Clinical trial NCT03679767
Conditions: Metastatic Non-small Cell Lung Cancer Locally Advanced Urothelial Cancer Metastatic Urothelial Cancer Unresectable Melanoma Metastatic Melanoma Locally Advanced Renal Cell Carcinoma Metastatic Clear-Cell Renal Cell Carcinoma
Keywords: PD-1inhibitor non-small cell lung cancer urothelial cancer melanoma renal cell carcinoma
Sponsor: Incyte Corporation
Start date: 2019-01-09; Completion date: 2022-06-28
Enrollment: 121 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with advanced solid tumors where the efficacy of PD-1 inhibitors has previously been established.

Detailed description:

Arms: arm 1: Participants with melanoma received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle. arm 2: Participants with non-small cell lung cancer (NSCLC) received retifanlimab 500 mg Q4W, administered by IV infusion over 30 minutes on Day 1 of each 28-day cycle. arm 3: Participants with urethelial carcinoma (UC) received retifanlimab 500 mg Q4W, administered by IV infusion over 30 minutes on Day 1 of each 28-day cycle. arm 4: Participants with renal cell carcinoma (RCC) received retifanlimab 500 mg Q4W, administered by IV infusion over 30 minutes on Day 1 of each 28-day cycle.
Interventions: intervention 1: Retifanlimab
Intervention descriptions: intervention 1: Retifanlimab administered intravenously at 500 mg every 4 weeks

Protocol documents:
Prot_000.pdf: 
Official Title: 
A Phase 2 Study of INCMGA00012 (PD-1 Inhibitor) in Participants With 
Selected Solid Tumors (POD1UM-203) 
NCT Number: 
NCT03679767 
Document Date: 
Clinical Study Protocol Amendment 5: 23 Jun 2021 


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Protocol INCMGA 0012-203 Am 5 
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Clinical Study Protocol 
 
TITLE PAGE 
INCMGA 0012-203 
A Phase 2 Study of INCMGA00012 (PD-1 Inhibitor) in Participants 
With Selected Solid Tumors (POD1UM-203) 
 
 
Product: 
INCMGA00012 
IND Number: 
130952 
EudraCT Number: 
2018-002941-12 
Phase of Study: 
2 
Sponsor: 
Incyte Corporation 
1801 Augustine Cut-Off 
Wilmington, DE 19803 
Original Protocol (Version 0): 
05 SEP 2018 
Amendment (Version) 1: 
17 JAN 2019 
Amendment (Version) 1-FR: 
11 JUN 2019 
Amendment (Version) 2: 
09 AUG 2019 
Amendment (Version) 3: 
10 DEC 2019 
Amendment (Version) 4: 
25 NOV 2020 
Amendment (Version) 5: 
23 JUN 2021 
 
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, applicable Good Clinical Practices, and applicable laws 
and country-specific regulations in which the study is being conducted. 
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 prior 
written consent. 


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INVESTIGATOR'S AGREEMENT 
I have read the INCMGA 0012-203 Protocol Amendment 5 (Version 5 dated 23 JUN 2021) 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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TABLE OF CONTENTS 
TITLE PAGE ...................................................................................................................................1 
INVESTIGATOR'S AGREEMENT ................................................................................................2 
TABLE OF CONTENTS .................................................................................................................3 
LIST OF ABBREVIATIONS ..........................................................................................................8 
1. 
PROTOCOL SUMMARY ..........................................................................................11 
2. 
INTRODUCTION ......................................................................................................16 
2.1. 
Background .................................................................................................................16 
2.1.1. 
INCMGA00012 ..........................................................................................................16 
2.2. 
Rationale for Study Design .........................................................................................17 
2.2.1. 
Population ...................................................................................................................17 
2.2.2. 
Dose and Schedule ......................................................................................................18 
2.3. 
Benefit/Risk Assessment ............................................................................................19 
3. 
OBJECTIVES AND ENDPOINTS ............................................................................20 
4. 
STUDY DESIGN .......................................................................................................21 
4.1. 
Overall Design ............................................................................................................21 
4.2. 
Overall Study Duration ...............................................................................................22 
4.3. 
Study Termination ......................................................................................................22 
5. 
STUDY POPULATION .............................................................................................23 
5.1. 
Inclusion Criteria ........................................................................................................23 
5.2. 
Exclusion Criteria .......................................................................................................24 
5.3. 
Lifestyle Considerations .............................................................................................26 
5.4. 
Screen Failures ............................................................................................................26 
5.5. 
Replacement of Participants .......................................................................................26 
6. 
STUDY TREATMENT ..............................................................................................27 
6.1. 
Study Treatments Administered .................................................................................27 
6.2. 
Preparation, Handling, and Accountability ................................................................27 
6.3. 
Measures to Minimize Bias:  Randomization and Blinding .......................................28 
6.4. 
Study Treatment Compliance .....................................................................................28 
6.5. 
Dose Modifications .....................................................................................................28 
6.5.1. 
Management of Suspected Infusion Reactions ...........................................................28 
6.5.2. 
Management of Suspected Immune-Related Adverse Events ....................................30 


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6.5.3. 
Permanent Discontinuation of Study Drug Due to Toxicity ......................................34 
6.6. 
Concomitant Medications and Procedures .................................................................34 
6.6.1. 
Permitted Medications and Procedures ......................................................................35 
6.6.2. 
Prohibited Medications and Procedures .....................................................................35 
6.7. 
Treatment After the End of the Study .........................................................................35 
7. 
DISCONTINUATION OF STUDY TREATMENT AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL ..................................................................35 
7.1. 
Discontinuation of Study Drug ...................................................................................35 
7.1.1. 
Reasons for Discontinuation .......................................................................................35 
7.1.2. 
Discontinuation Procedures ........................................................................................36 
7.2. 
Participant Withdrawal From the Study .....................................................................37 
7.3. 
Lost to Follow-Up .......................................................................................................37 
8. 
STUDY ASSESSMENTS AND PROCEDURES ......................................................37 
8.1. 
Administrative and General Procedures .....................................................................37 
8.1.1. 
Informed Consent Process ..........................................................................................37 
8.1.2. 
Screening Procedures ..................................................................................................38 
8.1.3. 
Interactive Response Technology Procedure ..............................................................38 
8.1.4. 
Distribution of Reminder Cards ..................................................................................38 
8.1.5. 
Demography and Medical History ..............................................................................39 
8.1.5.1. 
Demographics and General Medical History .............................................................39 
8.1.5.2. 
Disease Characteristics and Treatment History ..........................................................39 
8.2. 
Efficacy Assessments .................................................................................................39 
8.2.1. 
Tumor Imaging ...........................................................................................................39 
8.2.2. 
iRECIST .....................................................................................................................40 
8.2.3. 
Health Economics .......................................................................................................40 
8.3. 
Safety Assessments .....................................................................................................40 
8.3.1. 
Adverse Events ...........................................................................................................40 
8.3.2. 
Physical Examinations ................................................................................................41 
8.3.3. 
Vital Signs ..................................................................................................................41 
8.3.4. 
ECOG Performance Status .........................................................................................42 
8.3.5. 
Electrocardiograms .....................................................................................................42 
8.3.6. 
Laboratory Assessments .............................................................................................42 
8.3.6.1. 
Pregnancy Testing ......................................................................................................43 


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8.4. 
Pharmacokinetic Assessments ....................................................................................45 
8.5. 
Pharmacodynamic 
 Assessments ....................................................45 
8.5.1. 
Description of Analyses ..............................................................................................45 
 
45 
 
45 
8.6. 
Unscheduled Visits .....................................................................................................46 
8.7. 
End of Treatment and/or Early Termination ..............................................................46 
8.8. 
Follow-Up ...................................................................................................................46 
8.8.1. 
Safety Follow-Up ........................................................................................................46 
9. 
ADVERSE EVENTS:  DEFINITIONS AND PROCEDURES FOR 
RECORDING, EVALUATING, FOLLOW-UP, AND REPORTING ......................47 
9.1. 
Definition of Adverse Event .......................................................................................47 
9.2. 
Definition of Serious Adverse Event ..........................................................................48 
9.3. 
Recording and Follow-Up of Adverse Events and/or Serious Adverse Events .........49 
9.4. 
Reporting of Serious Adverse Events .........................................................................51 
9.5. 
Adverse Events of Special Interest .............................................................................52 
9.6. 
Emergency Unblinding of Treatment Assignment .....................................................52 
9.7. 
Pregnancy ...................................................................................................................53 
9.8. 
Warnings and Precautions ..........................................................................................53 
9.9. 
Product Complaints ....................................................................................................53 
10. 
STATISTICS ..............................................................................................................54 
10.1. 
Sample Size Determination ........................................................................................54 
10.2. 
Populations for Analysis .............................................................................................54 
10.3. 
Level of Significance ..................................................................................................55 
10.4. 
Statistical Analyses .....................................................................................................55 
10.4.1. 
Primary Analysis ........................................................................................................55 
10.4.1.1. 
Overall Response Rate ................................................................................................55 
10.4.1.2. 
Handling of Missing Data in Primary Analysis ..........................................................55 
10.4.2. 
Secondary Analysis ....................................................................................................56 
10.4.2.1. 
Duration of Response .................................................................................................56 
10.4.2.2. 
Disease Control Rate ..................................................................................................56 
10.4.2.3. 
Progression-Free Survival ..........................................................................................56 
10.4.2.4. 
Overall Survival ..........................................................................................................56 


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10.4.3. 
Safety Analyses ..........................................................................................................56 
10.4.3.1. 
Adverse Events ...........................................................................................................56 
10.4.3.2. 
Clinical Laboratory Tests ...........................................................................................56 
10.4.3.3. 
Vital Signs ..................................................................................................................57 
10.4.3.4. 
Electrocardiograms .....................................................................................................57 
10.4.3.5. 
Dose Intensity .............................................................................................................57 
10.4.4. 
Pharmacokinetics ........................................................................................................57 
 
57 
 
57 
 
57 
11. 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS ..................................................................................................58 
11.1. 
Investigator Responsibilities .......................................................................................58 
11.2. 
Data Management .......................................................................................................59 
11.3. 
Data Privacy and Confidentiality of Study Records ...................................................60 
11.4. 
Financial Disclosure ...................................................................................................60 
11.5. 
Publication Policy .......................................................................................................61 
11.6. 
Study and Site Closure ................................................................................................61 
12. 
REFERENCES ...........................................................................................................62 
APPENDIX A. INFORMATION REGARDING EFFECTIVENESS OF 
CONTRACEPTIVE METHODS ...............................................................................65 
APPENDIX B. RESPONSE EVALUATION CRITERIA FOR SOLID TUMORS 
VERSION 1.1 .............................................................................................................66 
APPENDIX C. PROTOCOL AMENDMENT SUMMARY OF CHANGES ............................68 
 


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LIST OF TABLES 
Table 1: 
Primary Objective and Endpoint ................................................................................11 
Table 2: 
Key Study Design Elements .......................................................................................11 
Table 3: 
Schedule of Activities .................................................................................................13 
Table 4: 
Pharmacokinetic 
 Sample Collections ............................................15 
Table 5: 
Activity of Other PD-1 Inhibitors ...............................................................................18 
Table 6: 
Objectives and Endpoints ...........................................................................................20 
Table 7: 
Exclusionary Laboratory Values ................................................................................24 
Table 8: 
Study Drug Information ..............................................................................................27 
Table 9: 
Guidelines for Management of Suspected Infusion Reactions ...................................29 
Table 10: Dose Modification and Toxicity Management Guidelines for 
Immune-Related Adverse Events ...............................................................................30 
Table 11: ECOG Performance Status .........................................................................................42 
Table 12: Required Laboratory Analytes ....................................................................................44 
Table 13: Response Rate and 95% Confidence Interval .............................................................54 
Table 14: Populations for Analysis .............................................................................................55 
 


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LIST OF ABBREVIATIONS 
Abbreviations and 
Special Terms 
Definition 
 
 
AE 
adverse event 
ALK 
alkaline phosphatase 
ALT 
alanine aminotransferase 
ANC 
absolute neutrophil count 
aPTT 
activated partial thromboplastin time 
AST 
aspartate aminotransferase 
AUC0-∞ 
area under the single-dose plasma or serum concentration-time curve 
extrapolated to infinity 
AUC0-t 
area under the plasma or serum concentration-time curve from time = 0 to the 
last measurable concentration at time = t 
BCG 
Bacillus Calmette–Guérin 
BSA 
body surface area 
CFR 
Code of Federal Regulations 
CI 
confidence interval 
Cmax 
maximum observed plasma or serum concentration 
Cmin 
minimum observed plasma or serum concentration over the dose interval 
Cmin,ss 
Cmin at steady state 
CNS 
central nervous system 
CPS 
combined positive score 
CR 
complete response 
CT 
computed tomography 
CTCAE 
Common Terminology Criteria for Adverse Events 
CTL 
cytotoxic T-lymphocyte 
DCR 
disease control rate 
 
 
DOR 
duration of response 
ECG 
electrocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
eCRF 
electronic case report form 
EDC 
electronic data capture 
EGFR 
epidermal growth factor receptor 
EOT 
end of treatment 
FAS 
full analysis set 
FDA 
Food and Drug Administration 


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Abbreviations and 
Special Terms 
Definition 
GCP 
Good Clinical Practice 
HAV 
hepatitis A virus 
HBc 
hepatitis B core 
HBsAg 
hepatitis B surface antigen 
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 
HSD 
Hwang-Shih-DeCani 
IB 
Investigator's Brochure 
ICF 
informed consent form  
ICH 
International Council on Harmonization of Technical Requirements for 
Registration of Pharmaceuticals for Human Use 
IEC 
independent ethics committee 
IgG 
immunoglobulin G 
IgG4 
immunoglobulin G4 
IgM 
immunoglobulin M 
IHC 
immunohistochemistry 
INR 
international normalized ratio 
irAE 
immune-related adverse event 
IRB 
institutional review board 
iRECIST 
modified RECIST v1.1 for immune-based therapeutics 
IRT 
interactive response technology 
IV 
intravenous 
LDL 
low-density lipoprotein 
mAb 
monoclonal antibody 
MedDRA 
Medical Dictionary for Regulatory Activities 
MRI 
magnetic resonance imaging 
NCI 
National Cancer Institute 
NSAID 
nonsteroidal anti-inflammatory drug 
NSCLC 
non-small cell lung cancer 
ORR 
overall response rate 
OS 
overall survival 
PBMC 
peripheral blood mononuclear cell 
PD 
progressive disease 


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Abbreviations and 
Special Terms 
Definition 
PD-1 
programmed cell death protein 1 
PD-L1 
programmed cell death-ligand 1 
PFS 
progression-free survival 
PK 
pharmacokinetic(s) 
PO 
oral 
PR 
partial response 
PT 
prothrombin time 
PTT 
partial thromboplastin time 
Q2W 
every 2 weeks 
Q4W 
every 4 weeks 
Q8W 
every 8 weeks 
Q12W 
every 12 weeks 
RECIST 
Response Evaluation Criteria in Solid Tumors 
RCC 
renal cell carcinoma 
RNA 
ribonucleic acid 
RNAseq 
ribonucleic acid sequencing 
RP2D 
recommended Phase 2 dose 
SAE 
serious adverse event 
SD 
stable disease 
SoA 
schedule of activities 
SOP 
standard operating procedure 
t½ 
apparent terminal-phase disposition half-life 
TEAE 
treatment-emergent adverse event 
TIL 
tumor-infiltrating lymphocyte 
TMB 
tumor mutational burden 
TPS 
tumor proportion score 
UC 
urethelial carcinoma 
ULN 
upper limit of normal 
WBC 
white blood cell 


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1. 
PROTOCOL SUMMARY 
Protocol Title:  A Phase 2 Study of INCMGA00012 (PD-1 Inhibitor) in Participants With 
Selected Solid Tumors (POD1UM-203) 
Protocol Number:  INCMGA 0012-203 
Objectives and Endpoints: 
Table 1 presents the primary objective and endpoint. 
Table 1: 
Primary Objective and Endpoint 
Objective 
Endpoint 
Primary 
To assess the efficacy of INCMGA00012 in terms 
of the ORR in tumor types of interest. 
ORR, defined as the percentage of participants 
having a CR or PR, according to RECIST v1.1 as 
determined by the investigator. 
Overall Design: 
Table 2 presents the key study design elements.  Further study details are presented after the 
table. 
Table 2: 
Key Study Design Elements 
Study Phase 
Phase 2 
Clinical Indication Treatment-naive metastatic NSCLC with high PD-L1 expression (TPS ≥ 50%) 
and no EGFR, ALK, or ROS activating genomic tumor aberrations. 
Locally-advanced or metastatic UC in cisplatin ineligible patients whose tumors 
express PD-L1 (CPS ≥ 10 of PD-L1). 
Unresectable or metastatic melanoma. 
Locally advanced or metastatic clear-cell RCC without prior systemic treatment. 
Population 
Male and female participants at least 18 years of age. 
Number of 
Participants 
Approximately 120 participants will be enrolled into disease-specific cohorts of 
approximately 30 participants per cohort. 
Study Design 
This is a Phase 2, open-label, multiple group, multicenter study. 
Estimated 
Duration of Study 
Participation 
The study consists of 3 periods:  screening, study drug treatment, and follow-up.  
Participants have up to 28 days to complete screening.  Treatment duration with 
study drug may last up to 2 years in the absence of disease progression, 
intolerable toxicity, death, withdrawal of consent, lost to follow-up, or premature 
discontinuation for any other reason.  Participants completing treatment or 
prematurely discontinuing the study drug will be followed for survival until 
death, withdrawal of consent, or the end of the study, whichever occurs first.  
Survival follow-up is not required of participants who have discontinued active 
treatment after the primary efficacy analysis is completed. 
Coordinating 
Principal 
Investigator  
 MD,
 
 
 Hungary 


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Treatment Groups and Duration: 
All eligible participants will receive INCMGA00012 at the RP2D of 500 mg IV Q4W.  
Treatment will be administered by IV infusion over 30 minutes on Day 1 of each 28-day cycle.  
Subsequent treatment cycles may be delayed due to toxicity for up to 12 weeks (see Section 6.5 
and Table 10). 
Participants unable to restart study drug treatment ≤ 12 weeks from the start of the treatment 
delay due to toxicity will be permanently discontinued from study treatment.  Treatment breaks 
of greater than 12 weeks for reasons other than toxicity (eg, for targeted radiotherapy or surgical 
resection of oligometastatic disease) will be considered on a case-by-case basis by the medical 
monitor. 
Table 3 presents the complete study-specific SoA.  Details regarding the sample collection for 
PK 
 analyses are defined in Table 4.  Table 12 presents the safety laboratory 
analytes to be evaluated.  Adherence to the study design requirements, including those specified 
in the SoA, is essential and required for study conduct. 
Some study procedures may be conducted by phone call, where appropriate, or as per 
institutional guidelines during the COVID-19 pandemic.  This information will be described in 
detail in the ICF.  Some tests such as ECG or CT scan assessments may require longer 
time-windows due to the COVID-19 pandemic and thus may be done outside the regularly 
scheduled visits or may be conducted at the next scheduled visit.  These delays will not be 
considered protocol deviations if they are due to administrative difficulties or travel restrictions 
during the COVID-19 pandemic and are documented accordingly. 


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Table 3: 
Schedule of Activities 
Visit Day (Range) 
Screening 
Treatment 
Follow-Up 
Notes 
28 Days 
Cycle 1 
Day 1 
Cycle ≥ 2 
Day 1  
(± 3 d) 
Q8W 
(± 7 d) 
EOTa 
28 Days After 
Last Dose 
(± 7 d) 
Administrative procedures 
Informed consent 
X 
 
 
 
 
 
 
IRT 
X 
X 
X 
 
X 
 
 
Inclusion/exclusion criteria 
X 
 
 
 
 
 
 
General and disease medical 
history 
X 
 
 
 
 
 
 
Prior/concomitant medications 
X 
X 
X 
 
X 
X 
 
Distribute reminder cards 
X 
X 
X 
 
X 
X 
 
Administer INCMGA00012* 
 
X 
X 
 
 
 
* Premedication with antipyretic (eg, acetaminophen/paracetamol)
and a histamine blocker (eg, diphenhydramine) should be 
considered for participants who have had previous systemic 
reactions to protein product infusions or when recommended by 
institutional policy. 
Safety assessments 
AE assessments 
X 
X 
X 
 
X 
X* 
* Immune-related AEs to be collected for 90 days after the last 
dose of study drug or until a new anticancer therapy is started, 
whichever occurs first. 
Physical examination 
X 
X 
X 
 
X 
X 
A comprehensive examination is performed at screening and at 
EOT.  All other scheduled examinations will be targeted. 
Vital signs/body weight/height 
X 
X 
X 
 
X 
X 
Height at screening only. 
12-lead ECG 
X 
 
 
 
 
X 
Either Fridericia or Bazett method of correction is acceptable for 
QT. 
Efficacy assessments 
Tumor imaging/response 
assessments 
X 
 
 
X* 
 
 
* After efficacy analysis is complete, imaging to be performed 
per standard of care.  Complete response or PR should be 
confirmed by imaging at least 4 weeks after initial 
documentation. 
ECOG performance status 
X 
X 
X 
 
X 
 
 
Post study anticancer therapy 
status 
 
 
 
 
X 
X 
 
Survival status 
 
 
 
 
X 
X 
 


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Table 3: 
Schedule of Activities (Continued) 
Visit Day (Range) 
Screening 
Treatment 
Follow-Up 
Notes 
28 Days 
Cycle 1 
Day 1 
Cycle ≥ 2 
Day 1  
(± 3 d) 
Q8W 
(± 7 d) 
EOTa 
28 Days After 
Last Dose 
(± 7 d) 
Clinical laboratory assessments 
Serum chemistries 
X 
X* 
X 
 
 
X 
* Not necessary on C1D1 if performed during screening within 
7 days on C1D1. 
Hematology 
X 
X* 
X 
 
 
X 
* Not necessary on C1D1 if performed during screening within 
7 days on C1D1. 
Lipid panel (fasting) 
X 
 
 
 
 
 
 
Coagulation panel 
X 
 
 
 
 
 
 
Thyroid panel 
X 
 
X* 
 
 
X 
* Every third cycle (C4, C7, C10, etc). 
Urinalysis 
X 
 
 
 
 
 
 
Pregnancy testing 
X 
X* 
X 
 
X** 
X** 
* Not necessary on C1D1 if performed during screening within 
7 days on C1D1. 
** Can be performed at either EOT visit or 28 days after last 
dose. 
Timing and type of testing may be adjusted based on 
country-specific requirements. 
a If EOT is ≥ 21 days postdose, the EOT visit will also serve as the 28-day follow-up visit.  If EOT is < 21 days postdose, the 28-day follow-up visit is required. 


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Table 4: 
Pharmacokinetic 
 Sample Collections 
Sample 
Collection 
Purpose/Analysis 
Treatment Period 
EOT 
Notes 
Cycle 1 
Day 1 
Cycle 2 
Day 1 
(± 3 d) 
Cycle 4 
Day 1  
(± 3 d) 
Cycle 6 
Day 1  
(± 3 d) 
Cycle 7 
Day 1  
(± 3 d) 
Cycle 8 
Day 1  
(± 3 d) 
Cycle 12 
Day 1  
(± 3 d) 
Serum 
PK serum 
PK 
X* 
X 
X 
X 
 
 
 
Xa * 
Samples will be collected preinfusion and 
10 minutes postinfusion (± 10 minutes) on 
Day 1 of Cycles 1, 2, 4 and 6.   
* Additional PK samples will be collected 
4 hours (± 15 minutes) postinfusion on 
Day 1 of Cycle 1 and at EOT. 
a A sample will be collected at the EOT visit or, if no separate EOT visit is performed, at the 28-day safety follow-up visit. 


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2. 
INTRODUCTION 
2.1. 
Background 
Immunotherapy has had a major impact on the treatment of advanced cancer.  Monoclonal 
antibodies against the immune checkpoints such as cytotoxic T-lymphocyte antigen-4 (CTLA-4) 
and PD-1 and its ligand, PD-L1, have been approved for many indications (Keytruda® 2018, 
Opdivo® 2018).  The PD-1 receptor is an inhibitory receptor expressed by T cells, which is 
engaged by the ligands PD-L1 and PD-L2, expressed by antigen presenting cells and, in many 
cases, tumor cells.  Interaction of PD-1 with its ligands leads to the delivery of a negative signal 
to the T-cell expressing PD-1, and inhibits T-cell function.  This pathway helps the body 
maintain self-tolerance.  Many tumor cells however have co-opted this pathway and express high 
levels of PD-L1 and thereby evade T-cell attack.  Within the tumor microenvironment, 
PD-1/PD-L1 interactions inhibit CTL activity.  Programmed cell death protein 1 activation 
inhibits CD8+ CTL proliferation, survival, and their effector function and can also induce 
apoptosis of TILs and promote differentiation of CD4+ T-cells into Treg cells. 
The immunotherapy treatment paradigm is characterized by deep and evolving clinical responses 
in association with the development of durable and specific immunity against the tumor 
(Topalian et al 2012).  In many settings, this has led to improved survival (Robert et al 2015, 
Brahmer et al 2017, Herbst et al 2016, Bellmunt et al 2017, and Motzer et al 2015). 
2.1.1. 
INCMGA00012 
INCMGA00012 is a humanized, hinge-stabilized, IgG4κ monoclonal antibody that recognizes 
human PD-1.  INCMGA00012 contains a human IgG4 Fc domain to limit effector function 
while retaining neonatal Fc receptor binding to extend circulating half-life.  INCMGA00012 is 
designed to target PD-1–expressing cells, including T cells, and to sustain/restore their effector 
function by blocking checkpoint inhibitory interactions between PD-1 and its 2 ligands, PD-L1 
and PD-L2. 
 
 
 
 
 
 
 
 
 
Results of the dose-escalation portion of Study INCMGA 0012-101 (POD1UM-101, 
NCT03059823) demonstrated acceptable tolerability with no DLTs observed at any dose level up 
to 10 mg/kg Q2W.  A maximum tolerated dose was not reached.  For both the 3 and 10 mg/kg 
dose levels, Cmax and AUC0-∞ were dose-proportional.  The t½ (β) was approximately 17 days, 
and steady state was achieved in approximately 85 days.  Full and sustained receptor occupancy 


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of INCMGA00012 on both CD4+ and CD8+ T cells along with complete loss of competing 
fluorescently labeled anti–PD-1 staining were seen at all dose levels (Condamine et al 2019, 
Lakhani et al 2017). 
POD1UM-101 had 4 tumor-specific dose-expansion cohorts (endometrial, cervical, sarcoma, and 
NSCLC) treated with 3 mg/kg Q2W and 3 fixed-dose cohorts (500 mg Q4W, 750 mg Q4W, and 
375 mg Q3W).  One hundred thirty-two participants were treated in the initial 4 tumor-specific 
expansion groups (Mehnert et al 2018).  Safety was favorable with an overall irAE incidence of 
12%.  Most irAE were transient, with the exception of endocrine-related irAE.  Nonendocrine 
irAEs that did not resolve were lipase increased, stomatitis, proctitis, diarrhea, ALT increased, 
and blood bilirubin increased (all 1 participant each).  There were no fatal AEs attributed to 
treatment with INCMGA00012.  The 375 mg Q3W and 500 mg Q4W doses were selected as the 
RP2Ds for further development. 
Confirmed RECIST responses were observed in all of the expansion cohorts, none of which had 
been enriched by a predictive biomarker (eg, microsatellite instability or PD-L1 status).  
Specifically, 5 of 27 (19%) of the evaluable participants with NSCLC had confirmed RECIST 
responses, as did 4 of 29 (14%) of participants with cervical cancer, 4 of 23 (17%) with 
endometrial cancer, and 1 of 28 (4%) with sarcoma.  The ORR and median duration of responses 
have not yet been established. 
2.2. 
Rationale for Study Design 
The study is an open-label, nonrandomized, multi-cohort trial that is designed to provide proof of 
concept for INCMGA00012 in key indications where other PD-1 inhibitors have already shown 
efficacy.  Clinical studies are an important mechanism for providing access to promising 
therapies where it may otherwise be limited (eg, due to labeling restrictions or insufficient 
reimbursement). 
2.2.1. 
Population 
Overall response to PD-1 directed therapy is an important early indication of whether a new 
immunotherapy is likely to prove useful in the clinic.  Since ORRs of 30% to 40% have been 
shown with other PD-1 inhibitors against the indications to be studied (see Table 5), this 
provides a useful benchmark for the development of new checkpoint therapies, like 
INCMGA00012, which can readily be evaluated in a screening trial. 


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Table 5: 
Activity of Other PD-1 Inhibitors 
Indication 
Pembrolizumab 
ORR (95% CI) 
Nivolumab 
ORR (95% CI) 
1L NSCLC (TPS ≥ 50%) 
45 (37, 53)a 
34 (24, 45)b 
Cisplatin ineligible UC (CPS ≥ 10) 
39 (28, 50)c 
28 (19, 39)d,e 
1L melanoma 
33 (27, 39)a  
40 (34, 46)f 
1L RCC 
38 (29, 48)g 
42 (37, 47)h,i 
a Refer to Keytruda 2018. 
b Refer to Carbone et al 2017. 
c Refer to Balar et al 2017. 
d TPS ≥ 5%. 
e Refer to Escudier et al 2017. 
f Refer to Robert et al 2015. 
g Refer to McDermott et al 2018. 
h In combination with ipilimumab. 
i Refer to Motzer et al 2018. 
2.2.2. 
Dose and Schedule 
Fixed doses of therapeutics have several advantages over weight-based doses, including 
convenience of preparation and administration, reduced errors in preparation calculation, and 
minimization of drug waste.  Body size–based doses and fixed doses of mAbs have been 
evaluated, and the 2 approaches perform similarly in terms of efficacy and safety 
(Wang et al 2009, Bai et al 2012). 
The flat dose regimen of 500 mg Q4W is based on clinical data from the ongoing first-in-human 
monotherapy study (INCMGA 0012-101; NCT03059823).  This dose-escalation study of 
INCMGA00012 was performed and evaluated 37 participants at the following doses:  1 mg/kg 
Q2W, 3 mg/kg Q2W, 3 mg/kg Q4W, 10 mg/kg Q2W, and 10 mg/kg Q4W.  While supra-dose 
proportionality was observed for AUC and Cmax for the first dose from 1 mg/kg to 10 mg/kg, 
linear PK was shown from 3 mg/kg to 10 mg/kg.  No dose-limiting toxicity was observed with 
any dose level, and a maximum tolerated dose was not reached. 
A population PK analysis was performed on these participants to characterize the effect of body 
weight on the PK of INCMGA00012.  The serum concentrations of INCMGA00012 can be 
adequately described by a 2-compartment model with first-order elimination.  Higher clearance 
of INCMGA00012 was estimated for 1 mg/kg than the other dose groups.  Body weight 
dependence of clearance was characterized by a power relationship with an exponent of 0.911. 
 
 
 
 
 
 


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2.3. 
Benefit/Risk Assessment 
Treatment directed at the PD-1/PD-L1 axis is a promising approach to the diseases under study.  
Monoclonal antibodies against PD-1 have shown benefit for these and other indications and 
safety of these agents has been well characterized (Keytruda 2018, Opdivo 2018).  Based on 
published experience from more than 200 study participants, the pharmacologic and clinical 
profile of INCMGA00012 is comparable to the approved PD-1 inhibitors; thus, similar efficacy 
can be anticipated where PD-1 inhibitors have already been shown to be active (Chen et al 2019, 
Condamine et al 2019, Lakhani et al 2017, Mehnert et al 2018). 
Based on these observations, the benefit/risk for INCMGA00012 should also be favorable, 
provided efficacy objectives in the proposed study are met. 
Close oversight of study conduct will be provided through safety team meetings and contact with 
participating investigators.  Additionally, irAEs will be monitored throughout the study as AEs 
of special interest with appropriate guidance provided to investigators for their assessment and 
management. 
More detailed information about the known and expected benefits and risks and reasonably 
expected AEs of INCMGA00012 may be found in the IB. 


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3. 
OBJECTIVES AND ENDPOINTS 
Table 6 presents the objectives and endpoints. 
Table 6: 
Objectives and Endpoints 
Objectives 
Endpoints 
Primary 
To assess the efficacy of INCMGA00012 in 
terms of the ORR in tumor types of interest. 
ORR, defined as the percentage of participants 
having a CR or PR, according to RECIST v1.1 as 
determined by the investigator. 
Secondary 
To determine the DOR to INCMGA00012. 
DOR, defined as the time from an initial objective 
response (CR or PR) according to RECIST v1.1 until 
first observation of documented disease progression 
as determined by investigator or death due to any 
cause. 
To determine the DCR. 
DCR, defined as the proportion of participants with 
either an objective response (CR and PR) or SD, 
according to RECIST v1.1. 
To determine the PFS of INCMGA00012. 
PFS, defined as the time from the start of therapy 
until disease progression, as determined by 
investigator or death due to any cause. 
To determine the OS of INCMGA00012. 
OS, defined as the time from the start of therapy until 
death due to any cause. 
To evaluate the safety of INCMGA00012. 
Safety, determined by the number of participants, 
frequency, duration, and severity of AEs, laboratory 
tests, vital signs, and ECGs. 
To determine the PK of INCMAG00012 when 
administered as a 30-minute infusion. 
The PK of INCMAG00012 including Cmax, tmax, Cmin, 
and AUCt, will be summarized. 
 
 
 
 
 
 
 
 


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4. 
STUDY DESIGN 
4.1. 
Overall Design 
This study is a Phase 2, open-label, multicenter study designed to assess the clinical activity and 
safety of INCMGA00012 in participants with advanced solid tumors where the efficacy of PD-1 
inhibitors has previously been established.  Participants with the following tumor types will be 
enrolled into disease-specific cohorts: 
• Treatment-naive metastatic NSCLC with high PD-L1 expression (TPS ≥ 50%) and no 
EGFR, ALK, or ROS activating genomic tumor aberrations. 
• Locally-advanced or metastatic urothelial cancer in cisplatin ineligible patients 
(determined by the investigator) whose tumors express PD-L1 (CPS ≥ 10) of PD-L1). 
• Unresectable or metastatic melanoma. 
• Locally advanced or metastatic clear–cell RCC without prior systemic treatment. 
The primary endpoint is ORR as determined by RECIST v1.1 as determined by the investigator. 
The study consists of 3 periods:  screening, study drug treatment, and follow-up. 
All eligible participants will receive INCMGA00012 at the RP2D of 500 mg IV Q4W.  
Treatment will be administered by IV infusion over 30 minutes on Day 1 of each 28-day cycle.  
Subsequent treatment cycles may be delayed due to toxicity for up to 12 weeks (see Section 6.5 
and Table 10). 
Participants unable to restart study drug treatment ≤ 12 weeks from the start of the treatment 
delay due to toxicity will be permanently discontinued from study treatment.  
Treatment breaks of greater than 12 weeks for reasons other than toxicity (eg, for targeted 
radiotherapy or surgical resection of oligometastatic disease) will be considered on a 
case-by-case basis by the medical monitor.  Treatment with study drug may continue up to 
2 years in the absence of disease progression (see Section 8.2), intolerable toxicity, death, 
withdrawal of consent, lost to follow-up, or premature discontinuation for any other reason.  
Participants who have been treated for at least 6 months and achieve a confirmed CR may 
discontinue INCMGA00012 after 2 additional cycles upon consultation with the medical 
monitor.  Patient management should follow either RECIST v1.1 (see Section 8.2.1) or iRECIST 
(see Section 8.2.2), with the decision to treat beyond conventional RECIST progression 
documented in the study file. 
A participant may receive up to 2 years of study drug in the absence of disease progression or 
unacceptable toxicity.  Participants will be evaluated for AEs/SAEs for approximately 28 days 
after the last dose of study drug and will be followed for irAEs for approximately 90 days after 
the last dose of study drug or until the start of a new anticancer therapy, whichever occurs first.  
The 90-day visit may be conducted via phone call.  Survival follow-up is not required of 
participants who have discontinued study drug once the primary efficacy analysis is completed.  
The primary efficacy analysis will be performed once all participants have been followed for at 
least 6 months from the start of treatment or have prematurely discontinued study treatment.  
Thereafter, participants will be treated with INCMGA00012 if they derive clinical benefit as per 
standard of care for the disease and local guidelines. 


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The complete study-specific assessment schedule required for participants in this clinical study is 
presented in Table 3.  The analytes to be evaluated in the safety laboratory analyses are found in 
Table 12.  Details regarding the sample collection for PK 
 analyses are defined 
in Table 4. 
4.2. 
Overall Study Duration 
The study begins when the first participant signs the ICF.  The end of the study is defined as the 
date of the last visit of the last participant in the study.  The study will end when the last 
participant completes 90 days of safety follow-up for irAEs.  No participant will be followed for 
longer than 27 months (ie, 2 years of study treatment followed by 90 days of observation for 
irAEs in the event the participant does not discontinue treatment prematurely or start a new 
anticancer therapy). 
4.3. 
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 IRB/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 or if required by regulatory decision.  If the study 
is terminated prematurely, the sponsor will notify the investigators, the IRBs and IECs, and the 
regulatory bodies of the decision and reason for termination of the study. 


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5. 
STUDY POPULATION 
Deviations from eligibility criteria are not allowed because they can potentially jeopardize the 
scientific integrity of the study, regulatory acceptability, and/or participant safety.  Therefore, 
adherence to the criteria as specified in the Protocol is essential.  Prospective approval of 
Protocol deviations to recruitment and enrollment criteria, also known as Protocol waivers or 
exemptions, are not permitted. 
5.1. 
Inclusion Criteria 
Participants are eligible to be included in the study only if all of the following criteria apply: 
1. Ability to comprehend and willingness to sign a written ICF for the study. 
2. Men and women 18 years of age or older (or as applicable per local country 
requirements). 
3. Confirmed diagnosis of one of the following:  
a. Treatment-naive metastatic NSCLC with high PD-L1 expression (TPS ≥ 50%) and no 
EGFR, ALK, or ROS activating genomic tumor aberrations. 
b. Locally-advanced or metastatic UC in participants who are not eligible for cisplatin 
therapy (determined by the investigator) and whose tumors express PD-L1 with a 
CPS ≥ 10. 
c. Unresectable or metastatic melanoma. 
d. Locally advanced or metastatic RCC with clear cell component (with or without 
sarcomatoid features) and having received no prior systemic therapy 
4. Measurable disease per RECIST v1.1. 
5. ECOG performance status 0 to 1. 
6. Willingness to avoid pregnancy or fathering children based on the criteria below. 
a. Men must agree to take appropriate precautions to avoid fathering children (with at 
least 99% certainty) from screening through 6 months after the last dose of study drug 
(or longer as appropriate based on country-specific requirements) and must refrain 
from donating sperm during this period.  Permitted methods that are at least 
99% effective in preventing pregnancy (see Appendix A) should be communicated to 
the participants and their understanding confirmed. 
b. Women of childbearing potential must have a negative serum pregnancy test at 
screening and must agree to take appropriate precautions to avoid pregnancy (with at 
least 99% certainty) from screening through 6 months 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 participants and their understanding 
confirmed. 
c. Women of nonchildbearing potential (ie, surgically sterile with a hysterectomy and/or 
bilateral oophorectomy OR ≥ 12 months of amenorrhea and at least 50 years of age) 
are eligible. 


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5.2. 
Exclusion Criteria 
Participants are excluded from the study if any of the following criteria apply: 
1. Receipt of anticancer therapy or participation in another interventional clinical study 
within 21 days before the first administration of study drug. 
2. Prior treatment with PD-1 or PD-L1 directed therapy (other immunotherapies may be 
acceptable with prior approval from the medical monitor). 
a. Adjuvant therapy that was completed ≥ 12 months before study entry may be 
acceptable but should be discussed with the medical monitor before enrolling the 
participant on study. 
3. Radiotherapy within 14 days of first dose of study treatment with the following caveats:  
a. 28 days for pelvic radiotherapy. 
b. 6 months for thoracic region radiotherapy that is > 30 Gy. 
c. 14 days for palliative radiation therapy.   
Note:  Participants must have recovered from all radiation-related toxicities, not 
require corticosteroids for this purpose, and not have had radiation pneumonitis. 
4. Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the 
exception of anemia not requiring transfusion support and any grade of alopecia).  
Endocrinopathy, if well-managed, is not exclusionary and should be discussed with 
sponsor medical monitor. 
5. Participant has not recovered adequately from toxicities and/or complications from 
surgical intervention before starting study drug. 
6. Participants with laboratory values at screening defined in Table 7. 
Table 7: 
Exclusionary Laboratory Values 
Laboratory Parameter 
Exclusion Criterion 
Hematology 
a 
Platelets 
≤ 100 × 109/L 
b 
Hemoglobin 
≤ 9 g/dL 
c 
ANC 
≤ 1.5 × 109/L 
Hepatic 
d 
ALT 
> 2.5 × ULN 
e 
AST 
> 2.5 × ULN 
f 
Bilirubin 
≥ 1.5 × 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. 
Renal 
g 
Calculated creatinine clearance 
< 30 mL/min 
Coagulation 
h 
INR or PT 
> 1.5 × ULN for participants not receiving anticoagulant therapy 
i 
aPTT 
> 1.5 × ULN for participants not receiving anticoagulant therapy 


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7. Known additional malignancy that is progressing or requires active treatment, or history 
of other malignancy within 3 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 participant has been disease-free for > 1 year, after treatment 
with curative intent. 
8. Active autoimmune disease requiring systemic immunosuppression in excess of 
physiologic maintenance doses of corticosteroids (> 10 mg of prednisone or equivalent). 
a. Physiologic corticosteroid replacement therapy at doses > 10 mg/day of prednisone or 
equivalent for adrenal or pituitary insufficiency and in the absence of active 
autoimmune disease is permitted. 
b. Participants with asthma that requires intermittent use of bronchodilators, inhaled 
steroids, or local steroid injections may participate. 
c. Participants using topical, ocular, intra-articular, or intranasal steroids (with minimal 
systemic absorption) may participate. 
d. Brief courses of corticosteroids for prophylaxis (eg, contrast dye allergy) or study 
treatment–related standard premedication are permitted. 
9. Evidence of interstitial lung disease or active noninfectious pneumonitis. 
10. Known active CNS metastases and/or carcinomatous meningitis.  
Note:  Participants with previously treated brain metastases may participate provided 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. 
11. Known active HAV, HBV, or HCV infection, as defined by elevated transaminases with 
the following serology:  positivity for HAV IgM antibody, anti-HCV, anti-HBc IgG or 
IgM, or HBsAg (in the absence of prior immunization). 
12. Active infections requiring systemic therapy. 
 
 
 
14. Known hypersensitivity to another mAb that cannot be controlled with standard measures 
(eg, antihistamines and corticosteroids). 
15. Participants with impaired cardiac function or clinically significant cardiac disease: 
a. New York Heart Association Class III or IV cardiac disease, including preexisting 
clinically significant ventricular arrhythmia, congestive heart failure, or 
cardiomyopathy. 
b. Unstable angina pectoris. 
c. Acute myocardial infarction ≤ 6 months before study participation. 
d. Other clinically significant heart disease (eg, ≥ Grade 3 uncontrolled hypertension). 


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16. Participant is pregnant or breastfeeding. 
17. Has received a live vaccine within 28 days of the 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, BCG, and typhoid vaccine.  
Seasonal influenza vaccines for injection are generally killed virus vaccines and are 
allowed; however, intranasal influenza vaccines (eg, FluMist®) are live-attenuated 
vaccines and are not allowed. 
18. Current use of prohibited medication as described in Section 6.6.2. 
19. 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 participant; or interfere with interpretation of study data. 
20. History of organ transplant, including allogeneic stem cell transplantation. 
21. The following patients are excluded in France:  vulnerable populations according to 
article L.1121-6 of the French Public Health code and adults under legal protection or 
who are unable to express their consent per article L.1121-8 of the French Public Health 
code. 
5.3. 
Lifestyle Considerations 
Not applicable. 
5.4. 
Screen Failures 
Screen failures are defined as participants who consent to participate in the clinical study but are 
not subsequently assigned to study drug. 
Tests with results that fail eligibility requirements may be repeated during screening.  
Additionally, a participant who fails screening may repeat the screening process once if the 
investigator believes that there has been a change in eligibility status.  Participants who rescreen 
must reconsent and be assigned a new participant number. 
5.5. 
Replacement of Participants 
Not applicable. 


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6. 
STUDY TREATMENT 
6.1. 
Study Treatments Administered 
Table 8 presents the study drug information. 
Table 8: 
Study Drug Information 
Study drug name: 
INCMGA00012 
Dosage formulation: 
Liquid formulation 
Dosage level: 
500 mg Q4W 
Route of administration: 
IV 
Administration instructions: Administered intravenously over 30 minutes (- 5/+ 15 minutes) 
Packaging and labeling: 
INCMGA00012 25 mg/mL will be provided in a glass vial for single 
use 
Each vial will be labeled as required per country requirement 
Storage: 
Upright under refrigeration at 2°C-8°C (36°F-46°F) 
Protected from light 
6.2. 
Preparation, Handling, and Accountability 
The investigator or designee must confirm appropriate temperature conditions have been 
maintained during transit for all study drug received and any discrepancies are reported and 
resolved before use of the study drug. 
Only participants enrolled in the study may receive study drug, and only authorized site staff 
may supply or administer study drug.  All study drug must be stored in a secure, environmentally 
controlled, and monitored (manual or automated) area in accordance with the labeled storage 
conditions with access limited to the investigator and authorized site staff. 
The investigator (or designee) is responsible for study drug accountability, reconciliation, and 
record maintenance (ie, receipt, reconciliation, and final disposition records).  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. 
• Lot numbers and/or vial numbers (as applicable) of study drug used to prepare the 
infusion solution. 
• Return of study drug to the investigator or designee by participants. 
The investigational product must be used only in accordance with the Protocol.  The investigator 
will also maintain records adequately documenting that the participants were provided the 
specified study drug.  These records should include dates, quantities, and any available batch or 


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serial numbers or unique code numbers assigned to the investigational product and study 
participants. 
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 SOPs.  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. 
Further guidance and information for the final disposition of unused study drug are provided in 
the Pharmacy Manual. 
6.3. 
Measures to Minimize Bias:  Randomization and Blinding 
Not applicable. 
6.4. 
Study Treatment Compliance 
Compliance with all study-related treatments should be emphasized to the participant by the site 
personnel, and appropriate steps should be taken to optimize compliance during the study.  
Compliance with study drug will be calculated by the sponsor based on the drug accountability 
documented by the site staff and monitored by the sponsor/designee. 
6.5. 
Dose Modifications 
Dose reduction is not allowed.  Before the start of each treatment cycle, the participant must 
meet the treatment continuation criteria (see Section 4.1).  Management guidelines for 
immune-related adverse reactions commonly observed with other PD-1 inhibitors are provided in 
the following sections. 
6.5.1. 
Management of Suspected Infusion Reactions 
Infusion or hypersensitivity reactions may be observed with administration of any foreign 
protein.  Premedication with an antipyretic (eg, acetaminophen/paracetamol) and a histamine 
blocker (eg, diphenhydramine) should be considered for participants who have had previous 
systemic reactions to protein product infusions or when recommended by institutional policy.  
Guidelines for management of suspected infusion reactions are provided in Table 9.  Grade 3 or 
4 infusion reactions should be reported within 24 hours to the study medical monitor regardless 
of whether criteria for reporting as an SAE are met. 


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Table 9: 
Guidelines for Management of Suspected Infusion Reactions 
Grade 
Descriptiona 
Treatment 
Subsequent Infusions 
1 
Mild reaction; interrupt or slow 
the rate of infusion; intervention 
not indicated. 
Monitor vital signs closely until 
medically stable. 
Premedication with an 
antipyretic (eg, acetaminophen/ 
paracetamol) and a histamine 
blocker (eg, diphenhydramine) 
should be considered for 
participants who have had 
previous systemic reactions to 
protein product infusions or 
when recommended by 
institutional policy. 
2 
Requires infusion interruption 
but responds promptly to 
symptomatic treatment 
(eg, antihistamines, NSAIDs, 
narcotics, IV fluids); 
prophylactic medications 
indicated for ≤ 24 hours. 
First occurrence:  Stop infusion 
and initiate appropriate medical 
measures (eg, IV fluids, 
antihistamines NSAIDs, 
antipyretic, narcotics, per 
institutional preferences). 
Monitor vital signs until medically 
stable. 
If symptoms resolve within 
1 hour, infusion may be resumed 
at 50% of the original infusion 
rate. 
Subsequent occurrences (after 
recommended prophylaxis):  
Permanently discontinue 
treatment. 
Premedicate at least 30 minutes 
before infusion with 
antihistamines 
(eg, diphenhydramine 
50 mg PO) and antipyretic 
(eg, acetaminophen/ 
paracetamol 500-1000 mg PO). 
Additional supportive 
measures may be acceptable 
(per institutional preference). 
Next infusion should start at 
50% of the original infusion 
rate.  If no reaction, rate of 
infusion can be increased by 
25% every 15 minutes until a 
rate of 100% has been 
reached.  Subsequent infusions 
can begin at 100%. 
3 or 4 
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). 
Grade 4:  Life-threatening; 
pressor or ventilatory support 
indicated. 
Stop infusion and initiate 
appropriate medical therapy 
(eg, IV fluids, antihistamines 
NSAIDs, antipyretic, narcotics, 
oxygen, pressors, epinephrine, 
corticosteroids, per institutional 
preferences). 
Monitor vital signs frequently 
until medically stable.  
Hospitalization may be indicated. 
Discontinue study drug. 
a Per NCI CTCAE v5.0, appropriate resuscitation equipment should be available at the bedside and a physician readily 
available during the period of study drug administration. 


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6.5.2. 
Management of Suspected Immune-Related Adverse Events 
Adverse events of a potential immunologic etiology or irAEs may be defined as an AE of 
unknown etiology, associated with drug exposure, and consistent with an immune phenomenon.  
Immune-related AEs may be predicted based on the nature of the compounds, their mechanism 
of action, and reported experience with immunotherapies that have a similar mechanism of 
action.  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. 
If an irAE is suspected, efforts should be made to rule out neoplastic, infectious, metabolic, 
toxin, or other etiologic causes before labeling an AE as an irAE.  Recommendations for 
management of specific immune-mediated AEs known to be associated with INCMGA00012 
and other PD-1 inhibitors (eg, pembrolizumab, nivolumab) are provided in Table 10. 
Management guidance for irAEs not detailed elsewhere in the Protocol should follow the ASCO 
or ESMO Clinical Practice Guidelines (Brahmer et al 2018, Haanen et al 2017, 
Haanen et al 2018, NCCN 2021). 
Table 10: 
Dose Modification and Toxicity Management Guidelines for 
Immune-Related Adverse Events 
Immune-Related 
Adverse Event 
Toxicity Grade or 
Conditions 
(CTCAE v5.0) 
Action Taken With 
INCMGA00012 
AE Management With Corticosteroid and/or 
Other Supportive Care Therapies 
Pneumonitis 
Grade 1 
No action. 
None. 
Grade 2 
Withhold until 
≤ Grade 1. 
• Administer systemic corticosteroids per local 
practice followed by taper. 
• Evaluate participants with suspected 
pneumonitis with radiographic imaging and 
initiate corticosteroid treatment. 
• Add prophylactic antibiotics for opportunistic 
infections. 
Grades 3 or 4, or 
recurrent Grade 2 
Permanently discontinue. 
Diarrhea/colitis 
Grade 1 
No action. 
None. 
Grades 2 or 3 
Withhold until 
≤ Grade 1. 
• Consider prompt initiation of standard 
antidiarrheal agents and other necessary 
supportive care as needed (eg, oral and/or IV 
fluids). 
• Administer systemic corticosteroids per local 
practice followed by taper. 
• Consider prophylactic antibiotics per local 
practice. 
• Consider gastrointestinal consultation and 
performing endoscopy to rule out colitis. 
Grade 4 or recurrent 
Grade 3 
Permanently discontinue. 
 
 


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Table 10: 
Dose Modification and Toxicity Management Guidelines for 
Immune-Related Adverse Events (Continued) 
Immune-Related 
Adverse Event 
Toxicity Grade or 
Conditions 
(CTCAE v5.0) 
Action Taken With 
INCMGA00012 
AE Management With Corticosteroid and/or 
Other Supportive Care Therapies 
Hepatitis with no 
tumor involvement 
of the livera 
AST or ALT increases 
to more than 3 and up to 
8 times ULN 
or 
Total bilirubin increases 
to more than 1.5 and up 
to 3 times ULN 
Withhold. 
• Administer systemic corticosteroids per local 
practice followed by taper. 
• Consider monitoring liver enzymes weekly (or 
more frequently) until liver enzyme value 
returns to baseline or is stable. 
AST or ALT increases 
to more than 8 times 
ULN 
or 
Total bilirubin increases 
to more than 3 times 
ULN 
Permanently discontinue. 
Hepatitis with 
tumor involvement 
of the liver 
Baseline AST or ALT is 
more than 1 and up to 
3 times ULN and 
increases to more than 5 
and up to 10 times ULN 
or 
Baseline AST or ALT is 
more than 3 and up to 
5 times ULN and 
increases to more than 8 
and up to 10 times ULN 
Withhold. 
• Administer systemic corticosteroids per local 
practice followed by taper. 
• Consider monitoring liver enzymes weekly (or 
more frequently) until liver enzyme value 
returns to baseline or is stable. 
ALT or AST increases 
to more than 10 times 
ULN 
or 
Total bilirubin increases 
to more than 3 times 
ULN 
Permanently discontinue. 
Endocrinopathies 
• Type 1 diabetes 
mellitus 
• Hyperglycemia 
• Hyperthyroidism 
• Hypothyroidism 
• Adrenal 
insufficiency 
Grades 1 and 2 
No action. 
None. 
Grades 3 or 4 Type 1 
diabetes mellitus (or 
hyperglycemia) 
Withhold until ≤ Grade 1 
or is otherwise clinically 
stable. 
Initiate treatment with antihyperglycemics as 
clinically indicated. 
Grades 3 and 4 
hyperthyroidism 
Withhold until ≤ Grade 1 
or is otherwise clinically 
stable. 
Initiate symptomatic management. 
Grades 3 and 4 
hypothyroidism 
Withhold until ≤ Grade 1 
or is otherwise clinically 
stable. 
Initiate thyroid replacement hormones 
(eg, levothyroxine or liothyronine) per standard of 
care. 
Grade 2 adrenal 
insufficiency 
Withhold until ≤ Grade 1 
or otherwise clinically 
stable. 
Initiate treatment with hormone replacement as 
clinically indicated. 
Grades 3 and 4 adrenal 
insufficiency 
Withhold until ≤ Grade 1 
after corticosteroid taper 
to ≤ 10 mg/day 
prednisone or equivalent 
or is otherwise clinically 
stable. 
Initial dose of 1 to 2 mg/kg/day prednisone or 
equivalent followed by a taper and hormone 
replacement as clinically indicated. 


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Table 10: 
Dose Modification and Toxicity Management Guidelines for 
Immune-Related Adverse Events (Continued) 
Immune-Related 
Adverse Event 
Toxicity Grade or 
Conditions 
(CTCAE v5.0) 
Action Taken With 
INCMGA00012 
AE Management With Corticosteroid and/or 
Other Supportive Care Therapies 
Endocrinopathies 
(continued) 
• Hypophysitis 
Grade 1  
No action. 
None. 
Grade 2 (asymptomatic) Withhold until ≤ Grade 1. 
May restart 
INCMGA00012 
treatment after controlled 
by hormone replacement 
therapy. 
Administer hormonal replacement. 
Grade 2 (symptomatic, 
eg, headaches, visual 
disturbances) 
Withhold until ≤ Grade 1. 
May restart 
INCMGA00012 
treatment after controlled 
with hormone 
replacement, if indicated, 
and steroid taper is 
complete. 
• Administer corticosteroids at initial dose of 
1 to 2 mg/kg/day prednisone or equivalent 
followed by a taper, and initiate other 
hormonal replacements as clinically indicated. 
• Consult with endocrinologist as needed. 
Grade 3 or 4 
(symptomatic)  
Permanent 
discontinuation should 
occur if after withholding 
INCMGA00012 the 
toxicity does not resolve 
to ≤ Grade 1 within 
12 weeks after last dose 
of INCMGA00012 
treatment, or if 
corticosteroid dosing 
cannot be reduced to 
≤ 10 mg prednisone or 
equivalent per day within 
12 weeks. 
Permanent 
discontinuation of 
INCMGA00012 should 
take place earlier at the 
investigator’s discretion, 
if corticosteroids and/or 
hormone replacement 
therapy cannot balance 
the participant's pituitary 
function. 
• Administer corticosteroids at initial dose of 
1 to 2 mg/kg/day prednisone or equivalent 
followed by a taper, and initiate other 
hormonal replacements as clinically indicated. 
• Consult with endocrinologist as needed. 


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Table 10: 
Dose Modification and Toxicity Management Guidelines for 
Immune-Related Adverse Events (Continued) 
Immune-Related 
Adverse Event 
Toxicity Grade or 
Conditions 
(CTCAE v5.0) 
Action Taken With 
INCMGA00012 
AE Management With Corticosteroid and/or 
Other Supportive Care Therapies 
Nephritis with renal 
dysfunction 
Grade 1 
No action. 
None. 
Grade 2 or Grade 3 
increased blood 
creatinine 
Withhold until ≤ Grade 1. Administer corticosteroids per local practice 
followed by taper. 
Grade 4 increased blood 
creatinine 
Permanently discontinue. 
Skin 
(eg, Stevens-
Johnson syndrome, 
or toxic epidermal 
necrolysis) 
Grade 1 
No action. 
None. 
Grade 2 
No action. 
Manage with topical steroids with or without drug 
interruption. 
Grade 3b or persistent 
Grade 2 (≥ 2 weeks) or 
suspected 
Stevens-Johnson 
syndromec 
Withhold until ≤ Grade 1 
after corticosteroid taper 
to ≤ 10 mg/day 
prednisone or equivalent 
• Administer corticosteroids per local practice 
followed by taper.  Additionally, oral 
antihistamines such as diphenhydramine or 
famotidine (per institutional preference) may 
be utilized as needed. 
• Should refer to dermatology if no resolution 
with these measures. 
Grade 4 or confirmed 
Stevens-Johnson 
syndromeb or toxic 
epidermal necrolysisd 
Permanently discontinue. 
• Initial dose of 1 to 2 mg/kg/day prednisone or 
equivalent followed by a taper. 
• Refer to dermatology consult. 
Myocarditis 
Grade 2 
Depending on severity of 
symptoms, withhold until 
symptoms fully resolve 
and management with 
corticosteroids is 
complete.  Permanent 
discontinuation of 
INCMGA00012 may 
take place earlier at the 
investigator’s discretion. 
• Treatment with systemic corticosteroids should 
be initiated (initial dose of 1-2 mg/kg per day 
of prednisone or equivalent).  Taper as 
appropriate. 
• Manage cardiac symptoms according to 
standard of care and with guidance from 
cardiology.  Consider cardiac MRI and 
myocardial biopsy for diagnosis. 
Grades 3 or 4 
Permanently discontinue. 
Important nervous 
system events 
(eg, Guillain-Barre 
syndrome, 
autoimmune 
encephalitis, 
myasthenia gravis, 
autonomic 
neuropathy, or 
transverse myelitis) 
Grade 2 
Withhold until ≤ 
Grade 1. 
• Neurology consultation is recommended for all 
neurologic irAEs ≥ Grade 2. 
• Treatment with systemic corticosteroids should 
be initiated (initial dose of 1-2 mg/kg per day 
of prednisone or equivalent).  Taper as 
appropriate. 
• For Grade 2 transverse myelitis consider 
permanent discontinuation. 
• Manage symptoms according to standard of 
care and with guidance from neurology. 
Grades 3 or 4 
Permanently discontinue. 


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Table 10: 
Dose Modification and Toxicity Management Guidelines for 
Immune-Related Adverse Events (Continued) 
Immune-Related 
Adverse Event 
Toxicity Grade or 
Conditions 
(CTCAE v5.0) 
Action Taken With 
INCMGA00012 
AE Management With Corticosteroid and/or 
Other Supportive Care Therapies 
All other irAEs 
Grade 2 or Grade 3 
based on severity and 
type of reaction 
Withhold until ≤ 
Grade 1. 
Based on severity of AE, administer 
corticosteroids. 
Recurrent Grade 3 or 
Persistent Grade 2 and 
Grade 3 
Permanently discontinue. 
Grade 4 (excluding 
endocrinopathies) 
Permanently discontinue. 
a If AST and ALT are less than or equal to ULN at baseline, withhold or permanently discontinue INCMGA00012 based on 
recommendations for hepatitis with no liver involvement. 
b Participants with Grade 3 rash in the absence of desquamation, with no mucosal involvement, not requiring systemic steroids, 
and resolving or improving to ≤ Grade 1 within 14 days do not need INCMGA00012 interrupted.  Permanent discontinuation 
of study drug may be necessary if there is recurrence of Grade 3 after resuming study drug. 
c Grade 3 Stevens-Johnson syndrome is defined as skin sloughing covering < 10% BSA with associated signs (eg, erythema, 
purpura, epidermal detachment, mucous membrane detachment).  Grade 4 Stevens-Johnson syndrome is defined as skin 
sloughing covering 10% to 30% BSA with associated signs (eg, erythema, purpura, epidermal detachment, mucous membrane 
detachment).  
d Toxic epidermal necrolysis is Grade 4 by definition and is defined as skin sloughing covering ≥ 30% BSA with associated 
symptoms (eg, erythema, purpura, epidermal detachment). 
6.5.3. 
Permanent Discontinuation of Study Drug Due to Toxicity 
The occurrence of unacceptable toxicity not caused by the underlying disease will require that 
the study treatment be permanently discontinued.  Unacceptable toxicity is defined as follows: 
• Occurrence of an AE that is related to study treatment that, in the judgment of the 
investigator or the sponsor's medical monitor, compromises the participant's ability to 
continue study-specific procedures or is considered to not be in the participant's best 
interest. 
• Persistent treatment-related AE requiring a delay of therapy for more than 12 weeks. 
• Any AE defined in the dose modifications management guidelines (see Section 6.5) 
requiring the study treatment be discontinued. 
A complete list of study treatment discontinuation reasons and procedures is found in Section 7. 
6.6. 
Concomitant Medications and Procedures 
All concomitant medications and treatments (including over-the-counter or prescription 
medicines, vitamins, vaccines, and/or herbal supplements) must be recorded in the eCRF.  Any 
medication received up to 30 days before the first dose of study drug and 28 days after the last 
dose of study drug (unless associated with the treatment of an AE), or until the participant begins 
a new anticancer therapy, whichever occurs first, will be recorded in the eCRF.  Any addition, 
deletion, or change in the dose of these medications will also be recorded.  Concomitant 
medications administered for the management of SAEs or irAEs should be recorded regardless 
of when they are provided.  Concomitant treatments/procedures that are required to manage a 


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participant's medical condition during the study will also be recorded in the eCRF.  The medical 
monitor should be contacted if there are any questions regarding concomitant or prior therapy. 
6.6.1. 
Permitted Medications and Procedures 
Recommended supportive measures for specific toxicities are described in Section 6.5.  Growth 
factors, bisphosphonates, anticoagulants, and transfusional support will also be permitted per 
standard institutional practice. 
Antiretroviral therapy should be continued for participants who are known to be HIV-positive. 
6.6.2. 
Prohibited Medications and Procedures 
• Other anticancer therapies, including investigational treatments within 21 days before 
the first administration of study drug, and throughout the treatment period of the 
study. 
• Immunosuppression in excess of physiologic maintenance corticosteroid doses 
(> 10 mg of prednisone or equivalent) within 14 days of first dose and throughout the 
treatment period of the study (with the exception of acute treatment for an AE). 
• Probiotic dietary supplements. 
• Live vaccines within 28 days before first administration of study drug, throughout the 
treatment period of the study, and for a duration of 90 days after the last dose 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, BCG, and typhoid 
vaccine.  Seasonal influenza vaccines for injection are generally killed virus vaccines 
and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are 
live-attenuated vaccines and are not allowed. 
6.7. 
Treatment After the End of the Study 
Once a participant has discontinued study treatment, no further treatment will be provided in this 
study. 
7. 
DISCONTINUATION OF STUDY TREATMENT AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
7.1. 
Discontinuation of Study Drug 
7.1.1. 
Reasons for Discontinuation 
Participants must be withdrawn from study drug for the following reasons: 
• Disease progression (see Section 4.1). 
• Unacceptable toxicity as noted in Section 6.5.3. 


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• The participant becomes pregnant.  If the female participant is no longer pregnant and 
meets the treatment continuation criteria within 12 weeks of the scheduled start of a 
cycle, study treatment may be resumed after approval has been received from the 
medical monitor (see Section 9.7). 
• Consent is withdrawn. 
Note:  Consent withdrawn means that the participant has explicitly indicated that they 
do not want to participate in the study or be followed any longer; in this case no 
further data may be solicited from or collected on the participant. 
• Further study treatment would be injurious to the participant's health or well-being, in 
the investigator's medical judgment. 
• The study is terminated by the sponsor. 
• The study is terminated by the local health authority, IRB, or IEC. 
A participant may be discontinued from study drug as follows: 
• If a participant is noncompliant with study procedures or study drug administration in 
the investigator's opinion, the sponsor should be consulted for instruction on handling 
the participant. 
7.1.2. 
Discontinuation Procedures 
In the event that the decision is made to permanently discontinue the study drug, the EOT visit 
should be conducted.  Reasonable efforts should be made to have the participant return for a final 
safety visit.  These visits are described in Table 3 and Table 4.  The last date of the last dose of 
study drug and the reason for discontinuation of study drug will be recorded in the eCRF. 
If a participant is discontinued from study drug: 
• The study monitor or sponsor must be notified. 
• The reason(s) for discontinuation from study drug must be documented in the 
participant's medical record, and the primary reason must be included in the eCRF. 
• The EOT visit should be performed. 
• The date of the EOT visit should be recorded in the IRT. 
• After the EOT visit, participants will remain in the study to be followed for safety and 
AEs per Sections 8.8 and 9.  The 90-day safety visit may be conducted via phone call. 
Discontinuation from study drug does not mean withdrawal from the study, and remaining study 
procedures should be completed as indicated by the study Protocol. 
If the participant discontinues study drug, the participant will complete the EOT visit.  However, 
if a participant actively withdraws consent for collection of follow-up data (safety follow-up), 
then no additional data collection should occur. 


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7.2. 
Participant Withdrawal From the Study 
A participant may withdraw from the study at any time at his/her own request or may be 
withdrawn at any time at the discretion of the investigator for safety, behavioral, compliance, or 
administrative reasons. 
If the participant withdraws consent for disclosure of future information, the sponsor may retain 
and continue to use any data collected before such a withdrawal of consent. 
If a participant withdraws from the study, he/she may request destruction of any samples taken 
and not tested, and the investigator must document this in the site study records. 
See Table 3 for data to be collected at the time of study withdrawal. 
7.3. 
Lost to Follow-Up 
A participant will be considered lost to follow-up and withdrawn from the study if he/she 
repeatedly fails to return for scheduled visits and is unable to be contacted by the study site. 
8. 
STUDY ASSESSMENTS AND PROCEDURES 
8.1. 
Administrative and General Procedures 
8.1.1. 
Informed Consent Process 
• The investigator or his/her representative will explain the nature of the study to the 
participant or his/her legally authorized representative and answer all questions 
regarding the study. 
− 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 participant.  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 participant records. 
− The ICF must contain all required elements and describe the nature, scope, and 
possible consequences of the study in a form understandable to the study 
participant. 
• Participants must be informed that their participation is voluntary.  Participants or 
their legally authorized representative will be required to sign a statement of informed 
consent that meets the applicable requirements and regulations for the countries in 
which the study is being conducted as well as the IRB/IEC or study center. 
• The participant must be informed that his/her personal study-related data will be used 
by the sponsor in accordance with local data protection laws.  The level of disclosure 
must also be explained to the participant. 


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• The participant must be informed that his/her medical records may be examined by 
Clinical Quality Assurance auditors or other authorized personnel appointed by the 
sponsor, by appropriate IRB/IEC members, and by inspectors from regulatory 
authorities. 
• The medical record must include a statement that written informed consent was 
obtained before the participant was enrolled in the study and the date the written 
consent was obtained.  The authorized person obtaining the informed consent must 
also sign the ICF. 
• Participants must provide consent to the most current version of the ICF(s) during 
their participation in the study. 
• A copy of the ICF(s) must be provided to the participant or the participant's legally 
authorized representative. 
Participants who are rescreened are required to sign a new ICF. 
8.1.2. 
Screening Procedures 
Screening is the interval between signing the ICF and the day the participant is enrolled in the 
study (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 participant'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 the procedure meets the Protocol-defined criteria and has been 
performed in the timeframe of the study (ie, within 28 days of Cycle 1 Day 1).  For participants 
who are enrolled in the study, information associated with eligibility requirements must be 
entered into the appropriate eCRF pages. 
Tests with results that fail eligibility requirements may be repeated.  For screening assessments 
that are repeated, the most recent available result before treatment assignment will be used to 
determine eligibility. 
See Sections 5.4 and 5.5 for information regarding screen failures and replacement of 
participants, respectively. 
8.1.3. 
Interactive Response Technology Procedure 
Each participant will be identified in the study by a participant ID number, which is a 
combination of the site ID and participant number.  After determining that the participant is 
eligible for study entry at screening, site staff should contact the IRT to obtain the participant ID 
number.  Additionally, the IRT will be contacted at each regular study visit to track the status of 
participation (eg, completion or premature discontinuations as well as to update the study drug 
supply.  Additional details are provided in the IRT manual. 
8.1.4. 
Distribution of Reminder Cards 
Participants will be provided with a reminder card at each visit.  The reminder card will indicate 
the date/time of the next visit and will also inform the participant about visit-specific procedures. 


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Some study procedures may be conducted by phone call, where appropriate, or as per 
institutional guidelines during the COVID-19 pandemic.  This information will be described in 
detail in the ICF.  Some tests such as ECG or CT scan assessments may require longer 
time-windows due to the COVID-19 pandemic and thus may be done outside the regularly 
scheduled visits or may be conducted at the next scheduled visit.  These delays will not be 
considered protocol deviations if they are due to administrative difficulties or travel restrictions 
during the COVID-19 pandemic and are documented accordingly.  Details may be found in the 
eCRF guidelines or study monitoring plan, as applicable. 
8.1.5. 
Demography and Medical History 
8.1.5.1. 
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 age, race, ethnicity, medical and surgical history, and 
current illnesses. 
8.1.5.2. 
Disease Characteristics and Treatment History 
A disease-targeted medical and treatment history will be collected at screening.  Details 
regarding the participant's malignancy under study, including date of diagnosis, initial and 
current cancer stage, tumor histology, and relevant disease characteristics, and prior treatments, 
including systemic treatments, radiation, and surgical procedures, will be recorded. 
8.2. 
Efficacy Assessments 
Objective assessment of disease status will be evaluated according to RECIST v1.1 
(Eisenhauer et al 2009) and entered into the eCRF.  Efficacy assessments of response should be 
performed according to schedule found in Table 3.  Scans should follow calendar days and 
should not be delayed for treatment holds or interruptions.  Confirmation of CR or PR should be 
confirmed by imaging at least 4 weeks after initial documentation.   
Participants who discontinue study treatment will not require further disease assessments. 
8.2.1. 
Tumor Imaging 
Disease assessment and tumor response to study drug will be evaluated according to 
RECIST v1.1 guidelines (Eisenhauer et al 2009) as described in Appendix B.  The recommended 
method for measuring and following tumor burden will be CT scan, which should be performed 
using consistent techniques and facilities.  Alternative modalities such as MRI may be 
substituted for a CT scan at the discretion of the investigator, provided that the same modality is 
used throughout the study and the methodology is consistent with RECIST v1.1.  Initial tumor 
imaging must be performed within 28 days before the first dose of study drug.  Tumor lesions 
that are located in a previously irradiated area or in an area subjected to other loco regional 
therapy should not be selected as target lesions unless there has been demonstrated progression 
in the lesion.  Additionally, it is recommended that tumor lesions selected for excisional biopsy 
not be selected as target lesions.  After completion of the primary efficacy analysis, scans may be 
performed per the institutional standard of care.  Only the overall assessment (eg, response 
category) by the investigator to support continuation of study drug will be collected in the EDC. 


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Computed tomography or MRI scan of the brain will be performed at screening if there are signs 
or symptoms suggesting that the participant has disease involvement in the CNS. 
8.2.2. 
iRECIST 
iRECIST is not used to determine efficacy of INCMGA00012 in this study but may be used for 
patient management with the decision to treat beyond conventional RECIST progression 
documented in the study file. 
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.  
iRECIST was developed to ensure a consistent methodology for assessing response to 
immunotherapy (Seymour et al 2017).  The use of iRECIST accounts for potentially different 
response patterns of immunotherapies and includes a requirement for the confirmation of 
progression to rule out or confirm pseudoprogression, which should be performed between 4 and 
8 weeks after the initial determination of iUPD. 
8.2.3. 
Health Economics 
Not applicable. 
8.3. 
Safety Assessments 
See Section 6.5 for guidelines regarding the management of relevant laboratory or other safety 
assessment abnormalities. 
8.3.1. 
Adverse Events 
Adverse events will be monitored from the time the participant signs the ICF until at least 
28 days after the last dose of study drug.  Immune-related AEs will be collected until 90 days 
after the last dose of study drug.  The 90-day visit may be conducted via phone call.  Adverse 
events that begin or worsen after informed consent should be recorded on the Adverse Events 
Form in the eCRF regardless of the assumption of a causal relationship with the study drug.  
Conditions that were already present at the time of informed consent should be recorded on the 
Medical History Form in the eCRF.  Adverse events (including laboratory abnormalities that 
constitute AEs) should be described using a diagnosis whenever possible rather than by 
individual underlying signs and symptoms.  Adverse events judged to be potentially 
immune-related should be described on the appropriate eCRF (recommended diagnostic 
algorithms are provided in the Study Procedures Manual). 
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, 
surrogate, or the participant's legally authorized representative).  The investigator and any 
qualified designees are responsible for detecting, documenting, and recording events that meet 
the definition of an AE or SAE and remain responsible for following-up on AEs that are serious, 
considered related to the study drug/procedures, or that caused the participant to discontinue the 
study drug.  Care will be taken not to introduce bias when detecting AEs and/or SAEs.  
Open-ended and nonleading verbal questioning of the participant, such as "How are you 
feeling?" is the preferred method to inquire about AE occurrences.  Adverse events may also be 


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detected when they are volunteered by the participant during the screening process or between 
visits, or through physical examinations, laboratory tests, or other assessments.  The definition, 
reporting, and recording requirements for AEs are described in Section 9. 
All SAEs will be recorded and reported to the sponsor or designee within 24 hours.  The 
investigator will submit any updated SAE data to the sponsor within 24 hours of it being 
available. 
After the initial AE/SAE report, the investigator is required to proactively follow each participant 
at subsequent visits/contacts.  All SAEs, and nonserious AEs of special interest (as defined in 
Section 9.5), will be followed until resolution, stabilization, the event is otherwise explained, the 
participant reaches the end of the study, or the participant is lost to follow-up before the safety 
follow-up visit (as defined in Section 7.3). 
8.3.2. 
Physical Examinations 
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.  Abnormalities identified after the first dose of study drug constitute an AE if they are 
considered clinically meaningful, induce clinical signs or symptoms, require concomitant 
therapy, or require changes in study drug (with the exception of abnormalities associated with 
disease progression).  Investigators should pay special attention to clinical signs related to 
previous serious illnesses. 
At the screening visit and EOT, a comprehensive physical examination should be conducted.  
The comprehensive physical examination will include height and body weight and assessment 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. 
During the study, participants will be assessed by the investigator or medically qualified 
designee per institutional standard of care.  These assessments should be an evaluation as 
indicated by participant symptoms, AEs, or other findings and documented on the AE eCRF.  
Weight will also be assessed at each study visit. 
In addition, a disease-related clinical assessment should be performed at each study visit. 
8.3.3. 
Vital Signs 
Vital sign measurements (to be taken before blood collection for laboratory tests) include blood 
pressure, weight, pulse, respiratory rate, and body temperature.  Blood pressure and pulse will be 
taken with the participant in the recumbent, semirecumbent, or sitting position after 5 minutes of 
rest.  Abnormal vital sign results identified after the first dose of study drug constitute an AE if 
they are considered clinically meaningful, induce clinical signs or symptoms, require 
concomitant therapy, or require changes in study drug. 


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8.3.4. 
ECOG Performance Status 
ECOG performance status will be assessed according to the criteria in Table 11. 
Table 11: 
ECOG Performance Status 
Grade 
Performance Status 
0 
Fully active, able to carry on all pre-disease 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. 
8.3.5. 
Electrocardiograms 
Electrocardiograms will be obtained as outlined in Table 3 according to the institutional standard 
of care.  A 12-lead machine that automatically calculates heart rate and measures PR, QRS, QT, 
and QTc intervals is recommended.  All ECGs should be performed with the participant in a 
recumbent or semirecumbent position after 5 minutes of rest. 
The 12-lead ECGs will be interpreted by the investigator at the site to be used for immediate 
participant management.  Additional 12-lead ECGs may be performed as clinically indicated to 
manage participant safety.  The decision to include or exclude a participant or withdraw a 
participant from the study drug based on an ECG flagged as "Abnormal, Clinically Significant" 
is the responsibility of the investigator, in consultation with the sponsor's medical monitor, as 
appropriate.  Clinically notable abnormalities that are considered clinically significant in the 
judgment of the investigator are to be reported as AEs. 
8.3.6. 
Laboratory Assessments 
Clinical safety laboratory analyses (ie, blood chemistries, hematology assessments, coagulation 
tests, endocrine function, lipid panel [fasting], and urinalysis) will be performed in certified local 
laboratories associated with study sites.  Blood and urine samples will be collected for laboratory 
analyses during study visits, before study treatment administration, according to the schedule in 
Table 3.  The laboratory analytes to be evaluated are presented in Table 12.  Additional testing 
may be required by the sponsor based on emerging safety data.  Additional tests may also be 
performed if clinically indicated. 
Analysis by local laboratories for study treatment–related decisions are acceptable using a 
certified laboratory available to the investigative site.  The investigative site will enter the results 
and normal ranges into the eCRF from any local laboratory analysis. 
Further detailed information regarding collection, processing, and shipping of laboratory 
assessments is provided in the Laboratory Manual. 
Abnormal laboratory findings associated with AEs and not associated with the underlying 
disease are considered clinically significant.  All abnormal laboratory assessments considered 


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clinically significant up to 28 days after the last dose of study treatment should be repeated until 
the values are no longer considered clinically significant by the investigator. 
Screening laboratory assessments for study eligibility evaluation must be performed within 
28 days of Cycle 1 Day 1.  If screening laboratory analyses are performed less than 7 days before 
initial administration of study treatment, laboratory analyses do not need to be repeated if the 
requirements for receiving study drug are met. 
If performed more than 7 days before Cycle 1 Day 1, then the tests must be repeated before the 
initial study treatment administration on Cycle 1 Day 1.  After Cycle 1, predose laboratory 
procedures can be conducted up to 72 hours before study treatment administration, and results 
should be reviewed by the investigator or qualified designee and found to be acceptable before a 
new cycle of treatment is initiated. 
A final laboratory analysis is required during the 28-day follow-up safety visit.  These laboratory 
assessments should only be performed at the EOT visit if the EOT visit is also serving as the 
28-day safety visit. 
For participants who are known to be HIV-positive, laboratory checks of HIV viral load and 
CD4+ cell count will be performed every 8 weeks during the first year of study drug treatment.  
Frequency of HIV management testing may be reduced to every 3 months during the second year 
of treatment. 
8.3.6.1. 
Pregnancy Testing 
Serum pregnancy tests are required for all women of childbearing potential during screening and 
either EOT or the safety follow-up visit 28 days after the last dose.  Pregnancy testing is required 
on Day 1 of all cycles and can be either serum- or urine-based and will be performed before 
administration of study treatment.  If a pregnancy test is performed during screening within 
7 days of Cycle 1 Day 1, it is not necessary to repeat on Cycle 1 Day 1 (unless necessary based 
on country-specific requirements). 
A positive urine pregnancy should be confirmed with a serum pregnancy test.  If a pregnancy is 
confirmed by a serum pregnancy test, see Section 9.7. 
Timing and type of pregnancy testing may be adjusted based on country-specific requirements. 


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Table 12: 
Required Laboratory Analytes 
Serum Chemistries 
Hematology 
Urinalysis With 
Microscopic Examination 
Coagulation 
Pregnancy Testing 
Albumin 
Alkaline phosphatase 
ALT 
AST 
Amylase 
Bicarbonate or CO2a 
Blood urea nitrogen or ureaa 
Calcium 
Chloride 
Creatinine 
Glucose 
Lactate dehydrogenase 
Lipase 
Phosphate 
Potassium 
Sodium 
Total bilirubin 
Direct bilirubin (if total bilirubin 
is elevated above ULN) 
Total protein 
Uric acid 
Complete blood count, 
including: 
• Hemoglobin 
• Hematocrit 
• Platelet count 
• Red blood cell count 
• WBC count 
 
Differential count, 
including: 
• Basophils 
• Eosinophils 
• Lymphocytes 
• Monocytes 
• Neutrophils 
 
Absolute values must be 
provided for: 
• WBC differential 
laboratory results 
Color and appearance 
pH and specific gravity 
Bilirubin 
Glucose 
Ketones 
Leukocytes 
Nitrite 
Occult blood 
Protein 
PT 
PTT or aPTT 
INR 
Women of childbearing 
potential  
Lipid Panel (Fasting) 
Endocrine Function 
HIV Management 
Total cholesterol 
Triglycerides 
LDL 
HDL 
Thyroid-stimulating hormone 
(TSH) 
Thyroxine (T4/FT4)a 
Triiodothyronine (T3/FT3)a 
Only applicable for 
participants known to be 
HIV-positive 
HIV viral load 
CD4+ cell count 
Note:  Additional tests may be required, as agreed by investigator and sponsor, based on emerging safety data. 
a If considered standard by the region. 


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8.4. 
Pharmacokinetic Assessments 
Assessment of PK is an important objective of this study, representing the first clinical 
experience with administration of INCMGA00012 as a 30-minute infusion.  Blood samples for 
PK 
 analysis will be obtained at the visits and timepoints indicated in Table 4.   
After the preinfusion PK sample is drawn, participants will begin the study drug infusion.  
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. 
8.5. 
Pharmacodynamic 
 Assessments 
8.5.1. 
Description of Analyses 
Additional optional specimens may be collected at any time during study to assess changes 
associated with safety, efficacy, or resistance to treatment. 
 
 
Analyses will be conducted by Incyte Corporation (Wilmington, DE) or Incyte’s designee.  The 
collection schedule is found in Table 4. 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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8.6. 
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. 
8.7. 
End of Treatment and/or Early Termination 
Once a participant permanently discontinues study treatment, the EOT visit should be conducted, 
and the data should be entered in the EOT visit in the eCRF.  If the EOT visit coincides with a 
regular study visit, the EOT evaluations will supersede those of that scheduled visit.  Should 
study treatment discontinuation occur < 21 days after the final dose of study treatment, a 28-day 
safety follow-up visit is required and should be conducted according to Table 3.  If the EOT visit 
occurs ≥ 21 days after the last study treatment, only a single EOT/28-day safety follow up is 
required; otherwise, the EOT visit will also serve as the 28-day safety follow-up visit, and the 
EOT assessment schedule will be followed. 
8.8. 
Follow-Up 
The study design includes a follow-up period for participants subsequent to the end of the study 
treatment period.  After discontinuation of study treatment, all study participants continue in the 
follow-up period of the study. 
8.8.1. 
Safety Follow-Up 
The safety follow-up period starts once the participant discontinues study treatment.  
Approximately 28 days after the final dose of study drug (± 7 days), participants are to attend a 
clinical visit for a safety evaluation.  During this visit, blood will be collected for safety 
laboratory analysis, a physical exam will be performed, and AEs and concomitant medications 
will be assessed according to the scheduled assessments found in Table 3.  Participants will be 
followed for irAEs for 90 days after the last dose of study drug or until the participant begins a 
new anticancer therapy, whichever occurs first.  If a participant is scheduled to begin a new 
anticancer therapy before the end of the 28-day safety follow-up period, the safety follow-up 
visit should be performed before the new anticancer therapy is started. 


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9. 
ADVERSE EVENTS:  DEFINITIONS AND PROCEDURES FOR 
RECORDING, EVALUATING, FOLLOW-UP, AND REPORTING 
9.1. 
Definition of Adverse Event 
Adverse Event Definition 
• An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or 
not considered drug-related. 
• An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory 
finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. 
Events Meeting the Adverse Event Definition 
• Any safety assessments (eg, ECG, vital signs measurements), including those that worsen from 
baseline, considered clinically significant in the medical and scientific judgment of the investigator 
(ie, not related to progression of underlying disease). 
• Abnormal laboratory test results constitute an AE if they are considered clinically meaningful, induce 
clinical signs or symptoms, require concomitant therapy, or require changes in study drug.  
Whenever possible, a diagnosis (eg, anemia, thrombocytopenia) should be recorded in the eCRF 
rather than the abnormal lab result (eg, low hemoglobin, platelet count decreased). 
• Exacerbation of a chronic or intermittent pre-existing condition including either an increase in 
frequency and/or intensity of the condition. 
• New conditions detected or diagnosed after study drug administration even though they may have 
been present before the start of the study. 
• Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction. 
• Signs, symptoms, or the clinical sequelae of a suspected overdose of either study drug or a 
concomitant medication.  Overdose per se will not be reported as an AE/SAE unless it is an 
intentional overdose taken with possible suicidal/self-harming intent.  Such overdoses should be 
reported regardless of sequelae. 


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Events NOT Meeting the Adverse Event Definition 
• Any clinically significant abnormal laboratory findings or other abnormal safety assessments that are 
associated with the underlying disease, unless judged by the investigator to be more severe than 
expected for the participant's condition. 
• The disease/disorder being studied or expected progression, signs, or symptoms of the 
disease/disorder being studied, unless more severe than expected for the participant's condition or 
considered to be treatment-related by the investigator. 
• Efficacy endpoints as outlined in Section 3 will not be reported as AE/SAEs, specifically, any event 
that is related to disease progression of the cancer under study.  Unblinded aggregated efficacy 
endpoint events and safety data will be monitored to ensure the safety of the participants in the study.  
Any suspected endpoint that upon review is not progression of the cancer under study will be 
forwarded to Incyte Pharmacovigilance as a SAE within 24 hours of determination that the event is 
not progression of the cancer under study. 
• Medical or surgical procedure (eg, endoscopy, appendectomy):  the condition that leads to the 
procedure is the AE if it occurred after signing informed consent.  If present before entering the 
study, the condition should be captured as medical history. 
• Situations in which an untoward medical occurrence did not occur (social and/or convenience 
admission to a hospital). 
• Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present or detected at 
the start of the study that do not worsen. 
9.2. 
Definition of Serious Adverse Event 
If an event is not an AE per definition above, then it cannot be an SAE even if serious conditions 
are met (eg, hospitalization for signs/symptoms of the disease under study, death due to 
progression of disease). 
A Serious Adverse Event is defined as any untoward medical occurrence that, at any dose: 
a. Results in death 
b. Is life-threatening 
The term 'life-threatening' in the definition of 'serious' refers to an adverse drug experience that places 
the participant, in the opinion of the initial reporter, at immediate risk of death from the adverse 
experience as it occurred.  This does not include an adverse drug experience that, had it occurred in a 
more severe form, might have caused death. 
c.  Requires inpatient hospitalization or prolongation of existing hospitalization 
In general, hospitalization signifies that the participant has been detained (usually involving at least an 
overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have 
been appropriate in the physician's office or outpatient setting.  Complications that occur during 
hospitalization are AEs.  If a complication prolongs hospitalization or fulfills any other serious criteria, 
the event is serious.  When in doubt as to whether "hospitalization" occurred or was necessary, the AE 
should be considered serious. 
Hospitalization for elective treatment of a pre-existing condition that did not worsen from baseline is 
not considered an AE. 


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d. Results in persistent or significant disability/incapacity 
• The term disability means a substantial disruption of a person's ability to conduct normal life 
functions. 
• This definition is not intended to include experiences of relatively minor medical significance, such 
as uncomplicated headache, nausea, vomiting, diarrhea, influenza, and accidental trauma (eg, 
sprained ankle), that may interfere with or prevent everyday life functions but do not constitute a 
substantial disruption. 
e.  Is a congenital anomaly/birth defect 
f. Other situations (Important Medical Event) 
An 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 
participant and may require medical or surgical intervention to prevent one of the outcomes listed in 
the above definition.  Examples of such events include invasive or malignant cancers (excluding the 
disease[s] under study in oncology protocols), intensive treatment in an emergency department or at 
home for allergic bronchospasm, blood dyscrasias, or convulsions that do not result in hospitalization, 
or development of drug dependency or drug abuse. 
9.3. 
Recording and Follow-Up of Adverse Events and/or Serious Adverse 
Events 
Adverse Event and Serious Adverse Event Recording 
• An AE/SAE that begins or worsens after informed consent is signed should be recorded on the 
Adverse Event Form in the eCRF.  Conditions that were present at the time informed consent was 
given should be recorded on the Medical History Form in the eCRF. 
• When an AE/SAE occurs, it is the responsibility of the investigator to review all documentation 
(eg, hospital progress notes, laboratory reports, and diagnostics reports) related to the event. 
• The investigator (or delegate) will then record all relevant AE/SAE information in the eCRF. 
• It is not acceptable for the investigator to send photocopies of the participant's medical records in 
lieu of completing the AE eCRF page. 
• There may be instances when copies of medical records for certain cases are requested.  In this case, 
all participant identifiers, with the exception of the participant number, will be redacted on the copies 
of the medical records before submission. 
• The investigator will attempt to establish a diagnosis of the event based on signs, symptoms, and/or 
other clinical information.  Whenever possible, the diagnosis (not the individual signs/symptoms) 
will be documented as the AE/SAE.  When a clear diagnosis cannot be identified, each sign or 
symptom should be reported as a separate AE/SAE. 
To the extent possible, each AE/SAE should be evaluated to determine: 
• The severity grade (CTCAE Grade 1 to 5).  See below for further instructions on the assessment of 
intensity. 
• Whether there is at least a reasonable possibility that the AE is related to the study drug:  suspected 
(yes) or not suspected (no).  See below for further instructions on the assessment of causality. 
• The start and end dates, unless unresolved at final follow-up. 
• The action taken with regard to each study drug as a result of the AE/SAE(s). 


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• The event outcome (eg, not recovered/not resolved, recovered/resolved, recovering/resolving, 
recovered/resolved with sequelae, fatal, unknown). 
• The seriousness, as per the SAE definition provided in Section 9.2. 
• The action taken with regard to the event.  Note:  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 appropriate eCRF (eg, Prior/Concomitant Medications, Procedures and Non-Drug 
Therapy). 
Assessment of Intensity 
The severity of AEs will be assessed using CTCAE v5.0 Grades 1 through 5.  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: 
The investigator will make an assessment of intensity for each AE and SAE reported during the study 
and assign it to 1 of the following categories: 
• Grade 1:  Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment 
not indicated. 
• Grade 2:  Moderate; minimal, local, or noninvasive treatment indicated; limiting age appropriate 
activities of daily living. 
• Grade 3:  Severe or medical 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 treatment indicated. 
• Grade 5:  Fatal. 
Assessment of Causality 
• The investigator is obligated to assess the relationship between each study drug and each occurrence 
of each AE/SAE. 
• A "reasonable possibility" of a relationship conveys that there are facts, evidence, and/or arguments 
to suggest a causal relationship, rather than that a relationship cannot be ruled out. 
• The investigator will use clinical judgment to determine the relationship. 
• The investigator will also consult the Reference Safety Information in the IB and/or Product 
Information, for marketed products, in his/her assessment. 
• Alternative causes, such as underlying disease(s), concomitant therapy, and other risk factors, as well 
as the temporal relationship of the event to study drug administration, will be considered and 
investigated. 
• For each AE/SAE, the investigator must document in the medical notes that he/she has reviewed the 
AE/SAE and has provided an assessment of causality. 
• With regard to assessing causality of SAEs: 
− There may be situations in which an SAE has occurred and the investigator has minimal 
information to include in the initial report.  However, the causality assessment is one of the criteria 
used when determining regulatory reporting requirements.  Therefore, it is very important that 
the investigator always make an assessment of causality for every event before the initial 
transmission of the SAE. 
− The investigator may change his/her opinion of causality in light of follow-up information and 
send a follow-up SAE report with the updated causality assessment. 


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Follow-Up of Adverse Events and Serious Adverse Events 
• The investigator is obligated to perform or arrange for the conduct of supplemental measurements 
and/or evaluations as medically indicated or as requested by the sponsor to elucidate the nature 
and/or causality of the AE or SAE as fully as possible.  This may include additional laboratory tests 
or investigations, histopathological examinations, or consultation with other health care 
professionals. 
• New or updated information will be recorded in the originally completed eCRF. 
• Any updated SAE data will be submitted to the sponsor (or designee) within 24 hours of receipt of 
the information. 
• 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. 
9.4. 
Reporting of Serious Adverse Events 
Regardless of suspected causality (eg, relationship to study drug or study procedures), all SAEs 
occurring after the participant has signed the ICF through 28 days after the last dose of study 
drug must be reported to the sponsor (or designee) within 24 hours of learning of its occurrence, 
unless otherwise specified by the Protocol.  Serious AEs that are irAEs must be reported until 
90 days after the last dose of study drug or the start of a new anticancer therapy, whichever 
occurs first.  The investigator will submit any updated SAE data to the sponsor (or designee) 
within 24 hours of it being available. 
Investigators are not obligated to actively seek AE or SAE information after conclusion of the 
study participation.  However, if the investigator learns of any SAE, including a death, at any 
time after a participant has been discharged from the study, and he/she considers the event to be 
reasonably related to the study drug or study participation, the investigator must notify the 
sponsor (or designee) within 24 hours of becoming aware of the event. 
After the initial AE/SAE report, the investigator is required to proactively follow each participant 
at subsequent visits/contacts.  All SAEs, and nonserious AEs of special interest (as defined in 
Section 9.5), will be followed until resolution, stabilization, the event is otherwise explained, the 
participant completes study, or the participant is lost to follow-up (as defined in Section 7.3). 
Prompt notification by the investigator to the sponsor of a SAE is essential so that legal 
obligations and ethical responsibilities towards the safety of participants and the safety of a study 
drug under clinical investigation are met. 
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 to inform all investigators involved in any study 
with the same drug that this SAE has been reported.  Suspected unexpected serious adverse 
reactions will be collected and reported to the competent authorities and relevant ethics 


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committees in accordance with Directive 2001/20/EC, or as per national regulatory requirements 
in participating countries. 
The sponsor has a legal responsibility to notify both the local regulatory authority and other 
regulatory agencies about the safety of a study drug under clinical investigation.  The sponsor 
will comply with country-specific regulatory requirements relating to safety reporting to the 
regulatory authority, IRB/IEC, and investigators. 
Investigator safety reports must be prepared for suspected unexpected serious adverse reactions 
according to local regulatory requirements and sponsor policy and forwarded to investigators as 
necessary. 
An investigator who receives an investigator safety report describing a SAE or other specific 
safety information (eg, summary or listing of SAEs) from the sponsor will review and then file it 
along with the IB and will notify the IRB/IEC, if appropriate according to local requirements. 
Serious Adverse Event Reporting 
• Information about all SAEs is collected and recorded on the Adverse Event Form in the eCRF. 
• The investigator must also complete the Incyte Serious Adverse Event Report Form, in English.  
Refer to the Incyte Reference Guide for Completing the Serious Adverse Event Report Form. 
• Facsimile or email transmission of the Serious Adverse Event Report Form is the preferred method 
to transmit this information to PhV/designee.  The contact information of the sponsor's study-specific 
representatives is listed in the Study Procedures Manual provided to each site.  The original copy of 
the Serious Adverse Event Report Form and the confirmation sheet must be kept at the study site. 
• Follow-up information is recorded on an amended or new Serious Adverse Event 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 Serious 
Adverse Event Report Form, such as the outcome of the event (eg, resolved or ongoing), treatment 
provided, action taken with each study drug because of the SAE (eg, dose interrupted or 
discontinued), or participant 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. 
• In rare circumstances and in the absence of facsimile or computer equipment, notification by 
telephone is acceptable with a copy of the Incyte Serious Adverse Event Report Form sent by 
overnight mail or courier service.  Initial notification via telephone does not replace the need for the 
investigator to complete and sign the Serious Adverse Event Report Form within the designated 
reporting time frames. 
• Contacts for SAE reporting can be found in the Study Procedures Manual. 
9.5. 
Adverse Events of Special Interest 
Adverse events that are potentially immune-related will be assessed as AEs of special interest.  
Examples of these (including diagnostic algorithms to be followed) are provided in the Study 
Procedures Manual. 
9.6. 
Emergency Unblinding of Treatment Assignment 
Not applicable. 


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9.7. 
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 participant during maternal or paternal exposure to study 
drug, the following procedures should be followed in order to ensure safety: 
• The study drug must be interrupted immediately (female participants only). 
• If the female participant is no longer pregnant and meets the treatment continuation 
criteria within 12 weeks of the scheduled start of a cycle, study drug may be resumed 
after approval has been received from the sponsor medical monitor. 
• 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. 
Data on fetal outcome 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 of a study participant must be recorded on the 
Serious Adverse Event Report Form and submitted to the sponsor or designee. 
Abnormal pregnancy outcomes (eg, spontaneous abortion, fetal death, stillbirth, congenital 
anomalies, or ectopic pregnancy) are considered SAEs (if occurring in the study participant) and 
must be reported as described in Section 9.4.  If an abnormal pregnancy outcome is reported in a 
study participant's partner, the event should be reported to the sponsor on the Clinical Trial 
Pregnancy Form. 
9.8. 
Warnings and Precautions 
Special warnings or precautions for study drug, derived from safety information collected by the 
sponsor or its designee, are presented in the IB.  Additional safety information collected between 
IB updates will be communicated in the form of Investigator Notifications.  Any important new 
safety information should be discussed with the participant during the study, as necessary.  If 
new significant risks are identified, they will be added to the ICF. 
9.9. 
Product Complaints 
The sponsor collects product complaints on study drug 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. 


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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 recorded as described in Section 9.3. 
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. 
10. 
STATISTICS 
10.1. 
Sample Size Determination 
This study is planned as a signal-finding study for efficacy in tumor types of interest for future 
development.  Approximately 30 participants are planned to be enrolled in each disease-specific 
cohort to provide a preliminary assessment of efficacy, safety, and PK.  The response rate and 
95% CI for each disease cohort based on 30 participants are provided in Table 13.  The relevant 
benchmarks are provided in Table 5. 
Table 13: 
Response Rate and 95% Confidence Interval 
10.2. 
Populations for Analysis 
Table 14 presents the populations for analysis. 
Sample Size 
Number of Responses 
Response Rate (%) 
95% CI (%) 
30 
3 
10.0 
2.1, 26.5 
30 
5 
16.7 
5.6, 34.7 
30 
7 
23.3 
9.9, 42.3 
30 
9 
30.0 
14.7, 49.4 
30 
11 
36.7 
19.9, 56.1 
30 
12 
40.0 
22.7, 59.4 


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Table 14: 
Populations for Analysis 
Population 
Description 
Full analysis set 
The FAS includes all study participants who have received at least 1 dose of study 
drug.  Participants will be analyzed based on disease-specific diagnosis.  The FAS 
will be used for demographics, baseline characteristics, and all efficacy analysis. 
Safety evaluable The safety evaluable population includes all participants who received at least one 
dose of study drug.  All safety analyses will be conducted using the safety evaluable 
population.  In this study, the FAS and safety evaluable population are identical. 
PK evaluable 
The PK evaluable population will include all participants who received at least 
1 dose of study drug and have provided a baseline and at least 1 postdose PK 
sample. 
10.3. 
Level of Significance 
There is no formal hypothesis testing in this study.  Response rate as well as the associated 
95% CI will be provided. 
10.4. 
Statistical Analyses 
The Statistical Analysis Plan will be developed and finalized before database lock and will 
describe the participant populations to be included in the analyses and procedures for accounting 
for missing, unused, and spurious data.  This section is a summary of the planned statistical 
analyses of the primary and secondary endpoints. 
10.4.1. 
Primary Analysis 
All efficacy analyses will be performed independently for each disease cohort. 
10.4.1.1. Overall Response Rate 
The primary endpoint of the study is ORR, defined as the proportion of participants with an 
objective response (CR or PR), according to RECIST v1.1 (Eisenhauer et al 2009) as determined 
by the investigator.  The primary analysis of ORR will be based on the FAS population as 
defined in Table 14 and will be performed once all participants on study treatment have been 
followed for at least 6 months from the start of treatment or prematurely discontinued study 
treatment.  Overall response rate and its exact 95% CI will be presented.  Overall response rate 
will not be recalculated after the primary analysis is performed. 
10.4.1.2. Handling of Missing Data in Primary Analysis 
A response assessment of CR or PR reported before any additional anticancer therapy will be 
considered as a response in the calculation of ORR irrespective of the number of missed 
assessments before response.  Participants with subsequent missing assessments that prevent the 
evaluation of the primary endpoint will be considered as nonresponders.  No data imputation will 
be applied. 


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10.4.2. 
Secondary Analysis 
10.4.2.1. Duration of Response 
Duration of response is defined as the time from first objective response (CR or PR) to the time 
of first documented disease progression according to RECIST v1.1 or death due to any cause.  
If a participant does not have disease progression or death, the DOR will be censored at the date 
of the last adequate tumor assessment before data cutoff or new anticancer therapy.  The 
Kaplan-Meier estimate of the distribution function will be constructed for DOR.  The estimated 
median along with 95% CI will be reported. 
10.4.2.2. Disease Control Rate 
Disease control rate is defined as the proportion of participants with either an objective response 
(CR or PR) or SD, according to RECIST v1.1. 
10.4.2.3. Progression-Free Survival 
Progression-free survival, defined as the time from first dose of study drug to the date of the first 
documented progression per RECIST v1.1 or death due to any cause.  Progression free survival 
data will be analyzed by the Kaplan-Meier method, including estimated median with 95% CI, 
and Kaplan-Meier estimated probabilities at several timepoints.  If an event is not observed, 
PFS will be censored at the last adequate tumor assessment before cutoff or new anticancer 
therapy. 
10.4.2.4. Overall Survival 
Overall survival is defined as the time from first dose of study drug to the date of death due to 
any cause.  Kaplan-Meier estimate of OS will be provided, including median and its 95% CI.  
Participants still alive at time of analysis will be censored at the date last confirmed to be alive.  
Kaplan-Meier curves, medians, and 95% CIs of the medians will be presented. 
10.4.3. 
Safety Analyses 
10.4.3.1. Adverse Events 
Safety analyses will be conducted for the safety evaluable population.  Adverse events will be 
coded by the MedDRA dictionary, and TEAE (ie, AEs reported for the first time or worsening of 
a pre-existing event after first dose of study drug) will be tabulated by preferred term and system 
organ class for all events, related events, and events of Grade 3 or higher. 
10.4.3.2. Clinical Laboratory Tests 
The clinical laboratory data will be analyzed using summary statistics.  In addition, distributions 
of key laboratory parameters may be plotted over time; these values will also be classified into 
CTCAE toxicity grades and tabulated. 
Laboratory test values outside 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 


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shift tables relative to baseline will be tabulated.  The following summaries will be produced for 
the laboratory data: 
• Number and percentage of participants with worst postbaseline CTCAE grade 
(regardless of baseline value).  Each participant 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. 
10.4.3.3. Vital Signs 
Descriptive statistics and mean change from baseline will be determined for vital signs (blood 
pressure, pulse, respiratory rate, weight, and body temperature) at each assessment time.  Vital 
sign results will be reviewed for clinically notable abnormalities, and participants exhibiting 
clinically notable vital sign abnormalities will be listed. 
10.4.3.4. Electrocardiograms 
Descriptive statistics and mean change from baseline will be determined for each ECG 
parameter.  Electrocardiogram results will be reviewed for clinically notable abnormalities 
according to predefined criteria as described in the Statistical Analysis Plan. 
10.4.3.5. Dose Intensity 
Measures of exposure (eg, days of exposure, dose intensity) of study drug will be summarized by 
means of summary statistics. 
10.4.4. 
Pharmacokinetics 
If there is a sufficient amount of serum concentration data from this study, the data will be 
analyzed by standard population PK methods using appropriate software (eg, NONMEM).  
Otherwise, the data will be pooled with data from other studies for a population PK analysis. 
 
  
 
 
 
 
 
 
 


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11. 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS 
11.1. 
Investigator Responsibilities 
• The Protocol, Protocol amendments, ICF, IB, and other relevant documents 
(eg, advertisements) must be submitted to an IRB/IEC by the investigator and 
reviewed and approved by the IRB/IEC before the study is initiated. 
• The investigator is responsible for ensuring that the safety reports provided by the 
sponsor are reviewed and processed in accordance with regulatory requirements, the 
policies and procedures established by the IRB/IEC, and institutional requirements. 
• Any amendments to the Protocol will require IRB/IEC approval before 
implementation of changes made to the study design, except for changes necessary to 
eliminate an immediate hazard to study participants. 
• The investigator will be responsible for the following: 
− Providing written summaries of the status of the study to the IRB/IEC annually or 
more frequently in accordance with the requirements, policies, and procedures 
established by the IRB/IEC. 
− Notifying the IRB/IEC of SAEs or other significant safety findings as required by 
IRB/IEC procedures. 
− Providing oversight of the conduct of the study at the site and adherence to GCP, 
IRB/IEC requirements, institutional requirements, and applicable laws and 
country-specific regulations. 
• 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 participants 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. 


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11.2. 
Data Management 
Data management will be performed in a validated EDC system.  The investigator will be 
provided with access to an EDC system so that an eCRF can be completed for each participant. 
The site will be provided eCRF completion guidelines for instructions on data entry in 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. 
The sponsor (or designee) will be responsible for: 
• The data management of this study including quality checking of the data. 
• Ensuring that study monitors perform ongoing source data verification to confirm that 
data entered into the eCRF by authorized site personnel are accurate, complete, and 
verifiable from source documents; that the safety and rights of participants are being 
protected; and that the study is being conducted in accordance with the currently 
approved protocol and any other study agreements, ICH GCP, and all applicable 
regulatory requirements. 
The investigator will be responsible for: 
• Ensuring participant data relating to the study is recorded in the eCRF unless 
transmitted to the sponsor or designee electronically (eg, laboratory data, diary data) 
or as otherwise specified in the Protocol.  The investigator is responsible for verifying 
that data entries are accurate and correct by physically or electronically signing the 
eCRF. 
• Maintaining accurate documentation (source data) that supports the information 
entered in the eCRF. 
− Source documents provide evidence for the existence of the participant and 
substantiate the integrity of the data collected.  Source documents are filed at the 
investigator's site. 
− Data reported on the CRF or entered in the eCRF that are transcribed from source 
documents must be consistent with the source documents or the discrepancies 
must be explained.  The investigator may need to request previous medical 
records or transfer records, depending on the study.  Also, current medical records 
must be available. 
• 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 
participant records at each monitoring visit.  The sponsor reserves the right to 
review radiology studies that were used in determining response to study drug at 
any point during conduct of the study. 


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− 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 participants. 
− 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. 
11.3. 
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. 
Participant names will not be supplied to the sponsor or its designee.  Only the participant 
number will be recorded in the eCRF; if the participant'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. 
Records and documents, including signed ICFs, pertaining to the conduct of this study must be 
retained by the investigator for 10 years after study completion unless local regulations or 
institutional policies require a longer retention period.  No records may be destroyed during the 
retention period without the written approval of the sponsor.  No records may be transferred to 
another location or party without written notification to the sponsor. 
11.4. 
Financial Disclosure 
Before study initiation, all clinical investigators participating in clinical studies subject to FDA 
Regulation Title 21 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 participants, 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 


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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. 
11.5. 
Publication Policy 
By signing the study Protocol, the investigator and his/her institution agree that the results of the 
study may be used by the sponsor, Incyte Corporation (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. 
The results of this study may be published or presented at scientific meetings.  If this is foreseen, 
the investigator agrees to submit all manuscripts or abstracts to the sponsor before submission.  
This allows the sponsor to protect proprietary information and to provide comments. 
The sponsor will comply with the requirements for publication of study results.  In accordance 
with standard editorial and ethical practice, the sponsor will generally support publication of 
multicenter studies only in their entirety and not as individual site data.  In this case, a 
coordinating investigator will be designated by mutual agreement. 
Authorship will be determined in line with International Committee of Medical Journal Editors 
authorship requirements. 
11.6. 
Study and Site Closure 
The sponsor designee reserves the right to close the study site or terminate the study at any time 
for any reason at the sole discretion of the sponsor.  Study sites will be closed upon study 
completion.  A study site is considered closed when all required documents and study supplies 
have been collected and a study-site closure visit has been performed. 
The investigator may initiate study-site closure at any time, provided there is reasonable cause 
and sufficient notice is given in advance of the intended termination. 
Reasons for the early closure of a study site by the sponsor or investigator may include but are 
not limited to: 
• Failure of the investigator to comply with the protocol, the requirements of the 
IRB/IEC or local health authorities, the sponsor's procedures, or GCP guidelines. 
• Inadequate recruitment of participants by the investigator. 
• Discontinuation of further study drug development. 


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12. 
REFERENCES 
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Balar AV, Castellano D, O’Donnell PH, et al. First-line pembrolizumab in cisplatin-ineligible 
patients with locally advanced and unresectable or metastatic urothelial cancer (KEYNOTE-
052): a multicentre, single-arm, phase 2 study. Lancet Oncol 2017;18:1483-1492. 
Bellmunt J, de Wit R, Vaughn DJ, et al. Pembrolizumab as second-line therapy for advanced 
urothelial carcinoma. N Engl J Med 2017;376:1015-1026. 
Brahmer J, Lacchetti C, Schneider B, et al. Management of immune-related adverse events in 
patients treated with immune checkpoint inhibitor therapy: American Society of Clinical 
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Brahmer J, Rodríguez-Abreu D, Robinson A, et al. OA 17.06 Updated analysis of 
KEYNOTE-024: pembrolizumab vs platinum-based chemotherapy for advanced NSCLC with 
PD-L1 TPS ≥50%. J Thorac Oncol 2017;12(supp2):S1793-S1794. 
Carbone DP, Reck M, Paz-Ares L, et al. First-line nivolumab in stage IV or recurrent non-small-
cell lung cancer. N Engl J Med 2017;376:2415-2426. 
Chen X, Wang P, Kaul S, Sumrow B, Yeleswaram S. Assessment of flat dosing strategy for 
INCMGA00012 in patients with advanced tumors. In: Proceedings of the 110th Annual Meeting 
of the American Association for Cancer Research; March 29-April 3, 2019; Atlanta, GA. 
Philadelphia, PA: AACR; 2019. Abstract LB-268. 
Clinical Trial Facilitation Group. Recommendations related to contraception and pregnancy 
testing in clinical trials. 2014. http://www.hma.eu/fileadmin/dateien/Human_Medicines/ 
01-About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf. 
Accessed September 4, 2018. 
Condamine T, Owens S, Feldman P, et al. Pharmacodynamic correlates in a Phase 1 study of 
INCMGA00012, a PD-1 antagonistic monoclonal antibody. In: Proceedings of the 110th Annual 
Meeting of the American Association for Cancer Research; March 29-April 3, 2019; Atlanta, 
GA. Philadelphia, PA: AACR; 2019. Abstract CT085. 
Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumors: 
revised RECIST guideline (version 1.1). Eur J Cancer 2009;45:228-247. 
Escudier B, Tannir N, McDermott D, et al. Checkmate 214: Efficacy and safety of nivolumab 
plus ipilimumab vs sunitinib for treatment-naïve advanced or metastatic renal cell carcinoma, 
including IMDC risk and PD-L1 expression subgroups. Presented at: European Society for 
Medical Oncology Annual Congress; September 8-12, 2017; Madrid, Spain. 
Freshwater T, Kondic A, Ahamadi M, et al. Evaluation of dosing strategy for pembrolizumab for 
oncology indications. J Immunother Cancer 2017;5:43. 


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Haanen JBAG, Carbonnel F, Robert C, et al. Management of toxicities from immunotherapy: 
ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 
2017;28:iv119-iv142. 
Haanen JBAG, Carbonnel F, Robert C, et al. ESMO Guidelines Committee. Management of 
toxicities from immunotherapy: ESMO Clinical Practice Guidelines for diagnosis, treatment and 
follow-up. Ann Oncol. 2018;29:iv264-iv266. 
Herbst RS, Baas P, Kim DW, et al. Pembrolizumab versus docetaxel for previously treated, 
PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised 
controlled trial. Lancet 2016;387:1540–1550. 
INCMGA00012 Investigator's Brochure. Wilmington, DE: Incyte Corporation. 
Keytruda (pembrolizumab) [prescribing information]. Merck & Co., Inc; June 2018. 
Lakhani N, Mehnert JM, Rasco D, et al. A phase 1 study of the safety, tolerability, and 
pharmacokinetics (PK) of MGA012 (anti-PD-1 antibody) in patients with advanced solid tumors. 
Poster presented at: 32nd Congress of the Society for Immunotherapy of Cancer; 
November 8-12, 2017; National Harbor, MD. Abstract P249. 
McDermott D, Lee J, Szczylik C, et al. Pembrolizumab monotherapy as first-line therapy in 
advanced clear cell renal cell carcinoma (accRCC): results from cohort A of KEYNOTE-427. 
J Clin Oncol 2018;36(suppl):Abstract 4500. 
Mehnert J, Joshua A, Lakhani N, et al. First-in-human Phase 1 study of INCMGA00012 in 
patients with advanced solid tumors: interim results of the cohort expansion phase. Presented at: 
The Society for Immunotherapy of Cancer Annual Meeting; November 7-11, 2018; Washington, 
DC. Abstract P669. 
Motzer R, Escudier B, McDermott D, et al. Nivolumab versus everolimus in advanced renal-cell 
carcinoma. N Engl J Med 2015;373:1803-1813. 
Motzer RJ, Tannin N, McDermott D, et al. Nivolumab plus ipilimumab versus sunitinib in 
advanced renal-cell carcinoma. N Engl J Med 2018;378:1277-1290. 
National Cancer Institute (NCI). Common Terminology Criteria for Adverse Events (CTCAE) 
Version 5.0. 2017. 
https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/CTCAE_v5_Quick_R
eference_5x7.pdf. Accessed August 8, 2019. 
National Comprehensive Cancer Network. National Comprehensive Cancer Network Clinical 
Practice Guidelines in Oncology: Management of Immunotherapy-Related Toxicities Version 1. 
2021. 
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. 
Opdivo (nivolumab) [prescribing information]. Bristol-Myers Squibb Company; August 2018. 
Robert C, Long GV, Brady, B, et al. Nivolumab in previously untreated melanoma without 
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Seymour L, Bogaerts J, Perrone A, et al. iRECIST: guidelines for response criteria for use in 
trials testing immunotherapeutics. Lancet Oncol 2017;18:e143-e152. 
Topalian SL, Hodi FS, Brahmer JR, et al. Safety, activity, and immune correlates of anti–PD-1 
antibody in cancer. N Engl J Med 2012;366:2443-2454. 
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of monoclonal antibodies in adult clinical trials. J Clin Pharmacol 2009;49:1012-1024. 


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APPENDIX A. INFORMATION REGARDING EFFECTIVENESS OF 
CONTRACEPTIVE METHODS 
For male participants in the study: 
Male participants should use a condom from screening through 6 months after the end of systemic 
exposure.  If the male participant has a partner that is of child-bearing potential, the partner should also 
use contraception through 6 months after the end of relevant systemic exposure.  In addition, male 
participants must refrain from donating sperm from screening through 6 months after the end of 
relevant systemic exposure.  Males who have had a vasectomy qualify as having met the requirement 
for a highly effective birth control method. 
For female participants 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: 
• 
Combined (estrogen and progestogen containing) hormonal contraception associated with 
inhibition of ovulationa 
− 
oral 
− 
intravaginal 
− 
transdermal 
• 
Progestogen-only hormonal contraception associated with inhibition of ovulationa 
− 
oral 
− 
injectable 
− 
implantableb 
• 
Intrauterine deviceb 
• 
Intrauterine hormone-releasing systemb 
• 
Bilateral tubal occlusionb 
• 
Vasectomized partnerbc 
• 
Sexual abstinenced 
Acceptable birth control methods that result in a failure rate of more than 1% per year include: 
• 
Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary 
mode of action 
• 
Male or female condom with or without spermicidee 
• 
Cap, diaphragm, or sponge with spermicidee 
• 
Tubal ligation 
a Hormonal contraception may be susceptible to interaction with the investigational medicinal product, which may 
reduce the efficacy of the contraception method. 
b Contraception methods that in the context of this guidance are considered to have low user dependency. 
c Vasectomized partner is a highly effective method of avoiding pregnancy provided that partner is the sole sexual 
partner of the woman of childbearing potential study participant and that the vasectomized partner has received 
medical assessment of the surgical success. 
d 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 study and the 
preferred and usual lifestyle of the participant. 
e A combination of male condom with either cap, diaphragm, or sponge with spermicide (double barrier methods) 
are also considered acceptable, but not highly effective, birth control methods. 
Source:  Clinical Trial Facilitation Group 2014. 


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APPENDIX B. RESPONSE EVALUATION CRITERIA FOR SOLID 
TUMORS VERSION 1.1 
Evaluation of Target Lesions 
CR 
Disappearance of all target lesions. 
PR 
At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. 
PD 
At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD 
recorded since the treatment started, and the sum must also demonstrate an absolute increase of at least 
5 mm or the appearance of 1 or more new lesions. 
SD 
Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference 
the smallest sum LD since the treatment started. 
CR = complete response; LD = longest diameter; PD = progressive disease; PR = partial response; SD = stable disease. 
Evaluation of Nontarget Lesions 
CR 
Disappearance of all nontarget lesions and normalization of tumor marker level. 
Incomplete non-CR/ 
non-PD/SD 
Persistence of 1 or more nontarget lesion(s) and/or maintenance of tumor marker level 
above the normal limits. 
PD 
Appearance of 1 or more new lesions and/or unequivocal progression of existing 
nontarget lesions.a 
CR = complete response; PD = progressive disease; SD = stable disease. 
a Although a clear progression of "nontarget" lesions only is exceptional, in such circumstances, the opinion of the treating 
physician should prevail, and the progression status should be confirmed later on by the review panel (or study chair). 
Evaluation of Best Overall Response 
• The best overall response is the best response recorded from the start of the treatment 
until disease progression/recurrence (taking as reference for PD the smallest 
measurements recorded since the treatment started).  In general, the participant's best 
response assignment will depend on the achievement of both measurement and 
confirmation criteria. 
• Note:  In nonrandomized studies where response is the primary endpoint, 
confirmation of PR or CR is needed to deem either one the ‘best overall response’. 
Target Lesions 
Nontarget Lesions 
New Lesions 
Overall Response 
CR 
CR 
No 
CR 
CR 
Incomplete response/SD 
No 
PR 
PR 
Non-PD or NE 
No 
PR 
SD 
Non-PD or NE 
No 
SD 
PD 
Any 
Yes or No 
PD 
Any 
PD 
Yes or No 
PD 
Any 
Any 
Yes 
PD 
CR = complete response; PD = progressive disease; PR = partial response; NE = not evaluable; SD = stable disease. 


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• Participants with a global deterioration of health status requiring discontinuation of 
treatment without objective evidence of disease progression at that time should be 
classified as having "symptomatic deterioration."  Every effort should be made to 
document the objective progression even after discontinuation of treatment. 
• In some circumstances, it may be difficult to distinguish residual disease from normal 
tissue.  When the evaluation of CR depends on this determination, it is recommended 
that the residual lesion be investigated (fine needle aspirate/biopsy) to confirm the 
CR status. 
Source:  Eisenhauer et al 2009. 


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APPENDIX C. PROTOCOL AMENDMENT SUMMARY OF CHANGES 
Document 
Date 
Amendment (Version) 1: 
17 JAN 2019 
Amendment (Version) 1-FR: 
11 JUN 2019 
Amendment (Version) 2: 
09 AUG 2019 
Amendment (Version) 3: 
10 DEC 2019 
Amendment (Version) 4: 
25 NOV 2020 
Amendment (Version) 5: 
23 JUN 2021 
Amendment 5 (23 JUN 2021) 
Overall Rationale for the Amendment:  The purpose of this amendment is to update the 
guidelines for management of suspected immune related events. 
1. Section 1, Protocol Summary (Table 2:  Key Study Design Elements) 
Description of change:  Under the estimated study duration of study participation 
section, the sentence about participants participating in the study for up to approximately 
3 years was removed. 
Rationale for change:  This sentence is no longer relevant.  Starting with Protocol 
Amendment 4, survival follow-up is not required for participants who have discontinued 
active treatment after the primary efficacy analysis is completed.  Participants will be 
followed for irAEs for 90 days after the last dose of study drug or until the participant 
begins a new anticancer therapy, whichever occurs first and will complete the study at the 
end of this period. 
2. Section 6.5.1, Management of Suspected Infusion Reactions (Table 9:  Guidelines for 
Management of Suspected Infusion Reactions) 
Description of change:  The guidance for Grade 1infusion reaction in Table 9 was 
revised from interruption is not indicated to interrupt or slow the rate of infusion. 
Rationale for change:  To align with guidance regarding Grade 1 infusion reaction to 
reflect the most recent information available with INCMGA00012 and other PD-1 
inhibitors (eg, pembrolizumab, nivolumab). 
3. Section 6.5.2, Management of Suspected Immune-Related Adverse Events 
(Table 10:  Dose Modification and Toxicity Management Guidelines for 
Immune-Related Adverse Events) 
Description of change:  Guidance was updated for management of diarrhea/colitis, 
hepatitis, endocrinopathies, nephritis, skin, myocarditis, and all other irAEs. 
Rationale for change:  To align with updated information available for immune-related 
AEs known to be associated with INCMGA00012 and other PD-1 inhibitors 
(eg, pembrolizumab, nivolumab).  Guidance regarding hypophysitis was updated in 
response to the request received from the regulatory agency in France. 


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4. Incorporation of administrative changes.  Other minor, administrative changes have 
been incorporated throughout the Protocol and are noted in the redline version of the 
amendment. 


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Amendment 4 (25 NOV 2020) 
Overall Rationale for the Amendment:  The main purpose of this amendment is to minimize 
the burden of data collection for ongoing participants after the primary objective of the study has 
been achieved. 
1. Section 1, Protocol Summary (Table 2:  Key Study Design Elements) 
Description of change:  The coordinating principal investigator for the study was added. 
Rationale for change:  To identify the study's coordinating principal investigator. 
2. Section 1, Protocol Summary (Table 3:  Schedule of Activities) 
Description of change:  Lipid panel, coagulation panel, and urinalysis assessments have 
been updated to only be required at screening. 
Rationale for change:  Based on the safety information from the 2020 IB (23 SEP 2020 
data-cut), there are no safety issues with the study drug that warrant continuation of these 
tests at routine intervals. 
3. Section 1, Protocol Summary (Table 2:  Key Study Design Elements; 
Table 3:  Schedule of Activities); Section 4.1, Overall Design; Section 4.2, Overall 
Study Duration; Section 6.7, Treatment After the End of the Study; Section 7.1.1, 
Reasons for Discontinuation; Section 7.1.2, Discontinuation Procedures; Section 7.3, 
Lost to Follow-Up; Section 8.2, Efficacy Assessments; Section 8.2.1 Tumor Imaging; 
Section 8.3.1 Adverse Events; Section 8.3.6, Laboratory Assessments; Section 8.8.2, 
Post-Treatment Disease Follow-Up; Section 8.8.3, Survival Follow-Up 
Description of change:  Added clarification that disease follow-up and survival 
follow-up are not required after the primary efficacy analysis is completed.  Relevant text 
requiring disease follow-up and survival follow-up visits and associated assessments was 
removed. 
Rationale for change:  Per Section 10.4.1.1, the primary efficacy analysis will be 
performed once all participants have been followed for at least 6 months from the start of 
treatment or discontinued prematurely.  The last participant was enrolled in the study in 
APR 2020, and all participants have been followed for at least 6 months or discontinued.  
For this type of benchmark study, it is sufficient for the secondary endpoint of OS to be 
estimated from the available participant information from the start of study treatment to 
the time of efficacy analysis.  Additional data from disease follow-up and survival 
follow-up are no longer required. 
4. Section 1, Protocol Summary (Table 3:  Schedule of Activities); Section 4.1 Overall 
Design; Section 4.2, Overall Study Duration; Section 7.1.2, Discontinuation 
Procedures; Section 8.3.1 Adverse Events; Section 8.8.1 Safety Follow-Up; 
Section 9.4, Reporting of Serious Adverse Events 
Description of change:  Provided clarification that all AEs and SAEs will be collected 
for 28 days after the last dose of study drug, whereas irAEs will be collected until 90 days 
after the last dose of study drug or until the start of a new anticancer therapy, whichever 
occurs first.  A 90-day visit can be performed by phone. 


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Rationale for change:  Unconfounded safety assessments will no longer be possible 
once a new therapy has begun, and delaying treatment with other anticancer therapies is 
not an option for participants with progressive cancer. 
5. Section 1, Protocol Summary, Section 8.1.4 Distribution of Reminder Cards 
Description of change:  Added clarification that some procedures may be conducted by 
phone call, where appropriate, or as per institutional guidelines during the COVID-19 
pandemic.  Due to COVID-19 pandemic, some tests may be done outside the regularly 
scheduled visits or may be conducted at the next scheduled visit.  Details may be found in 
the eCRF guidelines or study monitoring plan, as applicable. 
Rationale for change:  To provide flexibility with study visits for the safety of 
participants during the COVID-19 pandemic. 
6. Section 1, Protocol Summary (Table 4:  Pharmacokinetic 
 Sample 
Collections); 
 
Description of change:  
 
 
Rationale for change: 
 
 
7. Section 4.2, Overall Study Duration 
Description of change:  No participant will be followed for longer than 27 months 
(ie, 2 years of study treatment followed by 90 days of observation for irAEs in the event 
the participant does not discontinue treatment prematurely or start a new anticancer 
therapy). 
Rationale for change:  To clarify the duration of study participation and to specify that 
the study will end when the last participant completes 90 days of safety follow-up for 
irAEs. 
8. Section 6.5.2, Management of Suspected Immune-Related Adverse Events 
(Table 10:  Dose Modification and Toxicity Management Guidelines for 
Immune-Related Adverse Events) 
Description of change:  Action taken with INCMGA00012 for Grade 2 myocarditis was 
updated from withhold until ≤ Grade 1 to withhold until symptoms resolve and 
management with corticosteroids is complete. 
Rational for change:  Adverse event toxicity assessment is done per NCI CTCAE v5.0 
in this study, and Grade 1 myocarditis is not included in this version. 
9. Section 8.3.6, Laboratory Assessments 
Description of change:  All abnormal laboratory values associated with AEs are 
considered clinically significant and will be followed for up to 28 days instead of 90 days 
after the last dose of study treatment. 


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Rationale for change:  Based on the safety information from the 2020 IB (23 SEP 2020 
data-cut), 90-day follow-up is not required, which negates the rationale for extended 
safety assessments following completion of study drug. 
10. Section 8.3.6, Laboratory Assessments (Table 12:  Required Laboratory Analytes) 
Description of change:  Added FT4 so that sites can use either a total T4 or free T4 test. 
Rationale for change:  The FT4 test a standard practice at several participating sites.  
11. Incorporation of administrative changes.  Other minor, administrative changes have 
been incorporated throughout the Protocol and are noted in the redline version of the 
amendment. 


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Amendment 3 (10 DEC 2019) 
Overall Rationale for the Amendment:  The main purpose of this amendment is to adjust the 
overall study enrolment and statistical analysis, remove interim analysis and update the guidance 
for suspected immune related AEs based on the data from ongoing studies with INCMGA00012 
and recent IB update. 
1. Section 1, Protocol Summary; Section 10.1, Sample Size Determination; 
Section 10.5, Interim Analysis 
Description of change:  Enrollment for each disease-specific cohort was reduced from 
approximately 40 participants per cohort to approximately 30 participants per cohort, and 
overall study enrollment was reduced from approximately 160 participants to 
approximately 120 participants.  Statistical analysis assumptions were revised based on 
the revised enrollment numbers, and the interim analysis was removed. 
Rationale for change:  This study is planned as a signal-finding study for efficacy in 
tumor types of interest for future development.  Approximately 30 participants in each 
disease-specific cohort is sufficient to provide a preliminary assessment of efficacy, 
safety, and PK.  Based on the revised enrollment numbers, the response rate and 95% CIs 
were updated and an interim analysis was no longer needed. 
2. Section 1, Protocol Summary (Table 3: Schedule of Activities); Section 10.4.3.4, 
Electrocardiograms 
Description of change:  On-study ECG assessments were removed.  Participants are 
now required to have ECG assessments at screening and at the safety follow-up visit.  
Additional ECGs may be performed as clinically indicated to manage participant safety. 
Rationale for change:  INCMGA00012 does not demonstrate a large effect on the QTc 
interval (ie, > 20 milliseconds) based on extensive assessment in Study 
INCMGA 0012-101 (refer to the IB).   
3. Section 1, Protocol Summary (Table 3: Schedule of Activities) 
Description of change:  Frequency of urinalysis was changed from every 3 cycles to 
every 6 cycles. 
Rationale for change:  Based on data from ongoing INCMGA0012 studies, there are no 
safety signals to indicate frequent urinalysis assessments are required. 


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4. Section 3, Objectives and Endpoints (Table 6: Objectives and Endpoints); 
Section 8.2, Efficacy Assessments; Section 8.2.2, iRECIST; Section 10.4.5.3, 
Immune-Based RECIST Assessments 
Description of change:  
 
  Section 8.2.2 was 
updated to indicate iRECIST is not used to determine efficacy of INCMGA00012 but 
may be used for patient management. 
Rationale for change:  Historical ORRs were assessed using RECIST (Table 5: Activity 
of Other PD-1 Inhibitors), and this is the relevant methodology for benchmarking 
comparisons. 
5. Section 1, Protocol Summary; Section 4.2, Overall Study Duration 
Description of change:  Revised to specify how long participants will be followed for 
survival. 
Rationale for change:  For the purpose of clarification. 
6. Section 5.2, Exclusion Criteria 
Description of change:  Criterion 2 was updated to indicate prior adjuvant therapy 
completed ≥ 12 months before study entry may be allowed but should be discussed with 
the medical monitor. 
Rationale for change:  Received investigator feedback that these patients should be 
allowed to participate in the study. 
7. Section 6.5.2, Management of Suspected Immune-Related Adverse Events 
(Table 10:  Dose Modification and Toxicity Management Guidelines for Immune-
Related Adverse Events) 
Description of change:  Guidelines for management of nervous system‒related events 
were added. 
Rationale for change:  Guidelines were updated based on the data from the ongoing 
studies with INCMGA00012 and recent IB update. 
8. Section 8.3.3, Vital Signs; Section 10.4.3.3 Vital Signs 
Description of change:  Weight was added to vital signs data collection. 
Rationale for change:  For the purpose of clarification. 
9. Incorporation of administrative changes.  Other minor, administrative changes have 
been incorporated throughout the Protocol and are noted in the redline version of the 
amendment. 


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Amendment 2 (09 AUG 2019) 
Overall Rationale for the Amendment:  The main purpose of this amendment is to update the 
Protocol based on the information from the ongoing Phase 1 study, INCMGA 0012-101, and to 
update the PK sample collection schedule. 
1. Incorporate changes from Amendment 1-FR (11 JUN 2019) 
Description of change:  Changes as listed in Amendment 1-FR (11 JUN 2019). 
Rationale for change:  To align Protocol Amendment 2 as appropriate for all regions. 
2. Section 1, Protocol Summary; Section 4.1, Overall Design 
Description of change:  Criteria for treatment delays due to toxicity were removed and 
replaced with a cross-reference to Section 6.5 (Dose Modifications) and Table 10. 
Rationale for change:  Guidelines for dose modification and toxicity management are 
provided in Section 6.5, Table 10. 
3. Section 1, Protocol Summary (Table 3: Schedule of Activities) 
Description of change:  Added text that for ECG tests, either Fridericia or Bazett 
method of correction is acceptable for QT. 
Rationale for change:  For clarification. 
4. Section 2.1.1, INCMGA00012 
Description of change:  Provided updated data from the ongoing Phase 1 study, 
INCMGA 0012-101.  
Rationale for change:  To include recent safety information. 
5. Section 2.2, Rationale for Study Design 
Description of change:  Additional rationale for the study design provided. 
Rationale for change:  To provide additional information and clarification. 
6. Section 2.2.2, Dose and Schedule 
Description of change:  Revised the PK data based on the updates from the ongoing 
Phase 1 study, INCMGA 0012-101. 
Rationale for change:  To include recent PK information. 
7. Section 2.3 Benefit/Risk Assessment 
Description of change:  Provided additional justification for expecting efficacy in this 
study based on recent publications. 
Rationale for change:  New information from recent data. 
8. Section 4.1, Overall Design; Section 5.1, Inclusion Criteria (Criterion 3b) 
Description of change:  Added the text to indicate that cisplatin ineligibility in 
participants with UC will be determined by the investigator. 
Rationale for change:  For clarification. 


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9. Section 5.2, Exclusion Criteria 
a. Description of change:  Exclusion criterion 3 was updated to include a caveat for 
palliative radiation therapy:  that participants must have recovered from all radiation-
related toxicities, not require corticosteroids for this purpose, and not have had 
radiation pneumonitis. 
Rationale for change:  To clarify when prior palliative radiation therapy is allowed. 
b. Description of change:  Exclusion criterion 7 was updated to include more specific 
information regarding additional malignancies that are excluded (ie, additional 
malignancy that is progressing or requires active treatment, or history of other 
malignancy within 3 years of study entry with exceptions noted). 
Rationale for change: To provide clarification regarding exclusion of additional 
malignancies. 
c. Description of change:  Exclusion criterion 8 was updated to include additional 
guidance on active autoimmune disease requiring systemic immunosuppression. 
Rationale for change: To provide clarification and to be consistent with Incyte’s 
standard protocol text for INCMGA0012 studies. 
d. Description of change:  In exclusion criterion 15 (cardiac function and disease), 
15b (unstable angina pectoris) was updated to remove the time frame of ≤ 6 months 
before study participation, and 15d (other clinically significant heart disease) was 
updated to only include ≥ Grade 3 uncontrolled hypertension as an example. 
Rationale for change:  To further clarify eligibility as it relates to cardiac diagnoses. 
10. Section 5.2, Exclusion Criteria (Criterion 13c); Section 6.6.1, Permitted Medications 
and Procedures 
Description of change:  Highly active antiretroviral therapy was changed to 
antiretroviral therapy. 
Rationale for change:  These terms are now considered synonymous. 
11. Section 6.1, Study Treatments Administered (Table 8: Study Drug Information) 
Description of change: An infusion time range of -5/+ 15 minutes was added to the 
INCMGA00012 administration instructions. 
Rationale for change:  Updated based on supportive CMC information. 
12. Section 1, Protocol Summary (Table 3: Schedule of Activities); Section 6.5.1, 
Management of Suspected Infusion Reactions (including Table 9: Guidelines for 
Management of Suspected Infusion Reactions) 
Description of change:  Removed the requirement for premedication prophylaxis before 
the first dose of INCMGA00012 and added guidance to Table 9 for infusion rate for 
subsequent infusions. 
Rationale for change:  Updated for consistency with the INCMGA00012 IB and to 
provide additional guidance to investigators. 


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13. Sections 6.5.1, Management of Suspected Infusion Reactions (Table 9: Guidelines 
for Management of Suspected Infusion Reactions); Section 9.3, Recording and 
Follow-Up of Adverse Events and/or Serious Adverse Events 
Description of change:  NCI CTCAE v4.3 was updated to NCI CTCAE v5.0. 
Rationale for change:  Updated version (NCI CTCAE v5.0) will be used for grading 
AEs. 
14. Section 6.5.2, Management of Suspected Immune-Related Adverse Events 
Description of change:   This section was updated with revised Table 10 (Dose 
Modification and Toxicity Management Guidelines for Immune-Related Adverse 
Events).  Previous Sections 6.5.2.1 to 6.5.2.6 have been removed as the information is 
now presented in Table 10. 
Rationale for change:  Guidelines were updated based on recent information from other 
checkpoint inhibitors and ASCO guidelines.  Sections were consolidated to present the 
guidelines for all irAEs in 1 table. 
15. Section 6.6.2, Prohibited Medications and Procedures 
Description of change:  Added probiotic dietary supplements to the list of prohibited 
medications and procedures. 
Rationale for change:  Updated based on emerging epidemiologic evidence. 
 
 
 
  
17. Section 1, Protocol Summary (Table 4: Pharmacokinetic 
 Sample 
Collections); Section 8.4, Pharmacokinetic Assessments 
Description of change:  The PK sample collection schedule was updated.  An additional 
PK sample was added on Cycle 4 Day 1 at 10 minutes (±10 minutes) postinfusion.  
Collection of some PK samples at selected centers was revised; PK samples will be 
collected at all sites. 
Rationale for change:  To collect adequate PK data from this study. 
18. Section 10.1, Sample Size Determination 
Description of change:  Provided information about statistical power used for sample 
calculations. 
Rationale for change:  For clarification. 


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19. Section 10.4.1.2, Handling of Missing Data in Primary Analysis 
Description of change:  Information regarding the handling of missing data for the 
primary endpoint was added. 
Rationale for change:  This information was not previously included in the Protocol. 
20. Section 8.3.6, Laboratory Assessments (Table 12: Required Laboratory Analytes) 
Description of change:  Additional names were added for thyroid analytes. 
Rationale for change:  For clarification. 
21. Incorporation of administrative changes.  Other minor, administrative changes have 
been incorporated throughout the Protocol and are noted in the redline version of the 
amendment. 


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Amendment 1-FR (11 JUN 2019) 
Overall Rationale for the Amendment:  The purpose of this amendment is to add the 
country-specific information as requested by the ethics committee in France. 
1. Section 5.2, Exclusion Criteria (Exclusion Criterion #21) 
Description of change:  Added Exclusion Criterion #21: 
The following patients are excluded in France:  vulnerable populations according to 
article L.1121-6 of the French Public Health code and adults under legal protection or 
who are unable to express their consent per article L.1121-8 of the French Public Health 
code. 
Rationale for change:  Provide clarification about patient populations that are excluded 
per French Public Health code. 
2. Incorporation of administrative changes.  Other minor, administrative changes have 
been incorporated throughout the Protocol and are noted in the redline version of the 
amendment. 


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Amendment 1 (17 JAN 2019) 
Overall Rationale for the Amendment:  The primary purpose of this amendment is to address 
comments regarding the design of the study. 
1. Section 5.2, Exclusion Criteria (Exclusion Criterion #11) 
Description of change:  Added known active HAV infection to Exclusion Criterion #11: 
Known active HAVHBA, HBV, or HCV infection, as defined by elevated 
transaminases with the following serology:  positivity for HAV IgM antibody, 
anti-HCV, anti-HBc IgG or IgM, or HBsAg (in the absence of prior immunization). 
Rationale for change:  To add consistency to Exclusion Criterion #11. 
2. Section 5.2, Exclusion Criteria (Exclusion Criterion #20) 
Description of change:  Added Exclusion Criterion #20: 
History of organ transplant, including allogeneic stem cell transplantation. 
Rationale for change:  To clarify the exclusion of allogeneic organ or hematopoietic 
stem cell transplant patients. 
3. Section 10.5, Interim Analysis 
Description of change:  Added details to the interim analysis. 
The study will be stopped for futility if less than 4 out of 20 subjects responded at the 
time of the interim analysis. 
Rationale for change:  To include information regarding the interim analysis. 
4. Incorporation of administrative changes.  Other minor, administrative changes have 
been incorporated throughout the Protocol and are noted in the redline version of the 
amendment. 

SAP_001.pdf: 
Official Title: 
A Phase 2 Study of INCMGA00012 (PD-1 Inhibitor) in Participants With 
Selected Solid Tumors (POD1UM-203) 
NCT Number: 
NCT03679767 
Document Date: 
Statistical Analysis Plan Amendment 1: 23 Jun 2020 


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STATISTICAL ANALYSIS PLAN  
  
INCMGA 0012-203  
A Phase 2 Study of INCMGA00012 (PD-1 Inhibitor) in Participants 
With Selected Solid Tumors (POD1UM-203)  
  
  
  
IND Number  
130952  
EudraCT Number:  
2018-002941-12  
Sponsor:  
Incyte Corporation  
1801 Augustine Cut-Off  
Wilmington, DE 19803  
Protocol Version:  
Protocol Amendment 3 dated 10 DEC 2019  
CRF Approval Date:  
10 JAN 2019  
SAP Version:  
Amendment 1  
SAP Author:   
  
Biostatistician  
Date of Plan:  
23 JUN 2020  
  
  
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 .........................................................................................................5 
1.  INTRODUCTION ......................................................................................................................7 
2.  STUDY INFORMATION, OBJECTIVES, AND ENDPOINTS ...............................................7 
2.1.  Protocol and Case Report Form Version .................................................................................7 
2.2.  Study Objectives and Endpoints ..............................................................................................7 
3.  STUDY DESIGN ........................................................................................................................8 
3.1.  Overall Study Design ...............................................................................................................8 
3.2. Overall Study Duration .............................................................................................................8 
3.3. Randomization ..........................................................................................................................8 
3.4. Control of Type I Error .............................................................................................................9 
3.5.  Sample Size Considerations .....................................................................................................9 
3.6.  Schedule of Assessments .........................................................................................................9 
4.  DATA HANDLING DEFINITIONS AND CONVENTIONS ..................................................9 
4.1.  Scheduled Study Evaluations and Study Periods .....................................................................9 
4.1.1.  Study Drug and Dose Level ..................................................................................................9 
4.1.2.  Day 1 .....................................................................................................................................9 
4.1.3.  Study Day ..............................................................................................................................9 
4.1.4.  Baseline Value ....................................................................................................................10 
4.1.5.  Handling of Missing and Incomplete Data .........................................................................10 
4.1.6. Cycle Length and Duration ..................................................................................................11 
4.1.7. On-Treatment Assessment/Event ........................................................................................11 
4.2. Variable Definitions ................................................................................................................11 
4.2.1. Body Mass Index .................................................................................................................11 
4.2.2. Creatinine Clearance ............................................................................................................12 
4.2.3. Prior and Concomitant Medication ......................................................................................12 
5.  STATISTICAL METHODOLOGY .........................................................................................12 
5.1.  General Methodology ............................................................................................................12 
5.2.  Treatment Groups ..................................................................................................................12 
5.3.  Analysis Populations ..............................................................................................................13 
5.3.1.  Full Analysis Set .................................................................................................................13 
5.3.2.  Safety Evaluable Population ...............................................................................................13 
5.3.3.  Pharmacokinetic Evaluable Population ..............................................................................13 
6.  BASELINE, EXPOSURE, AND DISPOSITION VARIABLES AND  ..................................14 
ANALYSES ...............................................................................................................14 
6.1.  Baseline and Demographics, Physical Characteristics, and Disease History ........................14 
6.1.1.  Demographics .....................................................................................................................14 
6.1.2.  Baseline Disease Characteristics and Cancer History.........................................................14 
6.1.3.  Prior Therapy ......................................................................................................................15 
6.1.4.  Medical History...................................................................................................................15 
6.2.  Disposition of Participants .....................................................................................................15 
6.3.  Protocol Deviations ................................................................................................................15 


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6.4.  Exposure.................................................................................................................................15 
6.5.  Prior and Concomitant Medication ........................................................................................16 
7.  EFFICACY ...............................................................................................................................16 
7.1.  General Considerations ..........................................................................................................16 
7.2.  Efficacy Hypotheses ..............................................................................................................16 
7.3.  Analysis of the Efficacy Parameters ......................................................................................16 
7.3.1.  Response Criteria ................................................................................................................16 
7.3.2.  Primary Analysis .................................................................................................................17 
7.3.2.1. Overall Response Rate ......................................................................................................17 
7.3.2.2. Best Overall Response ......................................................................................................17 
7.3.3.  Secondary Analysis .............................................................................................................17 
7.3.3.1. Duration of Response ........................................................................................................17 
7.3.3.2. Disease Control Rate ........................................................................................................18 
7.3.3.3. Progression-Free Survival .................................................................................................18 
7.3.3.4.  Overall Survival ...............................................................................................................19 
7.3.3.5. Tumor Size Change Over Time ........................................................................................19 
8. SAFETY AND TOLERABILITY .............................................................................................20 
8.1. General Considerations ...........................................................................................................20 
8.2.  Adverse Events ......................................................................................................................20 
8.2.1.  Adverse Event Definitions ..................................................................................................20 
8.2.2.  Adverse Events of Special Interest .....................................................................................20 
8.2.3.  Adverse Event Summaries ..................................................................................................21 
8.3.  Clinical Laboratory Tests .......................................................................................................23 
8.3.1.  Laboratory Value Definitions .............................................................................................23 
8.3.2.  Laboratory Value Summaries .............................................................................................23 
8.4.  Vital Signs ..............................................................................................................................24 
8.5.  Electrocardiograms ................................................................................................................24 
9.  PHARMACOKINETIC 
 ANALYSES ..........................................25 
9.1.  Bioanalysis Materials and Methods .......................................................................................25 
9.2.  Pharmacokinetic Assessments ...............................................................................................25 
25 
26 
10.  CHANGES AND MODIFICATIONS TO THE ANALYSIS PLAN ....................................27 
10.1.  Changes to Protocol-Defined Analyses ...............................................................................27 
10.2.  Changes to the Statistical Analysis Plan ..............................................................................27 
10.2.1.  Amendment 1 ....................................................................................................................27 
11.  REFERENCES........................................................................................................................28 
APPENDIX A. PLANNED TABLES, FIGURES, AND LISTINGS ...........................................29 
 
  
 
 
 
 


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LIST OF TABLES  
Table 1:  
Objectives and Endpoints .............................................................................................8 
Table 2:  
Response Rate and 95% Confidence Interval .............................................................10
Table 3:  
RECIST Evaluation Criteria for Overall Response ....................................................18 
Table 4:  
Evaluation and Censoring of Progression-Free Survival ............................................19
Table 5:  
Baseline Laboratory Identification .............................................................................24 
Table 6:  
Criteria for Clinically Notable Vital Sign Abnormalities ...........................................25 
Table 7:  
Criteria for Clinically Notable Electrocardiogram Abnormalities .............................26 
Table 8:  
Statistical Analysis Plan Versions ..............................................................................28 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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LIST OF ABBREVIATIONS  
Abbreviation  
Definition  
  
  
AE  
adverse event  
AESI  
adverse event of special interest  
ALP  
alkaline phosphatase  
ALT  
alanine aminotransferase  
AST  
aspartate aminotransferase  
AUCt  
area under the plasma or serum concentration-time curve from time = 0 to the 
last measurable concentration at time = t  
BMI  
body mass index  
BOR  
best overall response  
CI  
confidence interval  
Cmax  
maximum observed plasma or serum concentration  
Cmin  
minimum observed plasma or serum concentration over the dose interval  
CR  
complete response according to RECIST v1.1  
CRF  
case report form  
CTCAE  
Common Terminology Criteria for Adverse Events  
DCR  
disease control rate  
DOR  
duration of response  
ECG  
electrocardiogram  
ECOG  
Eastern Cooperative Oncology Group  
eCRF  
electronic case report form  
EGFR  
epidermal growth factor receptor  
ELISA  
enzyme-linked immunosorbent assay  
FAS  
full analysis set  
HIV  
human immunodeficiency virus  
HR  
heart rate  
ICF  
informed consent form  
irAE  
immune-related adverse event  
iRECIST  
immune Response Evaluation Criteria in Solid Tumors  


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IV  
intravenously  
MedDRA  
Medical Dictionary for Regulatory Activities  
 
Abbreviation  
Definition  
NCI  
National Cancer Institute  
NSCLC  
non–small cell lung cancer  
ORR  
overall response rate  
OS  
overall survival  
PD  
progressive disease  
PD-1  
programmed cell death protein 1  
PD-L1  
programmed cell death ligand protein 1  
PFS  
progression-free survival  
PK  
pharmacokinetics  
PR  
partial response according to RECIST v1.1  
PT  
preferred term  
Q4W  
once every 4 weeks  
RCC  
renal cell carcinoma  
RECIST  
Response Evaluation Criteria in Solid Tumors  
ROS1  
Proto-Oncogene 1, Receptor Tyrosine Kinase  
SAP  
Statistical Analysis Plan  
SD  
stable disease  
SOC  
system organ class  
TEAE  
treatment-emergent adverse event  
Tmax  
time to maximum concentration  
UC  
urothelial carcinoma  
ULN  
upper limit of normal  
WHO  
World Health Organization  
 
 
 
 
 


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1. 
INTRODUCTION  
 
This study is a Phase 2, open-label, multicenter study designed to assess the clinical activity and 
safety of INCMGA00012 in participants with advanced solid tumors where the efficacy of PD-1 
inhibitors has previously been established.  
The purpose of this SAP is to provide details of the statistical analyses that have been outlined in 
the 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.  The analyses of PK and 
pharmacodynamics that will be executed by the Department of Clinical Pharmacokinetics and 
 respectively, are not described in detail in this SAP.  
2. 
STUDY INFORMATION, OBJECTIVES, AND ENDPOINTS  
2.1. 
Protocol and Case Report Form Version  
This SAP is based on INCMGA 0012-203 Protocol Amendment 3 dated 10 DEC 2019 and CRFs 
approved 10 JAN 2019.  Unless superseded by an amendment, this SAP will be effective for all 
subsequent Protocol amendments and CRF versions.  
2.2. 
Study Objectives and Endpoints  
The study objective and endpoints are presented in Table 1.  
 
Table 1:  
Objectives and Endpoints  
Objectives  
Endpoints  
Primary  
 
To assess the efficacy of INCMGA00012 in 
terms of the ORR in tumor types of interest.  
ORR, defined as the percentage of participants having 
a CR or PR, according to RECIST v1.1 as determined 
by the investigator.  
Secondary  
 
To determine the DOR to INCMGA00012.  
DOR, defined as the time from an initial objective 
response (CR or PR) according to RECIST v1.1 until 
first observation of documented disease progression as 
determined by investigator or death due to any cause.  
To determine the DCR.  
DCR, defined as the proportion of participants with 
either an objective response (CR and PR) or SD, 
according to RECIST v1.1.  
To determine the PFS of INCMGA00012.  
PFS, defined as the time from the start of therapy until 
disease progression, as determined by investigator or 
death due to any cause.  
To determine the OS of INCMGA00012.  
OS, defined as the time from the start of therapy until 
death due to any cause.  


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To evaluate the safety of INCMGA00012.  
Safety, determined by the number of participants, 
frequency, duration, and severity of AEs, laboratory 
tests, vital signs, and ECGs.  
To determine the PK of INCMAG00012 when 
administered as a 30-minute infusion.  
The PK of INCMAG00012, including Cmax, Tmax, Cmin, 
and AUCt, will be summarized.  
3. 
STUDY DESIGN  
3.1. 
Overall Study Design  
This study is a Phase 2, open-label, multicenter study designed to assess the clinical activity and 
safety of INCMGA00012 in participants with advanced solid tumors where the efficacy of PD-1 
inhibitors has previously been established.  Participants with the following tumor types will be 
enrolled into disease-specific cohorts:  
• 
Treatment-naïve metastatic NSCLC with high PD-L1 expression (TPS ≥ 50%) and no 
EGFR, ALK, or ROS activating genomic tumor aberrations.  
• 
Locally-advanced or metastatic urothelial cancer in cisplatin ineligible participants 
(determined by the investigator) whose tumors express PD-L1 (CPS ≥ 10 of PD-L1).  
• 
Unresectable or metastatic melanoma.  
• 
Locally advanced or metastatic clear–cell RCC without prior systemic treatment. The 
primary endpoint is ORR according to RECIST v1.1 as determined by the 
investigator. The study consists of 3 periods:  screening, study drug treatment, and 
follow-up.  
3.2. 
Overall Study Duration  
The study begins when the first participant signs the ICF.  The end of the study is defined as the 
date of the last visit of the last participant in the study.  Participants completing treatment or 
prematurely discontinuing the study drug will be followed for survival until death, withdrawal of 
consent, or the end of the study, whichever occurs first.  
3.3. 
Randomization  
Not applicable.  


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3.4. 
Control of Type I Error  
There is no formal hypothesis testing in this study and no control of Type I error rate.  Response 
rate as well as the associated 95% CI will be provided.  For analysis of efficacy endpoints such 
as ORR and DCR, 2-sided 95% confidence level will be reported.  
3.5. 
Sample Size Considerations  
This study is planned as a signal-finding study for efficacy in tumor types of interest for future 
development.  Approximately 30 participants are planned to be enrolled in each disease-specific 
cohort to provide a preliminary assessment of efficacy, safety, and PK.  The response rate and 
95% CIs based on numbers of responses among 30 participants are provided in Table 2.  
Table 2:  
Response Rate and 95% Confidence Interval  
Sample Size  
Number of Responses  
Response Rate (%)  
95% CI (%)  
30  
3  
10.0  
2.1, 26.5  
30  
5  
16.7  
5.6, 34.7  
30  
7  
23.3  
9.9, 42.3  
30  
9  
30.0  
14.7, 49.4  
30  
11  
36.7  
19.9, 56.1  
30  
12  
40.0  
22.7, 59.4  
3.6. 
Schedule of Assessments  
Refer to Protocol Amendment 3 dated 10 DEC 2019 for a full description of all study procedures 
and assessment schedules for this study.  
4. 
DATA HANDLING DEFINITIONS AND CONVENTIONS  
4.1. 
Scheduled Study Evaluations and Study Periods  
4.1.1. 
Study Drug and Dose Level  
INCMGA00012 is the only study drug in this study.  The dose level of INCMGA00012 is 500 
mg Q4W in this study, administered as a 30-minute infusion.  
4.1.2. 
Day 1  
Day 1 is the date when the first dose of INCMGA00012 is administered.  
4.1.3. 
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  


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Day # = (Visit/Reporting Date – Day 1 date).  
A study day of –1 indicates 1 day before Day 1.  
4.1.4. 
Baseline Value  
Baseline is the last nonmissing assessment obtained before the first administration of  
INCMGA00012.  
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.  
4.1.5. 
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.  
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.  
• 
No imputation will be done if the date is completely missing.  
For prior and concomitant medications, the start/stop dates recorded in the eCRF 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.  


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• 
If only the day is missing, and the first day of the month is on or after the first dose 
date on Day 1, then the concomitant medication will be considered as starting on or 
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, if the last day of the year is on or after the first dose date Day 1, the 
incomplete date will be imputed as if it is the first day of the year.  
• 
If the imputed start date through the above procedure is after stop date recorded in the 
eCRF, then the imputed start date will be set equal to stop date.  
4.1.6. 
Cycle Length and Duration  
One cycle is 28 days (4 weeks) for all participants in this study.  Cycle 1 Day 1 is the day the 
first infusion of INCMGA00012, with the exception for records of clinical laboratory tests, vital 
signs, and ECGs, where visit Cycle 1 Day 1 could be within 7 days before the day of first 
infusion of INCMGA00012.  Day 1 of subsequent cycles will correspond to the infusion date of 
INCMGA00012 within the cycle.  Tumor assessments follow Protocol-defined schedule, that is, 
Q8W with ± 7-day window within 1 year and Q12W with ± 14-day window after 1 year.   
Analysis of tumor response assessments follow the same time window.  
4.1.7. 
On-Treatment Assessment/Event  
Safety summaries and selected summaries of deaths will summarize only on-treatment 
assessments/events.  On-treatment assessment/event is defined as any assessment/event obtained 
in the time interval:  
• Date of first infusion of INCMGA00012 through date of last infusion of 
INCMGA00012 + 90 days;  
Adverse events that begin or worsen after informed consent obtained should be recorded in the 
Adverse Events CRF.  
If the last date of study drug administration is missing, on-treatment assessments/events include 
any assessment/event recorded in the database and those that occur after the start date of study 
drug unless there are other datasets indicating treatment is ended.  
Data listings will include all assessments/events, flagging those that are not on-treatment 
assessments/events.  
4.2. 
Variable Definitions  
The following variables will only be calculated if not reported on the eCRF.  
4.2.1. 
Body Mass Index  
Body mass index will be calculated as follows:  


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BMI (kg/m2) = [weight (kg)] / [height (m)]2.  
4.2.2. 
Creatinine Clearance  
Creatinine clearance by Cockcroft-Gault equation (Cockcroft and Gault 1976) is estimated from 
serum creatinine (mg/dL) determination using the following formula:  
Creatinine clearance (mL/min) = [140 − age (years)] × weight (kg) × {0.85* for female 
participants} / [72 × serum creatinine (mg/dL)]. *Note:  For male participants use 1.0.  
4.2.3. 
Prior and Concomitant Medication  
Prior medication is defined as any nonstudy medication started before the first dose of  
INCMGA00012.  
Concomitant medication is defined as any nonstudy medication that is started accordingly:   
• 
Before the date of first administration of INCMGA00012 and is ongoing throughout 
the study or ends on/after the date and time of first study drug administration.  
• 
On/after the date of first administration of INCMGA00012 and is ongoing or ends 
during the course of study drug administration.  
A medication could also be classified as "both prior and concomitant medication" if the end date 
is on or after the date of first administration of INCMGA00012.  In the listing, it will be 
indicated whether a medication is prior-only, concomitant-only, or both prior and concomitant 
medication.  
For the purposes of analysis, all medications will be considered concomitant medications unless 
the medications can unequivocally be defined as not concomitant (ie, if start date and end date 
are all missing, then the medication is considered as concomitant medication).  See Section 4.1.5 
for handling if missing/incomplete data.  
5. 
STATISTICAL METHODOLOGY  
5.1. 
General Methodology  
Unless otherwise noted, SAS® software (SAS Institute Inc, Cary, NC; v9.4 or later) will be used 
for the generation of all tables, figures, 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 participants in each category.  
5.2. 
Treatment Groups  
Analysis will be presented by disease-specific cohorts:  melanoma, NSCLC, urothelial cancer 
(bladder cancer), and RCC.  Safety data will also be presented for all cohorts combined.  


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5.3. 
Analysis Populations  
5.3.1. 
Full Analysis Set  
The FAS includes all participants who received at least 1 dose of study drug.  The FAS will be 
used for demographics, disposition, baseline characteristics, and all efficacy analyses.   
5.3.2. 
Safety Evaluable Population  
The safety evaluable population includes all participants who received at least 1 dose of study 
drug.  All safety and exposure analyses will be conducted using the safety evaluable population.   
In this study, the FAS and safety evaluable population are identical.  
5.3.3. 
Pharmacokinetic Evaluable Population  
The PK evaluable population will include all participants who received at least 1 dose of study 
drug and have provided a baseline and at least 1 postdose PK sample.  
 


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6. 
BASELINE, EXPOSURE, AND DISPOSITION VARIABLES AND  
ANALYSES  
Appendix A provides a list of planned tables, figures, and listings.  
6.1. 
Baseline and Demographics, Physical Characteristics, and Disease 
History  
Baseline disease characteristics and demographics will be summarized by disease-specific 
cohort.  Overall summaries combining 4 tumor-specific cohorts will be presented.  
6.1.1. 
Demographics  
Demographics will be listed in detail.  The following demographics will be summarized for the  
FAS by disease-specific cohort and overall FAS:  age, sex, race, ethnicity, body weight, height, 
BMI, and creatinine clearance.  Qualitative data will be summarized by contingency table while 
quantitative data will be summarized by descriptive summary statistics.  
6.1.2. 
Baseline Disease Characteristics and Cancer History  
According to data collected in the eCRF, the following information determined at initial 
diagnosis and baseline will be summarized for in the FAS by disease-specific cohort:  
• 
Melanoma:  time since initial diagnosis, time since unresectable/metastatic diagnosis, 
stage at baseline, classification M at baseline, histology at baseline, sites of disease at 
baseline, BRAF status, PD-L1 status, and ECOG performance status at baseline.  
• 
NSCLC:  time since initial diagnosis, time since metastatic diagnosis, histopathology 
at initial diagnosis, stage at baseline, T staging at baseline, N staging at baseline, M 
staging at baseline, sites of disease at baseline, PD-L1 status, EGFR mutation, ALK 
re-arrangement status, ROS1 re-arrangement status, and ECOG performance status at 
baseline.  
• 
Urothelial cancer (bladder cancer):  time since initial diagnosis, time since 
advanced/metastatic diagnosis, cancer type at initial diagnosis, histology at initial 
diagnosis, reason for cisplatin ineligibility at initial diagnosis, TNM classification T 
at baseline, TNM classification N at baseline, TNM classification M at baseline, 
grade at baseline, histology at baseline, sites of disease at baseline, stage at baseline, 
PD-L1 status, and ECOG performance status at baseline.  
• 
RCC:  time since initial diagnosis, time since advanced/metastatic diagnosis, 
histology at initial diagnosis, MSKCC criteria at initial diagnosis, stage of disease at 
baseline, TNM classification T at baseline, TNM classification N at baseline, TNM 
classification M at baseline, sites of disease at baseline, PD-L1 status, and ECOG 
performance status at baseline.  
Additional baseline disease characteristics and cancer history for individual cancer types listed in 
eCRF may be summarized or listed for all participants by tumor type specific cohort.  
Time since initial diagnosis (advanced/ unresectable /metastatic diagnosis) will be calculated as 
follows:  


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Time since initial diagnosis (months) = (Day 1 date – date of diagnosis + 1) / 30.4375.  
6.1.3. 
Prior Therapy  
The number and percentage of participants recording any prior systemic cancer therapy, prior 
radiotherapy, or prior surgery will be summarized.  The component drugs of prior systemic 
therapy regimens will be coded using the WHO Drug Dictionary.  Lines of prior systemic cancer 
therapy will be summarized by disease-specific cohort.  Best response from prior therapy, 
purpose, reason for discontinuation, as well as time to progression on prior therapy will be 
summarized and listed wherever the data are available.  
Number of participants who received prior radiotherapy will be listed for the FAS.  Anatomical 
location of the administration, start and stop date, reason for regimen, best response, number of 
fractions received and total dose will be listed.  
Number of participants who had prior surgery or surgical procedure for cancer treatment will be 
listed for the FAS.  Date and description of the surgery/surgical procedure will be listed. Detailed 
information on prior systemic cancer therapy, prior radiation, and prior surgery will be listed in 3 
separate listings.  
6.1.4. 
Medical History  
For all participants in the FAS, medical history will be summarized by disease-specific cohort.  
This summary will be presented by MedDRA primary SOC and PT.  
6.2. 
Disposition of Participants  
The number and percentage of participants who complete treatment, who are on treatment, who 
discontinue study drug with primary reason for discontinuation, who are on study, and who 
withdraw from the study with a primary reason for study withdrawal will be summarized for all 
participants in FAS by tumor type specific cohort.  All participants with deviations to inclusion 
and/or exclusion criteria will be listed.  
6.3. 
Protocol Deviations  
Protocol deviations recorded in the eCRF will be presented in the participant data listings.  
Protocol deviations will be summarized descriptively.  
6.4. 
Exposure  
For participants in the safety evaluable population, exposure to INCMGA00012 will be 
summarized descriptively by disease-specific cohort separately as follows:  
• 
Total number of infusions:  Total number of infusions by participant with a nonzero 
dose of INCMGA00012.  
• 
Total dose administered (mg):  Sum of the cumulative actual dose that has been 
administered.  Actual dose at each infusion is calculated as estimated volume 
delivered / prepared volume × 500 mg at each infusion.  
• 
Average dose (mg):  Total dose administered (mg) / total number of infusions.  


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• 
Duration of treatment (days):  Date of last dose of INCMGA00012 – date of first 
dose of INCMGA00012 + 1.  
• 
Dose modifications:  Number of participants who had dose delay or infusion 
interruption of INCMGA00012 and reason for infusion interruption will be 
summarized by disease-specific cohort.  
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.  Results will be summarized as 
number and percentage of participants with prior and concomitant medications by WHO drug 
class in the FAS.  For the summary of concomitant medication, only medications starting on or 
after the first dose of study drug and no later than 90 days after the last dose of INCMGA00012 
will be included.  Medications with missing start/end date will be considered as concomitant 
medications in summary.  Other medications will be provided in the listing.  Medications 
intended to manage irAEs as well as prophylaxis/premedication used to prevent infusion 
reactions may be summarized separately.  Post-therapy and nondrug therapy will also be listed 
per CRF.  
7. 
EFFICACY  
Appendix A provides a list of planned tables, figures, and listings.  
7.1. 
General Considerations  
Efficacy endpoints of this study include ORR together with DCR, DOR, and PFS as determined 
by the investigator based on RECIST v1.1, and OS.  Listings of response assessments at each 
visit will be provided.  All efficacy analysis will be presented by disease-specific cohort  
7.2. 
Efficacy Hypotheses  
Not applicable.  
7.3. 
Analysis of the Efficacy Parameters  
The efficacy parameters will be analyzed using FAS.  
7.3.1. 
Response Criteria  
Overall disease status will be categorized using RECIST v1.1.  Participants 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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7.3.2. 
Primary Analysis  
7.3.2.1. 
Overall Response Rate   
The primary endpoint of the study is ORR, defined as the percentage of participants with CR or 
PR at any postbaseline visit before the first assessment of PD or new anticancer therapy, 
according to RECIST v1.1 (Eisenhauer et al 2009) as determined by the investigator.   
Participants who do not have sufficient baseline data to ascertain a response will be included in 
the denominators in the calculation of ORR.  The analysis of ORR will be based on the FAS.  
Overall response rate and its exact 95% CI will be presented.  
For participants with measurable disease at baseline, the RECIST v1.1 assessment criteria 
presented in Table 3 can be used to determine the overall response at a given timepoint based on 
the target lesion, nontarget lesion, and new lesion assessments.  
Table 3:  
RECIST Evaluation Criteria for Overall Response  
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  
7.3.2.2. 
Best Overall Response  
The BOR is the best response recorded from the start of the treatment until the first PD, in the 
order of CR, PR, SD, PD, and NE.  Responses of CR, PR, or SD after a response of PD will not 
be considered in determining best response.  The BOR will be determined from response 
assessments before or on the same day as new anticancer therapy.  If any alternative cancer 
therapy is taken while on study, any subsequent assessments will be excluded from the BOR 
determination.  In the case of SD, measurements must meet the SD criteria at least after the date 
of first dose at a minimum of 7 weeks.  
7.3.3. 
Secondary Analysis  
7.3.3.1. 
Duration of Response  
Duration of response is defined as the time from first objective response (CR or PR) to the time 
of first documented PD or death due to any cause.  If a participant does not have an event before 
data cutoff or new anticancer therapy, DOR is censored at the date of the last adequate tumor 
assessment before data cutoff or new anticancer therapy following the same algorithm as 
censoring of PFS (see Table 4).  If there are sufficient observations for the responders, then a 
Kaplan-Meier estimate of the distribution function will be constructed for DOR, and the median 


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DOR along the 95% CI will be reported.  If the number of observed responders in each treatment 
group is not sufficient to estimate median DOR, a swimmer plot and listing for DOR may be 
generated in place of the summary table.  
Table 4:  
Evaluation and Censoring of Progression-Free Survival  
Situation  
Outcome  
Date of Progression or Censoring  
No baseline tumor assessments  
Censored  
Day 1  
No valid postbaseline response assessments in 
the absence of death prior to first scheduled 
tumor assessment  
Censored  
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 or missing)  
Study withdrawal for undocumented 
progression  
Censored  
Date of last valid radiologic assessment 
(not NE or missing)  
Study withdrawal for toxicity or other reason  
Censored  
Date of last valid radiologic assessment 
(not NE or missing)  
New anticancer treatment started  
Censored  
Date of last valid radiologic assessment 
(not NE or 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 documented progression immediately 
after missing 2 or more consecutive scheduled 
tumor assessment  
Censored  
Date of last valid radiologic assessment 
(not NE or missing) prior to missed 
assessments  
7.3.3.2. 
Disease Control Rate  
Disease control rate is defined as the proportion of participants with an overall response (CR and 
PR) or SD at any postbaseline visit before first PD or new anticancer therapy.  The DCR will be 
calculated, and exact 95% CI will be reported.  
7.3.3.3. 
Progression-Free Survival  
Progression-free survival is defined as the time from the first dose of study drug to the date of the 
first PD according to RECIST v1.1 or death due to any cause.  Progression-free survival will be 
analyzed by the Kaplan-Meier method, including estimated median with 95% CI and 
KaplanMeier estimated probabilities at several timepoints.  If participants have no observed 
death or disease progression before data cutoff or new anticancer therapy, the participants will be 
treated as censored at their last adequate tumor assessment before data cutoff or new anticancer 


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therapy according to Table 4.  Date of death will be determined using the Death Report, Survival 
Follow Up, and Subject Status eCRFs.  
7.3.3.4. 
Overall Survival  
Overall survival is defined as the time from first dose of study drug to the date of death due to 
any cause.  Date of death will be determined using the Death Report, Survival Follow Up, and 
Subject Status eCRFs.  Participants who are lost to follow-up or still alive at the time of analysis 
will be censored at the last known alive date.  The last known alive date is defined as the later of 
the last study visit and the date the participant was last known alive from the Survival Follow-Up 
and Subject Status eCRFs or any datasets with data entry that could reflect participant status.   
Kaplan Meier curves, medians, and 95% CIs of the medians will be presented for OS.  
7.3.3.5. 
Tumor Size Change Over Time     
Tumor size is defined as the sum of diameters of target lesions.  The best percentage change 
from baseline, defined as the largest decrease in tumor size for each participant, will be 
summarized descriptively.  In addition, the best percentage change may be presented by a 
waterfall plot.  The analysis will be performed in all participants in the FAS with baseline tumor 
size available.  
Per RECIST v1.1, target lesions considered "too small to measure" will be assigned a default 
value of 5 mm for the 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 timepoint.  


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8. 
SAFETY AND TOLERABILITY  
Appendix A provides a list of planned tables, figures, and listings.  
8.1. 
General Considerations  
The clinical safety data (eg, vital signs, ECGs, routine laboratory tests, physical examinations, 
and AEs) will be summarized using descriptive statistics (eg, mean, frequency) by disease-
specific cohort in safety evaluable population.  Overall summaries combining all 4 disease-
specific cohorts will be presented.  If sufficient HIV-positive participants are enrolled into the 
study, safety data for those participants will be presented.  
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 will be limited to TEAEs, but data listings will include 
all AEs regardless of their timing to study drug administration.  Adverse events will be tabulated 
by MedDRA SOC and PT.  Severity of AEs will be based on the NCI CTCAE v5.0 using Grades 
1 through 5 (NCI 2017).  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 have a relationship to the study drug will be 
considered to be treatment-related AEs.  If the investigator does not specify the relationship of 
the AEs to any component of study drug, the AE will be considered treatment-related.  The 
incidence of AEs and treatment-related AEs will be tabulated.  
An overall summary of AEs will include number (%) of participants reporting any TEAEs, any 
serious TEAEs, any Grade 3 or higher TEAEs, any treatment-related TEAEs, any fatal TEAEs, 
and any TEAEs leading to study drug interruption, dose reduction, or discontinuation and study 
withdrawal.  
Number (%) of participants reporting any TEAEs, any serious TEAEs, any Grade 3 or higher 
TEAEs, any treatment-related TEAEs, any fatal TEAEs, and any TEAEs leading to treatment 
interruption, dose reduction, or discontinuation will be tabulated by MedDRA SOC and PT. 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.  
Infusion-related reactions as well as irAEs (ie, AESIs) may be summarized separately.   
8.2.2. 
Adverse Events of Special Interest  
Immune-related AEs as well as infusion reactions will be considered AESIs in this study.  
Predefined PTs will be grouped into AESI categories and used to identify irAEs or infusion 
reactions without consideration of investigator's assessment of causality.  Diagnosis of infusion 


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reactions occurring anytime during the treatment period, symptoms of infusion reactions that 
occur within 1 day of infusion, and resolve within 2 days from onset, will be considered infusion 
reactions.  Adverse events of special interest identified by the investigator in the AE dataset will 
also be listed.  
Immune-related AEs and infusion reactions will be summarized in separate tables.  They will 
also be combined in an AESI overall summary table.  An overall summary of AESIs will include  
the number (%) of participants reporting any AESIs, any ≥ Grade 3 AESIs, any treatment-related 
AESIs, any fatal AESIs, and any AESIs leading to infusion interruption, delay in planned 
treatment, or study drug discontinuation.  
8.2.3. 
Adverse Event Summaries  
An overall summary of AEs may include the following:  
• 
Number (%) of participants reporting any TEAEs  
• 
Number (%) of participants reporting any serious TEAEs  
• 
Number (%) of participants reporting any Grade 3 or higher TEAEs  
• 
Number (%) of participants reporting any TEAEs related to study drug  
• 
Number (%) of participants reporting any serious TEAEs related to study drug  
• 
Number (%) of participants reporting any Grade 3 or higher TEAEs related to  
INCMGA00012  
• 
Number (%) of participants who temporarily interrupted study drug infusion because 
of TEAEs  
• 
Number (%) of participants who delayed next scheduled dose because of TEAEs   
• 
Number (%) of participants who permanently discontinued INCMGA00012 because 
of TEAEs  
• 
Number (%) of participants who had a fatal TEAE  
• 
Number (%) of participants who withdrew from study because of TEAEs The 
following summaries may be produced by MedDRA term:  
• 
Summary of TEAEs by SOC and PT  
• 
Summary of TEAEs by PT in decreasing order of frequency  
• 
Summary of TEAEs by SOC, PT, and maximum severity  
• 
Summary of Grade 3 or higher TEAEs by SOC and PT  
• 
Summary of Grade 3 or higher TEAEs by PT in decreasing order of frequency  
• 
Summary of serious TEAEs by SOC and PT  
• 
Summary of serious TEAEs by PT in decreasing order of frequency  
• 
Summary of treatment-related TEAEs by SOC and PT  
• 
Summary of treatment-related TEAEs by PT in decreasing order of frequency  
• 
Summary of treatment-related Grade 3 or higher TEAEs by SOC and PT  


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• 
Summary of treatment-related serious TEAEs by SOC and PT  
• 
Summary of TEAEs with a fatal outcome by SOC and PT  
• 
Summary of TEAEs leading to infusion interruption by SOC and PT  
• 
Summary of TEAEs leading to infusion delay in next scheduled dose by SOC and PT   
• 
Summary of leading to study drug discontinuation by SOC and PT  
• 
Summary of infusion-related reactions by SOC and PT  
• 
Signs/symptoms of infusion-related reactions  
• 
Summary of nonserious TEAEs by PT in decreasing order of frequency The 
following summaries for AEs of special interest will be included:  
• 
Overall summary of TEAEs of special interest  
• 
Summary TEAEs of special interest by group term and PT  
• 
Summary TEAEs of special interest by group term, PT, and maximum severity  
• 
Summary of Grade 3 or higher TEAEs of special interest by group term and PT  
• 
Summary of TEAEs of special interest with a fatal outcome by group term and PT  
• 
Summary of TEAEs of special interest leading to infusion interruption by group term 
and PT  
• 
Summary of TEAEs of special interest leading to infusion delay in next scheduled 
dose by group term and PT  
• 
Summary of TEAEs of special interest leading to study drug discontinuation by group 
term and PT  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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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 4.1.4.  If there are multiple values that meet the 
criteria for baseline, Table 5 will delineate which value will be defined as baseline.  
Table 5:  
Baseline Laboratory Identification  
Priority  
Laboratory Visit  
Proximity to Visit Window  
Tiebreaker  
1  
Scheduled  
In-window  
Use smallest laboratory 
sequence number  
2  
Unscheduled  
In-window  
3  
Scheduled  
Out-of-window  
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 will be listed.  
8.3.2. 
Laboratory Value Summaries  
All test results and associated normal ranges from laboratories will be reported in SI units.  Any 
laboratory test results and associated normal ranges from local laboratories will be converted to 
SI units.  For test results that will be summarized with available normal ranges, the number and 
percentage of participants 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 may 
be produced for each test for safety evaluable population.  The denominator for the percentage 
calculation will use the number of participants 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 numeric laboratory values, baseline value, postbaseline value, change from baseline, 
and percentage change from baseline will be summarized by visit.  
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 participants in the baseline category. 
 The following summaries will be produced for laboratory data (by laboratory parameter) 
reported on-treatment.  
• 
Number and percentage of participants with worst postbaseline CTC grade  
(regardless of the baseline status).  Each participant will be counted only for the worst 
grade observed postbaseline.  
• 
Shift tables using CTCAE grades comparing baseline with the worst postbaseline 
value will be produced for hematology and biochemistry laboratory parameters with 
CTCAE grades.  


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• 
For laboratory parameters where CTCAE grades are not defined, shift tables to the 
worst postbaseline value will be produced using the low/normal/high classifications 
based on laboratory reference ranges.  
• 
For laboratory parameters with any worsening postbaseline CTC grades than 
baseline, the worst postbaseline CTC grades will be summarized according to CTC 
severity grade levels.  If baseline grade is missing, any postbaseline abnormality 
(Grade 1-4) is considered worsening from baseline.  
• 
Number and percentage of participants meeting categorical liver function test criteria, 
including ALT, AST, and ALT or AST (> 3, 5, 8, 10, and 20 × ULN), total bilirubin 
(> 1 and 2 × ULN), ALP (> 1.5, 2, 3, 5, 8, and 10 × ULN), combined categories of 
ALT/AST and total bilirubin (eg, ALT or AST > 3 × ULN and total bilirubin > ULN) 
as well as laboratory Hy's Law criteria without medical adjudication (ALT or AST > 
3 × ULN and total bilirubin > 2 × ULN and ALP < 2 × ULN at the same visit or 
within a specified number of days).  The worst values observed postbaseline for each 
participant will be used for each of the categories.  The summary will be presented by 
baseline liver metastases status.  
8.4. 
Vital Signs   
Values at each scheduled visit, change, and percentage change from baseline for vital signs, 
including pulse, systolic blood pressure, diastolic blood pressure, respiratory rate, body 
temperature, and weight, will be summarized descriptively by disease-specific cohort.    
Criteria for clinically notable vital sign abnormalities are defined in Table 6.  The abnormal 
values for participants exhibiting clinically notable vital sign abnormalities will be listed.  Alert 
vital signs are defined as an absolute value outside the defined range and absolute percentage 
change from baseline greater than 25%.  The abnormal values for participants exhibiting alert 
vital sign abnormalities will be listed.  
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  
Respiratory rate  
> 24 breaths/min  
< 8 breaths/min  
8.5. 
Electrocardiograms  
Twelve-lead ECGs including HR, PR, QRS, QT, QTc, QTcF, and QTcB intervals will be 
obtained for each participant during the study.  Values at each scheduled visit, change, and 
percentage change from baseline will be summarized for each ECG parameter at baseline will be 
determined as the last nonmissing ECG measurements taken before the first administration of the 
study drug.  
Criteria for clinically notable ECG abnormalities are defined in Table 7.  Participants exhibiting 
clinically notable ECG abnormalities will be listed by study visit and disease-specific cohort.  


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Abnormal values for participants 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/QTcB/ 
QTc  
> 460 ms  
< 295 ms  
PR  
> 220 ms  
< 75 ms  
QRS  
> 120 ms  
< 50 ms  
QT  
> 500 ms  
< 300 ms  
HR  
≥ 100 bpm and increase from baseline of ≥ 25%  
≤ 50 bpm and decrease from baseline of ≥ 25%  
QTcB = Bazett correction; QTcF = Fridericia correction.  
A summary of outliers of QT, QTcB, and QTcF will be presented by study visit.  
9. 
PHARMACOKINETIC 
 ANALYSES  
9.1. 
Bioanalysis Materials and Methods  
All the bioanalysis work will be performed by Incyte or its designee.  Plasma concentrations of 
INCMGA00012 will be measured using an MSD-ECL method.  
 
  
9.2. 
Pharmacokinetic Assessments  
Assessment of PK is an important objective of this study, representing the first clinical 
experience with administration of INCMGA00012 as a 30-minute infusion.   
Trough serum concentrations by treatment cycles and/or across cycles ≥ 2 will be summarized.  
Serum PK parameters for INCMGA00012 including Cmax, Tmax, and AUC0-t after single dose 
administration will be derived from serum concentrations versus time data using model 
independent noncompartmental analysis methods.  The descriptive statistical analyses of serum 
concentrations and/or pharmacokinetic parameters will be performed with regard to 1 or several 
group variables such as cohort and/or visit, as a secondary endpoint of the study.  
Population PK analyses will be conducted using data from this study alone or combined with 
data from other studies, as deemed appropriate.  The planning and the execution of population 
PK analyses will be reported separately.  
 
  
 
 
 
  


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10. 
CHANGES AND MODIFICATIONS TO THE ANALYSIS PLAN  
All versions of the SAP are listed in Table 8.  
Table 8:  
Statistical Analysis Plan Versions  
SAP Version  
Date  
Original  
05 FEB 2020  
Amendment 1  
23 JUN 2020  
10.1. 
Changes to Protocol-Defined Analyses  
Not applicable.  
10.2. 
Changes to the Statistical Analysis Plan  
10.2.1. 
Amendment 1  
• 
Added Section 4.2.2 Creatinine Clearance as a variable to be calculated if not 
reported on the eCRF.  
• 
Clarified analysis of AESIs in Section 8.2.2 to include immune-related AEs and 
infusion reactions.  
• 
Updated AESI summaries in Section 8.2.3 to have AESIs summarized by group term.  
• 
Updated the plasma concentrations of INCMGA00012 to be measured using an 
MSD-ECL method in Section 9.1.  
• 
Updated Appendix A to include infusion reactions and summaries by group term.  
• 
Minor administrative changes have been incorporated throughout and are noted in the 
redline version of the amendment.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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11. 
REFERENCES  
Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 
1976; 16:31–41.  
Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumors: 
revised RECIST guideline (version 1.1). Eur J Cancer 2009;45:228-247.  
National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) Version 
5.0. 2017.  
 


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APPENDIX A. PLANNED TABLES, FIGURES, AND LISTINGS  
This appendix provides a list of the planned tables, figures, and listings for the Clinical Study 
Report.  Standard tables will follow the conventions in the Standard Safety Tables.  Shells are 
provided for nonstandard tables in a separate document.  In-text tables are identical in structure 
and content as appendix tables, but follow a Rich Text Format.  
The lists of tables, figures, and listings are to be used as guidelines.  Modifications of the lists 
that do not otherwise affect the nature of the analysis will not warrant an amendment to the SAP. 
Tables  
Table No.  
Title  
Population  
Baseline and Demographic Characteristics  
1.1  Disposition  
1.1.1  
Analysis Populations  
Enrolled  
1.1.2  
Summary of Participant Disposition  
FAS  
1.1.3  
Number of Participants Enrolled by Site and Country  
FAS  
1.1.4  
Summary of Protocol Deviations  
FAS  
1.2  Demographics  
1.2  
 Summary of Demographics and Baseline Characteristics  
 
FAS  
1.3  Baseline Disease Characteristics (refine per data collection)  
1.3.1  
Summary of Cancer History and Baseline Disease Characteristics:  Melanoma  
FAS  
1.3.2  
Summary of Cancer History and Baseline Disease Characteristics:  NSCLC  
FAS  
1.3.3  
Summary of Cancer History and Baseline Disease Characteristics:  Urothelial 
Cancer  
FAS  
1.3.4  
Summary of Cancer History and Baseline Disease Characteristics:  Renal Cell 
Carcinoma  
FAS  
1.4  Prior Medication and Concomitant Medication (refine per data collection)  
1.4.1  
Summary of Prior Medications  
FAS  
1.4.2  
Summary of Concomitant Medications  
FAS  
1.4.3  
Summary of Prior Therapy  
FAS  
1.5  Others  
1.5  
Summary of General Medical History  
FAS  
2  Efficacy   
2.1.1  
Summary of Best Overall Response According to RECIST v1.1   
FAS  
2.2.1  
Summary of Duration of Response According to RECIST v1.1   
FAS  
2.2.2  
Summary of Progression-Free Survival According to RECIST v1.1   
FAS  
2.2.3  
Summary of Overall Survival  
FAS  
2.2.4  
Summary of Largest Percentage Reduction in Sum of Diameters of Target 
Lesions  
FAS  
Safety  
3.1  Dose Exposure  
3.1.1  
Summary of Exposure to INCMGA00012  
Safety 
Evaluable  
3.1.2  
Summary of INCMGA00012 Dose Delay/Interruption  
Safety 
Evaluable  


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Table No.  
Title  
Population  
3.2  Adverse Events   
3.2.1.1  
Overall Summary of Treatment-Emergent Adverse Events  
Safety 
Evaluable  
3.2.1.2  
Overall Summary of Treatment-Emergent Adverse Events of Special Interest  
Safety 
Evaluable  
3.2.1.3  
Overall Summary of Treatment-Emergent Infusion Reaction  
Safety 
Evaluable  
3.2.1.4  
Overall Summary of Treatment-Emergent Immune Related Adverse Events   
Safety 
Evaluable  
3.2.2.1  
Summary of Treatment-Emergent Adverse Events by MedDRA System Organ 
Class and Preferred Term  
Safety 
Evaluable  
3.2.2.2  
Summary of Treatment-Emergent Infusion Reaction by Group Term and 
Preferred Term  
Safety 
Evaluable  
3.2.2.3  
Summary of Treatment-Emergent Immune Related Adverse Events by Group 
Term and Preferred Term  
Safety 
Evaluable  
3.2.3.1  
Summary of Treatment-Emergent Adverse Events by MedDRA Preferred 
Term in Decreasing Order of Frequency  
Safety 
Evaluable  
3.2.4.1  
Summary of Treatment-Emergent Adverse Events by MedDRA System Organ 
Class, Preferred Term, and Maximum Severity  
Safety 
Evaluable  
3.2.4.2  
Summary of Treatment-Emergent Infusion Reaction by Group Term, Preferred 
Term, and Maximum Severity  
Safety 
Evaluable  
3.2.4.3  
Summary of Treatment-Emergent Immune Related Adverse Events by Group 
Term, Preferred Term, and Maximum Severity  
Safety 
Evaluable  
3.2.6.1  
Summary of Grade 3 or Higher Treatment-Emergent Adverse Events by 
MedDRA System Organ Class and Preferred Term  
Safety 
Evaluable  
3.2.6.2  
Summary of Grade 3 or Higher Treatment-Emergent Infusion Reaction by 
Group Term and Preferred Term  
Safety 
Evaluable  
3.2.6.3  
Summary of Grade 3 or Higher Treatment-Emergent Immune Related Adverse 
Events by Group Term and Preferred Term  
Safety 
Evaluable  
3.2.7  
Summary of Grade 3 or Higher Treatment-Emergent Adverse Events by 
MedDRA Preferred Term in Decreasing Order of Frequency  
Safety 
Evaluable  
3.2.8  
Summary of Serious Treatment-Emergent Adverse Events by MedDRA 
System Organ Class and Preferred Term  
Safety 
Evaluable  
3.2.9  
Summary of Serious Treatment-Emergent Adverse Events by MedDRA 
Preferred Term in Decreasing Order of Frequency  
Safety 
Evaluable  
3.2.10  
Summary of Treatment-Related Treatment-Emergent Adverse Events by 
MedDRA System Organ Class and Preferred Term  
Safety 
Evaluable  
3.2.11  
Summary of Treatment-Related Treatment-Emergent Adverse Events by 
MedDRA Preferred Term in Decreasing Order of Frequency  
Safety 
Evaluable  
3.2.14  
Summary of Treatment-Related Grade 3 or Higher Treatment-Emergent 
Adverse Events by MedDRA System Organ Class and Preferred Term  
Safety 
Evaluable  
3.2.15  
Summary of Treatment-Related Serious Treatment-Emergent Adverse Events 
by MedDRA System Organ Class and Preferred Term  
Safety 
Evaluable  
3.2.16.1  
Summary of Treatment-Emergent Adverse Events With a Fatal Outcome by 
MedDRA System Organ Class and Preferred Term  
Safety 
Evaluable  


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3.2.16.2  
Summary of Treatment-Emergent Infusion Reaction With a Fatal Outcome by 
Group Term and Preferred Term  
Safety 
Evaluable  
3.2.16.3  
Summary of Treatment-Emergent Immune Related Adverse Events With a 
Fatal Outcome by Group Term and Preferred Term  
Safety 
Evaluable  
 
Table No.  
Title  
Population  
3.2.19.1  
Summary of Treatment-Emergent Adverse Events Leading to Infusion 
Interruption by MedDRA System Organ Class and Preferred Term  
Safety Evaluable 
3.2.19.2  
Summary of Treatment-Emergent Infusion Reaction Leading to Infusion 
Interruption by Group Term  and Preferred Term  
Safety Evaluable 
3.2.19.3  
Summary of Treatment-Emergent Immune Related Adverse Events Leading to 
Infusion Interruption by Group Term and Preferred Term  
Safety Evaluable 
3.2.19.4  
Summary of Treatment-Emergent Adverse Events Leading to Next Scheduled 
Dose Delay by MedDRA System Organ Class and Preferred Term  
Safety Evaluable 
3.2.19.5  
Summary of Treatment-Emergent Infusion Reaction Leading to Next 
Scheduled Dose Delay by Group Term and Preferred Term  
Safety Evaluable 
3.2.19.6  
Summary of Treatment-Emergent Immune Related Adverse Events Leading to 
Next Scheduled Dose Delay by Group Term and Preferred Term  
Safety Evaluable 
3.2.20.1  
Summary of Treatment-Emergent Adverse Events Leading to Discontinuation 
of Study Drug by MedDRA System Organ Class and Preferred Term  
Safety Evaluable 
3.2.20.2  
Summary of Treatment-Emergent Infusion Reaction Leading to  
Discontinuation of Study Drug by Group Term and Preferred Term  
Safety Evaluable 
3.2.20.3  
Summary of Treatment-Emergent Immune Related Adverse Events Leading to 
Discontinuation of Study Drug by Group Term and Preferred Term  
Safety Evaluable 
3.2.24  
Summary of Nonserious Treatment-Emergent Adverse Events by Preferred 
Term in Decreasing Order of Frequency  
Safety Evaluable 
3.3  Laboratory  
3.3.1.1  
Summary of Laboratory Values - Hematology  
Safety Evaluable 
3.3.1.2  
Summary of Laboratory Values - Chemistry  
Safety Evaluable 
3.3.1.3  
Summary of Laboratory Values - Coagulation  
Safety Evaluable 
3.3.1.4  
Summary of Laboratory Values - Urinalysis  
Safety Evaluable 
3.3.1.5  
Summary of Laboratory Values - Endocrine  
Safety Evaluable 
3.3.2.1  
Shift Summary of Hematology Laboratory Values - to the Worst Abnormal 
Value  
Safety Evaluable 
3.3.2.2  
Shift Summary of Chemistry Laboratory Values - to the Worst Abnormal 
Value  
Safety Evaluable 
3.3.2.3  
Shift Summary of Coagulation Laboratory Values - to the Worst Abnormal 
Value  
Safety Evaluable 
3.3.3.1  
Shift Summary of Hematology Laboratory Values in CTC Grade - to the Worst 
Abnormal Value  
Safety Evaluable 
3.3.3.2  
Shift Summary of Chemistry Laboratory Values in CTC Grade - to the Worst 
Abnormal Value  
Safety Evaluable 


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CONFIDENTIAL  
3.3.3.3  
Shift Summary of Coagulation Laboratory Values in CTC Grade - to the Worst 
Abnormal Value  
Safety Evaluable 
3.3.3.4  
Treatment-Emergent Worsening of Laboratory Abnormalities - Hematology  
Safety Evaluable 
3.3.3.5  
Treatment-Emergent Worsening of Laboratory Abnormalities - Chemistry  
Safety Evaluable 
3.3.3.6  
Treatment-Emergent Worsening of Laboratory Abnormalities - Coagulation  
Safety Evaluable 
Table No.  
Title  
Population  
3.3.6  
Summary of Liver Chemistry  
Safety 
Evaluable  
3.4  Vital Signs    
 
3.4.1  
Summary of Systolic Blood Pressure  
Safety 
Evaluable  
3.4.2  
Summary of Diastolic Blood Pressure  
Safety 
Evaluable  
3.4.3  
Summary of Pulse  
Safety 
Evaluable  
3.4.4  
Summary of Respiration Rate  
Safety 
Evaluable  
3.4.5  
Summary of Body Temperature  
Safety 
Evaluable  
3.4.6  
Summary of Body Weight  
Safety 
Evaluable  
3.5  ECG  
 
 
3.5.1  
Summary of PR Interval (ms) From 12-Lead ECG  
Safety 
Evaluable  
3.5.2  
Summary of QRS Interval (ms) From 12-Lead ECG  
Safety 
Evaluable  
3.5.3  
Summary of QT Interval (ms) From 12-Lead ECG  
Safety 
Evaluable  
3.5.4  
Summary of QTc Interval (ms) From 12-Lead ECG  
Safety 
Evaluable  
3.5.5  
Summary of QTcF Interval (ms) From 12-Lead ECG  
Safety 
Evaluable  
3.5.6  
Summary of QTcB Interval (ms) From 12-Lead ECG  
Safety 
Evaluable  
3.5.7  
Summary of Heart Rate (bpm) From 12-Lead ECG  
Safety 
Evaluable  
3.5.8  
Summary of Outliers of QT, QTcB, and QTcF Interval Values (ms) from 12-
Lead ECG by Visit  
Safety 
Evaluable  
Figures  
Figure No.  
Title  
Efficacy (by disease-specific cohort.  Laboratory figures may be added as needed)  
4.1  
Kaplan-Meier Estimates of Duration of Response According to RECIST v1.1 – by Disease-Specific 
Cohort (Optional Pending Data Availability)  


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4.2  
Kaplan-Meier Estimates of Progression Free Survival According to RECIST v1.1 – by Disease-
Specific Cohort   
4.3  
Kaplan-Meier Estimates of Overall Survival – by Disease-Specific Cohort  
4.4  
Waterfall Plot of Best Percentage Change in Sum of Target Lesions – by Disease-Specific Cohort  
4.5  
Swimmer Plot of Duration of Response According to RECIST v1.1 – by Disease-Specific Cohort  
5.1  
Mean and Standard Error of Laboratory Parameters – by Disease-Specific Cohort (Optional)  
Listings (data dump listings may be added)  
Listing No.  
Title  
2.1  Discontinued Participants (Participant Disposition)  
2.1.1  
Participant Enrollment and Disposition Status  
2.1.2  
Participant Inclusion and Exclusion Criteria Deviations  
2.2  Protocol Deviations  
2.2  
Protocol Deviations   
2.3  Data Excluded From PK, Efficacy, and/or Safety Analyses  
2.3  
Analysis Populations  
2.4  Demography and Baseline (Including Prior and Concomitant Medications)  
2.4.1  
Demographics and Baseline Characteristics  
2.4.2  
Cancer History and Baseline Disease Characteristics by Cancer Type  
2.4.3  
Prior Radiotherapy  
2.4.4  
Prior Systemic Cancer Therapy  
2.4.5  
Prior Surgery or Surgical Procedure  
2.4.6  
Medical History  
2.4.7  
Prior and Concomitant Medications  
2.4.8  
Procedures and Nondrug Therapy  
2.4.9  
Post Anticancer Therapy  
2.5  Drug Exposure   
2.5  
Study Drug Exposure  
2.6  Efficacy  
2.6.1  
Overall Survival Events and Assessments  
2.6.2  
Progression-Free Survival Events and Assessments According to RECIST v1.1  
2.6.3  
Overall Response Assessment According to RECIST v1.1  
2.6.4  
Duration of Response According to RECIST v1.1  
2.6.5  
Response Assessment:  Target Lesions  
2.6.6  
Response Assessment:  Nontarget Lesions  
2.6.7  
Response Assessment:  New Lesions  
2.6.8  
Sum of Diameters of Target Lesions  
2.6.9  
Overall Response Assessment According to iRECIST  
2.7  Adverse Events   
2.7.1  
Adverse Events  
2.7.2  
Serious Adverse Events  
2.7.3  
Fatal Adverse Events  
2.7.4  
Adverse Events Leading to Study Drug Discontinuation  
2.7.5  
Adverse Events Leading to Study Drug Interruption   


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2.7.6  
Adverse Events of Infusion Reaction  
2.7.7  
Immune Related Adverse Events  
2.7.8  
Grade 3 or Higher Adverse Events  
2.7.9  
Investigator Identified Adverse Events of Special Interest  
2.8  Laboratory Data  
2.8.1  
Clinical Laboratory Values – Hematology  
2.8.2  
Clinical Laboratory Values – Chemistry  
2.8.3  
Clinical Laboratory Values – Urinalysis  
Listing No.  
Title  
2.8.4  
Clinical Laboratory Values – Coagulation  
2.8.5  
Clinical Laboratory Values – Endocrine  
2.8.6.1  
Abnormal Clinical Laboratory Values – Hematology  
2.8.6.2  
Abnormal Clinical Laboratory Values – Chemistry  
2.8.6.3  
Abnormal Clinical Laboratory Values – Urinalysis  
2.8.6.4  
Abnormal Clinical Laboratory Values – Coagulation  
2.8.7  
Clinical Laboratory Values – Pregnancy  
2.8.8  
Clinical Laboratory Values – Liver Chemistry  
2.8.9  
HIV-Related Parameters  
2.8.10  
PK Blood Sampling Times  
2.9  Vital Signs  
2.9.1  
Vital Signs  
2.9.2  
Abnormal Vital Sign Values  
2.9.3  
Alert Vital Sign Values  
2.10  Electrocardiograms  
2.10.1  
12-Lead ECG Values  
2.10.2  
Abnormal 12-Lead ECG Values  
2.10.3  
Alert 12-Lead ECG Values  
2.11  Other  
2.11.1  
ECOG Performance Status  
2.11.2  
Tobacco Use  
2.11.3  
Alcohol Consumption  
  


 
 
Signature Manifest 
Document Number: IC-STS-SAP-0193 
Revision: 0 
Title: INCMGA 0012-203 SAP Amendment 1 
 
All dates and times are in Eastern Standard Time. 
INCMGA 0012-203 SAP Amendment 1 
Approval and Release 
 
 
 
 
Name/Signature 
Title 
Date 
Meaning/Reason 
24 Jun 2020, 07:41:08 AM 
Approved 
24 Jun 2020, 09:28:34 AM 
Approved 
24 Jun 2020, 02:36:23 PM 
Approved