A Phase 3 Global, Multicenter, Double-Blind Randomized Study of Carboplatin-Paclitaxel With INCMGA00012 or Placebo in Participants With Inoperable Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Anal Canal Not Previously Treated With Systemic Chemotherapy (POD1UM-303/InterAACT 2)
Phase: PHASE3
Conditions: Squamous Cell Carcinoma of the Anal Canal
Sponsor: Incyte Corporation

Official Title: 
A Phase 3 Global, Multicenter, Double-Blind Randomized Study of 
Carboplatin-Paclitaxel With INCMGA00012 or Placebo in Participants 
With Inoperable Locally Recurrent or Metastatic Squamous Cell 
Carcinoma of the Anal Canal Not Previously Treated With Systemic 
Chemotherapy (POD1UM-303/InterAACT 2) 
NCT Number: 
NCT04472429 
Document Date: 
Protocol INCMGA 0012-303 Am 3: 04 FEB 2025 
 
 
 

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Protocol INCMGA 0012-303 Am 3 
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CONFIDENTIAL 
 
 
Clinical Study Protocol 
INCMGA 0012-303 
A Phase 3 Global, Multicenter, Double-Blind Randomized Study of 
Carboplatin-Paclitaxel With INCMGA00012 or Placebo in Participants 
With Inoperable Locally Recurrent or Metastatic Squamous Cell 
Carcinoma of the Anal Canal Not Previously Treated With Systemic 
Chemotherapy (POD1UM-303/InterAACT 2) 
Product: 
INCMGA00012 
IND Number: 
139,333 
EudraCT Number: 
2020‐000826‐24 
EU CT Number: 
2024-512331-72-00 
Phase of Study: 
3 
Sponsor: 
Incyte Corporation 
1801 Augustine Cut-Off 
Wilmington, DE 19803 
Original Protocol (Version 1): 
17 MAR 2020 
Original Protocol (Version 1-UK): 01 SEP 2020 
Amendment 1 (Version 2): 
21 DEC 2021 
Amendment 2 (Version 3): 
25 MAY 2022 
Amendment 3 (Version 4) 
04 FEB 2025 
This study will be performed in accordance with ethical principles that have their origin in the Declaration of 
Helsinki (Brazil 2013) and conducted in adherence to the study Protocol, applicable Good Clinical Practices, and 
applicable laws and country-specific regulations, including WMO (Medical Research Involving Human Participants 
Act) and Clinical Trials Regulation (EU) No. 536/2014, in which the study is being conducted. 
The information in this document is confidential.  No part of this information may be duplicated, referenced, or 
transmitted in any form or by any means (electronic, mechanical, photocopy, recording, or otherwise) without prior 
written consent. 

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INVESTIGATOR'S AGREEMENT 
I have read the INCMGA 0012-303 Protocol Amendment 3 (dated 04 FEB 2025) and agree to 
conduct the study as outlined.  I agree to maintain the confidentiality of all information received 
or developed in connection with this Protocol. 
 
 
 
 
 
(Printed Name of Investigator) 
 
 
 
 
 
 
 
 
(Signature of Investigator) 
 
(Date) 

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TABLE OF CONTENTS 
TITLE PAGE ...................................................................................................................................1 
INVESTIGATOR'S AGREEMENT ................................................................................................2 
TABLE OF CONTENTS .................................................................................................................3 
LIST OF ABBREVIATIONS ..........................................................................................................9 
1. 
PROTOCOL SUMMARY ..........................................................................................14 
2. 
INTRODUCTION ......................................................................................................30 
2.1. 
Background and Study Rationale ...............................................................................30 
2.1.1. 
Rationale for Fixed Doses of INCMGA00012 ...........................................................31 
2.1.2. 
Justification for Study Drug Dose ..............................................................................32 
2.2. 
Benefit/Risk Assessment ............................................................................................32 
2.2.1. 
Benefit/Risk Assessment During the COVID-19 Pandemic ......................................33 
3. 
OBJECTIVES AND ENDPOINTS ............................................................................35 
4. 
STUDY DESIGN .......................................................................................................37 
4.1. 
Overall Design ............................................................................................................37 
4.2. 
Overall Study Duration ...............................................................................................38 
4.3. 
Study Termination ......................................................................................................38 
5. 
STUDY POPULATION .............................................................................................39 
5.1. 
Inclusion Criteria ........................................................................................................39 
5.2. 
Exclusion Criteria .......................................................................................................40 
5.3. 
Lifestyle Considerations .............................................................................................42 
5.4. 
Screen Failures ............................................................................................................42 
5.5. 
Data Monitoring Committee .......................................................................................42 
5.6. 
Replacement of Participants .......................................................................................43 
6. 
STUDY DRUGS ........................................................................................................43 
6.1. 
Study Drugs Administered .........................................................................................43 
6.1.1. 
Timing of Dose Administration ..................................................................................45 
6.1.2. 
Paclitaxel .....................................................................................................................45 
6.1.3. 
Carboplatin .................................................................................................................45 
6.1.4. 
INCMGA00012 or Placebo ........................................................................................46 
6.2. 
Preparation, Handling, and Accountability ................................................................46 
6.3. 
Measures to Minimize Bias:  Randomization and Blinding .......................................47 

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6.4. 
INCMGA00012 and Placebo Compliance .................................................................47 
6.5. 
Dose Modifications .....................................................................................................47 
6.5.1. 
General Dose Modifications .......................................................................................47 
6.5.2. 
Management of Suspected Infusion Reactions ...........................................................48 
6.5.2.1. 
Paclitaxel and Carboplatin ..........................................................................................48 
6.5.2.2. 
INCMGA00012 or Placebo ........................................................................................48 
6.5.3. 
Dose Modifications of Paclitaxel and Carboplatin .....................................................49 
6.5.4. 
Dose Modification of INCMGA00012 or Placebo .....................................................50 
6.5.4.1. 
Procedures for Participants Exhibiting Immune-Related Adverse Events .................50 
6.6. 
Concomitant Medications and Procedures .................................................................54 
6.6.1. 
Permitted Medications and Procedures ......................................................................55 
6.6.2. 
Prohibited Medications and Procedures .....................................................................55 
6.7. 
Treatment After the End of the Study .........................................................................56 
7. 
DISCONTINUATION OF STUDY DRUG ADMINISTRATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL .......................................57 
7.1. 
Discontinuation of Study Drug Administration ..........................................................57 
7.1.1. 
Reasons for Discontinuation of Study Drug Administration ......................................57 
7.1.2. 
Discontinuation Procedures ........................................................................................57 
7.2. 
Participant Withdrawal From the Study .....................................................................58 
7.3. 
Lost to Follow-Up.......................................................................................................58 
8. 
STUDY ASSESSMENTS AND PROCEDURES ......................................................59 
8.1. 
Administrative and General Procedures .....................................................................59 
8.1.1. 
Informed Consent Process ..........................................................................................59 
8.1.2. 
Screening Procedures ..................................................................................................60 
8.1.3. 
Interactive Response Technology Procedure ..............................................................60 
8.1.4. 
Distribution of Reminder Cards ..................................................................................60 
8.1.5. 
Distribution of Participant Identification Cards .........................................................60 
8.1.6. 
COVID-19 Vaccination ..............................................................................................61 
8.1.7. 
Demography and Medical History ..............................................................................61 
8.1.7.1. 
Demographics and General Medical History .............................................................61 
8.1.7.2. 
Disease Characteristics and Treatment History ..........................................................62 
8.1.8. 
ECOG Performance Status .........................................................................................62 
8.2. 
Efficacy Assessments .................................................................................................62 

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8.2.1. 
Tumor Imaging and Assessment of Disease ...............................................................62 
8.2.1.1. 
Initial Tumor Imaging and Eligibility Assessment During the Screening 
Period ..........................................................................................................................63 
8.2.1.2. 
Tumor Imaging During Study Drug Administration Period .......................................64 
8.2.1.3. 
Tumor Imaging During the Crossover Period ............................................................64 
8.2.1.4. 
Tumor Imaging During Disease Follow-up ................................................................64 
8.2.2. 
iRECIST Assessment of Disease ................................................................................64 
8.2.3. 
Health Economics .......................................................................................................65 
8.2.4. 
Health-Related Patient-Reported Outcomes ...............................................................65 
8.2.4.1. 
EuroQol-5D ................................................................................................................65 
8.2.4.2. 
European Organization for the Research and Treatment of Cancer Quality of 
Life Questionnaire ......................................................................................................65 
8.2.4.3. 
Quality of Life Questionnaire for Anal Cancer ..........................................................66 
8.3. 
Safety Assessments .....................................................................................................66 
8.3.1. 
Adverse Events ...........................................................................................................66 
8.3.2. 
Physical Examinations ................................................................................................67 
8.3.3. 
Vital Signs ..................................................................................................................67 
8.3.4. 
Electrocardiograms .....................................................................................................67 
8.3.5. 
Laboratory Assessments .............................................................................................68 
8.3.6. 
Pregnancy Testing ......................................................................................................70 
8.4. 
Pharmacokinetic and Antidrug Antibody Assessments ..............................................70 
8.5. 
Pharmacodynamic, Biomarker, and Translational Assessments ................................71 
8.5.1. 
Tumor Tissue Biopsies ...............................................................................................71 
8.5.2. 
Blood Sample Collection ............................................................................................71 
8.5.3. 
Stool Sampling............................................................................................................72 
8.6. 
Unscheduled Visits .....................................................................................................72 
8.7. 
Crossover Period .........................................................................................................72 
8.7.1. 
Crossover Criteria .......................................................................................................72 
8.8. 
End of Treatment and/or Early Termination ..............................................................73 
8.9. 
Follow-Up ...................................................................................................................73 
8.9.1. 
Safety (28-Day) Follow-Up ........................................................................................73 
8.9.2. 
Post-Treatment Disease Follow-Up ............................................................................74 
8.9.3. 
Survival Follow-Up ....................................................................................................74 

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9. 
ADVERSE EVENTS:  DEFINITIONS AND PROCEDURES FOR 
RECORDING, EVALUATING, FOLLOW-UP, AND REPORTING ......................75 
9.1. 
Definition of Adverse Event .......................................................................................75 
9.2. 
Definition of Serious Adverse Event ..........................................................................76 
9.3. 
Recording and Follow-Up of Adverse Events and/or Serious Adverse Events .........77 
9.4. 
Reporting of Serious Adverse Events .........................................................................79 
9.5. 
Emergency Unblinding of Study Drug Assignment ...................................................80 
9.6. 
Pregnancy ...................................................................................................................81 
9.7. 
Warnings and Precautions ..........................................................................................81 
9.8. 
Product Complaints ....................................................................................................82 
9.9. 
Treatment of Overdose of INCMGA00012 ................................................................82 
10. 
STATISTICS ..............................................................................................................83 
10.1. 
Sample Size Determination ........................................................................................83 
10.2. 
Populations for Analysis .............................................................................................83 
10.3. 
Level of Significance ..................................................................................................84 
10.4. 
Statistical Analyses .....................................................................................................84 
10.4.1. 
Efficacy Analyses .......................................................................................................84 
10.4.1.1. 
Primary Efficacy Analyses .........................................................................................84 
10.4.1.2. 
Key Secondary Efficacy Analyses ..............................................................................84 
10.4.1.3. 
Secondary Efficacy Analyses .....................................................................................85 
10.4.2. 
Safety Analyses ..........................................................................................................85 
10.4.2.1. 
Adverse Events ...........................................................................................................85 
10.4.2.2. 
Clinical Laboratory Tests ...........................................................................................85 
10.4.2.3. 
Vital Signs ..................................................................................................................86 
10.4.2.4. 
Electrocardiograms .....................................................................................................86 
10.4.2.5. 
Pharmacokinetics ........................................................................................................86 
10.4.3. 
Exploratory Analyses ..................................................................................................86 
10.4.3.1. 
 ........................................................................86 
10.4.3.2. 
 ........................................................................................86 
10.4.3.3. 
 .......................................................................................................87 
11. 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS ..................................................................................................87 
11.1. 
Investigator Responsibilities .......................................................................................87 

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11.1.1. 
Identification of the Coordinating Principal Investigator ...........................................89 
11.2. 
Data Management .......................................................................................................89 
11.3. 
Data Privacy and Confidentiality of Study Records ...................................................91 
11.4. 
Financial Disclosure ...................................................................................................91 
11.5. 
Publication Policy .......................................................................................................92 
11.6. 
Study and Site Closure................................................................................................92 
12. 
REFERENCES ...........................................................................................................94 
APPENDIX A. INFORMATION REGARDING EFFECTIVENESS OF 
CONTRACEPTIVE METHODS AND RELEVANT DEFINITIONS .....................99 
APPENDIX B. RESPONSE CRITERIA FOR SOLID TUMORS VERSION 1.1 ..................101 
APPENDIX C. ASSESSMENT OF TUMOR RESPONSE FOR IMMUNE-BASED 
THERAPEUTICS (IRECIST) ..................................................................................102 
APPENDIX D. COVID-19 PANDEMIC GUIDANCE ...........................................................103 
APPENDIX E. ADDITIONAL INFORMATION FOR HOSPITAL DISCHARGE 
FOR SITES IN JAPAN ............................................................................................107 
APPENDIX F. PROTOCOL AMENDMENT SUMMARY OF CHANGES ..........................108 
 

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LIST OF TABLES 
Table 1: 
Primary and Key Secondary Objectives and Endpoints .............................................14 
Table 2: 
Key Study Design Elements .......................................................................................15 
Table 3: 
Randomization Assignment ........................................................................................17 
Table 4: 
Schedule of Activities .................................................................................................18 
Table 5: 
Crossover Period Schedule of Activities ....................................................................26 
Table 6: 
Objectives and Endpoints ...........................................................................................35 
Table 7: 
Stratification Factors ...................................................................................................37 
Table 8: 
Exclusionary Laboratory Values ................................................................................41 
Table 9: 
Study Drug Information ..............................................................................................44 
Table 10: Guidelines for Management of Suspected Infusion Reactions for Study Drug ..........49 
Table 11: Suggested Dose Reduction for Paclitaxel and Carboplatin ........................................50 
Table 12: Dose Modifications of INCMGA00012 or Placebo and Toxicity 
Management Guidelines for Immune-Related Adverse Events .................................51 
Table 13: ECOG Performance Status .........................................................................................62 
Table 14: Required Laboratory Analytes ....................................................................................69 
Table 15: Pharmacokinetic and Antidrug Antibody Blood Sample Timing ...............................70 
Table 16: Populations for Analysis .............................................................................................83 
 
LIST OF FIGURES 
Figure 1: 
Study Design Schema .................................................................................................17 
 

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LIST OF ABBREVIATIONS 
Abbreviations and 
Special Terms 
Definition 
ADA 
antidrug antibody 
AE 
adverse event 
ALT 
alanine aminotransferase 
ANC 
absolute neutrophil count 
anti–HBc 
anti–hepatitis B core 
anti–HCV 
hepatitis C virus antibody 
aPTT 
activated partial thromboplastin time 
ART/HAART 
antiretroviral therapy/highly active antiretroviral therapy 
ASCO 
American Society of Clinical Oncology 
AST 
aspartate aminotransferase 
AUC 
area under the curve 
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 
AUS 
Australia 
BCG 
Bacillus Calmette–Guérin 
BICR 
blinded independent central radiographic review 
BSA 
body surface area 
CFR 
Code of Federal Regulations 
CI 
confidence interval 
CMH 
Cochran-Mantel-Haenszel 
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 
COVID-19 
coronavirus disease 2019 
CR 
complete response 
CrCl 
creatinine clearance 
CSF 
colony stimulating factor 
CSR 
Clinical Study Report 

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Abbreviations and 
Special Terms 
Definition 
CT 
computed tomography 
CTCAE 
Common Terminology Criteria for Adverse Events 
DCR 
disease control rate 
DDI 
drug-drug interaction 
DMC 
Data Monitoring Committee 
DNA 
deoxyribonucleic acid 
DOR 
duration of response 
ECG 
electrocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
eCRF 
electronic case report form 
EDC 
electronic data capture 
EEA 
European Economic Area 
EORTC-QLQ-C30 
European Organization for the Research and Treatment of Cancer Quality of 
Life Questionnaire 
EOT 
end of treatment 
EQ VAS 
EuroQol visual analogue scale 
EQ-5D 
EuroQol-5D 
ESMO 
European Society for Medical Oncology 
EU 
Europe Union 
FAS 
full analysis set 
FDA 
Food and Drug Administration 
FSH 
follicle-stimulating hormone 
FT3 
free triiodothyronine 
FT4 
free thyroxine 
FU 
fluorouracil 
GCP 
Good Clinical Practice 
GDPR 
General Data Protection Regulation 
HAV 
hepatitis A virus 
HBsAg 
hepatitis B surface antigen 
HBV 
hepatitis B virus 
HCV 
hepatitis C virus 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 

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Abbreviations and 
Special Terms 
Definition 
HIV 
human immunodeficiency virus 
HPV 
human papillomavirus 
HR 
hazard ratio 
HR-PRO 
health-related patient reported outcomes 
HRT 
hormone replacement therapy 
IB 
Investigator's Brochure 
ICD 
immunogenic cell death 
ICF 
informed consent form 
ICH 
International Council on Harmonisation of Technical Requirements for 
Registration of Pharmaceuticals for Human Use 
iCPD 
confirmed progressive disease per iRECIST 
IEC 
independent ethics committee 
IgG 
immunoglobulin G 
IgG4 
immunoglobulin G4 
IgM 
immunoglobulin M 
IHC 
immunohistochemistry 
INR 
international normalized ratio 
irAE 
immune-related adverse event 
IRB 
institutional review board 
iRECIST 
modified RECIST v1.1 for immune-based therapeutics 
IRT 
interactive response technology 
ITT 
intent-to-treat 
iUPD 
unconfirmed progressive disease per iRECIST 
IV 
intravenous(ly) 
IVRS 
interactive voice response system 
IWRS 
interactive web response system 
MedDRA 
Medical Dictionary for Regulatory Activities 
MRI 
magnetic resonance imaging 
MSI 
microsatellite instability status 
NA 
North America 
NCI 
National Cancer Institute 
NSAID 
nonsteroidal anti-inflammatory drug 

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Abbreviations and 
Special Terms 
Definition 
NSCLC 
non–small cell lung cancer 
ORR 
overall response rate 
ORR-CO 
overall response rate – Crossover Period 
OS 
overall survival 
PCR 
polymerase chain reaction 
PD 
progressive disease 
PD-1 
programmed cell death protein 1 
PD-L1 
programmed cell death-ligand 1 
PD-L2 
programmed cell death-ligand 2 
PET 
positron emission tomography 
PFS 
progression-free survival 
PFS2 
progression-free survival 2 
PK 
pharmacokinetic(s) 
PMDA 
Pharmaceuticals and Medical Devices Agency 
PO 
oral 
PR 
partial response 
PRO 
patient-reported outcome 
PT 
prothrombin time 
PTT 
partial thromboplastin time 
Q12W 
every 12 weeks 
Q2W 
every 2 weeks 
Q4W 
every 4 weeks 
Q8W 
every 8 weeks 
QLG 
Quality of Life Group 
QLQ-ANL27 
Quality of Life Questionnaire for Anal Cancer 
QoL 
quality of life 
RECIST 
Response Evaluation Criteria in Solid Tumors 
RNA 
ribonucleic acid 
ROW 
rest of world 
RSI 
Reference Safety Information 
RT-PCR 
reverse transcription-polymerase chain reaction 
SAE 
serious adverse event 

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Abbreviations and 
Special Terms 
Definition 
SARS-CoV-2 
severe acute respiratory syndrome coronavirus 2 
SCAC 
squamous cell carcinoma of the anal canal 
SD 
stable disease 
SJS 
Stevens-Johnson syndrome 
SoA 
schedule of activities 
SOC 
standard of care 
SOP 
standard operating procedure 
SUSAR 
suspected unexpected serious adverse reaction 
TEN 
toxic epidermal necrolysis 
T3 
triiodothyronine 
T4 
thyroxine 
TEAE 
treatment-emergent adverse event 
tmax 
time to maximum concentration 
TSH 
thyroid-stimulating hormone 
UK 
United Kingdom 
ULN 
upper limit of normal 
WOCBP 
women of childbearing potential 
WBC 
white blood cell 

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1. 
PROTOCOL SUMMARY 
Protocol Title:  A Phase 3 Global, Multicenter, Double-Blind Randomized Study of 
Carboplatin-Paclitaxel With INCMGA00012 or Placebo in Participants With Inoperable Locally 
Recurrent or Metastatic Squamous Cell Carcinoma of the Anal Canal Not Previously Treated 
With Systemic Chemotherapy (POD1UM-303/InterAACT 2) 
Protocol Number:  INCMGA 0012-303 
Objectives and Endpoints: 
Table 1 presents the primary and major/key secondary objectives and endpoints. 
Table 1: 
Primary and Key Secondary Objectives and Endpoints 
Objectives 
Endpoints 
Primary 
To compare the efficacy of carboplatin-paclitaxel 
with INCMGA00012 versus 
carboplatin-paclitaxel with placebo in 
participants with inoperable locally advanced or 
metastatic SCAC not previously treated with 
systemic chemotherapy. 
PFS, defined as the time from the date of 
randomization until disease progression according 
to RECIST v1.1 by BICR or death due to any 
cause. 
Key Secondary 
To compare the efficacy of carboplatin-paclitaxel 
with INCMGA00012 versus 
carboplatin-paclitaxel with placebo in 
participants with inoperable locally advanced or 
metastatic SCAC not previously treated with 
systemic chemotherapy. 
OS, defined as the time from the date of 
randomization until death due to any cause. 
Overall Design: 
Table 2 presents the key study design elements.  Further study details are presented after the 
table. 

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Table 2: 
Key Study Design Elements (Continued) 
Estimated Duration 
of Study 
Participation 
Up to 28 days for screening, study drug administration in consecutive 28-day 
cycles up to 
 cycles) as long as participants are receiving benefit and 
have not met any criteria for study drug discontinuation, INCMGA00012 
administration in consecutive 28-day cycles up to 
 cycles) during the 
Crossover Period for eligible participants, 28-day Safety Follow-Up, at least 
every  months during Disease Follow-Up, and at least every 
 weeks 
thereafter for Survival Follow-Up.  Follow-Up may occur through a phone 
call, email, or visit by the participant, as applicable. 
Participants will be followed until all participants have completed at least 
 cycles) of INCMGA00012 or placebo or have discontinued all 
assigned study drugs or have reached second disease progression. 
DMC 
Yes (external) 
Coordinating 
Principal 
Investigator 
 
Treatment Groups and Duration: 
Approximately 
 participants will be enrolled worldwide, and randomized 1:1 to a blinded 
study drug administration group (Group). 
Enrolled participants in each Group of this study will receive chemotherapy to up to 
 weeks 
(  cycles) of carboplatin 
 IV on Day 1 of each 28-day cycle and paclitaxel 
 mg/m2 IV on 
Days 
 of each 28-day cycle. 
INCMGA00012 
 mg or placebo will be administered via IV on Day 1 of each 28-day cycle 
(+/− 3 days) for up to 
 cycles) in the absence of unacceptable toxicity, disease 
progression, withdrawal of consent, loss to follow-up, or premature discontinuation for any other 
reason. 
Study periods will include Screening, Study Drug Administration, Crossover, and Follow-Up.  
The date of Cycle 1 Day 1 is the date of administration of the first dose of INCMGA00012 or 
placebo.  Enrolled participants will be assigned to Group A or Group B as summarized in 
Table 3. 

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Table 4: 
Schedule of Activities 
Visit Day (Range) 
Screening 
Study Drug Administration 
Follow-Up 
(If Not Continuing in Crossover) 
Notes 
28 Days 
Induction Cycles 
 
Postinduction 
Cycles 
 
 
(± 7 d) 
 
Safety 
Follow-Upb 
(+ 28 d) 
Disease 
Follow-Up 
Survival 
Follow-Up 
Day 1a 
 
(± 1 d) 
 
(± 1 d) 
Day 1 
(± 3 d) 
EOTb 
If Not  
Continuing 
in Crossover 
(+ 7 d) 
Administrative procedures 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
IRT 
X 
X 
 
 
X 
 
X 
 
 
 
 
Inclusion/ 
exclusion criteria 
X 
X* 
 
 
 
 
 
 
 
 
*C1D1 only 
General and disease 
medical history 
X 
 
 
 
 
 
 
 
 
 
 
Prior/concomitant 
medications 
X 
X 
X 
X 
X 
 
X 
X 
 
 
 
Distribution of 
participant 
identification card 
X 
 
 
 
 
 
 
 
 
 
 
ECOG performance 
status 
X 
X* 
 
 
X 
 
X 
 
 
 
*Does not have to be done at C1D1 if 
screening ECOG was performed within 
3 days before first dose of any study 
drug. 
Administer 
INCMGA00012 or 
placebo 
 
X 
 
 
X 
 
 
 
 
 
Premedication with an antipyretic 
(eg, acetaminophen/ paracetamol or 
equivalent) and a histamine blocker 
(eg, diphenhydramine or equivalent) 
should be considered for participants 
who have had previous systemic 
reactions to protein product infusions 
or when recommended by institutional 
policy. 

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Table 4: 
Schedule of Activities (Continued) 
Visit Day (Range) 
Screening 
Study Drug Administration 
Follow-Up 
(If Not Continuing in Crossover) 
Notes 
28 Days 
Induction Cycles 
 
Postinduction 
Cycles 
 
 
(± 7 d) 
 
Safety 
Follow-Upb 
(+ 28 d) 
Disease 
Follow-Up 
Survival 
Follow-Up 
Day 1a 
 
(± 1 d) 
 
(± 1 d) 
Day 1 
(± 3 d) 
EOTb 
If Not  
Continuing 
in Crossover 
(+ 7 d) 
Administrative procedures (continued) 
Administer 
paclitaxel 
 
X 
X 
X 
 
 
 
 
 
 
All participants should be 
premedicated with oral or IV steroid 
and antihistamines according to the 
approved label and/or standard 
practice.  Additional premedications 
should be administered as per standard 
practice. 
For participants known to be 
HIV-positive, consultations should 
occur prior to dosing and throughout 
the study to determine any potential 
DDIs and modification to anti-HIV 
medications, in particular protease 
inhibitors. 
Administer 
carboplatin 
 
X 
 
 
 
 
 
 
 
 
Before administration of carboplatin, 
participants should receive appropriate 
premedications based on institutional 
guidelines, investigator practice, local 
prescribing information, or standards 
of care. 
For participants known to be 
HIV-positive, consultations should 
occur prior to dosing and throughout 
the study to determine any potential 
DDIs and modification to anti-HIV 
medications, in particular protease 
inhibitors. 

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Table 4: 
Schedule of Activities (Continued) 
Visit Day (Range) 
Screening 
Study Drug Administration 
Follow-Up 
(If Not Continuing in Crossover) 
Notes 
28 Days 
Induction Cycles 
 
Postinduction 
Cycles 
 
 
(± 7 d) 
 
Safety 
Follow-Upb 
(+ 28 d) 
Disease 
Follow-Up 
Survival 
Follow-Up 
Day 1a 
 
(± 1 d) 
 
(± 1 d) 
Day 1 
(± 3 d) 
EOTb 
If Not  
Continuing 
in Crossover 
(+ 7 d) 
Safety assessments 
AE assessments 
X 
X 
X 
X 
X 
 
X 
X 
X* 
 
*Immune-related AEs to be collected 
for 90 days after the last dose of study 
drug, regardless of continuation of 
chemotherapy during induction cycles 
or start of a new anticancer therapy.  
Reasonable efforts should be made to 
align the first 12-week follow-up visit 
with the end of the 90-day irAE 
reporting period when appropriate. 
Physical 
examination 
X 
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 
 
X 
X 
 
 
Height at screening only. 
12-lead ECG 
X 
X* 
 
 
X* 
 
X** 
X** 
 
 
*Not necessary if screening assessment 
performed within 7 days of Cycle 1 
Day 1, unless clinical signs or 
symptoms are present; then at every 
fourth cycle (eg, screening/Day 1, 
). 
**Only at EOT if EOT and safety visit 
are performed separately. 

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Table 4: 
Schedule of Activities (Continued) 
Visit Day (Range) 
Screening 
Study Drug Administration 
Follow-Up 
(If Not Continuing in Crossover) 
Notes 
28 Days 
Induction Cycles 
 
Postinduction 
Cycles 
 
 
(± 7 d) 
 
Safety 
Follow-Upb 
(+ 28 d) 
Disease 
Follow-Up 
Survival 
Follow-Up 
Day 1a 
 
(± 1 d) 
 
(± 1 d) 
Day 1 
(± 3 d) 
EOTb 
If Not  
Continuing 
in Crossover 
(+ 7 d) 
Efficacy assessments 
Tumor 
imaging/response 
assessments 
X 
 
 
 
 
X* 
 
 
X*† 
 
*Imaging and response assessment 
should be performed every 8 weeks 
(56 days ± 7 days) during Study Drug 
Administration, Crossover, and/or 
Disease Follow-up regardless of any 
treatment delays, until second disease 
progression.  Complete response or PR 
should be confirmed by imaging at 
least 4 weeks after initial 
documentation. 
†Upon implementation of 
Amendment 3, imaging may be 
performed at intervals according to 
local institution standard practice (eg, 
every 3-4 months) but at least every 
6 months. 
HR-QoL 
assessments 
(HR-PRO 
assessments) 
 
X* 
 
 
 
X* 
X* 
X* 
 
 
When scheduled, participants are to 
complete the PRO assessments before 
meeting with medical professionals at 
site/imaging visits and before any 
study procedures are performed. 
*HR-PRO assessments will be 
performed at Cycle 1 and Cycle 2, then 
in alignment with imaging 
assessments, and at EOT or safety 
follow-up if EOT and safety follow-up 
visits are combined. 
New anticancer 
therapy status 
 
 
 
 
 
 
X 
X 
X 
X 
 
Survival status 
 
 
 
 
 
 
X 
X 
X 
X* 
*During survival follow-up, 
participants should be contacted by 
telephone, email, or visit at least every 
12 weeks. 

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Table 4: 
Schedule of Activities (Continued) 
Visit Day (Range) 
Screening 
Study Drug Administration 
Follow-Up 
(If Not Continuing in Crossover) 
Notes 
28 Days 
Induction Cycles 
 
Postinduction 
Cycles 
 
 
(± 7 d) 
 
Safety 
Follow-Upb 
(+ 28 d) 
Disease 
Follow-Up 
Survival 
Follow-Up 
Day 1a 
 
(± 1 d) 
 
(± 1 d) 
Day 1 
(± 3 d) 
EOTb 
If Not  
Continuing 
in Crossover 
(+ 7 d) 
Clinical laboratory assessments 
Blood chemistries 
X 
X* 
 
 
X 
 
X 
X 
 
 
*Not necessary on Cycle 1 Day 1 if 
performed during screening within 
7 days on Cycle 1 Day 1. 
Hematology 
X 
X* 
X 
X 
X 
 
X 
X 
 
 
*Not necessary on Cycle 1 Day 1 if 
performed during screening within 
7 days on Cycle 1 Day 1. 
Coagulation panel 
X 
 
 
 
 
 
X* 
X* 
 
 
*Only at EOT if EOT and safety visits 
are combined. 
Endocrine panel 
X 
X* 
 
 
X* 
 
X 
X 
 
 
*Every third cycle (ie, Cycles 
 
). 
Urinalysis 
X 
 
 
 
 
 
X* 
X* 
 
 
*At EOT if EOT and safety visits are 
combined. 
HIV management 
testing* 
(HIV viral load, 
CD4+ cell count) 
X 
 
 
 
 
X 
X 
X 
X 
 
*Only participants who are known to 
be HIV-positive. 
HIV management testing will occur 
Q8W during the study drug 
administration period.  Frequency of 
HIV management testing may be 
reduced to every 6 months during 
safety and disease follow-up. 

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Table 4: 
Schedule of Activities (Continued) 
Visit Day (Range) 
Screening 
Study Drug Administration 
Follow-Up 
(If Not Continuing in Crossover) 
Notes 
28 Days 
Induction Cycles 
 
Postinduction 
Cycles 
 
 
(± 7 d) 
 
Safety 
Follow-Upb 
(+ 28 d) 
Disease 
Follow-Up 
Survival 
Follow-Up 
Day 1a 
 
(± 1 d) 
 
(± 1 d) 
Day 1 
(± 3 d) 
EOTb 
If Not  
Continuing 
in Crossover 
(+ 7 d) 
Clinical laboratory assessments (continued) 
Pregnancy testing 
X 
X* 
 
 
X 
 
X** 
X** 
 
 
For WOCBP serum pregnancy test is 
performed at screening and safety 
follow-up; at other visits urine 
pregnancy testing is acceptable. 
*Not necessary if performed during 
screening within 7 days of C1D1. 
**Can be performed at either EOT  or 
safety follow-up visit through 120 days 
after the last dose of study drug or 
through 180 days after the last dose of 
chemotherapeutic agents, whichever 
occurs later (additional testing may be 
performed during the post-treatment 
follow-up period if recommended by the 
investigator, or required by local 
regulation, or local practice). 
Timing and type of testing may be 
adjusted based on country-specific 
requirements. 
Telephone/telehealth/video visits can be 
utilized to check pregnancy status (via 
testing, including home pregnancy tests) 
during the same period when 
contraception is mandatory. 
Sites in Germany:  This must be a 
serum test and performed on Day 1 of 
all cycles before administration of study 
treatment.  Required 1 time at 12 weeks 
post EOT for those in follow-up 
attending clinic visits. 

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Table 4: 
Schedule of Activities (Continued) 
Visit Day (Range) 
Screening 
Study Drug Administration 
Follow-Up 
(If Not Continuing in Crossover) 
Notes 
28 Days 
Induction Cycles 
 
Postinduction 
Cycles 
 
 
(± 7 d) 
 
Safety 
Follow-Upb 
(+ 28 d) 
Disease 
Follow-Up 
Survival 
Follow-Up 
Day 1a 
 
(± 1 d) 
 
(± 1 d) 
Day 1 
(± 3 d) 
EOTb 
If Not  
Continuing 
in Crossover 
(+ 7 d) 
Pharmacokinetic and translational laboratory assessments (central testing) 
PK 
 
X 
 
 
X 
 
 
 
 
 
Samples will be collected preinfusion 
on Day 1 of Cycles 
 
 
Samples are collected immediately 
after infusion (+ 10 min) on Day 1 of 
Cycles 
  There is a 2-hour 
window for the preinfusion collection 
at Cycle 1 Day 1 and a 24-hour 
window at the other visits. 
Detailed PK sampling is provided in 
Table 15. 
ADA 
 
X 
 
 
X 
 
 
 
 
 
Samples will be collected preinfusion 
on Day 1 of Cycles 
 
 
There is a 2-hour window for the 
preinfusion collection at Cycle 1 Day 1 
and a 24-hour window at the other 
visits. 
Detailed ADA sampling is provided in 
Table 15. 
Tumor sampling 
Tumor tissue sample 
collection 
X 
 
 
 
 
 
 
 
 
 
Fresh or archival sample is mandatory 
for stratification/randomization.  
Biopsy for archival samples should 
have occurred within 9 months before 
randomization. 

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Table 5: 
Crossover Period Schedule of Activities 
Visit Day (Range) 
Crossover 
Period 
Screening 
Study Drug Administration 
Follow-Up 
Notes 
28 Days 
Cycle 1 Cycles 2-
 
 
(± 7 d) 
 
(± 7 d) 
 
Safety 
(+ 28 d) 
Follow-Upb 
Disease 
Follow-Up 
Survival 
Follow-Up 
Day 1a 
Day 1 
(± 3 d) 
EOTb 
(+ 7 d) 
Administrative procedures 
IRT 
X 
X 
X 
 
 
X 
 
 
 
 
Inclusion/exclusion 
criteria 
X 
X 
 
 
 
 
 
 
 
 
Prior/concomitant 
medications 
X 
X 
X 
 
 
X 
X 
 
 
 
ECOG 
performance status 
X* 
X** 
X 
 
 
X 
 
 
 
*ECOG for screening is to be performed 
within 10 days before the first dose of 
study drug. 
**Does not have to be done at crossover 
C1D1 if screening ECOG was performed 
within 3 days before this visit. 
Administer 
INCMGA00012 
 
X 
X 
 
 
 
 
 
 
Premedication with an antipyretic 
(eg, acetaminophen/ paracetamol or 
equivalent) and a histamine blocker 
(eg, diphenhydramine or equivalent) 
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 
X* 
 
*Immune-related AEs to be collected for 
90 days after the last dose of 
INCMGA00012 regardless of start of a 
new anticancer therapy.  Reasonable 
efforts should be made to align the first 
12-week follow-up visit with the end of 
the 90-day irAE reporting period when 
appropriate. 
Physical 
examination 
X 
X 
X 
 
 
X 
X 
 
 
A comprehensive examination is 
performed at crossover period screening 
and at EOT.  All other scheduled 
examinations will be targeted. 
Vital signs/body 
weight 
X 
X 
X 
 
 
X 
X 
 
 
Height is not required to be collected 
during Crossover. 

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Table 5: 
Crossover Period Schedule of Activities (Continued) 
Visit Day (Range) 
Crossover 
Period 
Screening 
Study Drug Administration 
Follow-Up 
Notes 
28 Days 
Cycle 1 Cycles 2-
 
 
(± 7 d) 
 
(± 7 d) 
 
Safety 
(+ 28 d) 
Follow-Upb 
Disease 
Follow-Up 
Survival 
Follow-Up 
Day 1a 
Day 1 
(± 3 d) 
EOTb 
(+ 7 d) 
Safety assessments (continued) 
12-lead ECG 
X 
X* 
X* 
 
 
X** 
X** 
 
 
*Not necessary if crossover screening 
assessment is performed within 28 days of 
Cycle 1 Day 1 of the crossover period, 
unless clinical signs or symptoms are 
present; then at every fourth cycle (eg, 
screening/Day 1, 
 
). 
**Only at EOT if EOT and safety visit are 
performed separately. 
Efficacy assessments 
Tumor 
imaging/response 
assessments 
X* 
 
 
X** 
 
 
 
X**† 
 
*Imaging must be performed within 
28 days before starting treatment with the 
first cycle of INCMGA00012 monotherapy 
in the crossover period.  There must not be 
more than 12 weeks (+ 7 days) between the 
last imaging assessment during the main 
study that confirmed PD as verified by 
central imaging vendor and first scan in the 
crossover period. 
**Once INCMGA00012 is received in the 
crossover period, tumor response by the 
investigator's assessment is required every 
8 weeks (56 days ± 7 days) regardless of 
any treatment delays, until second disease 
progression (see Section 8.2.1.3). Imaging 
will be rebaselined prior to the participant 
beginning another anticancer therapy, 
including INCMGA00012 in the Crossover 
period. 
†Upon implementation of Amendment 3, 
imaging may be performed at intervals 
according to local institution standard 
practice (eg, every 3-4 months) but at least 
every 6 months. (see Section 8.2.1.4).  

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Table 5: 
Crossover Period Schedule of Activities (Continued) 
Visit Day (Range) 
Crossover 
Period 
Screening 
Study Drug Administration 
Follow-Up 
Notes 
28 Days 
Cycle 1 Cycles 2-
 
 
(± 7 d) 
 
(± 7 d) 
 
Safety 
(+ 28 d) 
Follow-Upb 
Disease 
Follow-Up 
Survival 
Follow-Up 
Day 1a 
Day 1 
(± 3 d) 
EOTb 
(+ 7 d) 
Efficacy assessments (continued) 
Post study 
anticancer therapy 
status 
 
 
 
 
 
X 
X 
X 
X 
 
Survival status 
X 
X 
X 
 
X 
X 
X 
X 
X* 
*During survival follow-up, participants 
should be contacted by telephone, email, 
or visit at least every 12 weeks. 
Clinical laboratory assessments 
Blood chemistries 
X* 
 
X 
 
 
 
X 
 
 
*To be performed within 10 days before 
the first dose of INCMGA00012 in the 
crossover period. 
Hematology 
X* 
 
X 
 
 
 
X 
 
 
*To be performed within 10 days before 
the first dose of INCMGA00012 in the 
crossover period. 
Coagulation panel 
X 
 
 
 
 
 
 
 
 
*To be repeated as clinically indicated. 
Endocrine panel 
X 
X 
X* 
 
 
 
X 
 
 
*Every third cycle (ie, Cycles 
 
). 
Urinalysis 
X 
 
 
 
 
X* 
X* 
 
 
*At EOT if EOT and safety visits are 
combined. 
HIV management 
testing 
(HIV viral load, 
CD4+ cell count) 
X* 
 
X* 
 
 
X 
X** 
X** 
 
Only participants who are known to be 
HIV-positive. 
*HIV management testing will occur 
Q8W during the crossover period.  Does 
not need to be performed during 
crossover screening visit if performed in 
the prior 8 weeks. 
**Frequency of HIV management testing 
may be reduced to every 6 months during 
safety and disease follow-up. 

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Table 5: 
Crossover Period Schedule of Activities (Continued) 
Visit Day (Range) 
Crossover 
Period 
Screening 
Study Drug Administration 
Follow-Up 
Notes 
28 Days 
Cycle 1 Cycles 2-
 
 
(± 7 d) 
 
(± 7 d) 
 
Safety 
(+ 28 d) 
Follow-Upb 
Disease 
Follow-Up 
Survival 
Follow-Up 
Day 1a 
Day 1 
(± 3 d) 
EOTb 
(+ 7 d) 
Clinical laboratory assessments (continued) 
Pregnancy testing 
X 
X* 
X 
 
 
X** 
X** 
 
 
*Not necessary on crossover period if 
performed during crossover period 
screening within 7 days on crossover 
period C1D1. 
**Can be performed at either EOT visit 
or safety follow-up visit through 
120 days after the last dose of study drug 
or through 180 days after the last dose of 
chemotherapeutic agents, whichever 
occurs later (additional testing may be 
performed during the post-treatment 
follow-up period if recommended by the 
investigator, or required by local 
regulation, or local practice). 
Timing and type of testing may be 
adjusted based on country-specific 
requirements. 
Telephone/telehealth/video visits can be 
utilized to check pregnancy status (via 
testing, including home pregnancy tests) 
during the same period when 
contraception is mandatory. 
Sites in Germany:  This must be a serum 
test and performed on Day 1 of all cycles 
before administration of study drug.  
Required 1 time at 12 weeks post EOT 
for those in follow-up attending clinic 
visits. 
a Cycle 1 Day 1 of the crossover period is the date when the first dose of INCMGA00012 is administered during the Crossover Period. 
b The EOT and 28-day safety follow-up visit may be combined if necessary provided all assessments for both visits are completed. 

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2. 
INTRODUCTION 
2.1. 
Background and Study Rationale 
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.  The 
InterAACT study (NCT02051868, NCCN 2019a) has established carboplatin with weekly 
paclitaxel as the cytotoxic platform for future combination trials.  Compared to the old standard 
of 5-FU with platinum, carboplatin with weekly paclitaxel demonstrated less toxicity while 
improving OS (median OS 20 months vs 12.3 months; Rao et al 2018). 
Immunotherapy is a promising new approach to treatment of metastatic SCAC.  Pembrolizumab 
has recently been shown to have activity in a cohort of participants with progression or 
intolerance to prior therapy for unresectable or metastatic disease (Marabelle et al 2020).  The 
RECIST response rate in this trial was 10.7% (14.7% in participants with PD-L1+ tumors).  
These responses were durable (range 6.0+ to 33.9+ months), which should predict for important 
clinical benefit, as has previously been noted with immunotherapy for other HPV-associated 
malignancies (ie, cervical or squamous head and neck cancer).  In a smaller study of nivolumab, 
the ORR in treatment-refractory SCAC was 24% (95% CI:  15, 33; Morris et al 2017).  Among 
the 37 participants enrolled, there were 2 complete responses and seven partial responses, and 
most of these responses were durable.  A pilot study of pembrolizumab in PD-L1+ SCAC 
(N = 24) also showed a similar ORR of 17% (Ott et al 2017). 
Participants 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). 
INCMGA00012 is a humanized, hinge-stabilized, IgG4κ monoclonal antibody that recognizes 
human PD-1.  INCMGA00012 contains a human IgG4 Fc domain to limit effector function 
while retaining neonatal Fc receptor binding to extend circulating half-life.  INCMGA00012 is 
designed to target PD-1–expressing cells, including T cells, and to sustain/restore their effector 
function by blocking checkpoint inhibitory interactions between PD-1 and its 2 ligands, PD-L1 
and PD-L2.  INCMGA00012 is being studied in patients with advanced cancer.  As of 
23 SEP 2019, 382 participants have been treated with INCMGA00012 in clinical studies.  
Recommended phase 2 doses have been established for both Q3W and Q4W flat dosing 
schedules.  The clinical pharmacology and safety profile are as expected for the PD-(L)1 
inhibitor class, and preliminary efficacy has been demonstrated against a variety of solid tumor 
types (Chen et al 2019, Condamine et al 2019, Lakhani et al 2017, Mehnert et al 2018, 
Mehnert et al 2019).  INCMGA00012 is currently being studied as monotherapy in the setting of 
locally advanced or metastatic SCAC following progression on platinum-based chemotherapy 
(POD1UM-202; NCT03597295).  Preliminary safety and efficacy are promising in this 
difficult-to-treat population and support further testing in this Phase 3 study (Rao et al 2019).  
Further details are provided in the current INCMGA00012 IB. 

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Accumulating evidence indicates that the efficacy of conventional and targeted anticancer agents 
does not only involve direct cytostatic/cytotoxic effects, but also relies on the (re)activation of 
tumor-targeting immune responses.  While chemotherapy has largely been thought to be 
immunosuppressive and exert its effect via direct cytotoxicity, there is an emerging body of 
evidence to suggest that some chemotherapies may influence an immune response to tumors via 
induction of ICD, elimination of immunosuppressive cells, or sensitization of tumor cells to 
immune effector cells (Apetoh et al 2015).  Some standard chemotherapy agents can impact both 
the tumor and host immune system, which provides strong rationale for their combination with 
selective immunotherapeutic interventions (Bracci et al 2014, Hato et al 2014); especially in 
patients for whom these chemotherapies are the accepted standard of care.  In particular, 
platinum agents have demonstrated immunogenic effects via ICD and enhancement of effector 
immune response through PD-L1 receptor expression (Hato et al 2014).  Paclitaxel has also been 
shown to restore antitumor activity of CD8+ T cells (Sevko et al 2013). 
Experience with combinations of platinum-based chemotherapy and PD-(L)1 inhibitors in other 
tumors has been good.  Safety at full dosing has been manageable (Gamerith et al 2018, 
Zhou et al 2018).  Major improvements in PFS and OS have been demonstrated over standard of 
care chemotherapy in NSCLC (Gandhi et al 2018, Gentzler et al 2018, Jotte et al 2018, 
Langer et al 2016, Socinski et al 2018), breast cancer (Schmid et al 2018), squamous cell 
carcinoma of the head and neck (Burtness et al 2018), urothelial carcinoma (Grande et al 2019), 
small cell lung cancer (Horn et al 2018), and gastric cancer (Tabernero et al 2019).  Based on the 
above evidence, this study has been designed to demonstrate the benefit of adding a PD-1 
inhibitor (INCMGA00012) to standard of care chemotherapy in the setting of advanced or 
metastatic SCAC. 
2.1.1. 
Rationale for Fixed Doses of INCMGA00012 
INCMGA00012 will be administered at 
 mg Q4W.  The selection of this dose was based on 
modeling of clinical PK data from the first-in-human monotherapy study, INCMGA 0012-101 
(NCT03059823), in which 37 participants were treated at doses of  mg/kg Q2W,  mg/kg Q2W, 
 mg/kg Q4W, 
 mg/kg Q2W, and 
 mg/kg Q4W. 
A simulation was conducted to investigate the use of weight-based and fixed doses for 
INCMGA00012 with the aim of targeting a steady-state trough concentration of approximately 
 μg/mL, which is the median trough concentration for pembrolizumab  mg/kg Q3W 
(Freshwater et al 2017).  The median INCMGA00012 exposure and distribution around the 
median at 
 mg Q4W were similar to  mg/kg Q4W in the simulated population, which 
justified clinical exploration in an expansion cohort of the INCMGA 0012-101 study. 
Pharmacokinetic data were obtained from 15 participants who received INCMGA00012 
 mg 
Q4W in Study INCMGA 0012-101.  The observed AUC0-∞ for 
 mg Q4W is close to the 
steady-state AUC0-t based on the population PK analysis of weight-based doses, as is the 
estimated clearance.  The estimated apparent terminal-phase disposition half-life (333 hours) is 
slightly shorter than the previous estimate of 
 hours.  The mean trough plasma concentration 
at Cycle 2 was 
 μg/mL, and the mean projected plasma Cmin,ss was 
 μg/mL with a mean 
accumulation index of 
  In addition, the 
 mg Q4W dose has approximately a 58% 
probability to obtain a steady-state trough plasma concentration ≥ 
 µg/mL, which is associated 
with maximum target engagement and greatest probability of efficacy, based on pembrolizumab 

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data (Chen et al 2019).  Based on these observations, 
 mg Q4W was chosen as the dose 
regimen. 
2.1.2. 
Justification for Study Drug Dose 
The dosing regimen of paclitaxel and carboplatin will be identical to the regimen established as 
the new standard of care by the InterAACT study and participants will receive up to  cycles of 
chemotherapy, corresponding to the median exposure in that trial.  Compared to the old standard 
of 5-FU with platinum, carboplatin with weekly paclitaxel demonstrated improved survival with 
less toxicity (Rao et al 2018).  The Q4W recommended Phase 2 dose of INCMGA00012, or 
placebo, will be administered in combination with carboplatin and paclitaxel in order to align 
with the Q4W chemotherapy cycles.  Based on extensive previous experience with other 
PD-(L)1 inhibitor chemotherapy combinations full dose combinations are feasible 
(Borghaei et al 2018, Borghaei et al 2019, Gandhi et al 2018, Jotte et al 2018, Paz-Ares et al 
2018, Socinski et al 2018); however, an early DMC safety review is planned as a prudent 
precautionary measure (see Section 5.5). 
2.2. 
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 (Marabelle et al 2020, 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 HIV infection. 
No interactions are expected between INCMGA00012 or placebo and standard antiretroviral 
medications (ART/HAART) used in HIV treatment and suppression.  In ongoing trials of 
INCMGA0012 that include participants known to be HIV-positive (POD1UM-202, 
POD1UM-201 NCT03599713), no drug interactions were observed, and no opportunistic 
infections or unexpected immune-related adverse events were reported (see INCMGA00012 IB).  
Despite the potential for DDIs and overlapping toxicities between HIV therapy and the 
chemotherapy regimen, select antiretrovirals can be safely coadministered with chemotherapy.  
HIV viral control has also been well-maintained in trials of INCMGA00012 (POD1UM-202) and 
in SCAC patients who received the carboplatin/paclitaxel regimen under study (Rao et al 2020).  
Participants should remain under the care of the specialist managing their HIV care, and the 
proposed therapy and ART/HAART for potential DDIs should be reviewed.  Local product 
labeling should be consulted for additional information as well, and local guidance should be 
followed in management of these participants (NCCN 2019b). 
Programmed cell death protein 1 inhibitors have proven efficacy against a wide variety of cancer 
types and the available preclinical and clinical data suggest that the pharmacologic activity of 
INCMGA00012 should be consistent with experience with other drugs in this class. 
Combining potentially immunomodulatory agents (ie, cytotoxic chemotherapy) to overcome 
drug resistance is an established therapeutic strategy that has proven clinically meaningful 
efficacy with a well-characterized tolerability profile.  The combination selected for this study 
represents an appropriate standard of care chemotherapy regimen and the dose of 
INCMGA00012 is supported by substantial preclinical and clinical experience.  Combinations of 
chemotherapy with other PD-(L)1 inhibitors have been extensively studied and safety is both 

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acceptable and manageable.  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 with appropriate guidance provided to investigators for their 
assessment and management.  In addition, a DMC will be formed to monitor safety and efficacy 
in this study, with an early safety look planned once the first 30 participants have completed a 
cycle of treatment. 
More detailed information about the known and expected benefits and risks and reasonably 
expected AEs of INCMGA00012 or each chemotherapy agent may be found in the 
INCMGA00012 IB and the local product labeling for each chemotherapy agent, respectively. 
Overall, the sponsor considers that this study will be conducted in a population with a potential 
clinical benefit and with an acceptable risk profile. 
2.2.1. 
Benefit/Risk Assessment During the COVID-19 Pandemic 
In 2020, ESMO and others highlighted the importance of clinical cancer research with 
immunotherapy or treatment with immunotherapy for patients with advanced cancer even during 
the unexpected COVID-19 pandemic, including potential investigational therapies similar to 
immunotherapy with a known survival benefit (Curigliano et al 2020).  Real-world data have 
indicated that the use of immunotherapy either alone or in combination with chemotherapy does 
not increase the risk of hospitalization upon SARS-CoV-2 infection (Horn et al 2020, 
Malek et al 2021, Ribas et al 2021) or cause an increased risk of mortality (Cohn et al 2021, 
Lee et al 2020, Ribas et al 2021, Sharafeldin et al 2021, Tenforde et al 2021).  While many 
efforts continue to be made to avoid becoming infected with SARS-CoV-2 (eg, proper social 
distancing, avoid unnecessary traveling) it is not always completely possible to avoid the 
infection; however, immunotherapy does not more negatively affect patients with cancer who are 
SARS-CoV-2–positive than those who test negative for SARS-CoV-2. 
In a recent observational prospective study, Mandala et al (2021) screened 293 patients with 
cancer for SARS-CoV-2 and further identified patients who were treated with immunotherapy 
and compared them with patients with the same cancer subtypes treated with targeted therapy or 
chemotherapy.  Cancer subtypes included melanoma, NSCLC, renal cell carcinoma, and other.  
Mortality of SARS-CoV-2–positive patients was statistically significantly higher compared with 
SARS-CoV-2–negative patients (8/89 vs 3/204, respectively, p = 0.004).  All deaths were due to 
COVID-19.  The incidence of SAEs in SARS-CoV-2–positive compared with SARS-CoV-2–
negative patients was similar in patients treated with immunotherapy and chemotherapy (17.3% 
and 3.7% respectively for positive and negative patients treated with immunotherapy and 15.4% 
and 2.7% respectively for those  treated with chemotherapy; Breslow-Day test p = 0.891).  
Serious AEs were COVID-19–related rather than treatment–related, confirming previous studies 
that treatment with immune checkpoint inhibitors does not significantly increase the risk of 
SAEs compared with chemotherapy (Mandala et al 2021).  Vaccinated patients with cancer 
living in areas of high SARS-CoV-2 infectivity may still contract COVID-19 but generally 
develop less severe disease and are less frequently hospitalized (Cohn et al 2021, Tenforde et al 
2021).  The prevention of severe COVID-19 is particularly important considering that patients 
with cancer are already immunocompromised, which puts them at risk for infections and 
opportunistic complications due to treatment.  A diagnosis of SARS-CoV-2 infection may also 
delay critical cancer treatment or cause the patient not to receive the full course of therapy. 

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The availability of approved vaccines have provided an increased chance for patients with 
advanced cancer to be protected from or have less severe cases of COVID-19 (Cohn et al 2021, 
Malek et al 2021, Ribas et al 2021, Sharafeldin et al 2021, Tenforde et al 2021).  Aligned with 
the published data and recommendations from many international oncology societies, such as 
ASCO, SITC, ESMO, NCCN, and AACR, the sponsor requires that potential participants are 
vaccinated before entering the study or become fully vaccinated during the trial.  This protocol 
inclusion requirement, in parallel with globally and publicly known principles to increase 
vaccination rates, is to minimize deaths related to COVID-19 and prevent severe cases of 
COVID-19 (ASCO 2021, ESMO 2021, Malek et al 2021, NCCN 2021b, Ribas et al 2021, 
SITC 2021). 
Further, the sponsor has implemented guidance for participation in the study in the context of the 
COVID-19 pandemic and study-treatment management in the event of SARS-CoV-2 infection 
(see Appendix D).  During the COVID-19 pandemic, unknown additional risks to participants 
may exist either related to going to a health care facility or as a result of study-related activities.  
The investigators need to frequently assess the participant's available medical data 
(eg, performance status, past medical history, comorbidities) at screening coupled with the need 
to conduct the needed primary endpoint trial procedures, in order to determine whether it is in 
best interests of the potential participant to enroll and participate into the study during peaks and 
troughs of the COVID-19 pandemic.  Consented participants who are suspected of being exposed 
to SARS-CoV-2 or have symptoms will undergo COVID-19 testing to demonstrate recovery 
prior to randomization. 
Due to the dynamic changes of the COVID-19 pandemic, evolving country-specific requirements 
may be followed with regard to COVID-19 testing frequency.  As per the investigator's clinical 
judgment and/or local practices to diagnose and treat potential SARS-CoV-2 infections, 
participants may have additional COVID-19 testing performed.  Participants will be monitored 
with safety procedures as described in Section 8 and with additional safety assessments as per 
standard of care.  Information regarding the flexibility of assessment/visit scheduling, where 
possible and warranted, and the strategy for participant management during the dynamic 
pandemic is described in Appendix D. 

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3. 
OBJECTIVES AND ENDPOINTS 
Table 6 presents the objectives and endpoints. 
Table 6: 
Objectives and Endpoints 
Objectives 
Endpoints 
Primary 
To compare the efficacy of carboplatin-paclitaxel 
with INCMGA00012 versus 
carboplatin-paclitaxel with placebo in participants 
with inoperable locally advanced or metastatic 
SCAC not previously treated with systemic 
chemotherapy. 
PFS, defined as the time from the date of 
randomization until disease progression according 
to RECIST v1.1 by BICR or death due to any 
cause. 
Key Secondary 
To compare the efficacy of carboplatin-paclitaxel 
with INCMGA00012 versus 
carboplatin-paclitaxel with placebo in participants 
with inoperable locally advanced or metastatic 
SCAC not previously treated with systemic 
chemotherapy. 
OS, defined as the time from the date of 
randomization until death due to any cause. 
Secondary 
To determine additional measures of clinical 
benefit. 
ORR, defined as the percentage of participants 
having a CR or PR, according to RECIST v1.1 as 
determined by BICR. 
DOR, defined as the time from the first 
documented response (CR or PR) according to 
RECIST v1.1 until disease progression as 
determined by BICR or death due to any cause. 
DCR, defined as the number of participants 
maintaining either an ORR or stable disease 
according to RECIST v1.1 as determined by 
BICR. 
To evaluate the safety of carboplatin-paclitaxel 
with INCMGA00012 or placebo in participants 
with SCAC not previously treated with systemic 
chemotherapy. 
Number of participants experiencing AEs and 
number of participants discontinuing study drug 
due to AEs. 
To determine the PK of INCMGA00012 when 
administered with carboplatin-paclitaxel to 
participants with SCAC not previously treated 
with systemic chemotherapy. 
Population PK, including Cmax, tmax, Cmin, and 
AUC0-t, will be summarized. 

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Table 6: 
Objectives and Endpoints (Continued) 
Objectives 
Endpoints 
Exploratory 

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4. 
STUDY DESIGN 
4.1. 
Overall Design 
This study is a Phase 3 global, multicenter, placebo-controlled double-blind randomized study 
that will enroll participants with inoperable locally recurrent or metastatic SCAC not previously 
treated with systemic chemotherapy.  Participants with well-controlled HIV infection will be 
eligible.  Participants will receive up to  induction cycles (
 weeks) of carboplatin (
 on 
Day 1) and paclitaxel (
 mg/m2 on Days 
 concurrently with INCMGA00012 or 
placebo.  INCMGA00012 
 mg Q4W or placebo will be administered for up to 
 cycles 
(
) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, 
lost to follow-up, or premature discontinuation of all assigned study drug administration or for 
any other reason.  Randomization to INCMGA00012 or placebo will be 1:1 and blinded.  
Stratification factors are presented in Table 7.  For the stratification category of PD-L1 status, 
participants with tumor results of PD-L1 negative and nonevaluable are grouped in the PD-L1 
< 1% stratum.  Participants with nonevaluable tumors for PD-L1 status will be capped at 10% of 
total population. 
Table 7: 
Stratification Factors 
Stratification Factory Category 
Stratum 
PD-L1 expression 
< 1%, ≥ 1% 
Extent of disease 
Locally recurrent, metastatic 
Region 
AUS/EU/NA/UK, ROW 
The study consists of 4 periods:  Screening, Study Drug Administration, Crossover, and 
Follow-Up.  The date of Cycle 1 Day 1 is the date of administration of the first dose of 
INCMGA00012 or placebo. 
INCMGA00012 or placebo will be administered by IV infusion of 
 minutes (-5/+15 minutes) 
prior to the scheduled chemotherapy on Day 1 of each 28-day cycle (+/- 3 days). 
In the event that chemotherapy must be discontinued for toxicity, INCMGA00012 or placebo 
should be continued if the participant is able to tolerate INCMGA00012 or placebo.  Similarly, 
chemotherapy should be continued, if able, when INCMGA00012 or placebo is stopped for 
unacceptable toxicity (see Section 6.5). 
Crossover will be allowed for participants who received placebo in combination with 
chemotherapy, following BICR verification of disease progression (see Section 8.7). 
Once participants complete or discontinue administration of all assigned study drugs in the Study 
Drug Administration Period, they enter the Crossover or Follow-Up Period as applicable and 
continue disease assessments until the second disease progression.  Upon second disease 
progression, participants will be followed for safety and/or survival as applicable until 
withdrawal of consent, lost to follow-up, the end of the study, or death. 
Immune-related AEs will be collected for 90 days after the last dose of INCMGA00012 or 
placebo, regardless of continuation of chemotherapy during induction cycles or start of a new 
anticancer therapy. 

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4.2. 
Overall Study Duration 
The study begins when the first participant signs the ICF.  The end of the study is defined as the 
last visit of the last participant that is required for OS analyses. If at the time of the final OS 
analyses there are still participants being treated with INCMGA00012, the participants may 
continue treatment at the discretion of the investigator if they are deriving benefit, and the study 
will end after last participant treated completes safety follow-up. 
Eligible participants who demonstrate clinical benefit with INCMGA00012 may be considered 
for poststudy drug provisions allowing them to continue receiving INCMGA00012 until a 
suitable alternative treatment option is identified. Poststudy drug provision at study closure will 
be in accordance with local laws and regulations. 
In the EU/EEA, the results of the study will be based on the date of the last visit of the last 
participant in the study globally to ensure the results are robust, meaningful, and representative 
of all multi-regions by having complete follow-up data determined by the statistical hypotheses 
for the objectives established.  Not using the global date could potentially jeopardize the trial 
integrity and invalidate the trial conclusions due to potential bias, thus potentially violating the 
statistical analysis assumptions described in Section 10. 
Participants will be followed until all participants have completed 
 of 
administration of INCMGA00012 or placebo, have discontinued all assigned study drugs, or 
have experienced second disease progression or conditions above are met. A participant is 
considered to have completed the study if he/she has completed all periods of the study including 
Survival Follow-Up. 
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/head of the study site (Japan) 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, for example, required by regulatory decision 
or upon advice of the DMC.  If the study is terminated prematurely, the sponsor will notify the 
investigators/head of the study site (Japan), the IRBs and IECs, and the regulatory bodies of the 
decision and reason for termination of the study.  Reduced data collection activities and 
procedures as per standard of care for the remaining participants on study drug may be 
performed for participants who wish to remain on-study if they derive clinical benefit as per 
investigator.  The DMC will recommend termination of the study if warranted, as described in 
Section 5.5.  For Japan, the decision from the sponsor will be via the head of the study site(s) 
who will notify the investigators and the IRBs of the decision and the reason for termination of 
the study. 
In addition, further recruitment in the study or at a particular study site may be stopped due to 
insufficient compliance with the Protocol, GCP and/or other applicable regulatory requirements, 
procedure-related problems, or the number of discontinuations for administrative reasons is too 
high. 

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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. Able to comprehend and willing to sign a written ICF for the study. 
2. Are 18 years of age or older (or as applicable per local country requirements). 
3. Histologically or cytologically verified, inoperable locally recurrent or metastatic SCAC. 
4. No prior systemic therapy other than the following: 
a. Chemotherapy administered concomitantly with radiotherapy as a radiosensitizing 
agent is permitted. 
b. Prior neoadjuvant or adjuvant therapy if completed ≥ 6 months before study entry. 
5. Has measurable disease per RECIST v1.1 as determined by local site 
investigator/radiology assessment, and after any tissue collected during biopsy.  Tumor 
lesions situated in a previously irradiated area, or in an area subjected to other 
loco-regional therapy, are usually not considered measurable unless there has been 
demonstrated progression in the lesion. 
6. Able and willing to provide adequate tissue sample and whole blood sample with central 
testing result prior to randomization.  Biopsy for archival samples should have occurred 
within 9 months prior to randomization. 
7. ECOG performance status 0 to 1. 
8. If HIV-positive, then must be stable as defined by: 
a. CD4+ count ≥ 200/μL, 
b. Undetectable viral load per standard of care assay, 
c. Receiving antiretroviral therapy (ART/HAART) for at least 4 weeks prior to study 
enrollment, and have not experienced any HIV-related opportunistic infection for at 
least 4 weeks prior to study enrollment. 

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9. 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 120 days after the last dose of 
INCMGA00012 or placebo or through 180 days after the last dose of 
chemotherapeutic agents, whichever occurs later (or longer as appropriate based on 
country-specific requirements) and must refrain from donating sperm during this 
period.  Permitted methods that are at least 99% effective in preventing pregnancy 
(see Appendix A) should be communicated to the participants and their understanding 
confirmed. 
b. Women of childbearing potential must have a negative serum pregnancy test at 
screening, agree to take appropriate precautions to avoid pregnancy (with at least 
99% certainty), and refrain from donating oocytes from screening through 120 days 
after the last dose of INCMGA00012 or placebo or through 180 days after the last 
dose of chemotherapeutic agents, whichever occurs later.  Permitted methods that are 
at least 99% effective in preventing pregnancy (see Appendix A) should be 
communicated to the participants and their understanding confirmed.  The definition 
of WOCBP is located in Appendix A. 
c. Women of nonchildbearing potential (ie, as per Appendix A) are eligible. 
10. Removed during Protocol Amendment 2. 
5.2. 
Exclusion Criteria 
Participants are excluded from the study if any of the following criteria apply: 
1. Has received prior PD-(L)1 directed therapy 
2. Has received prior radiotherapy with or without radiosensitizing chemotherapy within 
28 days of Cycle 1 Day 1; or 14 days for palliative radiotherapy (30 Gy or less) that is not 
directed to the pelvic region.  (Note:  all toxicities associated should have resolved to 
Grade ≤ 1). 
3. Participants with laboratory values at screening defined in Table 8. 

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Table 8: 
Exclusionary Laboratory Values 
Laboratory Parameter 
Exclusion Criterion 
Hematology 
a 
Platelets 
< 100 × 109/L 
b 
Hemoglobin 
< 9 g/dL 
c 
ANC 
< 1.5 × 109/L  
Hepatic 
d 
ALT 
> 2.5 × ULN 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 
CrCl 
< 50 mL/min calculated by Cockcroft-Gault equation (glomerular filtration 
rate can also be used in place of CrCl) 
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 
4. 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. 
5. Active autoimmune disease requiring systemic immunosuppression in excess of 
physiologic maintenance doses of corticosteroids (> 10 mg of prednisone or equivalent). 
6. Evidence of interstitial lung disease or active noninfectious pneumonitis. 
7. History of organ transplant, including allogeneic stem cell transplantation. 
8. Known active CNS metastases and/or carcinomatous meningitis, per Section 8.2.1.1. 
9. 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). 
10. Active infections requiring systemic therapy, or IV antibiotic use up to 7 days before 
Cycle 1 Day 1. 
Note:  If required by country or local regulations to be tested for COVID-19 during 
screening, a participant should be excluded if they have a positive test result for 
SARS-CoV-2 infection until both the retest result is negative and clinical recovery is 
obtained. 

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11. Known hypersensitivity to platinum, paclitaxel, another monoclonal antibody, or any of 
the excipients that cannot be controlled with standard measures (eg, antihistamines, 
corticosteroids). 
12. 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 or 
high-grade conduction disturbance.)  
13. Participant is pregnant or breastfeeding. 
14. Has received a live vaccine within 28 days of Cycle 1 Day 1. 
Note:  Examples of live vaccines include but are not limited to 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. 
15. Current use of prohibited medication as specified in Section 6.6.2. 
16. Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE v5. 
17. Any condition that would, in the investigator's judgment, interfere with full participation 
in the study, including administration of study drug and attending required study visits; 
pose a significant risk to the 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 entered in the study. 
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.  Rescreening more than 
once for administrative purposes (eg, scheduling logistics) may be allowed with sponsor 
approval.  Participants who rescreen must reconsent and be assigned a new participant number. 
5.5. 
Data Monitoring Committee 
This study will use an external DMC to monitor safety and efficacy throughout the duration of 
the study as specified in the DMC charter.  The voting members of the DMC will be external to 
the sponsor.  The members of the DMC will not be involved with the trial in any other way and 
will have no competing interests that could affect their roles with respect to the trial.  

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Safety will be reviewed by the DMC after approximately 30 participants have been enrolled and 
have completed at least 1 cycle of study drug(s) administration and at regular intervals 
throughout the duration of the study until the study is unblinded.  No interim analyses for 
efficacy are planned. 
Specific details regarding composition, responsibilities, and governance of the DMC, including 
the roles and responsibilities of the various members and the sponsor and protocol team, and 
requirements for proper documentation of DMC activities will be described in the DMC charter. 
5.6. 
Replacement of Participants 
No participants will be replaced at any time during this study. 
6. 
STUDY DRUGS 
6.1. 
Study Drugs Administered 
Table 9 presents the study drug information. 
INCMGA00012 and placebo will be provided centrally by the sponsor, and commercial and 
local supplies of chemotherapy agents will be used where allowable. 

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Table 9: 
Study Drug Information 
Study drug name: 
INCMGA00012 
Placebo 
Carboplatin 
Paclitaxel 
Dosage formulation: 
Liquid 
Liquid 
Liquid 
Liquid 
Unit dose 
strength(s)/ 
dosage level(s): 
 mg 
N/A 
 
(using Calvert formula; see 
Section 6.1.3) 
Carboplatin not to exceed 
 mg 
 mg/m2 
Dose frequency/ 
reason for use: 
Day 1 
of each 28-day cycle 
Investigational 
Day 1 
of each 28-day cycle 
Placebo 
Day 1 
of each 28-day cycle 
Cancer treatment 
Days 
 
of each 28-day cycle 
Cancer treatment 
Administration 
instructions: 
IV infusion 
of 
 minutes (-5/+15) 
IV infusion 
of 
 minutes (-5/+15) 
IV infusion 
of 
 minutes 
IV infusion 
of 
 minutes  
Packaging and 
labeling: 
INCMGA00012 25 mg/mL in a 
glass vial for single use.  Each 
vial will be labeled as required 
per country requirement. 
Placebo in a glass vial for single 
use.  Each vial will be labeled as 
required per country 
requirement. 
Marketed product 
Marketed product 
Storage: 
Upright under refrigeration at 
2°C-8°C (36°F-46°F) 
Protected from light 
Upright under refrigeration at 
2°C-8°C (36°F-46°F) 
Protected from light 
Per product label 
Per product label 
Source:  
Sponsor 
Sponsor 
Locally by the study site, or designee as permissible per regulatory 
requirements, or centrally by the sponsor. 
Study Drug 
Administration 
Period: 
Up to 
 
 cycles) 
Up to 
 
 cycles) 
Up to  months/
 weeks 
(  cycles) 
Up to  months/
 weeks 
(  cycles) 
Premedication: 
Antipyretics and/or 
antihistamine blockers should be 
considered for participants who 
have had previous systemic 
reactions to protein product 
infusions or when recommended 
by institutional policy. 
Antipyretics and/or 
antihistamine blockers should be 
considered for participants who 
have had previous systemic 
reactions to protein product 
infusions or when recommended 
by institutional policy. 
Prior to administration of 
carboplatin, participants should 
receive appropriate 
premedications based on 
institutional guidelines, 
investigator practice, local 
prescribing information, or 
standards of care. 
All participants should be 
premedicated with oral or IV 
steroid and antihistamines 
according to the approved label 
and/or standard practice.  
Additional premedications 
should be administered as per 
standard practice. 
 

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6.1.4. 
INCMGA00012 or Placebo 
INCMGA00012 or placebo will be administered in a blinded fashion by IV infusion of 
 minutes (-5/+15 minutes) on Day 1 of each 28-day cycle.  INCMGA00012 or placebo 
infusion should precede that of chemotherapy. 
Premedication with antipyretics and/or antihistamine blockers should be considered for 
participants who have had previous systemic reactions to protein product infusions or when 
recommended by institutional policy.  Participants may receive INCMGA00012 or placebo for 
up to 
 (or up to 
 administrations of INCMGA00012/placebo) unless criteria for early 
discontinuation from INCMGA00012 or placebo are met as per Section 7.1.1. 
Participants who received placebo in combination with chemotherapy who experience 
documented disease progression verified by BICR will have the opportunity to receive 
INCMGA00012 in the Crossover Period (see Section 8.7). 
Details on the preparation, reconstitution, and administration of the INCMGA00012 infusion and 
placebo infusion are provided in the Pharmacy Manual. 
6.2. 
Preparation, Handling, and Accountability 
The investigator or designee, or investigational drug storage manager (for Japan), must confirm 
appropriate temperature conditions have been maintained during transit for all vials of 
INCMGA00012 and placebo received and any discrepancies are reported and resolved before 
use. 
Only participants enrolled in the study may receive INCMGA00012 or placebo, and only 
authorized site staff may supply or administer these study drugs.  INCMGA00012 and placebo 
vials 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, investigational drug storage manager (for Japan), and authorized site staff. 
The investigator, investigational drug storage manager (for Japan), (or designee) is responsible 
for accountability, reconciliation, and record maintenance (ie, receipt, reconciliation, and final 
disposition records) of vials of INCMGA00012 and placebo.  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, 
investigational drug storage manager (for Japan), or designee must maintain records that 
document: 
• Delivery of INCMGA00012 and placebo vials to the study site. 
• Inventory of INCMGA00012 and placebo vials at the site. 
• Lot numbers and/or vial numbers (as applicable) of INCMGA00012 and placebo 
vials used to prepare the infusion solution. 
INCMGA00012 and placebo must be used only in accordance with the Protocol.  The 
investigator, investigational drug storage manager (for Japan), or designee 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 INCMGA00012 or placebo vials and study participants. 

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Completed accountability records will be archived by the site.  The investigator, investigational 
drug storage manager (for Japan), or designee will be expected to collect and retain all used, 
unused, and partially used INCMGA00012 and placebo vials until verified by the study monitor 
(unless otherwise agreed to by the sponsor).  At the conclusion of the study, the investigator, 
investigational drug storage manager (for Japan), or designee will oversee the destruction of any 
remaining study drug according to institutional SOPs. If, however, local procedures do not allow 
on-site destruction, shipment of the study drug back to the sponsor is allowed. In this case, 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 INCMGA00012 and placebo vials are 
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 INCMGA00012 or placebo 
vials are provided in the POD1UM-303 Pharmacy Manual. 
6.3. 
Measures to Minimize Bias:  Randomization and Blinding 
All participants will be centrally assigned to INCMGA00012 or placebo using an 
IRT/IVRS/IWRS.  Before the study is initiated, the telephone number and call-in directions for 
the IVRS and/or the log in information and directions for the IWRS will be provided to each site.  
Full details will be provided in the IRT Manual. 
Participants will be assigned to INCMGA00012 or placebo in accordance with the randomization 
schedule.  Participants, investigators, and the sponsor will remain blinded to each participant's 
assignment to INCMGA00012 or placebo throughout the study, until the Crossover Period.  
Additionally, PK results will not be shared with the investigative sites or study team prior to 
unblinding of the study, as PK is planned to be analyzed after the study is unblinded.  Emergency 
unblinding will occur if an AE requires the investigator to be made aware of the participant's 
assignment to INCMGA00012 or placebo (see emergency unblinding procedures in Section 9.5) 
and the POD1UM-303 Investigator Site File. 
A sponsor statistician who is not part of the study team may be unblinded and may provide 
summary aggregated data by Group to the sponsor and/or the DMC, but individual participant 
data will remain blinded. 
6.4. 
INCMGA00012 and Placebo Compliance 
Compliance with all study-related activities should be emphasized to the participant by the site 
personnel, and appropriate steps should be taken to optimize compliance during the study. 
Compliance with INCMGA00012 and placebo will be calculated by the sponsor based on the 
infusion records and monitored by the sponsor/designee. 
6.5. 
Dose Modifications 
6.5.1. 
General Dose Modifications 
Management guidelines for toxicities related to chemotherapy, INCMGA00012, or placebo are 
provided in the following sections. 

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If appropriate, the investigator may attribute each toxicity event to carboplatin, paclitaxel, or 
INCMGA00012 or placebo alone or to the combination.  Dose modifications must be based on 
the maximum toxicity experienced during a cycle. 
Dose interruption, delay, or discontinuation of 1 chemotherapy agent and not the other agent is 
appropriate if, in the opinion of the investigator, the toxicity is clearly related to 1 of the agents.  
If, in the opinion of the investigator, the toxicity is related to the combination of both 
chemotherapy agents, both chemotherapy drugs should be interrupted, delayed, or discontinued 
according to recommended dose modifications.  If the toxicity is deemed related to the 
combination of chemotherapy and INCMGA00012 or placebo, all 3 agents should be delayed, 
interrupted, or discontinued according to the recommended dose modifications. 
In the event that chemotherapy must be discontinued for toxicity, INCMGA00012 or placebo 
should be continued if the participant is able to tolerate INCMGA00012 or placebo.  Similarly, 
chemotherapy should be continued, if able, when INCMGA00012 or placebo is stopped for 
immune-related unacceptable toxicity. 
It is important to note that some chemotherapy-related AEs will overlap with potential irAEs 
(including but not limited to gastrointestinal toxicity, including diarrhea; renal insufficiency; 
high-grade laboratory abnormalities; rash/hypersensitivity).  In these cases, both the 
chemotherapy-related AE and irAE management guidance should be reviewed to determine the 
most appropriate management of therapy. 
For participants who are diagnosed with COVID-19 during the study (positive COVID-19 test) 
or presumed affected by SARS-CoV-2 infection (test pending/clinical suspicion), refer to 
Appendix D. 
6.5.2. 
Management of Suspected Infusion Reactions 
6.5.2.1. 
Paclitaxel and Carboplatin 
All participants should be premedicated with oral or intravenous steroid and antihistamines 
according to the approved product label and/or standard practice.  Additional premedications 
should be administered as per standard practice. 
Minor symptoms such as flushing, skin reactions, dyspnea, hypotension, or tachycardia do not 
require interruption of paclitaxel.  However, severe reactions, such as hypotension requiring 
treatment, dyspnea requiring bronchodilators, angioedema, or generalized urticaria require 
immediate discontinuation of paclitaxel and aggressive symptomatic therapy. 
6.5.2.2. 
INCMGA00012 or Placebo 
Infusion or hypersensitivity reactions may be observed with administration of any foreign 
protein.  Premedication with an antipyretic (eg, acetaminophen/paracetamol or equivalent) and a 
histamine blocker (eg, diphenhydramine or equivalent) 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 to INCMGA00012 or placebo are 
provided in Table 10. 

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Table 10: 
Guidelines for Management of Suspected Infusion Reactions for Study Drug 
Grade 
Descriptiona 
Treatment 
Subsequent Infusions 
1 
Mild reaction; infusion interruption 
not indicated; intervention not 
indicated. 
Monitor vital signs closely until 
medically stable. 
Premedication with an antipyretic 
(eg, acetaminophen/paracetamol) and 
a histamine blocker 
(eg, diphenhydramine) should be 
considered for participants who have 
had previous systemic reactions to 
protein product infusions or when 
recommended by institutional policy. 
2 
Requires infusion interruption but 
responds promptly to symptomatic 
treatment (eg, antihistamines, 
NSAIDs, narcotics, IV fluids); 
prophylactic medications indicated 
for ≤ 24 hours. 
First occurrence:  Stop infusion and 
initiate appropriate medical measures 
(eg, IV fluids, antihistamines 
NSAIDs, 
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 
INCMGA00012 or placebo. 
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. 
Next infusion should start at 50% of 
the original infusion rate.  If no 
reaction, rate of infusion can be 
increase by 25% every 15 minutes 
until a rate of 100% has been reached.  
Subsequent infusions can begin at 
100%. 
3 or 4 
Grade 3:  Prolonged (ie, not rapidly 
responsive to symptomatic 
medication and/or brief interruption 
of infusion); recurrence of symptoms 
following initial improvement; 
hospitalization indicated for other 
clinical sequelae (eg, renal 
impairment, pulmonary infiltrates). 
Grade 4:  Life-threatening; pressor or 
ventilatory support indicated. 
Stop infusion and initiate appropriate 
medical therapy (eg, IV fluids, 
antihistamines NSAIDs, 
acetaminophen/paracetamol, 
narcotics, oxygen, pressors, 
epinephrine, corticosteroids, per 
institutional preferences). 
Monitor vital signs frequently until 
medically stable.  Hospitalization may 
be indicated. 
Permanently discontinue 
INCMGA00012 or placebo. 
Note for NCI CTCAE (v5.0) Grade 3 
infusion related reactions:  if rapidly 
responsive to symptomatic medication 
and/or to brief interruption of 
infusion, study drug does not need to 
be permanently discontinued. 
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. 
6.5.3. 
Dose Modifications of Paclitaxel and Carboplatin 
Refer to local approved product labels and Table 11 for dose modifications regarding the 
chemotherapy regimen.  If a dose reduction for toxicity occurs with any chemotherapy agent, the 
dose may not be re-escalated.  Participants can have a maximum of 2 dose modifications to each 
of the chemotherapy drugs throughout the course of the study for toxicities.  If a participant 
experiences several toxicities and there are conflicting recommendations, the most conservative 
dose adjustment recommended should be followed (dose reduction appropriate to the most 
severe toxicity).  Participants who require a third dose modification to a particular chemotherapy 
drug will have that agent discontinued.  Participants who experience severe hypersensitivity 
reactions to paclitaxel should not be rechallenged with the drug. 
Reduction of 1 chemotherapy agent and not the other agent is appropriate if, in the opinion of the 
investigator, the toxicity is clearly related to 1 of the agents.  If, in the opinion of the investigator, 
the toxicity is related to the combination of both chemotherapy agents, both drugs should be 
reduced according to recommended dose modifications. 

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Chemotherapy may be interrupted for a maximum of 6 weeks (INCMGA00012/placebo may be 
interrupted for a maximum of 12 weeks). 
CTCAE v5.0 must be used to grade the severity of AEs.  All dose modifications should be based 
on the AE requiring the greatest dose modification. 
Table 11: 
Suggested Dose Reduction for Paclitaxel and Carboplatin 
Study Drug 
Dose Level 0 
Dose Reduction 1 
Dose Reduction 2 
Additional Dose 
Reductions 
Paclitaxela 
 mg/m2 
Days 
 
 mg/m2 
 mg/m2 
Discontinue 
Carboplatina  
 
Maximum dose 
 mg 
 
Maximum dose 
 mg 
 
Maximum dose 
 mg 
Discontinue 
a For participants known to be HIV-positive, consultations should occur before dosing and throughout the study to determine any 
potential DDIs and modification to anti-HIV medications, in particular protease inhibitors. 
6.5.4. 
Dose Modification of INCMGA00012 or Placebo 
Dose reduction of INCMGA00012 or placebo is not allowed.  If a dose hold or infusion 
interruption is necessary for the management of treatment-related TEAEs, INCMGA00012 or 
placebo may be held for a maximum of 12 weeks.  INCMGA00012 or placebo will be 
discontinued for participants requiring more than 12 weeks of interruption of INCMGA00012 or 
placebo.  Instructions for management in the event of irAEs are outlined in Section 6.5.4.1. 
6.5.4.1. 
Procedures for Participants Exhibiting Immune-Related Adverse Events 
Adverse events of a potential immunologic etiology, or irAEs, may be defined as AEs 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 
INCMGA00012 or placebo. 
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 Table 12.  Algorithms 
for the evaluation of selected immune toxicities that have previously been attributed to PD-1 
inhibitors and management guidelines for irAEs not detailed elsewhere in the Protocol should 
follow the ASCO or ESMO Clinical Practice Guidelines (Haanen et al 2017, NCCN 2021a, 
Schneider et al 2021). 

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Table 12: 
Dose Modifications of INCMGA00012 or Placebo and Toxicity Management 
Guidelines for Immune-Related Adverse Events 
Immune-Related 
Adverse Event 
Toxicity Grade or 
Conditions (CTCAE v5.0) 
Action Taken With 
INCMGA00012or Placebo 
AE Management With Corticosteroid 
and/or Other Supportive Care 
Therapiesa 
Pneumonitis 
Grade 1 
No action. 
None. 
Grade 2 
Withhold until ≤ Grade 1. 
• Administer systemic corticosteroids 
per local practice followed by taper. 
• Evaluate participants with suspected 
pneumonitis with radiographic 
imaging and initiate corticosteroid 
treatment. 
• Add prophylactic antibiotics for 
opportunistic infections. 
Grades 3 or 4, or recurrent 
Grade 2 
Permanently discontinue. 
Diarrhea/colitis 
Grade 1 
No action. 
• None. 
Grades 2 or 3 
Withhold until ≤ Grade 1. 
• Consider prompt initiation of 
standard anti-diarrheal agents. 
• Administer systemic corticosteroids 
per local practice followed by taper. 
• Consider prophylactic antibiotics per 
local practice. 
• Consider gastrointestinal consultation 
and performing endoscopy to rule out 
colitis. 
• Consider stool sample evaluation to 
rule out Clostridioides difficile and 
infectious etiologies. 
Grade 4 or recurrent Grade 3 Permanently discontinue. 
AST/ALT elevation 
and/or increased total 
bilirubin/hepatitis  
Grade 1 
No action. 
None  
Grade 2 ALT or AST 
increase 
OR 
Total bilirubin increases to 
more than 1.5 and up to 
3 times ULN 
Withhold until ≤ Grade 1.  
• Administer systemic corticosteroids 
per local practice followed by taper. 
• Consider monitoring liver enzymes 
weekly (or more frequently) until 
liver enzyme value returns to baseline 
or is stable. 
• Consider monitoring total bilirubin, 
direct bilirubin, and alkaline 
phosphatase weekly (or more 
frequently) 
Grade 3 or 4 ALT or AST 
increase  
OR 
In participants with liver 
metastases with baseline 
Grade 2 elevation of AST or 
ALT, hepatitis with AST or 
ALT increases ≥ 50% and 
lasts ≥ 1 week 
OR 
Total bilirubin increases to 
more than 3 times ULN. 
Permanently discontinue. 
Endocrinopathies 
Hyperglycemia 
Hyperthyroidism 
Hypothyroidism 
Type 1 diabetes 
mellitus 
Grades 1 and 2 
No action. 
• None. 
Grades 3 or 4 
hypothyroidism 
Withhold until ≤ Grade 1 or 
is otherwise clinically stable. 
• Initiate thyroid replacement hormones 
(eg, levothyroxine or liothyronine per 
standard of care). 
Grades 3 or 4 
hyperthyroidism 
Withhold until ≤ Grade 1 or 
is otherwise clinically stable. 
• Initiate symptomatic management 
Grades 3 and 4 Type 1 
diabetes mellitus (or 
hyperglycemia) 
Withhold until ≤ Grade 1 or 
is otherwise clinically stable. 
• Initiate treatment with 
antihyperglycemics as clinically 
indicated. 

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Table 12: 
Dose Modifications of INCMGA00012 or Placebo and Toxicity Management 
Guidelines for Immune-Related Adverse Events (Continued) 
Immune-Related 
Adverse Event 
Toxicity Grade or 
Conditions (CTCAE v5.0) 
Action Taken With 
INCMGA00012or Placebo 
AE Management With Corticosteroid 
and/or Other Supportive Care 
Therapiesa 
Adrenal insufficiency 
Grade 1 
No action. 
• None 
Grade 2 
Withhold until ≤ Grade 1 or 
is otherwise clinically stable. 
• Initiate treatment with hormonal 
replacement as clinically indicated. 
Grades 3 and 4  
Withhold until ≤ Grade 1 
after corticosteroid taper to 
≤10 mg/day prednisone or 
equivalent or is otherwise 
clinically stable. 
• Initial dose of 1 to 2 mg/kg/day 
prednisone or equivalent followed by 
a taper and hormone replacement as 
clinically indicated. 
Hypophysitis 
Grade 1 
No action. 
• None. 
Grade 2 (asymptomatic) 
Withhold until ≤ Grade 1. 
 
May restart INCMGA00012 
treatment after controlled by 
hormone replacement 
therapy. 
• Administer hormonal replacement. 
Grade 2 (symptomatic, 
eg headaches, visual 
disturbances) 
Withhold until ≤ Grade 1. 
 
May restart INCMGA00012 
after controlled with 
hormone replacement, if 
indicated, and steroid taper 
is complete. 
• Administer corticosteroids at initial 
dose of 1 to 2 mg/kg/day prednisone 
or equivalent followed by a taper and 
initiate other hormonal replacements 
as clinically indicated. 
• Consult with endocrinologist as 
needed. 
Grade 3 or 4 (symptomatic) 
Permanent discontinuation 
should occur if after 
withholding INCMGA00012 
the toxicity does not resolve 
to ≤ Grade 1 within 
12 weeks after last dose of 
INCMGA00012 treatment, 
or if corticosteroid dosing 
cannot be reduced to 
≤ 10 mg prednisone or 
equivalent per day within 
12 weeks. 
 
Permanent discontinuation 
of INCMGA00012 should 
take place earlier at the 
investigator's discretion, if 
corticosteroids and/or 
hormone replacement 
therapy cannot balance the 
participant's pituitary 
function. 
• Administer corticosteroids at initial 
dose of 1 to 2 mg/kg/day prednisone 
or equivalent followed by a taper and 
initiate other hormonal replacements 
as clinically indicated. 
• Consult with endocrinologist as 
needed. 
Nephritis with renal 
dysfunction 
Grade 1 
No action. 
• None. 
Grade 2 increased blood 
creatinine 
Withhold until ≤ Grade 1. 
• Administer corticosteroids per local 
practice followed by taper. 
Grades 3 or 4 increased 
blood creatinine 
Permanently discontinue.b 

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Table 12: 
Dose Modifications of INCMGA00012 or Placebo and Toxicity Management 
Guidelines for Immune-Related Adverse Events (Continued) 
Immune-Related 
Adverse Event 
Toxicity Grade or 
Conditions (CTCAE v5.0) 
Action Taken With 
INCMGA00012or Placebo 
AE Management With Corticosteroid 
and/or Other Supportive Care 
Therapiesa 
Skin Reactions 
Grade 1 
No action. 
• None. 
Grade 2 
No action. 
• Manage with topical steroids with or 
without drug interruption. 
Grade 3c or persistent 
Grade 2 (≥ 2 weeks) 
or Grade 3 SJS 
or 
suspected SJS 
or suspected TEN 
Withhold until ≤ Grade 1 
after corticosteroid taper to 
≤ 10 mg/day prednisone or 
equivalent. 
• Administer corticosteroids per local 
practice followed by taper.  
Additionally, oral antihistamines such 
as diphenhydramine or famotidine 
(per institutional preference) may be 
utilized as needed. 
• Should refer to dermatology if no 
resolution with these measures or if 
SJS or TEN is suspected. 
Grade 4 
or 
Grade 4 SJS or TEN 
Permanently discontinue. 
• Initial dose of 1 to 2 mg/kg/day 
prednisone or equivalent followed by 
a taper. 
• Refer to dermatology consult. 
Myocarditis 
Grade 2 
Depending on severity of 
symptoms, withhold until 
symptoms fully resolve and 
management with 
corticosteroids is complete. 
 
Permanent discontinuation 
of INCMGA00012 may take 
place earlier at the 
investigator’s discretion. 
• Treatment with systemic 
corticosteroids should be initiated 
(initial dose of 1-2 mg/kg per day of 
prednisone or equivalent).  Taper as 
appropriate. 
• Manage cardiac symptoms according 
to standard of care and with guidance 
from cardiology.  Consider cardiac 
MRI and myocardial biopsy for 
diagnosis. 
Grades 3 or 4 
Permanently discontinue. 
Important nervous 
system events 
(eg, Guillain-Barre 
syndrome, autoimmune 
encephalitis, 
myasthenia gravis, 
autonomic neuropathy, 
or transverse myelitis) 
Grade 2 
Withhold until ≤ Grade 1. 
• Neurology consultation is 
recommended for all neurologic 
irAEs ≥ Grade 2. 
• Treatment with systemic 
corticosteroids should be initiated 
(initial dose of 1-2 mg/kg per day of 
prednisone or equivalent).  Taper as 
appropriate. 
• For Grade 2 transverse myelitis, 
consider permanent discontinuation. 
• Manage symptoms according to 
standard of care and with guidance 
from neurology. 
Grade 3 or 4 
Permanently discontinue. 

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Table 12: 
Dose Modifications of INCMGA00012 or Placebo and Toxicity Management 
Guidelines for Immune-Related Adverse Events (Continued) 
Immune-Related 
Adverse Event 
Toxicity Grade or 
Conditions (CTCAE v5.0) 
Action Taken With 
INCMGA00012or Placebo 
AE Management With Corticosteroid 
and/or Other Supportive Care 
Therapiesa 
All other irAEs 
Grade 2 or Grade 3 based on 
severity and type of reaction 
Withhold until ≤ Grade 1. 
• Based on severity of AE, administer 
corticosteroids. 
• Ensure adequate evaluation to 
confirm etiology or exclude other 
causes. 
Recurrent Grade 3 or 
Persistent Grade 2 and 
Grade 3 
Permanently discontinue. 
Grade 4d (excluding 
endocrinopathies) 
Permanently discontinue. 
a As general instructions, the following should be followed: if treatment-related toxicity does not resolve to Grade 0-1 within 
12 weeks after the last dose of study drug, or if the corticosteroid dose cannot be reduced to ≤ 10 mg prednisone or equivalent 
per day within 12 weeks, study drug should be permanently discontinued. Severe and life-threatening irAEs should be treated 
with IV corticosteroids followed by oral corticosteroids. Other immunosuppressive treatment should begin if irAEs are not 
controlled by corticosteroids. 
b If INCMGA00012 and/or placebo is directly implicated in the renal toxicity. 
c Participants with Grade 3 rash in the absence of desquamation, with no mucosal involvement, not requiring systemic 
corticosteroids, and resolving or improving to ≤ Grade 1 within 14 days do not have to interrupt study drug/treatment. 
Permanent discontinuation of study drug/treatment may be necessary if there is recurrence of Grade 3 or higher rash after 
resuming study drug/treatment. 
d If Grade 4 lipase/amylase elevation is asymptomatic and abdominal imaging suggests no pathology, then study drug 
administration may continue with medical monitor approval. 
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(s) (unless associated with the treatment of an AE), will be recorded in the 
eCRF.  Antibiotics received up to 90 days before the first study drug administration must be 
reported.  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 
The following medications and procedures are permitted: 
• Antiretroviral therapy should be continued for participants who are known to be 
HIV-positive.  Participants should remain under the care of their specialist managing 
their HIV care, and the proposed therapy and ART/HAART for potential DDIs 
should be reviewed (NCCN 2019b). 
− Use of growth factors on a nonroutine basis (and following ASCO guidelines for 
CSF use), anticoagulants, and transfusional support will be permitted. 
− Bisphosphonates will also be permitted.  Of note:  Regular concomitant use of 
bisphosphonates and RANK-L inhibitors for the prevention or reduction of 
skeletal-related events in participants with bone metastases is allowed and should 
preferably be initiated prior to the first dose of study drug. 
• Prior to administration of INCMGA00012 or placebo, premedication with an 
antipyretic (eg, acetaminophen/paracetamol or equivalent) and a histamine blocker 
(eg, diphenhydramine or equivalent) should be considered for participants who have 
had previous systemic reactions to protein product infusions or when recommended 
by institutional policy. 
• Premedications prior to administration of chemotherapy agents should be given in 
accordance with prescribing information and standard practice. 
• SARS-CoV-2 vaccines. 
• Applicable ancillary procedures and tests (eg, SARS-CoV-2 RT-PCR test, chest 
x-ray, or chest CT scan) to fully diagnose, monitor, and treat COVID-19. 
6.6.2. 
Prohibited Medications and Procedures 
The following medications and procedures are prohibited: 
• Other anticancer therapies, including investigational treatments within 21 days before 
the first administration of any study drug (6 weeks for mitomycin C), and throughout 
the Study Drug Administration Period of the study. 
• Immunosuppression in excess of physiologic maintenance corticosteroid doses 
(> 10 mg of prednisone or equivalent) within 14 days of the first dose of 
INCMGA00012 or placebo and throughout the Study Drug Administration Period of 
the study (with the exception of premedication for chemotherapy per SOC, and with 
the exception of acute treatment for an AE, see Section 6.5). 
• Probiotic dietary supplements. 

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• Live vaccines within 28 days before the first administration of INCMGA00012 or 
placebo, throughout the Study Drug Administration Period of the study, and for a 
duration of 90 days after the last dose of INCMGA00012 or placebo. 
Note:  Examples of live vaccines include but are not limited to 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. 
• Investigators should refer to the local product labelling for the chemotherapy drugs 
selected for use in this study. 
6.7. 
Treatment After the End of the Study 
Once a participant has discontinued all assigned study drug administration, including 
INCMGA00012 to qualified participants in the Crossover Period, no further study drug will be 
provided in this study. 
Upon second disease progression, participants will be followed for safety and/or survival as 
applicable per Table 4 or Table 5 until withdrawal of consent, lost to follow-up, the end of the 
study, or death. 
Eligible participants who are deriving clinical benefit with INCMAG00012 may be considered 
for poststudy drug provisions allowing them to continue receiving INCMGA00012 until a 
suitable alternative treatment option is identified. 

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7. 
DISCONTINUATION OF STUDY DRUG ADMINISTRATION 
AND PARTICIPANT DISCONTINUATION/WITHDRAWAL 
7.1. 
Discontinuation of Study Drug Administration 
7.1.1. 
Reasons for Discontinuation of Study Drug Administration 
Participants must discontinue from assigned study drug(s) for the following reasons: 
• Completion of the assigned study drug(s) regimen. 
• Confirmed radiologic disease progression verified by BICR (see Section 8.2.1). 
Note: If radiographic progression of disease is verified by BICR using RECIST v1.1, 
the site may request unblinding of the Group in order to assess eligibility for the 
Crossover Period of the study (see Section 8.7). 
• Unacceptable toxicity as noted in Section 6.5. 
• 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 all study drug(s), including INCMGA00012 
received by eligible participants in the Crossover Period will remain in the study to be 
followed for progression and survival. 
• Further study drug administration 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 assigned study drug(s) 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 drug administration may be resumed after approval has been received 
from the medical monitor (see Section 9.6). 
• If, during the course of the study, a participant is found not to have met eligibility 
criteria, the medical monitor, in collaboration with the investigator, will determine 
whether the participant should be withdrawn from study drug administration. 
• If a participant is noncompliant with study procedures or study drug administration in 
the investigator's opinion, the sponsor should be consulted for instruction on handling 
the participant. 
7.1.2. 
Discontinuation Procedures 
In the event that the decision is made to permanently discontinue all assigned study drugs 
including administration of INCMGA00012 during the Crossover Period for eligible 
participants, the EOT visit should be conducted.  Following the EOT visit, the Follow-Up Period 
(28-day Safety Follow-Up, Disease Follow-Up, and Survival Follow-Up) visits will be 
performed as applicable.  These visits are described in Table 4 and Table 5.  The EOT and 

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28-day Safety Follow-Up visit may be combined if necessary provided all assessments for both 
visits are completed.  The last date of the last dose of all assigned study drug(s) and the reason 
for discontinuation will be recorded in the eCRF. 
If a participant is discontinued from all assigned study drug(s): 
• Adverse events including SAEs and irAEs must be collected as per Section 8.3.1. 
• 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 EOT and 28-day Safety Follow-Up visit 
may be combined if necessary provided all assessments for both visits are completed. 
• The date of the EOT visit should be recorded in the IRT. 
Completion of or early discontinuation of all study drugs, including INCMGA00012 received in 
by eligible participants during the Crossover period does not mean withdrawal from the study, 
and remaining study procedures should be completed as indicated by the Protocol. 
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 the participant's 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. 
7.3. 
Lost to Follow-Up 
A participant will be considered lost to follow-up if the participant 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, if necessary, a 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, the participant 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 investigator's representative will explain the nature of the study to 
the participant or the participant's 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 the participant's 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 the participant's 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 randomized into 
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 the ICF 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 
randomized into the study, information associated with eligibility requirements must be entered 
into the appropriate eCRF pages. 
Results from the screening visit evaluations will be reviewed to confirm eligibility as applicable 
before randomization or the administration of study treatment.  Tests with results that fail 
eligibility requirements may be repeated.  For screening assessments that are repeated, the most 
recent available result before randomization will be used to determine eligibility.  Administration 
of study drug(s) should start as soon as possible after randomization, but within 3 days after the 
date of randomization. 
See Section 5.4 and Section 5.6 for information regarding screen failures and replacement of 
participants, respectively. 
For tumor tissue requirements collected during screening to conduct central assessments 
(eg, PD-L1) see Section 8.5.1. 
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.  Site staff should contact the IRT to obtain the 
participant ID number during screening.  Upon determining that the participant is eligible for 
randomization, the IRT will be contacted to obtain the study drug(s) assignment.  Additionally, 
the IRT will be contacted at each regular study visit to update the study drug(s) supply.  
Additional details are provided in the IRT Manual. 
Once a randomization number is assigned to a participant, it cannot be reassigned to another 
participant. 
A single participant cannot be assigned more than 1 randomization number. 
8.1.4. 
Distribution of Reminder Cards 
Participants will be provided with a reminder card at each clinic study 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. 
Distribution of Participant Identification Cards 
All participants will be given a participant identification card identifying them as participants in 
a research study.  The card will contain trial site contact information (including direct telephone 
numbers) to be utilized in the event of an emergency.  The investigator or qualified designee will 

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provide the participant with a participant identification card upon written informed consent.  At 
the time of randomization, site personnel will add the randomization number to the participant 
identification card. 
8.1.6. 
COVID-19 Vaccination 
Although highly recommended, prior vaccination against SARS-CoV-2 is not required to 
participate in the study.  Investigators should strongly encourage vaccination in potential 
participants for whom no contraindication for vaccination exists.  For participants who are 
vaccinated while on study, refer to Appendix D for guidance on timing of vaccine with respect to 
study treatment administration. 
Applicable ancillary procedures and/or tests to supplement diagnosis (eg, SARS-CoV-2 RT-PCR 
test, chest x-ray, or chest CT scan), monitoring, and treatment of COVID-19 are allowed.  These 
procedures and/or tests will be documented in eCRFs as due to COVID-19 (see Section 6.6.1). 
Potential participants may need to be tested for COVID-19 during the study screening period 
and/or during the study as per local requirements or health authority requirements.  Participants 
with a positive SARS-CoV-2 test during screening are ineligible to be randomized until 
normalization of a test is obtained and clinical recovery from the infection is observed as per 
investigator's evaluation (see Section 5.2).  During the study, if participants are suspected of 
COVID-19 and test positive, they should recover first and be retested before continuing with 
study treatment.  If the SARS-CoV-2 test is negative, those participants can continue to be 
administered study treatment.  In addition, investigators in some countries may be obliged to 
report SARS-CoV-2–positive test results directly to the responsible health authority according to 
the local regulations at any time during the study.  Investigators are required to check health 
authority and/or local requirements for any possible specific obligations. 
8.1.7. 
Demography and Medical History 
8.1.7.1. 
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, medical and surgical history, and current illnesses. 
Medical history will include relevant medical or surgical treatment within the last 10 years that 
are considered to be clinically significant by the investigator.  
Data on ethnic group (eg, ancestry, ethnic origin) and gender will also be collected to evaluate 
differences in participants' efficacy outcomes.  Anal cancer is slightly more common in women 
than men (2.3 vs 1.6 cases per 100,000, respectively), black men than white men (2.2 vs 
1.6 cases per 100,000, respectively), and white women than black women (2.5 vs 1.8 cases per 
100,000, respectively) (NCI 2021).  It has been reported that black, gay and bisexual men with 
HIV had a significantly higher risk for anal cancer than nonblack men with the same 
characteristics (McNeil et al 2022).  In general, patients with HIV and HPV are noted to have 
higher incidence of anal cancer; therefore, studying these populations is warranted, as well as 
participants from varying demographic backgrounds such as ancestry, geographic location, and 
prior history of known risk factors. Additionally, subgroup analysis of outcomes may be 
performed based on gender. 

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8.1.7.2. 
Disease Characteristics and Treatment History 
A disease-targeted medical and treatment history will be collected at screening.  Details 
regarding the participant's malignancy under study, including date of diagnosis, initial and 
current cancer stage, tumor histology, and relevant disease characteristics, and prior treatments, 
including systemic treatments, radiation, and surgical procedures, will be recorded. 
8.1.8. 
ECOG Performance Status 
ECOG performance status will be assessed according to the criteria in Table 13. 
Table 13: 
ECOG Performance Status 
Grade 
Performance Status 
0 
Fully active, able to carry on all predisease performance without restriction. 
1 
Restricted in physically strenuous activity but ambulatory and able to carry out work of a 
light or sedentary nature (eg, light house work, office work). 
2 
Ambulatory and capable of all self-care but unable to carry out any work activities.  Up and 
about more than 50% of waking hours. 
3 
Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 
4 
Completely disabled.  Cannot carry on any self-care.  Totally confined to bed or chair. 
5 
Dead. 
Source:  Oken et al 1982. 
8.2. 
Efficacy Assessments 
Objective assessment of disease status will be evaluated according to RECIST v1.1 
(Eisenhauer et al 2009) as described in Appendix B, by the investigator and BICR.  The 
investigator's assessments will be recorded in the appropriate eCRF. 
8.2.1. 
Tumor Imaging and Assessment of Disease 
The process for image collection and transmission to the central imaging vendor can be found in 
the Imaging Manual.  All imaging supporting disease assessment must be submitted to the 
central imaging vendor.  For example, images (including via other modalities) that are obtained 
at an unscheduled timepoint to determine disease progression, as well as imaging obtained for 
other reasons that demonstrate radiologic progression, should also be submitted to the central 
imaging vendor as well as imaging performed at the scheduled timepoints. 
The recommended method for measuring and following tumor burden will be CT, 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 may be necessary, but must be consistent with RECIST v1.1.  The same 
imaging techniques regarding modality, ideally the same scanner, and the use of contrast should 
be used in a participant throughout the study to optimize the reproducibility of the assessment of 
existing and new tumor burden and improve the accuracy of the assessment of response or 
progression based on imaging. 
Imaging of the chest, abdomen, and pelvis are required for all participants at all scheduled 
imaging timepoints.  Imaging of other anatomical sites (ie, head, neck, and extremities) should 

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be performed as applicable if participant has disease involvement or suspected disease 
involvement in those areas.  Computed tomography or MRI scan of the brain will be performed 
if there are signs or symptoms suggesting that the participant has disease involvement in the 
CNS. 
Confirmation of CR or PR should be confirmed by imaging at least 4 weeks after initial 
documentation. 
Per iRECIST, participants with initial evidence of disease progression may continue to receive 
study drug pending confirmation of PD if they are clinically stable and per the investigator's 
discretion. 
In the Crossover Period, participants who have unconfirmed second disease progression may 
continue receiving INCMGA00012 at the discretion of the site investigator until second disease 
progression is confirmed by the site provided they have met the conditions detailed by iRECIST 
(see Section 8.2.2).  Participants who have confirmed second disease progression by iRECIST in 
the Crossover Period will discontinue administration of INCMGA00012 and continue to the next 
segment of the study (End of Treatment/Follow-Up). 
Imaging timepoints are provided in Table 4 and Table 5.  Imaging must follow calendar days 
based upon the date of Cycle 1 Day 1 and is not to be delayed for treatment holds or 
interruptions.  If a study participant is hospitalized due to a medical emergency during the study 
that causes a delay in imaging, the participant must undergo the imaging procedures as soon as 
the participant is recovered or stable. 
8.2.1.1. 
Initial Tumor Imaging and Eligibility Assessment During the Screening Period 
Initial tumor imaging must be performed within 28 days prior to the date of randomization, per 
Table 4.  Images 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 prior to the date 
of randomization and can be provided to the central imaging vendor and assessed by BICR. 
The site study team must review screening images prior to randomization to confirm the 
participant has measurable disease per RECIST v1.1.  The screening images must be submitted 
to the central imaging vendor for retrospective confirmation of eligibility. 
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. 
Participants with previously treated brain metastases may participate provided they have 
radiographically stable brain metastases, that is, without evidence of progression by imaging 
during screening, and confirmed by MRI if MRI was used at prior imaging, or confirmed by CT 
imaging if CT used at prior imaging obtained at least 4 weeks apart and show no evidence of 
intracranial progression.  Any neurologic symptoms must have returned to baseline and 
participants must have no clinical evidence of new or enlarging brain metastases, and have not 
used steroids for brain metastases for at least 14 days before the start of study drug 
administration.  This exception does not include carcinomatous meningitis, as participants with 
carcinomatous meningitis are excluded regardless of clinical stability. 

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8.2.1.2. 
Tumor Imaging During Study Drug Administration Period 
Imaging and response assessment should be performed every 8 weeks (56 days ± 7 days) until 
the Week 56 assessment and during the Crossover Period or Disease Follow-Up Period as 
appropriate until second disease progression, withdrawal of consent, death, or notification to site 
by the sponsor, whichever occurs first. 
Verification of disease progression by BICR:  The central imaging vendor will expedite the 
verification of PD upon request following local site investigator-assessed radiologic evidence of 
PD.  Expedited verification of radiologic PD by the central imaging vendor will be 
communicated to the study site and sponsor in order to determine eligibility for Crossover 
Period.  Investigator radiology assessments may be used to determine participant management; 
however, radiologic assessment for the primary study endpoint is according to BICR. 
8.2.1.3. 
Tumor Imaging During the Crossover Period 
For participants eligible to enter the Crossover Period (see Section 8.7), documented disease 
progression must be verified by BICR prior to starting the first cycle of INCMGA00012 
monotherapy in the Crossover Period.  Imaging must be performed within 28 days before 
starting treatment with the first cycle of INCMGA00012 monotherapy in the Crossover Period.  
There must not be more than 12 weeks (+ 7 days) between the last imaging assessment during 
the main study that confirmed PD as verified by central imaging vendor and the first scan in the 
Crossover Period. 
In the Crossover Period, the imaging schedule is every 8 weeks (56 days ± 7 days), until the 
participant experiences second disease progression, withdrawal of consent, death, or end of the 
study, whichever occurs first. 
8.2.1.4. 
Tumor Imaging During Disease Follow-up 
For participants who discontinue or complete all assigned study drug(s) but have not experienced 
second disease progression, continued monitoring of disease status by radiographic imaging will 
be performed every 8 weeks (56 days ± 7 days), until the participant experiences second disease 
progression, withdrawal of consent, death, or notification to site by the sponsor, whichever 
occurs first. 
Upon implementation of Amendment 3, imaging may be performed at intervals according to 
local institution standard practice (eg, every 3-4 months) but at least every 6 months. 
8.2.2. 
iRECIST Assessment of Disease 
Modified RECIST v1.1 for immune-based therapeutics may be used to assess tumor response to 
guide treatment decisions for discontinuation of INCMGA00012 due to disease progression 
(Seymour et al 2017). 
These disease assessments for clinically stable participants will be performed by the study site, 
and participants will need to have the opportunity to be reconsented in the case of administration 
of study treatment pending confirmation of PD. 

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Participants may receive study drug administration pending confirmation of disease progression 
if they are clinically stable as defined by the following criteria: 
• Absence of clinically significant signs and symptoms (including worsening of 
laboratory values) indicating disease progression. 
• No decline in ECOG performance status.  
• No requirement for intensified management of disease-related symptoms. 
• Absence of rapid progression of disease.  
• Absence of progressive tumor at critical anatomical sites (eg, spinal cord 
compression) requiring urgent alternative medical intervention.  
If radiologic imaging shows iUPD, tumor assessment should be repeated ≥ 4 weeks later (but no 
later than 8 weeks) to confirm iCPD with the option of continuing treatment while awaiting 
radiologic confirmation of progression.  Details of iRECIST categories and implementation are 
in Appendix C. 
8.2.3. 
Health Economics 
Not applicable. 
8.2.4. 
Health-Related Patient-Reported Outcomes 
Health-related patient-reported outcome assessments will be performed at Cycle 1 and Cycle 2, 
then in alignment with imaging assessments, and at EOT or at safety follow-up if EOT and 
safety follow-up visits are combined.  Examples of HR-PRO assessments may include EQ-5D, 
EORTC-QLQ-C30, and QLQ-ANL27. 
8.2.4.1. 
EuroQol-5D 
EuroQol-5D is a standardized instrument developed by the EuroQol Group as a measure of 
health-related QoL that can be used in a wide range of health conditions and treatments.  The 
EQ-5D consists of a descriptive system and the EQ VAS. 
The descriptive system comprises 5 dimensions:  mobility, self-care, usual activities, 
pain/discomfort, and anxiety/depression.  The EQ VAS records the participant's self-rated health 
on a vertical visual analogue scale.  This can be used as a quantitative measure of health outcome 
that reflects the participant's own judgement.  The scores on these 5 dimensions can be presented 
as a health profile or can be converted to a single summary index number (utility) reflecting 
preferability compared with other health profiles. 
The 5L version of the EQ-5D will be utilized in this study. 
8.2.4.2. 
European Organization for the Research and Treatment of Cancer Quality of 
Life Questionnaire 
The QLQ-C30 is a validated, self-administered questionnaire.  It incorporates 9 multi-item 
scales:  5 functional scales (physical, role, cognitive, emotional, and social); 3 symptom scales 
(fatigue, pain, and nausea and vomiting); and a global health and QoL scale.  Several single-item 
symptom measures are also included. 

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8.2.4.3. 
Quality of Life Questionnaire for Anal Cancer 
The QLQ-ANL27 is a self-administered anal cancer–specific supplemental questionnaire, 
developed using EORTC QLG guidelines, and is available for use in clinical studies 
(Sodergren et al 2018).  This module is expected to be validated by the EORTC QLG before the 
end of this study. 
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 
INCMGA00012 or placebo, regardless of continuation of chemotherapy during induction cycles 
or start of a new anticancer therapy.  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 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 chemotherapy and/or INCMGA00012 or placebo, including INCMGA0012 
received by eligible participants during Crossover study procedures, or that caused the 
participant to discontinue chemotherapy and/or INCMGA00012 or placebo, including 
INCMGA00012 received by eligible participants during Crossover.  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 irAEs regardless of severity 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 AEs 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.  Comprehensive and targeted examinations are to be conducted as scheduled in Table 4 
and Table 5. 
The comprehensive physical examination will include assessment(s) of the following organ or 
body systems:  skin; head, eyes, ears, nose, and throat; thyroid; lungs; cardiovascular system; 
abdomen (liver, spleen); extremities; and lymph nodes; as well as a brief neurological 
examination.  For chemotherapy agents, additional testing may be necessary.  Refer to approved 
product label information for each chemotherapy agent used as study treatment, and perform 
additional tests as clinically indicated and as recommended in the approved labels. 
During the study, targeted examinations will be conducted unless otherwise clinically indicated.  
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. 
Abnormalities identified after the first dose of chemotherapy and/or INCMGA00012 or placebo, 
including INCMGA00012 received by eligible participants during Crossover constitute an AE if 
they are considered clinically meaningful, induce clinical signs or symptoms, require 
concomitant therapy, or require changes in chemotherapy and/or INCMGA00012 or placebo, 
including INCMGA00012 receive by eligible participants during Crossover. 
8.3.3. 
Vital Signs 
Vital sign measurements (to be taken before blood collection for laboratory tests) include blood 
pressure, pulse, respiratory rate, body temperature, height (at screening or before any study drug 
administration on Cycle 1 Day 1 only) and body weight.  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 treatment constitute an AE if 
they are considered clinically meaningful, induce clinical signs or symptoms, require 
concomitant therapy, or require changes in chemotherapy and/or INCMGA00012 or placebo, 
including INCMGA00012 received by eligible participants during Crossover. 
8.3.4. 
Electrocardiograms 
Electrocardiograms will be obtained as outlined in Table 4 and Table 5 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 discontinue study 
drug(s) 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. 

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The Fridericia (preferred) or Bazett correction method for calculating QTc will be used for 
reporting in the eCRF. 
8.3.5. 
Laboratory Assessments 
Clinical safety laboratory analyses (ie, blood chemistries, hematology assessments, coagulation 
tests, endocrine function, 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 drug administration, according to the schedules in Table 4 and 
Table 5.  The laboratory analytes to be evaluated are presented in Table 14.  Additional testing 
may be required by the sponsor based on emerging safety data.  Additional tests may also be 
performed if clinically indicated or due to COVID-19. 
Analysis by local laboratories for study drug–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 drug(s) 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 drug(s), laboratory analyses do not need to be repeated if the 
requirements for receiving study drug are met. 
If screening laboratory assessments are performed more than 7 days before Cycle 1 Day 1, then 
the tests must be repeated and eligibility confirmed as applicable before the start of initial study 
drug administration on Cycle 1 Day 1.  After Cycle 1, predose laboratory procedures can be 
conducted up to 72 hours before study drug administration, and results should be reviewed by the 
investigator or qualified designee and found to be acceptable before a new cycle of treatment is 
initiated. 
A final laboratory analysis is required during the 28-day safety follow-up visit.  These laboratory 
assessments should only be performed at the EOT visit if the EOT visit is also serving as the 
28-day safety visit. 
For participants who are known to be HIV-positive, laboratory checks of HIV viral load and 
CD4+ cell count will be performed per the frequency in Table 4 and Table 5. 

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Table 14: 
Required Laboratory Analytes 
Blood Chemistries 
Hematology 
Urinalysis With 
Microscopic Examination 
(only if blood or protein 
is abnormal) 
Coagulation 
Pregnancy Testing 
Albumin 
Alkaline phosphatase 
ALT 
AST 
Amylase 
Bicarbonate or carbon dioxidea 
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 
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 
Human chorionic 
gonadotropin 
Endocrine Function 
HIV Management Testingb 
TSH 
T4 or FT4a 
T3 or FT3a 
FSH (as needed) 
HIV viral load 
CD4+ cell count 
SARS-CoV-2 Tests 
SARS-CoV-2 tests 
(including types of 
approved tests) as per local 
clinical practice standards 
and evolving needs of the 
COVID-19 pandemic. 
Note:  Additional tests may be required, as agreed by investigator and sponsor, based on emerging safety data, or based on regional geographical differences, or depending on the 
extent of COVID-19 pandemic.  Relevant test results will be documented in eCRFs.  Tests are performed locally; if particular analytes may not feasible locally, the sponsor will 
arrange for those tests to be performed centrally.  Additional tests (eg, ILD) may be performed at any time during the study as determined necessary by the investigator or required 
by local regulations, or necessary to resolve and diagnose irAEs, or required by regions.  Specialized tests (eg, endocrine function tests) can be sent for testing to the sponsor's 
central laboratory upon request if local site testing is not available. 
a If considered standard by the region. 
b Only participants who are known to be HIV-positive. 

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8.3.6. 
Pregnancy Testing 
Serum pregnancy tests are required for all women of childbearing potential during screening, at 
either the EOT or safety follow-up visit, and through 120 days after the last dose of 
INCMGA00012 or placebo or through 180 days after the last dose of chemotherapeutic agents, 
whichever occurs later (additional testing may be performed during the post-treatment follow-up 
period if recommended by the investigator, or required by local regulation, or local practice).  
Telephone visits or telehealth/video visits can be utilized to check pregnancy status (via testing, 
including home pregnancy tests) during the same period when contraception is mandatory.  
Pregnancy testing is required on Day 1 of all cycles and can be either serum- or urine-based as 
applicable per country-specific requirements as per Table 4 and Table 5, and will be performed 
before administration of study drug(s).  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 9.6. 
Timing and type of pregnancy testing may be adjusted based on country-specific requirements. 
8.4. 
Pharmacokinetic and Antidrug Antibody Assessments 
Blood samples for PK and ADA analysis will be obtained at the visits and timepoints indicated 
in Table 4 and Table 15.  Pharmacokinetic sample sets are planned to be collected for 
approximately 20% of participants receiving INCMGA00012 (approximately 120 participants, as 
the study is blinded and randomized 1:1).  After the INCMGA00012 or placebo preinfusion PK 
sample is drawn, participants will receive premedication as applicable and begin infusion of 
INCMGA00012 or placebo.  Adjustments to the collection of and timing of 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. 
Drug concentration information that may unblind the study will not be reported to investigative 
sites or blinded personnel until the study has been unblinded, as PK is planned to be analyzed 
after the study is unblinded. 
Table 15: 
Pharmacokinetic and Antidrug Antibody Blood Sample Timing 
Study Visit 
Assessments 
Timing of Sample for PKa 
Timing of Sample for ADAa 
Cycle 1 Day 1 
PK, ADA 
Preinfusion 
Postinfusion 
Preinfusion 
Cycle  Day 1 
PK, ADA 
Preinfusion 
Preinfusion 
Cycle  Day 1 
PK, ADA 
Preinfusion 
Postinfusion 
Preinfusion 
Cycle  Day 1 
PK, ADA 
Preinfusion 
Preinfusion 
Cycle  Day 1 
PK, ADA 
Preinfusion 
Preinfusion 
Cycle 
 Day 1 
PK, ADA 
Preinfusion 
Preinfusion 
a Preinfusion:  within 24 hours before the start of infusion (within 2 hours before the start of infusion at Cycle 1 Day 1).  
Postinfusion:  immediately after INCMGA00012/placebo infusion (+ 10 minutes).  Sample must be collected before 
dose/infusion of other agents. 

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• Participant must have not received any other systemic anticancer therapies since 
study start other than the chemotherapy administered during the Study Drug 
Administration Period. 
• If required, the participant must have completed palliative radiotherapy (30 Gy or 
less) ≥ 7 days before the first dose of INCMGA00012 during the Crossover Period. 
• Must have adequate organ function as indicated by the laboratory values in Table 8. 
8.8. 
End of Treatment and/or Early Termination 
Once a participant permanently discontinues or completes all assigned study drug administration, 
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 all assigned study drug discontinuation occur < 21 days after the 
final dose of study drug(s) administration, a 28-day safety follow-up visit is required and should 
be conducted according to Table 4 and Table 5. 
If the EOT visit occurs ≥ 21 days after the last study drug administration, only a single 
EOT/28-day safety follow-up is required, and all unique assessments for the EOT and 28-day 
follow-up visit will be performed once. 
8.9. 
Follow-Up 
The study design includes a Follow-Up Period for participants subsequent to the end of the Study 
Drug Administration Period or Crossover Period, as appropriate.  After discontinuation of all 
assigned study drugs, including administration of INCMGA00012 to qualified participants in the 
Crossover Period, all study participants continue in the Follow-Up Period of the study as 
described in Table 4 and Table 5. 
8.9.1. 
Safety (28-Day) Follow-Up 
The Safety (28-day) Follow-Up starts once the participant discontinues all assigned study 
drug(s).  Approximately 28 days after the final dose of study drug(s) (± 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 4 and 
Table 5. 
Immune-related AEs will be collected for 90 days after the last dose of INCMGA00012 or 
placebo, regardless of continuation of chemotherapy during induction cycles or start of a new 
anticancer therapy.  Reasonable efforts should be made to align the first 12-week follow-up visit 
with the end of the 90-day irAE reporting period when applicable.  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. 
If a participant is scheduled to begin a new anticancer therapy before the end of the Safety 
Follow-Up, the Safety Follow-Up visit should be performed before a new anticancer therapy is 
started. 

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8.9.2. 
Post-Treatment Disease Follow-Up 
Participants who complete or early discontinue all assigned study drug(s) and have not 
experienced second disease progression, will move into Disease Follow-Up and should be 
assessed every 8 weeks (56 days ± 7 days) by radiologic imaging to monitor disease status. 
Upon implementation of Amendment 3, imaging may be performed at intervals according to 
local institution standard practice, but at least every 6 months. 
Immune-related AEs will be collected for 90 days after the last dose of INCMGA00012 or 
placebo, regardless of continuation of chemotherapy during induction cycles or start of a new 
anticancer therapy.  Reasonable efforts should be made to align the first 12-week Follow-Up 
Period visit with the end of the 90-day irAE reporting period when applicable.  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. 
Information regarding disease status will be collected until: 
• Second disease progression. 
• Death. 
• The end of the study. 
• Participant is lost to follow-up. 
8.9.3. 
Survival Follow-Up 
Once a participant has experienced second disease progression, the participant moves into 
Survival Follow-Up 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. 
Immune-related AEs will be collected for 90 days after the last dose of INCMGA00012 or 
placebo, regardless of continuation of chemotherapy during induction cycles or start of a new 
anticancer therapy.  Reasonable efforts should be made to align the first 12-week follow-up visit 
with the end of the 90-day irAE reporting period when applicable.  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. 
For participants having entered the Survival Follow-Up, the site will use continuing participant 
records to supply data on subsequent treatment regimens, tumor assessments, 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 every 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 
treatment. 
Additional Guidance for 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), should be reported as an AE. 
• 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 laboratory test 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 constitute an AE. 
• New conditions detected or diagnosed after study treatment administration even though they may 
have been present before the start of the study, should be reported as an AE. 
• Signs, symptoms, or the clinical sequelae of a suspected DDI constitute an AE. 
• Signs, symptoms, or the clinical sequelae of a suspected overdose of either study treatment 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.  
• "Lack of efficacy" or "failure of expected pharmacological action" per se will not be reported as an 
AE or SAE (including disease progression).  Such instances will be captured in the efficacy 
assessments.  
• A condition that leads to a medical or surgical procedure (eg endoscopy, appendectomy) is an 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) need not be considered adverse events. 
• Anticipated day-to-day fluctuations of pre-existing disease(s), or condition(s) present, or detected at 
the start of the study judged by the investigator to have worsened more than expected for the 
participant's condition since study participation, should be reported as an AE. 

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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 or planned surgery (eg, stent replacement, hip surgery) is not 
considered an SAE. 
Hospitalization for medical interventions in which no unfavorable medical occurrence occurred (ie, 
elective procedures or routine medical visits) are not considered SAEs. 
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 1 of the outcomes listed in the 
above definition.  Examples of such events include invasive or malignant cancers (excluding the 
disease[s] under study), 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.  Secondary malignancies should always be considered SAEs. 
For Japan, an event that may lead to disability is also considered an important medical event.  It 
includes a case that is exposed to a risk of dysfunction to an extent that interferes with daily life when 
the adverse drug reaction occurs.  It does not include an adverse drug reaction that, had the reaction 
been more severe, may have caused disability. 

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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.  AEs/SAEs should be reported for enrolled participants, but only 
SAEs need to be reported for screen failure participants.  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.  These records can be submitted to Incyte 
Pharmacovigilance by email/fax per the contact information listed in the Investigator Site File or as 
per SAE completing guidelines. 
• 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 v5.0 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(s):  
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 chemotherapy and/or INCMGA00012 or placebo, including 
INCMGA00012 received by eligible participants during Crossover 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: 

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• 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 medically significant but not immediately life-threatening; hospitalization or 
prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. 
• Grade 4:  Life-threatening consequences; urgent treatment indicated. 
• Grade 5:  Fatal. 
Assessment of Causality 
• The investigator is obligated to assess the relationship between study drug and each occurrence of 
each AE/SAE.  If reference therapy is used in combination with an Incyte study drug or multiple 
Incyte study drugs are used, the relationship to each study drug must be assessed (ie, for the Incyte 
product(s) and for the other product(s) that is used in combination with the Incyte product).  If 
appropriate, the relationship to the combination may be assessed as well. 
• 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 RSI 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 and reported to 
Incyte Pharmacovigilance (in the SAE EDC CRF) until resolution, stabilization, the event is 
otherwise explained, or the participant is lost to follow-up. 
• Any updated SAE data (including SAEs being downgraded to nonserious) will be submitted to the 
sponsor (or designee) within 24 hours of receipt of the information. 

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• 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 
INCMGA00012 or placebo, regardless of continuation of chemotherapy during induction cycles 
or start of a new anticancer therapy.  The investigator will submit any updated SAE data to the 
sponsor (or designee) within 24 hours of it being available. 
For Japan, this information must also be reported immediately to the head of the study site. 
Investigators are not obligated to actively seek AE or SAE information after conclusion of the 
above-defined timeframes.  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 chemotherapy and/or INCMGA00012 or placebo, including 
INCMGA00012 received by eligible participants during Crossover 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 irAEs 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 RSI of 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.  All SUSARs will be collected 
and reported to the competent authorities via the EudraVigilance database and to relevant ethics 
committees in accordance with the Clinical Trials Regulation (EU) No. 536/2014, Clinical Trials 
Information System guidelines, or as per current 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 

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will comply with country-specific regulatory requirements relating to safety reporting to the 
regulatory authority, IRB/IEC, and investigators. 
For Japan, the sponsor will report suspected expected deaths and life-threatening events to the 
PMDA as per local regulatory requirements. 
Investigator safety reports must be prepared for suspected unexpected serious adverse reactions 
according to local regulatory requirements and sponsor policy and forwarded to investigators as 
necessary. 
An investigator who receives an investigator safety report describing a SAE or other specific 
safety information (eg, summary or listing of SAEs) from the sponsor will review and then file it 
along with the IB and will notify the IRB/IEC, if appropriate according to local requirements. 
Serious Adverse Event Reporting 
• Information about all SAEs is collected and recorded on the Adverse Event Form in the eCRF. 
• The investigator may also need to complete the Incyte Serious Adverse Event Report Form, in 
English.  Refer to the Incyte Reference Guide for Completing the Serious Adverse Event Report 
Form. 
• The investigator must report within 24 hours of learning of its occurrence any SAE via the EDC 
system (primary method) or by completing the Serious Adverse Event Report Form in English (only 
if the EDC system is not available).  The contact information for Incyte Pharmacovigilance by 
email/fax is listed in the Investigator Site File. 
• In circumstances where the EDC system is not accessible for reporting SAE information (initial 
and/or follow-up SAE information) to the sponsor within 24 hours, refer to the Incyte Reference 
Guide for Completing the Serious Adverse Report Form.  Once the EDC system is functional, the 
SAE report should be retrospectively added to the EDC system and follow-up should be completed 
through the EDC.  The original copy of the Serious Adverse Event Report Form and the email or 
facsimile confirmation sheet must be kept at the study site (refer to the Incyte Reference Guide for 
Completing the Serious Adverse Report Form or Investigator Site File). 
• Follow-up information is also recorded in the eCRF and transmitted to Incyte Pharmacovigilance via 
the EDC system.  The follow-up report should include information that was not provided previously, 
such as the outcome of the event, treatment provided, action taken with study drug(s) 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.  
9.5. 
Emergency Unblinding of Study Drug Assignment 
In case of a medical emergency, for a participant's safety management, the procedure for 
emergency unblinding is provided to the investigator in the IRT Manual.  If a participant's drug 
assignment undergoes emergency unblinding, the sponsor or its designee should be notified 
immediately for awareness. 
If an investigator, site personnel performing assessments, or participant is unblinded during 
emergency unblinding, the participant must be withdrawn from the study drug, unless there are 
ethical reasons to have the participant remain on the study drug.  In these cases, the investigator 
must obtain specific approval from the sponsor's (or its designees) medical monitor for the 
participant to continue to receive the unblinded study drug. 

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9.6. 
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: 
• Chemotherapy and INCMGA00012 or placebo, including INCMGA00012 received 
during Crossover, must be interrupted immediately (female participants only). 
• If the female participant is no longer pregnant and meets the treatment continuation 
criteria within 12 weeks of the scheduled start of a cycle, study drug may be resumed 
after approval has been received from the sponsor medical monitor. 
• The investigator must complete and submit the Incyte Clinical Trial Pregnancy Form 
to the sponsor or its designee within 24 hours of learning of the pregnancy. 
Data on fetal outcome are collected for regulatory reporting and drug safety evaluation.  
Follow-up should be conducted for each pregnancy to determine outcome, including spontaneous 
or voluntary termination, details of the birth, and the presence or absence of any birth defects, 
congenital abnormalities, or maternal and/or newborn complications, by following until the first 
well-baby visit.  Pregnancy should be recorded on a Clinical Trial Pregnancy Form and reported 
by the investigator to the sponsor or its designee.  Pregnancy follow-up information should be 
recorded on the same form and should include an assessment of the possible causal relationship 
to the sponsor's study drug to any pregnancy outcome, as well as follow-up to the first well-baby 
visit or the duration specified in local regulations, whichever is later.  Refer to the Incyte 
Reference Guide for Completing the Clinical Trial Pregnancy Form. 
Any SAE occurring during pregnancy of a study participant must be recorded and 
reported as described in Section  9.4. 
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. 
9.7. 
Warnings and Precautions 
Special warnings or precautions for INCMGA00012, 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.  Special 
warnings or precautions to the chemotherapy agents used are further detailed in the approved 
labels. 
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. 

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9.8. 
Product Complaints 
The sponsor collects product complaints on study drugs and drug delivery systems used in 
clinical studies in order to ensure the safety of study participants, monitor quality, and facilitate 
process and product improvements. 
All product complaints associated with material packaged, labeled, and released by the sponsor 
or its designee will be reported to the sponsor.  All product complaints associated with other 
study material will be reported directly to the respective manufacturer. 
The investigator or his/her designee is responsible for reporting a complete description of the 
product complaint via email or other written communication to the sponsor contact or respective 
manufacturer as noted in the packaging information.  Any AE associated with a product 
complaint should be 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. 
For Japan, complaints associated with unapproved medical devices will be reported to the 
sponsor with a Medical Device Report Form, and the sponsor will report medical device defects 
to the PMDA as per local regulatory requirements. 
9.9. 
Treatment of Overdose of INCMGA00012 
Overdose (accidental or intentional) is to be reported as an AE (see Section 9.1). If the overdose 
meets serious criteria, the overdose term should be reported as an SAE (see Section 9.2). 
Additionally, signs and/or symptoms resulting from overdose are to be reported as an AE/SAE. 
For this study, any dose of INCMGA00012 ≥ 
 mg within a 24-hour time period (± 1 hour) 
will be considered an overdose. 
The sponsor does not recommend specific treatment for an overdose.  In the event of an overdose 
of INCMGA00012, the investigator should: 
• Contact the medical monitor and sponsor immediately. 
• Closely monitor the participant for any AE/SAE and laboratory abnormalities as per 
Section 9.2. 
• Document the quantity of the excess dose as well as the duration of the overdose in 
the eCRF. 
Decisions regarding dose interruptions or modifications will be made by the investigator in 
consultation with the medical monitor based on the clinical evaluation of the participant. 
There has been no clinical experience with overdose of INCMGA00012.  Treatment of overdose 
should consist of general supportive measures. 

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10.3. 
Level of Significance 
The level of significance for the primary and key secondary endpoints of PFS and OS, 
respectively, is strongly controlled at 1-sided 2.5%.  A 1-sided 2.5% will be initially assigned to 
the PFS endpoint.  If the hypothesis testing of the PFS endpoint is rejected, the alpha will be 
allocated to test the OS endpoint.  Within the OS endpoint, the Type I error will be controlled by 
a group sequential design with Lan-DeMets (O'Brien and Fleming 1979) alpha spending 
function.  If both the PFS and OS tests indicate statistical significance, ORR by RECIST v1.1 
will be tested in an alpha-controlled manner. 
10.4. 
Statistical Analyses 
10.4.1. 
Efficacy Analyses 
10.4.1.1. Primary Efficacy Analyses 
Progression-free survival (PFS) is defined as the time from the date of randomization to the date 
of the first documented progression or death due to any cause.  The PFS will be assessed via 
BICR according to RECIST v1.1.  Survival data will be analyzed by the Kaplan-Meier method, 
treating participants with no observed death or disease progression as censored at the date of the 
last adequate tumor assessment before data cut off or new anticancer therapy.  The PFS as 
assessed via investigator may be provided as supportive analysis of the primary endpoint. 
The primary efficacy endpoint of PFS will be analyzed using a stratified log-rank test at an 
overall 1-sided 2.5% level of significance based on the data observed in the FAS population, 
according to the treatment group participants were randomized and the strata they were assigned 
at randomization.  The distribution of PFS will be estimated using the Kaplan-Meier method.  
The median PFS along with 95% confidence intervals will be presented by treatment group.  A 
stratified Cox regression with Efron's method for tie handling will be used to estimate the hazard 
ratio of PFS, along with 95% confidence intervals using the same strata information assigned at 
randomization. 
10.4.1.2. Key Secondary Efficacy Analyses 
Overall survival is defined as the time from the date of randomization to the date of death due to 
any cause.  The efficacy analysis of OS comparing the 2 treatment groups will be a stratified 
log-rank test at an overall 1-sided 2.5% level of significance in the FAS population, according to 
the treatment group participants were randomized and the strata they were assigned at 
randomization.  Kaplan-Meier curves, medians, and 95% confidence intervals of the median OS 
will be presented for each treatment group.  The hazard ratio for OS will be calculated, along 
with its 95% confidence interval, from a stratified Cox model using the same stratification 
factors as for the log-rank test with Efron's likelihood approximation to account for ties in event 
times.  The analysis of OS will follow gatekeeping procedure (ie, hypothesis testing on OS will 
only occur if hypothesis on PFS is rejected).  An interim OS analysis will be performed at the 
time of the PFS analysis, and final OS analysis will be performed when there are at least 
 death events observed or later.  Summary statistics of OS endpoint will still be provided if 
PFS does not cross boundary. 

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10.4.1.3. Secondary Efficacy Analyses 
• Overall response rate is defined as the percentage of participants with CR or PR, 
according to RECIST v1.1 (Eisenhauer et al 2009) as determined by BICR.  The 
analysis of ORR will be based on the FAS.  Objective response rate and its exact 
95% CI will be presented.  Odds ratio from CMH test will also be provided. 
• Duration of response is defined as the time from first documented response (CR or 
PR) to the time of first documented disease progression per RECIST v1.1 as 
determined by BICR or death due to any cause.  If a participant does not have an 
event, 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. 
• Disease control rate is defined as the proportion of participants with an overall 
response (CR and PR), or stable disease per RECIST v1.1, according to the BICR.  
The DCR will be estimated, and the exact 95% CI will be reported. 
10.4.2. 
Safety Analyses 
10.4.2.1. 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. 
10.4.2.2. Clinical Laboratory Tests 
The clinical laboratory data will be analyzed using summary statistics.  In addition, distributions 
of key laboratory parameters may be plotted over time; these values will also be classified into 
CTCAE toxicity grades and tabulated. 
Laboratory test values outside the normal range will be assessed for severity based on the normal 
ranges for the clinical reference laboratory.  The incidence of abnormal laboratory values and 
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. 

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− 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. 
− Ensuring study-site compliance with the requirements of EU CTR No. 536/2014. 
− Assigning tasks among the members of the team of investigators in a way that 
does not compromise the safety of participants or the reliability and robustness of 
the data generated at the clinical study site. 
• The investigator will adhere 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. 
− The investigator will retain the content of the clinical trial master file, essential 
documents, AE documentation, and medical and other study records in 
accordance with all local, national, and regulatory laws but for a minimum period 
of at least 30 years for the US, 25 years for EEA countries, and a flexible 
approach of up to 30 years for regions outside the US and EEA, unless specific 
country regulations dictate otherwise after completion or discontinuation of the 
study or as described in the final executed copy of the individual site agreement, 
or for 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 formal discontinuation of clinical 
development of the test article and the regulatory authority is notified, whichever 
is longer, 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 during the 
retention period 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. 
• For Japan, the record retainer (delegated by head of study site) will retain the  
J-GCP–defined essential documentation at this site until the regulatory approval of 
study drug(s)/treatment, or at least 3 years after the discontinuation or completion of 
the study conduct, whichever is longer.  If the sponsor requires retention of these 
documents for a longer period of time, the duration and method of retention will be 
decided upon through discussion between the sponsor and the study site.  It is the 
responsibility of the sponsor to inform the head of the study site as to when the 
documents no longer need to be retained. 

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11.1.1. 
Identification of the Coordinating Principal Investigator 
A coordinating principal investigator will be appointed by the sponsor medical monitor before 
the end of the study.  As part of his or her responsibilities, the coordinating principal investigator 
will review the final CSR.  Agreement with the final CSR will be documented by the dated 
signature of the coordinating principal investigator. 
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 with 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, study charters, or biomarker plans, as applicable. 
The sponsor (or designee) will be responsible for the following: 
• 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 the following: 
• 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, biomarker data, photographs, diary data), 
or as otherwise specified in the Protocol. 
• Maintaining adequate and accurate source documents and study records that include 
all pertinent observations on each of the site's study participants. Source data should 
be attributable, legible, contemporaneous, original, accurate, and complete. Changes 
to source data should be traceable, should not obscure the original entry, and should 
be explained if necessary (eg, via an audit trail). Source data are, in general, all 
information in original records and certified copies of original records of clinical 
findings, observations, or other activities in a clinical study necessary for the 

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reconstruction and evaluation of the study. Source data are contained in source 
documents (original records or certified copies). 
• 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 and 
available at the investigator's site. Examples of source documents are original 
documents, data, and records (eg, hospital records; electronic hospital records; 
clinical and office charts; laboratory notes; memoranda; participants' diaries or 
evaluation checklists; pharmacy dispensing records; recorded data from 
automated instruments; copies or transcriptions certified after verification as 
being accurate copies; microfiches; photographic negatives; microfilm or 
magnetic media; x-rays; participants' files; and e-records/records kept at the 
pharmacy, at the laboratories, and at medico-technical departments involved in 
the clinical study). 
− 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.  Current applicable medical records must be available. 
• Sending participants' data, either as unique samples, 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. 

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− 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 protection laws 
and regulations.  The investigator and the sponsor or its designee are responsible for ensuring 
that personal information is handled in accordance with local data protection laws (including but 
not limited to HIPAA and GDPR) as applicable.  Appropriate consent for collection, use and 
disclosure and/or transfer (if applicable) of personal information must be obtained in accordance 
with local data protection laws. 
To ensure confidentiality of records and protect personal data, participant names will not be 
supplied to the sponsor or its designee. There may be certain duly authorized and contracted 
vendors managing participants' services such as for travel and meal reimbursement, home 
delivery services, and/or parking, in which case those vendors will have the participant's directly 
identifiable personal information but in no circumstances will that directly identifiable 
information be transferred or sent to the sponsor.  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 appropriate technical and 
organizational measures as required by local data protection laws. 
In the event of a data breach involving participant data, the sponsor or its designee will follow 
the sponsor's incident response procedures.  The precise definition of a data breach varies in 
accordance with applicable law but may generally be understood as a breach of security leading 
to the accidental or unlawful destruction, loss, alteration, unauthorized disclosure of, or access to, 
personal data.  In accordance with its incident response procedures, the sponsor will assess the 
breach to consider its notification and remediation obligations under applicable law. 
11.4. 
Financial Disclosure 
Before study initiation, all clinical investigators participating in clinical studies subject to FDA 
Regulation Title 21 CFR Part 54 – Financial Disclosure by Clinical Investigators (ie, "covered 
studies") are required to submit a completed Clinical Investigator Financial Disclosure Form that 
sufficiently details any financial interests and arrangements that apply.  For the purpose of this 
regulation, "clinical investigator" is defined as any investigator or subinvestigator who is directly 
involved in the treatment or evaluation of research participants, including the spouse and each 
dependent child of the clinical investigator or subinvestigator.  These requirements apply to both 
US and foreign clinical investigators conducting covered clinical studies. 
Any new clinical investigators added to the covered clinical study during its conduct must also 
submit a completed Clinical Investigator Financial Disclosure Form.  During a covered clinical 
study, any changes to the financial information previously reported by a clinical investigator 

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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. 
11.6. 
Study and Site Closure 
The sponsor designee reserves the right to close the study site or terminate the study at any time 
at the sole discretion of the sponsor or the IRB/IEC.  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. 
For Japan, when the study is completed, the investigator should inform the head of the study site 
of the completion in writing and submit a written summary of the study's outcome, and then the 
head of the study site should promptly inform the IRB and sponsor or designee of the completion 
in writing. 
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. 

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Further reasons for the early closure of a study site (eg, premature termination) by the sponsor, 
investigator, or the IRB/IEC  may include but are not limited to the following: 
• Failure of the investigator to comply with the Protocol, the requirements of the 
IRB/IEC or local health authorities, the sponsor's procedures or site agreement, or 
GCP guidelines. 
• Inadequate recruitment of participants by the investigator. 
• Discontinuation of further study drug development. 
• Circumstances beyond the control of the sponsor or investigator that make it 
unreasonable to require the continuation of the study or site. 
• Failure to carry out the study in the interest of the health of the participants. 
• Failure to demonstrate that the continuation of an IRB-/IEC-approved study (ie, the 
IRB/IEC had previously issued a positive decision on the study) has scientific merit. 
• Financial reasons (eg, the sponsor is declared insolvent or a bankruptcy petition has 
been filed). 

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12. 
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Malek AE, Cornejo PP, Daoud N, Alam M. The mRNA COVID-19 vaccine in patients with 
cancer receiving checkpoint inhibitor therapy: what we know and what we don't [published 
online ahead of print November 8, 2021]. Immunotherapy. doi:10.2217/imt-2021-0235. 
Mandala M, Lorigan P, De Luca M, et al. SARS-CoV-2 infection and adverse events in patients 
with cancer receiving immune checkpoint inhibitors: an observational prospective study. J 
Immunother Cancer 2021;9:e001694. 
Marabelle A, Cassier P, Fakih M, et al. Pembrolizumab for advanced anal squamous cell 
carcinoma: results from the Phase 2 KEYNOTE-158 study. Oral presentation at ASCO-GI 2020, 
San Francisco, CA. 
McNeil CJ, Lee JS, Cole SR, et al. Centers for AIDS Research (CFAR) Network of Integrated 
Clinical Systems (CNICS). Anal cancer incidence in MSM with HIV: are black men at higher 
risk? AIDS 2022;36:657-664. 
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. 
Mehnert JJ, Paz-Ares L, Pikiel J, et al. A Phase 1 study of INCMGA00012, a PD-1 inhibitor, in 
patients with advanced solid tumors: preliminary results for patients with advanced cervical 
cancer (POD1UM-101). Presented at the 34th Annual Meeting of The Society for 
Immunotherapy of Cancer. November 6-10, 2019; National Harbor, MD. Abstract P394. 
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. 
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https://seer.cancer.gov/statfacts/html/anus.html. 
National Comprehensive Cancer Network. Anal Carcinoma (Version 2.2019 – August 28, 
2019a). 
National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Cancer in 
People Living with HIV (Version 2.2019 – July 2, 2019b). 
National Comprehensive Care Network. National Comprehensive Cancer Network Clinical 
Practice Guidelines in Oncology: Management of Immunotherapy Related Toxicities Version 
3.2021. 2021a. 

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National Comprehensive Care Network. NCCN: Cancer and COVID-19 Vaccination. 
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Vaccination Advisory Committee. Version 4.0. 2021b. 
O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics 
1979;35:549-556. 
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. 
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pembrolizumab in patients with recurrent carcinoma of the anal canal. Ann Oncol 
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Paz-Ares L, Luft A, Vicente D, et al. Pembrolizumab plus chemotherapy for squamous 
non-small-cell lung cancer. N Engl J Med 2018;379:2040-2051. 
Rao S, Capdevila J, Gilbert D, et al. Preliminary results of a Phase 2 study of INCMGA00012 in 
patients with squamous carcinoma of the anal canal (SCAC) who have progressed following 
platinum-based chemotherapy (NCT03597295). Poster presented at: 34th Congress of the 
Society for Immunotherapy of Cancer; November 9, 2019; National Harbor, MD. Abstract P826. 
Rao S, Sclafani F, Eng C, et al. InterAACT, a multicenter open label randomised Phase II 
advanced anal cancer trial of cisplatin (CDDP) plus 5 fluorouracil (5FU) vs carboplatin (C) plus 
weekly paclitaxel (P) in patients (pts) with inoperable locally recurrent (ILR) or metastatic 
treatment naïve disease - an international rare cancers initiative (IRCI ) trial. Ann Oncol 
2018;29:Abstract P669. 
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Phase II Trial of Cisplatin and Fluorouracil Versus Carboplatin and Paclitaxel in Advanced Anal 
Cancer: InterAAct. J Clin Oncol. 2020;38(22):2510-2518. 
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while vaccine supply is limited. Cancer Discov 2021;11:233-236. 
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triple-negative breast cancer. N Engl J Med 2018;379:2108-2121. 
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in patients treated with immune checkpoint inhibitor therapy: ASCO guideline update [erratum 
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of myeloid-derived suppressor cells and chronic inflammation in the spontaneous melanoma 
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trials testing immunotherapeutics. Lancet Oncol 2017;18:e143-e152. 
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releases/2020/sitc-statement-sars-cov-2-vaccination-cancer-immunotherapy 

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Socinski MA, Jotte RM, Cappuzzo F, et al. Atezolizumab for first-line treatment of metastatic 
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ANL27, a health-related quality of life questionnaire for anal cancer. Radiother Oncol 
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chemotherapy for advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma: the 
Phase III KEYNOTE-062 study. J Clin Oncol 2019;37:18(suppl):LBA4007. 
Tenforde MW, Self WH, Adams K, et al. Association between mRNA vaccination and 
COVID-19 hospitalization and disease severity. JAMA 2021;326:2043-2054. 
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systematic review and meta-analysis. J Immunother Cancer 2018;6:155. 

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APPENDIX A. INFORMATION REGARDING EFFECTIVENESS OF 
CONTRACEPTIVE METHODS AND RELEVANT 
DEFINITIONS 
Definitions: 
WOCBP:  A woman is considered fertile following menarche and until becoming postmenopausal 
unless permanently sterile (see below). 
Women in the following categories are not considered WOCBP: 
• 
Premenarchal 
• 
Premenopausal female with 1 of the following: 
o Documented hysterectomy 
o Documented bilateral salpingectomy 
o Documented bilateral oophorectomy 
Note:  Documentation can come from the site personnel's review of the participant's 
medical records, medical examination, or medical history interview. 
• 
Postmenopausal female 
o A postmenopausal state is defined as no menses for 12 months without an alternative 
medical cause. 
o A high follicle-stimulating hormone (FSH) level in the postmenopausal range may be used 
to confirm a postmenopausal state in women not using hormonal contraception or 
hormonal replacement therapy (HRT).  However, in the absence of 12 months of 
amenorrhea, confirmation with 2 FSH measurements in the postmenopausal range is 
required. 
o Females on HRT and whose menopausal status is in doubt will be required to use 1 of the 
nonhormonal highly effective contraception methods if they wish to continue their HRT 
during the study.  Otherwise, they must discontinue HRT to allow confirmation of 
postmenopausal status before study enrollment. 
For male participants of reproductive potential in the study: 
Male participants with female partners of childbearing potential are eligible to participate if they agree 
to 1 of the following during the protocol-defined timeframe in Section 5.1: 
• 
Be abstinent from penile-vaginal intercourse as their usual and preferred lifestyle (abstinent on a 
long-term and persistent basis) and agree to remain abstinent.  The reliability of sexual abstinence 
needs to be evaluated in relation to the duration of the clinical study and to the timeframe defined 
in Section 5.1 and the preferred and usual lifestyle of the participant.  Sexual abstinence is not an 
approved method of contraception in Japan. 
• 
Use a male condom plus partner use of an additional contraceptive method when having 
penile-vaginal intercourse with a woman of childbearing potential who is not currently pregnant. 
• 
Male participants who have had a successful vasectomy (medically assessed) qualify as having 
met the requirement for a highly effective birth control method. 

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For female participants in the study who are WOCBP: 
The following methods during the protocol-defined timeframe in Section 5.1 that can achieve a failure 
rate of less than 1% per year when used consistently and correctly are considered as highly effective 
birth control methods: 
• 
Combined (estrogen and progestogen containing) hormonal contraception associated with 
inhibition of ovulationa 
− 
oral 
− 
intravaginal (administration route not approved in Japan) 
− 
transdermal (administration route not approved in Japan) 
• 
Progestogen-only hormonal contraception associated with inhibition of ovulationa 
(progesterone-only hormonal contraception is not approved in Japan, so this bullet and its 
sub-bullets will not apply for Japan) 
− 
oral 
− 
injectable 
− 
implantableb 
• 
Intrauterine deviceb 
• 
Intrauterine hormone-releasing systemb 
• 
Bilateral tubal occlusionb 
• 
Vasectomized partnerbc 
• 
Sexual abstinenced (sexual abstinence is not approved in Japan) 
For female participants in the study who are WOCBP and male participants of reproductive 
potential in the study: 
Please refer to local labeling for paclitaxel and carboplatin for additional information regarding 
contraception and fertility issues, including oocyte and sperm preservation advice, with the use of these 
chemotherapeutic agents. 
a Hormonal contraception may be susceptible to interaction with the investigational medicinal product, which may 
reduce the efficacy of the contraception method. 
b Contraception methods that in the context of this guidance are considered to have low user dependency. 
c Vasectomized partner is a highly effective method of avoiding pregnancy provided that partner is the sole sexual 
partner of the woman of childbearing potential study participant and that the vasectomized partner has received 
medical assessment of the surgical success. 
d In the context of this guidance, sexual abstinence is considered a highly effective method only if defined as 
refraining from heterosexual intercourse during the entire period of risk associated with the study drugs.  The 
reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study, the time 
duration mentioned in Section 5.1, and the preferred and usual lifestyle of the participant. 
Source:  Clinical Trials Facilitation and Coordination Group 2014. 

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APPENDIX B. RESPONSE CRITERIA FOR SOLID TUMORS 
VERSION 1.1 
General principles of RECIST v1.1 are provided below.  For full details, please refer to 
Eisenhauer et al 2009. 
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. 
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. 
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. ASSESSMENT OF TUMOR RESPONSE FOR 
IMMUNE-BASED THERAPEUTICS (iRECIST) 
A modified version of RECIST v1.1 for immune-based therapeutics will be used to assess tumor 
response to guide treatment decisions for discontinuation of therapy due to disease progression 
(Seymour et al 2017).  These disease assessments for clinically stable participants will be 
performed by the study site and will be collected in the clinical database. 
Participants may receive study drug pending confirmation of PD if they are clinically stable as 
defined by the following criteria: 
• Absence of clinically significant signs and symptoms (including worsening of 
laboratory values) indicating disease progression. 
• No decline in ECOG performance status. 
• No requirement for intensified management of disease-related symptoms (requiring 
urgent medical intervention such as symptomatic pleural effusion, spinal cord 
compression). 
If radiologic imaging shows iUPD, tumor assessment should be repeated ≥ 4 weeks later (but no 
later than 8 weeks) to confirm PD by iRECIST with the option of continuing treatment while 
awaiting radiologic confirmation of progression.  Image measurements will be collected in the 
clinical database. 
When clinically stable, participants should not be discontinued from treatment until progression 
is confirmed per iRECIST.  The decision to continue treatment after iUPD is observed is at the 
investigator's discretion and should be based on the clinical status of the participant as described 
above. 
Participants who are clinically unstable are not required to continue to receive study drug once 
the investigator has determined PD by RECIST v1.1, and they are not required to have repeat 
imaging for the iCPD. 
If the participant continues to be clinically stable, and if the repeat imaging does not confirm PD 
by iRECIST as assessed by the investigator, study drug may continue and follow the imaging 
schedule. 
If PD is confirmed by iRECIST, participants will be discontinued from study drug. 
Every effort should be made to continue monitoring their disease status by radiologic imaging 
until the participant has iCPD, starts a new anticancer therapy, withdraws consent, or dies.  If a 
follow-up scan was not performed after unconfirmed PD (eg, due to patient refusal or patient 
death), the initial date of unconfirmed progression will be considered the date of PD. 

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APPENDIX D. COVID-19 PANDEMIC GUIDANCE 
Introduction 
The COVID-19 global pandemic, including peaks and troughs, presents challenges to the 
ongoing conduct of clinical trials.  In line with regulatory guidance regarding clinical study 
execution during the pandemic, the sponsor has standardized protocol considerations to ensure 
participant safety is maintained and adequate benefit/risk analyses are applied relative to 
participation in the study, completion of study procedures, and objectives (EMA 2021). 
Recognizing the dynamic nature of the COVID-19 pandemic and the flexibility required to 
manage the impact of the pandemic on ongoing clinical studies, details and additions may need 
to be added to respective study manuals and site-specific monitoring plans as applicable, with 
institutional and health authority requirements and approvals as warranted, and communicated 
and discussed with investigative sites as needed.  Relevant test results will be documented in the 
eCRF, and applicable changes to the ICF will be made and monitored. 
SARS-CoV-2 Infection and Participation in the Study 
Benefit/risk assessment in the context of the COVID-19 pandemic is provided in Section 2.2.1. 
COVID-19 Vaccination During Participation in the Study 
The following are guidelines for SARS-CoV-2 vaccination, timing, and precautions: 
• If participants are vaccinated during the study, it is recommended that a vaccine is not 
administered on the day of study treatment or study drug infusion.  Administration of 
study treatment or study drug is recommended to be given at least 3 days later to 
ensure possible acute AEs due to the vaccine are managed and resolved or stable. 
• The vaccination dose or doses and manufacturer, if known, must be entered in the 
EDC system as a concomitant medication.  
• Since corticosteroids may be given for defined, relatively brief periods such as in the 
management of irAE toxicity  investigators may consider delaying second dose of a 
vaccine against SARS-CoV-2 (if needed to be given during the study for example) 
until a corticosteroid regimen has been completed or the dose has been reduced to 
≤ 10 mg of prednisone or equivalent. 
• Any AEs resulting from the vaccination and medications for treating the AEs must be 
entered in the eCRFs. 
• While based on approved vaccines available worldwide, many vaccines are not live 
(mRNA and adenovirus vaccines do not contain live virus), if a live vaccine against 
SARS-CoV-2 is the only available option, prior consultation with the medical 
monitor should be obtained. 

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• If a potential participant recovered from COVID-19 within approximately 6 months 
before signing the ICF, a negative test (PCR or antigen) and consultation with the 
sponsor's medical monitor are required for eligibility.  This approach is necessary due 
to the dynamic changing nature of the COVID-19 pandemic, including but not limited 
to understanding of the available and approved (types) of tests, interpretation of 
SARS-CoV-2 antibody test results,  prior possible relevant vaccination received, and 
safety of a potential participant. 
Study Site Visits and Study Procedures 
If local travel restrictions, isolation requirements, or the investigator's benefit/risk assessment 
determines it to be unsafe for participants to attend study visits at the investigational site, the site 
staff may elect to pursue the following: 
• Predose laboratory procedures may be conducted ± 5 days before dosing (versus the 
± 3-day time window described in Section 8.3.5) and must be reviewed before dosing.  
During COVID-19 pandemic restrictions, safety labs may be conducted at hospitals 
near the participant's home, provided the data can be transferred to the study site and 
entered in the eCRFs, or at a relevant clinical facility authorized/certified (as legally 
required nationally) to perform such tests routinely, if this can be done within local 
restrictions on social distancing.  
− The sites should inform the sponsor about such arrangements.  
• In order to minimize participant risk, some study procedures such as a review of AEs 
and concomitant medications may be conducted via telemedicine modalities (phone 
or video) where appropriate or as per site institutional guidelines during the 
COVID-19 pandemic.  Information reviewed must be available in the investigator's 
site binder and entered in the eCRFs.  On-site visits should be conducted whenever 
feasible and are required for administration of study treatment. 
− The participant may also be asked to undergo additional safety laboratory 
assessments. 
• If study procedures are anticipated to be missed, then a potential participant should 
not be consented, as it is important to assess the safety and efficacy of the 
investigational study treatment. 
− In general, compliance with the Protocol should be ensured to such an extent that 
an ongoing benefit-risk assessment for the clinical trial and potential participants 
is still possible. 
• During COVID-19 pandemic restrictions only, scans for disease assessments may be 
delayed by an additional 7 days from the time allowed in the Protocol (see Table 4 
and Table 5 for details).  
• If necessary, scans may be done at a different hospital only if the quality and 
methodology is the same as the participating study site and the images can be 
transferred properly to the study site.  It is the investigator's responsibility to confirm 
that the external facility meets these requirements before any scans are performed at 
that location. 

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Note:  The sponsor has reviewed relevant guidance on the implications of COVID-19 on 
methodological aspects of ongoing clinical trials by the CHMP Biostatistics Working Party 
published on 25 MAR 2020 (EMA 2020). 
Study Drug and Study Treatment Administration 
If necessary, study treatment administration may be delayed up to 3 weeks due to COVID-19 
pandemic restrictions unless otherwise discussed with the sponsor.  The reason for interruption 
should be documented in the participant's medical records and eCRFs (eg, "due to COVID-19"). 
Chemotherapy and INCMGA00012/placebo cannot be administered at home. 
Study Treatment Management in the Event of SARS-CoV-2 Infection 
The following recommendations are necessary in the event of SARS-CoV-2 infection during the 
trial: 
• If a participant develops a SARS-CoV-2 infection, the event should be reported as an 
AE (or SAE if it meets the SAE definition requirements according to Section 9.2) and 
appropriate medical intervention should be provided. 
• Postbaseline SARS-CoV-2 testing should follow country-specific requirements 
depending on the extent of the COVID-19 pandemic, local institutional guidance, or 
investigator's clinical judgment. 
• For participants who are diagnosed with COVID-19 during the study (positive 
SARS-CoV-2 test) or presumed affected by SARS-CoV-2 infection (test pending), 
study treatment should be delayed until the SARS-CoV-2 test is negative and the 
participant has clinically recovered from symptoms. 
− In addition, prior to restarting treatment, the participant should be afebrile for 72 
hours and SARS-CoV-2–related symptoms (if any) should have resolved for a 
minimum of 72 hours. 
• Safety monitoring following COVID-19 should be implemented as per institutional 
guidance or clinical judgment (eg, coagulation factors). 
• Concomitant medication administered for treatment of SARS-CoV-2 infection should 
be carefully considered for potential drug-drug interactions, and medications should 
be recorded in the eCRFs. 
Clinical Study Monitoring 
Site monitoring guidelines and principles are listed below: 
• Study monitoring visits may be postponed; however, the site monitor and sponsor 
should continue to employ off-site monitoring practices such as routine 
communication methods (eg, phone calls, emails, video visits) with the sites to get 
information on study progress, participant status, and issue resolution. 

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• The study monitor may remotely review data entered into the eCRFs for accuracy and 
completeness if allowed and first approved by the national regulatory body or 
investigational site and/or in compliance with local authorities (EMA 2021). 
− If remote source data verification focusing on quality control of critical data as 
per the monitoring plan or equivalent is not permitted, an investigational site will 
not be able to enroll new participants. 
Reimbursement of Additional Expenses 
If permitted by local or legal requirements, the sponsor may reimburse participants for any 
extraordinary expenses, keeping appropriate documentation as evidence (eg, travel expenses for 
the local laboratory visit[s], private transportation, the costs of local [proximate] laboratory 
tests). 

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APPENDIX E. ADDITIONAL INFORMATION FOR HOSPITAL 
DISCHARGE FOR SITES IN JAPAN 
Japanese participants are required to be hospitalized until the investigator assesses their ability to 
safely tolerate the study treatment after the first administration.  The participant cannot be 
discharged if any of the following criteria are met on Cycle 1 Day 8: 
• Grade 4 thrombocytopenia or ≥ Grade 3 thrombocytopenia with clinically significant 
bleeding (requires hospitalization, transfusion of blood products, or other urgent 
medical intervention). 
• ≥ Grade 4 neutropenia. 
• ≥ Grade 3 febrile neutropenia. 
• Grade 4 anemia not explained by underlying disease or unrelated illnesses (eg, 
hemolysis). 
• Thrombocytopenia requiring platelet transfusion or anemia requiring red blood cell 
transfusion. 
• Grade 3 nausea/vomiting or diarrhea, which cannot be managed with adequate 
antiemetic and other supportive care. 
• Grade 3 fatigue. 
Note:  Updates may be included in an operational manual until a future amendment is 
planned. 

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APPENDIX F. PROTOCOL AMENDMENT SUMMARY OF CHANGES 
Amendment 3 (04 FEB 2025) 
The primary purpose of the amendment is to update the frequency of imaging during the disease 
follow-up phase of the study and to incorporate administrative updates required by EU CTR. 
Additional changes are summarized below. 
1. Section 1, Protocol Summary (Table 2: Key Study Design Elements); (Table 4: 
Schedule of Activities; Table 5: Crossover Period Schedule of Activities); 
Section 8.2.1.4, Tumor Imaging During Disease Follow-up; Section 8.9.2, 
Post-Treatment Disease Follow-up 
Description of change: Frequency of imaging during the disease follow-up period was 
updated to match local institution standard interval. 
Rationale for change: To add flexibility for participants now that the primary endpoint 
has been met. 
2. Title Page; Section 9.4, Reporting of Serious Adverse Events; Section 11.1, 
Investigator Responsibilities; Section 11.3, Data Privacy and Confidentiality of 
Study Records 
Description of change: Added text as required by new EU CTR directives. 
Rationale for change: Health authority requirement. 
3. Section 3, Objectives and Endpoints (Table 6: Objectives and Endpoints); 
Section 10.4.3, Exploratory Analyses 
Description of change: Removed the exploratory endpoint of 
 
Rationale for change: This analysis will not be performed. 
4. Section 4.2, Overall Study Duration 
Description of change: Updated definition of end of study. 
Rationale for change: To allow for timely study closure. 
5. Section 4.2, Overall Study Duration; Section 6.7, Treatment After the End of Study 
Description of change: Added text regarding possible access to INCMGA00012 after 
the study is closed. 
Rationale for change: Declaration of Helsinki updates. 
6. Incorporation of administrative changes. Other administrative changes have been 
incorporated throughout the Protocol and are noted in the redline version of the 
amendment. 
Document 
Date 
Original Protocol (Version 1-UK) 
01 SEP 2020 
Amendment 1 
21 DEC 2021 
Amendment 2 
25 MAY 2022 
Amendment 3 
04 FEB 2025 

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Amendment 2 (25 MAY 2022) 
Overall Rationale for the Amendment:  To update dose modification table, eligibility criteria 
for Japanese participants, SARS-CoV-2 vaccine requirement, and add justification for collection 
of participants' ethnic origin data.  Additional changes are summarized below. 
1. Section 1, Protocol Summary (Table 4:  Schedule of Activities); Section 5.1, 
Inclusion Criteria (Criterion 10); Section 8.1.6, COVID Vaccination; Appendix D, 
COVID-19 Pandemic Mitigation Strategies and Instructions 
Description of change:  Participant vaccination against SARS-CoV-2 changed from 
mandatory to highly recommended. 
Rationale for change:  In view of waning incidence and severity of new COVID-19 
cases in many geographic regions; and in order to be sensitive to potential participants 
who wish not to be vaccinated or have a contraindication to vaccination. 
2. Section 4.2, Overall Study Duration 
Description of change:  Added that in the EU/EEA, the results of the study will be based 
on the date of the last visit of the last participant in the study globally. 
Rationale for change:  As per recent EU Clinical Trial Regulation, it is required in the 
EU to post results within 1 year of study completion.  In this study, for analysis purposes, 
results will be posted after the last participant's last visit date has been reached globally 
(not just in the EU).  This will ensure the results are robust, meaningful, and 
representative of all multi-regions by having complete follow-up data determined by the 
statistical hypotheses for the objectives established. 
3. Section 5.1, Inclusion Criterion 2 
Description of change:  The age requirement for the study population enrolled in Japan 
will be updated to indicate that participants enrolled in this study on or prior to 
31 MAR 2022 must be aged ≥ 20 years; beginning 01 APR 2022, participants may be 
aged ≥ 18 years. 
Rationale for change:  Effective 01 APR 2022, the age of adulthood in Japan changes 
from ≥ 20 years to ≥ 18 years. 
4. Section 6.1.3, Carboplatin 
Description of change:  Correction of typographical error for CrCl. 
Rationale for change:  Editorial change. 
5. Section 6.5.2.2. INCMGA00012 or Placebo (Table 10:  Guidelines for Management 
of Suspected Infusion Reactions for Study Drug) 
Description of change:  Added a note to clarify management of Grade 3 infusion 
reactions. 
Rationale for change:  To allow for continued dosing for participants who are 
responsive to treatment. 

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6. Section 6.5.4.1, Procedures for Participants Exhibiting Immune-Related Adverse 
Events (Table 12:  Dose Modifications of INCMGA00012 or Placebo and Toxicity 
Management Guidelines for Immune-Related Adverse Events) 
Description of change:  Updated toxicity management for diarrhea/colitis, AST/ALT 
elevations, adrenal insufficiency, hypophysitis, nephritis, skin reactions, and all other 
irAEs. 
Rationale for change:  To align with current toxicity management used for 
INCMGA00012 program-wide. 
7. Section 8.1.7.1, Demography and Medical History 
Description of change:  Added scientific rationale for the collection of participants' 
ethnic origin and gender.  The term "race" was removed from the text. 
Rationale for change:  To provide justification for collection of sensitive data needed 
for analyses. 
8. Section 8.2.1, Tumor Imaging and Assessment of Disease; Section 8.2.2, iRECIST 
Assessment of Disease 
Description of change:  Updated use of iRECIST for participant management to be 
applied during both blinded and crossover phases of the study. 
Rationale for change:  To clarify intent of the protocol. 
9. Section 8.2.1.2, Tumor Imaging During Study Drug Administration Period; 
Section 8.7, Crossover Period 
Description of change:  Updated text to clarify eligibility for Crossover Period. 
Rationale for change:  To clarify intent and align with the other sections of the protocol. 
10. Section 8.5.1, Tumor Tissue Biopsies 
Description of change:  Removed reference to China. 
Rationale for change:  China will not be participating in the study. 
11. Incorporation of administrative changes.  Other minor, administrative changes have 
been incorporated throughout the Protocol and are noted in the redline version of the 
amendment. 

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Amendment 1 (21 DEC 2021) 
Overall Rationale for the Amendment:  To remove interim analyses, clarify eligibility criteria 
and contraceptive methods, and update dose modification table and other changes as requested 
by Health Authorities.  Additional changes are summarized below. 
1. Section 1, Protocol Summary (Table 2:  Key Study Design Elements); Section 5.5, 
Data Monitoring Committee; Section 10.1, Sample Size Determination; 
Section 10.4.1.1, Primary Efficacy Analyses; Section 10.5, Interim Analyses 
Description of change:  Removed planned interim analyses for efficacy. 
Rationale for change:  To address regulatory concerns that an interim analysis may not 
provide an accurate or reproducible estimate of treatment effect. 
2. Section 1, Protocol Summary (Table 2:  Key Study Design Elements); Section 4.1, 
Overall Design 
Description of change:  Added text to clarify that nonevaluable tumors refers to tumor 
tissue that cannot be analyzed for PD-L1 status. 
Rationale for change:  To clarify that nonevaluable tumor tissue is for determination of 
PD-L1 status for the purposes of stratification is capped at 10%. 
3. Section 1, Protocol Summary; Section 4.1, Overall Design 
Description of change:  Added 3-day window to dosing visits for INCMGA00012 or 
placebo. 
Rationale for change:  To allow for participant flexibility. 
4. Section 1, Protocol Summary (Table 4:  Schedule of Activities); Section 5.1, 
Inclusion Criteria (Criterion 6) 
Description of change:  Updated timeframe for archive biopsy sampling from within 
6 months to within 9 months. 
Rationale for change:  To improve feasibility of obtaining this information which is 
required for stratification. 
5. Section 1, Protocol Summary (Figure 1:  Study Design Schema); Section 5.1, 
Inclusion Criteria (Criterion 8a) 
Description of change:  Adjusted the CD4+ count criteria for HIV-positive participants 
from ≥ 300 to ≥ 200. 
Rationale for change:  Change made in line with evolving recommendations for 
inclusion of HIV-positive participants in clinical trials (NCCN 2019). 

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6. Section 1, Protocol Summary (Table 4:  Schedule of Activities; Table 5:  Crossover 
Period Schedule of Activities); Section 8.2.1.2, Tumor Imaging During Study Drug 
Administration Period; Section 8.2.1.3, Tumor Imaging During the Crossover 
Period; Section 8.2.1.4, Tumor Imaging During Disease Follow-up; Section 8.9.2, 
Post-Treatment Disease Follow-Up 
Description of change:  Updated the frequency of tumor imaging from Q12W to Q8W. 
Rationale for change:  To support exploratory endpoint of 
 and new exploratory 
endpoint of 
 during Crossover Period. 
7. Section 1, Protocol Summary (Table 4:  Schedule of Activities; Table 5:  Crossover 
Period Schedule of Activities), Section 8.3.6, Pregnancy Testing 
Description of change:  Updated timing and methods for pregnancy testing. 
Rationale for change: To address comments from health authorities. 
8. Section 2.2.1, Benefit/Risk Assessment During the COVID-19 Pandemic; 
Section 6.5.1, General Dose Modifications; APPENDIX D:  COVID-19 Pandemic 
Mitigation Strategies and Instructions 
Description of change:  Section and appendix were added to update the protocol with 
potential risks associated with the current COVID-19 outbreak along with risk mitigation 
measures.  
Rationale for change:  To address comments from health authorities. 
9. Section 2.2 Benefit/Risk Assessment 
Description of change:  Added information from completed and ongoing trials with 
participants known to be HIV-positive. 
Rationale for change:  To support risk:benefit assessment in HIV-positive participants. 
10. Section 3, Objectives and Endpoints (Table 6:  Objectives and Endpoints); 
Section 10.4.3.1, Progression-Free Survival After Next Line of Treatment 
(Progression Free Survival 2); Section 10.1, Sample Size Determination; 
Section 10.3, Level of Significance; Section 10.4.1.3, Secondary Efficacy Analyses 
Description of change:  Added new exploratory endpoint and updated associated 
statistical methods. 
Rationale for change:  To provide additional estimation of the treatment effect based on 
recommendations from health authorities. 

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11. Section 4.3, Study Termination; Section 5.1, Inclusion Criteria (Criterion 2a); 
Section 6.1.1, Timing of Dose Administration; Section 6.2, Preparation, Handling, 
and Accountability; Section 9.2, Definition of Serious Adverse Event; Section 9.4, 
Reporting of Serious Adverse Events; Section 9.10, Product Complaints; 
Section 11.1, Investigator Responsibilities; Section 11.6, Study and Site Closure; 
APPENDIX A:  Information Regarding Effectiveness of Contraceptive Methods and 
Relevant Definitions; APPENDIX E:  Additional Information for Hospital 
Discharge for Sites in Japan 
Description of change:  Added clarifications and administrative procedures specific to 
sites participating in Japan. 
Rationale for change:  To comply with Japanese GCP requirements. 
12. Section 5.1, Inclusion Criteria 
Description of change:  Updated inclusion criterion 5 to include any tissue collected 
during biopsy as a requirement for measurable disease. 
Rationale for change:  For clarification. 
13. Section 5.1 Inclusion Criteria; Section 6.6.1, Permitted Medications and Procedures; 
Section 8.1.6, COVID-19 Vaccination 
Description for Change:  New inclusion criterion 10 was added.  Potential participants 
are to be fully vaccinated against SARS-CoV-2 before randomization or complete 
vaccination during the trial.  SARS-CoV-2 vaccines and applicable ancillary procedures 
and tests were added to the list of permitted medications and procedures. 
Rationale for Change:  Participants with advanced cancer are at increased risk of 
developing severe COVID-19 and therefore will likely derive substantial benefit from 
vaccination against SARS-CoV-2.  Due to expanding protection for potential participants 
participating in a research study and as per recommendations by the main international 
worldwide oncology societies (eg, ASCO, ESMO), participants with cancer, including 
those undergoing treatments (eg, chemotherapy, immunotherapy, and targeted treatment), 
should receive an approved COVID-19 vaccination.  Thus, the sponsor is adding this new 
requirement as safety precaution. 
14. Section 5.2, Exclusion Criteria 
Description of change:  Added eligibility criteria to exclusion criterion 2 in regards to 
palliative radiotherapy. 
Rationale for change:  For clarification. 
15. Section 5.2, Exclusion Criteria 
Description of change:  Updated eligibility criteria for exclusion criterion 10 in regards 
to prior antibiotic use. 
Rationale for change:  To align with newer INCMGA00012 guidance regarding 
antibiotic use. 

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16. Section 5.2, Exclusion Criteria 
Description for Change: Under exclusion criterion 10, a note was added to indicate that 
participants may be tested for COVID-19 during screening if required by country or local 
regulations. A participant will be excluded if they have a positive screening test result for 
SARS-CoV-2 infection.  Participants should be included only after they have a negative 
screening retest result for SARS-CoV-2 infection and no clinical symptoms. 
Rationale for Change:  Part of dynamic COVID-19 safety, social, and community 
precautions.  It is understood that this requirement may evolve depending on the 
COVID-19 prevalence rate or surges, and vaccination rates in a region; thus, this 
requirement may change and is dependent on local COVID-19 country and/or local 
and/or legal requirements.  Documentation will be available in the investigator's site 
binder.  
17. Section 6.1, Study Drugs Administered (Table 9:  Study Drug Information) 
Description of change:  Updated carboplatin infusion period from 
 minutes to 
 minutes. 
Rationale for change:  To correct an existing discrepancy in the protocol for carboplatin 
infusion timeframe. 
18. Section 6.1, Study Drugs Administered (Table 9:  Study Drug Information); 
Section 6.1.2, Paclitaxel 
Description of change:  Updated paclitaxel infusion period from 
 minutes to 
 minutes. 
Rationale for change:  To add a window for paclitaxel infusion timeframe. 
19. Section 6.5.4.1, Procedures for Participants Exhibiting Immune-Related Adverse 
Events (Table 12:  Dose Modifications of INCMGA00012 or Placebo and Toxicity 
Management Guidelines for Immune-Related Adverse Events) 
Description of change:  Updated toxicity management for hepatitis, endocrinopathies, 
hypophysitis, nephritis, skin reactions, myocarditis, and all other irAEs. 
Rationale for change:  To align with current toxicity management used INCMGA00012 
program-wide. 
20. Section 6.6.2, Prohibited Medications and Procedures 
Description of change:  Updated exceptions for use of corticosteroids during study. 
Rationale for change:  To align with standard of care premedication prior to 
administration of chemotherapy agents. 
21. Section 8.2.4 Health-Related Patient-Reported Outcomes 
Description of change:  Updated timing of health-related patient-reported outcome 
assessments. 
Rationale for change: For clarification. 

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22. Section 8.3, Safety Assessments (Table 14:  Required Laboratory Analytes) 
Description of change:  Added FT4 to the required laboratory analytes. 
Rationale for change:  In consideration of local regions where this is standard testing, 
FT4, where appropriate, is allowed in place of T4. 
23. Section 9.2, Definition of Serious Adverse Event; Section 9.3, Recording and 
Follow-Up of Adverse Events and/or Serious Adverse Events 
Description of change:  Modified language to align with the most updated protocol 
template. 
Rationale for change:  Updated based on current protocol template. 
24. 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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Original Protocol (Version 1-UK; 01 SEP 2020) 
Overall Rationale for the Revised Version:  To clarify the emergency unblinding process and 
clarify reproductive, fertility, and contraceptive protocol guidance.  Additional changes are 
summarized below. 
1. Section 5.1, Inclusion Criteria 
Description of change:  Updated inclusion criterion 9 to include language for refraining 
from donating oocytes and to incorporate all language regarding WOCBP in Appendix A. 
Rationale for change:  To include a definition of WOCBP in the study protocol and to 
clarify that the timing for refraining from donating oocytes is the same as that for 
appropriate precautions to avoid pregnancy. 
2. Section 8.3.5, Laboratory Assessments (Table 14:  Required Laboratory Analytes) 
Description of change:  Added follicle-stimulating hormone to the required laboratory 
analytes. 
Rationale for change:  To confirm a postmenopausal state in women as described in 
Appendix A. 
3. Section 9.5, Emergency Unblinding of Study Drug Assignment 
Description of change:  Removed the phrase "if knowledge of the study drug assignment 
is necessary to determine optimal medical management."  
Rationale for change:  To clarify that the investigator cannot be required to discuss 
unblinding if he or she feels that emergent unblinding is necessary. 
4. Appendix A, Information Regarding Effectiveness of Contraceptive Methods and 
Relevant Definitions 
Description of change:  Added the definition of WOCBP. 
Rationale for change:  To clarify that for female participants in the study for which this 
appendix applies, these are WOCBP, and to provide the definition of WOCBP.  
Description of change:  Inserted the phrase "of reproductive potential" in the section 
regarding male participants in the study.  Deleted language regarding the timing of use of 
contraception and donation of sperm to avoid duplication, and added text regarding 
eligibility to participate. 
Rationale for change:  To clarify that for male participants in the study for which this 
appendix applies, these are men of reproductive potential, and the timing of use of 
contraception and donation of sperm already appears in inclusion criterion 10. 
Description of change:  Inserted the phrase "who are WOCBP" in the section regarding 
female participants in the study.  
Rationale for change:  To clarify that for female participants in the study for which this 
Appendix applies, these are WOCBP. 

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Description of change:  Deleted birth control methods with a failure rate of more than 
1% from the table and footnotes. 
Rationale for change:  To avoid confusion between highly effective contraceptive 
method (< 1% failure rate per year) and birth control methods with a failure rate of more 
than 1%. 
Description of change:  Inserted reference to local labeling for paclitaxel and 
carboplatin.  
Rationale for change:  To clarify the location of further information regarding 
contraception and fertility issues with the use of these chemotherapeutic agents, such as 
sperm preservation advice. 
5. Incorporation of administrative changes.  Other minor, administrative changes have 
been incorporated throughout the Protocol and are noted in the redline version of the 
amendment.