Conditions: Metastatic Merkel Cell Carcinoma
Keywords: Metastatic merkel cell carcinoma anti-PD-1 antibody immunoglobulin G4 (IgG4) monoclonal antibody INCMGA00012
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 107
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with advanced/metastatic Merkel cell carcinoma (MCC).

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Retifanlimab
Intervention descriptions: intervention 1: INCMGA00012 administered at 500 milligrams (mg) by intravenous infusion once every 4 weeks

Protocol document:
Prot_000.pdf: 
A Phase 2 Study of INCMGA00012 in Participants With Metastatic Merkel 
Official Title: 
NCT Number: 
NCT03599713
Document Date: 
Clinical Study Protocol Version 7.0: 16 December 2021
Cell Carcinoma (POD1UM-201) 


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Protocol INCMGA 0012-201 Am 7 
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CONFIDENTIAL 
Clinical Study Protocol 
INCMGA 0012-201 
A Phase 2 Study of INCMGA00012 in Participants With Metastatic 
Merkel Cell Carcinoma (POD1UM-201) 
Product: 
INCMGA00012 
IND Number: 
139,181 
EudraCT Number: 
2018-001627-39 
Phase of Study: 
2 
Sponsor: 
Incyte Corporation 
1801 Augustine Cut-Off 
Wilmington, DE 19803 
Original Protocol (Version 0): 
07 JUN 2018 
Amendment (Version) 1: 
27 JUN 2018 
Amendment (Version) 2: 
04 OCT 2018 
Amendment (Version) 3: 
05 DEC 2018 
Amendment (Version) 4: 
16 AUG 2019 
Amendment (Version) 5: 
09 APR 2020 
Amendment (Version) 6: 
22 OCT 2020 
Amendment (Version) 7: 
16 DEC 2021 
This study will be performed in accordance with ethical principles that have their origin in the Declaration of 
Helsinki and conducted in adherence to the study Protocol, applicable Good Clinical Practices, and applicable laws 
and country-specific regulations in which the study is being conducted. 
The information in this document is confidential.  No part of this information may be duplicated, referenced, or 
transmitted in any form or by any means (electronic, mechanical, photocopy, recording, or otherwise) without prior 
written consent. 


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INVESTIGATOR'S AGREEMENT 
I have read the INCMGA 0012-201 Protocol Amendment 7 (Version 7 dated 16 DEC 2021) and 
agree to conduct the study as outlined.  I agree to maintain the confidentiality of all information 
received or developed in connection with this Protocol. 
 
 
 
 
 
(Printed Name of Investigator) 
 
 
 
 
 
 
 
 
(Signature of Investigator) 
 
(Date) 


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TABLE OF CONTENTS 
LIST OF ABBREVIATIONS ..........................................................................................................9 
1. 
PROTOCOL SUMMARY ..........................................................................................12 
2. 
INTRODUCTION ......................................................................................................19 
2.1. 
Background .................................................................................................................19 
2.2. 
Study Rationale ...........................................................................................................20 
2.2.1. 
Justification for Dose ..................................................................................................20 
2.3. 
Benefit/Risk Assessment ............................................................................................21 
2.3.1. 
Benefit/Risk Assessment During the COVID-19 Pandemic ......................................21 
3. 
OBJECTIVES AND ENDPOINTS ............................................................................22 
4. 
STUDY DESIGN .......................................................................................................24 
4.1. 
Overall Design ............................................................................................................24 
4.2. 
Overall Study Duration ...............................................................................................25 
4.3. 
Study Termination ......................................................................................................25 
4.3.1. 
Data Monitoring Committee .......................................................................................25 
5. 
STUDY POPULATION .............................................................................................27 
5.1. 
Inclusion Criteria ........................................................................................................27 
5.2. 
Exclusion Criteria .......................................................................................................27 
5.3. 
Lifestyle Considerations .............................................................................................30 
5.4. 
Screen Failures ............................................................................................................30 
5.5. 
Replacement of Participants .......................................................................................30 
6. 
STUDY TREATMENT ..............................................................................................31 
6.1. 
Study Treatment Administered ...................................................................................31 
6.2. 
Preparation, Handling, and Accountability ................................................................31 
6.3. 
Measures to Minimize Bias:  Randomization and Blinding .......................................32 
6.4. 
Study Treatment Compliance .....................................................................................32 
6.5. 
Dose Modifications .....................................................................................................32 
6.5.1. 
Management of Suspected Infusion Reactions ...........................................................33 
6.5.2. 
Procedures for Participants Exhibiting Immune-Related Adverse Events .................34 
6.5.2.1. 
Immune-Mediated Pneumonitis ..................................................................................34 
6.5.2.2. 
Immune-Mediated Colitis/Enterocolitis/Diarrhea ......................................................35 
6.5.2.3. 
Immune-Mediated Hepatitis .......................................................................................35 


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6.5.2.4. 
Immune-Mediated Endocrinopathies ..........................................................................36 
6.5.2.5. 
Immune-Mediated Nephritis and Renal Dysfunction .................................................38 
6.5.2.6. 
Immune-Mediated Skin Reactions .............................................................................38 
6.5.2.7. 
Immune-Mediated Myocarditis ..................................................................................39 
6.5.2.8. 
Immune-Mediated Nervous System Events ...............................................................40 
6.5.2.9. 
Other Immune-Mediated Adverse Events ..................................................................40 
6.5.3. 
Permanent Discontinuation of Study Drug Due to Toxicity ......................................41 
6.6. 
Concomitant Medications and Procedures .................................................................41 
6.6.1. 
Permitted Medications and Procedures ......................................................................41 
6.6.2. 
Prohibited Medications and Procedures .....................................................................41 
6.7. 
Treatment After the End of the Study .........................................................................42 
7. 
DISCONTINUATION OF STUDY TREATMENT AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL ..................................................................43 
7.1. 
Discontinuation of Study Treatment ...........................................................................43 
7.1.1. 
Reasons for Discontinuation .......................................................................................43 
7.1.2. 
Discontinuation Procedures ........................................................................................43 
7.2. 
Participant Withdrawal From the Study .....................................................................44 
7.3. 
Lost to Follow-Up.......................................................................................................44 
8. 
STUDY ASSESSMENTS AND PROCEDURES ......................................................45 
8.1. 
Administrative and General Procedures .....................................................................45 
8.1.1. 
Informed Consent Process ..........................................................................................45 
8.1.2. 
Screening Procedures ..................................................................................................46 
8.1.3. 
Interactive Response Technology Procedure ..............................................................46 
8.1.4. 
Distribution of Reminder Cards ..................................................................................46 
8.1.5. 
Demography and Medical History ..............................................................................46 
8.1.5.1. 
Demographics and General Medical History .............................................................46 
8.1.5.2. 
Disease Characteristics and Treatment History ..........................................................47 
8.2. 
Efficacy Assessments .................................................................................................47 
8.2.1. 
Tumor Imaging ...........................................................................................................47 
8.2.2. 
Photographic Analysis of Skin Lesions ......................................................................48 
 
48 
8.2.4. 
Health Economics .......................................................................................................48 
 
48 


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48 
 
49 
8.3. 
Safety Assessments .....................................................................................................49 
8.3.1. 
Adverse Events ...........................................................................................................49 
8.3.2. 
Physical Examinations ................................................................................................50 
8.3.3. 
Vital Signs ..................................................................................................................50 
8.3.4. 
Eastern Cooperative Oncology Group Performance Status ........................................50 
8.3.5. 
Electrocardiograms .....................................................................................................51 
8.3.6. 
Laboratory Assessments .............................................................................................51 
8.3.6.1. 
Pregnancy Testing ......................................................................................................52 
8.4. 
Pharmacokinetic Assessments ....................................................................................54 
 
54 
 
54 
 
55 
 
55 
8.6. 
Unscheduled Visits .....................................................................................................56 
8.7. 
End of Treatment and/or Early Termination ..............................................................56 
8.8. 
Follow-Up ...................................................................................................................56 
8.8.1. 
Safety Follow-Up ........................................................................................................56 
8.8.2. 
Post-Treatment Disease Follow-Up ............................................................................57 
8.8.3. 
Survival Follow-Up ....................................................................................................57 
9. 
ADVERSE EVENTS:  DEFINITIONS AND PROCEDURES FOR 
RECORDING, EVALUATING, FOLLOW-UP, AND REPORTING ......................58 
9.1. 
Definition of Adverse Event .......................................................................................58 
9.2. 
Definition of Serious Adverse Event ..........................................................................59 
9.3. 
Recording and Follow-Up of Adverse Events and/or Serious Adverse Events .........60 
9.4. 
Reporting of Serious Adverse Events .........................................................................62 
9.5. 
Adverse Events of Special Interest .............................................................................63 
9.6. 
Emergency Unblinding of Treatment Assignment .....................................................63 
9.7. 
Pregnancy ...................................................................................................................64 
9.8. 
Warnings and Precautions ..........................................................................................64 
9.9. 
Product Complaints ....................................................................................................65 
9.10. 
Treatment of Overdose ...............................................................................................65 


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10. 
STATISTICS ..............................................................................................................66 
10.1. 
Sample Size Determination ........................................................................................66 
10.2. 
Populations for Analysis .............................................................................................66 
10.3. 
Level of Significance ..................................................................................................66 
10.4. 
Statistical Analyses .....................................................................................................67 
10.4.1. 
Primary Analysis ........................................................................................................67 
10.4.1.1. 
Overall Response Rate ................................................................................................67 
10.4.1.2. 
Handling of Missing Data in Primary Analysis ..........................................................67 
10.4.2. 
Secondary Analysis ....................................................................................................67 
10.4.2.1. 
Duration of Response .................................................................................................67 
10.4.2.2. 
Disease Control Rate ..................................................................................................67 
10.4.2.3. 
Progression-Free Survival ..........................................................................................68 
10.4.2.4. 
Overall Survival ..........................................................................................................68 
10.4.3. 
Safety Analyses ..........................................................................................................68 
10.4.3.1. 
Adverse Events ...........................................................................................................68 
10.4.3.2. 
Adverse Events of Special Interest .............................................................................68 
10.4.3.3. 
Clinical Laboratory Tests ...........................................................................................68 
10.4.3.4. 
Vital Signs ..................................................................................................................69 
10.4.3.5. 
Electrocardiograms .....................................................................................................69 
10.4.3.6. 
Dose Intensity .............................................................................................................69 
10.4.4. 
Pharmacokinetics ........................................................................................................69 
10.4.5. 
Exploratory Analyses ..................................................................................................69 
 
69 
 
69 
 
70 
 
70 
 
70 
10.4.5.6. 
Efficacy Endpoints for Full Study Population ............................................................70 
10.5. 
Futility Analysis..........................................................................................................70 
11. 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS ..................................................................................................71 
11.1. 
Investigator Responsibilities .......................................................................................71 
11.2. 
Data Management .......................................................................................................72 


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11.3. 
Data Privacy and Confidentiality of Study Records ...................................................73 
11.4. 
Financial Disclosure ...................................................................................................73 
11.5. 
Publication Policy .......................................................................................................74 
11.6. 
Study and Site Closure................................................................................................74 
12. 
REFERENCES ...........................................................................................................75 
APPENDIX A. INFORMATION REGARDING EFFECTIVENESS OF 
CONTRACEPTIVE METHODS ...............................................................................79 
APPENDIX B. RESPONSE EVALUATION CRITERIA FOR SOLID TUMORS 
VERSION 1.1 .............................................................................................................80 
82 
APPENDIX D. COVID-19 PANDEMIC MITIGATION STRATEGIES AND 
INSTRUCTIONS .......................................................................................................85 
APPENDIX E. PROTOCOL AMENDMENT SUMMARY OF CHANGES ............................87 
 
LIST OF TABLES 
Table 1: 
Primary and Secondary Objectives and Endpoints .....................................................12 
Table 2: 
Key Study Design Elements .......................................................................................13 
Table 3: 
Schedule of Activities .................................................................................................15 
Table 4: 
Pharmacokinetic 
 Sample Collections ............................................17 
Table 5: 
Objectives and Endpoints ...........................................................................................22 
Table 6: 
Exclusionary Laboratory Values ................................................................................28 
Table 7: 
Study Treatment Information .....................................................................................31 
Table 8: 
Guidelines for Management of Suspected Infusion Reactions ...................................33 
Table 9: 
Recommended Approach to Handling Pneumonitis ...................................................35 
Table 10: Recommended Approach for Handling Colitis/Enterocolitis/Diarrhea ......................35 
Table 11: Recommended Approach for Handling Hepatitis .......................................................36 
Table 12: Recommended Approach for Handling Hypophysitis ................................................37 
Table 13: Recommended Approach for Handling Thyroid Disorders ........................................37 
Table 14: Recommended Approach for Handling New Onset Type 1 Diabetes 
Mellitus/Hyperglycemia .............................................................................................38 
Table 15: Recommended Approach for Handling Adrenal Insufficiency ..................................38 
Table 16: Recommended Approach for Handling Nephritis and Renal Dysfunction ................38 
Table 17: Recommended Approach for Handling Skin Reactions .............................................39 


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Table 18: Recommended Approach for Handling Myocarditis ..................................................39 
Table 19: Recommended Approach for Handling Immune-Mediated Nervous System 
Events .........................................................................................................................40 
Table 20: Recommended Approach to Handling Other Immune-Mediated Adverse 
Events .........................................................................................................................40 
Table 21: Eastern Cooperative Group Performance Status Scoring ...........................................50 
Table 22: Required Laboratory Analytes ....................................................................................53 
Table 23: Pharmacokinetic and Antidrug Antibody Serum Blood Sample Timing ...................54 
56 
Table 25: Populations for Analysis .............................................................................................66 
 


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LIST OF ABBREVIATIONS 
Abbreviations and 
Special Terms 
Definition 
 
 
AE 
adverse event 
ALT 
alanine aminotransferase 
ANC 
absolute neutrophil count 
aPTT 
activated partial thromboplastin time 
ASCO 
American Society of Clinical Oncology 
AST 
aspartate aminotransferase 
CI 
confidence interval 
CNS 
central nervous system 
COVID-19 
coronavirus disease 2019 
CR 
complete response according to RECIST v1.1 
CRF 
case report form 
CT 
computerized tomography 
CTCAE 
Common Terminology Criteria for Adverse Events 
DCR 
disease control rate 
DMC 
Data Monitoring Committee 
 
 
DOR 
duration of response 
ECG 
electrocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
eCRF 
electronic case report form 
EDC 
electronic data capture 
EOT 
end of treatment 
 
  
ESMO 
European Society for Medical Oncology 
 
  
FAS 
full analysis set 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
GDPR 
General Data Protection Regulation 
HDL 
high-density lipoprotein 
HIPAA 
Health Insurance Portability and Accountability Act 
HIV 
human immunodeficiency virus 
 
 


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Abbreviations and 
Special Terms 
Definition 
IB 
Investigator's Brochure 
ICF 
informed consent form  
ICH 
International Council for Harmonisation of Technical Requirements for  
Pharmaceuticals for Human Use 
 
 
 
 
ICR 
Independent Central Radiographic Review 
IEC 
independent ethics committee 
 
 
INR 
international normalized ratio 
 
 
irAE 
immune-related adverse event 
IRB 
institutional review board 
 
 
IRT 
interactive response technology 
 
 
 
 
IV 
intravenous 
LDL 
low-density lipoprotein 
MCC 
Merkel cell carcinoma 
MedDRA 
Medical Dictionary for Regulatory Activities 
MRI 
magnetic resonance imaging 
mRNA 
messenger RNA 
MTD 
maximum tolerated dose 
NCCN 
National Comprehensive Cancer Network 
NCI 
National Cancer Institute 
NE 
not evaluable 
ORR 
overall response rate  
OS 
overall survival 
PD 
progressive disease  
PD-1 
programmed cell death protein 1 
PD-L1 
programmed cell death ligand protein 1 
PFS 
progression-free survival 
PK 
pharmacokinetic(s) 
PR 
partial response according to RECIST1.1 
 
 


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Abbreviations and 
Special Terms 
Definition 
PT 
prothrombin time 
PTT 
partial thromboplastin time 
Q2W 
once every 2 weeks 
Q4W 
once every 4 weeks 
RECIST v1.1 
Response Evaluation Criteria in Solid Tumors version 1.1 
 
 
RNAseq 
ribonucleic acid sequencing 
SAE 
serious adverse event 
SARS-CoV-2 
severe acute respiratory syndrome coronavirus 2 (a strain of the coronavirus 
family causing coronavirus disease 2019) 
SD 
stable disease 
TCR 
T-cell receptor 
TEAE 
treatment-emergent adverse event 
TIL 
tumor-infiltrating lymphocytes 
TSH 
thyroid-stimulating hormone 
ULN 
upper limit of normal 
UV 
ultraviolet 
WBC 
white blood cell 


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1. 
PROTOCOL SUMMARY 
Protocol Title:  A Phase 2 Study of INCMGA00012 in Participants With Metastatic Merkel Cell 
Carcinoma (POD1UM-201) 
Protocol Number:  INCMGA 0012-201 
Objectives and Endpoints: 
Primary and secondary endpoints and objectives are presented in Table 1. 
Table 1: 
Primary and Secondary Objectives and Endpoints 
Objectives 
Endpoints 
Primary 
To determine the efficacy of INCMGA00012 in 
terms of the ORR in chemotherapy-naive 
participants with advanced/metastatic MCC. 
ORR, defined as the percentage of participants 
having an objective response (CR or PR), 
according to RECIST v1.1, as determined by ICR. 
Secondary 
To determine the DOR, DCR, PFS, and OS in the 
chemotherapy-naive population with 
advanced/metastatic MCC treated with 
INCMGA00012. 
• DOR, defined as the time from an initial 
objective response (CR or PR) according to 
RECIST v1.1 until disease progression, or death 
due to any cause, as determined by ICR. 
• DCR, defined as the proportion of participants 
with either an objective response or SD lasting 
at least 6 months. 
• PFS, defined as the time from the start of 
therapy until disease progression, or death due 
to any cause, as determined by the ICR. 
• OS, defined as the time from the start of therapy 
until death due to any cause. 
To evaluate the safety of INCMGA00012 in 
participants with advanced/metastatic MCC. 
Safety, determined by the number, frequency, 
duration, and severity of AEs using CTCAE v5.0; 
laboratory tests; vital signs; and ECGs. 
To determine the PK of INCMGA00012 
administered to participants with 
advanced/metastatic MCC. 
The PK of INCMGA00012 when given to 
participants with advanced/metastatic MCC, 
including Cmax, tmax, Cmin, and AUCt, will be 
summarized. 
Overall Design: 
Key study design elements are presented in Table 2.  Further study details are presented after the 
table. 


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Table 2: 
Key Study Design Elements 
Study Phase 
Phase 2 
Clinical Indication 
Advanced/Metastatic MCC 
Population 
Male and female participants at least 18 years of age who have been diagnosed 
with advanced/metastatic MCC.  Participants must be chemotherapy-naive to 
be eligible. 
Participants who had received prior chemotherapy for MCC were enrolled up 
to Amendment 4. 
Number of 
Participants 
Approximately 100 chemotherapy-naive participants will be enrolled.  The 
primary analysis is planned with approximately 60 chemotherapy-naive 
participants, while the additional participants will be enrolled to support 
confirmation of efficacy and provide additional information on safety.   
Study Design 
This is a Phase 2, open-label, single-arm, multicenter study. 
Estimated Duration 
of Study 
Participation 
Participants will participate in the study for up to approximately 3 years. 
The study consists of 3 periods:  screening, study drug treatment, and 
follow-up.  Participants have up to 28 days to complete screening.  Treatment 
duration with study drug may last up to 2 years in the absence of disease 
progression, intolerable toxicity, death, withdrawal of consent, lost to 
follow-up, or premature discontinuation for any other reason.  Participants 
completing treatment or prematurely discontinuing the study will go to 
follow-up until study completion (see Section 4.2). 
DSMB/DMC 
Yes (external) 
Treatment Groups and Duration: 
This study will enroll participants with advanced/metastatic MCC who are chemotherapy-naive.  
Participants with locally advanced disease are eligible only if they have had a recurrence 
following locoregional therapy and are not considered amenable to further curative therapy with 
surgery or radiation.  The participants should not have received any prior therapy with 
PD-1/PD-L1 inhibitors.  Participants will be required to provide a tumor biopsy (fresh or 
archival), at screening for central pathology review.  Participants may be enrolled and initiate 
treatment before receiving results from the central pathology review.  All enrolled participants 
will receive INCMGA00012 at the recommended Phase 2 dose of 500 mg IV Q4W.  The 
primary endpoint is ORR in chemotherapy-naive participants as determined by ICR according to 
RECIST v1.1 (Eisenhauer et al 2009). 
The study consists of 3 periods:  screening, study drug treatment, and follow-up. 
Treatment with study drug may continue up to 2 years in the absence of disease progression, 
intolerable toxicity, death, withdrawal of consent, lost to follow up, or premature discontinuation 
for any other reason. 


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Eligible participants will receive treatment with single-agent INCMGA00012 500 mg.  
Treatment will be administered by IV infusion over 60 minutes on Day 1 of each 28-day cycle.  
Subsequent treatment cycles should be delayed until the following criteria are met: 
• Resolution of all immune-related toxicity to ≤ Grade 1 (with the exception of 
endocrinopathy that is controlled on hormonal replacement) 
• Resolution of all non–immune-related toxicity to ≤ Grade 1 or baseline (with the 
exception of alopecia or non–transfusion-dependent anemia). 
Note: transient asymptomatic laboratory elevations ≤ Grade 3 do not require dose 
interruption if the participant is asymptomatic, and if the elevation is clinically 
insignificant and has been discussed with the medical monitor. 
Participants unable to restart study drug treatment ≤ 12 weeks from the start of the treatment 
delay due to toxicity will be permanently discontinued from study treatment.  Treatment delays 
of > 12 weeks for logistical reasons (eg, travel restrictions due to COVID-19) may be acceptable 
but must be discussed with the medical monitor.   
The follow-up period will begin once a participant has completed or prematurely discontinued 
the study treatment.  Participants will be evaluated for AEs and other safety parameters for up to 
90 days after the last dose of study treatment or until the start of new anticancer therapy, 
whichever occurs first.  All participants entering follow-up will be assessed for survival until 
study completion.  Participants who enter the follow-up period without experiencing disease 
progression will continue tumor assessments according to the schedule of activities until they 
experience disease progression, the start of a new anticancer treatment, withdrawal of consent, 
lost to follow-up, the end of the study, or death.  
The complete study-specific schedule of activities required for participants in this clinical study 
is presented in Table 3.  Details regarding the sample collection for PK 
analyses 
are defined in Table 4.  The analytes to be evaluated in the safety laboratory analyses are found 
in Table 22.  Adherence to the study design requirements, including those specified in the 
schedule of activities, is essential and required for study conduct. 


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Table 3: 
Schedule of Activities 
Visit Day (Range) 
Screening 
Treatment 
EOT* 
Follow-Up 
Notes 
28 Days 
Cycle 1 
Day 1 
Cycle ≥ 2 
Day 1 
(± 7 d) 
Q8W 
(± 7 d) 
Safety 
28 Days After 
Last Dose 
(± 7 d)* 
Survival 
Q12W 
(± 14 d) 
* If EOT visit is > 21 days after the last dose, the EOT 
visit will also serve as the 28-day follow-up visit, and all 
EOT and 28-day follow-up required assessments will be 
performed. 
If EOT is ≤ 21 days after the last dose, the 28-day 
follow-up visit is required. 
Administrative procedures 
Informed consent 
X 
 
 
 
 
 
 
 
Interactive Response 
Technology 
X 
X 
X 
 
X 
 
 
 
Inclusion/exclusion criteria 
X 
 
 
 
 
 
 
 
General and disease medical 
history 
X 
 
 
 
 
 
 
 
Prior/concomitant medications 
X 
X 
X 
 
X 
X* 
 
* Concomitant Medications are collected from signing of the 
ICF until 90 days after the final dose of study drug or until 
the start of new anticancer therapy, whichever occurs first. 
Administer INCMGA00012 
 
X 
X 
 
 
 
 
Monitor participants for infusion reactions as per 
institutional guidelines. 
Safety assessments 
AE assessments 
X* 
X 
X 
 
X 
X* 
 
* Adverse events are collected from signing of the ICF until 
90 days after the final dose of study drug or until the start of 
new anticancer therapy, whichever occurs first. 
Physical examination 
X 
X 
X 
 
 
X 
 
A comprehensive examination is performed at screening and 
28-day safety follow-up.  All other scheduled examinations 
will be targeted. 
Vital signs 
X 
X 
X 
 
 
X 
 
 
12-lead ECG 
X 
X 
X* 
 
 
X 
 
* Performed every third cycle (C4, C7, C10, etc). 
ECOG performance status 
X 
X 
X 
 
 
X 
 
 
Efficacy assessments 
Tumor imaging/response 
assessments 
X 
 
 
X 
 
 
X* 
Includes photography of skin disease (if target lesions).  
Response assessments are to be performed every 8 weeks for 
the first 12 months (including the Week 56 scan) and then 
every 12 weeks thereafter. 
* Scans during follow-up will only be performed for 
participants continuing to be followed for disease status. 


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Table 3: 
Schedule of Activities (Continued) 
Visit Day (Range) 
Screening 
Treatment 
EOT* 
Follow-Up 
Notes 
28 Days 
Cycle 1 
Day 1 
Cycle ≥ 2 
Day 1 
(± 7 d) 
Q8W 
(± 7 d) 
Safety 
28 Days After 
Last Dose 
(± 7 d)* 
Survival 
Q12W 
(± 14 d) 
* If EOT visit is > 21 days after the last dose, the EOT 
visit will also serve as the 28-day follow-up visit, and all 
EOT and 28-day follow-up required assessments will be 
performed. 
If EOT is ≤ 21 days after the last dose, the 28-day 
follow-up visit is required. 
Post study anticancer therapy 
status 
 
 
 
 
X 
X 
X 
 
Survival status 
 
 
 
 
 
 
X 
Participants may be contacted for survival status at any time 
during the course of the study. 
Clinical laboratory assessments 
Blood chemistries 
X 
X* 
X 
 
 
X 
 
* Not necessary on C1D1 if performed during screening 
within 7 days on C1D1. 
Hematology 
X 
X* 
X 
 
 
X 
 
* Not necessary on C1D1 if performed during screening 
within 7 days on C1D1. 
Fasting lipid panel 
X 
 
X* 
 
 
 
 
Participants are expected to fast prior to sample collection 
for all lipid panel analyses. 
* Performed every third cycle (C4, C7, C10, etc). 
Coagulation panel 
X 
 
X* 
 
 
 
 
* Performed every third cycle (C4, C7, C10, etc). 
Endocrine panel 
X 
 
X 
 
 
 
 
 
Urinalysis 
X 
 
X* 
 
 
 
 
* Performed every third cycle (C4, C7, C10, etc). 
Pregnancy testing 
X 
X* 
X 
 
 
X 
 
Serum pregnancy test is performed at screening and 28 days 
after the last dose.  For other cycles, either urine- or 
serum-based testing is acceptable. 
* Not necessary on C1D1 if performed during screening 
within 7 days on C1D1. 


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Table 4: 
Pharmacokinetic 
 Sample Collections 
Sample 
Collection 
Purpose/ 
Analysis 
Screening 
Treatment Period 
EOT* 
Notes 
28 Days 
Cycle 1 
Day 1 
Cycle 2 
Day 1 
(± 7 d) 
Cycle 4 
Day 1  
(± 7 d) 
Cycle 6 
Day 1  
(± 7 d) 
Cycle 7 
Day 1  
(± 7 d) 
Cycle 8 
Day 1  
(± 7 d) 
Cycle 10 
Day 1  
(± 7 d) 
Cycle 12 
Day 1  
(± 7 d) 
* PK 
 samples are 
only collected at the EOT visit, 
including if the EOT visit also serves 
as the 28-day safety follow-up visit 
Whole 
blood 
PK serum 
PK 
 
X* 
X 
X 
X* 
X 
 
 
 
 
Samples will be collected preinfusion 
on Day 1 of Cycles 1, 2, 4, 6, and 7. 
* Samples are collected 10 minutes 
postinfusion (± 10 minutes) and 4 hours 
postinfusion (± 15 minutes) on Day 1 
of Cycles 1 and 6. 


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Table 4: 
Pharmacokinetic
 Sample Collections (Continued) 
Sample 
Collection 
Purpose/ 
Analysis 
Screening 
Treatment Period 
EOT* 
Notes 
28 Days 
Cycle 1 
Day 1 
Cycle 2 
Day 1 
(± 7 d) 
Cycle 4 
Day 1  
(± 7 d) 
Cycle 6 
Day 1  
(± 7 d) 
Cycle 7 
Day 1  
(± 7 d) 
Cycle 8 
Day 1  
(± 7 d) 
Cycle 10 
Day 1  
(± 7 d) 
Cycle 12 
Day 1  
(± 7 d) 
* PK 
 samples are 
only collected at the EOT visit, 
including if the EOT visit also serves 
as the 28-day safety follow-up visit 
 


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2. 
INTRODUCTION 
2.1. 
Background 
The clinical study INCMGA 0012-201 is a Phase 2, open-label, multicenter study designed to 
assess the clinical activity and safety of INCMGA00012 in participants with advanced/metastatic 
MCC. 
Merkel cell carcinoma is a rare, aggressive, cutaneous malignancy attributed to multiple factors, 
such as Merkel cell polyomavirus, UV irradiation, and immunosuppression.  This disease 
typically is found in older adults with light skin types and has a poor prognosis with lower 
survival rates compared with other skin malignancies.  Surgery and/or radiation therapy are 
indicated and potentially curative for local-regional disease, and relapse is common 
(Bhatia et al 2011). 
The 5-year survival rates for patients with MCC are 75%, 59%, and 25% for primary localized 
tumors, tumors with regional lymph node metastases (or local recurrences), and tumors with 
distant metastases, respectively (Becker 2010).  More than 30% of patients will develop distant 
metastatic disease (Voog et al 1999), and the 5-year survival rate for these patients is only 
approximately 10% (Allen et al 2005). 
Historically, metastatic MCC has been treated with chemotherapy regimens similar to those used 
for small cell lung cancer (NCCN 2017).  Platinum-based chemotherapy provides high initial 
response rates that are of short duration.  No survival advantage has ever been demonstrated for 
chemotherapy in this disease (Cassler et al 2016, Hughes et al 2014, Lebbe et al 2015, 
NCCN 2017, Voog et al 1999).  Management of patients with recurrent, locally advanced, 
unresectable MCC is also challenging (Becker et al 2017).  Similar to distant metastatic disease, 
patients with recurrent unresectable MCC require systemic therapy to achieve disease control. 
Chemotherapy is also associated with risk of severe toxicity and toxic death, particularly among 
older patients.  Responses to second-line chemotherapy are anecdotal, and current guidelines 
recommend clinical studies in this setting.  Other drug classes under early investigation for 
metastatic MCC include cytokines, adoptive T-cell therapy, toll-like receptor 4 agonists, and 
somatostatin analogues (Schadendorf et al 2017). 
Immunotherapy is a promising new approach to treatment of advanced/metastatic MCC.  
Updated results from a study with the PD-L1 inhibitor, avelumab, showed an ORR of 39.7% in 
chemotherapy-naive participants (D'Angelo et al 2019) and 32% in participants with 
chemotherapy-refractory metastatic disease, most of which were durable (Kaufman et al 2016).  
Responses occurred in patients with both PD-L1+ and negative tumors and were independent of 
Merkel cell polyomavirus status.  Recently, updated results from a study of pembrolizumab, a 
PD-1 inhibitor, in participants with advanced MCC were published.  In this Phase 2 trial, the 
objective response rate was 56% in participants with distant metastatic or recurrent, locoregional 
MCC not amenable to definitive surgery or radiation therapy (Nghiem et al 2019).  Based on 
these initial results, NCCN guidelines recommend pembrolizumab as a treatment option for 
patients with recurrent locally advanced disease (NCCN 2019). 


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2.2. 
Study Rationale 
Though initial results with checkpoint inhibitors are encouraging, there still remains an unmet 
medical need in the treatment of advanced/metastatic MCC.  In particular, safety, efficacy, and 
convenience of therapy could be improved by using alternative immunotherapies, either as 
monotherapy or as part of rational combination strategies.  Clinical trials also provide an 
important means by which promising investigational therapies can be delivered, when access is 
otherwise limited (eg, by labeling restrictions or reimbursement). 
The study drug, INCMGA00012, is a humanized, IgG4 monoclonal antibody that recognizes 
human PD-1.  As of the data cutoff date of 23 SEP 2021, 660 unique patients had been exposed 
to INCMGA00012 as monotherapy at doses of 1 mg/kg Q2W, 3 mg/kg Q2W, 3 mg/kg Q4W, 
10 mg/kg Q2W, 375 mg Q3W, 500 mg Q4W, or 750 mg Q4W.  The most frequently reported 
TEAEs seen in patients who received INCMGA00012 monotherapy were asthenia (17.3%), 
fatigue (16.1%), and diarrhea (15.9%).  Immune-related TEAEs occurred in 27.4% of patients.  
The most frequent irAE was hypothyroidism (9.2%) and the most frequent nonendocrine irAE 
was skin reactions (7.1%).  Most irAEs were Grade 1 or 2 in severity.  Grade ≥ 3 irAEs occurred 
in 6.7% of participants with most frequent being acute kidney injury and pneumonitis 
(0.9% each). 
Further details are presented in the INCMGA00012 IB.  INCMGA00012 has shown clinical 
activity as monotherapy against a variety of solid tumors, including chemotherapy-naïve and 
previously treated Merkel cell carcinoma, lung, urothelial, renal, squamous carcinoma of the anal 
canal, cervical, and endometrial carcinomas, as well as melanoma (Berton et al 2021, Grignani 
et al 2021, Maio et al 2021, Mehnert et al 2018, Mehnert et al 2019, Rao et al 2020). 
INCMGA00012 offers potential advantages over other checkpoint inhibitors in the treatment of 
MCC.  In particular, INCMGA00012 offers the convenience of Q4W flat dosing as opposed to 
the more frequent administration schedules for avelumab and pembrolizumab.  Development of 
combination therapies with the sponsor's portfolio of immunomodulatory drugs using the 
INCMGA00012 backbone will also be explored in future studies. 
2.2.1. 
Justification for Dose 
Fixed doses have several advantages over weight-based doses, including convenience of 
preparation and administration, reducing errors in preparation calculation, and minimization of 
drug waste.  Body size–based doses and fixed doses of monoclonal antibodies have been 
evaluated, and the 2 approaches performed similarly, with body size–based doses not always 
offering an advantage in reducing variability of exposure (Bai et al 2012, Wang et al 2009). 
The proposed flat dose regimen of 500 mg Q4W is based on modeling of clinical PK data from 
the ongoing first-in-human monotherapy study (NCT03059823) and benchmarking to 
pembrolizumab.  This dose-escalation study of INCMGA00012 evaluated 37 participants at the 
following doses:  1 mg/kg Q2W, 3 mg/kg Q2W, 3 mg/kg Q4W, 10 mg/kg Q2W, and 10 mg/kg 
Q4W.  While supra-dose proportionality was observed for AUC and Cmax for the first dose 
escalation from 1 mg/kg to 3 mg/kg, linear PK was shown from 3 mg/kg to 10 mg/kg.  No 
dose-limiting toxicity was observed at any dose level, and an MTD was not reached. 
A population PK analysis was performed on these participants to characterize the effect of body 
weight on the PK of INCMGA00012.  The plasma concentrations of INCMGA00012 can be 


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adequately described by a 2-compartment model with first-order elimination.  Higher clearance 
of INCMGA00012 was estimated for 1 mg/kg than the other dose groups.  Body weight 
dependence of clearance was characterized by a power relationship with an exponent of 0.911. 
A simulation was conducted to investigate the use of body weight based dosing and flat dosing 
for INCMGA00012 with the aim of targeting a steady-state trough concentration of ~21 μg/mL, 
the median trough concentration for pembrolizumab (Freshwater et al 2017).  The median 
INCMGA00012 exposure and distribution around the median at 500 mg Q4W were similar to 
7 mg/kg Q4W in the simulated population, which justified clinical exploration in an expansion 
cohort of the study.  The median steady-state concentration at 500 mg Q4W was 24.8 μg/mL, 
and 58% of participants had trough concentrations greater than target concentration. 
Pharmacokinetic data were obtained from 15 participants who received INCMGA00012 500 mg 
Q4W in the Cohort Expansion Phase of Study INCMGA 0012-101.  The observed AUC∞ for 
500 mg Q4W is close to the steady state AUCt based on the population PK analysis of 
weight-based dosing, as is the estimated clearance.  The estimated t½ (333 h) is slightly shorter 
than that from the previous estimate of 409 h.  The mean trough plasma concentration on Cycle 2 
was 17.1 μg/mL, and the mean projected plasma Cmin,ss is 23.1 μg/mL (which meets or slightly 
exceeds the targeted concentration based on pembrolizumab data) with a mean accumulation 
index of 1.50.  Overall, the 500 mg Q4W dose had very similar PK properties to 3 mg/kg dosing, 
and has ~77% probability for steady state trough plasma concentration ≥ 10 µg/mL, which is 
associated with maximum target engagement and greatest probability of efficacy.  Based on 
these observations, 500 mg Q4W was chosen as the dosing regimen for further development in 
the MCC indication. 
2.3. 
Benefit/Risk Assessment 
Treatment directed at the PD-1/PD-L1 axis is a promising approach to MCC.  Phase 2 results 
with avelumab and pembrolizumab show efficacy in terms of durable tumor response with 
preservation of health-related quality of life (Kaufman et al 2018, Nghiem et al 2019).  Safety of 
these agents has been well-characterized, and no unexpected safety findings have been reported 
in this population with either avelumab or pembrolizumab.  Alternative treatments 
(eg, chemotherapy) are associated with both inferior activity and serious toxicities.  Based on 
these observations, the benefit/risk for INCMGA00012 should also be favorable, provided 
efficacy objectives in the proposed study are met. 
Close oversight of study conduct will be provided through safety team meetings and contact with 
participating investigators.  Additionally, irAEs will be monitored throughout the study as AEs 
of special interest with appropriate guidance provided to investigators for their assessment and 
management. 
More detailed information about the known and expected benefits and risks and reasonably 
expected AEs of INCMGA00012 may be found in the IB. 
2.3.1. 
Benefit/Risk Assessment During the COVID-19 Pandemic 
An ESMO multidisciplinary panel highlighted the importance of clinical cancer research to find 
better therapeutic options for participants even during the pandemic, including potential 
investigational therapies similar to immunotherapy with a known survival benefit (Curigliano 


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et al 2020).  Data released based on real-world experience indicate that the use of 
immunotherapy does not appear to increase the risk of hospitalization upon COVID-19 infection 
(Horn et al 2020) or cause an increased risk of mortality (Lee et al 2020, Sharafeldin et al 2021).  
Real world experience has also shown that the risk of SAEs is higher in cancer patients who 
were SARS-CoV-2 positive; however, the incidence of SAEs is similar in patients treated with 
immunotherapy and chemotherapy.  Reported SAEs were generally COVID-19 related rather 
than related to the cancer therapy (Mandala et al 2021). 
Vaccines to SARS-CoV-2 are recommended for patients with cancer by oncology organizations 
such as NCCN, ASCO, and ESMO (NCCN 2021a, ASCO 2021, ESMO 2021).  There has been 
no indication of increased risk of new or worsening irAEs in patients receiving immunotherapy 
within a month of SARS-CoV-2 vaccination (Malek et al 2021). 
Participants will be monitored with safety procedures as described in Section 8 and with 
additional safety assessments as per standard of care.  Additional information regarding the 
flexibility of assessments/visits scheduling, where possible and warranted, and strategy for 
participant management during the dynamic pandemic as applicable is described in Appendix D. 
3. 
OBJECTIVES AND ENDPOINTS 
The study objectives and endpoints are presented in Table 5. 
Table 5: 
Objectives and Endpoints 
Objectives 
Endpoints 
Primary 
To determine the efficacy of INCMGA00012 in terms 
of the ORR in chemotherapy-naive participants with 
advanced/metastatic MCC. 
ORR, defined as the percentage of participants having 
an objective response (CR or PR), according to 
RECIST v1.1, as determined by ICR. 
Secondary 
To determine the DOR, DCR, PFS, and OS in the 
chemotherapy-naive population with 
advanced/metastatic MCC treated with 
INCMGA00012. 
• DOR, defined as the time from an initial objective 
response (CR or PR) according to RECIST v1.1 until 
disease progression, or death due to any cause, as 
determined by ICR. 
• DCR, defined as the proportion of participants with 
either an objective response or SD lasting at least 
6 months. 
• PFS, defined as the time from the start of therapy 
until disease progression, or death due to any cause, 
as determined by the ICR. 
• OS, defined as the time from the start of therapy 
until death due to any cause. 
To evaluate the safety of INCMGA00012 in 
participants with advanced/metastatic MCC. 
Safety, determined by the number, frequency, duration, 
and severity of AEs using CTCAE v5.0; laboratory 
tests; vital signs; and ECGs. 
To determine the PK of INCMGA00012 administered 
to participants with advanced/metastatic MCC. 
The PK of INCMGA00012 when given to participants 
with advanced/metastatic MCC, including Cmax, tmax, 
Cmin, and AUCt, will be summarized. 


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Table 5: 
Objectives and Endpoints (Continued) 
Objectives 
Endpoints 
Exploratory 
To determine the efficacy of INCMGA00012 in terms 
of the ORR, DOR, DCR, PFS, and OS in the full study 
population (chemotherapy-naive and chemotherapy-
refractory) with advanced/metastatic MCC. 
 
Note:  Chemotherapy-refractory participants enrolled 
before implementation of Amendment 5 will be 
included in these analyses. 
• ORR, defined as the percentage of participants 
having an objective response (CR or PR), according 
to RECIST v1.1, as determined by ICR. 
• DOR, defined as the time from an initial objective 
response (CR or PR) according to RECIST v1.1 until 
disease progression, or death due to any cause, as 
determined by ICR. 
• DCR, defined as the proportion of participants with 
either an objective response or SD lasting at least 
6 months. 
• PFS, defined as the time from the start of therapy 
until disease progression, or death due to any cause, 
as determined by the ICR. 
• OS, defined as the time from the start of therapy 
until death due to any cause. 


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4. 
STUDY DESIGN 
4.1. 
Overall Design 
The clinical study INCMGA 0012-201 is a Phase 2, open-label, single-arm, multicenter study 
designed to assess the clinical activity and safety of INCMGA00012 in participants with 
advanced/metastatic MCC.  This study will enroll participants with advanced/metastatic MCC 
who are chemotherapy-naive.  Participants with locally advanced disease are eligible only if they 
have had a recurrence following locoregional therapy and are not considered amenable to further 
curative therapy with surgery or radiation.  The participants should not have received any prior 
therapy with PD-1/PD-L1 inhibitors.  All participants must submit tissue samples (fresh or 
archival) for central pathology review.  Participants who do not have MCC confirmed by 
pathology may remain on study treatment but may be replaced for efficacy analysis (see 
Section 5.5). 
All participants who meet the eligibility criteria during screening will receive treatment with 
INCMGA00012.  The primary endpoint is ORR in chemotherapy-naive participants as 
determined by ICR according to RECIST v1.1. 
Approximately 100 chemotherapy-naive participants will be enrolled.  The primary analysis is 
planned with approximately 60 chemotherapy-naive participants, while the additional 
participants will be enrolled to support confirmation of efficacy and provide additional 
information on safety.  The primary analysis will occur after 60 chemotherapy-naive participants 
have been enrolled and followed for at least 6 months after confirmed response.  If the study 
meets the predefined efficacy threshold at the primary analysis (see Section 10.1), the final 
analysis will occur after all 100 participants have been enrolled and followed for survival for a 
minimum of 2 years.  Study enrollment may stop if the predefined efficacy threshold is not met 
at the time of primary analysis.   
Study treatment will consist of monotherapy INCMGA00012 administered at the recommended 
Phase 2 dose of 500 mg by IV infusion once every 28 days.  Treatment with study drug may 
continue up to 2 years in the absence of disease progression, intolerable toxicity, death, 
withdrawal of consent, lost to follow-up, or premature discontinuation for any other reason listed 
in Section 7.1. 
The study consists of 3 periods:  screening, study drug treatment, and follow-up. 
Eligible participants will receive treatment with single-agent INCMGA00012 500 mg 
administered by IV infusion over 60 minutes on Day 1 of each 28-day cycle.  Subsequent 
treatment cycles should be delayed until the following criteria are met: 
• Resolution of all immune-related toxicity to ≤ Grade 1 (with the exception of 
endocrinopathy that is controlled on hormonal replacement) 
• Resolution of all non–immune-related toxicity to ≤ Grade 1 or baseline (with the 
exception of alopecia or non–transfusion-dependent anemia) 
Note:  Transient asymptomatic laboratory elevations ≤ Grade 3 do not require 
dose interruption if the participant is asymptomatic, and if the elevation is 
clinically insignificant and has been discussed with the medical monitor. 


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Participants unable to restart study drug treatment ≤ 12 weeks from the start of the treatment 
delay due to toxicity will be permanently discontinued from study treatment (see 
Section 6.5.2.8).  Treatment delays of > 12 weeks for logistical reasons (eg, travel restrictions 
due to COVID-19) may be acceptable but must be discussed with the medical monitor. 
The follow-up period will begin once a participant has completed treatment or prematurely 
discontinued the study treatment.  Participants will be evaluated for AEs and other safety 
parameters for up to 90 days after the last dose of study treatment or until the start of new 
anticancer therapy, whichever occurs first. 
Once a participant discontinues treatment they enter the follow-up period and will be assessed 
for survival until study completion.  Participants who discontinue study treatment without 
experiencing disease progression will enter the follow-up period and continue to undergo tumor 
assessments according to the schedule of activities (see Table 3) until they experience disease 
progression, the start of a new anticancer treatment, withdrawal of consent, lost to follow-up, the 
end of the study, or death. 
The complete study-specific assessment schedule required for participants in this clinical study is 
presented in Table 3.  The analytes to be evaluated in the safety laboratory analyses are found in 
Table 22.  Details regarding the sample collection for PK 
 analyses are defined 
in Table 4. 
4.2. 
Overall Study Duration 
The study begins when the first participant signs the ICF.  Participants may receive study 
treatment for up to 2 years, unless prematurely discontinued.  Participants discontinuing 
treatment will enter the follow-up period after their last dose of study treatment.  The study ends 
once every participant receiving active treatment has been followed for at least 6 months after 
confirmed response or until all participants have been followed for survival for a minimum of 
2 years.  Participants remaining on active therapy at study conclusion may be eligible for 
continued treatment up to 2 years from first dose if, in the assessment of the investigator, they 
are tolerating therapy and receiving benefit. 
4.3. 
Study Termination 
The investigator retains the right to terminate study participation at any time, according to the 
terms specified in the study contract.  The investigator is to notify the IRB/IEC in writing of the 
study's completion or early termination, send a copy of the notification to the sponsor or 
sponsor's designee, and retain 1 copy for the site study regulatory file.  
The sponsor may terminate the study electively or if required by regulatory decision or upon 
advice of the DMC.  If the study is terminated prematurely, the sponsor will notify the 
investigators, the IRBs and IECs, and regulatory bodies of the decision and reason for 
termination of the study. 
4.3.1. 
Data Monitoring Committee 
An independent DMC will be formed.  The DMC will consist of qualified individuals who are 
not involved with the conduct of the study.  The establishment, composition, roles, duties, and 
responsibilities of the DMC will be addressed in the DMC charter. 


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Preplanned analyses of safety will be provided to an independent DMC as specified in the DMC 
charter.  In addition, the DMC will make recommendations to the sponsor at a planned interim 
analysis (see Section 10.5).  In terms of efficacy, the DMC will use the guidelines provided for 
recommendation of either continuation or early termination of the study at the interim analysis.  
Additionally, the DMC will review safety data of the ongoing study at regular intervals as 
specified in the DMC Charter.  The process by which the DMC will make recommendations and 
decisions will be documented in the DMC Charter. 
As of Protocol Amendment 6, the DMC has reviewed the data for the interim analysis.  The 
preliminary efficacy based on the ORR assessed by ICR exceeded the futility threshold, and the 
DMC recommended the study to proceed as planned.  


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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. Signed informed consent. 
2. Men and women, aged 18 or older (or as applicable per local country requirements). 
3. Diagnosis of MCC with distant metastatic disease or recurrent, advanced locoregional 
disease not amenable to surgery or radiation. 
4. ECOG performance status of 0 to 1 (see Table 21). 
5. Measurable disease according to RECIST v1.1.  Tumor lesions that are located in a 
previously irradiated area or in an area subjected to other locoregional therapy should 
only be selected as target lesions if progression has been demonstrated in such lesions. 
6. Availability of tumor tissue (fresh or archival) for central pathology review. 
7. Willingness to avoid pregnancy or fathering children based on the criteria below. 
a. Men must agree to take appropriate precautions to avoid fathering children (with at 
least 99% certainty) from screening through 6 months after the last dose of study 
treatment and must refrain from donating sperm during this period.  Permitted 
methods that are at least 99% effective in preventing pregnancy (see Appendix A) 
should be communicated to the participants and their understanding confirmed.  
b. Women of childbearing potential must have a negative serum pregnancy test at 
screening and before the first dose on Day 1 and must agree to take appropriate 
precautions to avoid pregnancy (with at least 99% certainty) from screening through 
120 days after the last dose of study treatment.  Permitted methods that are at least 
99% effective in preventing pregnancy (see Appendix A) should be communicated to 
the participants and their understanding confirmed. 
c. Women of nonchildbearing potential (ie, surgically sterile with a hysterectomy and/or 
bilateral oophorectomy OR ≥ 12 months of amenorrhea and at least 50 years of age) 
are eligible. 
5.2. 
Exclusion Criteria 
Participants are excluded from the study if any of the following criteria apply: 
1. Prior systemic therapy for MCC, including chemotherapy and prior PD-1– or  
PD-L1–directed therapy. 
2. Treatment with anticancer drugs or participation in another interventional clinical study 
within 21 days before the first administration of study drug. 


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3. Participant has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy 
(with the exceptions for anemia not requiring transfusion support and any grade of 
alopecia) and/or complications from prior surgical intervention within 7 days before 
starting study treatment. 
4. Radiation therapy administered within 2 weeks of first dose of study treatment or 
radiation therapy to the thoracic region that is > 30 Gy within 6 months of the first dose 
of study treatment. 
5. Known CNS metastases and/or carcinomatous meningitis. 
Note:  Participants with previously treated brain metastases may participate provided that 
they are stable (without evidence of progression by imaging for at least 28 days before 
the first dose of study drug and any neurologic symptoms have returned to baseline), 
have no evidence of new or enlarging brain metastases or CNS edema, and have not 
required steroids for at least 14 days before the first dose of study drug. 
6. Any known additional malignancy that is progressing or requires active treatment, or 
history of other malignancy within 3 years of study entry with the exception of cured 
basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate 
intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent 
malignancy, or cancers from which the participant has been disease-free for > 1 year, 
after treatment with curative intent. 
7. Participants with laboratory values at screening defined in Table 6. 
Table 6: 
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/total bilirubin 
≥ 1.5 × ULN unless conjugated bilirubin is ≤ ULN (conjugated bilirubin 
only needs to be tested if total bilirubin exceeds the ULN).  If there is no 
institutional ULN, then direct bilirubin must be < 40% of total bilirubin. 
Renal 
G 
Calculated creatinine clearance  
< 30 mL/min 
Coagulation 
H 
INR or PT 
> 1.5 × ULN 
I 
aPTT 
> 1.5 × ULN 


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8. Evidence of interstitial lung disease or active, noninfectious pneumonitis. 
9. Participants with impaired cardiac function or clinically significant cardiac disease: 
a. New York Heart Association Class III or IV cardiac disease, including preexisting 
clinically significant ventricular arrhythmia, congestive heart failure, or 
cardiomyopathy. 
b. Unstable angina pectoris ≤ 6 months before study participation. 
c. Acute myocardial infarction ≤ 6 months before study participation. 
d. Other clinically significant heart disease (ie, uncontrolled ≥ Grade 3 hypertension, 
history of labile hypertension, or poor compliance with an antihypertensive regimen).  
Must have recovered (to baseline or ≤ Grade 1) from toxicity associated with prior 
treatment. 
10. Active autoimmune disease requiring systemic immunosuppression in excess of 
physiologic maintenance doses of corticosteroids. 
11. Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or 
antiviral treatment. 
12. Known active hepatitis A, B, or C or active infections requiring systemic antibiotics. 
13. Has received a live vaccine within 28 days of planned start of study therapy. 
Note:  Examples of live vaccines include, but are not limited to, the following:  measles, 
mumps, rubella, chicken pox/zoster, yellow fever, rabies, Bacillus Calmette–Guérin, and 
typhoid vaccine.  Seasonal influenza vaccines for injection are generally killed virus 
vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are 
live-attenuated vaccines and are not allowed. 
14. Current use of prohibited medication as described in Section 6.6.2. 
15. Known hypersensitivity to another monoclonal antibody, which cannot be controlled with 
standard measures (eg, antihistamines and corticosteroids). 
16. Participant lacks the ability or is unlikely, in the opinion of the investigator, to comply 
with the Protocol requirements. 
17. Participant who is pregnant or breastfeeding 
18. Any condition that would, in the investigator's judgment, interfere with full participation 
in the study, including administration of study drug/treatment and attending required 
study visits; pose a significant risk to the participant; or interfere with interpretation of 
study data. 
19. History of organ transplant, including allogeneic stem cell transplantation. 
20. Known allergy or hypersensitivity to any component of the study drug formulation. 
21. Participants who are known to be HIV-positive, unless all of the following criteria are 
met: 
a. CD4+ count ≥ 300 μL. 
b. Undetectable viral load. 
c. Receiving highly active antiretroviral therapy. 


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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 do 
not meet all the eligibility criteria as defined in Sections 5.1 and 5.2. 
Tests with results that fail eligibility requirements may be repeated during screening.  
Additionally, a participant who fails screening may repeat the screening process if the 
investigator believes that there has been a change in eligibility status.  Participants may only 
rescreen once and, at the time of rescreening, must reconsent and be assigned a new participant 
number. 
5.5. 
Replacement of Participants 
Participants who do not meet the eligibility requirements or fail to have a MCC diagnosis by 
central pathology review, but initiated study treatment will be removed from study unless, in the 
judgment of the investigator, the participant is benefiting from treatment and there is no evidence 
of disease progression or unacceptable toxicity.  The sponsor’s medical monitor and the 
investigator will jointly evaluate such cases and make a decision regarding continued therapy on 
a case-by-case basis.  However, these participants may not be included in the efficacy analysis 
population (see Section 10.2) and may be replaced by further enrollment for the efficacy 
analysis. 


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6. 
STUDY TREATMENT 
6.1. 
Study Treatment Administered 
The study treatment information is presented in Table 7. 
Table 7: 
Study Treatment Information 
Study treatment name: 
INCMGA00012 
Dosage formulation: 
Liquid formulation supplied as 250 mg vials 
Unit dose strength/dosage level: 
500 mg Q4W 
Route of administration:  
IV 
Administration instructions: 
Administered IV over 60 minutes (+ 15 minutes) through a filter.  
Participants should be monitored for infusion reactions during the 
infusion as per institutional guidelines. 
Packaging and labeling: 
INCMGA00012 will be provided in a 250 mg vial. 
Each vial will be labeled as required per country requirement. 
Storage: 
Upright under refrigeration at 2°C-8°C (36°F-46°F) protected 
from light. 
6.2. 
Preparation, Handling, and Accountability 
The investigator or designee must confirm appropriate temperature conditions have been 
maintained during transit for all study treatments received and any discrepancies are reported and 
resolved before use of the study treatment. 
Only participants enrolled in the study may receive study treatment, and only authorized site 
staff may supply or administer study treatment.  All study treatment must be stored in a secure, 
environmentally controlled, and monitored (manual or automated) area in accordance with the 
labeled storage conditions with access limited to the investigator and authorized site staff. 
The investigator (or designee) is responsible for study treatment accountability, reconciliation, 
and record maintenance (ie, receipt, reconciliation, and final disposition records).  Inventory and 
accountability records must be maintained and readily available for inspection by the study 
monitor and are open to inspection at any time by any applicable regulatory authorities.  The 
investigator or designee must maintain records that document: 
• Delivery of study drug to the study site. 
• Inventory of study drug at the site. 
• Participant use of the study drug including vial counts from each supply dispensed. 
• Lot numbers and/or vial numbers of study drug used to prepare the infusion solution. 


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The investigational product must be used only in accordance with the Protocol.  The investigator 
will also maintain records adequately documenting that the participants were provided the 
specified study drug.  These records should include dates, quantities, and any available batch or 
serial numbers or unique code numbers assigned to the investigational product and study 
participants. 
Completed accountability records will be archived by the site.  The investigator or designee will 
be expected to collect and retain all used, unused, and partially used containers of study drug 
until verified by the study monitor (unless otherwise agreed to by the sponsor).  At the 
conclusion of the study, the investigator or designee will oversee shipment of any remaining 
study drug back to the sponsor or its designee for destruction according to institutional standard 
operating procedures.  If local procedures mandate on-site destruction of investigational supply, 
the site should (where local procedures allow) maintain the investigational supply until the study 
monitor inspects the accountability records in order to evaluate compliance and accuracy of 
accountability by the investigative site.  At sites where the study drug is destroyed before 
monitor inspection, the monitors rely on documentation of destruction per the site Standard 
Operating Procedures. 
Further guidance and information for the final disposition of unused study treatments are 
provided in the Pharmacy Manual. 
6.3. 
Measures to Minimize Bias:  Randomization and Blinding 
Not applicable. 
6.4. 
Study Treatment Compliance 
Compliance with all study-related treatments should be emphasized to the participant by the site 
personnel, and appropriate steps should be taken to optimize compliance during the study. 
Compliance with study drug administration will be calculated by the sponsor based on study 
treatment infusion records documented by the site staff and monitored by the sponsor/designee. 
6.5. 
Dose Modifications 
Dose interruptions of INCMGA00012 are allowed for AEs as outlined in the following 
subsections and tables located throughout Section 6.5.  No dose reductions or other 
modifications of INCMGA00012 are allowed for the management of toxicities for individual 
participants.  Doses of INCMGA00012 may be delayed up to 12 weeks for toxicity management. 
Before the start of each treatment cycle, the participant must meet the treatment continuation 
criteria noted in (see Section 4.1) before administration of INCMGA00012.  If the criteria are not 
met at the beginning of a treatment cycle, INCMGA00012 infusion may be delayed up to 
12 weeks to allow for resolution of any abnormal laboratory results or AEs.  Participants should 
be withdrawn from the active treatment portion of the study if re-treatment criteria are not met 
within 12 weeks of the scheduled start of a cycle.  Upon resolution, participants may resume 
treatment if no medical condition or other circumstance exists that, in the opinion of the 
investigator, would make the participant unsuitable for further participation in the study.  If 
INCMGA00012 must be discontinued due to unacceptable toxicity, then the participant should 
be withdrawn from active treatment and enter the follow-up period of the study. 


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6.5.1. 
Management of Suspected Infusion Reactions 
Infusion or hypersensitivity reactions may be observed with administration of any foreign 
protein.  Premedication with acetaminophen/paracetamol and a histamine blocker should be 
considered for participants who have had previous systemic reactions to protein product 
infusions or when recommended by institutional policy. 
Guidelines for management of suspected infusion reactions are provided in Table 8.  Grade 3 or 
Grade 4 infusion reactions should be reported within 24 hours to the study medical monitor 
regardless of whether criteria for reporting as a SAE are met. 
Table 8: 
Guidelines for Management of Suspected Infusion Reactions 
Grade 
Descriptiona 
Treatment 
Subsequent Infusions 
1 
Mild reaction; interrupt or slow the 
rate of infusion; intervention not 
indicated. 
Monitor vital signs closely 
until medically stable. 
Premedication with an 
antipyretic (eg, 
acetaminophen/paracetamol) 
and a histamine blocker 
(eg, diphenhydramine) should 
be considered, or as per 
institutional guidelines. 
2 
Requires infusion interruption but 
responds promptly to symptomatic 
treatment (eg, antihistamines, 
analgesic/antipyretic, narcotics, 
IV fluids); prophylactic medications 
indicated for ≤ 24 hours. 
First occurrence:  Stop 
infusion and initiate 
appropriate medical measures 
(eg, IV fluids, antihistamines, 
analgesic/antipyretic, narcotics, 
per institutional preferences). 
Monitor vital signs until 
medically stable. 
If symptoms resolve within 
1 hour, infusion may be 
resumed at 50% of the original 
infusion rate. 
Subsequent occurrences 
(despite recommended 
prophylaxis):  Permanently 
discontinue treatment. 
Premedicate at least 
30 minutes before infusion 
with antihistamines 
(eg, diphenhydramine 50 mg 
PO or comparable dose of 
antihistamine) and 
acetaminophen/ paracetamol 
(500-1000 mg PO or 
equivalent dose of 
analgesic/antipyretic). 
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, the rate 
of infusion can be increased 
by 25% every 15 minutes 
until a rate of 100% has been 
reached.  Subsequent 
infusions can begin at 100%. 


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Table 8: 
Guidelines for Management of Suspected Infusion Reactions (Continued) 
Grade 
Descriptiona 
Treatment 
Subsequent Infusions 
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 or rechallenge; 
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 
analgesic/antipyretic, narcotics, 
oxygen, pressors, epinephrine, 
corticosteroids, per institutional 
preferences). 
Monitor vital signs frequently 
until medically stable.  
Hospitalization may be 
indicated. 
Discontinue study treatment. 
Note:  NCI CTCAE Grade 3 
infusion related reaction 
(NCI CTCAE v5):  if rapidly 
responsive to symptomatic 
medication and/or to brief 
interruption of infusion, 
study treatment 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. 
6.5.2. 
Procedures for Participants Exhibiting Immune-Related Adverse Events 
Adverse events of a potential immunologic etiology or irAEs may be defined as an AE of 
unknown etiology, associated with drug exposure and consistent with an immune phenomenon.  
Immune-related AEs may be predicted based on the nature of the compounds, their mechanism 
of action, and reported experience with immunotherapies that have a similar mechanism of 
action.  Special attention should be paid to AEs that may be suggestive of potential irAEs.  An 
irAE can occur shortly after the first dose or several months after the last dose of treatment. 
If an irAE is suspected, efforts should be made to rule out neoplastic, infectious, metabolic, toxin 
or other etiologic causes before labeling an AE as an irAE. 
Recommendations for management of specific irAEs known to be associated with 
INCMGA00012 and other PD-1 inhibitors (eg, pembrolizumab, nivolumab) are detailed in the 
sections below. 
Algorithms for evaluation of selected immune toxicities that have previously been attributed to 
PD-1 inhibitors and management guidance for irAEs not detailed elsewhere in the Protocol 
should follow the American Society of Clinical Oncology or European Society for Medical 
Oncology Clinical Practice Guidelines or NCCN Guidelines (Brahmer et al 2018, Haanen et al 
2017, NCCN 2021b. 
6.5.2.1. 
Immune-Mediated Pneumonitis 
Participants with symptomatic pneumonitis should immediately stop receiving study treatment 
and have an evaluation.  The evaluation may include bronchoscopy and pulmonary function tests 
to rule out other causes such as infection.  Recommendations for management of study 
drug-associated pneumonitis are detailed in Table 9. 


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Table 9: 
Recommended Approach to Handling Pneumonitis 
Study Drug–Associated 
Pneumonitis 
Withhold/Discontinue 
Study Treatment 
Supportive Care 
Grade 1 (asymptomatic) 
No action. 
Intervention not indicated. 
Grade 2 
Withhold study treatment.  May return to 
treatment if condition improves to ≤ Grade 1. 
Permanently discontinue if toxicity does not 
resolve within 12 weeks of last dose or 
inability to reduce corticosteroid to ≤ 10 mg 
per day prednisone or equivalent within 
12 weeks. 
• Evaluate participants with 
suspected pneumonitis with 
radiographic imaging and initiate 
corticosteroid treatment. 
• Administer systemic 
corticosteroids per local practice 
followed by taper. 
• Add prophylactic antibiotics for 
opportunistic infections. 
Grades 3 and 4 or 
recurrent Grade 2 
Permanently discontinue study treatment. 
6.5.2.2. 
Immune-Mediated Colitis/Enterocolitis/Diarrhea 
Participants should be carefully monitored for signs and symptoms of colitis (eg, diarrhea, 
abdominal pain, mucus, or blood in stool, with or without fever).  In symptomatic participants, 
infectious etiologies should be ruled out, and endoscopic evaluation should be considered for 
persistent or severe symptoms.  Recommendations for management of enterocolitis are shown in 
Table 10. 
Table 10: 
Recommended Approach for Handling Colitis/Enterocolitis/Diarrhea 
Study Drug–Associated 
Colitis/Enterocolitis/ 
Diarrhea 
Withhold/Discontinue 
Study Treatment 
Supportive Care 
Grade 1 
No action. 
None. 
Grade 2 or 3 
Withhold study 
treatment until 
≤ Grade 1. 
• Consider prompt initiation of standard anti-diarrheal 
agents or and other necessary supportive care as 
needed (eg, oral and/or IV fluids). 
• Administer systemic corticosteroids per local practice 
followed by taper. 
• Consider prophylactic antibiotics per local practice. 
• Consider gastrointestinal consultation and performing 
endoscopy to rule out colitis. 
• Consider stool sample evaluation to rule out 
Clostridium difficile (C. diff) and infectious etiologies. 
Grade 4 or recurrent 
Grade 3 
Permanently 
discontinue study 
treatment. 
6.5.2.3. 
Immune-Mediated Hepatitis 
Liver chemistry testing (hepatic transaminase and bilirubin levels) should be monitored and 
participants assessed for signs and symptoms of hepatotoxicity before each dose of 
INCMGA00012.  In participants with hepatotoxicity, infectious or malignant causes should be 
ruled out, and frequency of liver chemistry monitoring increased until resolution.  
Recommendations for management of hepatitis are shown in Table 11. 


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Table 11: 
Recommended Approach for Handling Hepatitis 
Study Drug–Associated Hepatitis 
Withhold/Discontinue 
Study Treatment 
Supportive Care 
Grade 1 
No action. 
Increase frequency of liver chemistry 
monitoring to twice per week until liver 
chemistry tests return to baselinea. 
Grade 2 
Withhold study treatment. 
Systemic corticosteroids are indicated 
(initial dose of 0.5-1 mg/kg per day of 
prednisone or equivalent).  Taper as 
appropriate. 
Grades 3 and 4 
 
OR 
 
In case of liver metastasis with 
baseline Grade 2 elevation of ALT or 
AST, hepatitis with ALT or AST 
increases ≥ 50% and lasts ≥ 1 week 
Permanently discontinue 
study treatment. 
Treatment with systemic corticosteroids 
should be initiated (initial dose of 
1-2 mg/kg per day of prednisone or 
equivalent).  Taper as appropriate. 
a In addition to ALT and AST, consider monitoring total bilirubin, direct bilirubin, and alkaline phosphatase at an increased 
frequency. 
6.5.2.4. 
Immune-Mediated Endocrinopathies 
6.5.2.4.1. Hypophysitis 
Monitor for signs and symptoms of hypophysitis (including hypopituitarism).  Recommendations 
for management of hypophysitis are shown in Table 12. 


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Table 12: 
Recommended Approach for Handling Hypophysitis 
Study Drug–Associated 
Hypophysitis 
Withhold/Discontinue 
Study Treatment 
Supportive Care 
Grade 1 
No action. 
None. 
Grades 2 (asymptomatic) 
Withhold until ≤ Grade 1. 
May restart INCMGA00012 treatment 
after controlled by hormone replacement 
therapy. 
Administer hormonal replacement as 
clinically indicated. 
Grade 2 (symptomatic, 
e.g. 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. 
Grades 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. 
6.5.2.4.2. Thyroid Disorders 
Monitor participants for changes in thyroid function (at the start of treatment, periodically during 
treatment, and as indicated based on clinical evaluation) and for clinical signs and symptoms of 
thyroid disorders.  Recommendations for management of thyroid disorders are shown in 
Table 13. 
Table 13: 
Recommended Approach for Handling Thyroid Disorders 
Study Drug–Associated 
Thyroid Disorders 
Withhold/Discontinue 
Study Treatment 
Supportive Care 
Hypothyroidism 
Grades 1 and 2 
No action. 
None. 
Grades 3 and 4 
Withhold until ≤ Grade 1 or is otherwise 
clinically stable. 
Initiate thyroid replacement hormones 
(eg, levothyroxine or liothyronine) per 
standard of care. 
Hyperthyroidism 
Grades 1 and 2 
No action. 
None. 
Grades 3 and 4 
Withhold until ≤ Grade 1 or is otherwise 
clinically stable. 
Initiate symptomatic management. 


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6.5.2.4.3. New Onset Type 1 Diabetes Mellitus/Hyperglycemia 
Monitor participants for hyperglycemia or other signs and symptoms of diabetes mellitus.  
Recommendations for management of diabetes mellitus are shown in Table 14. 
Table 14: 
Recommended Approach for Handling New Onset Type 1 Diabetes 
Mellitus/Hyperglycemia 
Study Drug–Associated 
Diabetes Mellitus 
Withhold/Discontinue 
Study Treatment 
Supportive Care 
Grades 1 and 2 
No action. 
Intervention not indicated. 
Grades 3 and 4 
Type 1 diabetes mellitus 
(or hyperglycemia) 
Withhold study drug until ≤ Grade 1 
or is otherwise clinically stable. 
Initiate treatment with antihyperglycemics or 
insulin as clinically indicated. 
6.5.2.4.4. Adrenal Insufficiency 
Monitor for signs and symptoms of adrenal insufficiency.  Recommendations for management of 
adrenal insufficiency are shown in Table 15. 
Table 15: 
Recommended Approach for Handling Adrenal Insufficiency 
Study Drug-Associated 
Adrenal Insufficiency 
Withhold/Discontinue 
Study Treatment 
Supportive Care 
Grade 1 
No action. 
Intervention not indicated. 
Grade 2 
Withhold study drug until ≤ Grade 1 or 
is otherwise clinically stable. 
Initiate treatment with hormone 
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. 
6.5.2.5. 
Immune-Mediated Nephritis and Renal Dysfunction 
Monitor participants for changes in renal function.  Recommendations for management of 
nephritis and renal dysfunction are shown in Table 16. 
Table 16: 
Recommended Approach for Handling Nephritis and Renal Dysfunction 
Study Drug–Associated 
Nephritis and Renal Dysfunction 
Withhold/Discontinue 
Study Treatment 
Supportive Care 
Grade 1 
No action. 
Intervention not indicated. 
Grade 2 or Grade 3 increased 
blood creatinine 
Withhold study treatment until 
≤ Grade 1. 
Administer corticosteroids per local 
practice followed by taper. 
Grade 4 increased blood creatinine 
Permanently discontinue study 
treatment. 
6.5.2.6. 
Immune-Mediated Skin Reactions 
Immune-mediated rashes, including Stevens-Johnson syndrome, toxic epidermal necrolysis 
(some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur.  
Monitor participants for suspected severe skin reactions and exclude other causes.  
Recommendations for management of skin reactions are shown in Table 17. 


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Table 17: 
Recommended Approach for Handling Skin Reactions 
Study Drug–Associated Skin 
Reactions 
Withhold/Discontinue 
Study Treatment 
Supportive Care 
Grade 1 
No action. 
Intervention not indicated. 
Grade 2 
No action. 
Manage with topical steroids with or 
without study treatment interruption. 
Grade 3a or persistent Grade 2 
(≥ 2 weeks) 
OR 
Suspected Stevens-Johnson 
syndromeb 
Withhold study treatment until ≤ 
Grade 1 after corticosteroid taper 
to ≤10mg/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. Refer to dermatology if no 
resolution with these measures. 
• Refer to dermatology if SJS or TEN is 
suspected. 
Grade 4 
OR 
Confirmed Stevens-Johnson 
syndrome or toxic epidermal 
necrolysisc 
Permanently discontinue study 
treatment. 
• Initial dose of 1 to 2 mg/kg/day 
prednisone or equivalent followed by a 
taper. 
• Refer to dermatology consult. 
a Participants with Grade 3 rash in the absence of desquamation, with no mucosal involvement, not requiring systemic steroids, 
and resolving or improving to ≤ Grade 1 within 14 days do not have to interrupt INCMGA00012.  Permanent discontinuation 
of study treatment may be necessary if there is recurrence of Grade 3 after resuming the study treatment. 
b Grade 3 Stevens-Johnson syndrome is defined as skin sloughing covering < 10% BSA with associated signs (eg, erythema, 
purpura, epidermal detachment, mucous membrane detachment).  Grade 4 Stevens-Johnson syndrome is defined as skin 
sloughing covering 10-30% BSA with associated signs (eg, erythema, purpura, epidermal detachment, mucous membrane 
detachment).  
c Toxic epidermal necrolysis is Grade 4 by definition and is defined as skin sloughing covering ≥ 30% BSA with associated 
symptoms (eg, erythema, purpura, epidermal detachment) 
6.5.2.7. 
Immune-Mediated Myocarditis 
Immune-mediated myocarditis can occur (some cases with fatal outcome).  Monitor participants 
for suspected myocarditis and exclude other causes.  Recommendations for the management of 
immune-mediated myocarditis are shown in Table 18. 
Table 18: 
Recommended Approach for Handling Myocarditis 
Study Drug–Associated 
Myocarditis 
Withhold/Discontinue 
Study Treatment 
Supportive Care 
Grade 2, 3, and 4 
Permanently discontinue study 
treatment. 
• 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. 
• Timely cardiology referral. 


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6.5.2.8. 
Immune-Mediated Nervous System Events 
Immune-mediated nervous system events, including Guillain-Barre syndrome, autoimmune 
enceophalitis, myasthenia gravis, autonomic neuropathy, and transverse myelitis, can occur.  
Monitor participants for these immune-mediated nervous system events and exclude other 
causes.  Recommendations for the management of immune-mediated nervous system events are 
shown in Table 19. 
Table 19: 
Recommended Approach for Handling Immune-Mediated Nervous System 
Events 
Study Drug–Associated 
Nervous System Events 
Withhold/Discontinue 
Study Treatment 
Supportive Care 
Grade 1 
No action. 
Intervention not indicated. 
Grade 2 
Withhold study treatment 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 study 
treatment. 
6.5.2.9. 
Other Immune-Mediated Adverse Events 
Recommendations for management of immune-mediated adverse events not specified above are 
shown in Table 20. 
Table 20: 
Recommended Approach to Handling Other Immune-Mediated Adverse 
Events 
Study Drug-Associated 
Immune-Mediated Adverse 
Events 
Withhold/Discontinue  
Study Treatment 
Supportive Care 
Grade 1 
No action. 
None 
Grade 2 or Grade 3 based on 
severity and type of reaction 
Withhold until ≤ Grade 1. 
Based on severity of AE, administer 
corticosteroids. 
Recurrent Grade 3 or 
Persistent Grade 2 and 
Grade 3 
Permanently discontinue study 
treatment. 
Grade 4 (excluding 
endocrinopathies) 


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6.5.3. 
Permanent Discontinuation of Study Drug Due to Toxicity 
The occurrence of unacceptable toxicity not caused by the underlying disease will require that 
the study treatment be permanently discontinued.  Unacceptable toxicity is defined as follows: 
• Occurrence of an AE that is related to study treatment that, in the judgment of the 
investigator or the sponsor's medical monitor, compromises the participant's ability to 
continue study-specific procedures or is considered to not be in the participant's best 
interest. 
• Persistent AE requiring a delay of therapy for more than 12 weeks. 
• Any AE defined in the dose modifications management guidelines (Section 6.5) 
requiring the study treatment be discontinued. 
A complete list of study treatment discontinuation reasons and procedures is found in Section 7. 
6.6. 
Concomitant Medications and Procedures 
All concomitant medications and treatments (including over-the-counter or prescription 
medicines, vitamins, vaccines, and/or herbal supplements) and medical procedures must be 
recorded in the eCRF.  Any medication or procedure received from signing the ICF to 90 days 
after the last dose of study treatment, or until the participant begins a new anticancer therapy, 
whichever occurs first, will be recorded in the eCRF.  Any addition, deletion, or change in the 
dose of these medications will also be recorded.  Concomitant medications administered for the 
management of SAEs should be recorded regardless of when they are provided.  Concomitant 
medications and/or procedures administered to a participant for management of a medical 
condition during the study will also be recorded in the eCRF.  The medical monitor should be 
contacted if there are any questions regarding concomitant or prior therapy. 
6.6.1. 
Permitted Medications and Procedures 
Highly active antiretroviral therapy should be continued for participants who are known to be 
HIV-positive.  Recommended supportive measures for specific toxicities are described above.  
Growth factors, bisphosphonates, anticoagulants, and transfusional support will also be permitted 
at any point in the study. 
Premedication with an antipyretic (eg, acetaminophen/paracetamol) and a histamine blocker 
should be considered for participants who have had previous systemic reactions to protein 
product infusions or when recommended according to institutional policy. 
6.6.2. 
Prohibited Medications and Procedures 
• Other anticancer therapies, including investigational treatments. 
• Immunosuppression in excess of physiologic maintenance corticosteroid doses (with 
the exception of acute treatment for an AE).  The use of corticosteroids should be 
limited to the extent possible.  Chronic doses of corticosteroids in excess of 10 mg 
daily of prednisone or equivalent are prohibited other than for the management of 
drug-related adverse experiences.  Steroids may be employed in the treatment of 
suspected INCMGA00012-associated immune-inflammatory or autoimmune AEs in 
consultation with the sponsor. 


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• Live vaccines within 28 days prior to first administration of study drug, throughout 
the treatment phase of the study, and for a duration of 90 days after the last dose of 
study drug. 
Note:  Examples of live vaccines include, but are not limited to, the following:  
measles, mumps, rubella, chicken pox/zoster, yellow fever, rabies, Bacillus Calmette–
Guérin, 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. 
• Probiotic dietary supplements 
6.7. 
Treatment After the End of the Study 
Once a participant has discontinued study treatment, no further treatment will be provided in this 
study.  Participants who discontinue are eligible to enter the follow-up period to be evaluated for 
safety and survival.  Any participants entering the follow-up period for any reason other than PD 
will continue to be evaluated for disease status according to the scheduled assessments found in 
Table 3. 


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7. 
DISCONTINUATION OF STUDY TREATMENT AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
7.1. 
Discontinuation of Study Treatment 
7.1.1. 
Reasons for Discontinuation 
Participants must be withdrawn from study treatment for the following reasons: 
• Disease progression. 
• Unacceptable toxicity as noted in Section 6.5.2.8. 
• Consent is withdrawn. 
Note:  Consent withdrawn means that the participant has explicitly indicated that they 
do not want to 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 
may choose to discontinue study treatment and remain in the study to be followed for 
progression and survival. 
• Further participation would be, based on the medical judgment of the investigator, 
injurious to the health or well-being of the participant. 
• The study is terminated by the sponsor. 
• The study is terminated by the local health authority, IRB, or IEC. 
• The participant becomes pregnant (see Section 9.7). 
A participant may be discontinued from study treatment as follows: 
• If a participant is noncompliant with study procedures or treatment administration, 
and in the judgment of the investigator the participant is not receiving a clinical 
benefit.  When possible, the sponsor should be informed and/or consulted. 
• The participant achieves a confirmed CR after at least 6 months of treatment.  
Participants may continue on study treatment after confirmation of CR per the 
discretion of the investigator if they feel the participant may gain additional benefit.  
Note:  The participant should be continue to be followed for disease status and 
survival after discontinuation of treatment.  
7.1.2. 
Discontinuation Procedures 
In the event that the decision is made to permanently discontinue the study treatment, the EOT 
visit should be conducted.  Reasonable efforts should be made to have the participant return for a 
follow-up visit.  These visits are described in Table 3.  The last date of the last dose of study 
treatment and the reason for discontinuation of study treatment will be recorded in the eCRF. 
If a participant is discontinued from study treatment: 
• The study monitor or sponsor must be notified. 
• The reason(s) for withdrawal must be documented in the participant's medical record 
and the primary reason for withdrawal must be included in the eCRF. 


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• The EOT visit should be performed. 
• The date of the EOT visit should be recorded in the IRT. 
• Participants must be followed for safety for 90 days after the last study treatment, or 
until study treatment–related toxicities resolve, return to baseline, or are deemed 
irreversible, whichever is longest. 
If the participant discontinues study treatment and actively withdraws consent for collection of 
follow-up data (safety follow-up or disease assessment), then no additional data collection 
should occur; however, participants will have the option of withdrawing consent for study 
treatment and further assessments but allowing survival follow-up. 
7.2. 
Participant Withdrawal From the Study 
A participant may withdraw from the study at any time at his/her own request, or may be 
withdrawn at any time at the discretion of the investigator for safety, behavioral, compliance, or 
administrative reasons. 
If the participant withdraws consent for disclosure of future information, the sponsor may retain 
and continue to use any data collected before such a withdrawal of consent. 
If a participant withdraws consent from the study, he/she may request destruction of any samples 
taken and not tested, and the investigator must document this in the site study records. 
See Table 3 for data to be collected at the time of study discontinuation and follow-up and for 
any further evaluations that need to be completed. 
7.3. 
Lost to Follow-Up 
A participant will be considered lost to follow-up if he/she repeatedly fails to return for 
scheduled visits and is unable to be contacted by the study site. 
The following actions must be taken if a participant fails to return to the clinic for a required 
study visit: 
• The site must attempt to contact the participant and reschedule the missed visit as 
soon as possible and counsel the participant on the importance of maintaining the 
assigned visit schedule and ascertain whether or not the participant wishes to and/or 
should continue in the study. 
• Before a participant is deemed lost to follow-up, the investigator or designee must 
make every effort to regain contact with the participant (where possible, 3 telephone 
calls and, 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, he/she will be considered to have 
withdrawn from the study. 


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8. 
STUDY ASSESSMENTS AND PROCEDURES 
8.1. 
Administrative and General Procedures 
8.1.1. 
Informed Consent Process 
• The investigator or his/her representative will explain the nature of the study to the 
participant or his/her legally authorized representative and answer all questions 
regarding the study. 
− Informed consent must be obtained before any study-related procedures are 
conducted, unless otherwise specified by the Protocol. 
− Informed consent must be obtained using the IRB/IEC-approved version in a 
language that is native and understandable to the participant.  A template will be 
provided by the sponsor or its designee.  The sponsor or its designee must review 
and acknowledge the site-specific changes to the ICF template.  The ICF must 
include a statement that the sponsor or its designee and regulatory authorities have 
direct access to participant records. 
− The ICF must contain all required elements and describe the nature, scope, and 
possible consequences of the study in a form understandable to the study 
participant. 
• Participants must be informed that their participation is voluntary.  Participants or 
their legally authorized representative will be required to sign a statement of informed 
consent that meets the applicable requirements and regulations for the countries in 
which the study is being conducted as well as the IRB/IEC or study center. 
• The participant must be informed that his/her personal study-related data will be used 
by the sponsor in accordance with local data protection laws.  The level of disclosure 
must also be explained to the participant. 
• The participant must be informed that his/her medical records may be examined by 
Clinical Quality Assurance auditors or other authorized personnel appointed by the 
sponsor, by appropriate IRB/IEC members, and by inspectors from regulatory 
authorities. 
• The medical record must include a statement that written informed consent was 
obtained before the participant was enrolled in the study and the date the written 
consent was obtained.  The authorized person obtaining the informed consent must 
also sign the ICF. 
• Participants must provide consent to the most current version of the ICF(s) during 
their participation in the study. 
• A copy of the ICF(s) must be provided to the participant or the participant's legally 
authorized representative. 
Participants who are rescreened are required to sign a new ICF. 


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8.1.2. 
Screening Procedures 
Screening is the interval between signing the ICF and enrollment in the study (Cycle 1 Day 1).  
Screening may not exceed 28 days.  Assessments required to demonstrate eligibility will be 
performed during the screening period. 
Procedures conducted as part of the participant's routine clinical management (such as laboratory 
analyses) before signing the ICF may be used for screening or baseline purposes, provided the 
procedure meets the Protocol-defined criteria and has been performed within 28 days of Cycle 1 
Day 1. 
Tests with results that fail eligibility requirements may be repeated once during screening if the 
investigator believes the results to be in error.  For screening assessments that are repeated, the 
most recent available result before treatment assignment will be used to determine eligibility. 
See Sections 5.4 and 5.5 for information regarding screen failures and replacement of 
participants, respectively. 
8.1.3. 
Interactive Response Technology Procedure 
Each participant will be identified in the study by a participant ID number, which is a 
combination of the site ID and participant number.  Site staff should contact the IRT to obtain the 
participant ID number during screening upon determination of the final eligibility status of the 
participant, as well as once the participant prematurely discontinues or completes treatment.  
Additionally, the IRT will be used throughout the study to dispense study drug to the site for 
each infusion and to maintain the site inventory and update the study drug supply as needed.  
Details regarding the use of IRT will be provided in a separate document. 
8.1.4. 
Distribution of Reminder Cards  
Participants will be provided with a reminder card at each visit.  The reminder card will indicate 
the date and time of the next visit and will also inform the participant about visit-specific 
procedures. 
8.1.5. 
Demography and Medical History 
8.1.5.1. 
Demographics and General Medical History 
Demographic data and general medical history will be collected at screening by the investigator 
or qualified designee and will include date of birth, race, ethnicity, medical and surgical history, 
and current illnesses.  Medical history will include relevant medical or surgical treatment 
considered to be clinically significant by the investigator. 


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8.1.5.2. 
Disease Characteristics and Treatment History 
A disease-targeted medical and treatment history will be collected at screening.  Details 
regarding the participant's malignancy under study, including date of diagnosis, initial and 
current cancer stage, tumor histology, and relevant disease characteristics, and prior treatments, 
including systemic treatments, radiation, and surgical procedures, will be recorded. 
8.2. 
Efficacy Assessments 
Objective assessment of disease status will be evaluated according to RECIST v1.1 
(Eisenhauer et al 2009) by the ICR.  Participants should be actively monitored for RECIST 
response up until they start new anticancer therapy or have PD. 
 
 
 
 
The disease response assessments according to 
RECIST v1.1
 by investigators will be entered into the eCRF. 
Efficacy assessments of response should be performed according to schedule found in Table 3.  
Scans should follow calendar days and remain on the 8-week schedule (± 7 days), 
established on Cycle 1 Day 1, and should not be delayed for treatment holds or 
interruptions.  Disease status will be assessed every 8 weeks for the first 12 months and then 
every 12 weeks thereafter (ie, the schedule should switch to every 12 weeks after the Week 56 
scan).  For participants who discontinue study treatment for reasons other than disease 
progression, every effort should be made to continue monitoring their disease status by 
radiographic imaging according to the follow-up schedule. 
Participants who continue study participation in the follow-up period without experiencing 
disease progression will continue to have efficacy assessments every 12 weeks (± 7 days) from 
the previous scan until they complete participation in the study, start a new anticancer therapy, 
experience disease progression, or death. 
8.2.1. 
Tumor Imaging 
Disease assessment and tumor response to study drug will be evaluated according to 
RECIST v1.1 guidelines (Eisenhauer et al 2009) as described in Appendix B.  All imaging must 
be submitted to the central imaging vendor for independent review.  The recommended method 
for measuring and following tumor burden will be CT scan, which should be performed using 
consistent techniques and facilities.  Alternative modalities such as MRI may be substituted for a 
CT scan at the discretion of the investigator, provided that the same modality is used throughout 
the study and the methodology is consistent with RECIST v1.1.  Initial tumor imaging must be 
performed within 28 days before the first dose of study treatment.  Scans performed as part of 
routine clinical management are acceptable for use as the screening scan if they are of diagnostic 
quality and performed within 28 days before the first dose of study treatment.  Tumor lesions 
that are located in a previously irradiated area or in an area subjected to other locoregional 
therapy should only be selected as target lesions if progression has been demonstrated in such 
lesions.  Additionally, it is recommended that tumor lesions selected for biopsy not be selected as 
target lesions.  Images of the chest, abdomen, and pelvis are required for all subjects.  Additional 
imaging of anatomical sites (ie, head, neck, and extremities) should be performed as applicable if 
participant has suspected disease in those areas.  Computed tomography or MRI scan of the brain 


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will be performed at screening if there are signs or symptoms suggesting that the participant has 
disease involvement in the CNS. 
8.2.2. 
Photographic Analysis of Skin Lesions 
Photographic imaging of skin tumors that are being followed as target lesions is required and 
should follow the schedule of events for clinical tumor assessment.  Instructions are provided in 
the Photography User Manual. 
 
 
 
 
 
  
 
 
 
 
 
 
 
8.2.4. 
Health Economics 
Not applicable. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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8.3. 
Safety Assessments 
See Section 6.5 and refer to the American Society of Clinical Oncology and European Society 
for Medical Oncology Clinical Practice Guidelines (Brahmer et al 2018, Haanen et al 2017) for 
management guidelines regarding of known or potential AEs and toxicities. 
Safety will be monitored by ongoing review of AEs by the sponsor's study physician and 
pharmacovigilance physician.  Regularly scheduled meetings/teleconferences will be held for 
review of AEs by the sponsor's study physician and pharmacovigilance physician with 
participating investigators. 
8.3.1. 
Adverse Events 
Adverse events will be monitored from the time the participant signs the ICF until at least 
90 days after the last dose of study treatment or until the start of new anticancer therapy, 
whichever occurs first.  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 treatment(s).  Conditions that were already present at the time of 
informed consent should be recorded on the Medical History Form in the eCRF.  Adverse events 
(including laboratory abnormalities that constitute AEs) should be described using a diagnosis 
whenever possible rather than by individual underlying signs and symptoms.  Adverse events 
judged to be potentially immune-related should be described on the appropriate eCRF.  The 
severity of AEs will be determined using CTCAE v5.0. 
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, 
surrogate, or the participant's legally authorized representative).  The investigator and any 
qualified designees are responsible for detecting, documenting, and recording events that meet 
the definition of an AE or SAE and remain responsible for following-up on AEs that are serious, 
considered related to the study treatment/procedures, or that caused the participant to discontinue 
the study treatment.  Care will be taken not to introduce bias when detecting AEs and/or SAEs.  
Open-ended and nonleading verbal questioning of the participant, such as "How are you 
feeling?" is the preferred method to inquire about AE occurrences.  Adverse events may also be 
detected when they are volunteered by the participant during the screening process or between 
visits, or through physical examinations, laboratory tests, or other assessments.  The definition, 
reporting, and recording requirements for AEs are described in Section 9. 
All SAEs will be recorded and reported to the sponsor or designee within 24 hours.  The 
investigator will submit any updated SAE data to the sponsor within 24 hours of it being 
available. 
After the initial AE/SAE report, the investigator is required to proactively follow each participant 
at subsequent visits/contacts.  All SAEs, and nonserious AEs of special interest (as defined in 
Section 9.5), will be followed until resolution, stabilization, the event is otherwise explained, or 
the participant is lost to follow-up (as defined in Section 7.3). 


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8.3.2. 
Physical Examinations 
Physical examinations must be performed by a medically qualified individual, such as a licensed 
physician, physician's assistant, or an advanced registered nurse practitioner, as local law 
permits.  Abnormalities identified after signing the ICF constitute an AE if they are considered 
clinically meaningful, induce clinical signs or symptoms, require concomitant therapy, or require 
changes in study treatment (with the exception of abnormalities associated with clinical disease 
progression).  Investigators should pay special attention to clinical signs related to previous 
serious illnesses.  
At the screening visit, a comprehensive physical examination should be conducted.  The 
comprehensive physical examination will include height (only at screening), weight, and 
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. 
During the study, participants will be assessed by the investigator or medically qualified 
designee per institutional standard of care.  These assessments should be an evaluation as 
indicated by participant symptoms, AEs, or other findings.  Weight will also be assessed at each 
study visit. 
In addition, a disease-related clinical assessment should be performed at each study visit. 
8.3.3. 
Vital Signs 
Vital sign measurements including blood pressure, O2 saturation, pulse, respiratory rate, and 
body temperature should to be taken prior to the blood collection for laboratory analyses.  Blood 
pressure and pulse will be taken with the participant in the recumbent, semirecumbent, or sitting 
position after 5 minutes of rest.  If vital signs cannot be taken before blood collection for 
laboratory tests, there must be a minimum of 30 minutes from the completion of the blood 
collection procedures to the beginning of the vital signs collection.  Abnormal vital signs 
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 study treatment. 
8.3.4. 
Eastern Cooperative Oncology Group Performance Status 
The ECOG performance status score will be assessed according to the criteria in Table 21. 
Table 21: 
Eastern Cooperative Group Performance Status Scoring 
Grade 
ECOG Performance Status 
0 
Fully active, able to carry on all pre-disease performance without restriction 
1 
Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or 
sedentary nature, eg, light house work, office work 
2 
Ambulatory and capable of all self-care but unable to carry out any work activities; up and about more 
than 50% of waking hours 
3 
Capable of only limited self-care; confined to bed or chair more than 50% of waking hours 
4 
Completely disabled; cannot carry on any self-care; totally confined to bed or chair 
5 
Dead 
Source:  Oken et al 1982. 


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8.3.5. 
Electrocardiograms 
Electrocardiograms will be obtained as outlined in Table 3 according to the institutional standard 
of care.  ECGs only need to be performed in triplicate if there has been a QTc prolongation on 
study or the ECG shows a clinically significant abnormality not present at baseline.  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. 
Electrocardiograms should be performed before study drug infusion and will be interpreted by 
the investigator at the site to be used for immediate participant management.  Additional ECGs 
may be performed as clinically indicated to manage participant safety.  The decision to include 
or exclude a participant or withdraw a participant from the study treatment based on an ECG 
flagged as "Abnormal, Clinically Significant" is the responsibility of the investigator, in 
consultation with the sponsor's medical monitor, as appropriate.  Clinically notable abnormalities 
that are considered clinically significant in the judgment of the investigator are to be reported as 
AEs. 
8.3.6. 
Laboratory Assessments 
Clinical safety laboratory analyses (ie, blood chemistries, hematology assessments, coagulation 
tests, endocrine function, fasting lipid panel, and urinalysis) will be performed in certified local 
laboratories associated with study sites.  Blood and urine samples will be collected for laboratory 
analyses during study visits, before study treatment administration, according to the schedule in 
Table 3.  Participants are expected to fast prior to blood collection during visits that include lipid 
panel analysis.  The laboratory analytes to be evaluated are found in Table 22.  Additional testing 
may be required by the sponsor based on emerging safety data.  Additional tests may also be 
performed if clinically indicated. 
Analysis by local laboratories for study treatment–related decisions are acceptable using a 
certified laboratory available to the investigative site.  The investigative site will enter the results 
and normal ranges into the eCRF from any local laboratory analysis. 
Further detailed information regarding collection, processing, and shipping of laboratory 
assessments is provided in the Laboratory Manual. 
Clinically significant abnormal laboratory findings are those that are not associated with the 
underlying disease, unless judged by the investigator to be more severe than expected for the 
participant's condition.  All abnormal laboratory values considered clinically significantly up to 
90 days after the last dose of study treatment should be repeated until the values are no longer 
considered clinically significant by the investigator. 
Screening laboratory assessments for study eligibility evaluation must be performed within 
28 days of Cycle 1 Day 1.  If screening laboratory analyses are performed less than 7 days before 
initial administration of study treatment, laboratory analyses do not need to be repeated if the 
requirements for receiving study drug are met. 
If performed more than 7 days before Cycle 1 Day 1, then the tests must be repeated before the 
initial study treatment administration on Cycle 1 Day 1.  After Cycle 1, predose laboratory 
procedures can be conducted up to 72 hours before study treatment administration, and results 


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should be reviewed by the investigator or qualified designee and found to be acceptable before a 
new cycle of treatment is initiated. 
A final laboratory analysis is required during the 28-day follow-up safety visit.  These labs 
should only be performed at the EOT visit if the EOT visit is also serving as the 28-day safety 
visit. 
 
 
8.3.6.1. 
Pregnancy Testing 
Serum pregnancy tests are required for all women of childbearing potential during screening and 
either EOT or the safety follow-up visit 28 days after the last dose.  Pregnancy testing required 
on Day 1 of all cycles and can be either serum- or urine-based and will be performed before 
administration of study treatment.  If a pregnancy test is performed during screening within 
7 days of Cycle 1 Day 1, it is not necessary to repeat on Cycle 1 Day 1. 
A positive urine pregnancy should be confirmed with a serum pregnancy test.  Section 9.7 
provides reporting requirements in the case of confirmation by a serum pregnancy test. 


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Table 22: 
Required Laboratory Analytes 
Blood Chemistries 
Hematology 
Urinalysis With 
Microscopic Examination 
Coagulation 
Pregnancy Testing 
Albumin 
Alkaline phosphatase 
ALT 
AST 
Amylase 
Bicarbonate or CO2 
Blood urea nitrogen or urea 
Calcium 
Chloride 
Creatinine 
Glucose 
Lactate dehydrogenase 
Lipase 
Phosphate 
Potassium 
Sodium 
Total bilirubin 
Direct bilirubin (if total bilirubin 
is elevated above ULN) 
Total protein 
Uric acid 
Complete blood count, 
including: 
• Hemoglobin 
• Hematocrit 
• Platelet count 
• Red blood cell count 
• WBC count 
 
Differential count, including: 
• Basophils 
• Eosinophils 
• Lymphocytes 
• Monocytes 
• Neutrophils 
 
Absolute values must be 
provided for: 
• WBC differential 
laboratory results 
Color and appearance 
pH and specific gravity 
Bilirubin 
Glucose 
Ketones 
Leukocytes 
Nitrite 
Occult blood 
Protein 
PT 
PTT or aPTT 
INR 
Female participants of 
childbearing potential 
require a serum 
pregnancy test at 
screening and EOT, or 
28 days after the last 
dose. 
Either a serum or urine 
pregnancy test will be 
acceptable prior to 
receiving study treatment 
on Day 1 of each 
treatment cycle. 
Lipid Panela 
Endocrine Function 
 
 
 
Total cholesterol 
Triglycerides 
LDL 
HDL 
TSH 
T4/FT4 
T3/FT3 
 
 
SARS-CoV-2 
SARS-CoV-2 testing during 
the COVID-19 pandemic, as 
per country, local, 
institution's requirements 
Note:  Additional tests may be required, as agreed upon by the investigator and sponsor, based on emerging safety data. 
a Participants are required to fast prior to blood collection for lipid panel analysis. 


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8.4. 
Pharmacokinetic Assessments 
Blood samples for PK 
 analysis will be obtained at the visits and timepoints indicated 
in Table 4 and Table 23.  After the preinfusion PK sample is drawn, participants will begin the 
study drug infusion.  Adjustments to the timing of blood sampling may be made based on 
emerging PK data.  The exact dates and times of the PK blood collection will be recorded in the 
eCRF.  Instructions for sample preparation and shipping will be provided in the Laboratory 
Manual. 
Table 23: 
Pharmacokinetic and Antidrug Antibody Serum Blood Sample Timing 
Study Visit 
Assessment 
Timing of Sample 
Cycle 1 Day 1 
PK 
 
Preinfusion 
PK 
10 minutes post INCMGA00012 
infusion (± 10 minutes) 
4 hours post INCMGA00012 
infusion (± 15 minutes) 
Cycle 2 Day 1 
PK 
 
Preinfusion 
Cycle 4 Day 1 
PK 
 
Preinfusion 
Cycle 6 Day 1 
PK 
 
Preinfusion 
PK 
10 minutes post INCMGA00012 
infusion (± 10 minutes) 
4 hours post INCMGA00012 
infusion (± 15 minutes) 
Cycle 7 Day 1 
PK 
Preinfusion 


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8.6. 
Unscheduled Visits 
Unscheduled study visits may occur at any time if medically warranted.  Any assessments 
performed at those visits should be recorded in the eCRF. 
8.7. 
End of Treatment and/or Early Termination 
Once a participant permanently discontinues study treatment, the EOT visit should be conducted, 
and the data should be entered in the EOT visit in the eCRF.  If the EOT visit coincides with a 
regular study visit, the EOT evaluations will supersede those of that scheduled visit.  Should 
study treatment discontinuation occur ≤ 21 days after the final dose of study treatment, a 28-day 
safety follow-up visit is required and should be conducted according to Table 3.  If the EOT visit 
occurs > 21 days after the last study treatment, only a single EOT/28-day safety follow up is 
required and all assessments for the EOT and 28-day follow-up visits will be performed. 
8.8. 
Follow-Up 
The study design includes a follow-up period for participants subsequent to the end of the study 
treatment period.  After discontinuation of study treatment, all study participants, except for 
those who have actively withdrawn consent for any further participation in the study, should be 
encouraged to participate in the follow-up period. 
8.8.1. 
Safety Follow-Up 
The safety follow-up period starts once the participant discontinues study treatment.  
Approximately 28 (± 7) days after the final dose of study drug, participants are to attend a 
clinical visit for a safety evaluation.  During this visit, blood will be collected for safety 
laboratory analysis, and other safety assessments, such as a physical examination and recording 
AEs and concomitant medications, will be performed as described in Table 3.  Participants will 
be followed for AEs up to 90 days after the last dose of study drug or until the start of a new 
anticancer therapy, whichever occurs first.  Reasonable efforts should be made to align the first 


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12-week follow up visit with the end of the 90-day AE reporting period.  However, if necessary, 
contact by phone or other methods of communication are acceptable in order for the participant 
to report any AEs that may occur during this period. 
If a participant is scheduled to begin a new anticancer therapy before the end of the 28-day safety 
follow-up period, the safety follow-up visit should be performed before a new anticancer therapy 
is started.  Once a new anticancer therapy has been initiated, the participant will move into the 
survival follow-up period. 
8.8.2. 
Post-Treatment Disease Follow-Up 
Participants who discontinue study treatment for a reason other than disease progression will 
move into the disease status follow-up period and should be assessed according to the schedule 
of events until: 
• The start of new anticancer therapy. 
• Disease progression. 
• Death. 
• The end of the study. 
• Participant is lost to follow-up. 
8.8.3. 
Survival Follow-Up 
Once a participant has received the last dose of study treatment, has confirmed disease 
progression, or starts a new anticancer therapy, the participant moves into the survival follow-up 
period and should be contacted by telephone, email, or visit at least every 12 weeks to assess for 
survival status until death, withdrawal of consent, lost to follow-up, or the end of the study, 
whichever occurs first. 
For participants having entered the survival follow-up period of the study, the site will use 
continuing participant records to supply data on subsequent treatment regimens, tumor 
assessments (if discontinued treatment for a reason other than disease progression), and OS in 
the eCRF.  For participants who do not intend to return to the study investigator for their ongoing 
care, follow-up should be maintained by phone contact, patient records, and public 
records/databases (as permitted by local laws or regulations) at intervals of no longer than 
12 weeks. 


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


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


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d. Results in persistent or significant disability/incapacity 
• The term disability means a substantial disruption of a person's ability to conduct normal life 
functions. 
• This definition is not intended to include experiences of relatively minor medical significance, such 
as uncomplicated headache, nausea, vomiting, diarrhea, influenza, and accidental trauma 
(eg, sprained ankle), that may interfere with or prevent everyday life functions but do not constitute a 
substantial disruption. 
e.  Is a congenital anomaly/birth defect 
f. Other situations (Important Medical Event) 
An event that may not result in death, be immediately life-threatening, or require hospitalization, but 
may be considered serious when, based on appropriate medical judgment, the event may jeopardize the 
participant and may require medical or surgical intervention to prevent one of the outcomes listed in 
the above definition.  Examples of such events include invasive or malignant cancers (excluding the 
disease[s] under study in oncology protocols), intensive treatment in an emergency department or at 
home for allergic bronchospasm, blood dyscrasias, or convulsions that do not result in hospitalization, 
or development of drug dependency or drug abuse. 
9.3. 
Recording and Follow-Up of Adverse Events and/or Serious Adverse 
Events 
Adverse Event and Serious Adverse Event Recording 
• An AE/SAE that begins or worsens after informed consent is signed should be recorded on the 
Adverse Event Form in the eCRF.  Conditions that were present at the time informed consent was 
given should be recorded on the Medical History Form in the eCRF. 
• When an AE/SAE occurs, it is the responsibility of the investigator to review all documentation 
(eg, hospital progress notes, laboratory reports, and diagnostics reports) related to the event. 
• The investigator (or delegate) will then record all relevant AE/SAE information in the eCRF. 
• It is not acceptable for the investigator to send photocopies of the participant's medical records in 
lieu of completing the AE eCRF page. 
• There may be instances when copies of medical records for certain cases are requested.  In this case, 
all participant identifiers, with the exception of the participant number, will be redacted on the copies 
of the medical records before submission. 
• The investigator will attempt to establish a diagnosis of the event based on signs, symptoms, and/or 
other clinical information.  Whenever possible, the diagnosis (not the individual signs/symptoms) 
will be documented as the AE/SAE.  When a clear diagnosis cannot be identified, each sign or 
symptom should be reported as a separate AE/SAE. 
To the extent possible, each AE/SAE should be evaluated to determine: 
• The severity grade (CTCAE 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 treatment   
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 study drug as a result of the AE/SAE(s). 


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• The event outcome (eg, not recovered/not resolved, recovered/resolved, recovering/resolving, 
recovered/resolved with sequelae, fatal, unknown). 
• The seriousness, as per the SAE definition provided in Section 9.2. 
• The action taken with regard to the event. 
Note:  If an AE is treated with a concomitant medication or nondrug therapy, this action should be 
recorded on Adverse Event Form and the treatment should be specified on the appropriate eCRF 
(eg, Prior/Concomitant Medications, Procedures and Nondrug Therapy). 
Assessment of Intensity 
The severity of AEs will be assessed using CTCAE v5.0 Grades 1 through 5.  If an event is not 
classified by CTCAE, the severity of the AE will be graded according to the scale below to estimate the 
grade of severity: 
The investigator will make an assessment of intensity for each AE and SAE reported during the study 
and assign it to 1 of the following categories: 
• Grade 1:  Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment 
not indicated. 
• Grade 2:  Moderate; minimal, local, or noninvasive treatment indicated; limiting age appropriate 
activities of daily living. 
• Grade 3:  Severe or medical significant but not immediately life-threatening; hospitalization or 
prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. 
• Grade 4:  Life-threatening consequences; urgent treatment indicated. 
• Grade 5:  Fatal. 
Assessment of Causality 
• The investigator is obligated to assess the relationship between study treatment and each occurrence 
of each AE/SAE.   
• A "reasonable possibility" of a relationship conveys that there are facts, evidence, and/or arguments 
to suggest a causal relationship, rather than that a relationship cannot be ruled out. 
• The investigator will use clinical judgment to determine the relationship. 
• 
The investigator will also consult the Reference Safety Information in the IB and/or Product 
Information, for marketed products, in his/her assessment. 
• Alternative causes, such as underlying disease(s), concomitant therapy, and other risk factors, as well 
as the temporal relationship of the event to study treatment administration, will be considered and 
investigated. 
• For each AE/SAE, the investigator must document in the medical notes that he/she has reviewed the 
AE/SAE and has provided an assessment of causality. 
• With regard to assessing causality of SAEs: 
− There may be situations in which an SAE has occurred and the investigator has minimal 
information to include in the initial report.  However, the causality assessment is one of the criteria 
used when determining regulatory reporting requirements.  Therefore, it is very important that 
the investigator always make an assessment of causality for every event before the initial 
transmission of the SAE. 
− The investigator may change his/her opinion of causality in light of follow-up information and 
send a follow-up SAE report with the updated causality assessment. 


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Follow-Up of Adverse Events and Serious Adverse Events 
• The investigator is obligated to perform or arrange for the conduct of supplemental measurements 
and/or evaluations as medically indicated or as requested by the sponsor to elucidate the nature 
and/or causality of the AE or SAE as fully as possible.  This may include additional laboratory tests 
or investigations, histopathological examinations, or consultation with other health care 
professionals. 
• New or updated information will be recorded in the originally completed eCRF. 
• Any updated SAE data will be submitted to the sponsor (or designee) within 24 hours of receipt of 
the information. 
• Once an AE is detected, it should be followed until it has resolved or until it is judged to be 
permanent; assessment should be made at each visit (or more frequently if necessary) of any changes 
in severity, the suspected relationship to the study drug, the interventions required to treat the event, 
and the outcome. 
• When the severity of an AE changes over time for a reporting period (eg, between visits), each 
change in severity will be reported as a separate AE until the event resolves. 
9.4. 
Reporting of Serious Adverse Events 
Regardless of suspected causality (eg, relationship to study treatment or study procedure[s]), all 
SAEs occurring after the participant has signed the ICF through 90 days after the last dose of 
study treatment or until the participant starts a new anticancer therapy, whichever occurs earlier 
must be reported to the sponsor (or designee) within 24 hours of learning of its occurrence, 
unless otherwise specified by the Protocol.  The investigator will submit any updated SAE data 
to the sponsor (or designee) within 24 hours of it being available. 
Investigators are not obligated to actively seek AE or SAE information after conclusion of the 
study participation.  However, if the investigator learns of any SAE, including a death, at any 
time after a participant has been discharged from the study, and he/she considers the event to be 
reasonably related to the study treatment or study participation, the investigator must notify the 
sponsor (or designee) within 24 hours of becoming aware of the event. 
After the initial AE/SAE report, the investigator is required to proactively follow each participant 
at subsequent visits/contacts.  All SAEs, and nonserious AEs of special interest (as defined in 
Section 9.5), will be followed until resolution, stabilization, the event is otherwise explained, or 
the participant is lost to follow-up (as defined in Section 7.3). 
Prompt notification by the investigator to the sponsor of a SAE is essential so that legal 
obligations and ethical responsibilities towards the safety of participants and the safety of a study 
treatment under clinical investigation are met. 
If the SAE is not documented in the IB for the study drug (new occurrence) and is thought to be 
related to the sponsor's study drug, the sponsor or its designee may urgently require further 
information from the investigator for reporting to health authorities.  The sponsor or its designee 
may need to issue an Investigator Notification to inform all investigators involved in any study 
with the same drug that this SAE has been reported.  Suspected unexpected serious adverse 
reactions will be collected and reported to the competent authorities and relevant ethics 
committees in accordance with Directive 2001/20/EC, or as per national regulatory requirements 
in participating countries.  The sponsor has a legal responsibility to notify both the local 


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regulatory authority and other regulatory agencies about the safety of a study treatment under 
clinical investigation.  The sponsor will comply with country-specific regulatory requirements 
relating to safety reporting to the regulatory authority, IRB/IEC, and investigators. 
Investigator safety reports must be prepared for suspected unexpected serious adverse reactions 
according to local regulatory requirements and sponsor policy and forwarded to investigators as 
necessary. 
An investigator who receives an investigator safety report describing a SAE or other specific 
safety information (eg, summary or listing of SAEs) from the sponsor will review and then file it 
along with the IB and will notify the IRB/IEC, if appropriate according to local requirements. 
Serious Adverse Event Reporting 
• Information about all SAEs is collected and recorded on the Adverse Event Form in the eCRF. 
• The investigator must also complete the Incyte Serious Adverse Event Report Form, in English.  
Refer to the Incyte Reference Guide for Completing the Serious Adverse Event Report Form. 
• Facsimile or email transmission of the Serious Adverse Event Report Form is the preferred method 
to transmit this information to the PhV/designee.  The contact information of the sponsor's 
study-specific representatives is listed in the Investigator Site Binder provided to each site.  The 
original copy of the Serious Adverse Event Report Form and the confirmation sheet must be kept at 
the study site. 
• Follow-up information is recorded on an amended or new Serious Adverse Event Report Form, with 
an indication that it is follow-up to the previously reported SAE and the date of the original report.  
The follow-up report should include information that was not provided on the previous Serious 
Adverse Event Report Form, such as the outcome of the event (eg, resolved or ongoing), treatment 
provided, action taken with study drug because of the SAE (eg, dose reduced, interrupted, or 
discontinued), or participant disposition (eg, continued or withdrew from study participation).  Each 
recurrence, complication, or progression of the original event should be reported as follow-up to that 
event, regardless of when it occurs. 
• In rare circumstances and in the absence of facsimile or computer equipment, notification by 
telephone is acceptable with a copy of the Incyte Serious Adverse Event Report Form sent by 
overnight mail or courier service.  Initial notification via telephone does not replace the need for the 
investigator to complete and sign the Serious Adverse Event Report Form within the designated 
reporting time frames. 
• Contacts for SAE reporting can be found in the Investigator Site Binder. 
9.5. 
Adverse Events of Special Interest 
Adverse events that are potentially immune-related will be assessed as AEs of special interest.  
Examples of these (including diagnostic algorithms to be followed) are provided in the American 
Society of Clinical Oncology and European Society for Medical Oncology Clinical Practice 
Guidelines (Brahmer et al 2018, Haanen et al 2017).  Guidance for the management of irAEs are 
provided in Section 6.5.2. 
9.6. 
Emergency Unblinding of Treatment Assignment 
Not applicable. 


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9.7. 
Pregnancy 
Pregnancy, in and of itself, is not regarded as an AE unless there is suspicion that study drug may 
have interfered with the effectiveness of a contraceptive medication or method.  When a 
pregnancy has been confirmed in a participant during maternal or paternal exposure to study 
drug, the following procedures should be followed in order to ensure safety: 
• The study drug must be discontinued 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 treatment may be 
resumed after approval has been received from the sponsor medical monitor. 
• The investigator must complete and submit the Incyte Clinical Trial Pregnancy Form 
to the sponsor or its designee within 24 hours of learning of the pregnancy. 
Data on fetal outcome are collected for regulatory reporting and drug safety evaluation.  
Follow-up should be conducted for each pregnancy to determine outcome, including spontaneous 
or voluntary termination, details of the birth, and the presence or absence of any birth defects, 
congenital abnormalities, or maternal and/or newborn complications, by following until the first 
well-baby visit.  Pregnancy should be recorded on a Clinical Trial Pregnancy Form and reported 
by the investigator to the sponsor or its designee.  Pregnancy follow-up information should be 
recorded on the same form and should include an assessment of the possible causal relationship 
to the sponsor's study drug to any pregnancy outcome, as well as follow-up to the first well-baby 
visit or the duration specified in local regulations, whichever is later.  Refer to the Incyte 
Reference Guide for Completing the Clinical Trial Pregnancy Form. 
Any SAE occurring during pregnancy of a study participant must be recorded on the 
Serious Adverse Event Report Form and submitted to the sponsor or designee. 
Abnormal pregnancy outcomes (eg, spontaneous abortion, fetal death, stillbirth, congenital 
anomalies, or ectopic pregnancy) are considered SAEs (if occurring in the study participant) and 
must be reported as described in Section 9.4.  If an abnormal pregnancy outcome is reported in a 
study participant's partner, the event should be reported to the sponsor on the Clinical Trial 
Pregnancy Form. 
9.8. 
Warnings and Precautions 
Special warnings or precautions for the study treatment, derived from safety information 
collected by the sponsor or its designee, are presented in in the INCMGA00012 IB.  Additional 
safety information collected between IB updates will be communicated in the form of 
Investigator Notifications.  Any important new safety information should be discussed with the 
participant during the study, as necessary.  If new significant risks are identified, they will be 
added to the ICF. 


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9.9. 
Product Complaints 
The sponsor collects product complaints on study drugs and drug delivery systems used in 
clinical studies in order to ensure the safety of study participants, monitor quality, and facilitate 
process and product improvements. 
All product complaints associated with material packaged, labeled, and released by the sponsor 
or its designee will be reported to the sponsor.  All product complaints associated with other 
study material will be reported directly to the respective manufacturer. 
The investigator or his/her designee is responsible for reporting a complete description of the 
product complaint via email or other written communication to the sponsor contact or respective 
manufacturer as noted in the packaging information.  Any AE associated with a product 
complaint should be 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. 
9.10. 
Treatment of Overdose 
In the event of an overdose of more than 25%, the investigator should: 
• Contact the medical monitor immediately. 
• 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. 


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10. 
STATISTICS 
10.1. 
Sample Size Determination 
A pilot study of avelumab in participants with chemotherapy-naive metastatic MCC shows a 
confirmed ORR of 39.7% with lower 95% CI of 30.7% (D'Angelo et al 2019).  A pilot study of 
pembrolizumab in the same population showed an ORR of 56% with lower 95% CI of 35% 
(Nghiem et al 2016, Nghiem et al 2019). 
Based on the results from studies of avelumab and pembrolizumab, it is reasonable to target a 
response rate of approximately 48%.  Approximately 60 chemotherapy-naive participants will be 
enrolled for the primary analysis.  Based on a target ORR of 48% and a sample size of 
approximately 60, this study has over 80% power to exclude the lower 95% confidence limit of 
30% with α = 0.025 (1-sided) in the chemotherapy-naive population. 
Approximately 100 chemotherapy-naive participants will be enrolled for the final analysis.  This 
sample size ensures that half of the 95% CI will be approximately 10% for an ORR ranging from 
40% to 60%.  This sample size also ensures 99% power to detect any AE with an underlying 
event rate as low as 0.5%. 
Note:  Participants who had received prior chemotherapy for MCC were enrolled up to 
Amendment 4. 
10.2. 
Populations for Analysis 
Table 25: 
Populations for Analysis 
Population 
Description 
FAS 
The FAS includes all participants enrolled in the study who received at least 1 dose 
of study drug and will include the first 60 chemotherapy-naive participants.  The 
FAS will be used for the summary of demographics, baseline characteristics, 
participant disposition, and efficacy.  Note:  this analysis population will be used in 
the interim CSR. 
Efficacy 
evaluable 
population  
The efficacy evaluable population includes all participants from the FAS with a 
centrally confirmed diagnosis of MCC who are evaluable according to RECIST v1.1 
and have received at least 1 dose of study drug. 
Safety evaluable 
population 
The safety evaluable population includes all enrolled participants who received at 
least 1 dose of study drug.  The safety evaluable population will be used to support 
the safety analysis at the primary analysis and to support all analyses including 
efficacy at the final analysis. 
PK evaluable 
population 
The PK evaluable population will include all participants who received at least 
1 dose of study drug and have provided a baseline and at least 1 postdose PK 
sample. 
10.3. 
Level of Significance 
There is no formal hypothesis testing in this study.  Response rate as well as the associated 
95% CI will be provided. 


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10.4. 
Statistical Analyses 
The Statistical Analysis Plan will be developed and finalized before database lock and will 
describe the participant populations to be included in the analyses, and procedures for accounting 
for missing, unused, and spurious data.  This section is a summary of the planned statistical 
analyses of the primary and secondary endpoints. 
The primary analysis will occur after 60 chemotherapy-naive participants have been enrolled and 
followed for at least 6 months after confirmed response.  If the study meets the predefined 
efficacy threshold at the primary analysis (see Section 10.1), the final analysis will occur after all 
100 participants have been enrolled and followed for survival for a minimum of 2 years.  
10.4.1. 
Primary Analysis 
10.4.1.1. Overall Response Rate 
The primary endpoint of the study is ORR in the chemotherapy-naive population, defined as the 
proportion of participants with an objective response (CR or PR), according to RECIST v1.1 
(Eisenhauer et al 2009) as determined by an ICR.  The primary analysis of ORR will be based on 
the chemotherapy-naive subset of the FAS, as defined in Table 25.  Overall response rate and its 
exact 95% CI will be presented.  The analysis will be assessed using the efficacy evaluable 
population as a sensitivity analysis.  The ORR will be assessed again at the final analysis using 
the safety evaluable population. 
10.4.1.2. Handling of Missing Data in Primary Analysis 
The efficacy evaluable population must have measurable disease at baseline per RECIST v1.1.  
Participants with subsequent missing assessments that prevent the evaluation of the primary 
endpoint will be considered as nonresponders.  No data imputation will be applied.   
A response assessment of CR or PR reported before any additional anticancer therapy will be 
considered as a response in the calculation of ORR irrespective of the number of missed 
assessments before response. 
10.4.2. 
Secondary Analysis 
10.4.2.1. Duration of Response 
Duration of response is defined as the time from first documented objective response (CR or PR) 
to the time of first documented disease progression according to RECIST v1.1 or death due to 
any cause.  If a participant does not have disease progression or death, the DOR will be censored 
at the date of the last adequate tumor assessment before data cutoff or new anticancer therapy.  
Duration of response will be assessed for chemotherapy-naive participants.  The Kaplan-Meier 
estimate of the distribution function will be constructed for DOR.  The estimated median along 
with 95% CI will be reported.  Duration of response will be analyzed using the FAS at the 
primary analysis and may be assessed using the safety evaluable population at the final analysis. 
10.4.2.2. Disease Control Rate 
Disease control rate is defined as the proportion of participants with either an objective response 
(CR and PR) or SD lasting at least 6 months, according to RECIST v1.1.  Disease control rate 


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will be assessed for chemotherapy-naive participants using the FAS at the primary analysis and 
may be assessed using the safety evaluable population at the final analysis. 
10.4.2.3. Progression-Free Survival 
Progression-free survival, defined as the time from first dose of study treatment to the date of the 
first documented progression per RECIST v1.1 by ICR or death due to any cause.  
Progression-free survival data will be analyzed by the Kaplan-Meier method, including estimated 
median with 95% CI, and Kaplan-Meier estimated probabilities at several timepoints.  If an event 
is not observed, PFS will be censored at the last adequate tumor assessment before cutoff or new 
anticancer therapy.  Progression-free survival will be assessed for chemotherapy-naive 
participants using the FAS at the primary analysis and may be assessed using the safety 
evaluable population at the final analysis. 
10.4.2.4. Overall Survival 
Overall survival is defined as the time from first dose of study treatment to the date of death due 
to any cause.  Kaplan-Meier estimate of OS will be provided, including median and its 95% CI.  
Participants still alive at time of analysis will be censored at the date last confirmed to be alive.  
Kaplan-Meier curves, medians, and 95% CIs of the medians will be presented.  Overall survival 
will be assessed for chemotherapy-naive participants using the FAS at the primary analysis and 
may be assessed using safety evaluable population at the final analysis. 
10.4.3. 
Safety Analyses 
The clinical safety data (eg, vital signs, ECGs, routine laboratory tests, physical examinations, 
and AEs) will be summarized using descriptive statistics (eg, mean, frequency) using the safety 
evaluable population.  The safety analysis will be performed separately for chemotherapy-naive 
participants and the full study population. 
Summary tables may be replaced with listings when appropriate.  For instance, an AE frequency 
table may be replaced with a listing if it only contains a few unique preferred terms reported on 
relatively few participants. 
10.4.3.1. Adverse Events 
Safety analyses will be conducted for the safety evaluable population.  Adverse events will be 
coded according to MedDRA, and treatment-emergent AEs (ie, AEs reported for the first time or 
worsening of a pre-existing event after first dose of study treatment) will be tabulated by 
preferred term and system organ class for all events, related events, and events of Grade 3 or 
higher.   
10.4.3.2. Adverse Events of Special Interest 
Adverse events of special interest will include irAEs. 
10.4.3.3. Clinical Laboratory Tests 
The clinical laboratory data will be analyzed using summary statistics.  In addition, distributions 
of key laboratory parameters may be plotted over time; these values will also be classified into 
CTCAE toxicity grades, and tabulated.   


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Laboratory test values outside the normal range will be assessed for severity based on the normal 
ranges for the clinical reference laboratory.  The incidence of abnormal laboratory values and 
shift tables relative to baseline will be tabulated.  The following summaries will be produced for 
the laboratory data:  
• Number and percentage of participants with worst postbaseline CTCAE grade 
(regardless of baseline value).  Each participant will be counted only for the worst 
grade observed postbaseline. 
• Shift tables from baseline to the worst postbaseline value using CTCAE grade. 
• For laboratory parameters where CTCAE grades are not defined, shift tables to the 
worst postbaseline value using the low/normal/high classifications based on 
laboratory reference ranges. 
10.4.3.4. Vital Signs 
Descriptive statistics and mean change from baseline will be determined for vital signs (blood 
pressure, O2 saturation, pulse, respiratory rate, and body temperature) at each assessment time.  
Vital sign results will be reviewed for clinically notable abnormalities, and participants 
exhibiting clinically notable vital sign abnormalities will be listed. 
10.4.3.5. Electrocardiograms 
Descriptive statistics and mean change from baseline will be determined for each ECG parameter 
at each assessment time.  Electrocardiogram results will be reviewed for clinically notable 
abnormalities according to predefined criteria as described in the Statistical Analysis Plan. 
10.4.3.6. Dose Intensity 
Measures of exposure (eg, days of exposure, dose intensity) of study drug will be summarized by 
means of summary statistics. 
10.4.4. 
Pharmacokinetics 
If there is a sufficient amount of serum concentration data from this study, the data will be 
analyzed by standard population PK methods using appropriate software (eg, NONMEM).  
Otherwise, the data will be pooled with data from other studies for a population PK analysis. 
10.4.5. 
Exploratory Analyses 
 
 
 
 
 


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10.4.5.6. Efficacy Endpoints for Full Study Population 
Efficacy will be determined for the full study population, including participants who are 
chemotherapy-naive and those participants who received prior chemotherapy who enrolled 
before Amendment 5. 
The ORR in the full study population, comprised of chemotherapy-naive and chemotherapy-
refractory participants, will be evaluated as an exploratory endpoint.  The ORR and its exact 
95% CI will be presented.  The ORR in chemotherapy-refractory participants will be provided as 
a subgroup analysis.  The ORR in the full study population will be analyzed using the FAS at the 
primary analysis. 
Duration of response, DCR, PFS, and OS will be analyzed using the methods described in 
Sections 10.4.2.1, 10.4.2.2, 10.4.2.3, and 10.4.2.4.  These endpoints will be assessed separately 
for chemotherapy-naive participants and the full study population. 
10.5. 
Futility Analysis 
An analysis is planned after approximately 20 chemotherapy-naive participants are assessable for 
response.  The primary intent of this analysis is to minimize unnecessary exposure of participants 
to INCMGA00012 in the event of futility.  The futility analysis will be based on conditional 
power/probability of success to achieve the primary endpoint of target ORR.  Enrollment will 
continue while the analysis is being conducted.  This futility analysis will be reviewed by an 
independent DMC as specified in the DMC charter.  The process by which the DMC will review 
data and make recommendations and decisions will be documented in the DMC charter.  This 
futility analysis will be described in greater detail in the Statistical Analysis Plan. 
As of Protocol Amendment 6, the DMC has reviewed the data for the interim analysis.  The 
preliminary efficacy based on the ORR assessed by ICR exceeded the futility threshold, and the 
DMC recommended the study to proceed as planned. 


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11. 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS 
11.1. 
Investigator Responsibilities 
• The Protocol, Protocol amendments, ICF, IB, and other relevant documents 
(eg, advertisements) must be submitted to an IRB/IEC by the investigator and 
reviewed and approved by the IRB/IEC before the study is initiated. 
• The investigator is responsible for ensuring that the safety reports provided by the 
sponsor are reviewed and processed in accordance with regulatory requirements, the 
policies and procedures established by the IRB/IEC, and institutional requirements. 
• Any amendments to the Protocol will require health authorities or regulatory agencies 
and IRB/IEC approval before implementation of changes made to the study design, 
except for changes necessary to eliminate an immediate hazard to study participants. 
• The investigator will be responsible for the following: 
− Providing written summaries of the status of the study to the IRB/IEC annually or 
more frequently in accordance with the requirements, policies, and procedures 
established by the IRB/IEC. 
− Notifying the IRB/IEC of SAEs or other significant safety findings as required by 
IRB/IEC procedures. 
− Providing oversight of the conduct of the study at the site and adherence to GCP, 
IRB/IEC requirements, institutional requirements, and applicable laws and 
country-specific regulations. 
• Adhering to the Protocol as described in this document and agreeing that changes to 
the Protocol procedures, with the exception of medical emergencies, must be 
discussed and approved, first, by the sponsor or its designee and, second, by the 
IRB/IEC.  Each investigator is responsible for enrolling participants who have met 
the specified eligibility criteria. 
• Retaining records in accordance with all local, national, and regulatory laws, but for a 
minimum period of at least 2 years after the last marketing application approval in an 
ICH region and until there are no pending or contemplated marketing applications in 
an ICH region, or if not approved, 2 years after the termination of the test article for 
investigation to ensure the availability of study documentation should it become 
necessary for the sponsor or a regulatory authority to review. 
− The investigator must not destroy any records associated with the study without 
receiving approval from the sponsor.  The investigator must notify the sponsor or 
its designee in the event of accidental loss or destruction of any study records.  If 
the investigator leaves the institution where the study was conducted, the sponsor 
or its designee must be contacted to arrange alternative record storage options. 
− All eCRF data entered by the site (including audit trail), as well as computer 
hardware and software (for accessing the data), will be maintained or made 
available at the site in compliance with applicable record retention regulations.  
The sponsor will retain the original eCRF data and audit trail. 


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11.2. 
Data Management 
Data management will be performed in a validated EDC system.  Data from external vendors 
may also be integrated into the clinical database.  The investigator will be provided with access 
to an EDC system so that an eCRF can be completed for each participant. 
The site will be provided eCRF completion guidelines for instructions on data entry in the eCRF.  
The study monitor will reference the Monitoring Plan in order to ensure that each issue identified 
is appropriately documented, reported, and resolved in a timely manner in accordance with the 
plan's requirements. 
The sponsor (or designee) will be responsible for: 
• The data management of this study including quality checking of the data. 
• Ensuring that study monitors perform ongoing source data verification to confirm that 
data entered into the eCRF by authorized site personnel are accurate, complete, and 
verifiable from source documents; that the safety and rights of participants are being 
protected; and that the study is being conducted in accordance with the currently 
approved protocol and any other study agreements, ICH GCP, and all applicable 
regulatory requirements. 
The investigator will be responsible for: 
• Ensuring participant data relating to the study is recorded in the eCRF unless 
transmitted to the sponsor or designee electronically (eg, laboratory data, diary data) 
or as otherwise specified in the Protocol.  The investigator is responsible for verifying 
that data entries are accurate and correct by physically or electronically signing the 
eCRF. 
• Maintaining accurate documentation (source data) that supports the information 
entered in the eCRF. 
− Source documents provide evidence for the existence of the participant and 
substantiate the integrity of the data collected.  Source documents are filed at the 
investigator's site. 
− Data reported on the CRF or entered in the eCRF that are transcribed from source 
documents must be consistent with the source documents or the discrepancies 
must be explained.  The investigator may need to request previous medical 
records or transfer records, depending on the study.  Also, current medical records 
must be available. 
• Permitting study-related monitoring, sponsor audits, IRB/IEC review, and regulatory 
inspections by providing direct access to source data and other relevant clinical study 
documents. 
− Monitoring:  Qualified representatives of the sponsor or its designee, study 
monitors, will monitor the study according to a predetermined plan.  The 
investigator must allow the study monitors to review any study materials and 
participant records at each monitoring visit. 


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− Auditing:  Qualified representatives of the sponsor or its designee may audit the 
clinical study site and study data to evaluate compliance with the Protocol, 
applicable local clinical study regulations, and overall study conduct.  The 
investigator must allow the auditors to review original source records and study 
documentation for all participants. 
− Regulatory inspection:  Regulatory authorities may conduct an inspection of the 
study and the site at any time during the development of an investigational 
product.  The investigator and staff are expected to cooperate with the inspectors 
and allow access to all source documents supporting the eCRFs and other 
study-related documents.  The investigator must immediately notify the sponsor 
when contacted by any regulatory authority for the purposes of conducting an 
inspection. 
11.3. 
Data Privacy and Confidentiality of Study Records 
The investigator and the sponsor or its designee must adhere to applicable data privacy laws and 
regulations.  The investigator and the sponsor or its designee are responsible for ensuring that 
sensitive information is handled in accordance with local requirements (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. 
Participant names will not be supplied to the sponsor or its designee.  Only the participant 
number will be recorded in the eCRF; if the participant's name appears on any other document 
(eg, laboratory report), it must be obliterated on the copy of the document to be supplied to the 
sponsor or its designee.  Study findings stored on a computer will be stored in accordance with 
appropriate technical and organizational measures as required by local data protection laws. 
Records and documents, including signed ICFs, pertaining to the conduct of this study must be 
retained by the investigator for 10 years after study completion unless local regulations or 
institutional policies require otherwise.  No records may be destroyed during the retention period 
without the written approval of the sponsor.  No records may be transferred to another location 
or party without written notification to the sponsor. 
11.4. 
Financial Disclosure 
Before study initiation, all clinical investigators participating in clinical studies participant to 
FDA Regulation Title 21 CFR Part 54 – Financial Disclosure by Clinical Investigators 
(ie, "covered studies") are required to submit a completed Clinical Investigator Financial 
Disclosure form that sufficiently details any financial interests and arrangements that apply.  For 
the purpose of this regulation, "clinical investigator" is defined as any investigator or 
subinvestigator who is directly involved in the treatment or evaluation of research participants, 
including the spouse and each dependent child of the clinical investigator or subinvestigator.  
These requirements apply to both US and foreign clinical investigators conducting covered 
clinical studies. 
Any new clinical investigators added to the covered clinical study during its conduct must also 
submit a completed Investigator Financial Disclosure Form.  During a covered clinical study, 


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any changes to the financial information previously reported by a clinical investigator must be 
reported to the sponsor or its designee.  At the conclusion of the covered clinical study, the 
clinical investigators will be reminded of their obligations.  In the event that the clinical 
investigator is not reminded, they nevertheless will remain obligated to report to the sponsor or 
its designee any changes to the financial information previously reported, as well as any changes 
in their financial information for a period of 1 year after completion of the covered clinical study. 
11.5. 
Publication Policy 
By signing the study Protocol, the investigator and his/her institution agree that the results of the 
study may be used by the sponsor, Incyte Corporation, for the purposes of national and 
international registration, publication, and information for medical and pharmaceutical 
professionals.  Study results will be published in accordance with applicable local and national 
regulations.  If necessary, the authorities will be notified of the investigator's name, address, 
qualifications, and extent of involvement.  The terms regarding the publication of study results 
are contained in the agreement signed with the sponsor or its designee.  A signed agreement will 
be retained by the sponsor or its designee. 
The results of this study may be published or presented at scientific meetings.  If this is foreseen, 
the investigator agrees to submit all manuscripts or abstracts to the sponsor before submission.  
This allows the sponsor to protect proprietary information and to provide comments. 
The sponsor will comply with the requirements for publication of study results.  In accordance 
with standard editorial and ethical practice, the sponsor will generally support publication of 
multicenter studies only in their entirety and not as individual site data.  In this case, a 
coordinating investigator will be designated by mutual agreement. 
Authorship will be determined in line with International Committee of Medical Journal Editors 
authorship requirements. 
11.6. 
Study and Site Closure 
The sponsor designee reserves the right to close the study site or terminate the study at any time 
for any reason at the sole discretion of the sponsor.  Study sites will be closed upon study 
completion.  A study site is considered closed when all required documents and study supplies 
have been collected and a study-site closure visit has been performed. 
The investigator may initiate study-site closure at any time, provided there is reasonable cause 
and sufficient notice is given in advance of the intended termination. 
Reasons for the early closure of a study site by the sponsor or investigator may include but are 
not limited to: 
• Failure of the investigator to comply with the protocol, the requirements of the 
IRB/IEC or local health authorities, the sponsor's procedures, or GCP guidelines. 
• Inadequate recruitment of participants by the investigator. 
• Discontinuation of further study treatment development. 


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12. 
REFERENCES 
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Becker JC. Merkel cell carcinoma. Ann Oncol 2010;21(suppl 7):vii81–vii85. 
Becker JC, Stang A, DeCaprio JA, et al. Merkel cell carcinoma.  Nat Rev Dis Primers 
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Berton D, Pautier P, Lorusso D, et al. Retifanlimab (INCMGA00012) in patients with advanced 
solid tumors: top-line results for the recurrent MSI-high or dMMR endometrial cancer cohort of 
POD1UM-101. Presented at: SITC 36th Annual Meeting; November 10-14, 2021; 
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Bhatia S, Afanasiev O, Nghiem P. Immunobiology of Merkel cell carcinoma: implications for 
immunotherapy of a polyomavirus-associated cancer. Curr Oncol Rep 2011;13:488-497. 
Brahmer JR, Lacchetti C, Schneider B, et al. Management of immune-related adverse events in 
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Cassler NM, Merrill D, Bichakjian CK, Brownell I. Merkel cell carcinoma therapeutic update. 
Curr Treat Options Oncol 2016;17:36. 
Clinical Trial Facilitation Group. Recommendations related to contraception and pregnancy 
testing in clinical trials. 2014. http://www.hma.eu/fileadmin/dateien/ 
Human_Medicines/01-About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_ 
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Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumors: 
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European Society of Medical Oncology. ESMO Statement for vaccination against COVID-19 in 
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Freshwater T, Kondic A, Ahamadi M, et al. Evaluation of dosing strategy for pembrolizumab for 
oncology indications. J Immunother Cancer 2017;5:43. 
Grignani G, Rutkowski P, Lebbe C, et al. A phase 2 study of retifanlimab in patients with 
advanced or metastatic merkel cell carcinoma (POD1UM-201). Presented at: SITC 36th Annual 
Meeting; November 10-14, 2021; Washington, DC. Poster 545. 
Haanen JBAG, Carbonnel F, Robert C, et al.  Management of toxicities from immunotherapy: 
ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 
2017;28:iv119-iv142. 
Horn L, Whisenant J, Torri V, et al. Thoracic Cancers International COVID-19 Collaboration 
(TERAVOLT): impact of type of cancer therapy and COVID therapy on survival. J Clin Oncol 
2020;39(suppl 18):Abstract LBA111. 
Hughes MP, Hardee ME, Cornelius LA, Hutchins LF, Becker JC, Gao L. Merkel cell carcinoma: 
epidemiology, target, and therapy. Curr Dermatol Rep 2014;3:46-53. 
INCMGA00012 Investigator's Brochure. Wilmington, DE: Incyte Corporation. 
Kaufman HL, Russell J, Hamid O, et al. Avelumab in patient with chemotherapy-refractory 
metastatic Merkel cell carcinoma: a multicenter, single-group, open-label, phase 2 trail. Lancet 
Oncol 2016;17:1374-1385. 
Kaufman HL, Hunger M, Hennessy M, Schlichting M, Bharmal M. Nonprogression with 
avelumab treatment associated with gains in quality of life in metastatic Merkel cell carcinoma. 
Future Onc 2018;14:255-266. 
Lakhani N, Mehnert JM, Rasco D, et al. A phase 1 study of the safety, tolerability, and 
pharmacokinetics (PK) of MGA012 (anti-PD-1 antibody) in patients with advanced solid tumors. 
Poster presented at: 32nd Congress of the Society for Immunotherapy of Cancer; 
November 8-12, 2017; National Harbor, MD. Abstract P249. 
Lebbe C, Becker JC, Grob JJ, et al. Diagnosis and treatment of Merkel cell carcinoma. European 
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chemotherapy or other anticancer treatments: a prospective cohort study. Lancet 
2020;395:1919-1926. 
Maio M, Schenker M, Medioni J, et al. Phase 2 study of retifanlimab (INCMGA00012) in 
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2021;39(suppl):Abstract 2571. 
Malek AE, Cornejo PP, Daoud N, and Alam M. The mRNA COVID-19 vaccine in patients with 
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Mehnert J, Joshua AM, 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.  
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patients with advanced solid tumors: preliminary results for patients with advanced cervical 
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with advanced Merkel cell carcinoma receiving pembrolizumab as first-line therapy. J Clin 
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Sharafeldin N, Bates B, Song Q, et al. Outcomes of Covid-19 in patients with cancer: report from 
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APPENDIX A. INFORMATION REGARDING EFFECTIVENESS OF 
CONTRACEPTIVE METHODS 
For male participants in the study: 
Male participants should use a condom during treatment and through 6 months after the end of 
systemic exposure.  If the male participant has a partner that is of child-bearing potential, the partner 
should also use contraception through 6 months after the end of relevant systemic exposure.  In 
addition, male participants must refrain from donating sperm during the study through 6 months after 
the end of relevant systemic exposure.  Males who have had a vasectomy qualify as having met the 
requirement for a highly effective birth control method. 
For female participants in the study: 
The following methods that can achieve a failure rate of less than 1% per year when used consistently 
and correctly are considered as highly effective birth control methods: 
• 
Combined (estrogen and progestogen containing) hormonal contraception associated with 
inhibition of ovulationa 
− 
oral 
− 
intravaginal 
− 
transdermal 
• 
Progestogen-only hormonal contraception associated with inhibition of ovulationa 
− 
oral 
− 
injectable 
− 
implantableb 
• 
Intrauterine deviceb 
• 
Intrauterine hormone-releasing systemb 
• 
Bilateral tubal occlusionb 
• 
Vasectomized partnerbc 
• 
Sexual abstinenced 
Acceptable birth control methods that result in a failure rate of more than 1% per year include: 
• 
Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary 
mode of action 
• 
Male or female condom with or without spermicidee 
• 
Cap, diaphragm, or sponge with spermicidee 
• 
Tubal ligation 
a Hormonal contraception may be susceptible to interaction with the investigational medicinal product, which may 
reduce the efficacy of the contraception method. 
b Contraception methods that in the context of this guidance are considered to have low user dependency. 
c Vasectomized partner is a highly effective method of avoiding pregnancy provided that partner is the sole sexual 
partner of the woman of childbearing potential study participant and that the vasectomized partner has received 
medical assessment of the surgical success. 
d In the context of this guidance, sexual abstinence is considered a highly effective method only if defined as 
refraining from heterosexual intercourse during the entire period of risk associated with the study treatments.  The 
reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the 
preferred and usual lifestyle of the participant. 
e A combination of male condom with either cap, diaphragm, or sponge with spermicide (double barrier methods) 
are also considered acceptable, but not highly effective, birth control methods. 
Source:  Clinical Trial Facilitation Group 2014. 


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APPENDIX B. RESPONSE EVALUATION CRITERIA FOR SOLID 
TUMORS VERSION 1.1 
General principles of RECIST v1.1 are provided below.  For full details, refer to 
Eisenhauer et al 2009. 
Evaluation of Target Lesions 
CR 
Disappearance of all target lesions.  Any pathological lymph nodes (whether target or nontarget must 
have reduction in short axis to < 10 mm). 
PR 
At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum 
diameters. 
PD 
At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on 
study (this includes the baseline sum if that is the smallest on study), 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 diameters while on study. 
CR = complete response; 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.  All 
lymph  nodes must be nonpathological  in size (< 10 mm short axis). 
Non-CR/ 
Non-PD 
Persistence of 1 or more nontarget lesion(s) and/or maintenance of tumor marker level 
above the normal limits. 
PD 
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 New Lesions 
PD 
The appearance of new malignant lesions denotes disease progression.  The finding of a 
new lesions should be unequivocal.  


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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 
Non-CR/Non-PD 
No 
PR 
CR 
Not evaluated 
No 
PR 
PR 
Non-PD or Not all evaluated 
No 
PR 
SD 
Non-PD or Not all evaluated 
No 
SD 
Not all evaluated 
Non-PD 
No 
NE 
PD 
Any 
Yes or No 
PD 
Any 
PD 
Yes or No 
PD 
Any 
Any 
Yes 
PD 
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 "clinical progression."  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 D. COVID-19 PANDEMIC MITIGATION STRATEGIES AND 
INSTRUCTIONS 
The COVID-19 global pandemic presents challenges to the ongoing conduct of clinical trials.  In 
line with regulatory guidance regarding clinical study execution during the pandemic, the 
sponsor has issued the following protocol considerations to ensure participant safety is 
maintained and adequate benefit/risk analyses are applied relative to participation in the study, 
the completion of study procedures, and objectives. 
Recognizing the dynamic nature and flexibility required to manage the impact of the pandemic 
on this clinical study, additional details will be incorporated into respective study manuals and 
site-specific monitoring plans as applicable, with institutional requirements 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-CoV2 Infection and Participation in the Study 
Benefit/risk assessment in the context of the COVID-19 pandemic is provided in Section 2.3.1. 
During the COVID-19 pandemic, additional risks to participants exist either related to going to a 
healthcare facility or as a result of study-related activities.  It is at the investigator's discretion to 
balance the risk/benefit while considering the participant's safety, existing comorbidities, and 
current malignancy.  In addition, country-specific requirements are to be followed with regard to 
COVID-19 testing. 
Study Site Visits 
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: 
• In order to minimize participant risk, some study procedures may be conducted via 
telemedicine modalities (phone or video), where appropriate, or as per institutional 
guidelines during the COVID-19 pandemic.  At a minimum, a review of AEs and 
concomitant medications must be completed.  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. 
• During COVID-19 restrictions only, scans for disease assessments may be delayed 
by an additional 7 days from the time allowed in the protocol (see Table 3).  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 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. 
Study Treatment Administration: 
• Treatment delays of > 12 weeks for logistical reasons (eg, travel restrictions due to 
COVID-19) may be acceptable but must be discussed with the medical monitor. 


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Study Treatment Management in the Event of SARS-CoV-2 Infection 
If a participant develops a SARS-CoV2 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 provided.  COVID-19 testing should follow country-specific requirements 
depending on the extent of COVID-19 pandemic, local institutional guidance, or investigator's 
clinical judgment.  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), study treatment should be delayed until COVID-19 test normalization and clinical 
recovery.  Safety monitoring following COVID-19 infection 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. 
COVID-19 Vaccination During Participation in the Study 
Participants may receive the COVID-19 vaccine as long as it is not a live vaccine. 
• It is recommended that COVID vaccine is not administered on the day of 
INCMGA00012 infusion.  Administration of study treatment may be delayed by 
3 days to ensure vaccination is completed and acute AEs (if any) are managed. 
• The COVID-19 vaccination must be entered in the EDC as a concomitant medication. 
• Any AEs resulting from the vaccination and medications for treating the AEs must be 
entered in eCRFs. 
Clinical Study Monitoring 
Study monitoring visits could be postponed; however, the site monitor and sponsor will continue 
to employ off-site monitoring practices such as routine communication methods (eg, phone calls, 
emails, video visits, remote visits with source data monitoring where allowed) with the sites to 
get information on study progress, participant status, and information on issue resolution. The 
study monitor may remotely review data entered into the EDC for accuracy and completeness if 
allowed by the national regulatory body, investigational site, and/or in compliance with local 
authorities. 
Reimbursement of Additional Expenses 
The sponsor will reimburse for any extraordinary expenses, keeping appropriate documentation 
as evidence (eg, travel expenses for the local laboratory visit[s], the costs of local [proximate] 
laboratory tests). 


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APPENDIX E. PROTOCOL AMENDMENT SUMMARY OF CHANGES 
Document 
Date 
Amendment (Version) 1: 
27 JUN 2018 
Amendment (Version) 2: 
04 OCT 2018 
Amendment (Version) 3: 
05 DEC 2018 
Amendment (Version) 4: 
16 AUG 2019 
Amendment (Version) 5: 
09 APR 2020 
Amendment (Version) 6: 
22 OCT 2020 
Amendment (Version) 7: 
16 DEC 2021 
Amendment 7 (16 DEC 2021) 
Overall Rationale for the Amendment:  The primary purpose of this amendment is to update 
irAE management guidelines to reflect updated published guidance and to provide guidance on 
the management of participants during the COVID-19 pandemic.  Additional changes are 
summarized below. 
1. Section 2.2, Study Rationale 
Description of change:  Background information on safety and efficacy of 
INCMGA00012 was updated to reflect more recent data. 
Rationale for change:  To provide investigators with the most recent safety and efficacy 
data for their knowledge. 
2. Section 2.3.1, Benefit/Risk Assessment During the COVID-19 Pandemic; 
Section 8.3.6, Laboratory Assessments (Table 22:  Required Laboratory Analytes); 
Appendix D, COVID-19 Pandemic Mitigation Strategies and Instructions 
Description of change: Information regarding the COVID-19 pandemic including a 
risk/benefit assessment and instructions for changes to protocol-required procedures have 
been added to the protocol. 
Rationale for change:  To provide additional information regarding COVID-19. 
3. Section 6.5.1, Management of Suspected Infusion Reactions (Table 8:  Guidelines for 
Management of Suspected Infusion Reactions) 
Description of change:  Minor updates to guidance for infusion reactions. 
Rationale for change:  Updates reflect evolving guidance in published 
recommendations. 


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4. Section 6.5.2, Procedures for Participants Exhibiting Immune-Related Adverse 
Events; Section 9.5, Adverse Events of Special Interest 
Description of change:  Updated and/or added irAEs.  The added irAEs are included in 
Section 6.5.2.4.4, Section 6.5.2.8, and Section 6.5.2.9. 
Rational for change:  Updates and/or additions reflect evolving guidance in published 
recommendations. 
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. 


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Amendment 6 (22 OCT 2020) 
Overall Rationale for the Amendment:  The primary purpose of this amendment is to increase 
the sample size of the study to allow for more robust characterization of the primary and 
secondary endpoints.  
1. Section 1, Protocol Summary (Table 2:  Key Study Design Elements); Section 4.1, 
Overall Design; Section 4.2, Overall Study Duration; Section 10.1, Sample Size 
Determination; Section 10.2, Populations for Analysis (Table 22:  Populations for 
Analysis); Section 10.4, Statistical Analyses; Section 10.4.1.1, Overall Response 
Rate; Section 10.4.2.1, Duration of Response; Section 10.4.2.2, Disease Control Rate; 
Section 10.4.2.3, Progression-Free Survival; Section 10.4.2.4, Overall Survival; 
Section 10.4.5.6, Efficacy Endpoints for Full Study Population 
Description of change:  The number of participants to be enrolled was increased to 
100 chemotherapy-naive participants.  Based on this change, the study duration section 
was updated to clarify that the study will end once every participant receiving active 
treatment has been followed for at least 6 months after confirmed response or until all 
participants have been followed for survival for a minimum of 2 years.  The statistical 
section was also updated to clarify how the populations will be analyzed for the primary 
and final analyses. 
Rationale for change:  Guidance from a regulatory authority indicated that additional 
participants should be enrolled for more robust characterization of durability of response 
and OS.  As of Protocol Amendment 6, approximately 60 chemotherapy-naive 
participants have been enrolled in this study.  An independent, external DMC has 
reviewed the preliminary safety and efficacy data as part of the futility analysis.  The 
safety profile was as expected for agents of this class, and efficacy exceeded the futility 
threshold.  The DMC has recommended that the study proceed as planned.  Therefore, 
the benefit/risk profile of INCMGA00012 remains favorable in this population. 
The study will continue until all participants receiving active treatment have been 
followed for at least 6 months after confirmed response or until all participants have been 
followed for survival for a minimum of 2 years.  Following participants on active 
treatment for at least 6 months after confirmed response allows for robust 
characterization of durability of response.  Survival follow-up for a minimum of 2 years 
is likely to provide a durable estimate of OS.  The median OS for patients with metastatic 
MCC treated with avelumab was 20.3 months (D'Angelo et al 2019).  The median OS in 
patients treated with pembrolizumab was not reached at the time of publication (Nghiem 
et al 2019).  Based on these results, it is reasonable to assume that a minimum of 2 years 
of follow-up will provide a reliable estimate of OS. 


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2. Section 2.1, Background; Section 10.1, Sample Size Determination 
Description of change:  Information about avelumab in MCC was updated to reflect a 
recent publication of more mature data. 
Rationale for change:  To provide updated information to investigators.  Preliminary 
data from the JAVELIN Merkel 200 study of avelumab in 29 first-line MCC patients 
showed an ORR of 62.1% (D'Angelo et al 2018).  Updated data, presented in 2019, with 
a larger sample size (n = 116) and follow-up of ≥ 15 months show an ORR of 39.7% 
(D'Angelo et al 2019).  As the sample size and power for Study INCMGA 0012-201 are 
based on the preliminary data from the JAVELIN 200 study and published data on 
pembrolizumab, the updated data needed to be taken into account. 
3. Section 4.3.1, Data Monitoring Committee; Section 10.5, Futility Analysis 
Description of change:  An update on the futility analysis has been provided. 
Rationale for change:  This information was included to provide information to 
reviewers and investigators regarding the futility analysis. 
 
 
  
 
 
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. 


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Amendment 5 (09 APR 2020) 
Overall Rationale for the Amendment:  The primary purpose of this amendment is to clarify 
the definition of target lesions for participants who have progression in areas previously treated 
with locoregional therapy. 
1. Section 1, Protocol Summary (Table 1, Primary and Secondary Objectives and 
Endpoints; Table 2, Key Study Design Elements); Section 3, Objectives and 
Endpoints (Table 5: Objectives and Endpoints); Section 4.1, Overall Design; 
Section 5.1, Inclusion Criteria (Criterion 3); Section 5.2, Exclusion Criteria 
(Criterion 1); Section 10.1, Sample Size Determination; Section 10.4.2, Secondary 
Analyses; Section 10.4.5.6, Efficacy Endpoints for Full Study Population 
Description of change:  The study design and eligibility criteria were adjusted to 
exclude participants who have received prior systemic therapy for treatment of MCC.  
All relevant sections were updated accordingly. 
Rationale for change:  The treatment landscape for patients with advanced/metastatic 
MCC has changed with the availability of anti–PD-(L)1 therapies.  These therapies are 
increasingly available and reimbursed in many regions, and it is rare for patients to 
receive systemic chemotherapy before treatment with an anti–PD-(L)1 agent.  The 
primary endpoint of this study is ORR in chemotherapy-naive participants with 
advanced/metastatic MCC.  Chemotherapy-refractory patients are becomingly 
increasingly uncommon as demonstrated by slow recruitment in this study.  Only 
5 chemotherapy-refractory participants were enrolled in this study in 18 months.  
Chemotherapy-refractory participants are hence excluded from future enrollment in 
this study. 
2. Section 1, Protocol Summary; Section 4.1, Overall Design 
Description of change:  Updated to indicate that treatment delays of > 12 weeks for 
logistical reasons (eg, travel restrictions due to COVID-19) may be acceptable but must 
be discussed with the medical monitor. 
Rationale for change:  To allow for continued participation in the study if there are 
treatment delays longer than 12 weeks for certain logistical reasons. 
3. Section 2.2, Study Rationale 
Description of change:  Removed redundant text in the second paragraph. 
Rationale for change: The information is included elsewhere in the section. 
4. Section 5.1, Inclusion Criteria (Criterion 5); Section 8.2.1, Tumor Imaging 
Description of change:  Protocol language was updated to clarify that tumor lesions 
located in areas that have received prior locoregional therapy may be selected as target 
lesions if progression has been demonstrated in these lesions. 
Rationale for change:  In Amendment 4, the Protocol was revised to allow participants 
with recurrent, advanced locoregional MCC to enroll in the study.  Protocol language 
regarding the selection of target lesions in areas subjected to locoregional therapy needed 
to be updated to reflect this change. 


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5. Section 5.2, Exclusion Criteria (Table 6, Exclusionary Laboratory Values) 
Description of change:  Adjusted creatinine clearance value considered exclusionary 
was changed to < 30 mL/min. 
Rationale for change:  Monoclonal antibodies are not filtered by the kidney; therefore, 
the PK of INCMGA00012 should not be impacted by allowing participants with more 
limited renal function to be enrolled.  No significant drug-related renal toxicity has been 
observed in more than 300 participants treated with INCMGA00012 monotherapy.  
Additionally, nephritis is an uncommon drug-related AE seen with other drugs of this 
class that have used a creatinine clearance of 30 mL/min as threshold for administration. 
6. Section 8.3.6, Laboratory Assessments (Table 19, Required Laboratory Analytes) 
Description of change:  Added free T4 to the list of acceptable analytes. 
Rationale for change:  Either free T4 or total T4 is acceptable for monitoring thyroid 
hormone levels. 
7. Appendix B, Response Evaluation Criteria for Solid Tumors Version 1.1 
Description of change:  Language was updated to reflect RECIST v1.1 terminology. 
Rationale for change:  Language in the appendix was not consistent with RECIST v1.1 
guidance. 
8. Incorporation of administrative changes.  Other minor, administrative changes have 
been incorporated throughout the Protocol and are noted in the redline version of the 
amendment. 


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Amendment 4 (16 AUG 2019) 
Overall Rationale for the Amendment: 
The primary purpose of this amendment is to expand the eligibility criteria to include participants 
with recurrent locoregional advanced disease in addition to participants with distant metastatic 
MCC. 
1. Section 1, Protocol Summary; Section 2.1, Background; Section 2.2, Study 
Rationale; Section 3, Objectives and Endpoints; Section 4.1, Overall Design; 
Section 5.1, Inclusion Criteria (Criterion 3) 
Description of change:  Updated to allow participants with recurrent, advanced 
locoregional MCC to enroll in the trial. 
Rationale for change:  Approximately half of patients with locally advanced MCC 
experience disease recurrence within 2 years from diagnosis.  Management of patients 
with recurrent locally advanced unresectable MCC is challenging (Becker JC, Stang A, 
DeCaprio JA, et al. Merkel cell carcinoma.  Nat Rev Dis Primers 2017;3:17077.).  
Similar to distant metastatic disease, patients with recurrent unresectable MCC require 
systemic therapy to achieve disease control.  While MCC is responsive to chemotherapy, 
the responses are short lived.  Durable responses have been achieved with anti-PD-(L)1 
antibodies in patients with metastatic as well as recurrent locally advanced MCC 
(Nghiem P, Bhatia S, Lipson EJ, et al. Durable tumor regression and overall survival in 
patients with advanced Merkel cell carcinoma receiving pembrolizumab as first-line 
therapy. J Clin Oncol 2019;37:693-702.; D'Angelo SP, Russell J, Lebbé C, et al. Efficacy 
and safety of first-line avelumab treatment in patients with Stage IV metastatic Merkel 
cell carcinoma: a preplanned interim analysis of a clinical trial [published online ahead of 
print March 22, 2018]. JAMA Oncol doi:10.1001/jamaoncol.2018.0077.; Kaufman HL, 
Russell J, Hamid O, et al. Avelumab in patient with chemotherapy-refractory metastatic 
Merkel cell carcinoma: a multicenter, single-group, open-label, phase 2 trail. Lancet 
Oncol 2016;17:1374-1385.).  A 2019 update to the NCCN guidelines also indicate that 
pembrolizumab may be considered as a treatment option for patients with recurrent 
locally advanced disease (National Comprehensive Cancer Network. National 
Comprehensive Cancer Network Clinical Practice Guidelines in Oncology: Merkel Cell 
Carcinoma Version 2.2019. 2019. https://www.nccn.org/professionals/physician_gls/ 
pdf/mcc.pdf.). 
Patients with recurrent locally advanced disease who are not amenable to definitive 
surgery or radiation are likely to benefit from treatment with anti–PD-1 therapy and 
hence will be eligible for this trial. 
2. Section 1, Protocol Summary; Section 4.1, Overall Design 
Description of change:  Laboratory requirements for subsequent study treatment cycles 
were removed from the Protocol. 
Rationale for change:  Laboratory abnormalities are addressed in other criteria and do 
not need to be specifically listed as these abnormalities are not expected to worsen with 
immunotherapy. 


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4. Section 1, Protocol Summary (Table 4, Pharmacokinetic 
 Sample 
Collections); Section 8.4, Pharmacokinetic Assessments (Table 20, Pharmacokinetic 
 Serum Blood Sample Timing);
 
 
Description of change:  Added tables to detail the timing of PK,
 
 
Rationale for change:  To provide clarity to the investigational sites and to remove 
unnecessary blood sampling for study participants. 
5. Section 1, Protocol Summary; Section 10.1, Sample Size Determination; 
Section 10.2, Populations for Analysis; Section 10.4.2.1, Overall Response Rate 
Description of change:  The FAS population was updated to include all participants who 
received a dose of study drug. 
Rationale for change:  To address regulatory feedback from the United States Food and 
Drug Administration. 
 
 
 
 
 
7. Section 6.5.1, Management of Suspected Infusion Reactions (Table 8, Guidelines for 
Management of Suspected Infusion Reactions) 
Description of change:  Updated instruction for subsequent infusions for participants 
who have experienced a Grade 1 infusion reaction. 
Rationale for change:  Premedication is no longer required per Amendment 2, so 
guidelines for management of suspected infusion reactions were updated to instruct sites 
to consider premedication in participants who experienced Grade 1 infusion reactions. 
8. Section 6.5.2.4, Immune-Mediated Endocrinopathies; Section 6.5.2.6, 
Immune-Mediated Skin Reactions 
Description of change:  Updates were made to irAE guidance in regard to restarting 
study treatment. 
Rationale for change:  To make guidance consistent with ASCO clinical practice 
guidelines. 


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9. Section 6.6.2, Prohibited Medications and Procedures 
Description of change:  Added probiotic dietary supplements to the list of prohibited 
medications. 
Rationale for change:  Updated based on emerging evidence that indicates the use of 
probiotic supplements may be associated with lower chance of responding to 
immunotherapy. 
10. Incorporation of administrative changes.  Other minor, administrative changes have 
been incorporated throughout the Protocol and are noted in the redline version of the 
amendment. 


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Amendment 3 (05 DEC 2018) 
Overall Rationale for the Amendment: 
The primary purpose of this amendment is to address comments received from Health Canada.  
Additional clarifications and administrative changes were also made. 
1. Section 1, Protocol Summary; Section 4.1, Overall Design; Section 7.1.1, Reasons for 
Discontinuation 
Description of change:  Clarified that participants should be discontinued from study 
treatment for disease progression. 
Rationale for change:  Prior version of the Protocol required participants to discontinue 
from treatment for clinical disease progression; however, in general participants should 
also be removed from study treatment after radiographic disease progression. 
2. Section 1, Protocol Summary (Table 3, Schedule of Activities); Section 8.3.6, 
Laboratory Assessments (Table 19, Required Laboratory Analytes) 
Description of change:  Blood chemistry safety panel no longer specifies that it must be 
from serum. 
Rationale for change:  To allow convenience for sites who typically use plasma for 
blood chemistry panel. 
3. Section 1, Protocol Summary (Table 3, Schedule of Activities); Section 5.2, 
Exclusion Criteria; Section 6.6.1, Permitted Medications and Procedures; 
Section 8.3.6, Laboratory Assessments (including Table 19, Required Laboratory 
Analytes) 
Description of change:  Participants who are HIV-positive may be enrolled into the 
study provided they meet the criteria specified in exclusion criterion 21.  For those 
HIV-positive participants who do enroll, HIV management testing will be required and is 
now detailed in the Protocol. 
Rationale for change:  To allow inclusion of participants with well-controlled HIV in 
this study since preliminary experience with immunotherapy in HIV-associated 
malignancy is promising. 
 
 
 
 
 
 


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5. Section 1, Protocol Summary (Table 3, Schedule of Activities); Section 4.1, Overall 
Design; Section 8.8.1, Safety Follow-Up 
Description of change:  Clarified that AEs and concomitant medications are to be 
collected for 90 days after the last dose of study drug or until the participants start a new 
anticancer therapy. 
Rationale for change:  Editorial change to ensure consistency with Sections 6.6, 8.3, and 
9.4 in the Protocol. 
 
 
 
 
 
 
 
 
 
 
7. Section 1, Protocol Summary (Table 1); Section 3, Objectives and Endpoints 
(Table 5); Section 6.5.1, Management of Suspected Infusion Reactions (Table 8); 
Section 8.3.1, Adverse Events; Section 9.3, Recording and Follow-Up of Adverse 
Events and/or Serious Adverse Events 
Description of change:  Updated Protocol to indicate that CTCAE v5.0 will be used to 
assess the severity of AE. 
Rationale for change:  To use the most recent version of CTCAE. 
8. Section 1, Protocol Summary (Table 3, Schedule of Activities) 
Description of change:  Added note indicating that survival status may be requested at 
any point during the study. 
Rationale for change:  To allow flexibility for collecting updated survival data for 
analysis if required. 
9. Section 1, Protocol Summary (Table 3, Schedule of Activities; Table 4, 
Pharmacokinetic 
 Sample Collections) 
Description of change:  Adjusted the window for subsequent cycle visits to 7 days. 
Rationale for change:  To allow flexibility for participant scheduling. 
10. Section 2.2, Study Rationale 
Description of change:  Results from the first-in-human monotherapy study (INCMGA 
0012-101) were updated. 
Rationale for change:  Provide updated information to investigators. 


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11. Section 5.2, Exclusion Criteria 
Description of change:  The ALT and AST exclusionary laboratory values were adjusted 
to allow for the possibility of participants with liver metastases to enroll if their ALT or 
AST are ≤ 5 × ULN. 
Rationale for change:  Language in prior versions of the Protocol had strict exclusion 
criterion for ALT and AST that may have excluded participants with liver metastases that 
were otherwise good candidates for the study. 
12. Section 6.1, Study Treatment Administered (Table 7, Study Treatment 
Information); Section 6.5.1, Management of Suspected Infusion Reactions; 
Section 6.6.1, Permitted Medications and Procedures 
Description of change:  Removed the requirement for premedication prophylaxis before 
the first dose of INCMGA00012. 
Rationale for change:  Updated for consistency with the INCMGA00012 IB. 
13. Section 6.5.1, Management of Suspected Infusion Reactions (Table 8, Guidelines for 
Management of Suspected Infusion Reactions) 
Description of change:  Additional guidance on the rate of infusion after a suspected 
infusion reaction was provided. 
Rationale for change:  To provide clarification to sites. 
14. Section 7.1.1, Reasons for Discontinuation 
Description of change:  Added language that allows participants to discontinue study 
treatment if they achieve a confirmed CR and have received at least 6 months of study 
treatment. 
Rationale for change:  This change will allow flexibility for the investigator to decide if 
it is in the participant's best interest to discontinue study treatment after achieving a CR. 
 
 
 
. 
 
 
16. Section 8.3.3, Vital Signs 
Description of change:  Language was added to provide guidance on timing of vital 
signs in regards to blood collection when it is not feasible for vital signs to be taken 
before the blood collection. 
Rationale for change:  This language was added to allow flexibility for sites in 
scheduling procedures. 


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17. Section 8.3.5, Electrocardiograms 
Description of change:  Additional information was provided regarding the timing of 
ECGs and the need for triplicate ECGs. 
Rationale for change:  To provide additional information to the sites. 
18. Section 9.7, Pregnancy 
Description of change:  Updated the time frame for restarting study treatment to 
12 weeks. 
Rationale for change:  To make the time frame consistent with treatment interruptions 
for other reasons. 
19. Incorporation of administrative changes:  Other minor administrative changes have 
been incorporated throughout the Protocol and are noted in the redline version of the 
document. 


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Amendment 2 (04 OCT 2018) 
Overall Rationale for the Amendment: 
The primary purpose of this amendment is to address comments received from the European 
Competent Authorities during the VHP. 
1. Section 1, Protocol Summary; Section 4.1, Overall Design 
Description of change:  Prior to receiving infusion of INCMGA00012, participants must 
have a hemoglobin level of ≥ 9 g/dL. 
Rationale for change:   This requirement was changed based on feedback from the 
European Competent Authorities during the VHP and is consistent with the eligibility 
criterion for the study regarding hemoglobin. 
2. Section 1, Protocol Summary; Section 4.1, Overall Design; Section 6.5, Dose 
Modifications 
Description of change:  Edits were made to clarify that study treatment doses will not be 
modified, but dosing can be interrupted up to 12 weeks prior to restarting. 
Rationale for change:  Provide additional clarity to clinical sites. 
3. Section 1, Protocol Summary; Section 4.3, Study Termination; Section 4.3.1, Data 
Monitoring Committee; Section 10.5, Futility Analysis 
Description of change:  An independent data monitoring committee will be formed. 
Rationale for change:  To provide independent review of safety and efficacy data during 
the study. 
4. Section 1, Protocol Summary (Table 3, Schedule of Activities); Section 6.1, Study 
Treatment Administered (Table 7, Study Treatment Information) 
Description of change:  A note was added to Table 3 and Table 7 to remind sites to 
monitor for reactions during the infusion of INCMGA00012. 
Rationale for change:  To make it clear in the Protocol that sites should be monitoring 
participants for infusion reactions per their institutional guidelines during the infusion 
period. 
5. Section 2.2, Study Rationale 
Description of change:  Background information for INCMGA00012 was added to the 
Protocol. 
Rationale for change:  This language will provide updated safety information regarding 
the study treatment to investigators.   


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6. Section 5.1, Inclusion Criteria; Section 5.2, Exclusion Criteria; Section 6.6.2, 
Prohibited Medications and Procedures 
Description of changes: 
• Inclusion Criterion 7b:  The duration of contraception for females was changed to 
120 days after the last dose of study treatment.   
• Exclusion Criterion 13:  The criterion was edited to exclude participants who have 
received a live virus vaccine within 28 days of the start of study therapy.  The 
protocol previously used a 90-day timeframe prior to the start of study therapy.  This 
timeframe was updated in the prohibited medications and procedures section as well 
for consistency. 
• Exclusion Criterion 19:  This new criterion was added to exclude anyone with a 
history of organ transplant, including allogeneic stem cell transplantation. 
• Exclusion Criterion 20:  This new criterion was added to exclude anyone with a 
known allergy or hypersensitivity to any component of the study drug formulation. 
Rationale for changes:  Inclusion/exclusion criteria were updated to address 
inconsistencies and address comments from European Competent Authorities during the 
VHP. 
7. Section 5.5, Replacement of Participants 
Description of change:  Additional clarity was provided on how participants may be 
replaced if they do not meet eligibility criteria. 
Rationale for change:  Provide additional clarification to clinical sites. 
8. Section 6.5.1, Management of Suspected Infusion Reactions (Table 8:  Guidelines for 
Management of Suspected Infusion Reactions) 
Description of change:  Table 8 was updated to indicate that study treatment must be 
discontinued for any ≥ Grade 3 infusion-related reaction.  The definition of a Grade 3 
infusion reaction was also edited to match CTCAE guidance. 
Rationale for change:  Guidance for infusion-related reactions was edited to provide 
additional clarity to clinical sites.   
9. Section 6.5.2.7, Immune-Mediated Myocarditis 
Description of change:  Guidance for the management of immune-mediated myocarditis 
was added.  
Rationale for change:  These events can be serious, and therefore, it is prudent to 
provide guidance to the Investigators. 
10. Section 7.1.1, Reasons for Discontinuation 
Description of change:  Pregnancy was listed as a reason for discontinuation from study 
treatment. 
Rationale for change:  Provide additional clarification to clinical sites. 


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11. Section 8.2, Efficacy Assessments; Section 8.2.1, Tumor Imaging 
Description of change:  Language was added to specify that disease status will be 
evaluated by independent central radiographic review (ICR).   
Rationale for change:  The Protocol was not clear that the response assessments will be 
performed by an ICR for the primary endpoint. 


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Amendment 1 (27 JUN 2018) 
Overall Rationale for the Amendment: 
The primary purpose of this amendment is to address comments received from the US FDA. 
1. Section 1, Protocol Summary (Table 1:  Primary and Secondary Objectives and 
Endpoints); Section 3, Objectives and Endpoints (Table 5:  Objectives and 
Endpoints), Section 4.1, Overall Design 
Description of changes: 
• Assessment of the primary endpoint of ORR will be limited to the chemotherapy-
naive study population.  The ORR in the full study population, comprised of both 
chemotherapy-naive and chemotherapy-refractory participants, will be assessed as a 
secondary endpoint. 
• Multiple secondary endpoints have been added and/or revised to specify that the 
analysis will be performed on the chemotherapy-naive population and the full study 
population, comprised of both chemotherapy-naive and chemotherapy-refractory 
participants. 
Rationale for changes: 
• The primary efficacy assessment should be performed in a homogeneous population 
(per guidance from the FDA), since a higher ORR is expected in the 
chemotherapy-naive population based on emerging data. 
• The primary endpoint of the study has been revised and is now based only on the 
chemotherapy-naive population.  Therefore, the secondary efficacy analysis has been 
revised and will include analysis of the full study population. 
2. Section 1, Protocol Summary; Section 4.1, Overall Design 
Description of changes: 
• The following language was added to the description of study participants:  "The 
participants should not have received any prior therapy with PD-1/PD-L1 inhibitors." 
• The criteria for eligibility for subsequent treatment cycles was updated to address the 
maximum allowable length of time for delaying study drug treatment. 
Rationale for changes: 
• The added language regarding prior therapy with PD-1/PD-L1 inhibitors is intended 
to provide clarification of the study population. 
• The revised language regarding criteria for eligibility for subsequent treatment cycles 
provides further definition and clarification of the treatment criteria for subsequent 
cycles and the maximum length of time a participant can be on a drug hold before 
being permanently discontinued from study treatment. 


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3. Section 5.1, Inclusion Criteria 
Description of change:  Eligibility criterion #3 was modified to clarify that that the 
study population will be limited to participants with distant, metastatic disease. 
Rationale for change:  This language is intended to clarify, as this study excludes 
participants with locoregional disease. 
4. Section 1, Protocol Summary; Section 10.1, Sample Size Determination; 
Section 10.4, Statistical Analyses 
Description of change:  Assumptions and sample size were revised in accordance with 
literature estimates for ORR in both the primary efficacy population (chemotherapy-
naive) and the full study population of chemotherapy-naive and chemotherapy-refractory 
patients.  Final sample size also reflects allowance for attrition during the course of the 
study.  Statistical analyses were updated to align with the revised primary and secondary 
efficacy endpoints. 
Rationale for change:  Alignment with revised primary and secondary efficacy 
objectives and endpoints. 
The recent availability of avelumab, in many countries for frontline treatment of 
metastatic MCC, has impacted practice patterns.  While both chemotherapy and 
checkpoint inhibitor therapy may be appropriate for initial treatment based on practice 
guidelines (as per the NCCN) and local reimbursement policies, it is expected that, over 
the duration of the study, an increasing majority of participants will be offered 
checkpoint inhibitors as frontline therapy.  Therefore, a small excess of chemotherapy-
naive participants (55%) has been assumed for the projected enrollment in calculating 
the expected ORR for the full study population. 
5. Section 10.5, Futility Analysis 
Description of change:  Language was revised to indicate that the futility analysis will 
be based on responses in the chemotherapy-naive population.  The number of participants 
assessable for response needed for the analysis was updated from 25 to 20. 
Rationale for change:  Alignment with revised primary objective and endpoint. 
Incorporation of administrative changes.  Other minor, administrative changes have 
been incorporated throughout the Protocol and are noted in the redline version of the 
amendment. 


Signature Page for VV-CLIN-000630 v9.0
Signature Page for VV-CLIN-000630 v9.0
Approval
16-Dec-2021 15:28:42 GMT+0000
Approval
16-Dec-2021 15:41:35 GMT+0000
Approval
17-Dec-2021 03:02:40 GMT+0000
Approval
17-Dec-2021 08:09:51 GMT+0000

SAP_001.pdf: 
A Phase 2 Study of INCMGA00012 in Participants With Metastatic Merkel 
Official Title: 
NCT Number: 
NCT03599713
Document Date: 
Statistical Analysis Plan Version 2.0: 19 May 2021
Cell Carcinoma (POD1UM-201) 


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STATISTICAL ANALYSIS PLAN 
INCMGA 0012-201 
A Phase 2 Study of INCMGA00012 in Participants With Metastatic 
Merkel Cell Carcinoma (POD1UM-201) 
IND Number: 
139,181 
EudraCT Number: 
2018-001627-39 
Sponsor: 
Incyte Corporation 
1801 Augustine Cut-Off 
Wilmington, DE 19803 
Protocol Version: 
Protocol Amendment 6 dated 22 OCT 2020 
CRF Approval Date: 
26 AUG 2019 
SAP Version: 
Amendment 2 
SAP Author: 
 
 Biostatistics 
Date of Plan: 
19 MAY 2021 
This study is being conducted in compliance with good clinical practice, 
including the archiving of essential documents. 


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TABLE OF CONTENTS 
LIST OF ABBREVIATIONS ..........................................................................................................6 
1. 
INTRODUCTION ........................................................................................................8 
2. 
STUDY INFORMATION, OBJECTIVES, AND ENDPOINTS.................................9 
2.1. 
Protocol and Case Report Form Version ......................................................................9 
2.2. 
Study Objectives and Endpoints ...................................................................................9 
3. 
STUDY DESIGN .......................................................................................................11 
3.1. 
Overall Study Design ..................................................................................................11 
3.1.1. 
Treatment Discontinuation .........................................................................................11 
3.1.2. 
Study Duration ............................................................................................................12 
3.1.3. 
Response Assessment .................................................................................................12 
3.2. 
Randomization ............................................................................................................12 
3.3. 
Control of Type I Error ...............................................................................................12 
3.4. 
Sample Size Considerations .......................................................................................13 
3.5. 
Schedule of Assessments ............................................................................................13 
4. 
DATA HANDLING DEFINITIONS AND CONVENTIONS ..................................14 
4.1. 
Scheduled Study Evaluations and Study Periods .......................................................14 
4.1.1. 
Study Drug ..................................................................................................................14 
4.1.2. 
Day 1 ...........................................................................................................................14 
4.1.3. 
Study Day ...................................................................................................................14 
4.1.4. 
Analysis Grouping ......................................................................................................14 
4.1.5. 
Baseline Value ............................................................................................................14 
4.1.6. 
Handling of Missing and Incomplete Data .................................................................14 
4.1.7. 
Cycle Length and Duration .........................................................................................16 
4.1.8. 
On-Treatment Assessment/Event ...............................................................................16 
4.2. 
Variable Definitions ....................................................................................................16 
4.2.1. 
Body Mass Index ........................................................................................................16 
4.2.2. 
Creatinine Clearance ...................................................................................................16 
4.2.3. 
Hepatic Impairment ....................................................................................................17 
4.2.4. 
Prior and Concomitant Medication .............................................................................17 
5. 
STATISTICAL METHODOLOGY ...........................................................................18 
5.1. 
General Methodology .................................................................................................18 


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5.2. 
Treatment Groups .......................................................................................................18 
5.3. 
Analysis Populations ..................................................................................................18 
5.3.1. 
Full Analysis Set .........................................................................................................18 
5.3.2. 
Efficacy Evaluable Population ...................................................................................18 
5.3.3. 
Safety Evaluable Population .......................................................................................18 
5.3.4. 
Pharmacokinetic Evaluable Population ......................................................................18 
6. 
BASELINE, EXPOSURE, AND DISPOSITION VARIABLES AND 
ANALYSES ...............................................................................................................19 
6.1. 
Baseline and Demographics, Physical Characteristics, and Disease History .............19 
6.1.1. 
Demographics and Baseline Characteristics ...............................................................19 
6.1.2. 
Baseline Disease Characteristics and Disease History ...............................................19 
6.1.3. 
Prior Therapy ..............................................................................................................19 
6.1.4. 
Medical History ..........................................................................................................19 
6.2. 
Disposition of Participants ..........................................................................................20 
6.3. 
Protocol Deviations ....................................................................................................20 
6.4. 
Exposure .....................................................................................................................20 
6.5. 
Prior and Concomitant Medication .............................................................................20 
7. 
EFFICACY .................................................................................................................21 
7.1. 
General Considerations ...............................................................................................21 
7.2. 
Efficacy Hypotheses ...................................................................................................21 
7.3. 
Analysis of the Efficacy Parameters ...........................................................................21 
7.3.1. 
Response Criteria ........................................................................................................21 
7.3.2. 
Primary Analysis ........................................................................................................21 
7.3.2.1. 
Objective Response Rate ............................................................................................21 
7.3.2.2. 
Handling of Missing Data in Primary Analysis ..........................................................22 
7.3.2.3. 
Best Overall Response ................................................................................................22 
7.3.3. 
Secondary Analysis ....................................................................................................24 
7.3.3.1. 
Duration of Response .................................................................................................24 
7.3.3.2. 
Disease Control Rate ..................................................................................................24 
7.3.3.3. 
Progression-Free Survival ..........................................................................................24 
7.3.3.4. 
Overall Survival ..........................................................................................................25 
7.3.4. 
Tumor Size Change Over Time ..................................................................................25 
7.3.5. 
Subgroup Analysis ......................................................................................................26 


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7.3.6. 
Exploratory Analysis ..................................................................................................26 
7.3.6.1. 
Efficacy Assessments in Full Population ...................................................................26 
 
26 
 
28 
8. 
SAFETY AND TOLERABILITY ..............................................................................28 
8.1. 
General Considerations ...............................................................................................28 
8.2. 
Adverse Events ...........................................................................................................28 
8.2.1. 
Adverse Event Definitions ..........................................................................................28 
8.2.2. 
Adverse Events of Special Interest .............................................................................29 
8.2.3. 
Adverse Event Summaries ..........................................................................................29 
8.3. 
Clinical Laboratory Tests ...........................................................................................31 
8.3.1. 
Laboratory Value Definitions .....................................................................................31 
8.3.2. 
Laboratory Value Summaries .....................................................................................31 
8.4. 
Vital Signs ..................................................................................................................32 
8.5. 
Electrocardiograms .....................................................................................................32 
9. 
PHARMACOKINETIC 
 ANALYSIS .............................33 
9.1. 
Pharmacokinetic Assessments ....................................................................................33 
 
33 
 
33 
 
34 
 
34 
 
34 
11. 
INTERIM ANALYSES ..............................................................................................34 
12. 
CHANGES AND MODIFICATIONS TO THE ANALYSIS PLAN ........................35 
12.1. 
Changes to Protocol-Defined Analyses ......................................................................35 
12.2. 
Changes to the Statistical Analysis Plan .....................................................................35 
13. 
REFERENCES ...........................................................................................................36 
APPENDIX A.  PLANNED TABLES, FIGURES, AND LISTINGS ........................................37 
43 
 


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LIST OF TABLES 
Table 1: 
Objectives and Endpoints .............................................................................................9 
Table 2: 
Response Rates and 95% Confidence Intervals ..........................................................13 
Table 3: 
National Cancer Institute Organ Dysfunction Working Group Hepatic 
Impairment Criteria ....................................................................................................17 
Table 4: 
RECIST Evaluation Criteria for Overall Response ....................................................22 
Table 5: 
Confirmed Response Based on Subsequent Assessments ..........................................23 
Table 6: 
Evaluation and Censoring of Progression-Free Survival ............................................25 
 
27 
Table 8: 
Baseline Laboratory Identification .............................................................................31 
Table 9: 
Criteria for Clinically Notable Vital Sign Abnormalities ...........................................32 
Table 10: Criteria for Clinically Notable Electrocardiogram Abnormalities .............................33 
Table 11: Statistical Analysis Plan Versions ..............................................................................35 
 


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LIST OF ABBREVIATIONS 
 
Abbreviation 
Term 
 
 
AE 
adverse event 
AESI 
adverse event of special interest 
ALP 
alkaline phosphatase 
ALT 
alanine aminotransferase 
AST 
aspartate aminotransferase 
AUCt 
area under the plasma or serum concentration-time curve from time = 0 to the last 
measurable concentration at time = t 
BMI 
body mass index 
BOR 
best overall response 
CI 
confidence interval 
Cmax 
maximum observed plasma or serum concentration 
Cmin 
minimum observed plasma or serum concentration over the dose interval 
CR 
complete response 
CRF 
case report form 
CSR 
clinical study report 
CTC 
Common Terminology Criteria 
CTCAE 
Common Terminology Criteria for Adverse Events 
DCR 
disease control rate 
DOR 
duration of response 
DRR 
durable response rate 
ECG 
electrocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
eCRF 
electronic case report form 
ELISA 
enzyme-linked immunosorbent assay  
 
 
FAS 
full analysis set 
FDA 
Food and Drug Administration 
 
 
 
 
 
 
 
 
ICR 
independent central review 
 
 
irAE 
immune-related adverse event 


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Abbreviation 
Term 
 
 
 
 
IV 
intravenously 
MCC 
Merkel cell carcinoma 
MedDRA 
Medical Dictionary for Regulatory Activities 
NCI 
National Cancer Institute 
NE 
not evaluable 
ORR 
objective response rate 
OS 
overall survival 
PD 
progressive disease 
PD-1 
programmed death receptor-1 
PD-L1 
programmed death-ligand 
PFS 
progression-free survival 
PK 
pharmacokinetics 
PR 
partial response 
 
 
PT 
preferred term 
Q4W 
every 4 weeks 
QTcF 
QT interval corrected by Fridericia 
QTcB 
QT interval corrected by Bazett 
RECIST 
Response Evaluation Criteria in Solid Tumors 
SAP 
Statistical Analysis Plan 
SD 
stable disease 
SOC 
system organ class 
TEAE 
treatment-emergent adverse event 
tmax 
time to maximum concentration 
TPR 
timepoint response 
ULN 
upper limit of normal 
WHO 
World Health Organization 


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1. 
INTRODUCTION 
This study is an open-label, single-arm, multicenter, Phase 2 study that will enroll participants 
with advanced/metastatic MCC.  Per Protocol Amendment 5, the study will target the enrollment 
of approximately 60 chemotherapy-naive participants, while enrollment for participants who 
have had prior chemotherapy will be stopped.  Five participants who have had prior 
chemotherapy were enrolled in the study before implementation of Protocol Amendment 5.  
According to Protocol Amendment 6, the study will enroll approximately 
100 chemotherapy-naive participants.  The primary analysis will be performed after 
approximately 60 chemotherapy-naive participants have been enrolled and followed for at least 
6 months after confirmed response.  If the study meets the predefined efficacy threshold at the 
primary analysis, the final analysis will occur after all 100 participants have been enrolled and 
followed for survival for a minimum of 2 years.   
All participants will receive INCMGA00012 (retifanlimab) at the recommended Phase 2 dose of 
500 mg IV Q4W.  The primary endpoint is ORR in chemotherapy-naive participants as 
determined by ICR using RECIST v1.1. 
Participants will participate in the study for up to approximately 3 years.  The study consists of 
3 periods:  screening, study drug treatment, and follow-up.  Treatment may continue for up to 
2 years in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, 
lost to follow-up, or premature discontinuation for any other reason.  Participants unable to 
restart study drug treatment ≤ 12 weeks from the start of the treatment delay due to toxicity will 
be permanently discontinued from study treatment. 
The follow-up period will begin once a participant has completed or prematurely discontinued 
the study treatment.  Participants will be evaluated for AEs and other safety parameters for up to 
90 days after the last dose of study treatment or until the start of new anticancer therapy, 
whichever occurs first.  All participants entering follow-up will be assessed for survival until 
study completion.  Participants who enter the follow-up period without experiencing disease 
progression will continue tumor assessments according to the schedule of activities until they 
experience disease progression, the start of a new anticancer treatment, withdrawal of consent, 
lost to follow-up, the end of the study, or death.  
The purpose of this SAP is to provide details of the statistical analyses that have been outlined in 
the INCMGA 0012-201 Protocol.  The scope of this plan includes the primary and final analyses 
that are planned and will be executed by the Department of Biostatistics or designee.  The 
analyses of PK 
 will be executed by the Department of Clinical 
Pharmacokinetics 
, respectively. 


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2.
STUDY INFORMATION, OBJECTIVES, AND ENDPOINTS
2.1. 
Protocol and Case Report Form Version 
This SAP is based on INCMGA 0012-201 Protocol Amendment 6 dated 22 OCT 2020 and CRFs 
approved on 26 AUG 2019.  Unless superseded by an amendment, this SAP will be effective for 
all subsequent Protocol amendments and CRF versions. 
2.2. 
Study Objectives and Endpoints 
The study objectives and endpoints are presented in Table 1. 
Table 1: 
Objectives and Endpoints 
Objectives 
Endpoints 
Primary 
To determine the efficacy of INCMGA00012 in terms 
of the ORR in chemotherapy-naive participants with 
advanced/metastatic MCC. 
ORR, defined as the percentage of participants having 
an objective response (CR or PR), according to 
RECIST v1.1, as determined by ICR.  The primary 
analysis will include approximately 
60 chemotherapy-naive participants who have been 
enrolled and followed for at least 6 months after 
confirmed response.  The final analysis will include all 
enrolled participants for confirmatory purposes.   
Secondary
To determine the DOR, DCR, PFS, and OS in the 
chemotherapy-naive population with 
advanced/metastatic MCC treated with 
INCMGA00012. 
• DOR, defined as the time from an initial objective
response (CR or PR) according to RECIST v1.1 until
disease progression, or death due to any cause, as
determined by ICR.
• DCR, defined as the proportion of participants with
either an objective response or SD lasting at least
6 months.
• PFS, defined as the time from the start of therapy
until disease progression, or death due to any cause,
as determined by the ICR.
• OS, defined as the time from the start of therapy
until death due to any cause.
To evaluate the safety of INCMGA00012 in 
participants with advanced/metastatic MCC. 
Safety, determined by the number, frequency, duration, 
and severity of AEs using CTCAE v5.0; laboratory 
tests; vital signs; and ECGs. 
To determine the PK of INCMGA00012 administered 
to participants with advanced/metastatic MCC. 
The PK of INCMGA00012 when given to participants 
with advanced/metastatic MCC, including Cmax, tmax, 
Cmin, and AUCt, will be summarized. 


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Table 1: 
Objectives and Endpoints (Continued) 
Objectives 
Endpoints 
Exploratory 
To determine the efficacy of INCMGA00012 in terms 
of the ORR, DOR, DCR, PFS, and OS in the full study 
population (chemotherapy-naive and chemotherapy-
refractory) with advanced/metastatic MCC. 
 
Note:  Chemotherapy-refractory participants enrolled 
before implementation of Amendment 5 will be 
included in these analyses. 
• ORR, defined as the percentage of participants 
having an objective response (CR or PR), according 
to RECIST v1.1, as determined by ICR. 
• DOR, defined as the time from an initial objective 
response (CR or PR) according to RECIST v1.1 until 
disease progression, or death due to any cause, as 
determined by ICR. 
• DCR, defined as the proportion of participants with 
either an objective response or SD lasting at least 
6 months. 
• PFS, defined as the time from the start of therapy 
until disease progression, or death due to any cause, 
as determined by the ICR. 
• OS, defined as the time from the start of therapy 
until death due to any cause. 


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3.
STUDY DESIGN
3.1. 
Overall Study Design 
The study is a Phase 2, open-label, single-arm, multicenter study designed to assess the clinical 
activity and safety of INCMGA00012 in participants with advanced/metastatic MCC.  As of 
Protocol Amendment 5, this study will enroll participants with advanced/metastatic MCC who 
are chemotherapy-naive.  The participants should not have received any prior therapy with 
PD-1/PD-L1 inhibitors.  All participants must submit tissue samples (fresh or archival) for 
central pathology review.  Participants who do not have MCC confirmed by pathology may 
remain on study treatment. 
All participants who meet the eligibility criteria during screening will receive treatment with 
INCMGA00012.  The primary endpoint is ORR in chemotherapy-naive participants as 
determined by ICR according to RECIST v1.1. 
According to Protocol Amendment 6, approximately 100 chemotherapy-naive participants will 
be enrolled.  The primary analysis is planned with approximately 60 chemotherapy-naive 
participants, while the additional participants will be enrolled to support confirmation of efficacy 
and provide additional information on safety.  The primary analysis will occur after 
approximately 60 chemotherapy-naive participants have been enrolled and followed for at least 
6 months after confirmed response.  If the study meets the predefined efficacy threshold at the 
primary analysis (see Section 3.4), the final analysis will occur after all 100 participants have 
been enrolled and followed for survival for a minimum of 2 years.  Study enrollment may stop if 
the predefined efficacy threshold is not met at the time of primary analysis.   
Study treatment will consist of monotherapy INCMGA00012 administered at the recommended 
Phase 2 dose of 500 mg IV Q4W.  Treatment with study drug may continue up to 2 years in the 
absence of disease progression, intolerable toxicity, death, withdrawal of consent, lost to follow-
up, or premature discontinuation for any other reasons. 
3.1.1. 
Treatment Discontinuation 
Participants must be withdrawn from study treatment for the following reasons: 
•
Disease progression.
•
Unacceptable toxicity as noted in Protocol Section 6.5.3.
•
Consent is withdrawn.
•
Further participation would be, based on the medical judgment of the investigator,
injurious to the health or well-being of the participant.
•
The study is terminated by the sponsor.
•
The study is terminated by the local health authority, institutional review board, or
independent ethics committee.
•
The participant becomes pregnant.


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A participant may be discontinued from study treatment as follows:
•
If a participant is noncompliant with study procedures or treatment administration,
and in the judgment of the investigator the participant is not receiving a clinical
benefit.  When possible, the sponsor should be informed and/or consulted.
•
The participant achieves a confirmed CR after at least 6 months of treatment.
Participants may continue on study treatment after confirmation of CR per the
discretion of the investigator if they feel the participant may gain additional benefit.
3.1.2. 
Study Duration
The study begins when the first participant signs the informed consent form.  Participants may 
receive study treatment for up to 2 years, unless prematurely discontinued.  Participants 
discontinuing treatment will enter the follow-up period after their last dose of study treatment.  
The study ends once every participant receiving active treatment has been followed for at least 
6 months after confirmed response or until all participants have been followed for survival for a 
minimum of 2 years.  Participants remaining on active therapy at study conclusion may be 
eligible for continued treatment up to 2 years from first dose if, in the assessment of the 
investigator, they are tolerating therapy and receiving benefit. 
3.1.3. 
Response Assessment 
Objective assessment of disease status will be evaluated according to RECIST v1.1 
(Eisenhauer et al 2009) by the ICR.  Participants should be actively monitored for RECIST 
response up until they start new anticancer therapy or have PD.  
 
  
 
 
 The disease response assessments according to RECIST v1.1 
 by 
investigators will be entered into the eCRF. 
Efficacy assessments of response should be performed according to schedule.  Scans should 
follow calendar days and remain on the 8-week schedule (± 7 days), established on Cycle 1 
Day 1, and should not be delayed for treatment holds or interruptions.  Disease status will be 
assessed every 8 weeks for the first 12 months and then every 12 weeks thereafter.  For 
participants who discontinue study treatment for reasons other than disease progression, every 
effort should be made to continue monitoring their disease status by radiographic imaging 
according to the follow-up schedule. 
Participants who continue study participation in the follow-up period without experiencing 
disease progression will continue to have efficacy assessments every 12 weeks (± 7 days) from 
the previous scan until they complete participation in the study, start a new anticancer therapy, 
experience disease progression, or death. 
3.2. 
Randomization 
Not applicable. 
3.3. 
Control of Type I Error 
For analysis of response rate, 2-sided 95% confidence level will be reported. 


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3.4. 
Sample Size Considerations 
A pilot study of avelumab in participants with chemotherapy-naive metastatic MCC shows a 
confirmed ORR of 39.7% with lower 95% CI of 30.7% (D'Angelo et al 2019).  A pilot study of 
pembrolizumab in the same population showed an ORR of 56% with lower 95% CI of 35% 
(Nghiem et al 2016, Nghiem et al 2019). 
Based on the results from studies of avelumab and pembrolizumab, it is reasonable to target a 
response rate of approximately 48%.  Approximately 60 chemotherapy-naive participants will be 
included for the primary analysis.  Based on a target ORR of 48% and a sample size of 
approximately 60, this study has over 80% power to exclude the lower 95% confidence limit of 
30% with α = 0.025 (1-sided) in the chemotherapy-naive population. 
Approximately 100 chemotherapy-naive participants will be enrolled for the final analysis.  This 
sample size ensures that half of the 95% CI will be approximately 10% for an ORR ranging from 
40% to 60%.  This sample size also ensures 99% power to detect any AE with an underlying 
event rate as low as 0.5%. 
Note:  Participants who have received prior chemotherapy for MCC were enrolled up to Protocol 
Amendment 4. 
Table 2: 
Response Rates and 95% Confidence Intervals 
Sample Size 
Number of Responses 
Response Rate (%) 
95% Confidence Interval (%) 
60 
20 
33.3 
21.7-46.7 
60 
25 
41.7 
29.1-55.1 
60 
30 
50.0 
36.8-63.2 
60 
35 
58.3 
44.9-70.9 
60 
40 
66.7 
53.3-78.3 
3.5. 
Schedule of Assessments 
Refer to Protocol Amendment 6 dated 22 OCT 2020 for a full description of all study procedures 
and assessment schedules for this study. 


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4. 
DATA HANDLING DEFINITIONS AND CONVENTIONS 
4.1. 
Scheduled Study Evaluations and Study Periods 
4.1.1. 
Study Drug 
INCMGA00012 is the only study drug in this study. 
4.1.2. 
Day 1 
Day 1 is the date that the first dose (Cycle 1 Day 1) of INCMGA00012 is administered to 
participants. 
4.1.3. 
Study Day 
If a visit/reporting date is on or after Day 1, then the study day at the visit/reporting date will be 
calculated as 
Day # = (Visit/Reporting Date – Day 1 date + 1).  
If the visit/reporting date is before Day 1, then the study day at the visit/reporting date will be 
calculated as 
Day # = (Visit/Reporting Date – Day 1 date).  
A study day of −1 indicates 1 day before Day 1. 
4.1.4. 
Analysis Grouping 
For the primary CSR, all analyses will be presented by chemotherapy-naive, 
chemotherapy-refectory, and total population.  Within chemotherapy-naive participants, 
participants will be presented as advanced, metastatic, and total based on tumor stage at the time 
of screening.  
4.1.5. 
Baseline Value 
Baseline is the last nonmissing assessment obtained before the first administration of study drug. 
When scheduled assessments and unscheduled assessments occur on the same day and time of 
the assessment or time of first dose is not available, use the following convention to determine 
baseline: 
• If both a scheduled and an unscheduled visit are available on the day of the first dose 
and the time is missing, use the scheduled assessment as baseline. 
• If all scheduled assessments are missing on the day of the first dose and an 
unscheduled assessment is available, use the unscheduled assessment as baseline. 
4.1.6. 
Handling of Missing and Incomplete Data 
In general, values for missing data will not be imputed unless methods for handling missing data 
are specified in this section or relevant sections.  


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Partial disease/cancer diagnosis date will be handled as follows:  
• If only the day is missing, then the imputed day will be the first of the month. 
• If both the month and day are missing, then the imputed day and month will be 
01 JAN. 
• No imputation will be done if the date is completely missing. 
Missing or partial date of last dose will be handled as follows:  
• If only the day is missing, then the imputed date of the last dose will be the earlier 
date of the first day of the month or the date that the participant discontinued 
treatment.  
• Otherwise, the date that the participant discontinued treatment will be used as the date 
of the last dose.  
For relevant efficacy endpoints, partial death date will be imputed as follows:  
• If mmyyyy for the last contact date = mmyyyy for the death date, then the death date 
will be set to the day after the last contact date.  
• If mmyyyy for the last contact date < mmyyyy for the death date, then the death date 
will be set to the first day of the death month.  
• Otherwise, the partial death date will not be imputed.  
For prior and concomitant medications: 
The start/stop dates recorded in the eCRF by the investigator and his or her research staff will be 
used to identify when a concomitant medication was taken during the study.  Any missing start 
date must be queried for resolution.  Unresolved missing start dates will be handled as follows: 
• If the date is completely missing, the medication will be considered both prior and 
concomitant. 
• If only the day is missing, and the last day of the month is before the first dose date 
on Day 1, then the concomitant medication will be considered as starting before 
Day 1, and the incomplete date will be imputed as the last day of the month. 
• If only the day is missing, and the first day of the month is on or after the first dose 
date on Day 1, then the concomitant medication will be considered as starting after 
Day 1, and the incomplete date will be imputed as the first day of the month. 
• If only the day is missing, and the month is equal to the month of the first dose date 
on Day 1, then the incomplete date will be imputed as the first day of the month. 
• If both the month and day are missing, and the last day of the year is before the first 
dose date on Day 1, then the concomitant medication will be considered as starting 
before Day 1, and the incomplete date will be imputed as if it is the last day of the 
year.  Otherwise, if the last day of the year is on or after the first dose date Day 1, the 
incomplete date will be imputed as if it is the first day of the year. 


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•
If the imputed start date through the above procedure is after the stop date recorded in
the eCRF, then the imputed start date will be set equal to the stop date.
4.1.7. 
Cycle Length and Duration
One cycle is defined as 28 days (4 weeks) for participants in this study.  Cycle 1 Day 1 is the day 
of first infusion of INCMGA00012.  Day 1 of subsequent cycles will correspond with the 
infusion date of INCMGA00012 within the cycle.  Tumor imaging/response assessments will 
have a ± 7-day window during the treatment period and ± 14-day window during the follow-up 
period for participants who discontinued study treatment without experiencing disease 
progression. 
4.1.8. 
On-Treatment Assessment/Event 
Safety summaries and selected summaries of deaths will summarize only on-treatment 
assessments/events.  On-treatment assessment/event is defined as any assessment/event obtained 
in the following time interval: 
Date of first administration of study drug through the date of last administration of study 
drug + 90 days.  
Adverse events that begin or worsen after informed consent should be recorded in the Adverse 
Events eCRF. 
If the last date of study drug is missing, on-treatment assessments/events include any 
assessment/event recorded in the database that occurred after the start date of study drug. 
Data listings will include all assessments/events, and those which are not on-treatment 
assessments/events will be flagged. 
4.2. 
Variable Definitions 
The following variables will only be calculated if not reported on the eCRF. 
4.2.1. 
Body Mass Index 
Body mass index will be calculated as follows: 
BMI (kg/m2) = [weight (kg)] / [height (m)]2. 
4.2.2. 
Creatinine Clearance 
Creatinine clearance by Cockcroft-Gault equation (Cockcroft and Gault 1976) is estimated from 
serum creatinine (mg/dL) determination using the following formula: 
Creatinine clearance (mL/min) = [140 − age (years)] × weight (kg) × {0.85* for female 
participants} / [72 × serum creatinine (mg/dL)]. 
*Note:  For male participants use 1.0.


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4.2.3. 
Hepatic Impairment 
The baseline hepatic impairment category can be classified into normal, mild, moderate, or 
severe hepatic impairment based on NCI Organ Dysfunction Working Group criteria (NCI 2017) 
as shown in Table 3. 
Table 3: 
National Cancer Institute Organ Dysfunction Working Group Hepatic 
Impairment Criteria 
Hepatic Impairment 
Category 
Normal 
Mild 
Moderate 
Severe 
Total bilirubin 
 ULN 
B1:   ULN 
B2:  > 1.0-1.5 × ULN 
> 1.5-3 × ULN
> 3 × ULN
AST 
 ULN 
B1:  > ULN 
B2:  Any 
Any 
Any 
Note:  Mild hepatic impairment can be defined according to either of 2 criteria (B1 and B2). 
4.2.4. 
Prior and Concomitant Medication 
Prior medication is defined as any non-study medication started before the first dose of 
INCMGA00012. 
Concomitant medication is defined as any non-study medication that is started accordingly: 
•
Before the date of first administration of INCMGA00012 and is ongoing throughout
the study or ends on/after the date of first study drug administration.
•
On/after the date of first administration of INCMGA00012 and is ongoing or ends
during the course of study drug administration.
A prior medication could also be classified as "both prior and concomitant medication" if the end 
date is on or after first dose of INCMGA00012.  In the listing, it will be indicated whether a 
medication is prior-only, concomitant-only, or both prior and concomitant medication. 
For the purposes of analysis, all medications will be considered concomitant medications unless 
the medications can unequivocally be defined as not concomitant, that is, if the start date and end 
date are all missing, then the medication is considered as concomitant medication. 


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5.
STATISTICAL METHODOLOGY
5.1. 
General Methodology 
Unless otherwise noted, SAS® software (SAS Institute Inc, Cary, NC; v9.4 or later) will be used 
for the generation of all tables, figures, and statistical analyses.  Descriptive summaries for 
continuous variables will include, but not be limited to, the number of observations, mean, 
standard deviation, median, minimum, and maximum.  Descriptive summaries for categorical 
variables will include the number and percentage of participants in each category. 
Interim analyses are planned for this study as defined in Section 11. 
5.2. 
Treatment Groups 
There is only 1 treatment group in this study, that is, INCMGA00012. 
5.3. 
Analysis Populations 
5.3.1. 
Full Analysis Set 
The FAS includes all participants enrolled in the study who received at least 1 dose of study drug 
and are included in the primary analysis (ie, approximately 60 chemotherapy-naive participants 
and chemotherapy-refractory participants).  The FAS will be used for the summary of 
demographics, baseline characteristics, participant disposition, and efficacy.  Note:  This analysis 
population will be used in the CSR reporting the primary analyses.  
5.3.2. 
Efficacy Evaluable Population 
The efficacy evaluable population includes all participants from the FAS with a centrally 
confirmed diagnosis of MCC who have measurable disease at baseline according to RECIST 
v1.1. 
5.3.3. 
Safety Evaluable Population 
The safety evaluable population includes all enrolled participants who received at least 1 dose of 
study drug.  The safety evaluable population will be used to support the safety analysis at the 
primary analysis and to support all analyses, including efficacy at the final analysis.  
5.3.4. 
Pharmacokinetic Evaluable Population
The PK evaluable population will include all participants who received at least 1 dose of study 
drug and have provided a baseline and at least 1 postdose PK sample.  The study 
pharmacokineticist will review data listings of study drug administration and sample records to 
identify participants to be excluded from analyses of PK data. 
 
 


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6.
BASELINE, EXPOSURE, AND DISPOSITION VARIABLES AND
ANALYSES
Appendix A provides a list of planned tables, figures, and listings. 
6.1. 
Baseline and Demographics, Physical Characteristics, and Disease 
History 
The safety evaluable population and FAS will be used for all baseline disease characteristics and 
demographic summaries and data listings.   
6.1.1. 
Demographics and Baseline Characteristics 
Demographic and baseline characteristics will be listed in detail.  The following demographics 
will be summarized using the safety evaluable population and FAS:  age, sex, race, ethnicity, 
body weight, height, BMI, creatinine clearance, and hepatic function.  Qualitative data will be 
summarized by contingency tables while quantitative data will be summarized by descriptive 
summary statistics.  
6.1.2. 
Baseline Disease Characteristics and Disease History 
According to data collected in the eCRF, the following information determined at initial 
diagnosis will be summarized for all participants:  time since initial diagnosis; tumor staging, 
including T, N, and M staging; site of primary tumor; Merkel cell polyomavirus status; and 
PD-L1 assessment.  Current status will also be collected in the eCRF and summarized for all 
participants in the safety evaluable population including the following:  stage, including T, N, 
and M staging; Merkel cell polyomavirus status; sites of disease; HIV status; ECOG 
performance status; visceral disease; and liver metastasis.  Tumor tissue provided for each 
participant at baseline will be reviewed by a central pathologist, and information regarding 
PD-L1 status and Merkel cell polyomavirus will be summarized for all participants in the safety 
evaluable population and FAS. 
6.1.3. 
Prior Therapy 
The number and percentage of participants recording any prior systemic cancer therapy, prior 
radiation, and prior surgery will be presented in listings for chemotherapy-refractory and 
chemotherapy-naive participants wherever applicable in the safety evaluable population and 
FAS.  
6.1.4. 
Medical History 
Medical history will be summarized for all participants in the safety evaluable population.  This 
summary will be presented by primary SOC and PTs.  The safety evaluable population will be 
used to summarize medical history. 


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6.2. 
Disposition of Participants 
The number and percentage of participants who are on treatment, who discontinued study 
treatment with a primary reason for discontinuation, who are on study, and who withdrew from 
the study with a primary reason for study withdrawal will be summarized for all participants in 
the safety evaluable population and FAS. 
6.3. 
Protocol Deviations  
Protocol deviations will be presented in the participant data listings and summarized 
descriptively in the safety evaluable population. 
6.4. 
Exposure 
For participants in the safety evaluable population and FAS, exposure to INCMGA00012 will be 
summarized descriptively as follows: 
• Total number of infusions:  Total number of infusions per participant with an 
infusion of INCMGA00012.  
• Total dose administered (mg):  Estimated volume delivered divided by prepared 
volume × 500 mg. 
• Average dose (mg):  Total dose administered (mg) / total number of infusions. 
• Duration of treatment (days):  Date of last dose of INCMGA00012 – date of first 
dose of INCMGA00012 + 1. 
Duration of exposure in months will be calculated based on the assumption that each 
month has 30.4375 days.  The number and percentage of participants in each duration 
category (ie, 0 to < 3 months, < 3 months, < 6 months, < 9 months, < 12 months, and 
other timepoints as applicable) will be summarized. 
Infusion information collected in the eCRF will be listed.  Dose delay and temporary infusion 
interruption may be summarized and/or listed as needed. 
6.5. 
Prior and Concomitant Medication 
Prior medications and concomitant medications will be coded using the WHO Drug Dictionary 
and summarized by ATC drug class and WHO drug term.  Results will be summarized as 
number and percentage of participants with prior and concomitant medications by ATC class and 
WHO drug class in the safety evaluable population.  For the summary of concomitant 
medication, only medications starting on or after the first dose of study drug and no later than 
90 days after the last dose of study drug will be included.  Medications with missing start/end 
dates will be considered as concomitant medication in the summary.  Other medications will be 
provided in the listing.  Drugs intended to manage irAEs as well as prophylaxis/premedication 
used to prevent infusion reactions may be summarized separately.  Procedures and nondrug 
therapy will also be listed per the CRF. 


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7. 
EFFICACY
A list of planned tables, figures, and listings is provided in Appendix A. 
7.1. 
General Considerations 
Efficacy endpoints of this study include ORR, DOR, DCR, and PFS, based on RECIST v1.1 as 
determined by ICR, and OS. 
 
 
 
 
  For all efficacy analyses, 
participants with advanced and metastatic tumor status will be presented separately and 
combined together in the total column for chemotherapy-naive participants.  The primary CSR 
analysis will be performed in the FAS, which includes approximately 60 chemotherapy-naive 
participants, and the analysis may be repeated in the final analysis including approximately 
100 chemotherapy-naive participants. 
7.2. 
Efficacy Hypotheses 
Not applicable. 
7.3. 
Analysis of the Efficacy Parameters 
7.3.1. 
Response Criteria 
Overall response will be categorized using RECIST v1.1 
.  Participants will have 
their overall response evaluated as CR, PR, SD, PD, or NE for RECIST v1.1 
 
 at each postbaseline radiological assessment based on changes in 
target lesions, nontarget lesions, and appearance of new lesions.  Photographs will be taken for 
skin lesions if target lesions. 
7.3.2. 
Primary Analysis 
7.3.2.1. 
Objective Response Rate 
The primary endpoint of the study is ORR in chemotherapy-naive participants, defined as the 
percentage of participants with CR or PR at any postbaseline visit before first PD or new 
anticancer therapy, according to RECIST v1.1 (Eisenhauer et al 2009) as determined by an ICR.  
The primary analysis of ORR will be performed at least 6 months after the last participant in the 
FAS is enrolled in the study.  Participants who do not have sufficient baseline data to ascertain 
response will be included in the denominators in the calculation of ORR.  The primary analysis 
of ORR will be based on the chemotherapy-naive subset of the FAS.  Objective response rate 
and its exact 95% CI will be presented.  In addition, ORR by investigator assessment will be 
provided as sensitivity analysis for the primary endpoint.  The analysis will be repeated using the 
efficacy evaluable population as supportive analysis. 
For participants with measurable disease at baseline, the RECIST v1.1 assessment criteria 
presented in Table 4 can be used to determine the overall response at a given timepoint based on 
the target lesion, nontarget lesion, and new lesion assessment. 


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Table 4: 
RECIST Evaluation Criteria for Overall Response 
Target Lesions 
Nontarget Lesions 
New Lesions 
Overall Response 
CR 
CR 
No 
CR 
CR 
Non-CR/Non-PD 
No 
PR 
CR 
NE 
No 
PR 
PR 
Non-PD or NE 
No 
PR 
SD 
Non-PD or NE 
No 
SD 
Not all evaluated 
Non-PD 
No 
NE 
PD 
Any 
Yes or No 
PD 
Any 
PD 
Yes or No 
PD 
Any 
Any 
Yes 
PD 
7.3.2.2. 
Handling of Missing Data in Primary Analysis 
The study requires measurable disease at baseline per RECIST v1.1 as part of the inclusion 
criteria.  However, if a participant did not have measurable disease and was administered study 
drug, the participant will be counted as a denominator in the calculation of ORR.  Participants 
with subsequent missing assessments that prevent the evaluation of the primary endpoint will be 
considered nonresponders.  No data imputation will be applied. 
A response assessment of CR or PR reported before any additional anticancer therapy will be 
considered as a response in the calculation of ORR irrespective of the number of missed 
assessments before response. 
7.3.2.3. 
Best Overall Response 
The best overall response is the best response recorded from the start of the treatment until the 
first PD, in the order of CR, PR, SD, PD, and NE.  Responses of CR, PR, or SD after a response 
of PD will not be considered in determining best response.  The participant's best response 
assignment will depend on the achievement of both measurement and confirmation criteria.  The 
best overall response will be determined from response assessments before or on the same day as 
new anticancer therapy.  If any alternative cancer therapy is taken while on study, any 
subsequent assessments will be excluded from the best overall response determination. 
The best overall response for each participant is determined from the sequence of overall 
responses according to the following rules: 
• CR = at least 2 consecutive determinations of CR at least 4 weeks apart before 
progression. 
• PR = at least 2 consecutive determinations of PR or better at least 4 weeks apart 
before progression (and not qualifying for a CR). 
• SD = at least 1 SD assessment (or better) ≥ 7 weeks after start of treatment (and not 
qualifying for CR or PR). 
• PD = meets progression criteria comparing with nadir (and not qualifying for CR, PR, 
or SD). 
• NE = all other cases (ie, not qualifying for confirmed CR or PR and without SD after 
more than 7 weeks or PD) 


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In the case of SD, measurements must meet the SD criteria at least after the date of first dose at a 
minimum of 7 weeks (49 days).  Participants who fail to meet this criterion will have a best 
overall response of PD if the next available assessment indicates PD, or NE if there is no 
additional assessment available.  Table 5 lists some scenarios of responses that can occur after an 
unconfirmed CR or PR in the 4-week follow-up time and provides a rule for determining the best 
overall response in these scenarios.  Further detail of confirmed BOR can be found in confirmed 
BOR documentation. 
Table 5: 
Confirmed Response Based on Subsequent Assessments 
First Timepoint Responsea 
Second Timepoint Response 
Confirmed Responseb 
CR 
PR 
SD or PDc 
CR 
SD 
SD or PDc 
CR 
PD 
SD or PDc 
CR 
CR 
CR 
CR 
NEa 
SD or NEd 
CR 
No further evaluation 
SD or NEd,e 
PR 
CR 
PR 
PR 
PR 
PR 
PR 
SDa,e 
SD 
PR 
NEa 
SD or NEd 
PR 
PD 
SD or PDc 
PR 
No further evaluation 
SD or NEd,e 
SD 
PD 
SD or PDc 
SD 
CR 
SD 
SD 
PR 
SD 
SD 
SD 
SD 
SD 
NE 
SD or NEd 
SD 
No further evaluation 
SD or NEd,e 
NE 
CR 
SD 
NE 
PR 
SD 
NE 
SD 
SD 
NE 
NE 
NE 
NE 
PD 
PD 
NE 
No further evaluation 
NE 
PD 
No further evaluation 
PD 
a Subsequent documentation of CR may provide confirmation of a previously identified CR for participants where the second 
integrated response was NE.  Subsequent documentation of PR may provide confirmation of a previously identified PR for 
participants where the second integrated response was NE or SD.  If the third TPR confirms the CR (or PR,) then the confirmed 
response will be CR (or PR).  Only 1 intervening NE is allowed between CRs/PRs.  For example: CR NE CR = CR; PR NE 
PR/CR = PR.  Additionally, 1 SD (≥ 25% reduction in target lesions comparing with baseline) is allowed between PRs (eg, PR 
SD PR/CR = PR).  Note:  In the following scenario, PR SD NE PR, the second PR is not a confirmed PR. 
b A best response of SD can only be made after the participant is on study for a minimum of 49 days.  If the participant is on 
study less than 49 days, any tumor assessment indicating stable disease before this time period will have a Best Response of 
NE unless PD is identified. 
c Best response will be SD if the first TPR is at least 49 days on study.  Otherwise, the best response will be PD. 
d Best response will be SD if the first TPR is at least 49 days on study.  Otherwise, the best response will be NE. 
e TPR is SD if the increase from the first to the second assessment does not qualify for PD. 


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7.3.3. 
Secondary Analysis 
7.3.3.1. 
Duration of Response 
Duration of response is defined as the time from first documented response (CR or PR, which is 
confirmed subsequently) to the time of first documented disease progression or death due to any 
cause.  If a participant does not have an event before data cutoff or new anticancer therapy, DOR 
will be censored at the date of the last adequate tumor assessment before data cutoff or new 
anticancer therapy following the same algorithm as censoring of PFS (see Table 6).  Duration of 
response will be analyzed in chemotherapy-naive participants at least 6 months after the last 
participant in the FAS is enrolled in the study.  The Kaplan-Meier estimate of the distribution 
function will be constructed for DOR.  The estimated median along with 95% CIs will be 
reported.  A swimmer plot for DOR may be generated.  Analysis of DOR will be according to 
RECIST v1.1 as determined by ICR in the FAS.  In addition, DOR assessed by investigator may 
be provided.  Participants with confirmed response that lasts for 6 months from Kaplan-Meier 
estimate (6-month DOR estimate) will be provided as DRR.  The 95% CI of the DRR is derived 
by asymptotic CI using the standard formula for the variance of a product of independent random 
variables as follows:  
𝑉𝑎𝑟(𝑂𝑅𝑅∗𝐷𝑂𝑅6) = (𝜎𝑂𝑅𝑅
2
+ 𝜇𝑂𝑅𝑅
2
)(𝜎𝐷𝑂𝑅6
2
+ 𝜇𝐷𝑂𝑅6
2
) −𝜇𝑂𝑅𝑅
2
𝜇𝐷𝑂𝑅6
2
, 
where 𝜎2 is the variance and 𝜇 is the mean.  The percentage of participants with DOR longer 
than 6 months from landmark analysis will also be provided.  
7.3.3.2. 
Disease Control Rate 
Disease control rate is defined as the proportion of participants with an overall response (CR and 
PR) or SD lasting at least 6 months per RECIST v1.1, according to the ICR.  The DCR will be 
assessed in chemotherapy-naive participants using the FAS, and the exact 95% CI will be 
reported. 
7.3.3.3. 
Progression-Free Survival 
Progression-free survival is defined as the time from the first dose of study treatment to the date 
of the first documented progression per RECIST v1.1 according to ICR or death due to any 
cause.  Progression-free survival will be analyzed by the Kaplan-Meier method, including 
estimated median with 95% CIs and Kaplan-Meier estimated probabilities at several timepoints.  
If participants have no observed death or disease progression before data cutoff or new 
anticancer therapy, the participants will be treated as censored at their last adequate tumor 
assessment before cutoff or new anticancer therapy according to Table 6, which is based on the 
FDA Guidance for Industry:  Clinical Trial Endpoints for the Approval of Cancer Drugs and 
Biologics (2007).  Date of death will be determined using the Death Report, Survival Follow-Up, 
Subject Status, and other datasets collected in the eCRFs.  Progression-free survival will be 
assessed for chemotherapy-naive participants in the FAS. 


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Table 6: 
Evaluation and Censoring of Progression-Free Survival 
Situation 
Outcome 
Date of Progression or Censoring 
Incomplete or no baseline tumor assessments 
Censored 
First Dose Date 
No valid postbaseline response assessments in 
the absence of death prior to first scheduled 
tumor assessment 
Censored 
First Dose Date 
Progression documented between scheduled 
response assessments 
Progressed 
Date of first overall response of PD 
No progression 
Censored 
Date of last valid radiologic assessment 
(not NE or missing) 
Study discontinuation for undocumented 
progression 
Censored 
Date of last valid radiologic assessment 
(not NE or missing) 
Study discontinuation for toxicity or other 
reason 
Censored 
Date of last valid radiologic assessment 
(not NE or missing) 
New anticancer treatment started 
Censored 
Date of last valid radiologic assessment 
(not NE or missing) on/before starting a 
new anticancer treatment 
Death before first progressive response 
assessment 
Progressed 
Date of death 
Death between adequate response assessments 
Progressed 
Date of death 
Death or documented progression immediately 
after missing 2 or more consecutive scheduled 
tumor assessment 
Censored 
Date of last valid radiologic assessment 
(not NE or missing) prior to missed 
assessments 
7.3.3.4. 
Overall Survival 
Overall survival is defined as the time from first dose of study treatment to the date of death due 
to any cause.  Date of death will be determined using the Death Report, Survival Follow-Up, and 
Subject Status eCRFs.  Participants who are lost to follow-up or still alive at the time of analysis 
will be censored at the last known alive date.  The last known alive date is defined as the later of 
the last study visit and the date the participant was last known alive from the Survival 
Follow-Up, Subject Status, or other datasets collected in the eCRFs.  Kaplan-Meier curves, 
medians, and 95% CIs of the medians will be presented for OS.  Overall survival will be 
assessed for chemotherapy-naive participants using the FAS. 
7.3.4. 
Tumor Size Change Over Time 
Tumor size is defined as the sum of diameters of target lesions.  The best percentage change 
from baseline, defined as the largest decrease in tumor size for each participant, will be 
summarized descriptively.  In addition, the best percentage change may be presented by a 
waterfall plot.  The analysis will be performed in all participants in the FAS with a baseline 
tumor size available.  Tumor size change over time may be assessed for chemotherapy-naive 
participants. 
Per RECIST v1.1, target lesions considered "too small to measure" will be assigned a default 
value of 5 mm for purposes of this analysis.  Likewise, target lesions identified as "not present" 
at postbaseline assessments will be assigned 0 mm for this analysis.  In the event a target lesion 
is unaccounted for in a particular postbaseline timepoint (ie, assessment missing or NE), then the 
overall sum of diameters for target lesions will not be evaluable for that timepoint. 


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7.3.5. 
Subgroup Analysis 
Subgroup analyses will be performed on the following based on the participant's baseline status: 

Sex:  Male, Female

Baseline ECOG performance status:  0 vs 1

Age: < 65 years vs ≥ 65 years and < 75 years vs ≥ 75 years

Race:  Caucasian, other

Region:  North America, Europe

Ethnicity:  Non-Hispanic or Latino, other

PD-L1 status determined by central pathology review:  < 1% or missing, ≥ 1%

Merkel cell polyomavirus status determined by central pathology review:  positive,
negative/equivocal/missing
Subgroup analyses will only be performed if at least 5 participants are present in each subgroup.  
Some grouping of classes will be considered if there are too few participants in some subgroups. 
 
 
Subgroup analyses of the primary endpoint (ORR) will be performed on the FAS by presenting 
the point estimates in the subgroup with the exact 95% CIs.  Summary tables and forest plots 
may be presented. 
7.3.6. 
Exploratory Analysis 
7.3.6.1. 
Efficacy Assessments in Full Population 
Objective response rate, DOR, DCR, PFS, and OS will be analyzed in the full population 
following the same logic as the endpoints for the chemotherapy-naive participants. 
 
 
 
  
 
 
 
 
 
 
 


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8. 
SAFETY AND TOLERABILITY
A list of planned tables, figures, and listings is provided in Appendix A. 
8.1. 
General Considerations 
The clinical safety data (eg, vital signs, ECGs, routine laboratory tests, and AEs) will be 
summarized using descriptive statistics (eg, mean, frequency) using the safety evaluable 
population.  The safety analyses will be performed separately for chemotherapy-naive 
participants and the full study population.  In the chemotherapy-naive group, participants with 
advanced versus metastatic tumor status will be presented separately and combined together.  
 
 
Summary tables may be replaced with listings when appropriate.  For instance, an AE frequency 
table may be replaced with a listing if it only contains a few unique PTs reported on relatively 
few participants. 
8.2. 
Adverse Events 
8.2.1. 
Adverse Event Definitions 
A TEAE is any AE either reported for the first time or worsening of a pre-existing event after the 
first dose of study drug until 90 days after the last dose of study drug.  Adverse events that occur 
after anticancer therapy will not be included as TEAEs.  Analysis of AEs (as discussed below) 
will be limited to TEAEs, but data listings will include all AEs regardless of their timing in 
relation to study drug administration. 
Adverse events will be tabulated by MedDRA PT and SOC.  Severity of AEs will be graded 
using the NCI CTCAE v5.0.  The CTCAE reporting guidelines and grading details are available 
on the Cancer Therapy Evaluation Program website. 
The subset of AEs considered by the investigator to be related to study drug will be considered to 
be treatment-related AEs.  If the investigator does not specify the relationship of the AE to study 
drug, the AE will be considered to be treatment-related.  The incidence of AEs and 
treatment-related AEs will be tabulated.  In addition, serious TEAEs will also be tabulated. 
Any missing onset date, causality, or severity must be queried for resolution.  Unresolved 
missing causality and severity will be handled according to the following rules: 
•
An unresolved missing causality will be considered treatment-related.
•
An unresolved missing severity will be identified as an unknown severity.


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For purposes of analysis, all AEs will be considered TEAEs unless the AE can unequivocally be 
defined as not treatment-emergent. 
Infusion-related reactions as well as irAEs (AESIs) may be summarized separately. 
8.2.2. 
Adverse Events of Special Interest 
Immune-related AEs as well as infusion reactions will be considered AESIs in this study.  
Predefined PTs will be grouped into AESI categories and used to identify irAEs or infusion 
reactions without consideration of investigator's assessment of causality.  Diagnosis of infusion 
reactions occurring anytime during the treatment period, investigator-assessed infusion reaction, 
and symptoms of infusion reactions that occurred within 1 day of infusion, and resolved within 
2 days from onset, are infusion reactions.  Adverse events of special interest identified by 
investigator in the AE dataset will also be listed. 
Immune-related AEs and infusion reactions will be summarized in separate tables.  An overall 
summary of AESIs will include the number (%) of participants reporting any AESIs, any 
≥ Grade 3 AESIs, any treatment-related AESIs, any fatal AESIs, and any AESIs leading to 
infusion interruption, delay in planned treatment, or discontinuation. 
The AESI first onset time will be summarized by group term for all AESI groups.  The 
percentage of participants who experienced the events and the median time of onset from 
treatment start will also be provided. 
Resolution time of AESIs, defined as the time from the first onset of each AESI to the date of 
resolution of the last PT within the group, will be summarized by group term. 
8.2.3. 
Adverse Event Summaries 
An overall summary of AEs will include: 
• Number (%) of participants reporting any TEAEs 
• Number (%) of participants reporting any serious TEAEs 
• Number (%) of participants reporting any Grade 3 or higher TEAEs 
• Number (%) of participants reporting any TEAEs related to study drug 
• Number (%) of participants reporting any serious TEAEs related to study drug 
• Number (%) of participants reporting any Grade 3 or higher TEAEs related to study 
drug 
• Number (%) of participants who temporarily interrupted study drug infusion because 
of TEAEs 
• Number (%) of participants who the next scheduled study drug dose delayed because 
of TEAEs  


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• Number (%) of participants who permanently discontinued study drug because of 
TEAEs 
• Number (%) of participants who had a fatal TEAE 
The following summaries will be produced by MedDRA term (if 10 or fewer participants appear 
in a table, a listing may be appropriate): 
• Summary of TEAEs by SOC and PT 
• Summary of TEAEs by PT in decreasing order of frequency 
• Summary of TEAEs by SOC, PT, and maximum severity 
• Summary of ≥ Grade 3 TEAEs by SOC and PT 
• Summary of ≥ Grade 3 TEAEs by PT in decreasing order of frequency 
• Summary of ≥ Grade 3 TEAEs by SOC, PT, and maximum severity 
• Summary of treatment-related TEAEs by SOC and PT 
• Summary of treatment-related TEAEs by PT in decreasing order of frequency 
• Summary of treatment-related ≥ Grade 3 TEAEs by SOC and PT 
• Summary of TEAEs with a fatal outcome by SOC and PT 
• Summary of serious TEAEs by SOC and PT 
• Summary of treatment-related serious TEAEs by SOC and PT 
• Summary of serious TEAEs by PT in decreasing order of frequency 
• Summary of TEAEs leading to delay in the next scheduled study drug dose by SOC 
and PT 
• Summary of TEAEs leading to infusion interruption by SOC and PT 
• Summary of TEAEs leading to study drug discontinuation by SOC and PT 
The following summaries for AESIs will be included: 
• Overall summary of TEAEs of special interest 
• Summary of TEAEs of special interest by group term and PT 
• Summary of TEAEs of special interest by group term, PT, and maximum severity 
• Summary of TEAEs of special interest with a fatal outcome by group term and PT 
• Summary of TEAEs of special interest leading to delay in the next scheduled study 
drug dose by group term and PT 
• Summary of TEAEs of special interest leading to infusion interruption by group term 
and PT 
• Summary of TEAEs of special interest leading to study drug discontinuation by group 
term and PT 


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•
Summary of Grade 3 or higher TEAEs of special interest by group term and PT
•
Summary of Grade 3 or higher TEAEs of special interest by group term, PT, and
maximum severity
•
Summary of time–to-first onset and time-to-resolution of identified TEAEs of special
interest
8.3. 
Clinical Laboratory Tests
8.3.1. 
Laboratory Value Definitions 
Laboratory values and change from baseline values will be summarized descriptively by visit.  
Baseline will be determined according to Section 4.1.5.  If there are multiple values that meet 
the criteria for baseline, Table 8 may be referred as tiebreaker to delineate which value will be 
defined as baseline. 
Table 8: 
Baseline Laboratory Identification 
Priority 
Laboratory Visit 
Proximity to Visit Window 
Tiebreaker 
1 
Scheduled 
In-window 
Use smallest laboratory 
sequence number 
2 
Unscheduled 
In-window 
3 
Scheduled 
Out-of-window 
Laboratory test values outside the normal range will be assessed for severity based on CTCAE 
grade or similar criteria where clinical intervention is required for CTCAE grading.  The 
incidence of abnormal laboratory values and shift tables relative to baseline will be tabulated. 
8.3.2. 
Laboratory Value Summaries 
All test results and associated normal ranges from laboratories will be reported in SI units.  Any 
laboratory test results and associated normal ranges from local laboratories will be converted to 
SI units.  For test results that will be summarized with available normal ranges, the number and 
percentage of participants with the laboratory values being low (but never high), normal, high 
(but never low), and both low and high will be calculated for each test.  This shift summary may 
be produced for each test for the safety evaluable population.  The denominator for the 
percentage calculation will use the number of participants in the baseline category (ie, low, high, 
normal, missing) as the denominator for the percentage in each of the categories during the 
treatment period.  For numeric laboratory values, baseline value, postbaseline value, change from 
baseline, and percentage change from baseline will be summarized by visit. 
Shift tables will be presented showing change in CTC grade from baseline to worst postbaseline 
grade.  Separate summaries for abnormally high and abnormally low laboratory values will be 
provided when the laboratory parameter has both high and low grading criteria.  The 
denominator for the percentage calculation will be the number of participants in the baseline 
category. 


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The following summaries will be produced for laboratory data (by laboratory parameter) 
reported on treatment.  All laboratory assessments will be listed, and those collected later than 
90 days after the last treatment/exposure date will be flagged in the listings. 
•
Number and percentage of participants with worst postbaseline CTC grade
(regardless of the baseline status) will be summarized.  Each participant will be
counted only for the worst grade observed after baseline.
•
Shift tables using CTC grades comparing baseline with the worst postbaseline value
will be produced for hematology and chemistry laboratory parameters with CTC
grades.
•
For laboratory parameters where CTC grades are not defined, shift tables to the worst
postbaseline value will be produced using the low/normal/high classifications based
on laboratory reference ranges.
•
Number and percentage of participants meeting categorical liver function test criteria,
including ALT, AST and ALT/AST (> 3 ×, 5 ×, 8 ×, 10 ×, 20 × ULN), total bilirubin
(> 1 ×, 2 × ULN), ALP (> 1.5 ×, 2 ×, 3 ×, 5 ×, 8 ×, 10 × ULN), combined
categories of ALT/AST and total bilirubin (eg, ALT/AST > 3 × ULN and total
bilirubin > ULN), as well as Hy's Law criteria (ALT or AST > 3 × ULN and total
bilirubin > 2 × ULN and ALP < 2 × ULN).  The worst values observed postbaseline
for each participant will be used for each of the categories.
8.4. 
Vital Signs
Values at each scheduled visit, change, and percentage change from baseline for vital signs, 
including systolic blood pressure, diastolic blood pressure, pulse, respiratory rate, body 
temperature, and weight will be summarized descriptively. 
Criteria for clinically notable vital sign abnormalities are defined in Table 9.  The abnormal 
values for participants exhibiting clinically notable vital sign abnormalities will be listed.  Alert 
vital signs are defined as an absolute value outside the defined range and percentage change from 
baseline greater than 25%.  The abnormal values for participants exhibiting alert vital sign 
abnormalities will be listed. 
Table 9: 
Criteria for Clinically Notable Vital Sign Abnormalities 
Parameter 
High Threshold 
Low Threshold 
Systolic blood pressure 
> 155 mmHg
< 85 mmHg 
Diastolic blood pressure 
> 100 mmHg
< 40 mmHg 
Pulse 
> 100 bpm
< 45 bpm 
Respiratory rate 
> 24 breaths/min
< 8 breaths/min 
8.5. 
Electrocardiograms 
Twelve-lead ECGs including HR, RR, PR, QRS, QT, QTc, QTcF, and QTcB intervals will be 
obtained for each participant during the study.  Values at each scheduled visit, change, and 
percentage change from baseline will be summarized for each ECG parameter.  Baseline will be 


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determined as the last nonmissing ECG measurements taken on or before the first administration 
of study drug. 
Criteria for clinically notable ECG abnormalities are defined in Table 10.  Participants exhibiting 
clinically notable ECG abnormalities will be listed with study visit.  Abnormal values for 
participants with alert ECG values, defined as both the absolute value and the percentage change 
from baseline being outside normal ranges, will be identified and listed. 
Table 10: 
Criteria for Clinically Notable Electrocardiogram Abnormalities 
Parameter 
High Threshold 
Low Threshold 
QTcF/QTcB 
> 460 ms
< 295 ms 
PR 
> 220 ms
< 75 ms 
QRS 
> 120 ms
< 50 ms 
QT 
> 500 ms
< 300 ms 
RR 
> 1330 ms
< 600 ms 
HR 
≥ 100 bpm and ≥ 25% increase from baseline 
≤ 50 bpm and ≥ 25% decrease from baseline 
QTcB = Bazett correction; QTcF = Fridericia correction. 
9.
PHARMACOKINETIC 
 ANALYSIS
9.1. 
Pharmacokinetic Assessments 
Serum concentrations of INCMGA00012 will be monitored using a quantitative sandwich 
ELISA method.  Single- and multiple-dose PK parameters for INCMGA00012, Cmax, tmax, AUCt, 
and Cmin, will be derived from INCMGA00012 serum concentration versus time data as a 
secondary endpoint.  Population PK analyses may be conducted using data from this study alone 
or combined with data from other studies. 
 
 
 
 
 
 
 
 
 
 
 
 
 


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. 
 
 
 
  
 
 
  
 
 
 
 
 
 
 
11.
INTERIM ANALYSES
An analysis is planned after approximately 20 chemotherapy-naive participants are assessable for 
response according to RECIST v1.1.  The primary intent of this analysis is to minimize 
unnecessary exposure of participants to INCMGA00012 in the event of futility.  An ICR will be 
used for interim analysis if available; otherwise, investigator response assessment may be used.  
The study will be stopped for futility at the interim analysis if conditional power based on the 
interim result is lower than 20%, which is equivalent to fewer than 6 participants with an 
objective response.  Since confirmed BOR will be analyzed, all participants enrolled with at least 
2 postbaseline response assessments or participants who discontinued early will be included in 
the futility analysis.  Participants enrolled in the study without 2 or more postbaseline response 
assessments but who are ongoing in the study will not be included in the futility analysis for 
calculation of conditional power.  Enrollment will continue while the analysis is being 
conducted.  This futility analysis will be reviewed by an independent DMC as specified in the 
DMC charter.  The process by which the DMC will review data and make recommendations and 
decisions will be documented in the DMC charter. 
At the time of this amendment, the DMC has reviewed the data for the interim analysis.  The 
preliminary efficacy based on the ORR assessed by ICR exceeded the futility threshold, and the 
DMC recommended the study to proceed as planned. 


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12. 
CHANGES AND MODIFICATIONS TO THE ANALYSIS PLAN 
All versions of the SAP are listed in Table 11.
Table 11: 
Statistical Analysis Plan Versions
SAP Version 
Date 
Original 
13 MAR 2019 
Amendment 1 
01 JUN 2020 
Amendment 2 
19 MAY 2021 
12.1. 
Changes to Protocol-Defined Analyses 
Not applicable. 
12.2. 
Changes to the Statistical Analysis Plan 
The following updates were made; some are to align with Protocol Amendment 6: 

The target population was increased to 100 in the final analysis, and approximately
60 chemotherapy-naive participants will be included in the primary analysis.

Analysis grouping was added.

Analysis of DRR was added.

Summary of onset and resolution time to AESI were updated to include only
summary statistics.
The following updates were made to align with Protocol Amendment 5:  

The sample size was revised to approximately 60 chemotherapy-naive participants.

The endpoints of ORR, DOR, DCR, PFS, and OS in the full study population were
moved from the secondary endpoints to the exploratory endpoints.

The FAS definition was revised and updated to include efficacy analyses.

Creatinine clearance and hepatic function variables were added for program
consistency.

PD-L1 assessment, HIV status, ECOG performance status, and liver metastasis were
added to the list of disease summaries.

The interim analysis was updated to coincide with the confirmed BOR definition.

The AESI definition and related analysis were updated for program consistency.
Other minor administrative changes have been incorporated throughout and are noted in the 
redline version of the document. 


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13. 
REFERENCES 
 
 
Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 
1976;16:31-41. 
D'Angelo SP, Lebbé C, Mortier L, et al. First-line avelumab treatment in patients with metastatic 
Merkel cell carcinoma: primary analysis after ≥15 months of follow-up from JAVELIN Merkel 
200, a registrational phase 2 trial. J Immunother Cancer 2019;7(suppl 1):282 [abstr P362]. 
Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumors: 
revised RECIST guideline (version 1.1). Eur J Cancer 2009;45:228-247. 
Food and Drug Administration. Guidance for Industry: Clinical Trial Endpoints for the Approval 
of Cancer Drugs and Biologics. 2007. 
 
 
Kaufman HL, Russell J, Hamid O, et al. Avelumab in patients with chemotherapy-refractory 
metastatic Merkel cell carcinoma: a multicentre, single-group, open-label, phase 2 trial. Lancet 
Oncol 2016;17:1374-1385. 
National Cancer Institute. Specific Instructions for the Use of Organ Dysfunction Templates. 
2017. 
Nghiem P, Bhatia S, Lipson EJ, et al. Durable tumor regression and overall survival in patients 
with advanced Merkel cell carcinoma receiving pembrolizumab as first-line therapy. J Clin 
Oncol 2019;37:693-702. 
Nghiem PT, Bhatia S, Lipson EJ, et al. PD-1 blockade with pembrolizumab in advanced 
Merkel-cell carcinoma. N Engl J Med 2016;374:2542-2552. 
 


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APPENDIX A. PLANNED TABLES, FIGURES, AND LISTINGS 
This appendix provides a list of the planned tables, figures, and listings for the Clinical Study 
Report.  The lists of tables, figures, and listings are to be used as guidelines.  Modifications of 
the lists that do not otherwise affect the nature of the analysis will not warrant an amendment to 
the SAP.  The reference numbers are included here for reference purposes.  The output number 
will follow the standard shell template.  
Tables 
Table No. 
Title 
Population 
Baseline and Demographic Characteristics 
1.1  Disposition 
1.1.1 
Analysis Populations 
Enrolled 
1.1.2 
Summary of Participant Disposition 
Safety  
1.1.3 
Summary of Number of Participants Enrolled by Country and Site 
Enrolled 
1.1.4 
Summary of Protocol Deviations 
Safety 
1.2  Demography 
1.2.1 
Summary of Demographics 
Safety 
1.3  Baseline Disease Characteristics (refine per data collection) 
1.3.1 
Summary of Cancer History and Baseline Disease Characteristics 
Safety 
1.4  Prior Medication and Concomitant Medication (refine per data collection) 
1.4.1 
Summary of Prior Medications 
Safety 
1.4.2 
Summary of Concomitant Medications 
Safety 
1.4.3 
Summary of Prior Systemic Therapy 
Safety 
1.4.4 
Summary of Prior Radiotherapy 
Safety 
1.4.5 
Summary of Prior Surgery/Procedure 
Safety 
1.4.7 
Summary of Post Anticancer Therapy 
Safety 
1.5  Others 
1.5.1 
Summary of General Medical History 
Safety 
1.6.1 
Summary of Death 
Safety 
2  Efficacy (refine subgroup analysis as needed) 
2.1.1 
Summary of Best Overall Response by ICR According to RECIST 1.1 
FAS 
2.2.1 
Summary of Duration of Response by ICR According to RECIST 1.1 
FAS 
2.2.2 
Summary of Disease Control Rate by ICR According to RECIST 1.1 
FAS 
2.2.3 
Summary of Progression Free Survival by ICR According to RECIST 1.1 
FAS 
2.2.4 
Summary of Overall Survival 
FAS 
2.2.5.1 
Summary of Largest Percentage Reduction in Sum of Diameters of Target 
Lesions by Investigator 
FAS 
2.2.5.2 
Summary of Largest Percentage Reduction in Sum of Diameters of Target 
Lesions by ICR 
FAS 
2.2.5.3 
Summary of Sum of Diameters of Target Lesions by Visit by Investigator 
FAS 
2.2.5.4 
Summary of Sum of Diameters of Target Lesions by Visit by ICR 
FAS 
2.3.1 
Summary of Best Overall Response by ICR by Sex 
FAS 
2.3.2.1 
Summary of Best Overall Response by ICR by Age Group 1 
FAS 
2.3.2.2 
Summary of Best Overall Response by ICR by Age Group 2 
FAS 
2.3.3 
Summary of Best Overall Response by ICR by Race 
FAS 
2.3.4 
Summary of Best Overall Response by ICR by Ethnicity 
FAS 
2.3.5 
Summary of Best Overall Response by ICR by ECOG Status at Baseline 
FAS 
2.3.6 
Summary of Best Overall Response by ICR by PD-L1 Status at Baseline 
FAS 


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Table No. 
Title 
Population 
2.3.7 
Summary of Best Overall Response by ICR by Merkel Cell Polyomavirus at 
Baseline 
FAS 
2.3.8 
Summary of Best Overall Response by ICR by Pooled Region 
FAS 
 
 
 
 
 
 
2.5.1 
Summary of Best Overall Response by Investigator 
FAS 
2.5.2 
Summary of Duration of Response by Investigator Assessment According to 
RECIST 1.1 
FAS 
2.5.3 
Summary of Progression Free Survival by Investigator According to RECIST 
1.1 
FAS 
2.5.4 
Summary of Best Overall Response by ICR According to RECIST 1.1 
Efficacy 
Safety 
3.1  Dose Exposure 
3.1.1 
Summary of Exposure to INCMGA00012 
Safety 
3.1.2 
Summary of Dose Delay/Interruption 
Safety 
3.2  Adverse Events  
3.2.1.1 
Overall Summary of Treatment-Emergent Adverse Events 
Safety 
3.2.1.2 
Overall Summary of Treatment-Emergent Adverse Events of Special Interest 
Safety 
3.2.2.1 
Summary of Treatment-Emergent Adverse Events by MedDRA System Organ 
Class and Preferred Term  
Safety 
3.2.2.2 
Summary of Treatment-Emergent AESI by Group Term and Preferred Term 
Safety 
3.2.3.1 
Summary of Treatment-Emergent Adverse Events by MedDRA Preferred 
Term in Decreasing Order of Frequency 
Safety 
3.2.4.1 
Summary of Treatment-Emergent Adverse Events by MedDRA System Organ 
Class, Preferred Term, and Maximum Severity 
Safety 
3.2.4.2 
Summary of Treatment-Emergent Adverse Events of Special Interest  by 
Group Term, Preferred Term, and Maximum Severity 
Safety 
3.2.6.1 
Summary of Grade 3 or Higher Treatment-Emergent Adverse Events by 
MedDRA System Organ Class and Preferred Term 
Safety 
3.2.6.2 
Summary of Grade 3 or Higher Treatment-Emergent Adverse Events of 
Special Interest by Group Term and Preferred Term 
Safety 
3.2.7.1 
Summary of Grade 3 or Higher Treatment-Emergent Adverse Events by 
MedDRA Preferred Term in Decreasing Order of Frequency 
Safety 
3.2.8.1 
Summary of Serious Treatment-Emergent Adverse Events by MedDRA 
System Organ Class and Preferred Term 
Safety 
3.2.9.1 
Summary of Serious Treatment-Emergent Adverse Events by MedDRA 
Preferred Term in Decreasing Order of Frequency  
Safety 
3.2.10.1 
Summary of Treatment-Related Treatment-Emergent Adverse Events by 
MedDRA System Organ Class and Preferred Term 
Safety 
3.2.11.1 
Summary of Treatment-Related Treatment-Emergent Adverse Events by 
MedDRA Preferred Term in Decreasing Order of Frequency 
Safety 
3.2.14.1 
Summary of Treatment-Related Grade 3 or Higher Treatment-Emergent 
Adverse Events by MedDRA System Organ Class and Preferred Term 
Safety 
3.2.15.1 
Summary of Treatment-Related Serious Treatment-Emergent Adverse Events 
by MedDRA System Organ Class and Preferred Term 
Safety 
3.2.16.1 
Summary of Treatment-Emergent Adverse Events With a Fatal Outcome by 
MedDRA System Organ Class and Preferred Term 
Safety 
3.2.16.2 
Summary of Treatment-Emergent Adverse Events of Special Interest With a 
Fatal Outcome by Group Term and Preferred Term 
Safety 


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Table No. 
Title 
Population 
3.2.19.1 
Summary of Treatment-Emergent Adverse Events Leading to Infusion 
Interruption by MedDRA System Organ Class and Preferred Term 
Safety 
3.2.19.2 
Summary of Treatment-Emergent Adverse Events of Special Interest Leading 
to Infusion Interruption by Group Term and Preferred Term 
Safety 
3.2.19.3 
Summary of Treatment-Emergent Adverse Events Leading to Next Scheduled 
Dose Delayed by MedDRA System Organ Class and Preferred Term 
Safety 
3.2.19.4 
Summary of Treatment-Emergent Adverse Events of Special Interest Leading 
to Next Scheduled Dose Delayed by Group Term and Preferred Term 
Safety 
3.2.20.1 
Summary of Treatment-Emergent Adverse Events Leading to Study Drug 
Discontinuation by MedDRA System Organ Class and Preferred Term 
Safety 
3.2.20.2 
Summary of Treatment-Emergent Adverse Events of Special Interest Leading 
to Study Drug Discontinuation by Group Term and Preferred Term 
Safety 
3.2.27.1 
Summary of Onset and Resolution Time of Treatment-Emergent 
Sponsor-Defined Adverse Events of Special Interest 
Safety 
3.3  Laboratory 
3.3.1.1 
Summary of Laboratory Hematology Values  
Safety 
3.3.1.2 
Summary of Laboratory Chemistry Values 
Safety 
3.3.1.3 
Summary of Laboratory Coagulation Values  
Safety 
3.3.1.4 
Summary of Laboratory Urinalysis Values 
Safety 
3.3.1.5 
Summary of Laboratory Endocrine Values 
Safety 
3.3.2.1 
Shift Summary of Hematology Laboratory Values to the Worst Abnormal 
Value 
Safety 
3.3.2.2 
Shift Summary of Chemistry Laboratory Values to the Worst Abnormal Value 
Safety 
3.3.2.3 
Shift Summary of Coagulation Laboratory Values to the Worst Abnormal 
Value 
Safety 
3.3.3.1 
Shift Summary of Hematology Laboratory Values in CTC Grade to the Worst 
Abnormal Value 
Safety 
3.3.3.2 
Shift Summary of Chemistry Laboratory Values in CTC Grade to the Worst 
Abnormal Value 
Safety 
3.3.3.3 
Shift Summary of Coagulation Laboratory Values in CTC Grade to the Worst 
Abnormal Value 
Safety 
3.3.3.4 
Treatment-Emergent Worsening of Laboratory Abnormalities - Hematology 
Safety 
3.3.3.5 
Treatment-Emergent Worsening of Laboratory Abnormalities - Chemistry 
Safety 
3.3.3.6 
Treatment-Emergent Worsening of Laboratory Abnormalities - Coagulation 
Safety 
3.3.6 
Summary of Liver Chemistry 
Safety 
3.4  Vital Signs 
3.4.1 
Summary of Systolic Blood Pressure 
Safety 
3.4.2 
Summary of Diastolic Blood Pressure 
Safety 
3.4.3 
Summary of Pulse 
Safety 
3.4.4 
Summary of Respiration Rate 
Safety 
3.4.5 
Summary of Body Temperature 
Safety 
3.4.6 
Summary of Weight 
Safety 
3.5  ECG 
3.5.1 
Summary of PR Interval (ms) From 12-Lead ECG 
Safety 
3.5.2 
Summary of QRS Interval (ms) From 12-Lead ECG 
Safety 
3.5.3 
Summary of QT Interval (ms) From 12-Lead ECG 
Safety 
3.5.4 
Summary of RR Interval (ms) From 12-Lead ECG 
Safety 
3.5.5 
Summary of QTcF Interval (ms) From 12-Lead ECG 
Safety 
3.5.6 
Summary of QTcB Interval (ms) From 12-Lead ECG 
Safety 


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Table No. 
Title 
Population 
3.5.7 
Summary of Heart Rate From 12-Lead ECG 
Safety 
Figures 
Figure No. 
Title 
Efficacy (Lab figures may be added as needed.  Kaplan-Meier plots may be added for investigator and for 
different analysis population) 
4.1.1 
Kaplan-Meier Estimates of Duration of Response by ICR 
4.1.2 
Kaplan-Meier Estimates of Duration of Response by Investigator 
4.2.1 
Kaplan-Meier Estimates of Progression-Free Survival by ICR 
4.2.2 
Kaplan-Meier Estimates of Progression-Free Survival by Investigator 
4.3.1 
Kaplan-Meier Estimates of Overall Survival  
4.3.2.1 
Waterfall Plot of Best Percentage Change in Sum of Target Lesions by ICR 
4.3.2.2 
Waterfall Plot of Best Percentage Change in Sum of Target Lesions by Investigator 
4.3.3.1 
Swimmer Plot of Duration of Treatment by ICR 
4.3.3.2 
Swimmer Plot of Duration of Treatment by Investigator 
4.3.3.3 
Swimmer Plot of Duration of Treatment for Responders by ICR 
4.3.4.1 
Forest Plot of Overall Response and 95% CI by Investigator 
4.3.4.2 
Forest Plot of Overall Response and 95% CI by ICR  
4.5.X 
Mean and Standard Error of Lab Parameters  
 
 
Listings (data dump listings may be added) 
Listing No. 
Title 
2.1  Discontinued Participants (Participant Disposition) 
2.1.1 
Participant Enrollment and Disposition Status 
2.1.2 
Participant Inclusion and Exclusion Criteria Violations 
2.2  Protocol Deviations 
2.2 
Protocol Deviations 
2.3  Data Excluded From PK, Efficacy, and/or Safety Analyses 
2.3 
Analysis Populations 
2.4  Demography and Baseline (Including Prior and Concomitant Medications) 
2.4.1 
Demographic and Baseline Disease Characteristics 
2.4.2 
Cancer Disease History and Baseline Disease Characteristics 
2.4.3 
Prior Radiotherapy 
2.4.4 
Prior Systemic Cancer Therapy  
2.4.5 
Prior Surgery or Surgical Procedure 
2.4.6 
Medical History 
2.4.7 
Prior and Concomitant Medications 
2.4.8 
Procedures and Nondrug Therapy 


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Listing No. 
Title 
2.4.9 
Summary of Post Anticancer Therapy 
2.5  Drug Exposure 
2.5 
Study Drug Exposure 
2.6  Efficacy 
2.6.1 
Overall Survival Events and Assessments  
2.6.2 
Progression-Free Survival Events and Assessments by ICR 
2.6.3 
Overall Response Assessment by ICR 
2.6.4 
Duration of Response by ICR 
2.6.5.1 
Response Assessment by Investigator for Target Lesions 
2.6.5.2 
Response Assessment by ICR for Target Lesions 
2.6.6.1 
Response Assessment by Investigator for Non-Target Lesions 
2.6.6.2 
Response Assessment by ICR for Non-Target Lesions 
2.6.7.1 
Response Assessment by Investigator for New Lesions 
2.6.7.2 
Response Assessment by ICR for New Lesions 
2.6.8.1 
Largest Percentage Reduction in Sum of Diameters of Target Lesions by Investigator 
2.6.8.2 
Largest Percentage Reduction in Sum of Diameters of Target Lesions by ICR 
 
 
2.6.11 
Overall Response Assessment by Investigator Assessment 
2.6.12 
Duration of Response by Investigator Assessment According to RECIST 
2.6.13 
Progression-Free Survival Events and Assessments by Investigator  
2.7  Adverse Events 
2.7.1 
Adverse Events 
2.7.2 
Serious Adverse Events 
2.7.3 
Fatal Adverse Events 
2.7.4 
Adverse Events Leading to Study Drug Discontinuation 
2.7.5 
Adverse Events Leading to Study Drug Interruptions or Delays 
2.7.6 
Adverse Events of Special Interest 
2.7.7 
Adverse Events ≥ Grade 3 
2.7.8 
Investigator Identified Adverse Events of Special Interest 
2.8  Laboratory Data 
2.8.1 
Clinical Laboratory Values – Hematology 
2.8.2 
Clinical Laboratory Values – Chemistry 
2.8.3 
Clinical Laboratory Values – Urinalysis 
2.8.4 
Clinical Laboratory Values – Coagulation 
2.8.5 
Clinical Laboratory Values – Endocrine 
2.8.6.1 
Abnormal Clinical Laboratory Values – Hematology 
2.8.6.2 
Abnormal Clinical Laboratory Values – Chemistry 
2.8.6.4 
Abnormal Clinical Laboratory Values – Coagulation 
2.8.7 
Clinical Laboratory Values – Pregnancy 
2.8.8 
Clinical Laboratory Values With Toxicity Grade 3 or Higher – Hematology 
2.8.9 
Clinical Laboratory Values With Toxicity Grade 3 or Higher – Chemistry 
2.8.10 
Clinical Laboratory Values – Liver Chemistry 
2.8.11 
PK Blood Sampling Times 
 
 
2.9  Vital Signs 
2.9.1 
Vital Signs 
2.9.2 
Abnormal Vital Sign Values 


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Listing No. 
Title 
2.9.3 
Alert Vital Sign Values 
2.10  Electrocardiograms 
2.10.1 
ECG Values 
2.10.2 
Abnormal ECG Values 
2.10.3 
Alert ECG Values 
2.11  Other 
2.11.1 
Tobacco Use 
2.11.2 
Alcohol Assumption 
2.11.3 
ECOG Performance Status 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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