2.2 
Summary of RR Interval (msec) from Central Lab 
12-Lead ECG 
Part 2 FAS 
Population 
X 
 
3.5.3.1 
Summary of QT Interval (msec) from Central Lab 
12-Lead ECG 
Part 1 FAS 
Population 
X 
 
3.5.3.2 
Summary of QT Interval (msec) from Central Lab 
12-Lead ECG 
Part 2 FAS 
Population 
X 
 
3.5.4.1 
Summary of QRS Interval (msec) from Central Lab 
12-Lead ECG 
Part 1 FAS 
Population 
X 
 
3.5.4.2 
Summary of QRS Interval (msec) from Central Lab 
12-Lead ECG 
Part 2 FAS 
Population 
X 
 
3.5.5.1 
Summary of QTcF Interval (msec) from Central Lab 
12-Lead ECG 
Part 1 FAS 
Population 
X 
 
3.5.5.2 
Summary of QTcF Interval (msec) from Central Lab 
12-Lead ECG 
Part 2 FAS 
Population 
X 
 


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Table No. 
Title 
Population 
Standard 
In-Text 
3.5.6.1 
Summary of JTc Interval (msec) from Central Lab 
12-Lead ECG 
Part 1 FAS 
Population 
X 
 
3.5.6.2 
Summary of JTc Interval (msec) from Central Lab 
12-Lead ECG 
Part 2 FAS 
Population 
X 
 
3.5.7.1 
Summary of HR Interval (msec) from Central Lab 
12-Lead ECG 
Part 1 FAS 
Population 
X 
 
3.5.7.2 
Summary of HR Interval (msec) from Central Lab 
12-Lead ECG 
Part 2 FAS 
Population 
X 
 
3.5.8.1 
Summary of Outliers of QT, RR, and QTcF Interval 
Values from Central 12-Lead ECG 
Part 1 FAS 
Population 
X 
 
3.5.8.2 
Summary of Outliers of QT, RR, and QTcF Interval 
Values from Central 12-Lead ECG 
Part 2 FAS 
Population 
X 
 
Figures 
Figure No. 
Title 
4.1  Efficacy  
4.1.1 
Kaplan-Meier Estimates of Progression-Free Survival  
4.1.2 
Kaplan-Meier Estimates of Duration of Response  
4.1.3 
Swim Plot of Duration of Response 
4.1.4 
Waterfall Plot of Percent Change from Baseline in Sum of Target Lesions 
4.1.5 
Spider Plot of Percent Change from Baseline in Sum of Target Lesions 
4.2  AD HOC or Additional Analyses of Other Safety Data  
4.2.1 
Line Graph of Selected Laboratory Values  by Study Visit 
4.2.2 
Box-and-Whisker Plot of Selected Laboratory Values by Study Visit 
Listings 
Listing No. 
Title 
2.1  Discontinued Subjects (Subject Disposition) 
2.1.1 
Subject Enrollment and Disposition Status 
2.1.2 
Subject Inclusion and Exclusion Criteria Violations 
2.2  Protocol Deviation 
2.2.1 
Protocol Deviations and Violations 
2.3  Data Excluded from PK, Efficacy, and/or Safety Analyses 
2.3.1 
Analysis Population 
2.4  Demography and Baseline (including Prior and Concomitant Medications) 
2.4.1 
Demographic and Baseline Disease Characteristics  
2.4.2 
Demographic and Baseline Disease Characteristics for Part 1 Solid Tumor Types 
2.4.3 
Disease History 
2.4.4 
Prior Radiation Treatment 


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Listing No. 
Title 
2.4.5 
Prior Systemic Therapy 
2.4.6 
Prior Surgery or Surgical Procedure 
2.4.7 
Sponsor-Derived MSKCC  
2.4.8 
Medical History 
2.4.9 
Prior and Concomitant Medication 
2.5  Efficacy (and/or PK Data) 
2.5.1 
Best Overall Response 
2.5.2 
Overall Response Assessment   
2.5.3 
Response Assessment: Target Lesions  
2.5.4 
Response Assessment: Non-target Lesions  
2.5.5 
Response Assessment: New Lesions  
2.5.6 
ECOG status 
 
 
2.6  Adverse Events (and Exposure) 
2.6.1 
Study Drug Administration 
2.6.2 
Adverse Events  
2.6.3 
Dose-limiting Toxicities 
2.6.4 
Serious Adverse Events 
2.6.5 
Grade 3 and Higher Adverse Events 
2.6.6 
Fatal Adverse Events 
2.6.7 
Treatment Related Adverse Events 
2.6.8 
Adverse Events Leading to Delay, Reduction or Discontinuation of INCAGN01949 
2.6.9 
Deaths 
2.6.10 
Investigator-Identified Immune-Related Adverse Events 
2.6.11 
Sponsor-Identified Immune-Related Adverse Events 
2.6.12 
Grade 3 or Higher Investigator-Identified Immune-Related Adverse Events 
2.6.13 
Grade 3 or Higher Sponsor-Identified Immune-Related Adverse Events 
2.6.14 
Infusion Reactions 
2.7  Laboratory Data 
2.7.1 
Clinical Laboratory Values – Hematology 
2.7.2 
Clinical Laboratory Values – Chemistry 
2.7.3 
Abnormal Clinical Laboratory Values 
2.7.4 
PK Blood Sampling Times 
2.8  Vital Signs 
2.8.1 
Vital Signs 
2.8.2 
Abnormal Vital Sign Values 
2.8.3 
Alert Vital Sign Values 
2.9  ECG 
2.9.1 
12-Lead Local ECG Values 
2.9.2 
Abnormal 12-Lead Local ECG Values 
2.9.3 
Alert 12-Lead Local ECG Values 
2.9.4 
12-Lead Central ECG Values 
2.9.5 
Abnormal 12-Lead Central ECG Values 
2.9.6 
Alert 12-Lead Central ECG Values 
2.10  Physical Examination 
2.10.1 
Body Weight 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N)               
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                      DATABASE VERSION: Draft                
TLF VERSION: Draft 
 
 
                                                    Table 1.1.1.1 
  
                                                 Analysis Populations 
                                          (Population: Part 1 FAS Population) 
  
______________________________________________________________________________________________________________________ 
                                                                                    Treatment Group 
                                                                   ___________________________________________________ 
                                                                         Dose 1     Dose 2     Dose 3        Total 
        Variable                                                         (N=xx)     (N=xx)     (N=xx)        (N=xx)       
______________________________________________________________________________________________________________________ 
  
        Number(%) of Subjects in the Part 1 FAS Population               xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
        Number(%) of Subjects in the PK Evaluable Population             xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
        Number(%) of Subjects in the 
 Evaluable Population             xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
        Number(%) of Subjects in the PP Population                       xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
        Number(%) of Subjects in the 
 Evaluable Population         xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
        Number(%) of Subjects in the 
 Evaluable Population            xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX. LST                                        DATE(TIME): MMDDYYYY(hh:mm) 
 
Abbreviations: PK = Pharmacokinetics; 
; PP = Per Protocol; 
 
Reference: Listing 2.## 
 
 
 
 
 
 
 
 
 


Incyte Corporation 
Page 47 of 186 
INCAGN 1949-101 Statistical Analysis Plan 
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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N)               
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: Draft               
TLF VERSION: Draft 
 
                                                    Table 1.1.1.2 
  
                                                 Analysis Populations 
                                          (Population: Part 2 FAS Population) 
  
_______________________________________________________________________________________________________________________ 
                                                                               Recommended Dose 
                                                  _____________________________________________________________________ 
                                                       Endometrium   Ovarian    Melanoma    NSCLC     RCC      Total 
Variable                                                 (N=xx)      (N=xx)      (N=xx)     (N=xx)   (N=xx)    (N=xx)  
_______________________________________________________________________________________________________________________ 
  
Number(%) of Subjects in the Part 2 FAS Population       xx(xx.x)   xx(xx.x)    xx(xx.x)   xx(xx.x)  xx(xx.x)  xx(xx.x) 
 
Number(%) of Subjects in the PK Evaluable Population     xx(xx.x)   xx(xx.x)    xx(xx.x)   xx(xx.x)  xx(xx.x)  xx(xx.x) 
 
Number(%) of Subjects in the 
 Evaluable Population     xx(xx.x)   xx(xx.x)    xx(xx.x)   xx(xx.x)  xx(xx.x)  xx(xx.x) 
 
Number(%) of Subjects in the PP Population               xx(xx.x)   xx(xx.x)    xx(xx.x)   xx(xx.x)  xx(xx.x)  xx(xx.x)  
 
Number(%) of Subjects in the 
 Evaluable Population xx(xx.x)   xx(xx.x)    xx(xx.x)   xx(xx.x)  xx(xx.x)  xx(xx.x) 
 
Number(%) of Subjects in the 
 Evaluable Population    xx(xx.x)   xx(xx.x)    xx(xx.x)   xx(xx.x)  xx(xx.x)  xx(xx.x) 
   
_______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX. LST                                        DATE(TIME): MMDDYYYY(hh:mm)               
 
Abbreviations: PK = Pharmacokinetics; 
; PP = Per Protocol; 
 
Reference: Listing 2.## 
 
 
 
 
 
 
 
 


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Page 48 of 186 
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CONFIDENTIAL 
PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N)               
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                      DATABASE VERSION: Draft                
TLF VERSION: Draft 
  
                                                   TABLE 1.1.2.1 
  
                                           Summary of Subject Disposition 
                                        (Population: Part 1 FAS Population) 
 
 
                                                                                    Treatment Group 
                                                                     ______________________________________________ 
                                                                         Dose 1     Dose 2     Dose 3        Total 
        Variable                                                         (N=xx)     (N=xx)     (N=xx)        (N=xx)       
______________________________________________________________________________________________________________________ 
  
Number(%) of Subjects in the Part 1 FAS Population                       xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
 
Primary Reason for Discontinuation of Treatment: 
   Adverse Event                                                         xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
   Death                                                                 xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
   Lost to Follow-up                                                     xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
   Physician Decision                                                    xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
   Pregnancy                                                             xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
   Protocol Violation                                                    xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
   Study Terminated by the Sponsor                                       xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
   Withdrawal by Subject                                                 xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
   Other                                                                 xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
 
Primary Reason for Discontinuation of Study: 
   Death                                                                 xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
   Lost to Follow-up                                                     xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
   Physician Decision                                                    xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
   Protocol Violation                                                    xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
   Study Terminated by Sponsor                                           xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
   Withdrawal by Subject                                                 xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
   Other                                                                 xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
    
_______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX. LST                                        DATE(TIME): MMDDYYYY(hh:mm)  
Reference: Listing 2.1.1 
 
 
 


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CONFIDENTIAL 
PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N)               
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: Draft               
TLF VERSION: Draft 
                                                    TABLE 1.1.2.2 
  
                                             Summary of Subject Disposition 
                                          (Population: Part 2 FAS Population) 
 
 
                                                                         Recommended Dose 
                                             _____________________________________________________________________ 
                                             Endometrium       Ovarian    Melanoma      NSCLC      RCC      Total 
        Variable                                (N=xx)         (N=xx)      (N=xx)       (N=xx)    (N=xx)    (N=xx) 
_______________________________________________________________________________________________________________________ 
  
Number(%) of Subjects in the Part 2 FAS Population xx(xx.x)      xx(xx.x)    xx(xx.x)     xx(xx.x)  xx(xx.x)  xx(xx.x) 
 
Primary Reason for Discontinuation of Treatment: 
   Adverse Event                                xx(xx.x)      xx(xx.x)    xx(xx.x)     xx(xx.x)  xx(xx.x)  xx(xx.x) 
   Death                                        xx(xx.x)      xx(xx.x)    xx(xx.x)     xx(xx.x)  xx(xx.x)  xx(xx.x) 
   Lost to Follow-up                            xx(xx.x)      xx(xx.x)    xx(xx.x)     xx(xx.x)  xx(xx.x)  xx(xx.x) 
   Physician Decision                           xx(xx.x)      xx(xx.x)    xx(xx.x)     xx(xx.x)  xx(xx.x)  xx(xx.x) 
   Pregnancy                                    xx(xx.x)      xx(xx.x)    xx(xx.x)     xx(xx.x)  xx(xx.x)  xx(xx.x) 
   Protocol Violation                           xx(xx.x)      xx(xx.x)    xx(xx.x)     xx(xx.x)  xx(xx.x)  xx(xx.x) 
   Study Terminated by the Sponsor              xx(xx.x)      xx(xx.x)    xx(xx.x)     xx(xx.x)  xx(xx.x)  xx(xx.x) 
   Withdrawal by Subject                        xx(xx.x)      xx(xx.x)    xx(xx.x)     xx(xx.x)  xx(xx.x)  xx(xx.x) 
   Other                                        xx(xx.x)      xx(xx.x)    xx(xx.x)     xx(xx.x)  xx(xx.x)  xx(xx.x) 
 
Primary Reason for Discontinuation of Study: 
   Death                                        xx(xx.x)      xx(xx.x)    xx(xx.x)     xx(xx.x)  xx(xx.x)  xx(xx.x) 
   Lost to Follow-up                            xx(xx.x)      xx(xx.x)    xx(xx.x)     xx(xx.x)  xx(xx.x)  xx(xx.x) 
   Physician Decision                           xx(xx.x)      xx(xx.x)    xx(xx.x)     xx(xx.x)  xx(xx.x)  xx(xx.x) 
   Protocol Violation                           xx(xx.x)      xx(xx.x)    xx(xx.x)     xx(xx.x)  xx(xx.x)  xx(xx.x) 
   Study Terminated by Sponsor                  xx(xx.x)      xx(xx.x)    xx(xx.x)     xx(xx.x)  xx(xx.x)  xx(xx.x) 
   Withdrawal by Subject                        xx(xx.x)      xx(xx.x)    xx(xx.x)     xx(xx.x)  xx(xx.x)  xx(xx.x) 
   Other                                        xx(xx.x)      xx(xx.x)    xx(xx.x)     xx(xx.x)  xx(xx.x)  xx(xx.x) 
 
________________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX. LST                                        DATE(TIME): MMDDYYYY(hh:mm)               
  
Reference: Listing 2.1.1 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N)               
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: Draft               
TLF VERSION: Draft 
  
                                                   TABLE 1.1.3.1 
  
                                      Summary of Number of Subjects Enrolled by Site 
                                        (Population: Part 1 FAS Population) 
 
 
                                                                                  Treatment Group 
                                                                        _________________________________________ 
                                                                         Dose 1     Dose 2     Dose 3        Total 
        Variable                                                         (N=xx)     (N=xx)     (N=xx)        (N=xx)       
______________________________________________________________________________________________________________________ 
  
          Site 1                                                         xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
          Site 2                                                         xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
          Site 3                                                         xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
 
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX. LST                                       DATE(TIME): MMDDYYYY(hh:mm)                
  
Reference: Listing 2.## 
 
 
 
 
 
 
 
 
 
 
 
 
 


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CONFIDENTIAL 
PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N)               
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: Draft               
TLF VERSION: Draft  
 
 
 
                                                        TABLE 1.1.3.2 
  
                                        Summary of Number of Subjects Enrolled by Site 
                                             (Population: Part 2 FAS Population) 
 
 
                                                                         Recommended Dose 
                                             _____________________________________________________________________ 
                                             Endometrium       Ovarian      Melanoma       NSCLC        RCC       Total 
        Variable                                (N=xx)         (N=xx)        (N=xx)       (N=xx)       (N=xx)    (N=xx) 
_______________________________________________________________________________________________________________________ 
          
         Site 1                                xx(xx.x)       xx(xx.x)      xx(xx.x)     xx(xx.x)     xx(xx.x)   xx(xx.x) 
         Site 2                                xx(xx.x)       xx(xx.x)      xx(xx.x)     xx(xx.x)     xx(xx.x)   xx(xx.x) 
         Site 3                                xx(xx.x)       xx(xx.x)      xx(xx.x)     xx(xx.x)     xx(xx.x)   xx(xx.x)    
_________________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                         DATE(TIME): MMDDYYYY(hh:mm)               
  
Reference: Listing 2.## 
 
 
 
 
 
 
 
 
 
 
 
 


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Page 52 of 186 
INCAGN 1949-101 Statistical Analysis Plan 
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CONFIDENTIAL 
PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N)               
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: Draft               
TLF VERSION: Draft  
 
                                                       TABLE 1.2.1 
                                                  Summary of Demographics 
                                            (Population: Part 1 FAS Population) 
                                                                                    Treatment Group 
                                                                        ____________________________________________ 
                                                                         Dose 1     Dose 2     Dose 3        Total 
        Variable                                                         (N=xx)     (N=xx)     (N=xx)        (N=xx)       
______________________________________________________________________________________________________________________ 
  
       Age (yrs)                                                                        
            n                                                            xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
            Mean                                                         xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
            STD                                                          xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
            Min                                                          xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
            Median                                                       xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
            Max                                                          xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
       
      Sex – n (%)      
            Male                                                         xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x)    
            Female                                                       xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
 
      Race – n (%) 
            White/Caucasian                                              xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
            Black/African-American                                       xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
            Asian                                                        xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
            American-Indian/Alaska Native                                xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
            Native Hawaiian/Pacific Islander                             xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x)   
            Other                                                        xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
                                                                           
      Ethnicity – n (%)                                                                        
            Hispanic or Latino                                           xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
            Not Hispanic or Latino                                       xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
            Not Reported                                                 xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x)       
            Unknown                                                      xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
            Other                                                        xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
________________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                         DATE(TIME): MMDDYYYY(hh:mm)               
Abbreviation: STD = Standard Deviation; Min = Minimum; Max = Maximum. 
Reference: Listing 2.## 
 
 


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CONFIDENTIAL 
PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N)               
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: Draft               
TLF VERSION: Draft  
 
                                                         TABLE 1.2.2  
                                                   Summary of Demographics 
                                             (Population: Part 2 FAS Population) 
 
                                                                         Recommended Dose 
                                             _____________________________________________________________________ 
                                             Endometrium       Ovarian      Melanoma       NSCLC        RCC     Total 
    Variable                                    (N=xx)         (N=xx)        (N=xx)       (N=xx)      (N=xx)   (N=xx) 
______________________________________________________________________________________________________________________ 
          
    Age (yrs)                                                                        
       n                                       xx(xx.x)       xx(xx.x)      xx(xx.x)     xx(xx.x)    xx(xx.x)  xx(xx.x) 
       Mean                                    xx(xx.x)       xx(xx.x)      xx(xx.x)     xx(xx.x)    xx(xx.x)  xx(xx.x) 
       STD                                     xx(xx.x)       xx(xx.x)      xx(xx.x)     xx(xx.x)    xx(xx.x)  xx(xx.x) 
       Min                                     xx(xx.x)       xx(xx.x)      xx(xx.x)     xx(xx.x)    xx(xx.x)  xx(xx.x) 
       Median                                  xx(xx.x)       xx(xx.x)      xx(xx.x)     xx(xx.x)    xx(xx.x)  xx(xx.x) 
       Max                                     xx(xx.x)       xx(xx.x)      xx(xx.x)     xx(xx.x)    xx(xx.x)  xx(xx.x) 
       
   Sex – n (%)      
       Male                                    xx(xx.x)       xx(xx.x)      xx(xx.x)     xx(xx.x)    xx(xx.x)  xx(xx.x)    
       Female                                  xx(xx.x)       xx(xx.x)      xx(xx.x)     xx(xx.x)    xx(xx.x)  xx(xx.x) 
 
   Race – n (%) 
       White/Caucasian                         xx(xx.x)       xx(xx.x)      xx(xx.x)     xx(xx.x)    xx(xx.x)  xx(xx.x) 
       Black/African-American                  xx(xx.x)       xx(xx.x)      xx(xx.x)     xx(xx.x)    xx(xx.x)  xx(xx.x) 
       Asian                                   xx(xx.x)       xx(xx.x)      xx(xx.x)     xx(xx.x)    xx(xx.x)  xx(xx.x) 
       American-Indian/Alaska Native           xx(xx.x)       xx(xx.x)      xx(xx.x)     xx(xx.x)    xx(xx.x)  xx(xx.x) 
       Native Hawaiian/Pacific Islander        xx(xx.x)       xx(xx.x)      xx(xx.x)     xx(xx.x)    xx(xx.x)  xx(xx.x)   
       Other                                   xx(xx.x)       xx(xx.x)      xx(xx.x)     xx(xx.x)    xx(xx.x)  xx(xx.x) 
                                                                           
   Ethnicity – n (%)                                                                       
       Hispanic or Latino                      xx(xx.x)       xx(xx.x)      xx(xx.x)     xx(xx.x)    xx(xx.x)  xx(xx.x) 
       Not Hispanic or Latino                  xx(xx.x)       xx(xx.x)      xx(xx.x)     xx(xx.x)    xx(xx.x)  xx(xx.x) 
       Not Reported                            xx(xx.x)       xx(xx.x)      xx(xx.x)     xx(xx.x)    xx(xx.x)  xx(xx.x)       
       Unknown                                 xx(xx.x)       xx(xx.x)      xx(xx.x)     xx(xx.x)    xx(xx.x)  xx(xx.x) 
       Other                                   xx(xx.x)       xx(xx.x)      xx(xx.x)     xx(xx.x)    xx(xx.x)  xx(xx.x) 
                 
________________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                         DATE(TIME): MMDDYYYY(hh:mm)               
Abbreviation: STD = Standard Deviation; Min = Minimum; Max = Maximum.  
Reference: Listing 2.## 


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CONFIDENTIAL 
PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N)               
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: Draft               
TLF VERSION: Draft  
 
  
                                                     TABLE 1.3.1.1 
  
                           Summary of Baseline Disease Characteristics and Disease History  
                                          (Population: Part 1 FAS Population) 
 
                                                                               Treatment Group 
                                             _____________________________________________________________________ 
                                                                         Dose 1     Dose 2     Dose 3        Total 
        Variable                                                         (N=xx)     (N=xx)     (N=xx)        (N=xx)       
______________________________________________________________________________________________________________________ 
  
    Solid Tumor Cancer Type 
           Cancer 1                                                 xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x)    
           Cancer 2                                                 xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x)  
           Cancer 3                                                 xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
               
    Current Stage 
           Advanced                                                 xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
           Metastatic                                               xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
           Inoperable                                               xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
          
    PD-L1 Status Determined 
           Positive                                                 xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x)  
           Negative                                                 xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
           Unknown                                                  xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
 
    Number of Prior Regimens                                        xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x)                  
    Number of Advanced/Metastatic Regimens                          xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
    Number of Subjects with Prior Immuno Therapy                    xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
    Number of Subjects with Prior PD1/L1 Therapy                    xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
                 
________________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                         DATE(TIME): MMDDYYYY(hh:mm)               
  
Reference: Listing 2.4.2 
 
 
 
 
 


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CONFIDENTIAL 
PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N)               
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: Draft               
TLF VERSION: Draft  
  
                                                   TABLE 1.3.1.2.1 
  
                              Summary of Baseline Disease Characteristics and Disease History 
                                    (Population: Endometrium Part 2 FAS Population) 
                                       
                                                                   Recommended Dose       
           Variable                                                     (N=xx)           
  
_______________________________________________________________________________________________________________________ 
                                           
    Adenocarcinoma Grade 
           Grade 1                                                  xx(xx.x)       
           Grade 2                                                  xx(xx.x)    
           Grade 3                                                  xx(xx.x)    
           Other                                                    xx(xx.x)    
 
    Current Sites of Disease 
           Site 1                                                   xx(xx.x)    
           Site 2                                                   xx(xx.x)    
           Site 3                                                   xx(xx.x)    
 
    MSI Test Status Determined 
           MSI-High                                                 xx(xx.x)    
           MSI-Low                                                  xx(xx.x)    
           MSS-Stable                                               xx(xx.x)    
           Unknown                                                  xx(xx.x)    
 
    PD-L1 Status Determined 
           Positive                                                 xx(xx.x)    
           Negative                                                 xx(xx.x)    
           Unknown                                                  xx(xx.x)  
   
    Number of Prior Regimens                                        xx(xx.x)                                         
    Number of Advanced/Metastatic Regimens                          xx(xx.x)    
    Number of Subjects with Prior Immuno Therapy                    xx(xx.x)   
    Number of Subjects with Prior PD1/L1 Therapy                    xx(xx.x) 
_______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                         DATE(TIME): MMDDYYYY(hh:mm) 
Abbreviation: MSI = Microsatellite Instability 
Reference: Listing 2.4.1 
 


Incyte Corporation 
Page 56 of 186 
INCAGN 1949-101 Statistical Analysis Plan 
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CONFIDENTIAL 
PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N)               
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: Draft               
TLF VERSION: Draft  
  
                                                   TABLE 1.3.1.2.2 
  
                              Summary of Baseline Disease Characteristics and Disease History 
                                      (Population: Melanoma Part 2 FAS Population) 
                                                                                                            
                                                                  Recommended Dose         
             Variable                                                   (N=xx)           
_______________________________________________________________________________________________________________________ 
                                           
    Current Classification M: 
           M0                                                       xx(xx.x)    
           M1a                                                      xx(xx.x)        
           M1b                                                      xx(xx.x)    
           M1c                                                      xx(xx.x)    
 
    Current Sites of Disease 
           Site 1                                                   xx(xx.x)    
           Site 2                                                   xx(xx.x)    
           Site 3                                                   xx(xx.x)    
 
    BRAF Status Determined 
           Positive/Mutant                                          xx(xx.x)    
           Negative/Wild-type/No Mutations Detected                 xx(xx.x)    
           Unknown                                                  xx(xx.x)  
 
    PD-L1 Status Determined 
           Positive                                                 xx(xx.x)    
           Negative                                                 xx(xx.x) 
           Unknown                                                  xx(xx.x)    
 
    Number of Prior Regimens                                        xx(xx.x)                                         
    Number of Advanced/Metastatic Regimens                          xx(xx.x)    
    Number of Subjects with Prior Immuno Therapy                    xx(xx.x)   
    Number of Subjects with Prior PD1/L1 Therapy                    xx(xx.x) 
_______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                         DATE(TIME): MMDDYYYY(hh:mm) 
                                                                      
Reference: Listing 2.4.1 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N)               
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: Draft               
TLF VERSION: Draft  
                                                    TABLE 1.3.1.2.3  
                             Summary of Baseline Disease Characteristics and Disease History 
                                          (Population: NSCLC Part 2 FAS Population) 
                                         
                                                                   Recommended Dose        
               Variable                                                 (N=xx)           
_______________________________________________________________________________________________________________________ 
                                           
    Stage at Initial Diagnosis 
           Stage I                                                  xx(xx.x)    
           Stage II                                                 xx(xx.x)    
           Stage IIIA                                               xx(xx.x)    
           Stage IIIB                                               xx(xx.x)    
           Stage IV                                                 xx(xx.x)        
           Unknown                                                  xx(xx.x)   
  
    Histopathology 
           Adenocarcinoma                                           xx(xx.x)    
           Large Cell Carcinoma                                     xx(xx.x)    
           Bronchoalveolar                                          xx(xx.x)    
           Squamous                                                 xx(xx.x)    
           Adenosquamous(mixed)                                     xx(xx.x)    
           Other                                                    xx(xx.x)   
  
    Smoking History 
           Yes                                                      xx(xx.x)    
           No                                                       xx(xx.x)    
 
    Smoking Ongoing 
           Yes                                                      xx(xx.x)    
           No                                                       xx(xx.x)    
 
    Current Stage 
           Stage I                                                  xx(xx.x)    
           Stage II                                                 xx(xx.x)    
           Stage IIIA                                               xx(xx.x)    
           Stage IIIB                                               xx(xx.x)    
           Stage IV                                                 xx(xx.x)        
           Unknown                                                  xx(xx.x)    
_______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                         DATE(TIME): MMDDYYYY(hh:mm) 
Reference: Listing 2.4.1 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N)               
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: Draft               
TLF VERSION: Draft   
                                                   TABLE 1.3.1.2.3  
                             Summary of Baseline Disease Characteristics and Disease History 
                                          (Population: NSCLC Part 2 FAS Population) 
                                         
                                                                   Recommended Dose        
               Variable                                                 (N=xx)           
_______________________________________________________________________________________________________________________ 
 
    Current Sites of Disease 
           Site 1                                                   xx(xx.x)    
           Site 2                                                   xx(xx.x)    
           Site 3                                                   xx(xx.x)    
    EGFR Status Determined 
           Positive/Mutant                                          xx(xx.x)    
           Negative/Wild-type/No Mutations Detected                 xx(xx.x)    
           Unknown                                                  xx(xx.x)    
    KRAS Mutation Determined 
           Mutated                                                  xx(xx.x)      
               Wild-type/No Mutations Detecte                           xx(xx.x) 
               Unknown                                                  xx(xx.x)    
        ALK Re-arrangement Status Determined 
               Positive                                                 xx(xx.x)    
               Negative                                                 xx(xx.x) 
               Unknown                                                  xx(xx.x)   
        PD-L1 Status Determined 
               Positive                                                 xx(xx.x)    
               Negative                                                 xx(xx.x) 
               Unknown                                                  xx(xx.x)    
        ROS1 Re-arrangement Status Determined 
               Positive                                                 xx(xx.x)    
               Negative                                                 xx(xx.x) 
               Unknown                                                  xx(xx.x)    
    Number of Prior Regimens                                        xx(xx.x)                                         
    Number of Advanced/Metastatic Regimens                          xx(xx.x)    
    Number of Subjects with Prior Immuno Therapy                    xx(xx.x)   
    Number of Subjects with Prior PD1/L1 Therapy                    xx(xx.x)   
 
_______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                         DATE(TIME): MMDDYYYY(hh:mm) 
                                                                      
Reference: Listing 2.4.1 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N)               
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: Draft               
TLF VERSION: Draft   
 
                                                   TABLE 1.3.1.2.4  
 
                             Summary of Baseline Disease Characteristics and Disease History 
                                          (Population: Ovarian Part 2 FAS Population) 
 
                                                                   Recommended Dose        
        Variable                                                        (N=xx)            
_______________________________________________________________________________________________________________________               
        
        Histology  
               Serious                                                  xx(xx.x)    
           Endometrioid                                             xx(xx.x)    
           Mucinous                                                 xx(xx.x)                                
           Clear Cell                                               xx(xx.x)      
           Brenner                                                  xx(xx.x)          
           Mixed Epithelial                                         xx(xx.x)    
    Grade  
           Grade I                                                  xx(xx.x)    
           Grade II                                                 xx(xx.x)    
           Grade III                                                xx(xx.x)    
           Unknown                                                  xx(xx.x)  
    Current Sites of Disease 
           Site 1                                                   xx(xx.x)    
           Site 2                                                   xx(xx.x)    
           Site 3                                                   xx(xx.x)    
    BRCA Status Determined 
           Positive                                                 xx(xx.x)    
           Negative                                                 xx(xx.x)    
           Unknown                                                  xx(xx.x)    
           Not Done                                                 xx(xx.x)    
        PD-L1 Status Determined 
               Positive                                                 xx(xx.x)    
               Negative                                                 xx(xx.x) 
               Unknown                                                  xx(xx.x)    
 
_______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                         DATE(TIME): MMDDYYYY(hh:mm) 
                                                                      
Reference: Listing 2.4.1 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N)               
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: Draft               
TLF VERSION: Draft   
 
                                                   TABLE 1.3.1.2.4  
 
                             Summary of Baseline Disease Characteristics and Disease History 
                                          (Population: Ovarian Part 2 FAS Population) 
 
 
                                                                   Recommended Dose        
        Variable                                                        (N=xx)            
_______________________________________________________________________________________________________________________ 
  
    Number of Prior Regimens                                        xx(xx.x)                                         
    Number of Advanced/Metastatic Regimens                          xx(xx.x)    
    Number of Subjects with Prior Immuno Therapy                    xx(xx.x)   
        Number of Subjects with Prior PD1/L1 Therapy                    xx(xx.x)  
_______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                         DATE(TIME): MMDDYYYY(hh:mm) 
                                                                      
Reference: Listing 2.4.1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N)               
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: Draft               
TLF VERSION: Draft  
  
                                                   TABLE 1.3.1.2.5 
  
                             Summary of Baseline Disease Characteristics and Disease History 
                                           (Population: RCC Part 2 FAS Population) 
 
 
                                                                   Recommended Dose        
           Variable                                                     (N=xx)           
  
_______________________________________________________________________________________________________________________ 
                                           
    Stage at Initial Diagnosis 
           Stage 1                                                  xx(xx.x)    
           Stage 2                                                  xx(xx.x)    
           Stage 3                                                  xx(xx.x)    
           Stage 4                                                  xx(xx.x)    
           Unknown                                                  xx(xx.x)    
    Histology  
           Clear cell renal cell carcinoma                          xx(xx.x)    
           Other                                                    xx(xx.x)    
    Current Stage of Disease 
           Stage 1                                                  xx(xx.x)    
           Stage 2                                                  xx(xx.x)    
           Stage 3                                                  xx(xx.x)    
           Stage 4                                                  xx(xx.x)    
           Unknown                                                  xx(xx.x)    
    Current Sites of Disease 
           Site 1                                                   xx(xx.x)    
           Site 2                                                   xx(xx.x)    
           Site 3                                                   xx(xx.x)    
    MSKCC Criteria 
           Favorable                                                xx(xx.x)    
           Intermediate                                             xx(xx.x)    
           Poor                                                     xx(xx.x)    
           Unknown                                                  xx(xx.x)    
 
_______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                         DATE(TIME): MMDDYYYY(hh:mm) 
Abbreviation: MSKCC = Memorial Sloan-Kettering Cancer Center                                                                      
Reference: Listing 2.4.1 
         


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N)               
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: Draft               
TLF VERSION: Draft  
  
                                                   TABLE 1.3.1.2.5 
  
                             Summary of Baseline Disease Characteristics and Disease History 
                                           (Population: RCC Part 2 FAS Population) 
 
 
                                                                   Recommended Dose        
           Variable                                                     (N=xx)           
  
_______________________________________________________________________________________________________________________ 
 
        PD-L1 Status Determined 
           Positive                                                 xx(xx.x)    
           Negative                                                 xx(xx.x) 
           Unknown                                                  xx(xx.x)    
 
    Number of Prior Regimens                                    xx(xx.x)                                         
    Number of Advanced/Metastatic Regimens                      xx(xx.x)    
    Number of Subjects with Prior Immuno Therapy                xx(xx.x)   
        Number of Subjects with Prior PD1/L1 Therapy                xx(xx.x) 
_______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                         DATE(TIME): MMDDYYYY(hh:mm) 
Abbreviation: MSKCC = Memorial Sloan-Kettering Cancer Center                                                                      
Reference: Listing 2.4.1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N)               
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: Draft               
TLF VERSION: Draft 
  
                                                  TABLE 1.4.1.1 
  
                                          Summary of Prior Cancer Therapy 
                                        (Population: Part 1 FAS Population) 
 
 
                                                                             Treatment Group 
                                             _____________________________________________________________________ 
                                                                         Dose 1     Dose 2     Dose 3        Total 
        Variable                                                         (N=xx)     (N=xx)     (N=xx)        (N=xx)       
______________________________________________________________________________________________________________________ 
 Number(%) of Subjects with any Prior Cancer Therapy 
  
 Medication Class  
   Generic Name 1                                                        xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
   Generic Name 2                                                        xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
   Generic Name 3                                                        xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
 
_______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                         DATE(TIME): MMDDYYYY(hh:mm) 
                                                            
Reference: Listing 2.## 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N)               
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: Draft               
TLF VERSION: Draft 
  
                                                    TABLE 1.4.1.2 
  
                                           Summary of Prior Cancer Therapy 
                                         (Population: Part 2 FAS Population) 
 
 
                                                                         Recommended Dose 
                                             _____________________________________________________________________ 
                                             Endometrium       Ovarian      Melanoma       NSCLC       RCC      Total 
        Variable                               (N=xx)          (N=xx)        (N=xx)       (N=xx)      (N=xx)   (N=xx) 
______________________________________________________________________________________________________________________ 
Number(%) of Subjects with any Prior Cancer Therapy 
      
  Medication Class   
    Generic Name 1                            xx(xx.x)        xx(xx.x)     xx(xx.x)      xx(xx.x)    xx(xx.x)  xx(xx.x) 
    Generic Name 2                            xx(xx.x)        xx(xx.x)     xx(xx.x)      xx(xx.x)    xx(xx.x)  xx(xx.x) 
    Generic Name 3                            xx(xx.x)        xx(xx.x)     xx(xx.x)      xx(xx.x)    xx(xx.x)  xx(xx.x) 
_______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                         DATE(TIME): MMDDYYYY(hh:mm)               
  
Reference: Listing 2.## 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N)               
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: Draft               
TLF VERSION: Draft 
  
                                                      TABLE 1.4.2.1 
  
                                               Summary of Prior Medications 
                                            (Population: Part 1 FAS Population) 
 
 
 
                                                                              Treatment Group 
                                             _____________________________________________________________________ 
                                                                         Dose 1     Dose 2     Dose 3        Total 
        Variable                                                         (N=xx)     (N=xx)     (N=xx)        (N=xx)       
______________________________________________________________________________________________________________________ 
 Number(%) of Subjects with any Prior Medications 
  
 Medication Class  
   Generic Name 1                                                        xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
   Generic Name 2                                                        xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
   Generic Name 3                                                        xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
 
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                         DATE(TIME): MMDDYYYY(hh:mm)               
  
Reference: Listing 2.4.9 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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INCAGN 1949-101 Statistical Analysis Plan 
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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N)               
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: Draft               
TLF VERSION: Draft 
  
                                                    TABLE 1.4.2.2 
  
                                            Summary of Prior Medications 
                                         (Population: Part 2 FAS Population) 
 
 
 
                                                                         Recommended Dose 
                                             _____________________________________________________________________ 
                                             Endometrium       Ovarian      Melanoma       NSCLC        RCC     Total 
        Variable                                (N=xx)         (N=xx)        (N=xx)       (N=xx)      (N=xx)    (N=xx) 
______________________________________________________________________________________________________________________ 
Number(%) of Subjects with any Prior Medication 
      
  Medication Class   
    Generic Name 1                              xx(xx.x)       xx(xx.x)     xx(xx.x)     xx(xx.x)    xx(xx.x)  xx(xx.x) 
    Generic Name 2                              xx(xx.x)       xx(xx.x)     xx(xx.x)     xx(xx.x)    xx(xx.x)  xx(xx.x) 
    Generic Name 3                              xx(xx.x)       xx(xx.x)     xx(xx.x)     xx(xx.x)    xx(xx.x)  xx(xx.x) 
_______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                         DATE(TIME): MMDDYYYY(hh:mm)               
  
Reference: Listing 2.4.9 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N)               
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: Draft               
TLF VERSION: Draft 
  
                                                     TABLE 1.4.3.1 
  
                                            Summary of Concomitant Medications 
                                           (Population: Part 1 FAS Population) 
 
 
                                                                              Treatment Group 
                                             _____________________________________________________________________ 
                                                                         Dose 1     Dose 2     Dose 3        Total 
        Variable                                                         (N=xx)     (N=xx)     (N=xx)        (N=xx)       
______________________________________________________________________________________________________________________ 
 Number(%) of Subjects with any Concomitant Medications 
  
 Medication Class  
   Generic Name 1                                                        xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
   Generic Name 2                                                        xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
   Generic Name 3                                                        xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
 
_______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                         DATE(TIME): MMDDYYYY(hh:mm)               
  
Reference: Listing 2.4.9 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N)               
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: Draft               
TLF VERSION: Draft 
  
  
                                                      TABLE 1.4.3.2 
  
                                            Summary of Concomitant Medications 
                                           (Population: Part 2 FAS Population) 
 
 
                                                                         Recommended Dose 
                                             _____________________________________________________________________ 
                                             Endometrium      Ovarian    Melanoma      NSCLC       RCC       Total 
        Variable                                (N=xx)        (N=xx)      (N=xx)       (N=xx)     (N=xx)    (N=xx) 
______________________________________________________________________________________________________________________ 
Number(%) of Subjects with any Concomitant Medication 
      
  Medication Class   
    Generic Name 1                             xx(xx.x)       xx(xx.x)    xx(xx.x)     xx(xx.x)   xx(xx.x)  xx(xx.x) 
    Generic Name 2                             xx(xx.x)       xx(xx.x)    xx(xx.x)     xx(xx.x)   xx(xx.x)  xx(xx.x) 
    Generic Name 3                             xx(xx.x)       xx(xx.x)    xx(xx.x)     xx(xx.x)   xx(xx.x)  xx(xx.x) 
 
_______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                         DATE(TIME): MMDDYYYY(hh:mm)               
  
Reference: Listing 2.4.9 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N)               
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: Draft               
TLF VERSION: Draft 
  
 
                                                     TABLE 1.5.1 
  
                                           Summary of General Medical History 
                                           (Population: Part 1 FAS Population) 
 
 
 
                                                                              Treatment Group 
                                             _____________________________________________________________________ 
                                                                         Dose 1     Dose 2     Dose 3        Total 
        Variable                                                         (N=xx)     (N=xx)     (N=xx)        (N=xx)       
______________________________________________________________________________________________________________________ 
 Number(%) of Subjects with any General Medical History 
  
 System Organ Class 1 
   Preferred Term 1                                                      xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
   Preferred Term 2                                                      xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
   Preferred Term 3                                                      xx(xx.x)   xx(xx.x)   xx(xx.x)      xx(xx.x) 
 
_______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                         DATE(TIME): MMDDYYYY(hh:mm)               
  
Reference: Listing 2.4.8 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N)               
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: Draft               
TLF VERSION: Draft 
  
                                                       TABLE 1.5.2 
  
                                             Summary of General Medical History 
                                            (Population: Part 2 FAS Population) 
 
                                                                         Recommended Dose 
                                             _____________________________________________________________________ 
                                             Endometrium       Ovarian      Melanoma       NSCLC        RCC       Total 
        Variable                                (N=xx)         (N=xx)        (N=xx)        (N=xx)      (N=xx)    (N=xx) 
______________________________________________________________________________________________________________________ 
Number(%) of Subjects with any General Medical History 
      
  System Organ Class 1   
    Preferred Term 1                            xx(xx.x)       xx(xx.x)     xx(xx.x)      xx(xx.x)    xx(xx.x)  xx(xx.x) 
    Preferred Term 2                            xx(xx.x)       xx(xx.x)     xx(xx.x)      xx(xx.x)    xx(xx.x)  xx(xx.x) 
    Preferred Term 3                            xx(xx.x)       xx(xx.x)     xx(xx.x)      xx(xx.x)    xx(xx.x) xx(xx.x) 
_______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                         DATE(TIME): MMDDYYYY(hh:mm)               
  
Reference: Listing 2.4.8 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                               
 
 
 
    (Page 1 of N) 
         DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                                              
TLF VERSION: Draft                                                                           
 
 
 
   DATABASE VERSION: Draft 
TABLE 2.1.1 
                                       
                   
 
Summary of Best Response, Duration of Response, and Duration of Disease Control under RECIST v1.1 
                                                         
       (Population: Part 1 FAS Population) 
 
__________________________________________________________________________________________________________________________________________________________ 
 
  
 
 
 
 
 
 
 
 
 
Treatment Group 
                                                          ________________________________________________________________________________________ 
                                                            Dose Level 1              Dose Level 2          Dose Level 3 
 Variable                                      
 
(N=##)                    (N=##)                (N=##) 
         
__________________________________________________________________________________________________________________________________________________________ 
 
Overall Response[1]                                         ### (###.#)               ### (###.#)            ###  (###.#)          
   Complete Response                                        ### (###.#)               ### (###.#)            ###  (###.#)           
   Partial Response                                         ### (###.#)               ### (###.#)            ###  (###.#)           
 Stable Disease                                             ### (###.#)               ### (###.#)            ###  (###.#) 
         
 Progressive Disease                                        ### (###.#)               ### (###.#)            ###  (###.#) 
         
 Unable to Evaluate                                         ### (###.#)               ### (###.#)            ###  (###.#) 
         
 
RECIST v1.1 Criteria 
 Number of Responders (%)[2]                                ###.# (###.#)             ###.#(###.#)           ###.#(###.#) 
          
 Median Duration of Response (Days) [3]                     ###.# (###.#, ###.#)      ###.# (###.#, ###.#)   ###.# (###.#, ###.#)   
 Median Duration of Disease Control (Range) [4]             ###.# (###.#, ###.#)      ###.# (###.#, ###.#)   ###.# (###.#, ###.#)   
 
__________________________________________________________________________________________________________________________________________________________ 
 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                                                           DATE(TIME): MMDDYYYY(hh:mm) 
  
Reference: Listing 2.5.1 
 [1] Under RECIST v1.1, the best response is determined on subject level using the highest overall response achieved postbaseline prior to and including 
the first PD, in the order of CR, PR, SD, PD, and NE.  
 [2] Under RECIST v1.1, for objective responders, duration of response is the time from the first overall response contributing to an objective response 
(CR or PR) to the earlier of the subject's death from any cause or first assessment of PD.  
 [3] Median time and the 95% CI were estimated using Brookmeyer and Crowley. 
 [4] Under RECIST v1.1, duration of disease control is defined as the time from the first report of SD or better until disease progression determined 
under RECIST v1.1 or death from any cause if occurring sooner than progression. Confidence intervals are calculated based on the exact method for binomial 
distributions. 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                               
 
 
 
    (Page 1 of N) 
         DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                                              
TLF VERSION: Draft                                                                           
 
 
 
           DATABASE VERSION: Draft 
 
 
TABLE 2.1.2 
                                       
                   
 
Summary of Best Response, Duration of Response, and Duration of Disease Control under RECIST v1.1 
                                                                 (Population: Part 2 FAS Population) 
 
__________________________________________________________________________________________________________________________________________________________
 
Recommended Dose 
                                                          ________________________________________________________________________________________ 
                                                            Endometrium           Melanoma 
          NSCLC                RCC             Ovaian 
 Variable                                                   (N=##)                (N=##)                (N=##)                (N=##)           (N=##) 
__________________________________________________________________________________________________________________________________________________________ 
 
Overall Response[1]                                         ### (###.#)            ### (###.#)           ###  (###.#)          ###  (###.#)   
   Complete Response                                        ### (###.#)            ### (###.#)           ###  (###.#)          ###  (###.#) 
   Partial Response                                         ### (###.#)            ### (###.#)           ###  (###.#)          ###  (###.#) 
 Stable Disease                                             ### (###.#)            ### (###.#)           ###  (###.#)          ###  (###.#) 
 Progressive Disease                                        ### (###.#)            ### (###.#)           ###  (###.#)          ###  (###.#) 
 Unable to Evaluate                                         ### (###.#)            ### (###.#)           ###  (###.#)          ###  (###.#) 
 
RECIST v1.1 Criteria 
 Number of Responders (%)[2]                                ###.# (###.#)          ###.#(###.#)          ###.#(###.#)          ###.#(###.#) 
 Median Duration of Response (Days) [3]                     ###.# (###.#, ###.#)   ###.# (###.#, ###.#)  ###.# (###.#, ###.#)  ###.# (###.#, ###.#) 
 Median Duration of Disease Control (Range) [4]             ###.# (###.#, ###.#)   ###.# (###.#, ###.#)  ###.# (###.#, ###.#)  ###.# (###.#, ###.#) 
 
__________________________________________________________________________________________________________________________________________________________ 
 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                                                           DATE(TIME): MMDDYYYY(hh:mm) 
  
Reference: Listing 2.5.1 
 [1] Under RECIST v1.1, the best response is determined on subject level using the highest overall response achieved postbaseline prior to and including 
the first PD, in the order of CR, PR, SD, PD, and NE.  
 [2] Under RECIST v1.1, for objective responders, duration of response is the time from the first overall response contributing to an objective response 
(CR or PR) to the earlier of the subject's death from any cause or first assessment of PD.  
 [3] Median time and the 95% CI were estimated using Brookmeyer and Crowley. 
 [4] Under RECIST v1.1, duration of disease control is defined as the time from the first report of SD or better until disease progression determined 
under RECIST v1.1 or death from any cause if occurring sooner than progression. Confidence intervals are calculated based on the exact method for binomial 
distributions. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                               
 
 
 
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         DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                                              
TLF VERSION: Draft                                                                           
 
 
 
           DATABASE VERSION: Draft 
 
 
 
TABLE 2.2.1 
                                       
                   
 
Summary of Best Response, Duration of Response, and Duration of Disease Control under mRECIST v1.1 
                                                           (Population: Part 1 FAS Population) 
 
__________________________________________________________________________________________________________________________________________________________                   
Treatment Group 
                                                    _______________________________________________________________________________________ 
                                                    Dose Level 1             Dose Level 2              Dose Level 3 
 Variable                                             (N=##)                    (N=##)                    (N=##) 
 
    
 
__________________________________________________________________________________________________________________________________________________________ 
Overall Response[1]                                ### (###.#)               ### (###.#)                ###  (###.#)               
   Complete Response                               ### (###.#)               ### (###.#)                ###  (###.#)               
   Partial Response                                ### (###.#)               ### (###.#)                ###  (###.#)               
Stable Disease                                     ### (###.#)               ### (###.#)                ###  (###.#)               
Progressive Disease                                ### (###.#)               ### (###.#)                ###  (###.#)               
Unable to Evaluate                                 ### (###.#)               ### (###.#)                ###  (###.#)               
 
RECIST v1.1 Criteria 
   Number of Responders (%)[2]                     ###.# (###.#)             ###.# (###.#)              ###.# (###.#) 
          
   Median Duration of Response (Days) [3]          ###.# (###.#, ###.#)      ###.# (###.#, ###.#)       ###.# (###.#, ###.#)        
   Median Duration of Disease Control (Range)[4]   ###.# (###.#, ###.#)      ###.# (###.#, ###.#)       ###.# (###.#, ###.#)        
__________________________________________________________________________________________________________________________________________________________ 
 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                                                           DATE(TIME): MMDDYYYY(hh:mm) 
  
Reference: Listing 2.5.1 
Note: mRECIST v1.1 requires confirmation of progressive disease 4 to 6 weeks after the initial progression whenever possible. 
[1] Under mRECIST v1.1, for objective responders, duration of response is the time from the first overall response contributing to an objective response 
(CR or PR) to the earlier of the subject's death from any cause or first assessment of PD as assessed by mRECIST v1.1. If after an unconfirmed PD, a 
subject had EOS/EOT or started a new anti-cancer therapy, the unconfirmed PD will be counted as a PD. If after an unconfirmed PD a subject had an SD, PR, 
CR, or NE, the PD will not be counted as a PD and will be counted as the corresponding CR, PR, SD, or NE for the time point at which the SD, PR, CR, or NE 
occurred.  
[2] Under mRECIST v1.1, the best response is determined on subject level using the highest overall response achieved postbaseline prior to and including 
the first confirmed PD, in the order of CR, PR, SD, PD, and NE. 
[3] Median time and the 95% CI were estimated using Brookmeyer and Crowley. 
[4] Under mRECIST v1.1, duration of disease control is defined as the time from the first report of SD or better until disease progression determined 
under mRECIST v1.1 or death from any cause if occurring sooner than progression. Confidence intervals are calculated based on the exact method for 
binomial distributions. 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                               
 
 
 
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         DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                                              
TLF VERSION: Draft                                                                           
 
 
 
           DATABASE VERSION: Draft 
 
 
TABLE 2.2.2 
                                       
                   
 
 
Summary of Best Response, Duration of Response, and Duration of Disease Control under mRECIST v1.1 
                                                          (Population: Part 2 FAS Population) 
 
__________________________________________________________________________________________________________________________________________________________
Recommended Dose 
______________________________________________________________________________________________________________________________________________________ 
                                                    Endometrium               Melanoma                 NSCLC                     RCC              Ovarian 
 Variable                                           (N=##)                    (N=##)                   (N=##)                    (N=##)           (N=##) 
__________________________________________________________________________________________________________________________________________________________ 
Overall Response[1]                                ### (###.#)              ### (###.#)                ###  (###.#)              ###  (###.#)   
  Complete Response                                ### (###.#)              ### (###.#)                ###  (###.#)              ###  (###.#) 
  Partial Response                                 ### (###.#)              ### (###.#)                ###  (###.#)              ###  (###.#) 
Stable Disease                                     ### (###.#)              ### (###.#)                ###  (###.#)              ###  (###.#) 
Progressive Disease                                ### (###.#)              ### (###.#)                ###  (###.#)              ###  (###.#) 
Unable to Evaluate                                 ### (###.#)              ### (###.#)                ###  (###.#)              ###  (###.#) 
 
RECIST v1.1 Criteria 
  Number of Responders (%)[2]                      ###.# (###.#)             ###.# (###.#)             ###.# (###.#) 
         ###.# (###.#) 
  Median Duration of Response (Days) [3]           ###.# (###.#, ###.#)      ###.# (###.#, ###.#)      ###.# (###.#, ###.#)       ###.# (###.#, ###.#) 
  Median Duration of Disease Control (Range)[4]    ###.# (###.#, ###.#)      ###.# (###.#, ###.#)      ###.# (###.#, ###.#)       ###.# (###.#, ###.#) 
__________________________________________________________________________________________________________________________________________________________ 
 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                                                           DATE(TIME): MMDDYYYY(hh:mm) 
  
Reference: Listing 2.5.1 
Note: mRECIST v1.1 requires confirmation of progressive disease 4 to 6 weeks after the initial progression whenever possible. 
[1] Under mRECIST v1.1, for objective responders, duration of response is the time from the first overall response contributing to an objective response 
(CR or PR) to the earlier of the subject's death from any cause or first assessment of PD as assessed by mRECIST v1.1. If after an unconfirmed PD, a 
subject had EOS/EOT or started a new anti-cancer therapy, the unconfirmed PD will be counted as a PD. If after an unconfirmed PD a subject had an SD, PR, 
CR, or NE, the PD will not be counted as a PD and will be counted as the corresponding CR, PR, SD, or NE for the time point at which the SD, PR, CR, or NE 
occurred.  
[2] Under mRECIST v1.1, the best response is determined on subject level using the highest overall response achieved postbaseline prior to and including 
the first confirmed PD, in the order of CR, PR, SD, PD, and NE. 
[3] Median time and the 95% CI were estimated using Brookmeyer and Crowley. 
[4] Under mRECIST v1.1, duration of disease control is defined as the time from the first report of SD or better until disease progression determined 
under mRECIST v1.1 or death from any cause if occurring sooner than progression. Confidence intervals are calculated based on the exact method for 
binomial distributions. 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                               
 
 
 
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         DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                                              
TLF VERSION: Draft                                                                           
 
 
 
           DATABASE VERSION: Draft 
 
 
 
 
 
 
  
 
 
 
TABLE 2.3.1 
  
                                   
 
 
 Summary of Progression-Free Survival under RECIST v1.1 [1]  
       
     
 
 
     (Population: Part 1 FAS Population) 
 
 
__________________________________________________________________________________________________________________________________________________________________  
          
 
 
 
 
 
                    
 
Treatment Group 
                                                                 _______________________________________________________________________________ 
                                                                    Dose Level 1              Dose Level 2          Dose Level 3  
 
 
Variable                                                            (N=##)                    (N=##)                (N=##)        
__________________________________________________________________________________________________________________________________________________________________ 
 Number (%) of Subjects with Disease Progression or Death      
 Observed                                                           ### (###.#)              ### (###.#)             ### (###.#)           
      Deaths                                                        ### (###.#)              ### (###.#)             ### (###.#)           
 
      Disease Progression                                           ### (###.#)              ### (###.#)             ### (###.#)           
 Censored                                                           ### (###.#)              ### (###.#)             ### (###.#)           
                          
 
     
Median Time to Event (95% CI) [2]                                   ##.# (##.#,##.#)         ##.# (##.#,##.#)        ##.# (##.#,##.#)      
Month  3 Survival Rate (95% CI)                                     ##.# (##.#,##.#)         ##.# (##.#,##.#)        ##.# (##.#,##.#)      
Month  6 Survival Rate (95% CI)                                     ##.# (##.#,##.#)         ##.# (##.#,##.#)        ##.# (##.#,##.#)      
Month  9 Survival Rate (95% CI)                                     ##.# (##.#,##.#)         ##.# (##.#,##.#)        ##.# (##.#,##.#)      
Month 12 Survival Rate (95% CI)                                     ##.# (##.#,##.#)         ##.# (##.#,##.#)        ##.# (##.#,##.#)      
  
 
__________________________________________________________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                                                           DATE(TIME): MMDDYYYY(hh:mm) 
  
Reference: Listing 2.# 
[1] Under RECIST v1.1, progression free survival was defined as the length of time between the baseline visit (Day 1) and the earlier of death or first 
assessment of disease progression as assessed by RECIST v1.1.   
[2] The median time and the 95% CI were estimated using Brookmeyer and Crowley. 
Abbreviation: CI = Confidencce Interval 
 
 
 
 
 
 
 
 
 
 
PROTOCOL: INCAGN 1949-101                                                                               
 
 
 
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         DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                                              
TLF VERSION: Draft                                                                           
 
 
 
           DATABASE VERSION: Draft 
 
                                                     
 
 
 
 TABLE 2.3.2 
  
                                   
 
 
 Summary of Progression-Free Survival under RECIST v1.1 [1]  
       
     
 
 
  
        (Population: Part 2 FAS Population) 
  
 
__________________________________________________________________________________________________________________________________________________________________  
          
 
 
 
 
 
                    
 
Recommended Dose 
                                                                 _______________________________________________________________________________ 
                                                           Endometrium          Melanoma              NSCLC                RCC            Ovarian 
Variable                                                     (N=##)              (N=##)               (N=##)              (N=##)          (N=##) 
__________________________________________________________________________________________________________________________________________________________________ 
 Number (%) of Subjects with Disease Progression or  
     Death      
     Observed                                               ### (###.#)         ### (###.#)          ### (###.#)         ### (###.#)      ### (###.#) 
      Deaths                                                ### (###.#)         ### (###.#)          ### (###.#)         ### (###.#) 
 ### (###.#) 
      Disease Progression                                   ### (###.#)         ### (###.#)          ### (###.#)         ### (###.#)      ### (###.#) 
 Censored                                                   ### (###.#)         ### (###.#)          ### (###.#)         ### (###.#)  
 ### (###.#)                       
 
     
  
Median Time to Event (95% CI) [2]                           ##.# (##.#,##.#)    ##.# (##.#,##.#)     ##.# (##.#,##.#)    ##.# (##.#,##.#) ##.# (##.#,##.#) 
Month  3 Survival Rate (95% CI)                             ##.# (##.#,##.#)    ##.# (##.#,##.#)     ##.# (##.#,##.#)    ##.# (##.#,##.#) ##.# (##.#,##.#) 
Month  6 Survival Rate (95% CI)                             ##.# (##.#,##.#)    ##.# (##.#,##.#)     ##.# (##.#,##.#)    ##.# (##.#,##.#) ##.# (##.#,##.#) 
Month  9 Survival Rate (95% CI)                             ##.# (##.#,##.#)    ##.# (##.#,##.#)     ##.# (##.#,##.#)    ##.# (##.#,##.#) ##.# (##.#,##.#)   
Month 12 Survival Rate (95% CI)                             ##.# (##.#,##.#)    ##.# (##.#,##.#)     ##.# (##.#,##.#)    ##.# (##.#,##.#) ##.# (##.#,##.#) 
  
  
 
__________________________________________________________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                                                           DATE(TIME): MMDDYYYY(hh:mm) 
  
Reference: Listing 2.# 
[1] Under RECIST v1.1, progression free survival was defined as the length of time between the baseline visit (Day 1) and the earlier of death or first 
assessment of disease progression as assessed by RECIST v1.1.   
[2] The median time and the 95% CI were estimated using Brookmeyer and Crowley. 
Abbreviation: CI = Confidencce Interval 
 
 
 
 
 
 
 
 
 
 
 
 
 
PROTOCOL: INCAGN 1949-101                                                                               
 
 
 
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         DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                                              
TLF VERSION: Draft                                                                           
 
 
 
           DATABASE VERSION: Draft 
 
  
                                                     
 
TABLE 2.4.1 
 
                                   
    Summary of Progression-Free Survival under mRECIST v1.1 [1] 
 
       
     
 
       (Population: Part 1 FAS Population) 
  
 
__________________________________________________________________________________________________________________________________________________________  
          
 
 
 
 
 
                   Treatment Group 
                                                     ___________________________________________________________________________ 
                                                       Dose Level 1          Dose Level 2         Dose Level 3  
Variable                                               (N=##)                 (N=##)                (N=##)               
__________________________________________________________________________________________________________________________________________________________ 
 Number (%) of Subjects with Disease Progression or  
     Death      
     Observed                               
    ### (###.#)           ### (###.#)          ### (###.#)     
     
       Deaths 
 
 
 
 
    ### (###.#)           ### (###.#)          ### (###.#)     
     
 
       Disease Progression 
 
 
    ### (###.#)           ### (###.#)          ### (###.#)      
       
 Censored 
 
 
 
 
    ### (###.#)           ### (###.#)          ### (###.#)     
     
                              
 
      
Median Time to Event (95% CI) [2]                      ##.# (##.#,##.#)      ##.# (##.#,##.#)     ##.# (##.#,##.#)    
Month  3 Survival Rate (95% CI)                        ##.# (##.#,##.#)      ##.# (##.#,##.#)     ##.# (##.#,##.#)    
Month  6 Survival Rate (95% CI)                        ##.# (##.#,##.#)      ##.# (##.#,##.#)     ##.# (##.#,##.#)    
Month  9 Survival Rate (95% CI)                        ##.# (##.#,##.#)      ##.# (##.#,##.#)     ##.# (##.#,##.#)    
Month 12 Survival Rate (95% CI)                        ##.# (##.#,##.#)      ##.# (##.#,##.#)     ##.# (##.#,##.#)    
  
 
__________________________________________________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                                                           DATE(TIME): MMDDYYYY(hh:mm) 
  
Reference: Listing 2.# 
[1] Under mRECIST v1.1, progression free survival was defined as the length of time between the baseline visit (Day 1) and the earlier of subject's death 
or first overall confirmed response of PD. 
[2] The median time and the 95% CI were estimated using Brookmeyer and Crowley. 
Abbreviation: CI = Confidencce Interval 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                               
 
 
 
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         DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                                              
TLF VERSION: Draft                                                                           
 
 
 
           DATABASE VERSION: Draft 
 
  
                                                     
 
TABLE 2.4.2 
  
                                   
 Summary of Progression-Free Survival under mRECIST v1.1 [1] 
 
       
     
               (Population: Part 2 FAS Population) 
  
 
__________________________________________________________________________________________________________________________________________________________  
                   Recommended Dose 
                                                     ___________________________________________________________________________ 
                                                       Endometrium           Melanoma          NSCLC                RCC               Ovarian   
Variable                                               (N=##)              
(N=##)           (N=##)               (N=##)             (N=##)  
__________________________________________________________________________________________________________________________________________________________ 
 Number (%) of Subjects with Disease Progression or  
     Death      
     Observed                               
    ### (###.#)           ### (###.#)        ### (###.#)         ### (###.#)      ### (###.#) 
       Deaths 
 
 
 
 
    ### (###.#)           ### (###.#)        ### (###.#)         ### (###.#)      ### (###.#) 
       Disease Progression 
 
 
    ### (###.#)           ### (###.#)        ### (###.#)         ### (###.#)      ### (###.#) 
 Censored 
 
 
 
 
    ### (###.#)           ### (###.#)        ### (###.#)         ### (###.#)      ### (###.#)                          
 
     
  
Median Time to Event (95% CI) [2]                      ##.# (##.#,##.#)    ##.# (##.#,##.#)     ##.# (##.#,##.#)    ##.# (##.#,##.#) ##.# (##.#,##.#) 
Month  3 Survival Rate (95% CI)                        ##.# (##.#,##.#)    ##.# (##.#,##.#)     ##.# (##.#,##.#)    ##.# (##.#,##.#) ##.# (##.#,##.#) 
Month  6 Survival Rate (95% CI)                        ##.# (##.#,##.#)    ##.# (##.#,##.#)     ##.# (##.#,##.#)    ##.# (##.#,##.#) ##.# (##.#,##.#) 
Month  9 Survival Rate (95% CI)                        ##.# (##.#,##.#)    ##.# (##.#,##.#)     ##.# (##.#,##.#)    ##.# (##.#,##.#) ##.# (##.#,##.#)   
Month 12 Survival Rate (95% CI)                        ##.# (##.#,##.#)    ##.# (##.#,##.#)     ##.# (##.#,##.#)    ##.# (##.#,##.#) ##.# (##.#,##.#)  
 
__________________________________________________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                                                           DATE(TIME): MMDDYYYY(hh:mm) 
Abbreviation: CI = Confidencce Interval  
Reference: Listing 2.# 
[1] Under mRECIST v1.1, progression free survival was defined as the length of time between the baseline visit (Day 1) and the earlier of subject's death 
or first overall confirmed response of PD. 
[2] The median time and the 95% CI were estimated using Brookmeyer and Crowley. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N)               
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: Draft               
TLF VERSION: Draft 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
 
 
                                                    Table 3.1.1.1 
  
                                           Summary of Study Drug Exposure  
                                          (Population: Part 1 FAS Population) 
                                                       
                                                                            
_____________________________________________________________________________________________________________________ 
                                                               Descriptive Summary           
   Dose Level and Frequency                                 _____________________________________________________  
   (mg/kg)                    Variable                      N   Mean   STD     Min   Median Max    
_____________________________________________________________________________________________________________________ 
   Dose 1                     Number of Treatment Cycles    xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                              Duration of Treatment (Days)  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                              Average Dose (mg)             xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                              Average Dose (mg/kg)          xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
   Dose 2                     Number of Treatment Cycles    xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                              Duration of Treatment (Days)  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                              Average Dose (mg)             xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                              Average Dose (mg/kg)          xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
   Dose 3                     Number of Treatment Cycles    xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                              Duration of Treatment (Days)  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                              Average Dose (mg)             xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                              Average Dose (mg/kg)          xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
 
[a] Duration of treatment (days) = Date of last dose – Date of first dose + 1. 
[b] Average dose (mg/kg) = [total actual dose taken (mg/kg) by the subject]/[number of cycles with a nonzero dose] 
[c] Average dose (mg) = [total actual dose taken by each subject (mg) in a cycle]/[number of subjects with a nonzero 
dose in that cycle] 
 
Abbreviations: Min = minimum; Max = maximum; STD = standard deviation;                                                                          
Reference: Listings 2.6.1 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
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TLF VERSION: Draft 
                                                    Table 3.1.1.2  
                                           Summary of Study Drug Exposure  
                                          (Population: Part 2 FAS Population) 
                                                                                                                       
_____________________________________________________________________________________________________________________ 
                                                               Descriptive Summary           
   Cancer Type                                       _____________________________________________________  
   (mg/kg)                    Variable                      N   Mean   STD     Min   Median Max    
_____________________________________________________________________________________________________________________ 
   Endometrial                Number of Treatment Cycles    xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                              Duration of Treatment (Days)  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                              Average Dose (mg)             xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                              Average Dose (mg/kg)          xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
   Melanoma                   Number of Treatment Cycles    xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                              Duration of Treatment (Days)  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                              Average Dose (mg)             xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                              Average Dose (mg/kg)          xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
   NSCLC                      Number of Treatment Cycles    xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                              Duration of Treatment (Days)  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                              Average Dose (mg)             xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                              Average Dose (mg/kg)          xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
   Ovarian                    Number of Treatment Cycles    xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                              Duration of Treatment (Days)  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                              Average Dose (mg)             xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                              Average Dose (mg/kg)          xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
 
   RCC                        Number of Treatment Cycles    xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                              Duration of Treatment (Days)  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                              Average Dose (mg)             xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                              Average Dose (mg/kg)          xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
 
[a] Duration of treatment (days) = Date of last dose – Date of first dose + 1. 
[b] Average dose (mg/kg) = [total actual dose taken (mg/kg) by the subject]/[number of cycles with a nonzero dose] 
[c] Average dose (mg) = [total actual dose taken by each subject (mg) in a cycle]/[number of subjects with a nonzero 
dose in that cycle] 
Abbreviations: Min = minimum; Max = maximum; STD = standard deviation;                                                                          
Reference: Listings 2.6.1 


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CONFIDENTIAL 
PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
 
                                                   Table 3.1.2.1 
  
                                       Summary of Study Drug Exposure by Visit  
                                         (Population: Part 1 FAS Population) 
  
                                                       
                                                Descriptive Summary 
                                     ___________________________________________________ 
                                         
  Dose Level(mg)            Visit      Average Dose(mg)[a]  STD      Min      Median     Max                          
______________________________________________________________________________________________________________________ 
     Dose 1                Cycle 1          xxx.xx          xxx.xx   xxx       xxx.x     xxx                                  
                           Cycle 2          xxx.xx          xxx.xx   xxx       xxx.x     xxx                      
                           Cycle 3          xxx.xx          xxx.xx   xxx       xxx.x     xxx   
                           Cycle 4          xxx.xx          xxx.xx   xxx       xxx.x     xxx 
                           Cycle 5          xxx.xx          xxx.xx   xxx       xxx.x     xxx 
                           Cycle 6          xxx.xx          xxx.xx   xxx       xxx.x     xxx         
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
[a] Average dose (mg) =   [total actual dose taken by each subject (mg) in a cycle]/[number of subjects with a nonzero 
dose in that cycle]  
Abbreviation: STD = Standard Deviation; Min = Minimum; Max = Maximum. 
Reference: Listing 2.6.1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
 
                                                   Table 3.1.2.1 
  
                                        Summary of Study Drug Exposure by Visit 
                                          (Population: Part 1 FAS Population) 
  
                                                       
                                                Descriptive Summary 
                                     ___________________________________________________ 
                                         
  Dose Level(mg)            Visit     Average Dose(mg)[a]   STD      Min      Median     Max                          
______________________________________________________________________________________________________________________ 
     Dose 2                Cycle 1          xxx.xx          xxx.xx   xxx       xxx.x     xxx                              
                           Cycle 2          xxx.xx          xxx.xx   xxx       xxx.x     xxx                      
                           Cycle 3          xxx.xx          xxx.xx   xxx       xxx.x     xxx   
                           Cycle 4          xxx.xx          xxx.xx   xxx       xxx.x     xxx 
                           Cycle 5          xxx.xx          xxx.xx   xxx       xxx.x     xxx 
                           Cycle 6          xxx.xx          xxx.xx   xxx       xxx.x     xxx         
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
[a] Average dose (mg) =  [total actual dose taken by each subject (mg) in a cycle]/[number of subjects with a nonzero 
dose in that cycle]  
Abbreviation: STD = Standard Deviation; Min = Minimum; Max = Maximum.  
Reference: Listing 2.6.1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
 
                                                   Table 3.1.2.1 
  
                                       Summary of Study Drug Exposure by Visit 
                                         (Population: Part 1 FAS Population) 
  
                                                       
                                                Descriptive Summary 
                                     ___________________________________________________ 
                                         
  Dose Level(mg)            Visit     Average Dose(mg)[a]   STD      Min      Median     Max                          
______________________________________________________________________________________________________________________ 
     Dose 3                Cycle 1          xxx.xx          xxx.xx   xxx       xxx.x     xxx                                  
                           Cycle 2          xxx.xx          xxx.xx   xxx       xxx.x     xxx                      
                           Cycle 3          xxx.xx          xxx.xx   xxx       xxx.x     xxx   
                           Cycle 4          xxx.xx          xxx.xx   xxx       xxx.x     xxx 
                           Cycle 5          xxx.xx          xxx.xx   xxx       xxx.x     xxx 
                           Cycle 6          xxx.xx          xxx.xx   xxx       xxx.x     xxx         
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
[a] Average dose (mg) =  [total actual dose taken by each subject (mg) in a cycle]/[number of subjects with a nonzero 
dose in that cycle]  
Abbreviation: STD = Standard Deviation; Min = Minimum; Max = Maximum.  
Reference: Listing 2.6.1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
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TLF VERSION: Draft 
 
                                                   Table 3.1.2.2 
  
                                       Summary of Study Drug Exposure by Visit  
                                           (Population: Part 2 FAS Population) 
  
                                                       
                                                Descriptive Summary 
                                     ___________________________________________________ 
                                         
     Tumor Type            Visit      Average Dose(mg)[a]   STD      Min      Median     Max                          
______________________________________________________________________________________________________________________ 
     Endometrium           Cycle 1          xxx.xx          xxx.xx   xxx       xxx.x     xxx                                  
                           Cycle 2          xxx.xx          xxx.xx   xxx       xxx.x     xxx                      
                           Cycle 3          xxx.xx          xxx.xx   xxx       xxx.x     xxx   
                           Cycle 4          xxx.xx          xxx.xx   xxx       xxx.x     xxx 
                           Cycle 5          xxx.xx          xxx.xx   xxx       xxx.x     xxx 
                           Cycle 6          xxx.xx          xxx.xx   xxx       xxx.x     xxx         
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
[a] Average dose (mg) =   [total actual dose taken by each subject (mg) in a cycle]/[number of subjects with a nonzero 
dose in that cycle]  
Abbreviation: STD = Standard Deviation; Min = Minimum; Max = Maximum.  
Reference: Listing 2.6.1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
 
                                                   Table 3.1.2.2 
  
                                       Summary of Study Drug Exposure by Visit  
                                          (Population: Part 2 FAS Population) 
  
                                                       
                                                Descriptive Summary 
                                     ___________________________________________________ 
                                         
     Tumor Type            Visit      Average Dose(mg)[a]   STD      Min      Median     Max                          
______________________________________________________________________________________________________________________ 
     Melanome              Cycle 1          xxx.xx          xxx.xx   xxx       xxx.x     xxx                                  
                           Cycle 2          xxx.xx          xxx.xx   xxx       xxx.x     xxx                      
                           Cycle 3          xxx.xx          xxx.xx   xxx       xxx.x     xxx   
                           Cycle 4          xxx.xx          xxx.xx   xxx       xxx.x     xxx 
                           Cycle 5          xxx.xx          xxx.xx   xxx       xxx.x     xxx 
                           Cycle 6          xxx.xx          xxx.xx   xxx       xxx.x     xxx         
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
[a] Average dose (mg) =   [total actual dose taken by each subject (mg) in a cycle]/[number of subjects with a nonzero 
dose in that cycle]  
Abbreviation: STD = Standard Deviation; Min = Minimum; Max = Maximum.  
Reference: Listing 2.6.1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
 
                                                   Table 3.1.2.2 
  
                                       Summary of Study Drug Exposure by Visit  
                                          (Population: Part 2 FAS Population) 
  
                                                       
                                                Descriptive Summary 
                                     ___________________________________________________ 
                                         
     Tumor Type            Visit      Average Dose(mg)[a]   STD      Min      Median     Max                          
______________________________________________________________________________________________________________________ 
     NSCLC                 Cycle 1          xxx.xx          xxx.xx   xxx       xxx.x     xxx                                  
                           Cycle 2          xxx.xx          xxx.xx   xxx       xxx.x     xxx                      
                           Cycle 3          xxx.xx          xxx.xx   xxx       xxx.x     xxx   
                           Cycle 4          xxx.xx          xxx.xx   xxx       xxx.x     xxx 
                           Cycle 5          xxx.xx          xxx.xx   xxx       xxx.x     xxx 
                           Cycle 6          xxx.xx          xxx.xx   xxx       xxx.x     xxx         
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
[a] Average dose (mg) =   [total actual dose taken by each subject (mg) in a cycle]/[number of subjects with a nonzero 
dose in that cycle]  
Abbreviation: STD = Standard Deviation; Min = Minimum; Max = Maximum.  
Reference: Listing 2.6.1 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
 
                                                   Table 3.1.2.2 
  
                                       Summary of Study Drug Exposure by Visit  
                                           (Population: Part 2 FAS Population) 
  
                                                       
                                                Descriptive Summary 
                                     ___________________________________________________ 
                                         
     Tumor Type            Visit      Average Dose(mg)[a]   STD      Min      Median     Max                          
______________________________________________________________________________________________________________________ 
     Ovarian               Cycle 1          xxx.xx          xxx.xx   xxx       xxx.x     xxx                                  
                           Cycle 2          xxx.xx          xxx.xx   xxx       xxx.x     xxx                      
                           Cycle 3          xxx.xx          xxx.xx   xxx       xxx.x     xxx   
                           Cycle 4          xxx.xx          xxx.xx   xxx       xxx.x     xxx 
                           Cycle 5          xxx.xx          xxx.xx   xxx       xxx.x     xxx 
                           Cycle 6          xxx.xx          xxx.xx   xxx       xxx.x     xxx         
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
[a] Average dose (mg) =   [total actual dose taken by each subject (mg) in a cycle]/[number of subjects with a nonzero 
dose in that cycle]  
Abbreviation: STD = Standard Deviation; Min = Minimum; Max = Maximum.  
Reference: Listing 2.6.1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
 
                                                   Table 3.1.2.2 
  
                                       Summary of Study Drug Exposure by Visit  
                                          (Population: Part 2 FAS Population) 
  
                                                       
                                                Descriptive Summary 
                                     ___________________________________________________ 
                                         
     Tumor Type            Visit      Average Dose(mg)[a]     STD    Min      Median     Max                          
______________________________________________________________________________________________________________________ 
     RCC                   Cycle 1          xxx.xx          xxx.xx   xxx       xxx.x     xxx                                  
                           Cycle 2          xxx.xx          xxx.xx   xxx       xxx.x     xxx                      
                           Cycle 3          xxx.xx          xxx.xx   xxx       xxx.x     xxx   
                           Cycle 4          xxx.xx          xxx.xx   xxx       xxx.x     xxx 
                           Cycle 5          xxx.xx          xxx.xx   xxx       xxx.x     xxx 
                           Cycle 6          xxx.xx          xxx.xx   xxx       xxx.x     xxx         
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
[a] Average dose (mg) =   [total actual dose taken by each subject (mg) in a cycle]/[number of subjects with a nonzero 
dose in that cycle]  
Abbreviation: STD = Standard Deviation; Min = Minimum; Max = Maximum.  
Reference: Listing 2.6.1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
 
                                                    Table 3.2.1.1 
  
                                 Overall Summary of Treatment-Emergent Adverse Events 
                                          (Population: Part 1 FAS Population) 
  
                                                          ___________________________________________________________ 
                                                                        Dose Level (mg/kg) 
                                                          _______________________________________________ 
                                                          Dose 1      Dose 2      Dose 3      Dose 4      Total 
                                                          (N=xx)      (N=xx)      (N=xx)      (N=xx)      (N=xx) 
______________________________________________________________________________________________________________________ 
    
    Subjects who had a TEAE                               xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
    Subjects who had a treatment-related TEAE             xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
         
    Subjects who had a SAE                                xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
Subjects who had an AE of grade 3 or higher           xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
 
    Subjects who had a fatal AE                           xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
    Subjects who had AE leading to                        xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
      - discontinuation of study medication 
 
    Subjects who had a DLT                                xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
    Subjects who had an irAE                              xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
    Subjects who had a Grade 3 or higher irAE             xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
 
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
 
Immune-Related Adverse Event: any AE consistent with an immune phenomenon associated with drug exposure after all other 
etiologies have been eliminated.  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
Treatment-Related AEs: treatment-emergent AEs judged as related by the investigator or with a missing causality. 
 
Reference: Listings 2.6.# 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
 
 
                                                    Table 3.2.1.2 
  
                                 Overall Summary of Treatment-Emergent Adverse Events 
                                           (Population: Part 2 FAS Population) 
  
                                                          ___________________________________________________________ 
                                                                                  Cancer Type 
                                                          ___________________________________________________________ 
                                                     Endometrium  Melanoma     NSCLC         RCC       Ovarian   Total 
  Variable                                            (N=xx)      (N=xx)      (N=xx)       (N=xx)      (N=xx)    (N=xx) 
______________________________________________________________________________________________________________________ 
     
    Subjects who had a TEAE                           xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
    Subjects who had a treatment-related TEAE         xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
         
    Subjects who had a SAE                            xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
    Subjects who had an AE of grade 3 or higher       xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
         
    Subjects who had a fatal AE                       xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
    Subjects who had AE leading to                    xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
       - discontinuation of study medication 
 
    Subjects who had a DLT                            xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
    Subjects who had an irAE                          xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
    Subjects who had a Grade 3 or higher irAE         xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
 
Immune-Related Adverse Event: any AE consistent with an immune phenomenon associated with drug exposure after all other 
etiologies have been eliminated.  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
Treatment-Related AEs: treatment-emergent AEs judged as related by the investigator or with a missing causality. 
  
Reference: Listings 2.6 xx 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
 
 
                                                    Table 3.2.2.1 
  
             Summary of Treatment-Emergent Adverse Events by MedDRA System Organ Class and Preferred Term 
                                          (Population: Part 1 FAS Population) 
  
                                                        ___________________________________________________________ 
                                                                      Dose Level (mg/kg) 
                                                        _______________________________________________ 
     MedDRA System Organ Class/                         Dose 1      Dose 2      Dose 3      Dose 4      Total 
      MedDRA Preferred Term                             (N=xx)      (N=xx)      (N=xx)      (N=xx)      (N=xx) 
______________________________________________________________________________________________________________________ 
     Number (%) of subjects with any                    xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
     treatment-emergent adverse events 
  
     System Organ Class 1                               xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
       Preferred term 1                                 xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
       Preferred term 2                                 xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
       Preferred term 3                                 xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
       ...                                              xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
  
     System Organ Class 2                               xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
       Preferred term 1                                 xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
       Preferred term 2                                 xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
       Preferred term 3                                 xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
       ...                                              xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
  
     System Organ Class 3                               xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
       Preferred term 1                                 xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
       ...                                              xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under each MedDRA system organ class and preferred term. 
Note #: xxxxxxxxx 
Reference: Listings 2.6 xx 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
 
 
                                                    Table 3.2.2.2 
  
             Summary of Treatment-Emergent Adverse Events by MedDRA System Organ Class and Preferred Term 
                                          (Population: Part 2 FAS Population) 
  
                                                        ___________________________________________________________ 
                                                                                Cancer Type 
                                                        ___________________________________________________________ 
     MedDRA System Organ Class/                      Endometrium   Melanoma     NSCLC        RCC       Ovarian  Total 
      MedDRA Preferred Term                             (N=xx)      (N=xx)      (N=xx)      (N=xx)      (N=xx)   (N=xx) 
______________________________________________________________________________________________________________________ 
     Number (%) of subjects with any                    xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
     treatment-emergent adverse events 
  
     System Organ Class 1                               xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
       Preferred term 1                                 xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
       Preferred term 2                                 xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
       Preferred term 3                                 xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
       ...                                              xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
  
     System Organ Class 2                               xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
       Preferred term 1                                 xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
       Preferred term 2                                 xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
       Preferred term 3                                 xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
       ...                                              xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
  
     System Organ Class 3                               xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
       Preferred term 1                                 xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
       ...                                              xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under each MedDRA system organ class and preferred term. 
Note #: xxxxxxxxx 
Reference: Listings 2.6 xx 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
 
 
                                                    Table 3.2.3.1 
  
        Summary of Treatment-Emergent Adverse Events by MedDRA Preferred Term in Decreasing Order of Frequency 
                                           (Population: Part 1 FAS Population) 
  
                                                        ___________________________________________________________ 
                                                                      Dose Level (mg/kg) 
                                                        _______________________________________________ 
                                                        Dose 1      Dose 2      Dose 3      Dose 4      Total 
     MedDRA Preferred Term                              (N=xx)      (N=xx)      (N=xx)      (N=xx)      (N=xx) 
______________________________________________________________________________________________________________________ 
     Xxxxxxxxxxxx                                       xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
     Xxxxxxxxxxxx                                       xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
     Xxxxxxxxxxxx                                       xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
     Xxxxxxxxxxxx                                       xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
     Xxxxxxxxxxxx                                       xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs:any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted only once under each MedDRA preferred term. 
Note 2: Footnote explaining how the descending frequency is driven (table specific). 
Note x: Other customized footnotes (study dependent). 
Reference: Listings 2.6 xx 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                   DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.2.3.2 
  
        Summary of Treatment-Emergent Adverse Events by MedDRA Preferred Term in Decreasing Order of Frequency 
                                           (Population: Part 2 FAS Population) 
  
                                                        ___________________________________________________________ 
                                                                                Cancer Type 
                                                        ___________________________________________________________ 
                                                        Endometrium Melanoma    NSCLC       RCC         Ovarian  Total 
     MedDRA Preferred Term                              (N=xx)      (N=xx)      (N=xx)      (N=xx)      (N=xx)   (N=xx) 
______________________________________________________________________________________________________________________ 
     Xxxxxxxxxxxx                                       xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
     Xxxxxxxxxxxx                                       xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
     Xxxxxxxxxxxx                                       xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
     Xxxxxxxxxxxx                                       xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
     Xxxxxxxxxxxx                                       xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x)   xx (xx.x) 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs:any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted only once under each MedDRA preferred term. 
Note 2: Footnote explaining how the descending frequency is driven (table specific). 
Note x: Other customized footnotes (study dependent). 
Reference: Listings 2.6 xx 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
 
 
                                                    Table 3.2.4.1 
  
Summary of Grade 3 or Higher Treatment- Emergent Adverse Events 
by MedDRA Preferred Term in Decreasing Order of Frequency 
(Population: Part 1 FAS Population) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.2.2.1 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under each MedDRA system organ class and preferred term. 
  
Reference: Listings 2.6 xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                       DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
 
 
                                                    Table 3.2.4.2 
  
Summary of Grade 3 or Higher Treatment- Emergent Adverse Events 
by MedDRA Preferred Term in Decreasing Order of Frequency 
(Population: Part 2 FAS Population) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.2.2.1 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under each MedDRA system organ class and preferred term. 
  
Reference: Listings 2.6 xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.2.5.1 
  
   Summary of Treatment-Emergent Adverse Events by MedDRA System Organ Class, Preferred Term, and Maximum Severity 
                                          (Population: Part 1 FAS Population) 
  
                                                 ____________________________________________________________________ 
                                                         Dose 1                 Dose 2                 Dose 3 
                                                        (N=xxx)                (N=xxx)                (N=xxx) 
   MedDRA System Organ Class/                    ______________________ ______________________ ______________________ 
    MedDRA Preferred Term                        G1 G2 G3 G4 Any        G1 G2 G3 G4 Any        G1 G2 G3 G4 Any 
______________________________________________________________________________________________________________________ 
   Number (%) of subjects with any adverse event xx xx xx xx xxx (xx.x) xx xx xx xx xxx(xx.x)  xx xx xx xx xxx (xx.x) 
  
   System Organ Class 1                          xx xx xx xx xxx (xx.x) xx xx xx xx xxx(xx.x)  xx xx xx xx xxx (xx.x) 
     Preferred term 1                            xx xx xx xx xxx (xx.x) xx xx xx xx xxx(xx.x)  xx xx xx xx xxx (xx.x) 
     Preferred term 2                            xx xx xx xx xxx (xx.x) xx xx xx xx xxx(xx.x)  xx xx xx xx xxx (xx.x) 
     Preferred term 3                            xx xx xx xx xxx (xx.x) xx xx xx xx xxx(xx.x)  xx xx xx xx xxx (xx.x) 
   ...                                           xx xx xx xx xxx (xx.x) xx xx xx xx xxx(xx.x)  xx xx xx xx xxx (xx.x) 
  
   System Organ Class 2                          xx xx xx xx xxx (xx.x) xx xx xx xx xxx(xx.x)  xx xx xx xx xxx (xx.x) 
     Preferred term 1                            xx xx xx xx xxx (xx.x) xx xx xx xx xxx(xx.x)  xx xx xx xx xxx (xx.x) 
     Preferred term 2                            xx xx xx xx xxx (xx.x) xx xx xx xx xxx(xx.x)  xx xx xx xx xxx (xx.x) 
     Preferred term 3                            xx xx xx xx xxx (xx.x) xx xx xx xx xxx(xx.x)  xx xx xx xx xxx (xx.x) 
   ...                                           xx xx xx xx xxx (xx.x) xx xx xx xx xxx(xx.x)  xx xx xx xx xxx (xx.x) 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under the highest grade; AEs with unknown severity were included only in the 'Any' 
column. 
 
Severity vs CTCAE Grade: Mild=G1, Moderate=G2, Severe=G3, Life-Threatening=G4. 
Reference: Listings 2.6 xx 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                   DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.2.5.2 
  
   Summary of Treatment-Emergent Adverse Events by MedDRA System Organ Class, Preferred Term, and Maximum Severity 
                                          (Population: Part 2 FAS Population) 
  
                                                 ____________________________________________________________________ 
                                                      Endometrium              Melanoma                NSCLC 
                                                        (N=xxx)                (N=xxx)                (N=xxx) 
   MedDRA System Organ Class/                    ______________________ ______________________ ______________________ 
    MedDRA Preferred Term                        G1 G2 G3 G4 Any        G1 G2 G3 G4 Any        G1 G2 G3 G4 Any 
______________________________________________________________________________________________________________________ 
   Number (%) of subjects with any adverse event xx xx xx xx xxx (xx.x) xx xx xx xx xxx(xx.x)  xx xx xx xx xxx (xx.x) 
  
   System Organ Class 1                          xx xx xx xx xxx (xx.x) xx xx xx xx xxx(xx.x)  xx xx xx xx xxx (xx.x) 
     Preferred term 1                            xx xx xx xx xxx (xx.x) xx xx xx xx xxx(xx.x)  xx xx xx xx xxx (xx.x) 
     Preferred term 2                            xx xx xx xx xxx (xx.x) xx xx xx xx xxx(xx.x)  xx xx xx xx xxx (xx.x) 
     Preferred term 3                            xx xx xx xx xxx (xx.x) xx xx xx xx xxx(xx.x)  xx xx xx xx xxx (xx.x) 
   ...                                           xx xx xx xx xxx (xx.x) xx xx xx xx xxx(xx.x)  xx xx xx xx xxx (xx.x) 
  
   System Organ Class 2                          xx xx xx xx xxx (xx.x) xx xx xx xx xxx(xx.x)  xx xx xx xx xxx (xx.x) 
     Preferred term 1                            xx xx xx xx xxx (xx.x) xx xx xx xx xxx(xx.x)  xx xx xx xx xxx (xx.x) 
     Preferred term 2                            xx xx xx xx xxx (xx.x) xx xx xx xx xxx(xx.x)  xx xx xx xx xxx (xx.x) 
     Preferred term 3                            xx xx xx xx xxx (xx.x) xx xx xx xx xxx(xx.x)  xx xx xx xx xxx (xx.x) 
   ...                                           xx xx xx xx xxx (xx.x) xx xx xx xx xxx(xx.x)  xx xx xx xx xxx (xx.x) 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under the highest grade; AEs with unknown severity were included only in the 'Any' 
column. 
 
Severity vs CTCAE Grade: Mild=G1, Moderate=G2, Severe=G3, Life-Threatening=G4. 
Reference: Listings 2.6 xx 
 
 
 
 
 
 


Incyte Corporation 
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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.2.6.1 
  
    Summary of Grade 3 or Higher Treatment-Emergent Adverse Events by MedDRA System Organ Class and Preferred Term 
                                          (Population: Part 1 FAS Population) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.2.2.1 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under each MedDRA system organ class and preferred term. 
Note #: xxxxxxxxx 
Reference: Listings 2.6 xx            */ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                   DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.2.6.2 
  
    Summary of Grade 3 or Higher Treatment-Emergent Adverse Events by MedDRA System Organ Class and Preferred Term 
                                           (Population: Part 2 FAS Population) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.2.2.2 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under each MedDRA system organ class and preferred term. 
Note #: xxxxxxxxx 
Reference: Listings 2.6 xx            */ 
 
 


Incyte Corporation 
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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.2.7.1 
  
                               Summary of INCAGN01949 Treatment-Related Adverse Events 
                                   by MedDRA System Organ Class and Preferred Term 
                                           (Population: Part 1 FAS Population) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.2.2.1 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under each MedDRA system organ class and preferred term. 
  
Reference: Listings 2.6 xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                   DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.2.7.2 
  
                               Summary of INCAGN01949 Treatment-Related Adverse Events 
                                   by MedDRA System Organ Class and Preferred Term 
                                           (Population: Part 2 FAS Population) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.2.2.2 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under each MedDRA system organ class and preferred term. 
  
Reference: Listings 2.6 xx 
 
 


Incyte Corporation 
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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.2.8.1 
  
                      Summary of Grade 3 or Higher INCAGN01949 Treatment-Related Adverse Events 
                                   by MedDRA System Organ Class and Preferred Term 
                                           (Population: Part 1 FAS Population) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.2.2.1 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under each MedDRA system organ class and preferred term. 
  
Reference: Listings 2.6 xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Incyte Corporation 
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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                   DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.2.8.2 
  
                      Summary of Grade 3 or Higher INCAGN01949 Treatment-Related Adverse Events 
                                   by MedDRA System Organ Class and Preferred Term 
                                          (Population: Part 2 FAS Population) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.2.2.2 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under each MedDRA system organ class and preferred term. 
  
Reference: Listings 2.6 xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                               (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                          DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
 
Table 3.2.9.1 
 
Summary of Grade 3 or Higher INCAGN01949 Treatment-Related Adverse Events 
by MedDRA Preferred Term in Order of Decreasing Order of Frequency 
(Population: Part 1 FAS Population) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.2.2.1 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under each MedDRA system organ class and preferred term. 
  
Reference: Listings 2.6 xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Incyte Corporation 
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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                   DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.2.9.2 
  
    Summary of Grade 3 or Higher INCAGN01949 Treatment-Related Adverse Events 
by MedDRA Preferred Term in Decreasing Order of Frequency 
(Population: Part 2 FAS Population) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.2.2.2 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under the highest grade; AEs with unknown severity were included only in the 'Any' 
column. 
Note x: Other customized footnotes (study dependent). 
Severity vs CTCAE Grade: Mild=G1, Moderate=G2, Severe=G3, Life-Threatening=G4. 
Reference: Listings 2.6 xx 
 
 


Incyte Corporation 
Page 108 of 186 
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CONFIDENTIAL 
PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.2.10.1 
  
                               Summary of INCAGN01949 Treatment-Related Adverse Events 
                          by MedDRA System Organ Class, Preferred Term, and Maximum Severity 
                                           (Population: Part 1 FAS Population) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.2.2.1 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under the highest grade; AEs with unknown severity were included only in the 'Any' 
column. 
Note x: Other customized footnotes (study dependent). 
Severity vs CTCAE Grade: Mild=G1, Moderate=G2, Severe=G3, Life-Threatening=G4. 
Reference: Listings 2.6 xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Incyte Corporation 
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CONFIDENTIAL 
PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                   DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.2.10.2 
  
                               Summary of INCAGN01949 Treatment-Related Adverse Events 
                          by MedDRA System Organ Class, Preferred Term, and Maximum Severity 
                                          (Population: Part 2 FAS Population) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.2.2.2 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under the highest grade; AEs with unknown severity were included only in the 'Any' 
column. 
Note x: Other customized footnotes (study dependent). 
Severity vs CTCAE Grade: Mild=G1, Moderate=G2, Severe=G3, Life-Threatening=G4. 
Reference: Listings 2.6 xx 
 
 


Incyte Corporation 
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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.2.11.1 
  
                          Summary of Treatment-Emergent Adverse Events with a Fatal Outcome 
                                   by MedDRA System Organ Class and Preferred Term 
                                           (Population: Part 1 FAS Population) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.2.2.1 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under each MedDRA system organ class and preferred term. 
  
Reference: Listings 2.6 xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                   DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.2.11.2 
  
                          Summary of Treatment-Emergent Adverse Events with a Fatal Outcome 
                                   by MedDRA System Organ Class and Preferred Term 
                                          (Population: Part 2 FAS Population) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.2.2.2 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under each MedDRA system organ class and preferred term. 
  
Reference: Listings 2.6 xx 
 
 


Incyte Corporation 
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CONFIDENTIAL 
PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.2.12.1 
  
                                 Summary of Serious Treatment-Emergent Adverse Events 
                                   by MedDRA System Organ Class and Preferred Term 
                                           (Population: Part 1 FAS Population) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.2.2.1 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under each MedDRA system organ class and preferred term. 
  
Reference: Listings 2.6 xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Incyte Corporation 
Page 113 of 186 
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CONFIDENTIAL 
PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                           DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.2.12.2 
  
                                 Summary of Serious Treatment-Emergent Adverse Events 
                                   by MedDRA System Organ Class and Preferred Term 
                                           (Population: Part 2 FAS Population) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.2.2.2 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under each MedDRA system organ class and preferred term. 
  
Reference: Listings 2.6 xx 
 
 


Incyte Corporation 
Page 114 of 186 
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CONFIDENTIAL 
PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.2.13.1 
  
                                 Summary of Serious Treatment-Emergent Adverse Events 
                              by MedDRA Preferred Term in Decreasing Order of Frequency 
                                            (Population: Part 1 FAS Population) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.2.2.1 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs:any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted only once under each MedDRA preferred term. 
Note 2: Footnote explaining how the descending frequency is driven (table specific). 
Note x: Other customized footnotes (study dependent). 
Reference: Listings 2.6 xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Incyte Corporation 
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CONFIDENTIAL 
PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                           DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.2.13.2 
  
                                 Summary of Serious Treatment-Emergent Adverse Events 
                              by MedDRA Preferred Term in Decreasing Order of Frequency 
                                           (Population: Part 2 FAS Population) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.2.2.2 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted only once under each MedDRA preferred term. 
Note 2: Footnote explaining how the descending frequency is driven (table specific). 
Note x: Other customized footnotes (study dependent). 
Reference: Listings 2.6 xx 
 
 


Incyte Corporation 
Page 116 of 186 
INCAGN 1949-101 Statistical Analysis Plan 
05 JAN 2017 
CONFIDENTIAL 
PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.2.14.1 
  
                               Summary of Non-Serious Treatment-Emergent Adverse Events 
                                   by MedDRA System Organ Class and Preferred Term 
                                            (Population: Part 1 FAS Population) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.2.2.1 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under each MedDRA system organ class and preferred term. 
  
Reference: Listings 2.6 xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                           DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.2.14.2 
  
                               Summary of Non-Serious Treatment-Emergent Adverse Events 
                                   by MedDRA System Organ Class and Preferred Term 
                                           (Population: Part 2 FAS Population) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.2.2.2 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under each MedDRA system organ class and preferred term. 
  
Reference: Listings 2.6 xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.2.15.1 
  
                           Summary of INCAGN01949 Treatment-Related Serious Adverse Events 
                                   by MedDRA System Organ Class and Preferred Term 
                                            (Population: Part 1 FAS Population) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.2.2.1 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under each MedDRA system organ class and preferred term. 
  
Reference: Listings 2.6 xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                           DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.2.15.2 
  
                           Summary of INCAGN01949 Treatment-Related Serious Adverse Events 
                                   by MedDRA System Organ Class and Preferred Term 
                                           (Population: Part 2 FAS Population) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.2.2.2 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under each MedDRA system organ class and preferred term. 
  
Reference: Listings 2.6 xx 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.2.16.1 
  
                  Summary of Treatment-Emergent Adverse Events Leading to INCAGN01949 Dose Reduction 
                                   by MedDRA System Organ Class and Preferred Term 
                                           (Population: Part 1 FAS Population) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.2.2.1 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under each MedDRA system organ class and preferred term. 
  
Reference: Listings 2.6 xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                           DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.2.16.2 
  
                  Summary of Treatment-Emergent Adverse Events Leading to INCAGN01949 Dose Reduction 
                                   by MedDRA System Organ Class and Preferred Term 
                                           (Population: Part 2 FAS Population) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.2.2.2 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under each MedDRA system organ class and preferred term. 
  
Reference: Listings 2.6 xx 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.2.17.1 
  
                Summary of Treatment-Emergent Adverse Events Leading to INCAGN01949 Dose Interruption 
                                   by MedDRA System Organ Class and Preferred Term 
                                           (Population: Part 1 FAS Population) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.2.2.1 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under each MedDRA system organ class and preferred term. 
  
Reference: Listings 2.6 xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                           DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.2.17.2 
  
                Summary of Treatment-Emergent Adverse Events Leading to INCAGN01949 Dose Interruption 
                                   by MedDRA System Organ Class and Preferred Term 
                                           (Population: Part 2 FAS Population) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.2.2.2 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under each MedDRA system organ class and preferred term. 
  
Reference: Listings 2.6 xx 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.2.18.1 
  
                Summary of Treatment-Emergent Adverse Events Leading to Discontinuation of INCAGN01949 
                                   by MedDRA System Organ Class and Preferred Term 
                                          (Population: Part 1 FAS Population) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.2.2.1 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under each MedDRA system organ class and preferred term. 
  
Reference: Listings 2.6 xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                           DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.2.18.2 
  
                Summary of Treatment-Emergent Adverse Events Leading to Discontinuation of INCAGN01949 
                                   by MedDRA System Organ Class and Preferred Term 
                                          (Population: Part 2 FAS Population) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.2.2.2 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under each MedDRA system organ class and preferred term. 
  
Reference: Listings 2.6 xx 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.2.19.1 
  
                  Summary of Treatment-Emergent Immune-Related Adverse Events (Investigator Identified) 
                                    by MedDRA System Organ Class and Preferred Term  
                                           (Population: Part 1 FAS Population) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.2.2.1 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under each MedDRA system organ class and preferred term. 
  
Reference: Listings 2.6 xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                           DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.2.19.2 
  
                  Summary of Treatment-Emergent Immune-Related Adverse Events (Investigator Indentified) 
                                   by MedDRA System Organ Class and Preferred Term  
                                          (Population: Part 2 FAS Population) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.2.2.2 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under each MedDRA system organ class and preferred term. 
  
Reference: Listings 2.6 xx 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.2.20.1 
  
                  Summary of Treatment-Emergent Immune-Related Adverse Events (Sponsor Identified) 
                                   by MedDRA System Organ Class and Preferred Term  
                                            (Population: Part 1 FAS Population) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.2.2.1 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under each MedDRA system organ class and preferred term. 
  
Reference: Listings 2.6 xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                           DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.2.20.2 
  
                  Summary of Treatment-Emergent Immune-Related Adverse Events (Sponsor Identified) 
                                 by MedDRA System Organ Class and Preferred Term  
                                           (Population: Part 2 FAS Population) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.2.2.2 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under each MedDRA system organ class and preferred term. 
  
Reference: Listings 2.6 xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.2.21.1 
  
                              Summary of Treatment-Emergent Immune-Related Adverse Events 
                            by MedDRA System Organ Class, Preferred Term, and Maximum Severity 
                                           (Population: Part 1 FAS Population) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.2.2.1 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under each MedDRA system organ class and preferred term. 
  
Reference: Listings 2.6 xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                           DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.2.21.2 
  
                            Summary of Treatment-Emergent Immune-Related Adverse Events 
                          by MedDRA System Organ Class, Preferred Term, and Maximum Severity 
                                            (Population: Part 2 FAS Population) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.2.2.2 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under each MedDRA system organ class and preferred term. 
  
Reference: Listings 2.6 xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.2.22.1 
  
                    Summary of Grade 3 or Higher Treatment-Emergent Immune-Related Adverse Events 
                                 by MedDRA System Organ Class and Preferred Term 
                                           (Population: Part 1 FAS Population) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.2.2.1 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under each MedDRA system organ class and preferred term. 
  
Reference: Listings 2.6 xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                           DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.2.22.2 
  
                    Summary of Grade 3 or Higher Treatment-Emergent Immune-Related Adverse Events 
                                   by MedDRA System Organ Class and Preferred Term  
                                          (Population: Part 2 FAS Population) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.2.2.2 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Treatment-Emergent AEs: any AE either reported for the first time or worsening of a pre-existing event after first dose 
of study medication. 
  
Note 1: Subjects were counted once under each MedDRA system organ class and preferred term. 
  
Reference: Listings 2.6 xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
 
 
                                                     TABLE 3.2.23 
                Life Table Estimate of Time to First Grade 3 or Higher Treatment-Emergent Adverse Event 
                                            (Population: Part 2 FAS Population) 
  
 
                                                            Adenocarcinoma of the Endometrium                                     
  MedDRA System Organ Class/            _______________________________________________________________________________            
  MedDRA Preferred Term                   0-3 W              >=3-6 W             >=6-9 W             >=9-18 W        
_______________________________________________________________________________________________________________________ 
 
  Number (%) of Subjects with any  
    Adverse Events                    ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   
 
    System Organ Class 1               ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
      Preferred Term 1                 ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
      Preferred Term 2                 ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
      Preferred Term 3                 ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
 
    System Organ Class 2               ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
      Preferred Term 1                 ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
      Preferred Term 2                 ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
      Preferred Term 3                 ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
_______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                                                           
DATE(TIME): MMDDYYYY(hh:mm) 
  
Note: Percentage of subjects for each event was based on the effective sample size of the time interval (number of 
subjects at risk at the beginning of the interval minus half of the censored subjects during the time interval) 
 
Reference: Listing 2.## 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
 
 
                                                     TABLE 3.2.23 
                Life Table Estimate of Time to First Grade 3 or Higher Treatment-Emergent Adverse Event 
                                            (Population: Part 2 FAS Population) 
  
 
                                                                      Melanoma                                                       
  MedDRA System Organ Class/            _______________________________________________________________________________            
  MedDRA Preferred Term                   0-3 W              >=3-6 W             >=6-9 W             >=9-18 W        
_______________________________________________________________________________________________________________________ 
 
  Number (%) of Subjects with any  
    Adverse Events                    ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   
 
    System Organ Class 1               ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
      Preferred Term 1                 ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
      Preferred Term 2                 ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
      Preferred Term 3                 ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
 
    System Organ Class 2               ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
      Preferred Term 1                 ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
      Preferred Term 2                 ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
      Preferred Term 3                 ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
_______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                                                           
DATE(TIME): MMDDYYYY(hh:mm) 
  
Note: Percentage of subjects for each event was based on the effective sample size of the time interval (number of 
subjects at risk at the beginning of the interval minus half of the censored subjects during the time interval) 
 
Reference: Listing 2.## 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
 
 
                                                     TABLE 3.2.23 
                Life Table Estimate of Time to First Grade 3 or Higher Treatment-Emergent Adverse Event 
                                            (Population: Part 2 FAS Population) 
  
 
                                                                       NSCLC                                                       
  MedDRA System Organ Class/            _______________________________________________________________________________            
  MedDRA Preferred Term                   0-3 W              >=3-6 W             >=6-9 W             >=9-18 W        
_______________________________________________________________________________________________________________________ 
 
  Number (%) of Subjects with any  
    Adverse Events                    ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   
 
    System Organ Class 1               ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
      Preferred Term 1                 ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
      Preferred Term 2                 ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
      Preferred Term 3                 ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
 
    System Organ Class 2               ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
      Preferred Term 1                 ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
      Preferred Term 2                 ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
      Preferred Term 3                 ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
_______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                                                           
DATE(TIME): MMDDYYYY(hh:mm) 
  
Note: Percentage of subjects for each event was based on the effective sample size of the time interval (number of 
subjects at risk at the beginning of the interval minus half of the censored subjects during the time interval) 
 
Reference: Listing 2.## 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
 
 
                                                     TABLE 3.2.23 
                Life Table Estimate of Time to First Grade 3 or Higher Treatment-Emergent Adverse Event 
                                            (Population: Part 2 FAS Population) 
  
 
                                                                      Ovarian                                                       
  MedDRA System Organ Class/            _______________________________________________________________________________            
  MedDRA Preferred Term                   0-3 W              >=3-6 W             >=6-9 W             >=9-18 W        
_______________________________________________________________________________________________________________________ 
 
  Number (%) of Subjects with any  
    Adverse Events                    ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   
 
    System Organ Class 1               ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
      Preferred Term 1                 ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
      Preferred Term 2                 ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
      Preferred Term 3                 ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
 
    System Organ Class 2               ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
      Preferred Term 1                 ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
      Preferred Term 2                 ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
      Preferred Term 3                 ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
_______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                                                           
DATE(TIME): MMDDYYYY(hh:mm) 
  
Note: Percentage of subjects for each event was based on the effective sample size of the time interval (number of 
subjects at risk at the beginning of the interval minus half of the censored subjects during the time interval) 
 
Reference: Listing 2.## 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
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TLF VERSION: Draft 
 
 
                                                     TABLE 3.2.23 
                Life Table Estimate of Time to First Grade 3 or Higher Treatment-Emergent Adverse Event 
                                            (Population: Part 2 FAS Population) 
  
 
                                                                        RCC                                                       
  MedDRA System Organ Class/            _______________________________________________________________________________            
  MedDRA Preferred Term                   0-3 W              >=3-6 W             >=6-9 W             >=9-18 W        
_______________________________________________________________________________________________________________________ 
 
  Number (%) of Subjects with any  
    Adverse Events                    ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   
 
    System Organ Class 1               ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
      Preferred Term 1                 ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
      Preferred Term 2                 ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
      Preferred Term 3                 ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
 
    System Organ Class 2               ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
      Preferred Term 1                 ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
      Preferred Term 2                 ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
      Preferred Term 3                 ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)   ###/###.# (###.#)    
_______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                                                           
DATE(TIME): MMDDYYYY(hh:mm) 
  
Note: Percentage of subjects for each event was based on the effective sample size of the time interval (number of 
subjects at risk at the beginning of the interval minus half of the censored subjects during the time interval) 
 
Reference: Listing 2.## 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                           DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.3.1 
  
                                      Summary of Laboratory Values - Hematology 
                                           (Population: Part 2 FAS Population) 
  
 Laboratory Test (unit): xxxxxxxxx (xxxx) 
  
   __________________________________________________________________________________________________________________ 
                                                     Descriptive Summary                   N (%) of Subjects 
                                            _____________________________________ ___________________________________ 
   Cancer Type        Visit                 N   Mean   STD     Min   Median Max   Low         Normal      High 
   __________________________________________________________________________________________________________________ 
   Endometrium        Baseline   Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx xxx (xxx.x) xxx (xxx.x) xxx (xxx.x) 
  
                      xxxxx      Measured   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx xxx (xxx.x) xxx (xxx.x) xxx (xxx.x) 
                                 Change     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                                 % Change   xx  xx.xx  xxx.xxx xxx.x xx.xx  xxx.x 
  
                      EOS        Measured   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx xxx (xxx.x) xxx (xxx.x) xxx (xxx.x) 
                                 Change     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                                 % Change   xx  xx.xx  xxx.xxx xxx.x xx.xx  xxx.x 
  
   Melanoma           Baseline   Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx xxx (xxx.x) xxx (xxx.x) xxx (xxx.x) 
  
                      xxxxx      Measured   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx xxx (xxx.x) xxx (xxx.x) xxx (xxx.x) 
                                 Change     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                                 % Change   xx  xx.xx  xxx.xxx xxx.x xx.xx  xxx.x 
  
                      EOS        Measured   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx xxx (xxx.x) xxx (xxx.x) xxx (xxx.x) 
                                 Change     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                                 % Change   xx  xx.xx  xxx.xxx xxx.x xx.xx  xxx.x 
  
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Abbreviation: STD = Standard Deviation; Min = Minimum; Max = Maximum  
 
Reference: Listings 2.7.xx 
 
 


Incyte Corporation 
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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                           DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.3.1 
  
                                      Summary of Laboratory Values - Hematology 
                                          (Population: Part 2 FAS Population) 
  
 Laboratory Test (unit): xxxxxxxxx (xxxx) 
______________________________________________________________________________________________________________________ 
                                                     Descriptive Summary                   N (%) of Subjects 
                                            _____________________________________ ___________________________________ 
   Cancer Type        Visit                 N   Mean   STD     Min   Median Max   Low         Normal      High 
______________________________________________________________________________________________________________________ 
   NSCLC              Baseline   Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx xxx (xxx.x) xxx (xxx.x) xxx (xxx.x) 
  
                      xxxxx      Measured   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx xxx (xxx.x) xxx (xxx.x) xxx (xxx.x) 
                                 Change     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                                 % Change   xx  xx.xx  xxx.xxx xxx.x xx.xx  xxx.x 
  
                      EOS        Measured   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx xxx (xxx.x) xxx (xxx.x) xxx (xxx.x) 
                                 Change     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                                 % Change   xx  xx.xx  xxx.xxx xxx.x xx.xx  xxx.x 
  
   RCC                Baseline   Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx xxx (xxx.x) xxx (xxx.x) xxx (xxx.x) 
  
                      xxxxx      Measured   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx xxx (xxx.x) xxx (xxx.x) xxx (xxx.x) 
                                 Change     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                                 % Change   xx  xx.xx  xxx.xxx xxx.x xx.xx  xxx.x 
  
                      EOS        Measured   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx xxx (xxx.x) xxx (xxx.x) xxx (xxx.x) 
                                 Change     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                                 % Change   xx  xx.xx  xxx.xxx xxx.x xx.xx  xxx.x 
  
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Abbreviation: STD = Standard Deviation; Min = Minimum; Max = Maximum  
 
Reference: Listings 2.7.xx 
 
 


Incyte Corporation 
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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                           DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.3.1 
  
                                      Summary of Laboratory Values - Hematology 
                                           (Population: Part 2 FAS Population) 
  
 Laboratory Test (unit): xxxxxxxxx (xxxx) 
______________________________________________________________________________________________________________________ 
                                                     Descriptive Summary                   N (%) of Subjects 
                                            _____________________________________ ___________________________________ 
   Cancer Type        Visit                 N   Mean   STD     Min   Median Max   Low         Normal      High 
______________________________________________________________________________________________________________________ 
   Ovarian            Baseline   Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx xxx (xxx.x) xxx (xxx.x) xxx (xxx.x) 
  
                      xxxxx      Measured   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx xxx (xxx.x) xxx (xxx.x) xxx (xxx.x) 
                                 Change     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                                 % Change   xx  xx.xx  xxx.xxx xxx.x xx.xx  xxx.x 
  
                      EOS        Measured   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx xxx (xxx.x) xxx (xxx.x) xxx (xxx.x) 
                                 Change     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                                 % Change   xx  xx.xx  xxx.xxx xxx.x xx.xx  xxx.x 
  
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Abbreviation: STD = Standard Deviation; Min = Minimum; Max = Maximum  
 
Reference: Listings 2.7.xx 
 
 
 
 
 


Incyte Corporation 
Page 142 of 186 
INCAGN 1949-101 Statistical Analysis Plan 
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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.3.2.1 
  
               Shift Summary of Hematology Laboratory Values in CTC Grade - To the Worst Abnormal Value 
                                           (Population: Part 1 FAS Population) 
  
 Laboratory Test (unit): xxxxxxxx (xxxxx) 
  
   _________________________________________________________________________________________________________________ 
                               Baseline[1]                           Worst Post-Baseline Value [2] 
                        __________________________ _________________________________________________________________ 
   Dose Level (mg/kg)   Grade           n (%)      Grade 0    Grade 1    Grade 2    Grade 3    Grade 4    Missing 
   _________________________________________________________________________________________________________________ 
   Dose 1               Grade 0         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 1         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 2         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 3         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 4         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Missing         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Total           xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
  
   Dose 2               Grade 0         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 1         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 2         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 3         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 4         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Missing         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Total           xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
  
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
[1] The percentages for the baseline column were calculated using the baseline total as the denominator. 
[2] For each row, the percentages were calculated using the number of subjects with a given grade at baseline as the 
denominator. 
    Worst post-baseline laboratory value was the worst grade observed post-baseline for a given subject. 
  
Note x: xxxxxxxx 
Reference: Listings 2.7.xx 
 
 


Incyte Corporation 
Page 143 of 186 
INCAGN 1949-101 Statistical Analysis Plan 
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CONFIDENTIAL 
PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.3.2.1 
  
               Shift Summary of Hematology Laboratory Values in CTC Grade - To the Worst Abnormal Value 
                                           (Population: Part 1 FAS Population) 
  
 Laboratory Test (unit): xxxxxxxx (xxxxx) 
______________________________________________________________________________________________________________________ 
                               Baseline[1]                           Worst Post-Baseline Value [2] 
                        __________________________ _________________________________________________________________ 
   Dose Level (mg/kg)   Grade           n (%)      Grade 0    Grade 1    Grade 2    Grade 3    Grade 4    Missing 
______________________________________________________________________________________________________________________ 
   Dose 3               Grade 0         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 1         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 2         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 3         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 4         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Missing         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Total           xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
  
   Dose 4               Grade 0         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 1         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 2         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 3         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 4         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Missing         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Total           xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
  
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
[1] The percentages for the baseline column were calculated using the baseline total as the denominator. 
[2] For each row, the percentages were calculated using the number of subjects with a given grade at baseline as the 
denominator. 
    Worst post-baseline laboratory value was the worst grade observed post-baseline for a given subject. 
  
Note x: xxxxxxxx 
Reference: Listings 2.7.xx 
 
 


Incyte Corporation 
Page 144 of 186 
INCAGN 1949-101 Statistical Analysis Plan 
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CONFIDENTIAL 
PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.3.2.1 
  
               Shift Summary of Hematology Laboratory Values in CTC Grade - To the Worst Abnormal Value 
                                           (Population: Part 1 FAS Population) 
  
 Laboratory Test (unit): xxxxxxxx (xxxxx) 
______________________________________________________________________________________________________________________ 
                               Baseline[1]                           Worst Post-Baseline Value [2] 
                        __________________________ _________________________________________________________________ 
   Dose Level (mg/kg)   Grade           n (%)      Grade 0    Grade 1    Grade 2    Grade 3    Grade 4    Missing 
______________________________________________________________________________________________________________________ 
   Total                Grade 0         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 1         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 2         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 3         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 4         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Missing         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Total           xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
  
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
[1] The percentages for the baseline column were calculated using the baseline total as the denominator. 
[2] For each row, the percentages were calculated using the number of subjects with a given grade at baseline as the 
denominator. 
    Worst post-baseline laboratory value was the worst grade observed post-baseline for a given subject. 
  
Note x: xxxxxxxx 
Reference: Listings 2.7.xx 
 
 
 
 
 
 
 
 
 
 
 
 


Incyte Corporation 
Page 145 of 186 
INCAGN 1949-101 Statistical Analysis Plan 
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CONFIDENTIAL 
PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                           DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.3.2.2 
  
               Shift Summary of Hematology Laboratory Values in CTC Grade - To the Worst Abnormal Value 
                                          (Population: Part 2 FAS Population) 
  
 Laboratory Test (unit): xxxxxxxx (xxxxx) 
  
   _________________________________________________________________________________________________________________ 
                               Baseline[1]                           Worst Post-Baseline Value [2] 
                        __________________________ _________________________________________________________________ 
   Cancer Type          Grade           n (%)      Grade 0    Grade 1    Grade 2    Grade 3    Grade 4    Missing 
   _________________________________________________________________________________________________________________ 
   Endometrium          Grade 0         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 1         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 2         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 3         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 4         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Missing         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Total           xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
  
   Melanoma             Grade 0         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 1         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 2         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 3         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 4         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Missing         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Total           xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
  
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
[1] The percentages for the baseline column were calculated using the baseline total as the denominator. 
[2] For each row, the percentages were calculated using the number of subjects with a given grade at baseline as the 
denominator. 
    Worst post-baseline laboratory value was the worst grade observed post-baseline for a given subject. 
  
Note x: xxxxxxxx 
Reference: Listings 2.7.xx 
 
 


Incyte Corporation 
Page 146 of 186 
INCAGN 1949-101 Statistical Analysis Plan 
05 JAN 2017 
CONFIDENTIAL 
PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                           DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.3.2.2 
  
               Shift Summary of Hematology Laboratory Values in CTC Grade - To the Worst Abnormal Value 
                                           (Population: Part 2 FAS Population) 
  
 Laboratory Test (unit): xxxxxxxx (xxxxx) 
______________________________________________________________________________________________________________________ 
                               Baseline[1]                           Worst Post-Baseline Value [2] 
                        __________________________ _________________________________________________________________ 
   Cancer Type          Grade           n (%)      Grade 0    Grade 1    Grade 2    Grade 3    Grade 4    Missing 
______________________________________________________________________________________________________________________ 
   NSCLC                Grade 0         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 1         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 2         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 3         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 4         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Missing         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Total           xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
  
   RCC                  Grade 0         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 1         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 2         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 3         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 4         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Missing         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Total           xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
  
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
[1] The percentages for the baseline column were calculated using the baseline total as the denominator. 
[2] For each row, the percentages were calculated using the number of subjects with a given grade at baseline as the 
denominator. 
    Worst post-baseline laboratory value was the worst grade observed post-baseline for a given subject. 
  
Note x: xxxxxxxx 
Reference: Listings 2.7.xx 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                           DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.3.2.2 
  
               Shift Summary of Hematology Laboratory Values in CTC Grade - To the Worst Abnormal Value 
                                          (Population: Part 2 FAS Population) 
  
 Laboratory Test (unit): xxxxxxxx (xxxxx) 
______________________________________________________________________________________________________________________ 
                               Baseline[1]                           Worst Post-Baseline Value [2] 
                        __________________________ _________________________________________________________________ 
   Cancer Type          Grade           n (%)      Grade 0    Grade 1    Grade 2    Grade 3    Grade 4    Missing 
______________________________________________________________________________________________________________________ 
   Ovarian              Grade 0         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 1         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 2         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 3         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Grade 4         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Missing         xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
                        Total           xxx xx.x%  xxx xx.x%  xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x%   xx xx.x% 
  
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
[1] The percentages for the baseline column were calculated using the baseline total as the denominator. 
[2] For each row, the percentages were calculated using the number of subjects with a given grade at baseline as the 
denominator. 
    Worst post-baseline laboratory value was the worst grade observed post-baseline for a given subject. 
  
Note x: xxxxxxxx 
Reference: Listings 2.7.xx 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
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TLF VERSION: Draft 
                                                    Table 3.3.3 
  
                                       Summary of Laboratory Values - Chemistry 
                                          (Population: Part 2 FAS Population) 
  
 Laboratory Test (unit): xxxxxxxx (xxxxx) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.3.1 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Note: xxxxxxx 
Reference: Listings 2.7.xx 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.3.4.1 
  
                Shift Summary of Chemisty Laboratory Values in CTC Grade - To the Worst Abnormal Value 
                                          (Population: Part 1 FAS Population) 
  
 Laboratory Test (unit): xxxxxxxx (xxxxx) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.3.2.1 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
[1] The percentages for the baseline column were calculated using the baseline total as the denominator. 
[2] For each row, the percentages were calculated using the number of subjects with a given grade at baseline as the 
denominator. 
    Worst post-baseline laboratory value was the worst grade observed post-baseline for a given subject. 
  
Note x: xxxxxxxx 
Reference: Listings 2.7.xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                           DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.3.4.2 
  
                Shift Summary of Chemisty Laboratory Values in CTC Grade - To the Worst Abnormal Value 
                                         (Population: Part 2 FAS Population) 
  
 Laboratory Test (unit): xxxxxxxx (xxxxx) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.3.2.2 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
[1] The percentages for the baseline column were calculated using the baseline total as the denominator. 
[2] For each row, the percentages were calculated using the number of subjects with a given grade at baseline as the 
denominator. 
    Worst post-baseline laboratory value was the worst grade observed post-baseline for a given subject. 
  
Note x: xxxxxxxx 
Reference: Listings 2.7.xx 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.4.1.1 
  
                                      Summary of Systolic Blood Pressure (mmHg) 
                                          (Population: Part 1 FAS Population) 
  
 Dose Level (mg/kg) :Dose 1 
  
    ________________________________________________________________________________________________________________ 
                                                Descriptive Summary             Low     Normal     High      Alert 
                                        ____________________________________ _________ _________ _________ _________ 
    Study Visit            Variable     N     Mean  STD   Min   Median Max    N   %     N   %     N   %     N   % 
    ________________________________________________________________________________________________________________ 
    Baseline               Baseline     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
    Week xx                Measured     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           Change       xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           % Change     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
    Week xx                Measured     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           Change       xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           % Change     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Note 1: Baseline is the last value collected before the first dose of study drug. 
Note 2: The normal range for SBP is 85 - 155 mm/Hg. Alert values are defined as the measured value being outside the 
normal range and the percent change from baseline being > 25%. 
  
Reference: Listings 2.8.1 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                           DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.4.1.2 
  
                                      Summary of Systolic Blood Pressure (mmHg) 
                                         (Population: Part 2 FAS Population) 
  
 Cancer Type :Endometrium 
  
    ________________________________________________________________________________________________________________ 
                                                Descriptive Summary             Low     Normal     High      Alert 
                                        ____________________________________ _________ _________ _________ _________ 
    Study Visit            Variable     N     Mean  STD   Min   Median Max    N   %     N   %     N   %     N   % 
    ________________________________________________________________________________________________________________ 
    Baseline               Baseline     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
    Week xx                Measured     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           Change       xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           % Change     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
    Week xx                Measured     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           Change       xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           % Change     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Note 1: Baseline is the last value collected before the first dose of study drug. 
Note 2: The normal range for SBP is 85 - 155 mm/Hg. Alert values are defined as the measured value being outside the 
normal range and the percent change from baseline being > 25%. 
  
Reference: Listings 2.8.1 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.4.2.1 
  
                                      Summary of Diastolic Blood Pressure (mmHg) 
                                           (Population: Part 1 FAS Population) 
  
 Dose Level (mg/kg) :Dose 1 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.4.1.1 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Note 1: Baseline is the last value collected before the first dose of study drug. 
Note 2: The normal range for DBP is 40 - 100 mmHg. Alert values are defined as the measured value being outside the 
normal range and the percent change from baseline being > 25%. 
  
Reference: Listings 2.8.XX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                           DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.4.2.2 
  
                                      Summary of Diastolic Blood Pressure (mmHg) 
                                          (Population: Part 2 FAS Population) 
  
 Cancer Type :Endometrium 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.4.1.2 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Note 1: Baseline is the last value collected before the first dose of study drug. 
Note 2: The normal range for DBP is 40 - 100 mmHg. Alert values are defined as the measured value being outside the 
normal range and the percent change from baseline being > 25%. 
  
Reference: Listings 2.8.XX 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.4.3.1 
  
                                             Summary of Heart Rate (bpm) 
                                          (Population: Part 1 FAS Population) 
  
 Dose Level (mg/kg) :Dose 1 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.4.1.1 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Note 1: Baseline is the last value collected before the first dose of study drug. 
Note 2: The normal range for Pulse is 45 - 100 bpm. Alert values are defined as the measured value being outside the 
normal range and the percent change from baseline being > 25%. 
  
Reference: Listings 2.8.XX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                           DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.4.3.2 
  
                                             Summary of Heart Rate (bpm) 
                                          (Population: Part 2 FAS Population) 
  
 Cancer Type :Endometrium 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.4.1.2 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Note 1: Baseline is the last value collected before the first dose of study drug. 
Note 2: The normal range for Pulse is 45 - 100 bpm. Alert values are defined as the measured value being outside the 
normal range and the percent change from baseline being > 25%. 
  
Reference: Listings 2.8.XX 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.4.4.1 
  
                                          Summary of Respiration Rate (bpm) 
                                         (Population: Part 1 FAS Population) 
  
 Dose Level (mg/kg) :Dose 1 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.4.1.1 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Note 1: Baseline is the last value collected before the first dose of study drug. 
Note 2: normal range for Respiratory Rate is 8 - 24 breaths/min. Alert values are defined as the measured value being 
outside the normal range and the percent change from baseline being > 25%. 
  
Reference: Listings 2.8.XX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                           DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.4.4.2 
  
                                          Summary of Respiration Rate (bpm) 
                                          (Population: Part 2 FAS Population) 
  
 Cancer Type :Endometrium 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.4.1.2 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Note 1: Baseline is the last value collected before the first dose of study drug. 
Note 2: normal range for Respiratory Rate is 8 - 24 breaths/min. Alert values are defined as the measured value being 
outside the normal range and the percent change from baseline being > 25%. 
  
Reference: Listings 2.8.XX 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.4.5.1 
  
                                           Summary of Body Temperature (ºC) 
                                          (Population: Part 1 FAS Population) 
  
 Dose Level (mg/kg) :Dose 1 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.4.1.1 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Note 1: Baseline is the last value collected before the first dose of study drug. 
Note 2: The normal range for Body Temperature is 35.5 - 38 C. Alert values are defined as the measured value being 
outside the normal range and the percent change from baseline being > 25%. 
  
Reference: Listings 2.8.XX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                           DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.4.5.2 
  
                                           Summary of Body Temperature (ºC) 
                                          (Population: Part 2 FAS Population) 
  
 Cancer Type :Endometrium 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.4.1.2 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Note 1: Baseline is the last value collected before the first dose of study drug. 
Note 2: The normal range for Body Temperature is 35.5 - 38 C. Alert values are defined as the measured value being 
outside the normal range and the percent change from baseline being > 25%. 
  
Reference: Listings 2.8.XX 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.4.6.1  
                                             Summary of Body Weight (kg) 
                                          (Population: Part 1 FAS Population)                                                         
                                                                                             
                                                        Descriptive Summary                    
   Dose Level                               __________________________________________  
   (mg/kg)            Visit                     N   Mean   STD     Min   Median Max    
______________________________________________________________________________________________________________________ 
     Dose 1           Baseline                 xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                       
                      Cycle 2                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
                      Cycle 3                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
                      Cycle 4                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
  
                      Cycle 5                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
                      Cycle 6                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
  
                      EOS                      xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
 ______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
Abbreviation: STD = Standard Deviation; Min = Minimum; Max = Maximum.  
Reference: Listings 2.10.1       */ 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.4.6.1  
                                             Summary of Body Weight (kg) 
                                          (Population: Part 1 FAS Population)                                                         
                                                                                             
                                                        Descriptive Summary                    
   Dose Level                               __________________________________________  
   (mg/kg)            Visit                     N   Mean   STD     Min   Median Max    
______________________________________________________________________________________________________________________ 
     Dose 2           Baseline                 xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
  
                      Cycle 2                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
                      Cycle 3                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
                      Cycle 4                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
  
                      Cycle 5                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
                      Cycle 6                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
  
                      EOS                      xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
 ______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
Abbreviation: STD = Standard Deviation; Min = Minimum; Max = Maximum.  
Reference: Listings 2.10.1       */ 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.4.6.1  
                                             Summary of Body Weight (kg) 
                                          (Population: Part 1 FAS Population)                                                         
                                                                                             
                                                        Descriptive Summary                    
   Dose Level                               __________________________________________  
   (mg/kg)            Visit                     N   Mean   STD     Min   Median Max    
______________________________________________________________________________________________________________________ 
     Dose 3           Baseline                 xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
  
                      Cycle 2                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
                      Cycle 3                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
                      Cycle 4                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
  
                      Cycle 5                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
                      Cycle 6                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
  
                      EOS                      xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
 ______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
Abbreviation: STD = Standard Deviation; Min = Minimum; Max = Maximum.  
Reference: Listings 2.10.1       */ 
 
 
 
 


Incyte Corporation 
Page 164 of 186 
INCAGN 1949-101 Statistical Analysis Plan 
05 JAN 2017 
CONFIDENTIAL 
PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.4.6.2  
                                             Summary of Body Weight (kg) 
                                          (Population: Part 2 FAS Population)                                                         
                                                                                             
                                                        Descriptive Summary                    
   Cancer Type                               __________________________________________  
                      Visit                     N   Mean   STD     Min   Median Max    
______________________________________________________________________________________________________________________ 
   Endometrium        Baseline                 xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
  
                      Cycle 2                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
                      Cycle 3                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
                      Cycle 4                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
  
                      Cycle 5                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
                      Cycle 6                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
  
                      EOS                      xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
 ______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
Abbreviation: STD = Standard Deviation; Min = Minimum; Max = Maximum.  
Reference: Listings 2.10.1       */ 
 
 
 
 


Incyte Corporation 
Page 165 of 186 
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CONFIDENTIAL 
PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.4.6.2  
                                             Summary of Body Weight (kg) 
                                          (Population: Part 2 FAS Population)                                                         
                                                                                             
                                                        Descriptive Summary                    
   Cancer Type                               __________________________________________  
                      Visit                     N   Mean   STD     Min   Median Max    
______________________________________________________________________________________________________________________ 
    Melanoma          Baseline                 xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
  
                      Cycle 2                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
                      Cycle 3                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
                      Cycle 4                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
  
                      Cycle 5                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
                      Cycle 6                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
  
                      EOS                      xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
 ______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
Abbreviation: STD = Standard Deviation; Min = Minimum; Max = Maximum.  
Reference: Listings 2.10.1       */ 
 
 
 
 


Incyte Corporation 
Page 166 of 186 
INCAGN 1949-101 Statistical Analysis Plan 
05 JAN 2017 
CONFIDENTIAL 
PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.4.6.2  
                                             Summary of Body Weight (kg) 
                                          (Population: Part 2 FAS Population)                                                         
                                                                                             
                                                        Descriptive Summary                    
   Cancer Type                               __________________________________________  
                      Visit                     N   Mean   STD     Min   Median Max    
______________________________________________________________________________________________________________________ 
      NSCLC           Baseline                 xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
  
                      Cycle 2                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
                      Cycle 3                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
                      Cycle 4                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
  
                      Cycle 5                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
                      Cycle 6                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
  
                      EOS                      xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
 ______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
Abbreviation: STD = Standard Deviation; Min = Minimum; Max = Maximum.  
Reference: Listings 2.10.1       */ 
 
 
 
 


Incyte Corporation 
Page 167 of 186 
INCAGN 1949-101 Statistical Analysis Plan 
05 JAN 2017 
CONFIDENTIAL 
PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.4.6.2  
                                             Summary of Body Weight (kg) 
                                          (Population: Part 2 FAS Population)                                                         
                                                                                             
                                                        Descriptive Summary                    
   Cancer Type                               __________________________________________  
                      Visit                     N   Mean   STD     Min   Median Max    
______________________________________________________________________________________________________________________ 
    Ovarian           Baseline                 xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
  
                      Cycle 2                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
                      Cycle 3                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
                      Cycle 4                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
  
                      Cycle 5                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
                      Cycle 6                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
  
                      EOS                      xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
 ______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
Abbreviation: STD = Standard Deviation; Min = Minimum; Max = Maximum.  
Reference: Listings 2.10.1       */ 
 
 
 
 


Incyte Corporation 
Page 168 of 186 
INCAGN 1949-101 Statistical Analysis Plan 
05 JAN 2017 
CONFIDENTIAL 
PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.4.6.2  
                                             Summary of Body Weight (kg) 
                                          (Population: Part 2 FAS Population)                                                         
                                                                                             
                                                        Descriptive Summary                    
   Cancer Type                               __________________________________________  
                      Visit                     N   Mean   STD     Min   Median Max    
______________________________________________________________________________________________________________________ 
       RCC            Baseline                 xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
  
                      Cycle 2                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
                      Cycle 3                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
                      Cycle 4                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
  
                      Cycle 5                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
                      Cycle 6                  xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
  
                      EOS                      xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      Change from Baseline     xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx 
                      % Change from Baseline   xxx x.xxxx x.xxxxx x.xxx x.xxxx x.xxx  
 
 ______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
Abbreviation: STD = Standard Deviation; Min = Minimum; Max = Maximum.  
Reference: Listings 2.10.1       */ 
 


Incyte Corporation 
Page 169 of 186 
INCAGN 1949-101 Statistical Analysis Plan 
05 JAN 2017 
CONFIDENTIAL 
PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.5.1.1 
  
                                  Summary of PR Interval (msec) from Central Lab 12-Lead ECG 
                                          (Population: Part 1 FAS Population) 
  
 Dose Level (mg/kg) : Dose 1 
  
    ________________________________________________________________________________________________________________ 
                                                Descriptive Summary             Low     Normal     High      Alert 
                                        ____________________________________ _________ _________ _________ _________ 
    Study Visit            Variable     N     Mean  STD   Min   Median Max    N   %     N   %     N   %     N   % 
    ________________________________________________________________________________________________________________ 
    Baseline               Baseline     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
    Week xx                Measured     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           Change       xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           % Change     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
    Week xx                Measured     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           Change       xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           % Change     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Note 1: Baseline definition is from SAP. 
Note 2: The normal range for PR is 75 - 220 mm/Hg. 
        Alert values are defined as the measured value being outside the normal range and the percent change from 
        Baseline being > 25%. 
Abbreviation: STD = Standard Deviation; Min = Minimum; Max = Maximum.   
Reference: Listings 2.9.4 
 
 
 
 
 
 
 
 
 
 
 


Incyte Corporation 
Page 170 of 186 
INCAGN 1949-101 Statistical Analysis Plan 
05 JAN 2017 
CONFIDENTIAL 
PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                           DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.5.1.2 
  
                              Summary of PR Interval (msec) from Central Lab 12-Lead ECG 
                                          (Population: Part 2 FAS Population) 
  
 Cancer Type : Endometrium 
  
    ________________________________________________________________________________________________________________ 
                                                Descriptive Summary             Low     Normal     High      Alert 
                                        ____________________________________ _________ _________ _________ _________ 
    Study Visit            Variable     N     Mean  STD   Min   Median Max    N   %     N   %     N   %     N   % 
    ________________________________________________________________________________________________________________ 
    Baseline               Baseline     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
    Week xx                Measured     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           Change       xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           % Change     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
    Week xx                Measured     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           Change       xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           % Change     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Note 1: Baseline definition is from SAP. 
Note 2: The normal range for PR is 75 - 220 mm/Hg. 
        Alert values are defined as the measured value being outside the normal range and the percent change from 
        Baseline being > 25%. 
Abbreviation: STD = Standard Deviation; Min = Minimum; Max = Maximum.   
Reference: Listings 2.9.4 
 
 


Incyte Corporation 
Page 171 of 186 
INCAGN 1949-101 Statistical Analysis Plan 
05 JAN 2017 
CONFIDENTIAL 
PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                              Table 3.5.2.1 
  
                             Summary of RR Interval (msec) from Central Lab 12-Lead ECG 
                                    (Population: Part 1 FAS Population) 
  
 Dose Level (mg/kg) : Dose 1 
  
    ________________________________________________________________________________________________________________ 
                                                Descriptive Summary             Low     Normal     High      Alert 
                                        ____________________________________ _________ _________ _________ _________ 
    Study Visit            Variable     N     Mean  STD   Min   Median Max    N   %     N   %     N   %     N   % 
    ________________________________________________________________________________________________________________ 
    Baseline               Baseline     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
    Week xx                Measured     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           Change       xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           % Change     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
    Week xx                Measured     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           Change       xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           % Change     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Note 1: Baseline is the average of all measurements collected before the first dose of study drug. 
Note 2: The normal range for RR is 600 - 1330 mm/Hg. 
        Alert values are defined as the measured value being outside the normal range and the percent change from 
        Baseline being > 25%. 
Abbreviation: STD = Standard Deviation; Min = Minimum; Max = Maximum.   
Reference: Listings 2.9.4 
 
 
 
 
 
 
 
 
 
 
 


Incyte Corporation 
Page 172 of 186 
INCAGN 1949-101 Statistical Analysis Plan 
05 JAN 2017 
CONFIDENTIAL 
PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                           DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.5.2.2 
  
                                  Summary of RR Interval (msec) from Central Lab 12-Lead ECG 
                                           (Population: Part 2 FAS Population) 
  
 Cancer Type : Endometrium 
  
    ________________________________________________________________________________________________________________ 
                                                Descriptive Summary             Low     Normal     High      Alert 
                                        ____________________________________ _________ _________ _________ _________ 
    Study Visit            Variable     N     Mean  STD   Min   Median Max    N   %     N   %     N   %     N   % 
    ________________________________________________________________________________________________________________ 
    Baseline               Baseline     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
    Week xx                Measured     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           Change       xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           % Change     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
    Week xx                Measured     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           Change       xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           % Change     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Note 1: Baseline is the average of all measurements collected before the first dose of study drug. 
Note 2: The normal range for RR is 600 - 1330 mm/Hg. 
        Alert values are defined as the measured value being outside the normal range and the percent change from 
        Baseline being > 25%. 
Abbreviation: STD = Standard Deviation; Min = Minimum; Max = Maximum.   
Reference: Listings 2.9.4 
 
 


Incyte Corporation 
Page 173 of 186 
INCAGN 1949-101 Statistical Analysis Plan 
05 JAN 2017 
CONFIDENTIAL 
PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.5.3.1 
  
                              Summary of QT Interval (msec) from Central Lab 12-Lead ECG 
                                          (Population: Part 1 FAS Population) 
  
 Dose Level (mg/kg) : Dose 1 
  
    ________________________________________________________________________________________________________________ 
                                                Descriptive Summary             Low     Normal     High      Alert 
                                        ____________________________________ _________ _________ _________ _________ 
    Study Visit            Variable     N     Mean  STD   Min   Median Max    N   %     N   %     N   %     N   % 
    ________________________________________________________________________________________________________________ 
    Baseline               Baseline     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
    Week xx                Measured     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           Change       xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           % Change     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
    Week xx                Measured     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           Change       xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           % Change     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Note 1: Baseline is the average of all measurements collected before the first dose of study drug. 
Note 2: The normal range for QT is 300 - 500 mm/Hg. 
        Alert values are defined as the measured value being outside the normal range and the percent change from 
        Baseline being > 25%. 
Abbreviation: STD = Standard Deviation; Min = Minimum; Max = Maximum.   
Reference: Listings 2.9.4 
 
 
 
 
 
 
 
 
 
 
 


Incyte Corporation 
Page 174 of 186 
INCAGN 1949-101 Statistical Analysis Plan 
05 JAN 2017 
CONFIDENTIAL 
PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                           DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.5.3.2 
  
                                Summary of QT Interval (msec) from Central Lab 12-Lead ECG 
                                           (Population: Part 2 FAS Population) 
  
 Cancer Type : Endometrium 
  
    ________________________________________________________________________________________________________________ 
                                                Descriptive Summary             Low     Normal     High      Alert 
                                        ____________________________________ _________ _________ _________ _________ 
    Study Visit            Variable     N     Mean  STD   Min   Median Max    N   %     N   %     N   %     N   % 
    ________________________________________________________________________________________________________________ 
    Baseline               Baseline     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
    Week xx                Measured     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           Change       xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           % Change     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
    Week xx                Measured     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           Change       xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           % Change     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Note 1: Baseline is the average of all measurements collected before the first dose of study drug. 
Note 2: The normal range for QT is 300 - 500 mm/Hg. 
        Alert values are defined as the measured value being outside the normal range and the percent change from 
        Baseline being > 25%. 
Abbreviation: STD = Standard Deviation; Min = Minimum; Max = Maximum.   
Reference: Listings 2.9.4 
 
 


Incyte Corporation 
Page 175 of 186 
INCAGN 1949-101 Statistical Analysis Plan 
05 JAN 2017 
CONFIDENTIAL 
PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.5.4.1 
  
                               Summary of QRS Interval (msec) from Central Lab 12-Lead ECG 
                                          (Population: Part 1 FAS Population) 
  
 Dose Level (mg/kg): Dose 1 
  
    ________________________________________________________________________________________________________________ 
                                                Descriptive Summary             Low     Normal     High      Alert 
                                        ____________________________________ _________ _________ _________ _________ 
    Study Visit            Variable     N     Mean  STD   Min   Median Max    N   %     N   %     N   %     N   % 
    ________________________________________________________________________________________________________________ 
    Baseline               Baseline     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
    Week xx                Measured     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           Change       xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           % Change     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
    Week xx                Measured     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           Change       xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           % Change     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Note 1: Baseline is the average of all measurements collected before the first dose of study drug. 
Note 2: The normal range for QRS is 50 - 120 mm/Hg. 
        Alert values are defined as the measured value being outside the normal range and the percent change from 
        Baseline being > 25%. 
Abbreviation: STD = Standard Deviation; Min = Minimum; Max = Maximum.   
Reference: Listings 2.9.4 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                           DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.5.4.2 
  
                                 Summary of QRS Interval (msec) from Central Lab 12-Lead ECG 
                                          (Population: Part 2 FAS Population) 
  
 Cancer Type : Endometrium 
  
    ________________________________________________________________________________________________________________ 
                                                Descriptive Summary             Low     Normal     High      Alert 
                                        ____________________________________ _________ _________ _________ _________ 
    Study Visit            Variable     N     Mean  STD   Min   Median Max    N   %     N   %     N   %     N   % 
    ________________________________________________________________________________________________________________ 
    Baseline               Baseline     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
    Week xx                Measured     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           Change       xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           % Change     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
    Week xx                Measured     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           Change       xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           % Change     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Note 1: Baseline is the average of all measurements collected before the first dose of study drug. 
Note 2: The normal range for QRS is 50 - 120 mm/Hg. 
        Alert values are defined as the measured value being outside the normal range and the percent change from 
        Baseline being > 25%. 
Abbreviation: STD = Standard Deviation; Min = Minimum; Max = Maximum.   
Reference: Listings 2.9.4 
 
 


Incyte Corporation 
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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.5.5.1 
  
                              Summary of QTcF Interval (msec) from Central Lab 12-Lead ECG 
                                          (Population: Part 1 FAS Population) 
  
 Dose Level (mg/kg) : Dose 1 
  
    ________________________________________________________________________________________________________________ 
                                                Descriptive Summary             Low     Normal     High      Alert 
                                        ____________________________________ _________ _________ _________ _________ 
    Study Visit            Variable     N     Mean  STD   Min   Median Max    N   %     N   %     N   %     N   % 
    ________________________________________________________________________________________________________________ 
    Baseline               Baseline     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
    Week xx                Measured     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           Change       xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           % Change     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
    Week xx                Measured     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           Change       xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           % Change     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Note 1: Baseline is the average of all measurements collected before the first dose of study drug. 
Note 2: The normal range for QTcF is 295 - 460 mm/Hg. 
        Alert values are defined as the measured value being outside the normal range and the percent change from 
        Baseline being > 25%. 
Abbreviation: STD = Standard Deviation; Min = Minimum; Max = Maximum.   
Reference: Listings 2.9.4 
 
 
 
 
 
 
 
 
 
 
 


Incyte Corporation 
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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                           DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.5.5.2 
  
                                 Summary of QTcF Interval (msec) from Central Lab 12-Lead ECG 
                                          (Population: Part 2 FAS Population) 
  
 Cancer Type : Endometrium 
  
    ________________________________________________________________________________________________________________ 
                                                Descriptive Summary             Low     Normal     High      Alert 
                                        ____________________________________ _________ _________ _________ _________ 
    Study Visit            Variable     N     Mean  STD   Min   Median Max    N   %     N   %     N   %     N   % 
    ________________________________________________________________________________________________________________ 
    Baseline               Baseline     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
    Week xx                Measured     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           Change       xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           % Change     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
    Week xx                Measured     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           Change       xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           % Change     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Note 1: Baseline is the average of all measurements collected before the first dose of study drug. 
Note 2: The normal range for QTcF is 295 - 460 mm/Hg. 
        Alert values are defined as the measured value being outside the normal range and the percent change from 
        Baseline being > 25%. 
Abbreviation: STD = Standard Deviation; Min = Minimum; Max = Maximum.   
Reference: Listings 2.9.4 
 
 


Incyte Corporation 
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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.5.6.1 
  
                              Summary of JTc Interval (msec) from Central Lab 12-Lead ECG 
                                          (Population: Part 1 FAS Population) 
  
 Dose Level (mg/kg) : Dose 1 
  
    ________________________________________________________________________________________________________________ 
                                                Descriptive Summary             Low     Normal     High      Alert 
                                        ____________________________________ _________ _________ _________ _________ 
    Study Visit            Variable     N     Mean  STD   Min   Median Max    N   %     N   %     N   %     N   % 
    ________________________________________________________________________________________________________________ 
    Baseline               Baseline     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
    Week xx                Measured     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           Change       xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           % Change     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
    Week xx                Measured     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           Change       xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           % Change     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Note 1: Baseline is the average of all measurements collected before the first dose of study drug. 
Note 2: Alert values are defined as the measured value being outside the normal range and the percent change from 
        Baseline being > 25%. 
Abbreviation: STD = Standard Deviation; Min = Minimum; Max = Maximum.   
Reference: Listings 2.9.4 
 
 
 
 
 
 
 
 
 
 
 
 


Incyte Corporation 
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CONFIDENTIAL 
PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                           DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.5.6.2 
  
                               Summary of JTc Interval (msec) from Central Lab 12-Lead ECG 
                                          (Population: Part 2 FAS Population) 
  
 Cancer Type : Endometrium 
  
    ________________________________________________________________________________________________________________ 
                                                Descriptive Summary             Low     Normal     High      Alert 
                                        ____________________________________ _________ _________ _________ _________ 
    Study Visit            Variable     N     Mean  STD   Min   Median Max    N   %     N   %     N   %     N   % 
    ________________________________________________________________________________________________________________ 
    Baseline               Baseline     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
    Week xx                Measured     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           Change       xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           % Change     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
    Week xx                Measured     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           Change       xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           % Change     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Note 1: Baseline is the average of all measurements collected before the first dose of study drug. 
Note 2: Alert values are defined as the measured value being outside the normal range and the percent change from 
        Baseline being > 25%. 
Abbreviation: STD = Standard Deviation; Min = Minimum; Max = Maximum.   
Reference: Listings 2.9.4 
 


Incyte Corporation 
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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.5.7.1 
  
                           Summary of HR Interval (msec) from Central Lab 12-Lead ECG 
                                          (Population: Part 1 FAS Population) 
  
 Dose Level (mg/kg) : Dose 1 
  
    ________________________________________________________________________________________________________________ 
                                                Descriptive Summary             Low     Normal     High      Alert 
                                        ____________________________________ _________ _________ _________ _________ 
    Study Visit            Variable     N     Mean  STD   Min   Median Max    N   %     N   %     N   %     N   % 
    ________________________________________________________________________________________________________________ 
    Baseline               Baseline     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
    Week xx                Measured     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           Change       xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           % Change     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
    Week xx                Measured     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           Change       xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           % Change     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Note 1: Baseline is the average of all measurements collected before the first dose of study drug. 
Note 2: The normal range for HR is 40 - 100 mm/Hg. 
        Alert values are defined as the measured value being outside the normal range and the percent change from 
        Baseline being > 25%. 
Abbreviation: STD = Standard Deviation; Min = Minimum; Max = Maximum.   
Reference: Listings 2.9.4 
 
 
 
 
 
 
 
 
 
 
 


Incyte Corporation 
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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                           DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.5.7.2 
  
                            Summary of HR Interval (msec) from Central Lab 12-Lead ECG 
                                          (Population: Part 2 FAS Population) 
  
 Cancer Type : Endometrium 
  
    ________________________________________________________________________________________________________________ 
                                                Descriptive Summary             Low     Normal     High      Alert 
                                        ____________________________________ _________ _________ _________ _________ 
    Study Visit            Variable     N     Mean  STD   Min   Median Max    N   %     N   %     N   %     N   % 
    ________________________________________________________________________________________________________________ 
    Baseline               Baseline     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
    Week xx                Measured     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           Change       xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           % Change     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
    Week xx                Measured     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           Change       xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
                           % Change     xxx   xxx.x xxx.x xxx.x xxx.x  xxx.x xxx xx.x  xxx xx.x  xxx xx.x  xxx xx.x 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Note 1: Baseline is the average of all measurements collected before the first dose of study drug. 
Note 2: The normal range for HR is 40 - 100 mm/Hg. 
        Alert values are defined as the measured value being outside the normal range and the percent change from 
        Baseline being > 25%. 
Abbreviation: STD = Standard Deviation; Min = Minimum; Max = Maximum.   
Reference: Listings 2.9.4 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                               DATABASE VERSION: XXXXX 
TLF VERSION: Draft 
                                                    Table 3.5.8.1 
  
                Summary of Outliers of QT, RR and QTcF Interval Values from Central Lab 12-Lead ECG by Visit 
                                          (Population: Part 1 FAS Population) 
  
  Dose Level (mg/kg) : Dose 1 
  
     _______________________________________________________________________________________________________________ 
                                                                                         Number (%) of Subjects 
                                                                                    ________________________________ 
     Dose Level                                                                         QT        QTcB       QTcF 
     (mg/kg)          Study Visit                      Variable                        (ms)       (ms)       (ms) 
     _______________________________________________________________________________________________________________ 
     Dose 1             Baseline                       Number of Subjects              xxx        xxx        xxx 
                                                       Measured Value>=450 ms       xx(xxx.x)  xx(xxx.x)  xx(xxx.x) 
                                                       Measured Value>=480 ms       xx(xxx.x)  xx(xxx.x)  xx(xxx.x) 
                                                       Measured Value>=500 ms       xx(xxx.x)  xx(xxx.x)  xx(xxx.x) 
  
                        Week xx                        Number of Subjects              xxx        xxx        xxx 
                                                       Measured Value>=450 ms       xx(xxx.x)  xx(xxx.x)  xx(xxx.x) 
                                                       Measured Value>=480 ms       xx(xxx.x)  xx(xxx.x)  xx(xxx.x) 
                                                       Measured Value>=500 ms       xx(xxx.x)  xx(xxx.x)  xx(xxx.x) 
                                                       Change From Baseline>=30 ms  xx(xxx.x)  xx(xxx.x)  xx(xxx.x) 
                                                       Change From Baseline>=60 ms  xx(xxx.x)  xx(xxx.x)  xx(xxx.x) 
  
                        At any time during the study   Number of Subjects              xxx        xxx        xxx 
                                                       Measured Value>=450 ms       xx(xxx.x)  xx(xxx.x)  xx(xxx.x) 
                                                       Measured Value>=480 ms       xx(xxx.x)  xx(xxx.x)  xx(xxx.x) 
                                                       Measured Value>=500 ms       xx(xxx.x)  xx(xxx.x)  xx(xxx.x) 
                                                       Change From Baseline>=30 ms  xx(xxx.x)  xx(xxx.x)  xx(xxx.x) 
                                                       Change From Baseline>=60 ms  xx(xxx.x)  xx(xxx.x)  xx(xxx.x) 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Note 1: Baseline is the average of all measurements collected before the first dose of study drug. 
  
  
Reference: Listings 2.9.4 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                           DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                    Table 3.5.8.2 
  
                Summary of Outliers of QT, RR and QTcF Interval Values from Central Lab 12-Lead ECG by Visit 
                                          (Population: Part 2 FAS Population) 
  
  Cancer Type : Endometrium 
  
     _______________________________________________________________________________________________________________ 
                                                                                         Number (%) of Subjects 
                                                                                    ________________________________ 
                                                                                        QT        QTcB       QTcF 
     Cancer Type      Study Visit                      Variable                        (ms)       (ms)       (ms) 
     _______________________________________________________________________________________________________________ 
     Endometrium        Baseline                       Number of Subjects              xxx        xxx        xxx 
                                                       Measured Value>=450 ms       xx(xxx.x)  xx(xxx.x)  xx(xxx.x) 
                                                       Measured Value>=480 ms       xx(xxx.x)  xx(xxx.x)  xx(xxx.x) 
                                                       Measured Value>=500 ms       xx(xxx.x)  xx(xxx.x)  xx(xxx.x) 
  
                        Week xx                        Number of Subjects              xxx        xxx        xxx 
                                                       Measured Value>=450 ms       xx(xxx.x)  xx(xxx.x)  xx(xxx.x) 
                                                       Measured Value>=480 ms       xx(xxx.x)  xx(xxx.x)  xx(xxx.x) 
                                                       Measured Value>=500 ms       xx(xxx.x)  xx(xxx.x)  xx(xxx.x) 
                                                       Change From Baseline>=30 ms  xx(xxx.x)  xx(xxx.x)  xx(xxx.x) 
                                                       Change From Baseline>=60 ms  xx(xxx.x)  xx(xxx.x)  xx(xxx.x) 
  
                        At any time during the study   Number of Subjects              xxx        xxx        xxx 
                                                       Measured Value>=450 ms       xx(xxx.x)  xx(xxx.x)  xx(xxx.x) 
                                                       Measured Value>=480 ms       xx(xxx.x)  xx(xxx.x)  xx(xxx.x) 
                                                       Measured Value>=500 ms       xx(xxx.x)  xx(xxx.x)  xx(xxx.x) 
                                                       Change From Baseline>=30 ms  xx(xxx.x)  xx(xxx.x)  xx(xxx.x) 
                                                       Change From Baseline>=60 ms  xx(xxx.x)  xx(xxx.x)  xx(xxx.x) 
  
______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                       DATE(TIME): MMDDYYYY(hh:mm) 
  
Note 1: Baseline is the average of all measurements collected before the first dose of study drug. 
  
  
Reference: Listings 2.9.4 
 
 
 


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PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                   DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
                                                                                                                             TABLE 3.6.1 
 
 
(Population: 
Evaluable Population) 
Test (Unit): PD Marker (Unit) 
_______________________________________________________________________________________________________________________ 
                                   Descriptive Summary                          N (%) of Subjects [1] 
                               ____________________________________________  __________________________________________  
Visit                           N    Mean     STD     Min  Median     Max       Below LLOQ   Within LOQ   Above ULOQ 
_______________________________________________________________________________________________________________________ 
Baseline          Measured     ###  ##.##   ##.##    ##.#  ##.##     ##.#       ### (###.#)  ### (###.#)   ### (###.#) 
 
Cycle 2           Measured     ###  ##.##   ##.##    ##.#  ##.##     ##.#       ### (###.#)  ### (###.#)   ### (###.#) 
                  Change       ###  ##.##   ##.##    ##.#  ##.##     ##.#            
                  % Change     ###  ##.##   ##.##    ##.#  ##.##     ##.#       
 
Cycle 3           Measured     ###  ##.##   ##.##    ##.#  ##.##     ##.#       ### (###.#)  ### (###.#)   ### (###.#) 
                  Change       ###  ##.##   ##.##    ##.#  ##.##     ##.#            
                  % Change     ###  ##.##   ##.##    ##.#  ##.##     ##.#       
 
Cycle 4           Measured     ###  ##.##   ##.##    ##.#  ##.##     ##.#       ### (###.#)  ### (###.#)   ### (###.#) 
                  Change       ###  ##.##   ##.##    ##.#  ##.##     ##.#            
                  % Change     ###  ##.##   ##.##    ##.#  ##.##     ##.#       
 
Cycle 5           Measured     ###  ##.##   ##.##    ##.#  ##.##     ##.#       ### (###.#)  ### (###.#)   ### (###.#) 
                  Change       ###  ##.##   ##.##    ##.#  ##.##     ##.#            
                  % Change     ###  ##.##   ##.##    ##.#  ##.##     ##.#       
 
Cycle 6           Measured     ###  ##.##   ##.##    ##.#  ##.##     ##.#       ### (###.#)  ### (###.#)   ### (###.#) 
                  Change       ###  ##.##   ##.##    ##.#  ##.##     ##.#            
                  % Change     ###  ##.##   ##.##    ##.#  ##.##     ##.#       
 
_______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                                                           
DATE(TIME): MMDDYYYY(hh:mm) 
Note:For descriptive summaries, subject study visits with analysis values outside of the limits of quantification used 
     ½ of the LLOQ if below the LLOQ or the ULOQ if above the LLOQ for calculations. 
[1] LLOQ = Lower Limit of Quantification.   LOQ  = Limit of Quantification.   ULOQ = Upper Limit of Quantification. 
 
Abbreviations: Min = Minimum; Max = Maximum; STD = standard deviation. 
 
Reference: Listing x.x.x 


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CONFIDENTIAL 
PROTOCOL: INCAGN 1949-101                                                                                 (Page n of N) 
DRUG/INDICATION: OX40/Advanced or Metastatic Solid Tumors                                   DATABASE VERSION: XXXXX2016 
TLF VERSION: Draft 
 
                                                                                                                             TABLE 3.6.2 
(Population:
Evaluable Population) 
 
Test (Unit):
 (Unit) 
_____________
_________________________________________________________________________________________________ 
Test (Unit)             Visit         Percent Change From Baseline               Dose 1         Dose 2        Dose 3 
_________________________________________________________________________________(N=xx)_________(N=xx) ______ (N=xx)___ 
 (Unit)        Cycle 2        Subjects with Both Results               ### (###.#)   ### (###.#)   ### (###.#)               
                                       Subjects with >50% reduction             ### (###.#)   ### (###.#)   ### (###.#)          
                                       Subjects with >25% reduction             ### (###.#)   ### (###.#)   ### (###.#) 
                                       Subjects with >10% reduction             ### (###.#)   ### (###.#)   ### (###.#) 
                                       Subjects with >0% reduction              ### (###.#)   ### (###.#)   ### (###.#) 
                                       Subjects with >0% increase               ### (###.#)   ### (###.#)   ### (###.#) 
                                       Subjects with >10% increase              ### (###.#)   ### (###.#)   ### (###.#) 
                                       Subjects with >25% increase              ### (###.#)   ### (###.#)   ### (###.#) 
                                       Subjects with >50% increase              ### (###.#)   ### (###.#)   ### (###.#) 
 
                        Cycle 3        Subjects with Both Results               ### (###.#)   ### (###.#)   ### (###.#)               
                                       Subjects with >50% reduction             ### (###.#)   ### (###.#)   ### (###.#)          
                                       Subjects with >25% reduction             ### (###.#)   ### (###.#)   ### (###.#) 
                                       Subjects with >10% reduction             ### (###.#)   ### (###.#)   ### (###.#) 
                                       Subjects with >0% reduction              ### (###.#)   ### (###.#)   ### (###.#) 
                                       Subjects with >0% increase               ### (###.#)   ### (###.#)   ### (###.#) 
                                       Subjects with >10% increase              ### (###.#)   ### (###.#)   ### (###.#) 
                                       Subjects with >25% increase              ### (###.#)   ### (###.#)   ### (###.#) 
                                       Subjects with >50% increase              ### (###.#)   ### (###.#)   ### (###.#) 
 
_______________________________________________________________________________________________________________________ 
FOLDER\PROGRAM\OUTPUT: XXXXXX\XXXXXX.SAS\XXXXXX.LST                                                                           
DATE(TIME): MMDDYYYY(hh:mm) 
Reference: Listing 2.## 


Signature Manifest
Document Number: IC-STS-SAP-0080
Revision: 0
Title: INCAGN 1949-101 SAP Original
All dates and times are in Eastern Standard Time.
INCAGN 1949-101 SAP Review
Approval
Name/Signature
Title
Date
Meaning/Reason
05 Jan 2017, 04:11:26 PM
Approved
 
06 Jan 2017, 09:04:50 AM
Approved
09 Jan 2017, 09:53:57 AM
Approved
 
16 Jan 2017, 07:03:09 PM
Approved
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Signature Manifest
1/16/2017