Clinical trial NCT03597295
Conditions: Squamous Cell Carcinoma of Anal Canal
Keywords: Squamous carcinoma of the anal canal anti-PD-1 antibody IgG4 monoclonal antibody INCMGA00012
Sponsor: Incyte Corporation
Start date: 2018-10-08; Completion date: 2021-11-10
Enrollment: 94 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the efficacy of INCMGA00012 in participants with locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) who have progressed after platinum-based chemotherapy.

Detailed description:

Arms: arm 1: Retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).
Interventions: intervention 1: Retifanlimab
Intervention descriptions: intervention 1: Retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).

Protocol documents:
Prot_000.pdf: 
 
Official Title: 
A Phase 2 Study of INCMGA00012 in Participants With Squamous Carcinoma 
of the Anal Canal Who Have Progressed Following Platinum-Based 
Chemotherapy (POD1UM-202) 
NCT Number: 
NCT03597295 
 
Document Date: 
 
Clinical Study Protocol Version 4: 08 July 2019 
 
 
 
 
 
 
 
 


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Protocol INCMGA 0012-202 Am 4 
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CONFIDENTIAL 
 
Clinical Study Protocol 
 
 
INCMGA 0012-202 
A Phase 2 Study of INCMGA00012 in Participants With Squamous 
Carcinoma of the Anal Canal Who Have Progressed Following 
Platinum-Based Chemotherapy (POD1UM-202) 
 
 
Product: 
INCMGA00012 
IND Number: 
139,333 
EudraCT Number: 
2018-002070-51 
Phase of Study: 
2 
Sponsor: 
Incyte Corporation 
1801 Augustine Cut-Off 
Wilmington, DE 19803 
Original Protocol (Version 0): 
12 JUN 2018 
Amendment (Version) 1: 
06 AUG 2018 
Amendment (Version) 2: 
04 OCT 2018 
Amendment (Version) 2-NL: 
26 NOV 2018 
Amendment (Version) 3: 
21 MAR 2019 
Amendment (Version) 4: 
08 JUL 2019 
 
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 research in the Netherlands is carried 
out in accordance with the Declaration of Helsinki (Brazil, 2013) and the WMO (Medical Research Involving 
Human Subjects Act). 
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 0012-202 Protocol Amendment 4 (Version 4 dated 08 JUL 2019) 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 
LIST OF ABBREVIATIONS ..........................................................................................................8 
1. 
PROTOCOL SUMMARY..........................................................................................11 
2. 
INTRODUCTION ......................................................................................................19 
2.1. 
Background .................................................................................................................19 
2.1.1. 
INCMGA00012 ..........................................................................................................19 
2.2. 
Rationale for Study Design .........................................................................................20 
2.3. 
Rationale for Fixed Doses of INCMGA00012 ...........................................................21 
2.4. 
Benefit/Risk Assessment ............................................................................................22 
3. 
OBJECTIVES AND ENDPOINTS ............................................................................23 
4. 
STUDY DESIGN .......................................................................................................24 
4.1. 
Overall Design ............................................................................................................24 
 
25 
4.2. 
Overall Study Duration ...............................................................................................25 
4.3. 
Study Termination ......................................................................................................26 
4.3.1. 
Data Monitoring Committee .......................................................................................26 
5. 
STUDY POPULATION .............................................................................................27 
5.1. 
Inclusion Criteria ........................................................................................................27 
5.2. 
Exclusion Criteria .......................................................................................................28 
5.3. 
Lifestyle Considerations .............................................................................................30 
5.4. 
Screen Failures............................................................................................................30 
5.5. 
Replacement of Participants .......................................................................................30 
6. 
STUDY TREATMENT ..............................................................................................31 
6.1. 
Study Treatments Administered .................................................................................31 
6.2. 
Preparation, Handling, and Accountability.................................................................31 
6.3. 
Measures to Minimize Bias:  Randomization and Blinding .......................................32 
6.4. 
Study Treatment Compliance .....................................................................................32 
6.5. 
Dose Modifications .....................................................................................................32 
6.5.1. 
Procedures for Participants Exhibiting Immune-Related Adverse Events .................34 
6.5.1.1. 
Immune-Mediated Pneumonitis..................................................................................34 
6.5.1.2. 
Immune-Mediated Colitis ...........................................................................................34 
6.5.1.3. 
Immune-Mediated Hepatitis .......................................................................................35 


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6.5.1.4. 
Immune-Mediated Endocrinopathies..........................................................................36 
6.5.1.5. 
Immune-Mediated Nephritis and Renal Dysfunction .................................................37 
6.5.1.6. 
Immune-Mediated Skin Reactions..............................................................................37 
6.5.1.7. 
Immune-Mediated Myocarditis ..................................................................................37 
6.5.2. 
Permanent Discontinuation of Study Drug Due to Toxicity.......................................38 
6.6. 
Concomitant Medications and Procedures .................................................................38 
6.6.1. 
Permitted Medications and Procedures.......................................................................39 
6.6.2. 
Prohibited Medications and Procedures .....................................................................39 
6.7. 
Treatment After the End of the Study.........................................................................39 
7. 
DISCONTINUATION OF STUDY TREATMENT AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL ..................................................................40 
7.1. 
Discontinuation of Study Drug ...................................................................................40 
7.1.1. 
Reasons for Discontinuation .......................................................................................40 
7.1.2. 
Discontinuation Procedures ........................................................................................41 
7.2. 
Participant Withdrawal From the Study .....................................................................41 
7.3. 
Lost to Follow-Up.......................................................................................................42 
8. 
STUDY ASSESSMENTS AND PROCEDURES......................................................43 
8.1. 
Administrative and General Procedures .....................................................................43 
8.1.1. 
Informed Consent Process ..........................................................................................43 
8.1.2. 
Screening Procedures..................................................................................................44 
8.1.3. 
Interactive Response Technology Procedure..............................................................44 
8.1.4. 
Distribution of Reminder Cards..................................................................................44 
8.1.5. 
Demography and Medical History..............................................................................44 
8.1.5.1. 
Demographics and General Medical History..............................................................44 
8.1.5.2. 
Disease Characteristics and Treatment History ..........................................................44 
8.2. 
Efficacy Assessments .................................................................................................45 
8.2.1. 
Tumor Imaging ...........................................................................................................45 
 
46 
8.2.3. 
Health Economics .......................................................................................................46 
 
46 
 
46 
 
46 
 
47 


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8.3. 
Safety Assessments .....................................................................................................47 
8.3.1. 
Adverse Events ...........................................................................................................47 
8.3.2. 
Physical Examinations ................................................................................................48 
8.3.3. 
Vital Signs...................................................................................................................48 
8.3.4. 
ECOG Performance Status .........................................................................................48 
8.3.5. 
Electrocardiograms .....................................................................................................49 
8.3.6. 
Laboratory Assessments .............................................................................................49 
8.3.6.1. 
Pregnancy Testing.......................................................................................................50 
8.4. 
Pharmacokinetic Assessments ....................................................................................52 
8.5. 
Pharmacodynamic 
 Assessments ....................................................52 
8.5.1. 
Description of Analyses ..............................................................................................52 
8.5.2. 
Tissue Biopsies ...........................................................................................................52 
8.5.3. 
Blood Sample Collection ............................................................................................53 
8.6. 
Unscheduled Visits .....................................................................................................53 
8.7. 
End of Treatment and/or Early Termination...............................................................53 
8.8. 
Follow-Up ...................................................................................................................53 
8.8.1. 
Safety Follow-Up........................................................................................................53 
8.8.2. 
Post-Treatment Disease Follow-Up ............................................................................54 
8.8.3. 
Survival Follow-Up ....................................................................................................54 
9. 
ADVERSE EVENTS:  DEFINITIONS AND PROCEDURES FOR 
RECORDING, EVALUATING, FOLLOW-UP, AND REPORTING ......................55 
9.1. 
Definition of Adverse Event .......................................................................................55 
9.2. 
Definition of Serious Adverse Event ..........................................................................56 
9.3. 
Recording and Follow-Up of Adverse Events and/or Serious Adverse Events .........57 
9.4. 
Reporting of Serious Adverse Events .........................................................................58 
9.5. 
Adverse Events of Special Interest .............................................................................60 
9.6. 
Emergency Unblinding of Treatment Assignment .....................................................60 
9.7. 
Pregnancy....................................................................................................................60 
9.8. 
Warnings and Precautions ..........................................................................................61 
9.9. 
Product Complaints.....................................................................................................61 
10. 
STATISTICS ..............................................................................................................62 
10.1. 
Sample Size Determination ........................................................................................62 
10.2. 
Populations for Analysis .............................................................................................62 


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10.3. 
Level of Significance ..................................................................................................62 
10.4. 
Statistical Analyses .....................................................................................................62 
10.4.1. 
Primary Analysis.........................................................................................................63 
10.4.1.1. 
Overall Response Rate ................................................................................................63 
10.4.1.2. 
Handling of Missing Data in Primary Analysis ..........................................................63 
10.4.2. 
Secondary Analysis.....................................................................................................63 
10.4.2.1. 
Duration of Response..................................................................................................63 
10.4.2.2. 
Disease Control Rate ..................................................................................................63 
10.4.2.3. 
Progression-Free Survival...........................................................................................63 
10.4.2.4. 
Overall Survival ..........................................................................................................63 
10.4.3. 
Safety Analyses...........................................................................................................64 
10.4.3.1. 
Adverse Events ...........................................................................................................64 
10.4.3.2. 
Adverse Events of Special Interest .............................................................................64 
10.4.3.3. 
Clinical Laboratory Tests............................................................................................64 
10.4.3.4. 
Vital Signs...................................................................................................................64 
10.4.3.5. 
Electrocardiograms .....................................................................................................64 
10.4.3.6. 
Dose Intensity .............................................................................................................64 
10.4.4. 
Pharmacokinetics ........................................................................................................65 
 
65 
 
65 
 
65 
 
65 
 
65 
 
65 
10.5. 
Interim Analysis..........................................................................................................66 
 
66 
11. 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS ..................................................................................................67 
11.1. 
Investigator Responsibilities .......................................................................................67 
11.2. 
Data Management .......................................................................................................68 
11.3. 
Data Privacy and Confidentiality of Study Records ...................................................69 
11.4. 
Financial Disclosure ...................................................................................................70 
11.5. 
Publication Policy .......................................................................................................70 


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11.6. 
Study and Site Closure................................................................................................71 
12. 
REFERENCES ...........................................................................................................72 
APPENDIX A. INFORMATION REGARDING EFFECTIVENESS OF 
CONTRACEPTIVE METHODS ...............................................................................74 
APPENDIX B. RESPONSE EVALUATION CRITERIA FOR SOLID TUMORS 
VERSION 1.1 .............................................................................................................75 
APPENDIX C. PROTOCOL AMENDMENT SUMMARY OF CHANGES............................77 
 
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 (
 
).....................................................................16 
Table 5: 
 
.17 
Table 6: 
Objectives and Endpoints ...........................................................................................23 
Table 7: 
Exclusionary Laboratory Values ................................................................................29 
Table 8: 
Study Drug Information ..............................................................................................31 
Table 9: 
Guidelines for Management of Suspected Infusion Reactions ...................................33 
Table 10: Recommended Approach to Handling Pneumonitis...................................................34 
Table 11: Recommended Approach for Handling Enterocolitis/Diarrhea..................................35 
Table 12: Recommended Approach for Handling Hepatitis.......................................................35 
Table 13: Recommended Approach for Handling Hypophysitis ................................................36 
Table 14: Recommended Approach for Handling Thyroid Disorders........................................36 
Table 15: Recommended Approach for Handling New Onset Diabetes Mellitus ......................36 
Table 16: Recommended Approach for Handling Nephritis and Renal Dysfunction ................37 
Table 17: Recommended Approach for Handling Skin Reactions .............................................37 
Table 18: Recommended Approach for Handling Myocarditis ..................................................38 
Table 19: ECOG Performance Status .........................................................................................48 
Table 20: Required Laboratory Analytes ....................................................................................51 
Table 21: Populations for Analysis .............................................................................................62 
 


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LIST OF ABBREVIATIONS 
Abbreviations and 
Special Terms 
Definition 
 
 
AE 
adverse event 
ALT 
alanine aminotransferase 
ANC 
absolute neutrophil count 
aPTT 
activated partial thromboplastin time 
ART 
antiretroviral therapy 
ASCO 
American Society of Clinical Oncology 
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 
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 
CR 
complete response 
CT 
computed tomography 
CTCAE 
Common Terminology Criteria for Adverse Events 
CTFG 
Clinical Trial Facilitation Group 
DCR 
disease control rate 
DMC 
Data Monitoring Committee 
DNA 
deoxyribonucleic acid 
DOR 
duration of response 
EBV 
Epstein–Barr Virus 
ECG 
electrocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
eCRF 
electronic case report form 
EDC 
electronic data capture 
 
 
 
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 
HPV 
human papillomavirus 
 
 
IB 
Investigator's Brochure 
ICF 
informed consent form  
ICH 
International Council on Harmonization of Technical Requirements for 
Registration of Pharmaceuticals for Human Use 
ICR 
Independent Central Radiographic Review 
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 
 
 
IRT 
interactive response technology 
IV 
intravenous 
LDL 
low-density lipoprotein 
MedDRA 
Medical Dictionary for Regulatory Activities 
MTD 
maximum tolerated dose 
NCI 
National Cancer Institute 
NSAID 
nonsteroidal anti-inflammatory drug 
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 1 
PFS 
progression-free survival 
PK 
pharmacokinetic 
PO 
oral 


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Abbreviations and 
Special Terms 
Definition 
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 
QLG 
Quality of Life Group 
 
 
 
 
RECIST 
Response Evaluation Criteria in Solid Tumors 
 
 
SAE 
serious adverse event 
SCAC 
squamous carcinoma of the anal canal 
SD 
stable disease 
SOP 
standard operating procedure 
SUSAR 
suspected unexpected serious adverse reaction 
t½ 
apparent terminal-phase disposition half-life 
T3/FT3 
triiodothyronine 
T4 
thyroxine 
TEAE 
treatment-emergent adverse event 
Tmax 
time to maximum concentration 
TSH 
thyroid-stimulating hormone 
ULN 
upper limit of normal 
WBC 
white blood cell 
WMO 
World Medical Association 


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1. 
PROTOCOL SUMMARY 
Protocol Title:  A Phase 2 Study of INCMGA00012 in Participants With Squamous Carcinoma 
of the Anal Canal Who Have Progressed Following Platinum-Based Chemotherapy 
(POD1UM-202) 
Protocol Number:  INCMGA 0012-202 
Objectives and Endpoints: 
Table 1 presents the primary objective and endpoint. 
Table 1: 
Primary Objective and Endpoint 
Objective 
Endpoint 
Primary 
To assess efficacy of INCMGA00012 in terms of 
the ORR in participants with locally advanced or 
metastatic SCAC who have progressed after 
platinum-based chemotherapy. 
ORR, defined as the percentage of participants 
having a CR or PR, according to RECIST v1.1 as 
determined by ICR. 
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 
Locally advanced or metastatic SCAC in participants who have progressed after 
treatment with platinum-based chemotherapy. 
Population 
Male and female participants at least 18 years of age with locally advanced or 
metastatic SCAC who have progressed after platinum-based chemotherapy. 
Number of 
Participants 
Approximately 81 participants will be enrolled. 
Study Design 
This is an open-label, single-group, multicenter, Phase 2 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 clinical disease progression, 
intolerable toxicity, death, withdrawal of consent, lost to follow-up, or premature 
discontinuation for any other reason. 
Independent Central 
Radiographic 
Review 
Imaging will undergo independent central radiographic review in support of 
efficacy endpoints. 
Data Monitoring 
Committee (DMC) 
Yes (external) 


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Treatment Groups and Duration: 
All participants will receive INCMGA00012 at the recommended Phase 2 dose of 500 mg IV 
Q4W.  Treatment will be administered by IV infusion over 60 minutes on Day 1 of each 28-day 
cycle.  Subsequent treatment cycles should be delayed (for up to 12 weeks, Section 6.5) until the 
following criteria are met:  
 Hemoglobin ≥ 8 gm/dL. 
 ANC ≥ 1.0 × 109/L. 
 Platelet count ≥ 75 × 109/L. 
 ALT/AST/bilirubin ≤ Grade 2. 
 Resolution of all immune-related toxicity to ≤ Grade 1 (with the exception of 
endocrinopathy that is controlled on hormonal replacement), other than unacceptable 
toxicity per Section 6.5.2. 
 Resolution of all non–immune-related toxicity to Grade ≤ 1 or baseline (with the 
exception of alopecia or non–transfusion-dependent anemia). 
Note:  Transient asymptomatic laboratory elevations ≤ Grade 3 do not require dose 
interruption or reduction if the participant is asymptomatic and the elevation is 
clinically insignificant and has been discussed with the medical monitor (eg, amylase, 
lipase). 
 Daily dose of corticosteroid ≤ 10 mg prednisone or equivalent. 
Table 3 presents the complete study-specific schedule of activities.  Details regarding the sample 
collection for pharmacokinetic 
 analyses are defined in Table 4 and Table 5.  
Table 20 presents the safety laboratory analytes to be evaluated.  Adherence to the study design 
requirements, including those specified in the schedule of activities, is essential and required for 
study conduct.  
 
 


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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) 
EOT
a 
Safety 
28-Days After 
Last Dose (± 7 d) 
Disease/ 
Survival 
Administrative procedures 
Informed consent 
X 
 
 
 
 
 
 
 
Interactive Response 
Technology 
X 
X 
X 
 
X 
 
 
 
Inclusion/exclusion 
criteria 
X 
 
 
 
 
 
 
 
General and disease 
medical history 
X 
 
 
 
 
 
 
 
Prior/concomitant 
medications 
X 
X 
X 
 
X 
X 
 
 
Administer 
INCMGA00012 
 
X 
X 
 
 
 
 
Premedication with acetaminophen/paracetamol and a histamine 
blocker 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 
X* 
* Immune-related AEs to be collected for 90 days after the last 
dose of study drug, regardless of whether a new anticancer 
therapy is started.  Reasonable efforts should be made to align 
the first 12-week follow-up visit with the end of the 90-day irAE 
reporting period. 
Physical examination 
X 
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 
X* 
 
 
X 
 
* Every third cycle (C4, C7, C10, etc). 


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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 
Safety 
28-Days After 
Last Dose (± 7 d) 
Disease/ 
Survival 
Efficacy assessments 
Tumor imaging/response 
assessments 
X 
 
 
X 
 
 
X* 
* Scans during follow-up will only be performed for participants 
continuing to be followed for disease status.  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 
X 
 
Survival status 
 
 
 
 
X 
X 
X* 
* During survival follow-up period, participants should be 
contacted by telephone, email, or visit at least every 12 weeks 
per Section 8.8.3. 


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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 
Safety 
28-Days After 
Last Dose (± 7 d) 
Disease/ 
Survival 
Clinical laboratory assessments 
Blood 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 
 
X* 
 
 
X 
 
* Every third cycle (C4, C7, C10, etc). 
Coagulation panel 
X 
 
X* 
 
 
X 
 
* Every third cycle (C4, C7, C10, etc). 
Endocrine panel 
X 
 
X* 
 
 
X 
 
* Every third cycle (C4, C7, C10, etc). 
Urinalysis 
X 
 
X* 
 
 
X 
 
* Every third cycle (C4, C7, C10, etc). 
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 safety follow-up visit.  If EOT is < 21 days postdose, the 28-day safety follow-up visit is required. 




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2. 
INTRODUCTION 
2.1. 
Background 
Monoclonal antibodies that inhibit the interaction of the PD-1 receptor with its ligands have 
recently been approved for treatment of a wide variety of cancers based on prolonged durable 
remissions, which, for some tumor types, have been associated with improved progression-free 
or overall survival (Keytruda® 2017, Opdivo® 2018). 
Squamous cell carcinoma of the anal canal accounts for almost 3% of digestive system cancers 
and is increasing in frequency due to its association with HPV and HIV infection 
(Ghosn et al 2015).  Although most patients have localized disease, systemic metastases will 
develop in approximately 25% of patients, and 5-year survival is poor in these individuals.  
Salvage chemotherapy with platinum-based regimens is an accepted standard of care; however, 
responses are not durable, and progression-free and overall survival after these treatments is 
measured only in months.  There are no accepted salvage treatments for patients who progress 
after first-line chemotherapy (Eng et al 2014). 
Immunotherapy is a promising new approach to treatment of metastatic SCAC.  The ORR to 
single-agent nivolumab in treatment-refractory SCAC was 24% (95% CI: 15, 33), and most of 
these responses were durable (Morris et al 2017).  A pilot study of pembrolizumab in PD-L1+ 
SCAC showed a similar ORR of 17% (Ott et al 2017).  Patients with well-controlled HIV 
infection were included on the nivolumab study, and no unexpected safety issues were reported.  
Anecdotal reports suggest that PD-1 inhibitor treatment may actually improve the outcome of 
chronic HIV infection through multiple mechanisms, including restoration of HIV-specific 
CD8 T-cell function (Guihot et al 2018). 
2.1.1. 
INCMGA00012 
The study drug, INCMGA00012, is a humanized, IgG4 monoclonal antibody that recognizes 
human PD-1.  Phase 1 results of INCMGA00012 in patients with advanced cancer (N = 37) have 
been presented (Lakhani et al 2017).  INCMGA00012 demonstrated acceptable tolerability with 
no dose-limiting toxicity observed at doses ranging from 1 to 10 mg/kg Q2W and Q4W.  A 
maximum tolerated dose was not reached.  T½ (β) was approximately 17 days, and steady-state 
was achieved in approximately 85 days.  Full and sustained receptor occupancy of 
INCMGA00012 on both CD4+ and CD8+ T cells along with complete loss of competing 
fluorescently labeled anti–PD-1 staining (eJBio105 clone) were seen at all dose levels.  
INCMGA00012 is currently being evaluated in expansion cohorts and in combination with other 
potentially immunomodulatory agents. 


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INCMGA00012 demonstrated acceptable tolerability with no DLTs observed at any dose level 
up to 10 mg/kg Q2W.  An MTD was not reached.  Treatment-related ≥ Grade 3 AEs occurred in 
4/37 (10.8%) participants and included increased lipase (n = 3) and vulvovaginal 
ulceration/inflammation (n = 1).  The most common treatment-related AEs were fatigue (n = 9, 
24.3%), rash (n = 5, 13.5%), nausea (n = 5, 13.5%), tumor flare (n = 4, 10.8%), and pruritus 
(n = 4, 10.8%).  A single, treatment-related SAE of aphasia (occurring in the setting of new brain 
metastases) was reported.  Immune-related AEs were limited to rash (n = 5, 13.5%), 
hypothyroidism (n = 3, 8.1%), hyperthyroidism (n = 2, 5.4%), vaginal ulceration/inflammation 
(n = 1, 2.7%), and infusion-related reaction (n = 1, 2.7%). 
INCMGA00012 is currently being evaluated in tumor-specific expansion cohorts of 
35 participants each in Study INCMGA 0012-101.  The expansion cohorts include cervical 
cancer, NSCLC, selected sarcoma subtypes, and endometrial cancer (including microsatellite 
instability-high, mismatch repair deficient, and/or DNA polymerase ε exonuclease domain 
mutation positive disease).  As of 23 SEP 2018, 132 participants have been treated with 3 mg/kg 
INCMGA00012 in one of the above noted cohorts.  The most frequently reported TEAEs were 
fatigue (13.6%), diarrhea (10.6%), and dyspnea (10.6%).  Forty-six participants (34.8%) had a 
TEAE of ≥ Grade 3; the most frequently reported events of ≥ Grade 3 were colitis, 
hypoalbuminemia, and hyponatremia (2.3% each).  Serious AEs occurred in 33 participants 
(25.0%).  SAEs occurring in more than 1 participant included colitis (3.0%), acute kidney injury 
(2.3%), dyspnea (2.3%), and pleural effusion (1.5%).  Immune-related AEs occurred in 
16 participants (12.1%); colitis (2.3%) and infusion-related reaction (2.3%) were the only 
immune-related AEs occurring in more than 1 participant.  INCMGA00012 has also been 
assessed in 2 fixed dose groups (500 mg Q4W and 750 mg Q4W) of 15 participants each.  No 
new safety signals were evident based on fixed doses compared with weight-based doses.  
Further details are presented in the IB.  Preliminary efficacy results indicated that objective 
responses have been observed in participants with NSCLC, cervical cancer, endometrial cancer, 
soft-tissue sarcoma, ovarian cancer, and breast cancer (Mehnert et al 2018). 
As of 23 SEP 2018, 199 participants have received INCMGA00012 monotherapy in 
Study INCMGA 0012-101.  Preliminary activity based on confirmed RECIST responses has 
been observed in multiple tumor types, including all of the disease-specific expansion cohorts 
(previously treated cervical cancer, endometrial cancer, NSCLC, and sarcoma; Mehnert 
et al 2018). 
2.2. 
Rationale for Study Design 
Though initial results with checkpoint inhibitors are encouraging, there still remains an unmet 
medical need in the treatment of SCAC.  In particular, safety, efficacy, and convenience of 
therapy could be improved by using alternative immunotherapies, either as monotherapy or as 
part of rational combination strategies. 


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2.3. 
Rationale for Fixed Doses of INCMGA00012 
Fixed doses have several advantages over weight-based doses, including convenience of 
preparation and administration, reducing errors in preparation calculation, and minimization of 
drug waste.  Body size–based doses and fixed doses of monoclonal antibodies have been 
evaluated, and the 2 approaches performed similarly, with body size–based doses not always 
offering an advantage in reducing variability of exposure (Wang et al 2009, Bai et al 2012). 
The proposed flat dose regimen of 500 mg Q4W is based on modeling of preclinical and clinical 
data from the ongoing first-in-human monotherapy study (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 an MTD 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. 
A simulation was conducted to investigate the use of body weighted dosing and flat dosing for 
INCMGA00012, with the aim of targeting a steady-state trough concentration of approximately 
21 μg/mL, the median trough concentration for pembrolizumab (Freshwater et al 2017).  The 
median INCMGA00012 exposure and its distribution around the median at 500 mg Q4W were 
similar to 7 mg/kg Q4W in the simulated population, which justified clinical exploration in an 
expansion cohort of the study.  The median steady-state concentration at 500 mg Q4W is 
24.8 μg/mL, and 58% of participants have trough concentrations greater than target 
concentration. 
Pharmacokinetic data were obtained from 15 participants who received INCMGA00012 500 mg 
Q4W in the cohort expansion phase of Study INCMGA 0012-101.  The observed AUC0-∞ for 
500 mg Q4W is close to the steady-state AUC0-t based on the population PK analysis of 
weight-based dosing, as is the estimated clearance.  The estimated t½ (333 h) is slightly shorter 
than that from the previous estimate of 409 hours.  The mean trough serum concentration on 
Cycle 2 was 17.1 μg/mL, and the mean projected serum Cmin,ss is 23.1 μg/mL (which meets or 
slightly exceeds the targeted concentration based on pembrolizumab data) with mean 
accumulation index of 1.50.  Overall, the 500 mg Q4W dose had very similar PK properties to 
the 3 mg/kg dosing and has approximately a 58% probability for steady-state trough serum 
concentration ≥ 21 μg/mL, which is associated with maximum target engagement and greatest 
probability of efficacy.  Based on these observations, 500 mg Q4W was chosen as the dose 
regimen as the dosing regimen for this study. 


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2.4. 
Benefit/Risk Assessment 
Treatment directed at the PD-1/PD-L1 axis is a promising approach to SCAC.  Phase 2 results 
with both nivolumab and pembrolizumab in chemotherapy-refractory populations show 
promising efficacy in terms of durable tumor response (Morris et al 2017, Ott et al 2017).  
Importantly, no unexpected safety findings have been reported in this population, despite the 
frequent association of SCAC with chronic HIV and HPV infections.  Alternative treatments 
(eg, chemotherapy) are associated with both inferior activity and serious toxicities.  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 efficacy of INCMGA00012 in terms of the 
ORR in participants with locally advanced or metastatic 
SCAC who have progressed after platinum-based 
chemotherapy. 
ORR, defined as the percentage of participants having a 
CR or PR, according to RECIST v1.1 as determined by 
ICR. 
Secondary 
To determine additional measures of clinical benefit, 
specifically, DOR, DCR, PFS, and OS. 
DOR, defined as the time from an initial objective 
response (CR or PR) according to RECIST v1.1 until 
disease progression as determined by ICR or death due 
to any cause. 
DCR, defined as the number of participants maintaining 
either an ORR or stable disease. 
PFS, defined as the time from the first dose of study 
treatment until disease progression by ICR or death due 
to any cause. 
OS, defined as the time from the start of therapy until 
death due to any cause. 
To evaluate the safety of INCMGA00012 in participants 
with previously-treated SCAC. 
Safety, determined by the number of participants; the 
frequency, duration, and severity of AEs per CTCAE 
v5.0; laboratory tests; vital signs; and ECGs. 
To determine the PK of INCMGA00012 administered to 
participants with SCAC. 
Population PK, including Cmax, Tmax, Cmin, and AUC0-t, 
will be summarized. 


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4. 
STUDY DESIGN 
4.1. 
Overall Design 
This study is an open-label, single-group, multicenter, Phase 2 study that will enroll participants 
with locally advanced or metastatic SCAC who have progressed on a standard-of-care 
platinum-based chemotherapy regimen.  Participants with well-controlled HIV infection will be 
eligible.  All participants will receive INCMGA00012 at the recommended Phase 2 dose of 
500 mg IV Q4W. 
The primary endpoint is ORR as determined by independent central review using RECIST v1.1. 
The study consists of 3 periods:  screening, study drug treatment, and follow-up.  Treatment may 
continue for up to 2 years in the absence of clinical disease progression (see Section 8.2), 
intolerable toxicity, death, withdrawal of consent, lost to follow-up, or premature discontinuation 
for any other reason. 
Treatment will be administered by IV infusion over 60 minutes (±15 minutes) on Day 1 of each 
28-day cycle.  Subsequent treatment cycles should be delayed (for up to 12 weeks, see 
Section 6.5) until the following criteria are met: 
 Hemoglobin ≥ 8 gm/dL. 
 ANC ≥ 1.0 × 109/L. 
 Platelet count ≥ 75 × 109/L. 
 ALT/AST/bilirubin ≤ Grade 2. 
 Resolution of all immune-related toxicity to ≤ Grade 1 (with the exception of 
endocrinopathy that is controlled on hormonal replacement), other than unacceptable 
toxicity per Section 6.5. 
 Resolution of all non–immune-related toxicity to Grade ≤ 1 or baseline (with the 
exception of alopecia or non–transfusion-dependent anemia). 
Note:  Transient asymptomatic laboratory elevations ≤ Grade 3 do not require dose 
interruption or reduction if the participant is asymptomatic and the elevation is 
clinically insignificant and has been discussed with the medical monitor (eg, amylase, 
lipase). 
 Daily dose of corticosteroid ≤ 10 mg prednisone or equivalent. 
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 
interruptions of > 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.   
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. 


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Patient management should follow either RECIST v1.1 (see Section 8.2.1)
 
 with the decision to treat beyond conventional RECIST progression documented 
in the study file. 
The follow-up period will begin once a participant has completed 2 years of study drug or 
prematurely discontinued from study drug.  Participants will be evaluated for irAEs for 90 days 
after the last dose of study drug, regardless of whether a new anticancer therapy is started. 
Once participants discontinue treatment, they enter the follow-up period and will be assessed for 
survival until study completion.  Participants who discontinue study treatment without 
experiencing disease progression will enter the follow-up period and continue to undergo tumor 
assessments according to the schedule of activities (see Table 3) until they experience disease 
progression, the start of a new anticancer treatment, withdrawal of consent, lost to follow-up, the 
end of the study, or death. 
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 20.  Details regarding the sample collection for pharmacokinetic 
 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.  Participants completing treatment or 
prematurely discontinuing the study drug will be followed for survival until all participants have 
completed at least 2 years of treatment with INCMGA00012 or discontinued. 
A participant is considered to have completed the study if he/she has completed all periods/parts 
of the study including survival follow-up. 


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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, if required by regulatory decision, or upon 
advice of the DMC.  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. 
4.3.1. 
Data Monitoring Committee 
An independent DMC will be formed.  The DMC will consist of qualified individuals who are 
not involved with the conduct of the study.  The establishment, composition, roles, duties, and 
responsibilities of the DMC will be addressed in the DMC Charter. 
Preplanned analyses of safety will be provided to the independent DMC as specified in the DMC 
Charter.  In addition, the DMC will make recommendations to the sponsor at a planned interim 
analysis.  In terms of efficacy, the DMC will use the guidelines provided for recommendation of 
either continuation or early termination of the study at the interim analysis.  Additionally, the 
DMC will review safety data of the ongoing study at regular intervals as specified in the DMC 
Charter.  The process by which the DMC will make recommendations and decisions will be 
documented in the DMC Charter. 


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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 locally advanced or metastatic SCAC. 
4. Participants must have had progression on or after platinum-based therapy unless 
ineligible for or intolerant of platinum. 
a. No more than 2 prior lines of systemic therapy for metastatic disease are permitted. 
b. Participants who are ineligible for platinum must have received at least 1 prior line of 
systemic therapy. 
c. Participants receiving platinum-based radiosensitizing chemotherapy are eligible if 
relapse occurs < 6 months from completion of treatment. 
5. Must have measurable disease by RECIST v1.1. 
6. ECOG performance status 0 to 1. 
7. If a participant is known to be HIV-positive, then all of the following criteria must also 
be met: 
a. CD4+ count ≥ 300/μL. 
b. Undetectable viral load. 
c. Receiving antiretroviral therapy (ART). 
8. 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. 


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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. 
9. 
 
 
 
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; 6 weeks for mitomycin C.  
2. 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 in 2 Gy fractions. 
3. Prior treatment with PD-1 or PD-L1 directed therapy (other immunotherapies may be 
acceptable with prior approval from the medical monitor). 
4. Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the 
exception of any grade of alopecia and anemia not requiring transfusion support).  
Endocrinopathy, if well-managed, is not exclusionary and should be discussed with 
sponsor medical monitor. 
5. Participants with laboratory values at screening defined in Table 7. 


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Table 7: 
Exclusionary Laboratory Values 
Laboratory Parameter 
Exclusion Criterion 
Hematology 
a 
Platelets 
≤ 75 × 109/L 
b 
Hemoglobin 
≤ 9 g/dL 
c 
ANC 
 ≤ 1.5 × 109/L 
Hepatic 
d 
ALT 
> 2.5 × ULN OR > 5 × ULN for participants with liver metastases 
e 
AST 
> 2.5 × ULN OR > 5 × ULN for participants with liver metastases 
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 
6. 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. 
7. Active autoimmune disease requiring systemic immunosuppression in excess of 
physiologic maintenance doses of corticosteroids (> 10 mg of prednisone or equivalent). 
8. Evidence of interstitial lung disease or active noninfectious pneumonitis. 
9. 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. 
10. 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). 
11. Active infections requiring systemic therapy. 
12. Known hypersensitivity to another monoclonal antibody that cannot be controlled with 
standard measures (eg, antihistamines and corticosteroids) or known allergy or 
hypersensitivity to any component of INCMGA00012 or formulation components. 


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13. 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 (ie, ≥ uncontrolled Grade 3 hypertension.)  
14. Participant is pregnant or breastfeeding. 
15. Participant is expecting to conceive or father children within the projected duration of the 
study, from screening through 6 months after the last dose of study drug. 
16. Participant has not recovered adequately from toxicities and/or complications from 
surgical intervention before starting study drug. 
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. 
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 
Unit dose strength/dosage level: 
500 mg Q4W 
Route of administration:  
IV 
Administration instructions: 
Administered IV over 60 minutes (±15 minutes) 
Packaging and labeling: 
INCMGA00012 will be provided in a 250 mg vial. 
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(s) to the study site. 
 Inventory of study drug(s) at the site. 
 Participant use of the study drug(s) including tablet and vial counts (as appropriate for 
each study drug) from each supply dispensed. 
 Lot numbers and/or vial numbers (as applicable) of study drug used to prepare the 
infusion solution. 
 Return of study drug(s) to the investigator or designee by participants. 


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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 
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 in Section 4.1. 
Infusion or hypersensitivity reactions may be observed with administration of any foreign 
protein.  Premedication with acetaminophen/paracetamol and a histamine blocker 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. 


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Table 9: 
Guidelines for Management of Suspected Infusion Reactions 
Grade 
Descriptiona 
Treatment 
Subsequent Infusions 
1 
Mild reaction; infusion interruption 
not indicated; intervention not 
indicated. 
Monitor vital signs closely until 
medically stable. 
Premedication with 
acetaminophen/paracetamol 
and a histamine blocker 
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, 
acetaminophen/paracetamol, 
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 
acetaminophen/paracetamol 
(500-1000 mg PO). 
Additional supportive 
measures may be acceptable 
(per institutional preference) 
but should be discussed with 
medical monitor. 
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, 
acetaminophen/paracetamol, 
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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6.5.1. 
Procedures for Participants Exhibiting 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 other PD-1 inhibitors (eg, pembrolizumab, nivolumab) are detailed in the sections below. 
Management guidance for irAEs not detailed elsewhere in the Protocol should follow the ASCO 
Clinical Practice Guideline (Brahmer et al 2018), provided in the Study Procedures Manual. 
6.5.1.1. 
Immune-Mediated Pneumonitis 
Participants with symptomatic pneumonitis should immediately stop receiving study drug and 
have an evaluation.  The evaluation may include bronchoscopy and pulmonary function tests to 
rule out other causes such as infection.  If the participant is determined to have study 
drug–associated pneumonitis, the suggested treatment plan is detailed in Table 10. 
Table 10: 
Recommended Approach to Handling Pneumonitis 
Study Drug–Associated 
Pneumonitis 
Withhold/Discontinue Study Drug 
Criteria for restarting study drug are 
in Section 4.1. 
Supportive Care 
Grade 1 (asymptomatic) 
No action. 
Intervention not indicated. 
Grade 2 
Withhold study drug.   
Systemic corticosteroids are indicated (initial 
dose of 1-2 mg/kg per day of prednisone or 
equivalent).  Taper as appropriate. 
Grades 3 and 4 or 
recurrent Grade 2 
Permanently discontinue study drug. 
Systemic corticosteroids are indicated. 
6.5.1.2. 
Immune-Mediated Colitis 
Participants should be carefully monitored for signs and symptoms of colitis (such as diarrhea, 
abdominal pain, mucus, or blood in stool, with or without fever).  In symptomatic participants, 
infectious etiologies should be ruled out, and endoscopic evaluation should be considered for 
persistent or severe symptoms.  Recommendations for management of enterocolitis are shown in 
Table 11. 


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Table 11: 
Recommended Approach for Handling Enterocolitis/Diarrhea 
Study Drug–Associated 
Enterocolitis/Diarrhea 
Withhold/Discontinue Study Drug 
Criteria for restarting study drug are 
located in Section 4.1. 
Supportive Care 
Grade 1 
No action. 
All participants who have diarrhea should be 
advised to drink liberal quantities of clear 
fluids.  If sufficient oral fluid intake is not 
feasible, fluid and electrolytes should be 
substituted via IV infusion.  An antidiarrheal 
can be started. 
Grade 2 
Withhold study drug. 
Systemic corticosteroids are indicated (initial 
dose of 1 mg/kg to 2 mg/kg per day of 
prednisone or equivalent).  Taper as 
appropriate.  Treatment with infliximab is 
acceptable per institutional guidelines. 
Grade 3  
Withhold study drug. 
Treatment with systemic corticosteroids 
should be initiated.  Treatment with infliximab 
is acceptable per institutional guidelines. 
Grade 4 or recurrent 
Grade 3 
Permanently discontinue study drug. 
6.5.1.3. 
Immune-Mediated Hepatitis 
Liver chemistry testing (hepatic transaminase and bilirubin levels) should be monitored and 
participants assessed for signs and symptoms of hepatotoxicity before each dose of 
INCMGA00012.  In participants with hepatotoxicity, infectious or malignant causes should be 
ruled out, and frequency of liver chemistry monitoring should be increased until resolution.  
Recommendations for management of hepatitis are shown in Table 12. 
Table 12: 
Recommended Approach for Handling Hepatitis 
Study Drug–Associated 
Hepatitis 
Withhold/Discontinue Study Drug 
Criteria for restarting study drug are 
located in Section 4.1. 
Supportive Care 
Grade 1 
No action. 
Increase frequency of liver chemistry 
monitoring to twice per week until liver 
chemistry tests return to baseline. 
Grade 2 
Withhold study drug. 
Systemic corticosteroids are indicated (initial 
dose of 0.5 mg/kg to 1 mg/kg per day of 
prednisone or equivalent).  Taper as 
appropriate. 
Grades 3 and 4 
Permanently discontinue study drug. 
Treatment with systemic corticosteroids should 
be initiated (initial dose of 1 mg/kg to 2 mg/kg 
per day of prednisone or equivalent).  Taper as 
appropriate. 


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6.5.1.4. 
Immune-Mediated Endocrinopathies 
6.5.1.4.1. Hypophysitis 
Monitor for signs and symptoms of hypophysitis (including hypopituitarism and adrenal 
insufficiency).  Recommendations for management of hypophysitis are shown in Table 13. 
Table 13: 
Recommended Approach for Handling Hypophysitis 
Study Drug–Associated 
Hypophysitis 
Withhold/Discontinue Study Drug 
Criteria for restarting study drug are 
located in Section 4.1. 
Supportive Care 
Grade 1 
No action. 
Administer corticosteroids and hormone 
replacement as clinically indicated. 
Grade 2 
Withhold study drug. 
Grade 3 
Withhold or discontinue study drug. 
Grade 4 
Permanently discontinue study drug. 
6.5.1.4.2. Thyroid Disorders 
Monitor participants for changes in thyroid function (at the start of treatment, periodically during 
treatment, and as indicated based on clinical evaluation) and for clinical signs and symptoms of 
thyroid disorders.  Recommendations for management of thyroid disorders are shown in 
Table 14. 
Table 14: 
Recommended Approach for Handling Thyroid Disorders 
Study Drug–Associated 
Thyroid Disorders 
Withhold/Discontinue Study Drug 
Criteria for restarting study drug are 
located in Section 4.1. 
Supportive Care 
Grades 1 and 2 
No action. 
Administer replacement hormones for 
hypothyroidism and manage hyperthyroidism 
with thionamides and beta-blockers as 
appropriate. 
Grade 3 
Withhold or discontinue study drug. 
Grade 4 
Permanently discontinue study drug. 
6.5.1.4.3. New Onset Diabetes Mellitus 
Monitor participants for hyperglycemia or other signs and symptoms of diabetes.  
Recommendations for management of diabetes mellitus are shown in Table 15. 
Table 15: 
Recommended Approach for Handling New Onset Diabetes Mellitus 
Study Drug–Associated 
Diabetes Mellitus 
Withhold/Discontinue Study Drug 
Criteria for restarting study drug are 
located in Section 4.1. 
Supportive Care 
Grades 1 and 2 
No action. 
Intervention not indicated. 
Grade 3 
Withhold study drug. 
Administer insulin for Type 1 diabetes and 
administer antihyperglycemics in participants 
with severe hyperglycemia. 
Grade 4 
Permanently discontinue study drug. 


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6.5.1.5. 
Immune-Mediated Nephritis and Renal Dysfunction 
Monitor participants for changes in renal function.  Recommendations for management of 
nephritis and renal dysfunction are shown in Table 16. 
Table 16: 
Recommended Approach for Handling Nephritis and Renal Dysfunction 
Study Drug–Associated 
Nephritis and Renal 
Dysfunction 
Withhold/Discontinue Study Drug 
Criteria for restarting study drug are 
located in Section 4.1. 
Supportive Care 
Grade 1 
No action. 
Intervention not indicated. 
Grade 2 
Withhold study drug. 
Treatment with systemic corticosteroids should 
be initiated (initial dose of 1 mg/kg to 2 mg/kg 
per day of prednisone or equivalent).  Taper as 
appropriate. 
Grades 3 or 4 
Permanently discontinue study drug. 
6.5.1.6. 
Immune-Mediated Skin Reactions 
Immune-mediated rashes, including Stevens-Johnson syndrome, toxic epidermal necrolysis 
(some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur.  
Monitor participants for suspected severe skin reactions and exclude other causes.  
Recommendations for management of skin reactions are shown in Table 17. 
Table 17: 
Recommended Approach for Handling Skin Reactions 
Study Drug–Associated 
Skin Reactions 
Withhold/Discontinue Study Drug 
Criteria for restarting study drug are 
located in Section 4.1. 
Supportive Care 
Grade 1 
No action. 
Intervention not indicated. 
Grade 2 
Withhold study drug. 
Treatment with systemic corticosteroids 
should be initiated (initial dose of 1 mg/kg to 
2 mg/kg per day of prednisone or equivalent).  
Taper as appropriate. 
Note:  May consider IV immunoglobulin 
(IVIG) or cyclosporine as an alternative or in 
corticosteroid-refractory cases, for Grade for 
SCARs, DRESS/DIHS. 
Grade 3 or suspected 
Stevens-Johnson 
syndrome or toxic 
epidermal necrolysis 
Withhold study drug. 
Grade 4 or confirmed 
Stevens-Johnson 
syndrome or toxic 
epidermal necrolysis 
Permanently discontinue study drug. 
6.5.1.7. 
Immune-Mediated Myocarditis 
Immune-mediated myocarditis can occur (some cases with fatal outcome).  Monitor participants 
for suspected myocarditis and exclude other causes.  Recommendations for management of 
myocarditis are shown in Table 18. 


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Table 18: 
Recommended Approach for Handling Myocarditis 
Study Drug–Associated 
Myocarditis 
Withhold/Discontinue Study Drug 
Criteria for restarting study drug are 
located in Section 4.1. 
Supportive Care 
Grades 2, 3, and 4 
Permanently discontinue study drug. 
Upon signs and symptoms, all grades warrant 
work-up and intervention given potential for 
cardiac compromise. 
Treatment with systemic corticosteroids 
should be initiated (initial dose of 1 mg/kg to 
2 mg/kg per day of prednisone or equivalent).  
Taper as appropriate. 
Management of cardiac symptoms according 
to standard of care and with guidance from 
cardiology.  Consider cardiac MRI and 
myocardial biopsy for diagnosis. 
6.5.2. 
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 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 
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. 


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6.6.1. 
Permitted Medications and Procedures 
Antiretroviral therapy (ART) should be continued for participants who are known to be 
HIV-positive. 
Recommended supportive measures for specific toxicities are described in Section 6.5. 
Growth factors, bisphosphonates, anticoagulants, and transfusional support will also be permitted 
and must be reported into the eCRF. 
Premedication with acetaminophen/paracetamol and a histamine blocker should be considered 
for participants who have had previous systemic reactions to protein product infusions or when 
recommended by institutional policy. 
6.6.2. 
Prohibited Medications and Procedures 
 Other anticancer therapies, including investigational treatments within 21 days before 
the first administration of study drug (6 weeks for mitomycin C), 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.  Participants who discontinue study drug will enter the follow-up period to be evaluated 
for safety and survival.  Any participants entering the follow-up period for any reason other than 
PD will continue to be evaluated for disease status according to the scheduled assessments found 
in Table 3. 


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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: 
 Clinical disease progression. 
 Unacceptable toxicity as noted in Section 6.5.2. 
 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, except data in public domain, may be solicited from or collected on the 
participant.  Participants who discontinue study drug will remain in the study to be 
followed for progression and survival. 
 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: 
 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). 
 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. 


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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 
follow-up visit.  These visits are described in Table 3.  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 
progression and survival and will be followed for safety and AEs per Sections 8.8 
and 9. 
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 and move 
into the follow-up portion of the study per Table 3.  However, if a participant actively withdraws 
consent for collection of follow-up data (safety follow-up or disease assessment), then no 
additional data collection should occur (with the exception of data in the public domain.) 
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. 


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7.3. 
Lost to Follow-Up 
A participant will be considered lost to follow-up if he/she repeatedly fails to return for 
scheduled visits and is unable to be contacted by the study site. 
The following actions must be taken if a participant fails to return to the clinic for a required 
study visit: 
 The site must attempt to contact the participant and reschedule the missed visit as 
soon as possible and counsel the participant on the importance of maintaining the 
assigned visit schedule and ascertain whether or not the participant wishes to and/or 
should continue in the study. 
 Before a participant is deemed lost to follow-up, the investigator or designee must 
make every effort to regain contact with the participant (where possible, 3 telephone 
calls and at least 1 certified letter to the participant's last known mailing address or 
local equivalent methods).  These contact attempts should be documented in the 
participant's medical record. 
 Should the participant continue to be unreachable, he/she will be considered to have 
withdrawn from the study. 


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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. 
 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. 
 


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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. 
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. 


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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 remain on the 8-week schedule, established on Cycle 1 
Day 1, 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.  For participants 
who discontinue study treatment for reasons other than disease progression, every effort should 
be made to continue monitoring their disease status by radiographic imaging according to the 
follow-up schedule. 
Participants who continue study participation in the follow-up period without experiencing 
disease progression will continue to have efficacy assessments every 12 weeks until they 
complete participation in the study, start a new anticancer therapy, experience disease 
progression, or death. 
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.  The CT portion of PET-CT may be acceptable if it is 
of identical diagnostic quality to a diagnostic CT (with IV and oral contrast.)  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.  Imaging performed as part of routine clinical management are acceptable for use 
as the screening images if they are of diagnostic quality and 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.  Imaging of the chest, 
abdomen, and pelvis are required for all participants.  Imaging of other anatomical sites (ie, head, 
neck, and extremities) should be performed as applicable if participant has disease or suspected 
disease in those areas. 
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. 


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8.2.3. 
Health Economics 
Not applicable. 


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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, regardless of whether a new anticancer therapy is 
started.  Immune-related AEs will be collected until 90 days after the last dose of study drug.  
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 
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, or 
the participant is lost to follow-up (as defined in Section 7.3). 
The severity of adverse events will be determined per CTCAE v5.0. 


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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, 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. 
8.3.4. 
ECOG Performance Status 
ECOG performance status will be assessed according to the criteria in Table 19. 
Table 19: 
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. 


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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 20.  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. 
Clinically significant abnormal laboratory findings are those that are not associated with the 
underlying disease, unless judged by the investigator to be more severe than expected for the 
participant's condition.  All abnormal laboratory values considered clinically significant up to 
90 days after the last dose of study treatment should be repeated until the values are no longer 
considered clinically significant by the investigator, regardless of whether a new anticancer 
therapy is started. 
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. 


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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. 
 
  
 
 
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 20: 
Required Laboratory Analytes 
Blood 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 Testingb 
(Only participants who are 
known to be HIV-positive) 
Total cholesterol 
Triglycerides 
LDL 
HDL 
TSH 
T4 
T3/FT3a 
 
 
a If considered standard by the region. 
 
 
Note:  Additional tests may be required, as agreed by investigator and sponsor, based on emerging safety data. 


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8.4. 
Pharmacokinetic Assessments 
Blood samples for PK 
 analysis will be obtained at the visits and timepoints indicated 
in Table 4 and Table 5.  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 
8.5.2. 
Tissue Biopsies  
Tumor tissue should be collected during screening (fresh or archival tissue) according to the 
schedule outlined in Table 4.  Detailed information regarding procedures for handling and 
shipping of tissue samples will be provided in a separate laboratory manual. 
 
 


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8.5.3. 
Blood Sample Collection 
Whole blood, serum, and plasma will be collected according to the schedule outlined in Table 4.  
Detailed information regarding procedures for handling and shipping of specimens will be 
provided in a separate laboratory manual. 
 
 
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 and Table 4.  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 as described in Table 3. 
 
 
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, regardless of whether a new 
anticancer therapy is started.  Reasonable efforts should be made to align the first 12-week 
follow-up visit with the end of the 90-day irAE reporting period.  However, if necessary, contact 
by phone or other methods of communication are acceptable in order for the participant to report 
any AEs that may occur during this period. 


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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 a new anticancer therapy 
is started.  Once a new anticancer therapy has been initiated, the participant will move into the 
survival follow-up period. 
8.8.2. 
Post-Treatment Disease Follow-Up 
Participants who discontinue study drug for a reason other than disease progression will move 
into the disease status follow-up period and should be assessed every 12 weeks ± 7 days by 
radiologic imaging to monitor disease status.  Every effort should be made to collect information 
regarding disease status until: 
 The start of new anticancer therapy. 
 Disease progression. 
 Death. 
 The end of the study. 
 Participant is lost to follow-up. 
8.8.3. 
Survival Follow-Up 
Once a participant has received the last dose of study drug, has confirmed disease progression, or 
starts a new anticancer therapy, the participant moves into the survival follow-up period and 
should be contacted by telephone, email, or visit at least every 12 weeks to assess for survival 
status until death, withdrawal of consent, or the end of the study, whichever occurs first. 
For participants having entered the survival follow-up period of the study, the site will use 
continuing participant records to supply data on subsequent treatment regimens, tumor 
assessments (if discontinued treatment for a reason other than progression), and OS in the eCRF.  
For participants who do not intend to return to the study investigator for their ongoing care, 
follow-up should be maintained by phone contact, patient records, and public records/databases 
at intervals of no longer than 12 weeks. 


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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. 
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. 


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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. 
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. 


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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). 
 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. 


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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. 
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, regardless of whether a new anticancer therapy is started, 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.  The investigator will submit any updated SAE data to the sponsor (or designee) within 
24 hours of it being available. 


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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, 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.  SUSARs will be collected and reported to 
the competent authorities and relevant ethics 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 SUSARs 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. 


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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 reduced, 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 
Not applicable. 
9.6. 
Emergency Unblinding of Treatment Assignment 
Not applicable. 
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. 


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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. 
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. 


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10. 
STATISTICS 
10.1. 
Sample Size Determination 
In a recent single-arm Phase 2 study, nivolumab achieved an ORR of 24% in participants with 
unresectable metastatic anal cancer (Morris et al 2017). 
Based on a target ORR of 25% and a sample size of 81, the study has 80% power to exclude a 
lower confidence limit of 13% with alpha equal to 0.025 (1-sided).  The sample size calculation 
is based on participants’ full analysis set defined in the next section. 
10.2. 
Populations for Analysis 
Table 21 presents the populations for analysis. 
Table 21: 
Populations for Analysis 
Population 
Description 
Full analysis set 
The FAS includes all participants enrolled in the study who received at least 1 dose 
of study drug.  The FAS will be used for the summary of demographics, baseline 
characteristics, and participant disposition as well as efficacy analysis. 
Safety evaluable 
The safety evaluable population includes all enrolled participants who received at 
least 1 dose of study drug. 
All safety analyses will be conducted using the safety evaluable population. 
PK evaluable 
The PK evaluable population will include all participants who received at least 
1 dose of study drug and provided at least 1 postdose serum sample (1 PK 
measurement). 
 
 
 
 
 
 
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. 


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10.4.1. 
Primary Analysis 
10.4.1.1. Overall Response Rate 
The primary endpoint of the study is ORR, defined as the percentage of participants with CR or 
PR, according to RECIST v1.1 (Eisenhauer et al 2009) as determined by an ICR.  The primary 
analysis of ORR will be based on the FAS.  Objective response rate and its exact 95% CI will be 
presented. 
10.4.1.2. Handling of Missing Data in Primary Analysis 
Complete response or PR reported before any additional anticancer therapy will be considered as 
response in the calculation of ORR irrespective of the number of missed assessments before 
response. 
10.4.2. 
Secondary Analysis 
10.4.2.1. Duration of Response 
Duration of response is defined as the time from first documented response (CR or PR) to the 
time of first documented disease progression 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 cut off or new anticancer therapy.  The Kaplan-Meier 
estimate of the distribution function will be constructed for DOR.  The estimated median along 
with 95% CIs will be reported. 
10.4.2.2. Disease Control Rate 
Disease control rate defined as the proportion of participants with an overall response (CR and 
PR), or stable disease per RECIST v1.1, according the ICR.  The DCR will be estimated, and the 
exact 95% CI will be reported. 
10.4.2.3. Progression-Free Survival 
Progression-free survival, defined as the time from the first dose of study treatment 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 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 cutoff or 
new anticancer therapy. 
10.4.2.4. Overall Survival 
Overall survival is defined as the time from first dose of study treatment to the date of death due 
to any cause.  Participants still alive at the time of analysis will be censored at the date of last 
known alive.  Kaplan-Meier curves, medians, and 95% CIs of the medians will be presented. 


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10.4.3. 
Safety Analyses 
10.4.3.1. Adverse Events 
Safety analyses will be conducted for the safety population.  Adverse events will be coded by the 
MedDRA dictionary, and TEAEs (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. Adverse Events of Special Interest 
Adverse events of special interest will include irAEs. 
10.4.3.3. 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 
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. 
10.4.3.4. Vital Signs 
Descriptive statistics and mean change from baseline will be determined for vital signs (blood 
pressure, pulse, respiratory rate, and body temperature) at each assessment time.  Vital sign 
results will be reviewed for clinically notable abnormalities, and participants exhibiting clinically 
notable vital sign abnormalities will be listed. 
10.4.3.5. Electrocardiograms 
Descriptive statistics and mean change from baseline will be determined for each ECG parameter 
at each assessment time.  Electrocardiogram results will be reviewed for clinically notable 
abnormalities according to predefined criteria as described in the Statistical Analysis Plan. 
10.4.3.6. Dose Intensity 
Measures of exposure (eg, days of exposure, dose intensity, etc) of study drug will be 
summarized by means of summary statistics. 


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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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10.5. 
Interim Analysis 
An analysis is planned after approximately 25 participants are assessable for response according 
to RECIST v1.1.  The primary intent of this analysis is to minimize unnecessary exposure of 
participants to INCMGA00012 in the event of futility.  The study will be stopped for futility at 
the interim analysis if conditional power based on interim result is lower than 20%, which is 
equivalent to less than 2 participants responded.  All participants enrolled with a postbaseline 
response assessment or participants early discontinued will be included in the futility analysis.  
Participants enrolled in the study without any postbaseline response assessment but are ongoing 
in the study will not be included in the futility analysis for calculation of conditional power.  
Enrollment will continue while the analysis is being conducted.  This futility analysis will be 
reviewed by an independent DMC as specified in the DMC Charter.  The process by which the 
DMC will review data and make recommendations and decisions will be documented in the 
DMC Charter.  The Statistical Analysis Plan will describe the planned interim analyses in greater 
detail. 
 
 
 
 


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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.  Other data outside the EDC system required in the study conduct of the 
protocol such as documents or results transmitted to the sponsor via a central laboratory or 
specialized technical vendors, and as designated by the sponsor, will have their own data flow 
management plans, or study charters,
 as applicable. 
The sponsor (or designee) will be responsible for: 
 Managing the integrity of the data and the quality of the conduct of the study, such as 
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. 
 Managing and reconciling the data generated, and/or collected including documents 
and results such as laboratory or imaging data analyzed centrally by a designated 
vendor of the sponsor. 
The investigator will be responsible for: 
 Recording, or ensuring the recording of, all relevant data relating to the study in the 
eCRF. 
 Delivering, or ensuring the delivery of, all other results, documents, data, know-how, 
or formulas relating to the study to the sponsor or designee electronically and/or 
centrally (eg, laboratory data, imaging data,
, photographs, diary data), 
or as otherwise specified in the Protocol. 
 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, or sent to a central vendor designated by the sponsor, or as 
described in other study and data flow manuals. 
 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 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 applicable medical records must be 
available. 


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 May have responsibility for sending participants' data, either as unique samples, or 
copies, or photographs, to be evaluated centrally or analyzed centrally, or both, by a 
qualified vendor designated by the sponsor.  
 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. 
 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.  In the Netherlands, it is mandatory to 
keep the data for 15 years after the end of the research.  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. 


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11.4. 
Financial Disclosure 
Before study initiation, all clinical investigators participating in clinical studies participant 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 
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. 


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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 
Bai S, Jorga K, Xin Y, et al. A guide to rational dosing of monoclonal antibodies. Clin 
Pharmacokinet 2012;51:119-135. 
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 
Oncology Clinical Practice Guideline. J Clin Oncol 2018;36:1714-1768. 
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 October 2, 2017. 
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. 
Eng C, Chang GJ, You YN, et al. The role of systemic chemotherapy and multidisciplinary 
management in improving the overall survival of patients with metastatic squamous cell 
carcinoma of the anal canal. Oncotarget 2014;5:11133-11142. 
Freshwater T, Kondic A, Ahamadi M, et al. Evaluation of dosing strategy for pembrolizumab for 
oncology indications. J Immunother Cancer 2017;5:43. 
Ghosn M, Kourie HR, Abdayem P, Antoun J, Nasr D. Anal cancer treatment:  current status and 
future perspectives. World J Gastroenterol 2015;21:2294-2302. 
 
 
INCMGA00012 Investigator's Brochure. Wilmington, DE: Incyte Corporation. 
Keytruda (pembrolizumab) [prescribing information]. Merck & Co., Inc; November 2017. 
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. 
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. Abstract 
P669 presented at: The Society for Immunotherapy of Cancer; November 7-11, 2018; 
Washington, DC. 
Morris VK, Salem ME, Nimeiri H, et al. Nivolumab for previously treated unresectable 
metastatic anal cancer (NCI9673): a multicentre, single-arm, phase 2 study. Lancet Oncol 
2017;18:446-453. 
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; April 2018. 


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Ott PA, Piha-Paul SA, Munster P, et al. Safety and antitumor activity of the anti-PD-1 antibody 
pembrolizumab in patients with recurrent carcinoma of the anal canal. Ann Oncol 
2017;28:1036-1041. 
 
 
 
 
Wang DD, Zhang S, Zhao H, Men AY, Parivar K. Fixed dosing versus body size-based dosing 
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 during treatment and 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 during the study 
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. 
Such methods include: 
 Combined (estrogen and progestogen containing) hormonal contraception associated 
with inhibition of ovulation1 
 oral 
 intravaginal 
 transdermal 
 Progestogen-only hormonal contraception associated with inhibition of ovulation1 
 oral 
 injectable 
 implantable2 
 Intrauterine device (IUD)2 
 Intrauterine hormone-releasing system (IUS)2 
 Bilateral tubal occlusion2 
 Vasectomised partner2,3 
 Sexual abstinence4 
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 spermicide5 
 cap, diaphragm or sponge with spermicide5 
 tubal ligation 
1  Hormonal contraception may be susceptible to interaction with the IMP, which may reduce the efficacy of the contraception 
method. 
2  Contraception methods that in the context of this guidance are considered to have low user dependency. 
3  Vasectomised partner is a highly effective method of avoiding pregnancy provided that partner is the sole sexual partner of the 
woman of childbearing potential trial participant and that the vasectomised partner has received medical assessment of the 
surgical success. 
4  In the context of this guidance, sexual abstinence is considered a highly effective method only if defined as refraining from 
heterosexual intercourse during the entire period of risk associated with the study drug.  The reliability of sexual abstinence 
needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. 
5 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:  CTFG 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: 
06 AUG 2018 
Amendment (Version) 2: 
04 OCT 2018 
Amendment (Version) 2-NL: 
26 NOV 2018 
Amendment (Version) 3: 
21 MAR 2019 
Amendment (Version) 4: 
08 JUL 2019 
Amendment 4 (08 JUL 2019) 
Overall Rationale for the Amendment:  Clarification of eligibility criteria. 
 
 
 
 
 
 
 
 
 
 
 
3. Section 5.1, Inclusion Criteria 
Description of change:  Revised inclusion criterion #4 as follows: 
Participants must have had progression on or after platinum-based therapy unless 
ineligible for or intolerant of platinum. 
a. No more than 2 prior lines of systemic therapy for metastatic disease are permitted. 
(this includes radiosensitizing chemotherapy). 
b. Participants who are ineligible for platinum must have received at least 1 prior line of 
systemic therapy.   
c. Participants receiving platinum-based radiosensitizing chemotherapy are 
eligible if relapse occurs < 6 months from completion of treatment. 
Rationale for change:  To clarify the relationship of prior anticancer therapy to 
eligibility. 


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4. Section 5.2, Exclusion Criteria(Table 7:  Exclusionary Laboratory Values) 
Description of change:  Changed hemoglobin units from L to dL in exclusion 
criterion #5, Table 7. 
Rationale for change:  To provide consistency throughout the document. 
5. Section 5.2, Exclusion Criteria 
Description of change:  Revised exclusion criterion #13 as follows: 
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. ≤ 6 months before study participation. 
c. Acute myocardial infarction ≤ 6 months before study participation. 
d. Other clinically significant heart disease (ie, ≥ uncontrolled Grade 3 hypertension)., 
history of labile hypertension, or poor compliance with an antihypertensive regimen) 
must have recovered (to baseline or ≤ Grade 1) from toxicity associated with prior 
treatment. 
Rationale for change:  To further clarify eligibility as it relates to cardiac diagnoses. 
6. Section 6.6.2, Prohibited Medications and Procedures 
Description of change:   Added probiotic dietary supplements as a prohibited 
medication. 
Rationale for change:  To clarify that probiotic dietary supplements are prohibited while 
on study. 
7. 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 (21 MAR 2019) 
Overall Rationale for the Amendment: 
 to remove requirement for premedication prophylaxis. 
1. Incorporate changes from Amendment 2-NL (26 NOV 2018) 
Description of change:  Changes as listed in Amendment 2-NL (26 NOV 2018). 
Rationale for change:  To align Protocol Amendment 3 as appropriate for all regions. 
2. Section 1, Protocol Summary (Table 3:  Schedule of Activities); Section 6.5.1, 
Management of Suspected Infusion Reactions (Table 9:  Guidelines for Management 
of Suspected Infusion Reactions); Section 6.6.1, Permitted Medications and 
Procedures 
Description of change:  Removed the requirement for premedication prophylaxis before 
the first dose of INCMGA00012. 
Rationale for change:  Updated for consistency with the INCMGA00012 IB. 
3. Section 1, Protocol Summary (Table 3:  Schedule of Activities); Section 6.6, 
Concomitant Medications and Procedures; Section 8.3, Safety Assessments; 
Section 9.4, Reporting of Serious Adverse Events 
Description of change:  Clarified that irAEs are collected up to 90 days after last dose of 
study drug. 
Rationale for change:  Immune-related adverse events are collected up to 90 days after 
last dose of study drug. 
4. Section 1, Protocol Summary (Table 5:  Pharmacokinetic 
 Sample 
Collections [
]); Section 3, Objectives and 
Endpoints (Table 6); 
 
; Section 5.1, Inclusion Criteria (Criterion #9); 
Section 8.1.1 Informed Consent Process; Section 8.5, Pharmacodynamic 
 Assessments;  Section 8.7, End of Treatment and/or Early 
Termination; Section 8.8, Follow-Up; Section 10.4.5.5, HIV Viral Control; 
 
Description of change:  
 
Rationale for change:  
 
5. Section 2.1.1, INCMGA00012 
Description of change:  Updated INCMGA00012 safety data. 
Rationale for change:  To provide updated data and align with the current IB. 
6. Incorporation of administrative changes.  Other minor, administrative changes 
including updates to the Schedule of Activities (Table 3) have been incorporated 
throughout the Protocol and are noted in the redline version of the amendment. 


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Amendment 2-NL (26 NOV 2018) 
Overall Rationale for the Amendment: 
The purpose of this amendment is to address comments regarding the design of the study. 
1. Cover Page 
Description of change:  Added the following statement:  "The research in the 
Netherlands is carried out in accordance with the Declaration of Helsinki (Brazil, 2013) 
and the WMO (Medical Research Involving Human Subjects Act)." 
Rationale for change:  To clarify. 
2. Section 8.5.1, Description of Analyses 
Description of change:  Added the following text:  "Biological samples will be stored 
for up to 10 years from the first clinical study report publication.  The research performed 
on those samples will be study-related.  Additional research outside of study-related 
research will not be performed." 
Rationale for change:  To clarify how long the body material is stored after the 
investigation and for which purpose this material is stored. 
3. Section 11.3, Data Privacy and Confidentiality of Study Records 
Description of change:  Added the following text:  "In the Netherlands, it is mandatory 
to keep the data for 15 years after the end of the research." 
Rationale for change:  To clarify how long the data will be stored at the research 
location in the Netherlands. 
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 2 (04 OCT 2018) 
Overall Rationale for the Amendment: 
The purpose of this amendment is to address comments regarding the design of the study. 
1. Section 1, Protocol Summary; Section 4.3, Study Termination; Section 4.3.1, Data 
Monitoring Committee; Section 10.5 Futility Analysis 
Description of change:  Added a DMC. 
Rationale for change:  To clarify that an independent DMC will be formed. 
2. Section 5.1, Inclusion Criteria 
Description of change:  Inclusion criterion #4 was revised as follows: 
Participants must have received no more than 2 prior lines of therapy and must have 
progressed after at least 1 platinum-based regimen.  Participants ineligible for platinum-
based therapy must have received at least 1 line of prior systemic therapy. 
a. Participants ineligible for platinum-based therapy may enroll. 
b. Participants intolerant of platinum-based therapy may enroll. 
c. Participants who developed advanced, recurrent, or metastatic disease within 
6 months of completing platinum-based chemoradiation with curative intent may 
enroll. 
Must have received (or been intolerant to or ineligible for) at least 1 prior line of 
platinum based chemotherapy and received no more than 2 prior systemic treatments. 
Rationale for change:  To clarify that participants will be included if they progressed 
after standard-of-care platinum-based chemotherapy. 
3. Section 5.2, Exclusion Criteria 
Description of change:  Exclusion criterion #2 was revised as follows: 
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 in 2 Gy fractions. 
Rationale for change:  To clarify that the limit is a total dose equivalent to 30 Gy in 
2 Gy fractions. 
4. Section 5.2, Exclusion Criteria 
Description of change:  Exclusion Criterion #12 was revised as follows: 
Known hypersensitivity to another monoclonal antibody that cannot be controlled with 
standard measures (eg, antihistamines and corticosteroids) or known allergy or 
hypersensitivity to any component of INCMGA00012 or formulation components. 
Rationale for change:  To clarify that known hypersensitivity to any excipient contained 
in the INCMGA00012 drug formulation is exclusionary. 


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5. Section 6.5.2.7, Immune-Mediated Myocarditis (Table 17:  Recommended Approach 
for Handling Myocarditis) 
Description of change:  Added Section 6.5.2.7, Immune-Mediated Myocarditis. 
Rationale for change:  To add guidance regarding management of immune-mediated 
myocarditis. 
6. Section 10.5, Futility Analysis 
Description of change:  Added additional details to clarity the stopping rules and 
responsibilities of the futility analysis. 
Rationale for change:  To clarify criteria for stopping the trial for futility. 


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Amendment 1 (06 AUG 2018) 
Overall Rationale for the Amendment: 
The primary purpose of this amendment is to address comments regarding the design of the 
study. 
1. Section 1, Protocol Summary (Table 3, Schedule of Activities); Section 4.1, Overall 
Design; Section 8.3.1, Adverse Events; Section 8.3.6, Laboratory Assessments; 
Section 8.8.1, Safety Follow-Up; Section 9.4, Reporting of Serious Adverse Events 
Description of change:  Updated text to reflect that participants will be evaluated for 
AEs for 90 days after the last dose of study drug regardless of whether a new anticancer 
therapy is started, or until the start of another anticancer therapy, whichever occurs first. 
Rationale for change:  Participants will be followed for AEs for 90 days after the last 
dose of study drug, regardless of whether a new anticancer therapy is started. 
2. Section 5.1, Inclusion Criteria (Inclusion Criterion #4) 
Description of change:  Updated Inclusion Criterion #4: 
4.  No more than 2 prior systemic treatments, at least 1 of which must have included 
platinum based chemotherapy unless the participant is intolerant of platinum therapy, is 
ineligible for platinum, or has refused platinum based chemotherapy (with medical 
monitor approval). 
4.  Must have received (or been intolerant to or ineligible for) at least 1 prior line of 
platinum-based chemotherapy and received no more than 2 prior systemic treatments. 
Rationale for change:  To clarify the eligibility criteria to explicitly state that 
participants must have received (or been intolerant to or ineligible for) at least 1 prior line 
of platinum-based systemic therapy to be eligible. 
3. Section 1, Protocol Summary (Table 3, Schedule of Activities); Section 8.3.6, 
Laboratory Assessments; Section 8.3.6, Laboratory Assessments (Table 18, 
Required Laboratory Analytes) 
Description of change:  Added:  
 
 
  
 
 
 
Rationale for change:  
 
 
 


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4. Section 1, Protocol Summary (Table 4, Pharmacokinetic 
 Sample 
Collection); Section 8.5.1, Description of Analysis 
Description of change:  
 
 
Rationale for change:  
 
 
5. Section 1, Protocol Summary (Table 4, Pharmacokinetic 
 Sample 
Collections) 
Description of change:  
 
 
Rationale for change:  
 
 
6. Section 6.6.1, Permitted Medications and Procedures 
Description of change:  Added:  Highly active antiretroviral therapy (HAART) should 
be continued for participants who are known to be HIV positive. 
Rationale for change:  To clarify that HAART is a permitted medication in this study. 
 
 
 
 
 
 
8. Section 10.2, Population for Analysis; Section 10.4.1.2, Handling of Missing Data in 
Primary Analysis 
Description of change:  Edited Full Analysis Set (FAS):  The FAS includes all 
participants enrolled in the study have measurable disease per RECIST v1.1who received 
at least 1 dose of study drug.  The FAS will be used for the summary of demographics, 
baseline characteristics, and participant disposition as well as efficacy analysis. 
Rationale for change:  Measurable disease by RECIST v1.1 is an eligibility criterion. 
9. Section 3, Objectives and Endpoints (Table 5, Objectives and Endpoints); 
Section 10.4.2.2, Disease Control Rate 
Description of change:  Edited Disease Control Rate (DCR):  DCR, defined as the 
number of participants maintaining either an ORR or stable disease lasting at least 6 
months. 
Rationale for change:  In SCAC, DCR does not require maintaining SD for 6 months. 
10. 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 in Participants With Squamous Carcinoma 
of the Anal Canal Who Have Progressed Following Platinum-Based 
Chemotherapy (POD1UM-202) 
NCT Number: 
NCT03597295 
 
Document Date: 
 
Statistical Analysis Plan Version 1: 17 October 2019 
 
 
 
 
 
 
 
 


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INCMGA 0012-202 SAP Amendment 1 
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STATISTICAL ANALYSIS PLAN 
 
INCMGA 0012-202 
A Phase 2 Study of INCMGA00012 in Participants With Squamous 
Carcinoma of the Anal Canal Who Have Progressed Following 
Platinum-Based Chemotherapy (POD1UM-202) 
 
 
 
 
 
IND Number: 
139,333 
EudraCT Number: 
2018-002070-51 
Sponsor: 
Incyte Corporation 
1801 Augustine Cut-Off 
Wilmington, DE 19803 
Protocol Version: 
Protocol Amendment 4 dated 08 JUL 2019 
CRF Approval Date: 
11 MAR 2019 
SAP Version: 
Amendment 1 
SAP Author:  
Date of Plan: 
17 OCT 2019 
 
 
This study is being conducted in compliance with good clinical practice, 
including the archiving of essential documents. 
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TABLE OF CONTENTS 
LIST OF ABBREVIATIONS ..........................................................................................................6 
1. 
INTRODUCTION ........................................................................................................8 
2. 
STUDY INFORMATION, OBJECTIVES, AND ENDPOINTS.................................9 
2.1. 
Protocol and Case Report Form Version ......................................................................9 
2.2. 
Study Objectives and Endpoints ...................................................................................9 
3. 
STUDY DESIGN .......................................................................................................11 
3.1. 
Overall Study Design ..................................................................................................11 
3.1.1. 
Survival Follow-Up Period .........................................................................................11 
3.1.2. 
Treatment Discontinuation .........................................................................................11 
3.1.3. 
Study Duration ............................................................................................................12 
3.1.4. 
Response Assessment .................................................................................................12 
3.2. 
Randomization ............................................................................................................12 
3.3. 
Control of Type I Error ...............................................................................................12 
3.4. 
Sample Size Considerations .......................................................................................13 
3.5. 
Schedule of Assessments ............................................................................................13 
4. 
DATA HANDLING DEFINITIONS AND CONVENTIONS ..................................14 
4.1. 
Scheduled Study Evaluations and Study Periods .......................................................14 
4.1.1. 
Study Drug ..................................................................................................................14 
4.1.2. 
Day 1 ...........................................................................................................................14 
4.1.3. 
Study Day ...................................................................................................................14 
4.1.4. 
Baseline Value ............................................................................................................14 
4.1.5. 
Handling of Missing and Incomplete Data .................................................................14 
4.1.6. 
Cycle Length and Duration .........................................................................................15 
4.1.7. 
On-Treatment Assessment/Event ...............................................................................15 
4.2. 
Variable Definitions ....................................................................................................16 
4.2.1. 
Body Mass Index ........................................................................................................16 
4.2.2. 
Prior and Concomitant Medication .............................................................................16 
5. 
STATISTICAL METHODOLOGY ...........................................................................17 
5.1. 
General Methodology .................................................................................................17 
5.2. 
Treatment Groups .......................................................................................................17 
5.3. 
Analysis Populations ..................................................................................................17 
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5.3.1. 
Full Analysis Set .........................................................................................................17 
5.3.2. 
Safety Evaluable Population .......................................................................................17 
5.3.3. 
Pharmacokinetic Evaluable Population ......................................................................17 
 
17 
6. 
BASELINE, EXPOSURE, AND DISPOSITION VARIABLES AND 
ANALYSES ...............................................................................................................18 
6.1. 
Baseline and Demographics, Physical Characteristics, and Disease History .............18 
6.1.1. 
Demographics and Baseline Characteristics ...............................................................18 
6.1.2. 
Baseline Disease Characteristics and Disease History ...............................................18 
6.1.3. 
Prior Therapy ..............................................................................................................18 
6.1.4. 
Medical History ..........................................................................................................18 
6.2. 
Disposition of Participants ..........................................................................................18 
6.3. 
Protocol Deviations ....................................................................................................18 
6.4. 
Exposure .....................................................................................................................19 
6.5. 
Prior and Concomitant Medication .............................................................................19 
7. 
EFFICACY .................................................................................................................20 
7.1. 
General Considerations ...............................................................................................20 
7.2. 
Efficacy Hypotheses ...................................................................................................20 
7.3. 
Analysis of the Efficacy Parameters ...........................................................................20 
7.3.1. 
Response Criteria ........................................................................................................20 
7.3.2. 
Primary Analysis ........................................................................................................20 
7.3.2.1. 
Overall Response Rate ................................................................................................20 
7.3.2.2. 
Handling of Missing Data in Primary Analysis ..........................................................21 
7.3.2.3. 
Best Overall Response ................................................................................................21 
7.3.3. 
Secondary Analysis ....................................................................................................22 
7.3.3.1. 
Duration of Response .................................................................................................22 
7.3.3.2. 
Disease Control Rate ..................................................................................................23 
7.3.3.3. 
Progression-Free Survival ..........................................................................................23 
7.3.3.4. 
Overall Survival ..........................................................................................................24 
7.3.4. 
Tumor Size Change Over Time ..................................................................................24 
7.3.5. 
Subgroup Analysis ......................................................................................................24 
 
25 
 
25 
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26 
8. 
SAFETY AND TOLERABILITY ..............................................................................26 
8.1. 
General Considerations ...............................................................................................26 
8.2. 
Adverse Events ...........................................................................................................26 
8.2.1. 
Adverse Event Definitions ..........................................................................................26 
8.2.2. 
Adverse Events of Special Interest .............................................................................27 
8.2.3. 
Adverse Event Summaries ..........................................................................................27 
8.3. 
Clinical Laboratory Tests ...........................................................................................29 
8.3.1. 
Laboratory Value Definitions .....................................................................................29 
8.3.2. 
Laboratory Value Summaries .....................................................................................29 
8.4. 
Vital Signs ..................................................................................................................30 
8.5. 
Electrocardiograms .....................................................................................................31 
9. 
PHARMACOKINETIC 
 ANALYSES ............................32 
9.1. 
Pharmacokinetic Assessments ....................................................................................32 
 
32 
 
32 
 
33 
 
33 
 
33 
 
33 
11. 
INTERIM ANALYSES ..............................................................................................33 
12. 
CHANGES AND MODIFICATIONS TO THE ANALYSIS PLAN ........................34 
12.1. 
Changes to Protocol-Defined Analyses ......................................................................34 
12.2. 
Changes to the Statistical Analysis Plan .....................................................................34 
12.2.1. 
Amendment 1 ..............................................................................................................34 
13. 
REFERENCES ...........................................................................................................35 
APPENDIX A. PLANNED TABLES, FIGURES, AND LISTINGS ........................................36 
 
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LIST OF TABLES 
Table 1: 
Objectives and Endpoints .............................................................................................9 
Table 2: 
Response Rates and 95% Confidence Intervals ..........................................................13 
Table 3: 
RECIST Evaluation Criteria for Overall Response ....................................................21 
Table 4: 
Confirmed Response Based on Subsequent Assessments ..........................................22 
Table 5: 
Evaluation and Censoring of Progression-Free Survival ............................................23 
Table 6: 
Confirmed Response Based on Subsequent Assessments ..........................................25 
Table 7: 
Baseline Laboratory Identification .............................................................................29 
Table 8: 
Criteria for Clinically Notable Vital Sign Abnormalities ...........................................30 
Table 9: 
Criteria for Clinically Notable Electrocardiogram Abnormalities .............................31 
Table 10: Statistical Analysis Plan Versions ..............................................................................34 
 
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Abbreviation 
Term 
 
 
 
 
IV 
intravenously 
MedDRA 
Medical Dictionary for Regulatory Activities 
NCI 
National Cancer Institute 
NE 
not evaluable 
ORR 
overall response rate 
OS 
overall survival 
PD 
progressive disease 
PD-L1 
programmed death-ligand 
PFS 
progression-free survival 
PK 
pharmacokinetics 
PR 
partial response 
PRO 
patient reported outcome 
PT 
preferred term 
Q4W 
every 4 weeks 
 
 
QTcF 
QT interval corrected by Fridericia 
QTcB 
QT interval corrected by Bazett 
RECIST 
Response Evaluation Criteria In Solid Tumors 
SAP 
Statistical Analysis Plan 
SCAC 
squamous carcinoma of the anal canal 
SD 
stable disease 
SOC 
system organ class 
TEAE 
treatment-emergent adverse event 
Tmax 
time to maximum concentration 
TPR 
timepoint response 
WHO 
World Health Organization 
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1. 
INTRODUCTION 
This study is an open-label, single-group, multicenter, Phase 2 study that will enroll participants 
with locally advanced or metastatic SCAC who have progressed on or after a standard-of-care 
platinum-based chemotherapy regimen.  Participants with well-controlled HIV infection will be 
eligible.  The study will enroll approximately 81 participants.  All participants will receive 
INCMGA00012 at the recommended Phase 2 dose of 500 mg IV Q4W.  The primary endpoint is 
ORR as determined by ICR using RECIST v1.1. 
The study consists of 3 periods:  screening, study drug treatment, and follow-up.  Treatment may 
continue for up to 2 years in the absence of clinical disease progression, intolerable toxicity, 
death, withdrawal of consent, lost to follow-up, or premature discontinuation for any other 
reason.  Participants who are treated for at least 6 months and achieve a confirmed CR may 
discontinue INCMGA00012 after 2 additional cycles upon consultation with the medical 
monitor. 
The follow-up period will begin once a participant has completed 2 years of study drug or 
prematurely discontinued from study drug.  Participants will be evaluated for irAEs for 90 days 
after the last dose of study drug, regardless of whether a new anticancer therapy is started. 
Once participants discontinue treatment, they enter the follow-up period and will be assessed for 
survival until study completion.  Participants who discontinue study treatment without 
experiencing disease progression will enter the follow-up period and continue to undergo tumor 
assessments according to the schedule of activities until they experience disease progression, the 
start of a new anticancer treatment, withdrawal of consent, lost to follow-up, the end of the study, 
or death. 
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 will be executed by the Department of Clinical Pharmacokinetics and the 
Department of Translational Sciences, respectively. 
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2. 
STUDY INFORMATION, OBJECTIVES, AND ENDPOINTS 
2.1. 
Protocol and Case Report Form Version 
This SAP is based on Study INCMGA 0012-202 Protocol Amendment 4 dated 08 JUL 2019 and 
CRFs approved on 11 MAR 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 efficacy of INCMGA00012 in terms of 
the ORR in participants with locally advanced or 
metastatic SCAC who have progressed after 
platinum-based chemotherapy. 
ORR, defined as the percentage of participants 
having a CR or PR, according to RECIST v1.1 as 
determined by ICR. 
Secondary 
To determine additional measures of clinical 
benefit, specifically, DOR, DCR, PFS, and OS. 
DOR, defined as the time from an initial objective 
response (CR or PR) according to RECIST v1.1 
until disease progression as determined by ICR or 
death due to any cause. 
DCR, defined as the number of participants 
maintaining either an ORR or stable disease. 
PFS, defined as the time from the first dose of 
study treatment until disease progression by ICR or 
death due to any cause. 
OS, defined as the time from the start of therapy 
until death due to any cause. 
To evaluate the safety of INCMGA00012 in 
participants with previously-treated SCAC. 
Safety, determined by the number of participants; 
the frequency, duration, and severity of AEs per 
CTCAE v5.0; laboratory tests; vital signs; and 
ECGs. 
To determine the PK of INCMGA00012 
administered to participants with SCAC. 
Population PK, including Cmax, Tmax, Cmin, and 
AUC0-t, will be summarized. 
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Table 1: 
Objectives and Endpoints (Continued) 
Objectives 
Endpoints 
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3. 
STUDY DESIGN 
3.1. 
Overall Study Design 
This study is an open-label, single-group, multicenter, Phase 2 study that will enroll participants 
with locally advanced or metastatic SCAC who have progressed on or after a standard-of-care 
platinum-based chemotherapy regimen.  Participants with well-controlled HIV infection will be 
eligible.  All participants will receive INCMGA00012 at the recommended Phase 2 dose of 
500 mg IV Q4W.  The primary endpoint is ORR as determined by ICR using RECIST v1.1. 
The study consists of 3 periods:  screening, study drug treatment, and follow-up.  Treatment may 
continue for up to 2 years in the absence of clinical disease progression, intolerable toxicity, 
death, withdrawal of consent, lost to follow-up, or premature discontinuation for any other 
reason. 
Treatment will be administered by IV infusion over 60 minutes (± 15 minutes) on Day 1 of each 
28-day cycle.  Subsequent treatment cycles should be delayed (for up to 12 weeks) until certain 
criteria are met.  The follow-up period will begin once a participant has completed 2 years of 
study drug or prematurely discontinued from study drug. 
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 
interruptions of > 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. 
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. 
3.1.1. 
Survival Follow-Up Period 
All participants will be followed for survival assessment until study completion.  During this 
time, participants will be followed via telephone or other electronic contact at least every 
12 weeks for follow-up of overall survival. 
3.1.2. 
Treatment Discontinuation 
Participants must be withdrawn from study treatment for the following reasons: 
• Clinical disease progression. 
• Unacceptable toxicity as noted in Protocol Section 6.5.2. 
• Consent is withdrawn. 
• 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. 
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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. 
• 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, per Protocol Section 9.7. 
3.1.3. 
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 all participants have 
completed at least 2 years of treatment with INCMGA00012 or discontinued. 
A participant is considered to have completed the study if he/she has completed all periods/parts 
of the study including survival follow-up. 
3.1.4. 
Response Assessment 
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 the schedule of activities.  
Scans should follow calendar days and remain on the 8-week schedule, established on Cycle 1 
Day 1 (date of first dose of study drug), 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.  For participants who discontinue study treatment for reasons other than 
disease progression, every effort should be made to continue monitoring their disease status by 
radiographic imaging according to the follow-up schedule. 
Participants who continue study participation in the follow-up period without experiencing 
disease progression will continue to have efficacy assessments every 12 weeks until they 
complete participation in the study, start a new anticancer therapy, experience disease 
progression, or death. 
3.2. 
Randomization 
Not applicable. 
3.3. 
Control of Type I Error 
There is no formal hypothesis testing in this study.  For analysis of response rate, 2-sided 95% CI 
will be reported. 
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3.4. 
Sample Size Considerations 
In a recent single-arm Phase 2 study, nivolumab achieved an ORR of 24% in participants with 
unresectable metastatic anal cancer (Morris et al 2017). 
Based on a target ORR of 25% and a sample size of 81, the study has 80% power to exclude a 
lower confidence limit of 13% with alpha equal to 0.025 (1-sided).  Response rate and associated 
95% CI are provided in Table 2.  The sample size calculation is based on the FAS (see 
Section 5.3.1). 
Table 2: 
Response Rates and 95% Confidence Intervals 
3.5. 
Schedule of Assessments 
Refer to Protocol Amendment 4 dated 08 JUL 2019 for a full description of all study procedures 
and assessment schedules for this study. 
Sample Size 
Number of Responses 
Response Rate (%) 
95% CI (%) 
81 
10 
12.3 
6.1-21.5 
81 
15 
18.5 
10.8-28.7 
81 
20 
24.7 
15.8-35.5 
81 
25 
30.9 
21.1-42.1 
81 
30 
37.0 
26.6-48.5 
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4. 
DATA HANDLING DEFINITIONS AND CONVENTIONS 
4.1. 
Scheduled Study Evaluations and Study Periods 
4.1.1. 
Study Drug 
INCMGA00012 is the only study drug in this study. 
4.1.2. 
Day 1 
Day 1 is the date that the first dose of INCMGA00012 is administered to the participants. 
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 
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 conventions 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. 
• No imputation will be done if the date is completely missing. 
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For relevant efficacy endpoints, partial death date will be imputed as follows: 
• If mmyyyy for the last contact date = mmyyyy for the death date, then the death date 
will be set to the day after the last contact date. 
• If mmyyyy for the last contact date < mmyyyy for the death date, then the death date 
will be set to the first day of the death month. 
• Otherwise, the partial death date will not be imputed. 
For prior and concomitant medications: 
The start/stop dates recorded in the 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. 
• If only the day is missing, and the first day of the month is after the first dose date on 
Day 1, then the concomitant medication will be considered as starting after Day 1, 
and the incomplete date will be imputed as the first day of the month. 
• If only the day is missing, and the month is equal to the month of the first dose date 
on Day 1, then the incomplete date will be imputed as the first day of the month. 
• If both the month and day are missing, and the last day of the year is before the first 
dose date on Day 1, then the concomitant medication will be considered as starting 
before Day 1, and the incomplete date will be imputed as if it is the last day of the 
year.  Otherwise, if the last day of the year is after the first dose date Day 1, the 
incomplete date will be imputed as if it is the first day of the year. 
4.1.6. 
Cycle Length and Duration 
One cycle is defined as 28 days (4 weeks) for participants in this study.  Cycle 1 Day 1 is the day 
of first infusion of INCMGA00012.  Day 1 of subsequent cycles will correspond with the 
infusion date of INCMGA00012 within the cycle.  Scheduled visits will have a ± 3-day window.  
Tumor assessments will have ± 7-day 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 following time interval: 
Date of first administration of study drug through the date of last administration of study 
drug + 90 days. 
Adverse events that begin or worsen after informed consent should be recorded in the Adverse 
Events CRF. 
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If the last date of study drug is missing, on-treatment assessments/events include any 
assessment/event recorded in the database that occurred after the start date of study drug. 
Data listings will include all assessments/events, and those which are not on-treatment 
assessments/events will be flagged. 
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: 
BMI (kg/m2) = [weight (kg)] / [height (m)]2. 
4.2.2. 
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 non-study 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 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 prior medication could also be classified as "both prior and concomitant medication" if the end 
date is on or after first dose of INCMGA00012.  In the listing, it will be indicated whether a 
medication is prior-only, concomitant-only, or both prior and concomitant. 
For the purposes of analysis, all medications will be considered concomitant medications unless 
the medications can unequivocally be defined as not concomitant, that is, if the start date and end 
date are all missing, then the medication is considered as concomitant medication. 
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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 
The FAS will be used for all baseline disease characteristics and demographic summaries and 
data listings. 
6.1.1. 
Demographics and Baseline Characteristics 
Demographic and baseline characteristics will be listed in detail.  The following demographics 
will be summarized using the safety evaluable population and FAS:  age, sex, race, ethnicity, 
body weight, height, and BMI.  Qualitative data will be summarized by contingency tables while 
quantitative data will be summarized by descriptive summary statistics. 
6.1.2. 
Baseline Disease Characteristics and Disease History 
According to data collected in the eCRF, time since initial diagnosis, tumor stage at initial 
diagnosis, site of primary tumor at initial diagnosis, PD-L1 assessment, MSI status, HPV status, 
HIV infection, ECOG performance status, and current sites of disease will be summarized for all 
participants in FAS. 
6.1.3. 
Prior Therapy 
The number and percentage of participants recording any prior systemic cancer therapy, prior 
radiation, or prior surgery will be summarized.  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.  Detailed information on prior systemic cancer 
therapy, prior radiation, and prior surgery will be listed in 3 separate listings. 
6.1.4. 
Medical History 
Medical history will be summarized for all participants in the FAS.  This summary will be 
presented by primary SOC and PT. 
6.2. 
Disposition of Participants 
The number and percentage of participants who are on treatment, who discontinue study 
treatment with a 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 
the FAS. 
6.3. 
Protocol Deviations 
Protocol deviations recorded on the eCRF will be presented in the participant data listings.  If 
data warrant, protocol deviations will be summarized descriptively. 
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6.4. 
Exposure 
For participants in the safety evaluable population, exposure to INCMGA00012 will be 
summarized descriptively as follows: 
• Total number of infusions:  Total number of infusions of INCMGA00012 per 
participant. 
• Total dose administered (mg):  Estimated volume delivered / prepared volume 
× 500 mg. 
• Average dose (mg):  Total dose administered (mg) / total number of infusions. 
• Duration of treatment (days):  Date of last dose of INCMGA00012 – date of first 
dose of INCMGA00012 + 1. 
Infusion information collected in the eCRF will be listed.  Dose delay and temporary infusion 
interruption may be summarized/listed as needed. 
6.5. 
Prior and Concomitant Medication 
Prior medications and concomitant medications will be coded using the WHO Drug Dictionary 
and summarized by ATC drug class and WHO drug term.  Results will be summarized as 
number and percentage of participants with prior and concomitant medications by ATC class and 
WHO drug term in safety population.  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 study drug will be included.  Medications with missing start/end dates will be considered 
as concomitant medication in the summary.  Post-treatment anti-cancer therapy will be 
summarized.  Other medications will be provided in the listing.  Drugs intended to manage irAEs 
as well as prophylaxis/premedication used to prevent infusion reactions may be summarized 
separately.  Procedures and nondrug therapies will also be summarized/listed per CRF. 
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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. 
Handling of Missing Data in Primary Analysis 
The study requires measurable disease at baseline per RECIST v1.1 as part of the inclusion 
criteria.  However, if a participant did not have measurable disease and was administered study 
drug, the participant will also be counted as denominator in the calculation of ORR.  For this 
study, participants without measurable disease at baseline will be considered nonresponders.  
Participants with subsequent missing assessments that prevent the evaluation of the primary 
endpoint will be considered nonresponders.  No data imputation will be applied. 
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. 
7.3.2.3. 
Best Overall Response 
The best overall response 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 participant's best response 
assignment will depend on the achievement of both measurement and confirmation criteria.  The 
best overall response 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 best overall response determination.  The best 
overall response for each participant is determined from the sequence of overall responses 
according to the following rules: 
• CR = at least 2 consecutive determinations of CR at least 4 weeks apart before 
progression 
• PR = at least 2 consecutive determinations of PR or better at least 4 weeks apart 
before progression (and not qualifying for a CR) 
• SD = at least 1 SD assessment (or better) ≥ 7 weeks after start of treatment (and not 
qualifying for CR or PR) 
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• PD = meet progression criteria comparing with nadir (and not qualifying for CR, PR, 
or SD) 
• NE = all other cases (ie, not qualifying for confirmed CR or PR and without SD after 
more than 7 weeks or PD) 
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 (49 days).  Participants who fail to meet this criterion will have a best 
overall response of PD if the next available assessment indicated PD or NE if there is no 
additional assessment available.  Table 4 lists the scenarios of responses that can occur after an 
unconfirmed CR or PR in the 4-week follow-up time and provides a rule for determining the best 
overall response in each scenario. 
Table 4: 
Confirmed Response Based on Subsequent Assessments 
First Timepoint Response
a 
Second Timepoint Response 
Confirmed Response
b 
CR 
PR/SD/PD 
SD or NEb 
CR 
CR 
CRa 
CR 
NEa 
SD or NEb 
PR 
CR/PR 
PRa 
PR 
SD/PD 
SD or NEb 
PR 
NEa 
SD or NEb 
SD 
CR/PR/SD/PD/NE 
SD or NEb 
PD 
No further evaluation 
PD 
a Subsequent documentation of CR may provide confirmation of a previously identified CR for participants where the second 
integrated response was NE.  Subsequent documentation of PR may provide confirmation of a previously identified PR for 
participants where the second integrated response was NE or SD.  If the third TPR confirms the CR (or PR,) then the confirmed 
response will be CR (or PR).  Only 1 intervening NE is allowed between CRs/PRs.  For example:  CR NE CR = CR; PR NE 
PR/CR = PR.  Additionally, 1 SD (≥ 25% reduction in target lesions comparing with baseline) is allowed between PRs (eg, PR 
SD PR/CR = PR).  Note:  In the following scenario, PR SD NE PR, the second PR is not a confirmed PR. 
b A confirmed response of SD can only be made after the participant is on study for a minimum of 49 days.  If the participant is 
on study less than 49 days, any tumor assessment indicating SD before this time period will have a confirmed response of NE 
unless PD is identified. 
7.3.3. 
Secondary Analysis 
7.3.3.1. 
Duration of Response 
Duration of response is defined as the time from first documented response (CR or PR, which is 
confirmed subsequently) to the time of first documented disease progression 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 5).  The DOR endpoint will 
be analyzed at least 6 months after the last participant is enrolled in the study.  The Kaplan-Meier 
estimate of the distribution function will be constructed for DOR.  The estimated median along 
with 95% CIs will be reported.  A swim plot for DOR may be generated.  Analysis of DOR will 
be according to RECIST v1.1 as determined by ICR in the FAS. 
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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 per RECIST v1.1, according the ICR.  The DCR will be estimated, and the 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 treatment to the date 
of the first documented progression per RECIST v1.1 according to ICR or death due to any cause.  
Progression-free survival will be analyzed by the Kaplan-Meier method, including estimated 
median with 95% CI and Kaplan-Meier 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 therapy according to Table 5, which is based on the FDA 
Guidance for Industry:  Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics 
(2007).  Date of death will be determined using the Death Report, Survival Follow-Up, and 
Subject Status eCRFs. 
Table 5: 
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 discontinuation for undocumented 
progression 
Censored 
Date of last valid radiologic assessment 
(not NE or missing) 
Study discontinuation 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 
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7.3.3.4. 
Overall Survival 
Overall survival is defined as the time from first dose of study treatment 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.  Kaplan-Meier curves, medians, and 95% CIs of the medians will be 
presented for OS. 
7.3.4. 
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. 
7.3.5. 
Subgroup Analysis 
Subgroup analyses will be performed on the following based on the participant's baseline status: 
• Sex:  Male, Female 
• Baseline ECOG performance status:  0 vs 1 
• Age:  < 65 years, ≥ 65 years and < 75 years, ≥ 75 years 
• Race:  Caucasian, non-Caucasian 
• Ethnicity:  Hispanic or Latino, Not Hispanic or Latino 
• HIV status:  Known HIV-positive, negative, or unknown 
• Prior lines of therapy:  less than 2 lines of prior therapy vs more than 2 lines of prior 
therapy 
• Liver metastatic:  Yes, No 
• HPV, MSI, and/or PD-L1 assessment (if tumor tissue is available at screening):  
< 1%, ≥ 1% 
Subgroup analyses will only be performed if at least 5 participants are present in each subgroup.  
Some grouping of classes will be considered if there are too few participants in some subgroups. 
Efficacy analyses in subgroups will generally be exploratory and are intended to explore the 
intrinsic consistency of any treatment effects found overall. 
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Subgroup analyses of the primary endpoint (ORR) will be performed on the FAS by presenting 
the point estimates in the subgroup with the exact 95% CIs.  Summary tables and forest plots 
may be presented. 
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8. 
SAFETY AND TOLERABILITY 
A list of planned tables, figures, and listings is provided in Appendix A. 
8.1. 
General Considerations 
The clinical safety data (eg, vital signs, ECGs, routine laboratory tests, and AEs) will be 
summarized using descriptive statistics (eg, mean, frequency) using the safety evaluable 
population.  Some safety analyses such as AEs and laboratory values may be performed within a 
known HIV-positive subgroup if a sufficient number of participants are enrolled. 
Summary tables may be replaced with listings when appropriate.  For instance, an AE frequency 
table may be replaced with a listing if it only contains a few unique PTs reported on relatively 
few participants. 
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 the 
first dose of study drug.  Analysis of AEs (as discussed below) will be limited to TEAEs, but 
data listings will include all AEs regardless of their timing in relation to study drug 
administration. 
Adverse events will be tabulated by MedDRA PT and SOC.  Severity of AEs will be graded 
using the NCI CTCAE v5.  The CTCAE reporting guidelines and grading details are available on 
the Cancer Therapy Evaluation Program website. 
The subset of AEs considered by the investigator to be related to study drug will be considered to 
be treatment-related AEs.  If the investigator does not specify the relationship of the AE to study 
drug, the AE will be considered to be treatment-related.  The incidence of AEs and 
treatment-related AEs will be tabulated.  In addition, serious TEAEs will also be tabulated. 
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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. 
Cumulative toxicity including cumulative adverse event rates may be provided at specific 
timepoints including 3, 6, and 12 months. 
8.2.2. 
Adverse Events of Special Interest 
Adverse events that are potentially immune-related will be assessed as AESIs.  Adverse events 
of special interest identified in the AE dataset will be summarized.  In addition, predefined PTs 
may be used to summarize AESIs. 
An overall summary of AESIs will include number (%) of participants reporting any AESIs, any 
≥ Grade 3 AESIs, any treatment-related AESIs, any fatal AESIs, and any AESIs leading to 
treatment interruption/delay in planned treatment/dose reduction/discontinuation. 
Time of the first onset of the AESI, time to the first onset of AESI, defined as from study Day 1 
to the date of first onset of each AESI, as well as duration of AESI may be summarized. 
Immune-related AEs are to be collected for 90 days after the last dose of study drug, regardless 
of whether a new anticancer therapy is started.  Reasonable efforts should be made to align the 
first 12-week follow-up visit with the end of the 90-day irAE reporting period. 
8.2.3. 
Adverse Event Summaries 
An overall summary of AEs will include: 
• 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 who temporarily interrupted study drug infusion because 
of TEAEs 
• Number (%) of participants who delayed the next scheduled study drug infusion 
because of TEAEs 
• Number (%) of participants who permanently discontinued study drug because of 
TEAEs 
• Number (%) of participants who had a fatal TEAE 
• Number (%) of participants reporting any infusion-related reactions 
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The following summaries will be produced by MedDRA term (if 10 or fewer participants appear 
in a table, a listing may be appropriate): 
• Overall summary of TEAEs 
• 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 treatment-related TEAEs by SOC and PT 
• Summary of treatment-related TEAEs by PT in decreasing order of frequency 
• Summary of TEAEs with a fatal outcome by SOC and PT 
• Summary of serious TEAEs by SOC and PT 
• Summary of treatment-related serious TEAEs by SOC and PT 
• Summary of serious TEAEs by PT in decreasing order of frequency 
• Summary of TEAEs leading to dose delay by SOC and PT 
• Summary of TEAEs leading to infusion interruption by SOC and PT 
• Summary of TEAEs 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 AESIs will be included: 
• Overall summary of TEAEs of special interests 
• Summary of TEAEs of special interest by SOC and PT 
• Summary of TEAEs of special interest by PT in decreasing order of frequency 
• Summary of TEAEs of special interest with a fatal outcome by SOC and PT 
• Summary of TEAEs of special interest leading to dose delay by SOC and PT 
• Summary of TEAEs of special interest leading to infusion interruption by SOC and 
PT 
• Summary of TEAEs of special interest leading to study drug discontinuation by SOC 
and PT 
• Summary TEAEs of special interest by SOC, PT, and maximum severity 
• Summary of Grade 3 or higher TEAEs of special interest by SOC and PT 
• Summary of time of first onset and duration of identified TEAEs of special interest 
• Summary of clinical interventions used to manage TEAEs of special interest 
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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 7 may be referred as tiebreaker to delineate which value will be 
defined as baseline. 
Table 7: 
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 and shift tables relative to baseline will be tabulated. 
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 the safety 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. 
Shift tables will be presented showing change in CTCAE grade from baseline to worst 
postbaseline grade.  Separate summaries for abnormally high and abnormally low laboratory 
values will be provided when the laboratory parameter has both high and low grading criteria.  
The denominator for the percentage calculation will be the number of participants in the baseline 
category. 
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The following summaries will be produced for laboratory data (by laboratory parameter) 
reported on treatment.  All laboratory assessments will be listed, and those collected later than 
90 days after the last treatment/exposure date will be flagged in the listings. 
• Number and percentage of participants with worst postbaseline CTCAE grade 
(regardless of the baseline status) will be summarized.  Each participant will be 
counted only for the worst grade observed after baseline. 
• Shift tables using CTCAE grades comparing baseline with the worst postbaseline 
value will be produced for hematology and biochemistry laboratory parameters with 
CTCAE grades. 
• 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. 
• Number and percentage of participants meeting categorical liver function test criteria, 
including ALT, AST, and ALT/AST (> 3 ×, 5 ×, 8 ×, 10 ×, 20 × ULN), total bilirubin 
(> 1 ×, 2 × ULN), ALP (> 1.5 ×, 2 ×, 3 ×, 5 ×, 8 ×, 10 × ULN), combined categories 
of ALT/AST and total bilirubin (eg, ALT/AST > 3 × UNL & total bilirubin > ULN) 
as well as Hy's Law criteria (ALT or AST > 3 × ULN and total bilirubin > 2 × ULN 
and ALP < 2 × ULN at the same visit).  The worst values observed postbaseline for 
each participant will be used for each of the categories. 
8.4. 
Vital Signs 
Values at each scheduled visit, change, and percentage change from baseline for vital signs, 
including systolic blood pressure, diastolic blood pressure, pulse, respiratory rate, body 
temperature, and weight will be summarized descriptively. 
Criteria for clinically notable vital sign abnormalities are defined in Table 8.  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 percentage change from 
baseline greater than 25%.  The abnormal values for participants exhibiting alert vital sign 
abnormalities will be listed. 
Table 8: 
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 
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8.5. 
Electrocardiograms 
Twelve-lead ECGs including HR, RR, 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.  Baseline will be 
determined as the last nonmissing ECG measurements taken on or before the first administration 
of study drug. 
Criteria for clinically notable ECG abnormalities are defined in Table 9.  Participants exhibiting 
clinically notable ECG abnormalities will be listed with study visit.  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 9: 
Criteria for Clinically Notable Electrocardiogram Abnormalities 
Parameter 
High Threshold 
Low Threshold 
QTcF/QTcB 
> 460 ms 
< 295 ms 
PR 
> 220 ms 
< 75 ms 
QRS 
> 120 ms 
< 50 ms 
QT 
> 500 ms 
< 300 ms 
RR 
> 1330 ms 
< 600 ms 
HR (bpm) 
≥ 100 and ≥ 25% increase from baseline 
≤ 50 and ≥ 25% decrease from baseline 
QTcB = Bazett correction; QTcF = Fridericia correction. 
Twelve-lead ECGs will be obtained for each participant during the study.  Electrocardiogram 
abnormalities, both at baseline and postbaseline visits, will be tabulated.  Incidences of 
abnormalities will be listed with study visit and a description of the abnormality.  
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11. 
INTERIM ANALYSES 
An analysis is planned after approximately 25 participants are assessable for 
investigator-assessed response according to RECIST v1.1.  The primary intent of this analysis is 
to minimize unnecessary exposure of participants to INCMGA00012 in the event of futility.  An 
ICR will be used for interim analysis if available; otherwise, investigator response assessment 
may be used.  The study will be stopped for futility at the interim analysis if conditional power 
based on interim result is lower than 20%, which is equivalent to less than 2 participants 
responded.  All participants enrolled with a postbaseline response assessment or participants who 
discontinued early will be included in the futility analysis.  Participants enrolled in the study 
without any postbaseline response assessment but are ongoing in the study will not be included 
in the futility analysis for calculation of conditional power.  Enrollment will continue while the 
analysis is being conducted.  This futility analysis will be reviewed by an independent DMC as 
specified in the DMC Charter.  The process by which the DMC will review data and make 
recommendations and decisions will be documented in the DMC Charter. 
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12. 
CHANGES AND MODIFICATIONS TO THE ANALYSIS PLAN 
All versions of the SAP are listed in Table 10. 
Table 10: 
Statistical Analysis Plan Versions 
SAP Version 
Date 
Original 
14 MAY 2019 
Amendment 1 
17 OCT 2019 
12.1. 
Changes to Protocol-Defined Analyses 
Not applicable. 
12.2. 
Changes to the Statistical Analysis Plan 
12.2.1. 
Amendment 1 
The following changes were made to the SAP: 
• Clarification regarding the timing of analysis of the ORR and DOR endpoints was 
added in Sections 7.3.2.1 and 7.3.3.1. 
• Clinical notable vital sign criteria for body temperature were removed in Table 8. 
• Minor administrative changes have been incorporated throughout and are noted in the 
redline version of the amendment. 
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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 CSR.  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.  Analysis 
to support the DMC will be performed as marked pending data availability. 
Tables 
Table No. 
Title 
Population 
DMC 
Baseline and Demographic Characteristics 
1.1  Disposition 
1.1.1 
Analysis Populations 
Enrolled 
 
1.1.2 
Summary of Participant Disposition 
FAS 
Y 
1.1.3 
Summary of Number of Participants Enrolled by Country and Site 
Enrolled 
 
1.1.4 
Summary of Protocol Deviations 
FAS 
 
1.2  Demography 
1.2.1 
Summary of Demographics 
FAS 
Y 
1.3  Baseline Disease Characteristics (refine per data collection) 
1.3.1 
Summary of Cancer History and Baseline Disease Characteristics 
FAS 
Y 
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 Systemic Cancer Therapy 
FAS 
Y 
1.4.4 
Summary of Prior Radiotherapy 
FAS 
 
1.4.5 
Summary of Prior Surgery/Procedure 
FAS 
 
1.4.6 
Summary of Nondrug Procedure 
FAS 
 
1.4.7 
Summary of Post Anticancer Therapy 
FAS 
 
1.5  Others 
1.5.1 
Summary of General Medical History 
FAS 
 
Efficacy (additional subgroup analysis may be performed if data permitted) 
2.1.1 
Summary of Best Overall Response by ICR 
FAS 
Y 
2.2.1 
Summary of Duration of Response by ICR 
FAS 
 
2.2.2 
Summary of Disease Control Rate by ICR 
FAS 
 
2.2.3 
Summary of Progression Free Survival by ICR 
FAS 
 
2.2.4 
Summary of Overall Survival 
FAS 
 
2.2.5 
Summary of Largest Percentage Reduction in Sum of Diameters of Target 
Lesions 
FAS 
 
2.3.1 
Summary of Best Overall Response by ICR by Gender 
FAS 
 
2.3.2 
Summary of Best Overall Response by ICR by Age Group 
FAS 
 
2.3.3 
Summary of Best Overall Response by ICR by Race 
FAS 
 
2.3.4 
Summary of Best Overall Response by ICR by Ethnicity 
FAS 
 
2.3.5 
Summary of Best Overall Response by ICR by ECOG Status at Baseline 
FAS 
 
2.3.6 
Summary of Best Overall Response by ICR by HIV Status at Baseline 
FAS 
 
2.3.7 
Summary of Best Overall Response by ICR by Prior Lines of Therapy  
FAS 
 
2.3.8 
Summary of Best Overall Response by ICR by Liver Metastatic Status 
FAS 
 
2.3.9 
Summary of Best Overall Response by ICR by PD-L1 status 
FAS 
 
 
 
 
 
 
  
 
 
2.5.1 
Summary of Best Overall Response by Investigator 
FAS 
Y 
2.5.2 
Summary of Duration of Response by Investigator 
FAS 
 
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Table No. 
Title 
Population 
DMC 
Safety 
3.1  Dose Exposure 
3.1.1 
Summary of Exposure to INCMGA00012 
Safety 
Y 
3.1.2 
Summary of Dose Delay/Interruption 
Safety 
 
3.2  Adverse Events  
3.2.1 
Overall Summary of Treatment-Emergent Adverse Events 
Safety 
Y 
3.2.1.1 
Overall Summary of Treatment-Emergent Adverse Events of Special 
Interest 
Safety 
Y 
3.2.2.1 
Summary of Treatment-Emergent Adverse Events by MedDRA System 
Organ Class and Preferred Term 
Safety 
Y 
3.2.2.2 
Summary of Treatment-Emergent Adverse Events of Special Interest by 
MedDRA System Organ Class and Preferred Term 
Safety 
Y 
3.2.3.1 
Summary of Treatment-Emergent Adverse Events by MedDRA Preferred 
Term in Decreasing Order of Frequency 
Safety 
Y 
3.2.3.2 
Summary of Treatment-Emergent Adverse Events of Special Interest by 
MedDRA Preferred Term in Decreasing Order of Frequency 
Safety 
Y 
3.2.4 
Summary of Treatment-Emergent Adverse Events by MedDRA System 
Organ Class, Preferred Term, and Maximum Severity 
Safety 
Y 
3.2.4.1 
Summary of Treatment-Emergent Adverse Events of Special Interest by 
MedDRA System Organ Class, Preferred Term, and Maximum Severity 
Safety 
 
3.2.6 
Summary of Grade 3 or Higher Treatment-Emergent Adverse Events by 
MedDRA System Organ Class and Preferred Term  
Safety 
Y 
3.2.6.1 
Summary of Grade 3 or Higher Treatment-Emergent Adverse Events of 
Special Interest by MedDRA System Organ Class and Preferred Term 
Safety 
Y 
3.2.7 
Summary of Grade 3 or Higher Treatment-Emergent Adverse Events by 
MedDRA Preferred Term in Decreasing Order of Frequency 
Safety 
 
3.2.8 
Summary of Serious Treatment-Emergent Adverse Events by MedDRA 
System Organ Class and Preferred Term 
Safety 
Y 
3.2.9 
Summary of Serious Treatment-Emergent Adverse Events by MedDRA 
Preferred Term in Decreasing Order of Frequency  
Safety 
 
3.2.10 
Summary of Treatment-Related Treatment-Emergent Adverse Events by 
MedDRA System Organ Class and Preferred Term 
Safety 
Y 
3.2.11 
Summary of Treatment-Related Treatment-Emergent Adverse Events by 
MedDRA Preferred Term in Decreasing Order of Frequency 
Safety 
 
3.2.12 
Summary of Treatment-Emergent Adverse Events Leading to Dose Delay 
by MedDRA System Organ Class and Preferred Term 
Safety 
 
3.2.12.1 
Summary of Treatment-Emergent Adverse Events of Special Interest 
Leading to Dose Delay by MedDRA System Organ Class and Preferred 
Term 
Safety 
 
3.2.15 
Summary of Treatment-Related Serious Treatment-Emergent Adverse 
Events by MedDRA System Organ Class and Preferred Term  
Safety 
 
3.2.16 
Summary of Treatment-Emergent Adverse Events With a Fatal Outcome 
by MedDRA System Organ Class and Preferred Term 
Safety 
Y 
3.2.16.1 
Summary of Treatment-Emergent Adverse Events of Special Interest With 
a Fatal Outcome by MedDRA System Organ Class and Preferred Term 
Safety 
 
3.2.19 
Summary of Treatment-Emergent Adverse Events Leading to Infusion 
Interruption by MedDRA System Organ Class and Preferred Term 
Safety 
 
3.2.19.1 
Summary of Treatment-Emergent Adverse Events of Special Interest 
Leading to Infusion Interruption by MedDRA System Organ Class and 
Preferred Term 
Safety 
 
3.2.20 
Summary of Treatment-Emergent Adverse Events Leading to Study Drug 
Discontinuation by MedDRA System Organ Class and Preferred Term 
Safety 
Y 
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Table No. 
Title 
Population 
DMC 
 
 
 
 
 
 
 
 
Figures 
Figure No. 
Title 
Efficacy (Lab figures may be added as needed.  Kaplan-Meier plots may be added per investigator and for 
different analysis populations) 
4.1 
Kaplan-Meier Estimates of Duration of Response by IRC 
4.2 
Kaplan-Meier Estimates of Progression-Free Survival by IRC 
4.3.1 
Kaplan-Meier Estimates of Overall Survival 
4.3.2 
Waterfall Plot of Best Percentage Change in Sum of Target Lesions 
4.3.3 
Swimmer Plot of Duration of Response by IRC 
4.3.4 
Forest Plot of Overall Response and 95% CI by IRC 
 
  
4.5.X 
Mean and Standard Error of Laboratory Parameters  
4.6.X 
Mean and Standard Error of HIV Parameters 
Listings (Data Dump Listings May Be Added) 
Listing No. 
Title 
DMC 
2.1  Discontinued Participants (Participant Disposition) 
2.1.1 
Participant Enrollment and Disposition Status 
Y 
2.1.2 
Participant Inclusion and Exclusion Criteria Violations 
 
2.2  Protocol Deviations 
2.2 
Protocol Deviations 
Y 
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 
Demographic and Baseline Disease Characteristics 
Y 
2.4.2 
Cancer Disease History 
Y 
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 
Y 
2.6  Efficacy 
2.6.1 
Overall Survival Events and Assessments  
 
2.6.2 
Progression-Free Survival Events and Assessments by IRC 
 
2.6.3 
Overall Response Assessment by IRC 
 
2.6.4 
Duration of Response by IRC 
 
2.6.5 
Response Assessment:  Target Lesions 
 
2.6.6 
Response Assessment:  Nontarget Lesions 
 
2.6.7 
Response Assessment:  New Lesions 
 
2.6.8 
Largest Percentage Reduction in Sum of Diameters of Target Lesions by IRC 
 
2.6.9 
ECOG Performance Status 
 
 
 
 
 
 
2.6.12 
Overall Response Assessment by Investigator per RECIST 
 
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Listing No. 
Title 
DMC 
2.7  Adverse Events 
2.7.1 
Adverse Events 
Y 
2.7.2 
Serious Adverse Events 
Y 
2.7.3 
Fatal Adverse Events 
Y 
2.7.4 
Adverse Events Leading to Study Drug Discontinuation 
Y 
2.7.5 
Adverse Events Leading to Study Drug Interruptions or Delays 
 
2.7.6  
Adverse Events of Special Interest 
 
2.7.7 
Adverse Events Grade 3 or Higher 
Y 
2.7.8 
Infusion-Related Reactions 
 
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  
 
2.8.4 
Clinical Laboratory Values – Coagulation 
 
2.8.5 
Abnormal Clinical Laboratory Values 
 
2.8.6 
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  Physical Examinations 
2.11.1 
Physical Examinations 
 
2.11.2 
Body Weight 
 
 
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