A Phase 3, Open Label, Randomized, Non-Inferiority Pharmacokinetic Study of Nivolumab Subcutaneous (Nivo SC) Versus Intravenous (Nivo IV) Administration in Participants With Stage IIIA/B/C/D or Stage IV Adjuvant Melanoma Following Complete Resection
Phase: PHASE3
Conditions: Melanoma
Sponsor: Bristol-Myers Squibb

Official Title of Study: 
A Phase 3, Open Label, Randomized, Non-Inferiority Pharmacokinetic Study of Nivolumab 
Subcutaneous (Nivo SC) Versus Intravenous (Nivo IV) Administration in Participants With Stage 
IIIA/B/C/D or Stage IV Adjuvant Melanoma Following Complete Resection 
 
NCT Number: NCT05297565 
 
Document Date (Date in which document was last revised): 25 May 2023 

Approved v 21.0 
930174717 2.0 
 
Page: 1 
Protocol Number: CA2096GE 
Date: 30-Sep-2021 
Revised Date: 25-May-2023 
 
 
 
CLINICAL PROTOCOL CA2096GE 
A Phase 3, Open Label, Randomized, Non-Inferiority Pharmacokinetic Study of Nivolumab 
Subcutaneous (Nivo SC) Versus Intravenous (Nivo IV) Administration in Participants with 
Stage IIIA/B/C/D or Stage IV Adjuvant Melanoma Following Complete Resection 
 
(CheckMate-6GE: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 6GE) 
 
Brief Title: 
A Pharmacokinetic Study of Nivolumab Subcutaneous vs Intravenous Administration in 
Participants with Stage IIIA/B/C/D or Stage IV Melanoma Following Complete Resection 
Protocol Amendment 01 
Incorporates Administrative Letters 01, 02, and 03 
 
Clinical Trial Physician-Medical 
Monitor 
Bristol-Myers Squibb Company 
3401 Princeton Pike Lawrenceville, NJ 08648 
email 
Clinical Scientist 
Bristol-Myers Squibb Company 
3401 Princeton Pike Lawrenceville, NJ 08648 
email: 
24-hr Emergency Telephone Number 
USA: 
International: 
 
Bristol-Myers Squibb Company 
Route 206 & Province Line Road 
Lawrenceville, NJ 08543 
 
Avenue de Finlande 4 
B-1420 Braine-l'Alleud, Belgium 
 
REGULATORY AGENCY IDENTIFIER NUMBER(S) 
IND: 150,904 
EudraCT/EU Trial Number: 2021-003208-42 
UTN: U1111-1266-6116 
Phone 
: 
Phone 

Clinical Protocol 
BMS-986298 
CA2096GE 
nivolumab 
Protocol Amendment No.: 01 
Date: 25-May-2023 
2 
Approved v 21.0 
930174717 2.0 
 
 
This document is the confidential and proprietary information of Bristol-Myers Squibb 
Company and its global affiliates (BMS). By reviewing this document, you agree to keep it 
confidential and to use and disclose it solely for the purpose of assessing whether your 
organization will participate in and/or the performance of the proposed BMS sponsored 
study. Any permitted disclosures will be made only on a confidential "need to know" basis 
within your organization or to your independent ethics committee(s). Any other use, 
copying, disclosure or dissemination of this information is strictly prohibited unless 
expressly authorized in writing by BMS. Any supplemental information (eg, amendments) 
that may be added to this document is also confidential and proprietary to BMS and must 
be kept in confidence in the same manner as the contents of this document. Any person 
who receives this document without due authorization from BMS is requested to return 
it to BMS or promptly destroy it. References to BMS in this protocol may apply to partners 
to which BMS has transferred obligations (eg, a Contract Research Organization [CRO]). 
 
 
 
© 2023 Bristol-Myers Squibb Company 

Clinical Protocol 
BMS-986298 
CA2096GE 
nivolumab 
Protocol Amendment No.: 01 
Date: 25-May-2023 
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DOCUMENT HISTORY 
 
Document 
Date of Issue 
Summary of Change 
• 
Bristol-Myers Squibb has made a strategic decision to 
terminate the CA2096GE trial. This decision was not 
related to any safety concerns. Study recruitment has 
closed and treatment of ongoing, active participants will 
continue per Protocol Amendment 01. Changes 
implemented in this amendment aim to alleviate 
participant and site burden and include updates to sample 
collection, study procedures, and study design. 
Protocol Amendment 
01 
25-May-2023 
• 
Pharmacokinetic (PK) co-primary endpoints, and 
secondary endpoints have been removed. Efficacy, 
patient-reported outcomes (PROs), and biomarker 
analyses will not be completed. Samples already 
collected for PK and immunogenicity assessments will 
be 
analyzed 
bioanalytically 
for 
nivolumab 
concentrations and anti-drug antibodies (ADAs) and 
reported as listings. Further collections for PK, ADAs, 
biomarkers, and PROs will be discontinued. Only safety 
assessments will be conducted. 
• 
• 
Balanced the frequency of clinic visits between 
treatment arms. 
• 
Original Protocol 
30-Sep-2021 
N/A 

Clinical Protocol 
BMS-986298 
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nivolumab 
Protocol Amendment No.: 01 
Date: 25-May-2023 
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OVERALL RATIONALE FOR GLOBAL PROTOCOL AMENDMENT 01: 
Bristol-Myers Squibb (BMS) has made a strategic decision to terminate the CA2096GE trial. This 
decision was not related to any safety concerns. Study recruitment has closed; treatment and 
follow-up of ongoing active participants will continue per Protocol Amendment 01. Changes 
implemented in this amendment aim to alleviate participant and site burden and include updates 
to sample collection, study procedures, and study design. 
Pharmacokinetic (PK) co-primary endpoints, and secondary endpoints have been removed. 
Efficacy, patient-reported outcomes (PROs), and biomarker analyses will not be completed. 
Samples already collected for PK and immunogenicity assessments will be analyzed 
bioanalytically for nivolumab concentrations and anti-drug antibodies (ADAs) and reported as 
listings. Further collections for PK, ADAs, biomarkers, and PROs will be discontinued. Only 
safety assessments will be conducted. 
 
Changes were made to balance the frequency of clinic visits between Part 1 Arm A and Part 1 
Arm B. Participants in Part 1 Arm A will now have assessments in the clinic every 4 weeks (Q4W), 
beginning on Cycle 5, Day 1. 
 
 
Other edits were made throughout the protocol to fix minor errors, add clarity, and improve 
consistency and alignment. The Summary was updated to reflect changes in the amendment. 
 
SUMMARY OF CHANGES FOR PROTOCOL AMENDMENT 01 
Section Number & Title 
Description of Change 
Brief Rationale 
Title Page 
Updated title. 
Per Administrative 
Letter 02. 
Table 2-1: Screening Procedural Outline 
(CA2096GE) 
Table 2-2: On Study Treatment Procedural 
Outline (Arm A) 
(CA2096GE) 
• Marked as not applicable per 
Protocol Amendment 01. 
 
 
• Removed PK, efficacy, PRO, 
IMG, and biomarker analyses. 
To reflect study 
procedures that are no 
longer applicable due to 
trial termination. 
Table 2-3: On Study Treatment Procedural 
Outline (Arm B) (Nivo IV) (CA2096GE) 
Section 3.1.1: Research Hypotheses 
Table 4-1: Objectives & Endpoints 
Section 5.1: Overall Design 

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SUMMARY OF CHANGES FOR PROTOCOL AMENDMENT 01 
Section Number & Title 
Description of Change 
Brief Rationale 
Section 5.1.1: Screening Period 
Section 5.4.2: Rationale for Part 1 Endpoints 
and Non-Inferiority Margin 
 
Section 5.4.6: Rationale for Inclusion of 
Clinical Outcome Assessments/PROs (Part 1) 
 
Section 6.1: Inclusion Criteria 
Section 6.2: Exclusion Criteria 
 
Section 6.4: Screen Failures 
Table 7.1-1: Study Interventions 
Section 8.1.2: Post-study Intervention Study 
Follow-up 
Section 9.1.4.1: FACT-G7 (Part 1 Only) 
Section 9.1.4.2: EQ-5D-5L (Part 1 Only) 
Section 9.1.4.3: Modified CTSQ (Part 1 Only) 
Section 9.1.4.4: Modified TASQ (Part 1 Only) 
Section 9.1.4.5: SIAQ (Part 1 Only) 
 
Section 9.5: Pharmacokinetics 
Section 9.5.1: Pharmacokinetics and 
Anti-Drug Antibody Sample Collection and 
Processing 
Section 9.8: Biomarkers 
Section 9.9: Additional Research 
Section 9.11: Health Economics OR Medical 
Resource Utilization and Health Economics 
Section 10: Statistical Considerations 
Section 10.1: Statistical Hypotheses 
 
Section 10.4.2.1: Part 1 PK Co-Primary 
Endpoints 
 
Section 10.4.3: Secondary Endpoint(s) 
Section 10.4.6.1: Exposure-Response 
Analyses 
Section 10.4.6.2: Immunogenicity Analyses 
Section 10.4.6.3: Outcomes Research 

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SUMMARY OF CHANGES FOR PROTOCOL AMENDMENT 01 
 
Section Number & Title 
Section 10.4.6.4: Biomarkers 
Section 10.4.7.1: Part 1 
Description of Change 
Brief Rationale 
 
Table 2-2: On Study Treatment Procedural 
Outline (Arm A) 
(CA2096GE) 
 
Table 2-2: On Study Treatment Procedural 
Outline (Arm A) 
(CA2096GE) 
Section 5.1.2.1: Randomized Study Cohort 
Table 2-2: On Study Treatment Procedural 
Outline (Arm A) 
(CA2096GE) 
Table 2-3: On Study Treatment Procedural 
Outline (Arm B) (Nivo IV) (CA2096GE) 
Table 2-5: Follow-up Assessments 
(CA2096GE) 
Section 9.1.1: Efficacy Assessment for the 
Study 
Section 9.1.2: Imaging Assessment for the 
Study 
Section 9.1.3.1: Investigator Assessment of 
Recurrence 
Table 2-2: On Study Treatment Procedural 
Outline (Arm A) 
(CA2096GE) 
Section 7.4.5.1: Systemic Reactions Occurring 
In-clinic 
 
 
 
 
 
 
 
Updated details about frequency of 
imaging, body parts to undergo 
imaging, and requirements of 
imaging. 
To balance the 
frequency of physical 
examinations. 
To provide 
clarification. 
 
To ensure consistency 
with updates made 
throughout the protocol. 
 
 
 
 
 
 
 
 
 
 
To provide additional 
safety guidance. 
 
 
 
 
Table 2-2: On Study Treatment Procedural 
Outline (Arm A) 
(CA2096GE) 
Section 5.1: Overall Design 
Section 5.1.2: Treatment Period 
Section 5.1.2.1: Randomized Study Cohort 
Section 9.2.5: Pregnancy 

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SUMMARY OF CHANGES FOR PROTOCOL AMENDMENT 01 
Section Number & Title 
Description of Change 
Brief Rationale 
Table 2-2: On Study Treatment Procedural 
Outline (Arm A) 
(CA2096GE) 
• 
• Updated table notes to provide 
more details about procedures. 
• 
• Removed “infusion”-related 
adverse events (AEs). 
To provide consistency 
with updates made 
throughout the protocol. 
• 
• 
Table 2-2: On Study Treatment Procedural 
Outline (Arm A) 
(CA2096GE) 
Table 2-3: On Study Treatment Procedural 
Outline (Arm B) (Nivo IV) (CA2096GE) 
Table 2-5: Follow-up Assessments 
(CA2096GE) 
• Deleted “Targeted” from 
physical examination 
• Deleted references to 
 
• Added “Physical examination, 
including targeted physical 
examination for detection of 
disease recurrence.” 
To clarify that target 
physical examination 
refers specifically to 
detection of disease 
recurrence. 
Table 2-3: On Study Treatment Procedural 
Outline (Arm B) (Nivo IV) (CA2096GE) 
• 
Updated footnote a. 
To provide clarification 
and consistency with 
updates made 
throughout the protocol. 
Table 2-5: Follow-up Assessments 
(CA2096GE) 
Section 5.1.3: Follow-Up Period 
Section 5.3: End of Study Definition 
Section 8.1.2: Post-study Intervention Study 
Follow-up 
Removed Survival Follow-up. 
Due to trial termination, 
survival follow-up has 
been removed to 
alleviate participant and 
site burden. 
Table 2-5: Follow-up Assessments 
(CA2096GE) 
Section 3.3.3: Nivolumab Overall 
Benefit/Risk Conclusion 
Section 9.2: Adverse Events 
 
 
Section 3: Introduction 
To reflect the strategy 
of the Sponsor to 
terminate the study. 
Section 3.1: Study Rationale 
Added overall rationale for Protocol 
Amendment 01. 
To describe the 
decision to terminate 
the CA2096GE trial. 

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Protocol Amendment No.: 01 
Date: 25-May-2023 
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SUMMARY OF CHANGES FOR PROTOCOL AMENDMENT 01 
Section Number & Title 
Description of Change 
Brief Rationale 
Deleted language that states Arm A 
versus Arm B will be subjected to 
statistical hypothesis testing. 
It is no longer possible 
to perform hypothesis 
testing due to limited 
number of participants 
in the study due to 
study termination. 
Section 3.2: Background 
Section 5.5.6: Safety/IMG with Nivo SC + 
rHuPH20 
Section 5.6.2: Clinical Pharmacology of 
Recombinant Human Hyaluronidase PH20 
Included additional background 
information. 
To include latest data 
from the nivolumab 
Investigator’s Brochure 
v5.0. 
Section 3.3: Benefit/Risk Assessment 
Added details about SC 
administration of nivolumab 
coformulated with recombinant 
human hyaluronidase PH20 enzyme 
(rHuPH20). 
To provide additional 
safety guidance. 
Section 3.3: Benefit/Risk Assessment 
Section 3.3.3: Nivolumab Overall 
Benefit/Risk Conclusion 
Section 5.1.4: Data Monitoring Committee 
and Other Committees 
Updated Data Monitoring Committee 
(DMC) and Study Steering 
Committee (SSC) language. 
To align with the 
current requirements of 
the DMC and SSC 
following study 
termination. 
Section 4: Objectives and Endpoints 
Table 4-1: Objectives and Endpoints 
Section 10.4.2: Primary Endpoint(s) 
Table 10.4.2-1: Primary Endpoint 
Section 10.4.5: Other Safety Analysis 
Updated objectives and endpoints as 
well as removed the main estimands. 
Safety is now the primary objective. 
To reflect the current 
status of analyses that 
will and will no longer 
be conducted. 
Section 5.1: Overall Design 
Section 5.2: Number of Participants 
Updated the number of participants. 
To reflect the current 
status of number of 
participants based on 
study termination. 
Figure 5.1-1: Study Design Schema 
Updated the Study Design Schema. 
To align with updates 
to the study design. 
Section 5.1: Overall Design 
Section 5.1.2.1: Randomized Study Cohort 
Changed “expected” to “required” 
regarding in-clinic visits for 
participants in the Nivo 
arm. 
To provide 
clarification. 
Section 5.1.2: Treatment Period 
Section 8.1.3: Study Treatment Beyond 
Recurrence 
Removed: “In certain circumstances, 
participants with recurrence of 
disease but with otherwise stable or 
improved performance and clinical 
status may continue to be treated in 
the event of a perceived benefit per 
the investigator. Investigator must 
contact the Sponsor for approval” 
and deleted relevant Section 8.1.3. 
There will not be 
treatment beyond 
progression. 

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Protocol Amendment No.: 01 
Date: 25-May-2023 
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SUMMARY OF CHANGES FOR PROTOCOL AMENDMENT 01 
Section Number & Title 
Description of Change 
Brief Rationale 
Section 5.1.2.1: Randomized Study Cohort 
 
Added Section 5.1.2.3 to clarify 
participant decision for opting out 
and investigator criteria for opting 
out. 
Added a flowchart to illustrate opt- 
out. 
Clarified that participants are unable 
to transfer between Arm A and Arm 
B. 
To provide 
clarification. 
Figure 5.5.3-1: Predicted Nivolumab 
Exposures by Dose, Route of Administration, 
and Body Weight Tertiles for Base Case 
Bioavailability (70%) in Adjuvant Melanoma 
Figure 5.5.3-2: Predicted Nivolumab 
Exposures by Dose, Route of Administration, 
and Body Weight Tertiles for Worse Case 
Bioavailability (60%) in Adjuvant Melanoma 
Added figures. 
These were 
inadvertently left out of 
the original protocol. 
Added to correct the 
error. 
Section 5.5.4: Rationale for Switch from Q2W 
to Q4W (Arm B [IV]) 
Added a new section. 
To reduce participant 
burden. 
Section 5.5.5: Rationale for Continued 
Adjuvant Therapy for Participants Who Are 
Diagnosed with Melanoma in Situ During 
Study Treatment 
Added a new section. 
To clarify continued 
adjuvant therapy for 
participants who are 
diagnosed with 
melanoma in situ 
during study treatment. 
Section 6.1: Inclusion Criteria 
Section 9.2: Adverse Events 
Appendix 2: Study Governance 
Considerations 
Removed participants’ use of a 
legally accepted representative to 
sign the informed consent form. 
Legally acceptable 
representatives are no 
longer allowed under 
global Protocol 
Amendment 01. 
Section 6.2: Exclusion Criteria 
Removed phrase “while enrolled on 
study” from criterion 3) k) i). 
Administrative edit. 

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CA2096GE 
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Protocol Amendment No.: 01 
Date: 25-May-2023 
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SUMMARY OF CHANGES FOR PROTOCOL AMENDMENT 01 
Section Number & Title 
Description of Change 
Brief Rationale 
Section 7.1.2: Study Treatment Details for 
with rHuPH20 
 
To 
provide 
further 
clarification. 
 
Section 7.6: Treatment Compliance 
Added out-of-window dosing. Added 
text to ensure participants are given 
instructions on how to proceed in 
case of out-of-window dosing. 
To provide additional 
safety guidance. 
Section 9.11: Health Economics OR Medical 
Resource Utilization and Health Economics 
Removed collection of Healthcare 
Resource Use data. 
To mitigate burden on 
study sites. 
Section 9.1.3.3: Definitions 
• Excluded malignant melanoma 
in situ in defining recurrence as 
appearance of new melanoma 
lesions. 
• Updated definitions for 
recurrences and added new 
definitions. 
• To clarify 
recurrence 
definition. 
• To provide further 
clarification. 
Section 9.1.4: Health Outcomes Assessments 
Added paragraph that PRO data 
collection is being removed; 
however, the data may be used 
internally at some point in the future. 
To clarify that the data 
may be used at some 
point in the future to 
help develop PRO 
strategies in future 
clinical trials. 
. 
Section 10.2: Sample Size Determination 
Updated language describing the aim 
of the study. 
To reflect that safety is 
the only primary 
objective. 
Section 10.3: Analyses Sets 
Revised descriptions for analysis sets 
and populations. 
To simplify the text. 
Section 10.4.2: Primary Endpoint(s) 
Section 10.4.5: Other Safety Analysis 
Moved language in Section 10.4.5 to 
Section 10.4.2. 
To align with safety 
being the primary 
objective. 
Section 10.4.7.3: Final Analysis 
Added a new section to define the 
final analysis database lock. 
To provide 
clarification. 

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SUMMARY OF CHANGES FOR PROTOCOL AMENDMENT 01 
Section Number & Title 
Description of Change 
Brief Rationale 
Appendix 2: Study Governance 
Considerations 
• 
Added 2 sections: 
− 
BMS Commitment to 
Diversity in Clinical Trials 
To align with BMS 
commitment to 
diversity in clinical 
trials and to comply 
with European Union 
Clinical Trials 
Regulation requirement. 
To align with changes 
in the protocol (legally 
acceptable 
representative was 
removed). 
To provide clarification 
on process of 
destruction or return of 
study intervention. 
− 
Data Protection, Data 
Privacy, and Data Security 
• 
Removed references to legally 
acceptable representative. 
• 
Revised text to remove the 
in the 
destruction/return of 
local regulations will be 
followed. 
Appendix 11: Product Quality Issues 
Added a new appendix to include 
guidance on product quality issue 
reporting. 
To provide information 
on potential product 
quality issues and how 
to report them. 

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TABLE OF CONTENTS 
TITLE PAGE ................................................................................................................ 
1 
DOCUMENT HISTORY.............................................................................................. 
3 
OVERALL RATIONALE FOR GLOBAL PROTOCOL AMENDMENT 01:........... 
4 
SUMMARY OF CHANGES FOR PROTOCOL AMENDMENT 01 ......................... 
4 
TABLE OF CONTENTS.............................................................................................. 
12 
1 PROTOCOL SUMMARY......................................................................................... 
17 
2 SCHEDULE OF ACTIVITIES.................................................................................. 
24 
3 INTRODUCTION ..................................................................................................... 
46 
3.1 Study Rationale ................................................................................................. 
47 
3.1.1 Research Hypotheses ............................................................................... 
47 
3.2 Background ....................................................................................................... 
48 
3.2.1 Adjuvant Treatment of Stage III/IV Melanoma........................................ 
48 
3.2.2 Nivolumab Mechanism of Action ............................................................. 
49 
3.2.3 Nivolumab Clinical Activity ..................................................................... 
49 
3.2.4 Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20)............ 
50 
50 
51 
3.3 Benefit/Risk Assessment .................................................................................. 
52 
3.3.1 Risk Assessment ....................................................................................... 
53 
3.3.2 Benefit Assessment ................................................................................... 
54 
3.3.3 Nivolumab Overall Benefit/Risk Conclusion ........................................... 
54 
4 OBJECTIVES AND ENDPOINTS ........................................................................... 
55 
5 STUDY DESIGN....................................................................................................... 
56 
5.1 Overall Design .................................................................................................. 
56 
5.1.1 Screening Period 
............................................................ 
57 
5.1.2 Treatment Period ..................................................................................... 
58 
5.1.2.1 Randomized Study Cohort............................................................... 
58 
59 
59 
5.1.3 Follow-Up Period .................................................................................... 
61 
5.1.4 Data Monitoring Committee and Other Committees............................... 
61 
5.2 Number of Participants ..................................................................................... 
61 
5.3 End of Study Definition .................................................................................... 
62 
5.4 Scientific Rationale for Study Design............................................................... 
62 
5.4.1 Rationale for One Year Duration of Treatment ....................................... 
62 
5.4.2 Rationale for Part 1 Endpoints and Non-Inferiority Margin................... 
62 
63 
63 
63 
5.4.6 Rationale for Inclusion of Clinical Outcome Assessments/PROs (Part 1) 
..................................................................................................................... 
64 
5.4.7 Rationale for Open Label......................................................................... 
64 
5.5 Justification for Dose ........................................................................................ 
64 
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5.5.2 Rationale for Dosing Regimen - Intravenous (Arm B) ............................ 
 
5.5.4 Rationale for Switch from Q2W to Q4W (Arm B [IV])............................ 
5.5.5 Rationale for Continued Adjuvant Therapy for Participants Who Are 
Diagnosed with Melanoma in Situ During Study Treatment ...................... 
5.5.6 Safety/IMG with SC Nivolumab + rHuPH20 .......................................... 
5.6 Clinical Pharmacology Summary ..................................................................... 
5.6.1 Clinical Pharmacology of Nivolumab ..................................................... 
5.6.2 Clinical Pharmacology of Recombinant Human Hyaluronidase PH20 .. 
6 STUDY POPULATION ............................................................................................ 
6.1 Inclusion Criteria .............................................................................................. 
6.2 Exclusion Criteria ............................................................................................. 
6.3 Lifestyle Restrictions (Arm A Only) ................................................................ 
6.3.1 Meals and Dietary Restrictions ............................................................... 
 
6.4 Screen Failures.................................................................................................. 
6.4.1 Retesting During Screening-in Period..................................................... 
7 STUDY INTERVENTION(S) AND CONCOMITANT THERAPY ....................... 
7.1 Study Interventions Administered .................................................................... 
7.1.1 Study Treatment Details for Intravenous Administration of Nivolumab . 
 
7.2 Method of Study Intervention Assignment....................................................... 
7.3 Blinding............................................................................................................. 
7.4 Dosage Modification......................................................................................... 
7.4.1 Dose Delay Criteria for Nivolumab In-Clinic ......................................... 
7.4.3 Criteria to Resume Treatment.................................................................. 
7.4.4 Management Algorithms for Nivolumab.................................................. 
7.4.5 Treatment of Related Infusion- and Injection-Reactions ......................... 
7.4.5.1 Systemic Reactions Occurring In-clinic.......................................... 
 
7.4.5.3 Management of Local Infusion or Injection Site Reactions............ 
7.5 Preparation/Handling/Storage/Accountability .................................................. 
7.5.1 Retained Samples for Bioavailability/Bioequivalence/Biocomparability 
7.6 Treatment Compliance...................................................................................... 
7.7 Concomitant Therapy........................................................................................ 
7.7.1 Prohibited and/or Restricted Treatments................................................. 
7.7.2 Other Restrictions and Precautions......................................................... 
7.7.2.1 Imaging Restriction and Precautions ............................................. 
7.8 Continued Access to Study Intervention After the End of the Study ............... 
8 DISCONTINUATION CRITERIA ........................................................................... 
8.1 Discontinuation From Study Intervention ........................................................ 
8.1.1 Nivolumab Discontinuation ..................................................................... 
8.1.2 Post-study Intervention Study Follow-up................................................. 
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8.2 Discontinuation From the Study ....................................................................... 
8.2.1 Individual Discontinuation Criteria ........................................................ 
8.3 Lost to Follow-up.............................................................................................. 
9 STUDY ASSESSMENTS AND PROCEDURES..................................................... 
9.1 Imaging Assessments........................................................................................ 
9.1.1 Efficacy Assessment for the Study............................................................ 
9.1.2 Imaging Assessment for the Study............................................................ 
9.1.3 Investigator Assessment of Baseline Disease Status................................ 
9.1.3.1 Investigator Assessment of Recurrence .......................................... 
9.1.3.2 General Considerations for Determining Recurrence.................... 
9.1.3.3 Definitions....................................................................................... 
9.1.3.4 Date of Recurrence ......................................................................... 
9.1.4 Health Outcomes Assessments ................................................................. 
9.1.4.1 FACT-G7 (Part 1 Only) .................................................................. 
9.1.4.2 EQ-5D-5L (Part 1 Only) ................................................................. 
9.1.4.3 Modified CTSQ (Part 1 Only)......................................................... 
9.1.4.4 Modified TASQ (Part 1 Only) ......................................................... 
9.1.4.5 SIAQ (Part 1 Only) ......................................................................... 
 
9.2 Adverse Events ................................................................................................. 
9.2.1 Time Period and Frequency for Collecting AE and SAE Information .... 
9.2.2 Method of Detecting AEs and SAEs......................................................... 
9.2.3 Follow-up of AEs and SAEs ..................................................................... 
9.2.4 Regulatory Reporting Requirements for SAEs......................................... 
9.2.5 Pregnancy ................................................................................................ 
9.2.6 Laboratory Test Result Abnormalities ..................................................... 
9.2.7 Potential Drug-Induced Liver Injury ....................................................... 
9.2.8 Other Safety Considerations .................................................................... 
9.3 Overdose ........................................................................................................... 
9.4 Safety ................................................................................................................ 
9.4.1 Physical Examinations............................................................................. 
9.4.2 Vital Signs ................................................................................................ 
9.4.3 Electrocardiograms ................................................................................. 
 
 
 
 
9.4.6 Suicidal Risk Monitoring ......................................................................... 
9.4.7 Imaging/Other Safety Assessment............................................................ 
9.5 Pharmacokinetics .............................................................................................. 
9.5.1 Pharmacokinetics and Anti-Drug Antibody Sample Collection and 
Processing................................................................................................... 
9.5.2 Pharmacokinetic and Immunogenicity Sample Analyses ........................ 
9.6 Immunogenicity Assessments........................................................................... 
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9.7 Genetics ............................................................................................................ 
9.8 Biomarkers ........................................................................................................ 
9.8.1 Tumor Acquisition.................................................................................... 
9.8.2 Serum ....................................................................................................... 
9.8.3 Germline Control Whole Blood Analysis by Genomics ........................... 
9.9 Additional Research.......................................................................................... 
9.10 Other Assessments .......................................................................................... 
9.10.1 Investigational Site Training.................................................................. 
9.11 Health Economics OR Medical Resource Utilization and Health Economics 
........................................................................................................................... 
10 STATISTICAL CONSIDERATIONS .................................................................... 
10.1 Statistical Hypotheses ..................................................................................... 
 
10.3 Analysis Sets ................................................................................................... 
10.4 Statistical Analyses ......................................................................................... 
10.4.1 General Considerations ......................................................................... 
10.4.2 Primary Endpoint(s) .............................................................................. 
10.4.2.1 Part 1 PK Co-Primary Endpoints................................................. 
10.4.3 Secondary Endpoint(s)........................................................................... 
10.4.3.1 Part 1 Secondary Endpoint(s)....................................................... 
 
10.4.4 Exploratory Endpoint(s) ........................................................................ 
10.4.5 Other Analyses ....................................................................................... 
10.4.5.1 Exposure-Response Analyses........................................................ 
10.4.5.2 Immunogenicity Analyses.............................................................. 
10.4.5.3 Outcomes Research....................................................................... 
10.4.5.4 Biomarkers .................................................................................... 
10.4.6 Study Analyses Timeframe ..................................................................... 
10.4.6.1 Part 1 ............................................................................................ 
10.4.6.3 Final Analysis ............................................................................... 
10.5 Interim Analyses ............................................................................................. 
11 REFERENCES ........................................................................................................ 
12 APPENDICES ......................................................................................................... 
APPENDIX 1 ABBREVIATIONS AND TRADEMARKS ........................................ 
APPENDIX 2 STUDY GOVERNANCE CONSIDERATIONS ................................. 
APPENDIX 3 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS: 
DEFINITIONS AND PROCEDURES FOR RECORDING, EVALUATING, 
FOLLOW-UP, AND REPORTING ....................................................................... 
APPENDIX 4 WOMEN OF CHILDBEARING POTENTIAL DEFINITIONS AND 
METHODS OF CONTRACEPTION..................................................................... 
 
APPENDIX 6 PARAMETER ESTIMATES FROM PPK MODEL USED FOR 
SIMULATIONS ..................................................................................................... 
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APPENDIX 7 MANAGEMENT ALGORITHMS FOR STUDIES UNDER CTCAE 
VERSION 5.0 ......................................................................................................... 
APPENDIX 8 ECOG PERFORMANCE STATUS ..................................................... 
APPENDIX 9 AJCC MELANOMA STAGING (CANCER STAGING MANUAL 
8TH EDITION)....................................................................................................... 
APPENDIX 10 COUNTRY SPECIFIC REQUIREMENTS ....................................... 
APPENDIX 11 PRODUCT QUALITY ISSUES ......................................................... 
 
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1 
PROTOCOL SUMMARY 
Protocol Title: A Phase 3, Open Label, Randomized, Non-Inferiority Pharmacokinetic Study of 
Nivolumab Subcutaneous (Nivo SC) Versus Intravenous (Nivo IV) Administration in Participants 
with Stage IIIA/B/C/D or Stage IV Adjuvant Melanoma Following Complete Resection 
Brief Title: A Pharmacokinetic Study of Nivolumab Subcutaneous vs Intravenous Administration 
in Participants with Stage IIIA/B/C/D or Stage IV Melanoma Following Complete Resection 
Rationale: 
Study CA2096GE is a Phase 3, open-label, randomized study of nivolumab administered 
subcutaneously 
versus intravenous (IV) administration of nivolumab 
(Nivo) in participants with resected Stage IIIA/B/C/D or Stage IV melanoma in an adjuvant setting. 
Repeated IV infusion appointments require travel to a clinic or infusion center, time, and resources 
and have physical and emotional impacts on patients. For healthcare systems, the preparation and 
administration of IV infusions require time and resource utilization. Given that the growing cancer 
population will increase the burden on healthcare resources, there is a need for more efficient 
treatment options, such as alternative routes of administration and new delivery technologies. 
The development of 
 aims to address the current and evolving burden of cancer and 
cancer treatment on patients, caregivers, health care providers (HCPs), and the healthcare system. 
Overall Rationale for Protocol Amendment 01 
Bristol-Myers Squibb has made a strategic decision to terminate the CA2096GE trial. This 
decision was not related to any safety concerns. Study recruitment has closed and treatment of 
ongoing, active participants will continue per Protocol Amendment 01. Changes implemented in 
this amendment aim to alleviate participant and site burden and include updates to sample 
collection, study procedures, and study design. 
Objectives and Endpoints 
Per Protocol Amendment 01, PK co-primary endpoints, secondary endpoints, and Part 2 of 
the study have been removed. Efficacy, patient-reported outcomes (PROs), and biomarker 
analyses will not be completed. Samples already collected for PK and immunogenicity 
assessments will be analyzed bioanalytically for nivolumab concentrations and anti-drug 
antibodies (ADAs) and reported as listings. Further collections for PK, ADAs, biomarkers, 
and PROs will be discontinued. Only safety assessments will be conducted. 
 
 
 
 
Abbreviations: AE, adverse event; 
; IV, intravenous; rHuPH20, recombinant human hyaluronidase 
PH20 enzyme; SAE, serious adverse event; SC, subcutaneous. 
Objectives 
Endpoints 
Primary 
• 
To assess the safety and tolerability of nivolumab SC 
coformulated with rHuPH20 and nivolumab IV 
• 
AEs/SAEs and treatment-related AEs/SAEs 

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Overall Design: 
Study CA2096GE is a multicenter, open-label, Phase 3 study that will assess the safety and 
tolerability of 
 vs Nivo IV in participants with completely resected Stage IIIA/B/C/D 
or Stage IV melanoma by American Joint Committee on Cancer (AJCC) 8th edition. This study is 
comprised of 2 arms: Arm A and Arm B. 
Per Protocol Amendment 01, PK co-primary endpoints, secondary endpoints, and Part 2 of 
the study have been removed. Efficacy, PROs, and biomarker analyses will not be completed. 
Samples already collected for PK and immunogenicity assessments will be analyzed 
bioanalytically for nivolumab concentrations and ADAs and reported as listings. Further 
collections for PK, ADAs, biomarkers, and PROs will be discontinued. Only safety 
assessments will be conducted. Therefore, the study design has been adapted to reflect Protocol 
Amendment 01 changes, 
Part 1 is no longer 
hypothesis-driven, but rather descriptive in nature (Arm A and Arm B), with the primary objective 
being safety and tolerability. 
• Arm A (n = 6): 
− 
 
 
 
 
• Arm B (n = 8): 
− Nivo IV (BMS-936558) 240 mg Q2W for Cycles 1 through 4. 
− Nivo IV 480 mg every 4 weeks (Q4W) Cycle 5 onwards for up to a total of 52 weeks. 
− All dosing will be performed in-clinic. 
 
Participants will be stratified by stage (Stages IIIA/B vs IIIC/D/IV) per AJCC 8th edition 
 
 
 
 
All participants will be treated until recurrence of disease, unacceptable toxicity, participant 
withdrawal of consent, death, or a maximum of 52 weeks of treatment from first dose, whichever 
occurs first. 
 
The study design schema is presented below. 
600 mg 
hyaluronidase PH20 (rHuPH20) 
of recombinant human 

 
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Study Design Schema 
 
Abbreviations: AJCC, American Joint Committee on Cancer; CNS, central nervous system; FU, follow-up; IV, intravenous; N, number of participants; 
Nivo, nivolumab; PK, pharmacokinetic, Q2W, every 2 weeks; Q4W, every 4 weeks; RT, radiation therapy; SC, subcutaneous; vs, versus. 
a Treatment until recurrence of disease, unacceptable toxicity, participant withdrawal of consent, death, or a maximum of 52 weeks of treatment from first dose, 
whichever occurs first. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Number of Participants: 
The trial has been terminated. 
14 participants 
randomized and treated in the study with 6 participants in Arm A and 8 participants in Arm B. 
Study Population: 
Not applicable per Protocol Amendment 01 (as of 24-Feb-2023, enrollment in this study has 
been closed). 
Male and female participants ≥ 18 years of age or age of majority with completely resected Stage 
IIIA/B/C/D or Stage IV melanoma. 
Key Inclusion: 
• All participants must have been diagnosed with either Stage IIIA (> 1 mm tumor in lymph 
node)/B/C/D or Stage IV melanoma by AJCC 8th edition and have histologically confirmed 
melanoma (as documented in the pathology report) that is completely surgically resected (free 
of disease) with negative margins in order to be eligible. All melanomas, except uveal and 
mucosal melanoma, regardless of primary site of disease, will be allowed. 
• Participants are eligible if central nervous system (CNS) metastases have been resected and 
participants are neurologically stable. 
− Prior resected CNS metastases must be without evidence of recurrence, as determined by 
magnetic resonance imaging (MRI) performed at least 4 weeks after resection is complete 
and within 28 days prior to randomization (Part 1) 
− Participants must be off immunosuppressive doses of systemic steroids (>10 mg/day 
prednisone or equivalent) for at least 14 days prior to study drug administration and must 
have returned to neurologic baseline post-operatively. 
− For CNS lesion(s), a pathology report indicating that there has been complete resection of 
CNS lesion(s) will suffice as confirmation of negative margins. 
• Complete resection must be performed within 12 weeks prior to randomization (Part 1) 
Management of residual lymph nodes after positive sentinel 
lymph node biopsy (ie, completion lymph node dissection) will be as per local standards and 
recommendations for the individual participant. 
• All participants must have disease-free status documented by a complete physical examination 
within 14 days prior to randomization (Part 1) 
and imaging 
studies within 28 days prior to randomization/treatment assignment. Imaging studies must 
include computed tomography (CT) scan of the chest; CT or MRI scans of the abdomen, pelvis, 
and all known sites of resected disease; and brain MRI or CT (brain CT allowable if MRI is 
contraindicated). 
• Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status 
of ≤ 1. 
• 

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Key Exclusion: 
• History of uveal or mucosal melanoma. 
• Untreated/unresected CNS metastases or leptomeningeal metastases. 
• Participants with an active, known or suspected autoimmune disease. Participants with type I 
diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such 
as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected 
to recur in the absence of an external trigger are permitted to enroll. 
• Participants with serious or uncontrolled medical disorders within 4 weeks prior to screening. 
− Additionally, in the case of prior severe acute respiratory syndrome coronavirus 2 
(SARS-CoV-2) infection, acute symptoms must have resolved and based on investigator 
assessment in consultation with the Medical Monitor, there are no sequelae that would 
place the participant at a higher risk of receiving investigational treatment. 
• Concurrent malignancy (present during screening) requiring treatment or history of prior 
malignancy active within 2 years prior to randomization (Part 1) 
(ie, participants with a history of prior malignancy are eligible if treatment was completed 
at least 2 years before randomization/treatment assignment and the patient has no evidence of 
disease). Participants with history of prior early stage basal/squamous cell skin cancer or non- 
invasive or in situ cancers that have undergone definitive treatment at any time are also eligible. 
• Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg 
daily prednisone equivalent) within 14 days or other immunosuppressive medications within 
30 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid 
doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune 
disease. 
• Any condition that according to investigator criteria makes a participant ineligible from 
participation in the study, including but not limited to medical conditions (including 
psychological, psychiatric), or social conditions; or conditions that can impact ability to 
comply with protocol requirements (eg, conditions that preclude the use of IV or subcutaneous 
[SC] route of study drug administration) or that can put the participant at risk. Participants with 
history of self-harm including suicidal attempts will be excluded from the study. 
• Prior immunotherapy treatments for any prior malignancies are not permitted (such as, but not 
limited to anti-programmed death-1, anti-programmed death-ligand 1, anti-programmed 
death-ligand 2, or any other antibody or drug specifically targeting T-cell co-stimulation or 
immune checkpoint pathways). 
• 
Participants treated with anti-cancer therapy directed against the resected melanoma (for 
example, but not limited to, systemic, local, radiation, and radiopharmaceuticals) except: 
• Surgery for the melanoma lesion(s) 
− Adjuvant radiation therapy after neurosurgical resection for CNS lesions 
− Prior adjuvant interferon completed ≥ 6 months prior to randomization (Part 1) 
 
• Treatment with any live attenuated vaccine within 30 days of first study treatment (Vaccines 
that are not live attenuated are allowed, including COVID-19 vaccines). 
• History of allergy or hypersensitivity to study drug components 

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Intervention Groups and Duration: 
As described in Overall Design. 
Study intervention: 
 
Study Intervention for CA2096GE 
Medication 
Potency 
IMP/Non-IMP 
Subcutaneous nivolumab 
administered 
coformulated with rHuPH20 
 
IMP 
Nivolumab IV 
10 mg/mL 
IMP 
Abbreviations: IMP, investigational medicinal product; IV, intravenous; Non-IMP, non-investigational medicinal 
product; rHuPH20, recombinant human hyaluronidase PH20. 
 
 
Statistical Methods 
• This is an open-label, parallel group study in which participants are randomized 1:1 to either 
of the 2 treatment groups: subcutaneous nivolumab 
or 
nivolumab administered intravenously. Randomization will be stratified by AJCC 8th edition 
staging and weight. 
• The aim of the study is to assess the safety and tolerability of 
 and Nivo IV. This 
has changed from the original protocol’s study objective of PK. Sample size calculations are 
not based on statistical considerations. There were 14 participants randomized and treated at 
the time of Protocol Amendment 01. 
 
Data Monitoring Committee: Yes 
A safety DMC will be implemented in this study to provide safety oversight throughout the course 
of Part 1 of the study. The DMC charter will describe the procedures related to the committee 
operations in greater detail. On 26-Oct-2022, enrollment was paused and a total of 14 participants 
had been randomized. On 24-Feb-2023, the study was terminated with no additional participants 
having been randomized. As this is an open-label study, the Sponsor will continue the safety 
monitoring of remaining participants in the study. No subsequent DMC meeting will occur. 
Other Committee: Yes 
A Study Steering Committee (SSC) will be established to provide advisory oversight of the quality 
of the trial, with the objective of ensuring scientific integrity and the successful conduct of the 
CA2096GE Study. On 26-Oct-2022, enrollment was paused and a total of 14 participants had been 
randomized. On 24-Feb-2023, the study was terminated with no additional participants having 
been randomized. The Sponsor will continue to ensure the scientific integrity and successful 
conduct of the study. No SSC meeting will occur. 

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Brief Summary: 
The purpose of this study is to assess the safety and tolerability of 
and Nivo IV. Study 
details include the following: 
Study Duration: approximately 16 months 
Study Intervention Duration: 52 weeks 
Study Visit Frequency: 
 600 mg Q2W) 
 
 
Arm B (Nivo IV 240 mg Q2W/480 mg Q4W) 
In-clinic visits will be scheduled Q2W during Cycle 1, Day 1 through Cycle 4, Day 15, followed 
by Q4W for the remainder of study treatment. 
Arm A 

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2 
SCHEDULE OF ACTIVITIES 
An overview of the schedule of major assessments in this study are provided in Table 2-1 
(Screening), Table 2-2 (On-Treatment Arm A), Table 2-3 (On-Treatment Arm B), Table 2-4 
and Table 2-5 (Follow-up Assessments). 
In the event that multiple procedures are required at a single time point, vital signs may be obtained 
up to 10 minutes earlier or later, and clinical laboratory samples may be obtained up to 5 minutes 
earlier than the nominal time point. 

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Table 2-1: 
Screening Procedural Outline (CA2096GE) Part 1 
Not applicable per Protocol Amendment 01 (enrollment closed). 
Procedure 
Screening Visit 
(Day -28 to Day -1) 
Notes:a 
All windows are based on calendar days. 
Eligibility Assessments 
Informed Consent 
X 
Must be obtained prior to performing any screening procedures. 
Study allows for re-enrollment of a participant that has discontinued the study as a 
pre-treatment failure. If re-enrolled, the participant must be re-consented and 
assigned a new participant number from IRT. 
Contact IRT 
X 
Register in IRT system to obtain participant number on the day of consent. 
Inclusion/Exclusion Criteria 
X 
Must be confirmed prior to randomization (Part 1) 
See Sections 6.1 and 6.2. 
Medical History 
X 
All medical history relevant to the disease (including COVID-19) under study. 
Tumor Sample Submission 
X 
Formalin fixed, paraffin-embedded (FFPE) tumor tissue block (preferred) or a 
minimum of 15 unstained slides* of tumor tissue obtained from the recent resection 
(preferred) or an archival biopsy conducted within 6 months prior to enrollment, 
and preferably with no intervening systemic anti-cancer treatment between time of 
acquisition and enrollment, must be submitted to the central lab. Tissue availability 
needs to be determined during the screening period. It is recommended that tumor 
tissue is submitted during the screening period, however, it must be submitted no 
later than 14 days post-randomization/treatment assignment. Fine-needle aspirates 
or other cytology samples are not acceptable. 
*If despite best efforts, a minimum of 15 unstained slides are not obtainable, 
submission of 5 unstained slides is acceptable. 
Please refer to Section 9.8 and Lab Manual for additional information. 
Review of Pathology Report 
X 
Confirm negative margins prior to randomization (Part 1) 
and file as a source document. 

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Table 2-1: 
Screening Procedural Outline (CA2096GE) Part 1 
Not applicable per Protocol Amendment 01 (enrollment closed). 
Procedure 
Screening Visit 
(Day -28 to Day -1) 
Notes:a 
All windows are based on calendar days. 
Body Imaging 
X 
Contrast-enhanced CT of the chest (if CT contrast is contraindicated, then non- 
contrast CT should be acquired). CT/MRI of the abdomen, pelvis, and all other 
known and/or suspected sites of disease, within 28 days prior to randomization 
(Part 1) 
See Section 9.1.1 for further details. 
Brain Imaging 
X 
MRI of the brain (without and with contrast) is required for ALL participants during 
screening to rule out brain metastases, within 28 days prior to randomization 
(Part 1) 
CT of the brain (without and with 
contrast) can be performed if MRI is contraindicated. See Section 9.1.1 for further 
details. 
Safety Assessments 
Physical Examination, Measurements, 
Vital Signs, Performance Status, and 
Assessment of Signs and Symptoms 
X 
Height, weight, ECOG Performance Status (Appendix 8), BP, heart rate, 
temperature, and oxygen saturation by pulse oximetry at screening only. Assess all 
signs and symptoms. Must be collected within 14 days prior to 
randomization (Part 1) 
Concomitant Medication Collection 
X 
Within 14 days prior to randomization (Part 1) 
Document vaccine use within 30 days prior to first dose of study treatment. See 
Sections 6.2 and 7.7. 
Serious Adverse Events (SAE) 
Assessment 
X 
All SAEs must be collected from the time of signing the informed consent, 
including those thought to be associated with protocol-specified procedures. SAEs 
are to be assessed continuously using NCI CTCAE v5. For participants who are 
enrolled but not randomized, SAEs must be collected for 30 days from the date of 
signing the informed consent. 
For participants who are randomized but not treated, SAE collection should 
continue for 30 days from the date of randomization (Part 1) 
. 
All SAEs/AEs related to SARS-CoV-2 will follow the SAE reporting requirements 
as described above. See Section 9.2.1. 

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Table 2-1: 
Screening Procedural Outline (CA2096GE) Part 1 
Not applicable per Protocol Amendment 01 (enrollment closed). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: AE, adverse event; 
; BP, blood pressure; COVID-19, coronavirus disease 2019; CRF, case report form; CT, computed tomography; 
CTCAE, Common Terminology Criteria for Adverse Events; ECG, electrocardiogram; ECOG, Eastern Cooperative Oncology Group; FFPE, formalin-fixed 
paraffin embedded; FSH, follicle stimulating hormone; HCG, human chorionic gonadotropin; HIV, human immunodeficiency virus; IRT, Interactive Response 
Technology; IU, international units; L, liter; MRI, magnetic resonance imaging; NCI, National Cancer Institute; Nivo, nivolumab; SAE, serious adverse event; 
SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; SC, subcutaneous; v, version; WOCBP, women of childbearing potential. 
a Some of the assessments referred to in this section may not be captured as data in the CRF. They are intended to be used as safety monitoring by the treating 
physician. Additional testing or assessments may be performed as clinically necessary or where required by institutional or local regulations. 
Procedure 
Screening Visit 
(Day -28 to Day -1) 
Notes:a 
All windows are based on calendar days. 
ECG 
X 
At rest. Within 14 days prior to randomization (Part 1) 
Laboratory Tests 
Clinical Laboratory Assessments 
X 
On-site/local laboratory tests must be performed within 14 days prior to 
randomization (Part 1) 
Viral testing to be completed within 28 days prior to randomization. For HIV: 
testing at sites where locally mandated; see Appendix 10. 
Refer to Section 9.4.4 for list of laboratory tests to conduct. 
Pregnancy Test (Women of 
Childbearing Potential [WOCBP] 
Only) 
X 
Serum or urine pregnancy test (minimum sensitivity equivalent units 25 IU/L or 
equivalent units of HCG) to be done at screening visit and repeated within 24 hours 
prior to first dose of study treatment. See Section 6.1. 
FSH 
X 
Women only - for confirmation of postmenopausal status, defined as 12 months 
of amenorrhea in a woman over age 45 years in the absence of other biological 
or physiological causes for females under the age of 55 years. Women must 
have a serum FSH level > 40 mIU/mL to confirm menopause. 
Study Treatment 
Randomize (Part 1 only) 
X 
IRT contact for randomization into 1 of the 2 treatment arms should occur when 
eligibility criteria are met. Study treatment must begin within 3 calendar days of 
randomization in IRT. 

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Table 2-2: 
On Study Treatment Procedural Outline (Arm A) 
(CA2096GE) 
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Procedure 
Arm A 
600 mg Q2W with 8,000 U 
rHuPH20a 
Cycle Length = 28 Days 
Notes:b 
In-clinic Periodc 
 
Cycles 1 - 4 
Cycle 
5 
Cycle 
5 
Cycles 6 - 13 
Day 1 
Day 15 
Day 1 
Day 
15 
Day 1 
Day 
15 
Dosing windows are ± 1 day 
Study Treatment 
In-clinic Dosing Visit 
X 
X 
X 
For dosing, clinical labs, and other safety assessments. 
In-clinic Non-dosing 
Visit 
C1D2, C1D4, 
C1D8, and 
C1D22 
X 
C6D1-C13D1: clinical labs, pregnancy test (if applicable) and other safety 
assessments. 
Study Treatment 
Administration 
X 
X 
X 
X 
X 
X 

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Table 2-2: 
On Study Treatment Procedural Outline (Arm A) 
(CA2096GE) 
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Procedure 
Arm A 
600 mg Q2W with 8,000 U 
rHuPH20a 
Cycle Length = 28 Days 
Notes:b 
In-clinic Periodc 
 
Cycles 1 - 4 
Cycle 
5 
Cycle 
5 
Cycles 6 - 13 
Day 1 
Day 15 
Day 1 
Day 
15 
Day 1 
Day 
15 
Dosing windows are ± 1 day 
Study Calls 
24 Hours Post-injection 
Phone Assessment 
See Table 9.4.5-1 for required time points. 
Refer to Section 9.4.5.2 for additional details. 
Safety Assessment 
Physical Examination, 
Measurements, Vital 
Signs, and Performance 
Status 
X 
X 
X 
X 
Physical examination, including targeted physical examination for detection 
of disease recurrence, weight, BP, heart rate, temperature, pulse oximetry, 
and ECOG performance status (refer to Appendix 8). 
After Cycle 5, Day 1, this assessment will be performed once every 4 weeks 
in the clinic (non-dosing visits). 
Adverse Event (AE), 
Serious Adverse Event 
(SAE) Assessment 
Continuously 
Record at each visit. Collect continuously throughout the treatment period. 
All AEs (SAEs or non-serious AEs), including injection-related AEs and 
those associated with SARS-CoV-2 infection, must be collected 
continuously during the treatment period. 
 
 
Record at each visit. Collect continuously throughout the treatment period. 
those associated with SARS-CoV-2 infection, must be collected 
continuously during the treatment period. 
Report of Product 
Complaints 
Continuously 
By site and participant/participant caregiver. Refer to Appendix 5. 

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Table 2-2: 
On Study Treatment Procedural Outline (Arm A) 
(CA2096GE) 
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Procedure 
Arm A 
600 mg Q2W with 8,000 U 
rHuPH20a 
Cycle Length = 28 Days 
Notes:b 
In-clinic Periodc 
 
Cycles 1 - 4 
Cycle 
5 
Cycle 
5 
Cycles 6 - 13 
Day 1 
Day 15 
Day 1 
Day 
15 
Day 1 
Day 
15 
Dosing windows are ± 1 day 
Concomitant 
Medications Use 
Continuously 
Record at each visit. 
Laboratory Tests 
Pregnancy Test 
(WOCBP) 
X 
X 
X 
Serum or urine within 24 hours prior to first dose and then every 4 weeks 
(± 1 week) regardless of dosing schedule.d 
Clinical Laboratory 
Assessments 
X 
X 
X 
X 
During Cycle 1, Day 1 to Cycle 5, Day 1, perform on site/local laboratory 
testing within 72 hours prior to each dose. 
After Cycle 5, Day 1, perform testing every 4 weeks (within 72 hours prior 
to dosing) during in-clinic visits. 
For the first treatment visit, labs need not be repeated if they were performed 
within 72 hours and the results are available and have been reviewed for 
eligibility. 
Refer to Section 9.4.4 for the list of laboratory tests to be conducted. 
Efficacy Surveillance 
Body Imaging 
X 
(see Notes) 
Contrast-enhanced CT of the chest, CT/MRI of the abdomen, pelvis, and all 
other known and/or suspected sites of disease every 12 weeks (± 7 days) is 
recommended; however, imaging per local standard of care is allowed, 
starting from date of first dose until investigator-assessed local, regional, or 
distant recurrence or the 100-day safety follow-up (whichever comes first) 
for all participants. See Section 9.1.1 for details. If a participant starts 
systemic therapy for melanoma recurrence, or for a new non-melanoma 
tumor after study drug discontinuation, follow-up scans for this trial should 
be discontinued. 

Clinical Protocol 
BMS-986298 
CA2096GE 
nivolumab 
Table 2-2: 
On Study Treatment Procedural Outline (Arm A) 
(CA2096GE) 
Protocol Amendment No.: 01 
Date: 25-May-2023 
31 
Approved v21.0 
930174717 2.0 
 
 
 
 
 
Procedure 
Arm A 
600 mg Q2W with 8,000 U 
rHuPH20a 
Cycle Length = 28 Days 
Notes:b 
In-clinic Periodc 
 
Cycles 1 - 4 
Cycle 
5 
Cycle 
5 
Cycles 6 - 13 
Day 1 
Day 15 
Day 1 
Day 
15 
Day 1 
Day 
15 
Dosing windows are ± 1 day 
Brain Imaging 
X 
(see Notes) 
For participants with a history of brain metastasis or symptoms, it is 
recommended to perform a surveillance MRI (without and with contrast) 
approximately every 12 weeks ± 7 days; however, brain imaging per local 
standard of care is allowed, starting from date of first dose until 
investigator-assessed local, regional, or distant recurrence or the 100-day 
safety follow-up (whichever comes first), for all participants or sooner if 
clinically indicated. See Section 9.1.1 for further details. 
Health Outcomes Assessmentse 
Abbreviations: AE, adverse event; 
; BP, blood pressure; C, cycle; CRF, case report form; CT, computed tomography; D, day; 
ECOG, Eastern Cooperative Oncology Group; MRI, magnetic resonance imaging; Nivo, nivolumab; 
Q2W, every 2 weeks; rHuPH20, recombinant human hyaluronidase PH20 enzyme; SAE, serious adverse event; SARS-CoV-2, severe acute respiratory syndrome 
coronavirus 2; SC, subcutaneous; WOCBP, women of childbearing potential. 
a If a dose is delayed, the procedures scheduled for that same time point must also be delayed to coincide with when that time point’s dosing actually occurs, with 
the exception of tumor assessments, which must occur as scheduled. 
b Some of the assessments referred to in this section may not be captured as data in the CRF. They are intended to be used as safety monitoring by the treating 
physician. Additional testing or assessments may be performed as clinically necessary or where required by institutional or local regulations. 

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c Study treatment must be administered in-clinic for a minimum of Cycle 1, Day 1 through Cycle 5, Day 1, inclusive. 
d If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be discontinued 
from study intervention if the serum pregnancy result is positive. 

Clinical Protocol 
BMS-986298 
CA2096GE 
nivolumab 
Table 2-3: 
On Study Treatment Procedural Outline (Arm B) (Nivo IV) (CA2096GE) 
Protocol Amendment No.: 01 
Date: 25-May-2023 
33 
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Procedure 
Arm B Nivo IV 240 mg Q2W for Cycles 
1 - 4 and 480 mg Q4W for all 
subsequent cycles.a 
Cycle Length = 28 Days 
Notes:b 
Cycles 1 - 4 
All Subsequent 
Cycles 
For Q2W dosing cycles, participants may be dosed no less than 12 days from 
the previous dose. Dosing windows for Q2W = ± 3 days; for Q4W = ± 3 days. 
Day 1 
Day 15 
Day 1 Only 
Study Treatment 
In-clinic Dosing Visit 
X 
X 
X 
In-clinic Non-dosing 
Visit 
C1D8 and C1D22 
Dispense Study Drug 
X 
X 
X 
Participant must receive the first dose of study medication within 3 calendar days from 
randomization. 
Study Treatment 
Administration 
X 
X 
X 
Refer to Section 7.1.1 for details. 
Safety Assessment 
Physical Examination, 
Measurements, Vital 
signs, and Performance 
Status 
X 
X 
(see 
Notes) 
X 
Physical examination, including targeted physical examination for detection of 
disease recurrence, weight, BP, heart rate, temperature, pulse oximetry, and ECOG 
Performance Status (Appendix 8). 
Assessment of IV 
Injection Site 
X 
(see 
Notes) 
X 
(see 
Notes) 
Only applicable for Cycle 1, Days 1 and 15. Refer to Section 7.1.1. 
Adverse Event (AE) 
Assessment and Serious 
Adverse Events (SAE) 
Continuously 
Record at each visit. Collect continuously throughout the treatment period. 
All AEs (SAEs or non-serious AEs), including infusion-related AEs and those 
associated with SARS-CoV-2 infection, must be collected continuously during the 
treatment period. 
Concomitant Medications 
Use 
Continuously 
Record at each visit. 

Clinical Protocol 
BMS-986298 
CA2096GE 
nivolumab 
Table 2-3: 
On Study Treatment Procedural Outline (Arm B) (Nivo IV) (CA2096GE) 
Protocol Amendment No.: 01 
Date: 25-May-2023 
34 
Approved v21.0 
930174717 2.0 
 
 
 
 
 
Procedure 
Arm B Nivo IV 240 mg Q2W for Cycles 
1 - 4 and 480 mg Q4W for all 
subsequent cycles.a 
Cycle Length = 28 Days 
Notes:b 
Cycles 1 - 4 
All Subsequent 
Cycles 
For Q2W dosing cycles, participants may be dosed no less than 12 days from 
the previous dose. Dosing windows for Q2W = ± 3 days; for Q4W = ± 3 days. 
Day 1 
Day 15 
Day 1 Only 
Laboratory Tests 
Pregnancy Test 
(WOCBP) 
X 
X 
Serum or urine within 24 hours prior to first dose and then every 4 weeks (± 1 week) 
regardless of dosing schedule.c 
Clinical Laboratory 
Assessments 
X 
X 
X 
Perform on site/local laboratory testing within 72 hours prior to each dose. 
For the first treatment visit, labs need not be repeated if they were performed within 
72 hours and the results are available and have been reviewed for eligibility. 
Refer to Section 9.4.4 for the list of laboratory tests to be conducted. 
Efficacy Surveillance 
Body Imaging 
X 
(see notes) 
Contrast-enhanced CT of the chest, CT/MRI of the abdomen, pelvis, and all other 
known and/or suspected sites of disease every 12 weeks (± 7 days) is recommended; 
however, imaging per local standard of care is allowed, starting from date of first 
dose until investigator assessed local, regional, or distant recurrence or the 100-day 
safety follow-up (whichever comes first) for all participants. See Section 9.1.1 for 
further details. If a participant starts systemic therapy for melanoma recurrence, or 
for a new non-melanoma tumor after study drug discontinuation, follow-up scans for 
this trial should be discontinued. 
Brain Imaging 
X 
(see notes) 
For participants with a history of brain metastasis or symptoms, it is recommended 
to perform a surveillance MRI (without and with contrast) approximately every 12 
weeks ± 7 days; however, brain imaging per local standard of care is allowed, 
starting from date of first dose until investigator-assessed local, regional, or distant 
recurrence or the 100-day safety follow-up (whichever comes first), for all 
participants or sooner if clinically indicated. See Section 9.1.1 for further details. 
Abbreviations: AE, adverse event; BP, blood pressure; C, cycle; CRF, case report form; CT, computed tomography; D, day; ECOG, Eastern Cooperative Oncology 
Group; IV, intravenous; MRI, magnetic resonance imaging; Nivo, nivolumab; Q2W, every 2 weeks; Q4W, every 4 weeks; SAE, serious adverse event; 
SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; WOCBP, women of childbearing potential. 

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a If a dose is delayed, the procedures scheduled for that same time point must also be delayed to coincide with when that time point’s dosing actually occurs, with 
the exception of tumor assessments, which must occur as scheduled. The start of 480 mg Q4W dosing must occur on C5D1 (14 days, ± 3 days) following C4D15. 
b Some of the assessments referred to in this section may not be captured as data in the CRF. They are intended to be used as safety monitoring by the treating 
physician. Additional testing or assessments may be performed as clinically necessary or where required by institutional or local regulations. 
c If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be discontinued 
from study intervention if the serum pregnancy result is positive. 

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Clinical Protocol 
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Protocol Amendment No.: 01 
Date: 25-May-2023 
37 
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Clinical Protocol 
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CA2096GE 
nivolumab 
Protocol Amendment No.: 01 
Date: 25-May-2023 
38 
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Clinical Protocol 
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CA2096GE 
nivolumab 
Protocol Amendment No.: 01 
Date: 25-May-2023 
39 
Approved v21.0 
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Clinical Protocol 
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CA2096GE 
nivolumab 
Protocol Amendment No.: 01 
Date: 25-May-2023 
40 
Approved v21.0 
930174717 2.0 
 
 
 

Clinical Protocol 
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CA2096GE 
nivolumab 
Protocol Amendment No.: 01 
Date: 25-May-2023 
41 
Approved v21.0 
930174717 2.0 
 
 
 

Clinical Protocol 
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CA2096GE 
nivolumab 
Protocol Amendment No.: 01 
Date: 25-May-2023 
42 
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Clinical Protocol 
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Protocol Amendment No.: 01 
Date: 25-May-2023 
43 
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Clinical Protocol 
BMS-986298 
CA2096GE 
nivolumab 
Table 2-5: 
Follow-up Assessments (CA2096GE) 
Protocol Amendment No.: 01 
Date: 25-May-2023 
44 
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Procedure 
Follow-up 
Visits 1 & 
2a 
(In-clinic) 
Notes:b 
Safety Assessment 
Physical Examination, 
Measurements, Vital Signs, 
and Performance Status 
X 
Physical examination, including targeted physical examination for detection of disease recurrence, weight, BP, 
heart rate, temperature, pulse oximetry, and ECOG performance status (refer to Appendix 8). 
Adverse Event (AE) and 
Serious Adverse Events 
(SAE) Assessment 
X 
Record at each visit. Collect continuously throughout the treatment period and for a minimum of 100 days 
following discontinuation of dosing. 
*Beyond 100 days from the last dose of study therapy, participants will be followed for drug-related 
AEs/SAEs/ 
until resolution, returns to baseline, or is deemed irreversible, or until the participant 
is lost to follow-up or withdraws study consent. 
All SAEs and non-serious AEs should be collected continuously during the treatment period and for a minimum 
of 100 days following discontinuation of study treatment. 
Participants will be followed for all SAEs and all AEs (SAEs and non-serious AEs) associated with confirmed or 
suspected SARS-CoV-2 infection until resolution, the condition stabilizes, the event is otherwise explained, the 
event is deemed irreversible, the participant is lost to follow-up (as defined in Section 8.3), or for suspected cases, 
until SARS-CoV-2 infection is ruled-out. 
Concomitant Medications 
Review 
X 
Record at each visit. 
Subsequent Cancer Therapy 
X 
Include documentation of subsequent cancer therapy (ie, systemic therapy, tumor-directed surgery, or radiation 
therapy). 
Pregnancy Test (WOCBP) 
X 
Serum or urine (minimum sensitivity equivalent units 25 IU/L or equivalent units of HCG). 
Clinical Laboratory 
Assessments 
X 
To be performed at Follow-up Visit 1, repeat at Follow-up Visit 2 if study drug-related toxicity persists. 
Refer to Section 9.4.4 Clinical Safety Laboratory Assessments for the list of laboratory tests. 
Survival Status 
X 
Include documentation of subsequent cancer therapy (ie, systemic therapy, tumor-directed surgery, or radiation 
therapy). 

Clinical Protocol 
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Table 2-5: 
Follow-up Assessments (CA2096GE) 
Protocol Amendment No.: 01 
Date: 25-May-2023 
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930174717 2.0 
 
 
 
 
 
Procedure 
Follow-up 
Visits 1 & 
2a 
(In-clinic) 
Notes:b 
Body Imaging 
See Notes. 
Contrast-enhanced CT of the chest, CT/MRI of the abdomen, pelvis, and all other known and/or suspected sites 
of disease every 12 weeks (± 7 days) is recommended; however, imaging per local standard of care is allowed, 
starting from date of first dose until investigator-assessed local, regional, or distant recurrence or the 100-day 
safety follow-up (whichever comes first) for all participants. See Section 9.1.1 for further details. If a participant 
starts systemic therapy for melanoma recurrence, or for a new non-melanoma tumor after study drug 
discontinuation, follow-up scans for this trial should be discontinued. 
Brain Imaging 
See Notes. 
For participants with a history of brain metastasis or symptoms, it is recommended to perform a surveillance MRI 
(without and with contrast) approximately every 12 weeks ± 7 days; however, brain imaging per local standard of 
care is allowed, starting from date of first dose until investigator-assessed local, regional, or distant recurrence or 
the 100-day safety follow-up (whichever comes first), for all participants or sooner if clinically indicated. See 
Section 9.1.1 for further details. 
Abbreviations: AE, adverse event; BP, blood pressure; CRF, case report form; CT, computed tomography; 
ECOG, Eastern Cooperative Oncology Group; HCG, human chorionic gonadotropin; MRI, magnetic resonance 
imaging; SAE, serious adverse event; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; WOCBP, women of childbearing potential. 
a Participants must be followed for at least 100 days after last dose of study treatment. Follow-up Visit 1 must occur 30 days from the last dose (± 7 days) or can 
be performed on the date of discontinuation if that date is greater than 30 days after last dose. Follow-up Visit 2 occurs approximately 100 days (± 7 days) from 
last dose of study medication. 
b Some of the assessments referred to in this section may not be captured as data in the CRF. They are intended to be used as safety monitoring by the treating 
physician. Additional testing or assessments may be performed as clinically necessary or where required by institutional or local regulations. 
c 

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3 
INTRODUCTION 
The burden of cancer on the healthcare system is increasing at a rapid pace, with potential to cause 
significant impact to both patients and the healthcare system. In 2018, an estimated 18.1 million 
new cases of cancer were diagnosed globally; however, by 2040, that number will increase by 
more than 11 million, to approximately 29.5 million cancer cases.1 
Globally, individuals and families suffering from cancer endure significant physical, financial, and 
emotional strain.2,3,4,5,6,7,8,9,10 One of these burdens includes the treatment route of administration, 
which has largely been intravenous (IV) therapies. Burdens associated with IV therapies affect 
patients, healthcare providers (HCPs), and the healthcare system in a variety of ways. 
Repeated IV infusion appointments require travel to a clinic or infusion center, time, and resources 
and have physical and emotional impacts on patients. For healthcare systems, the preparation and 
administration of IV infusions require time and resource utilization. Given that the growing cancer 
population will increase the burden on healthcare resources, there is a need for more efficient 
treatment options, such as alternative routes of administration and new delivery technologies. 
The development of nivolumab administered subcutaneously 
 
 aims 
to address the current and evolving burden of cancer and cancer treatment on patients, caregivers, 
HCPs, and the healthcare system.11 
• For patients, potential advantages include the following: 
− Patients prefer subcutaneous (SC) over IV administration as this option provides them with 
more comfort and convenience 
− Time savings associated with shorter injection time, decreased wait times at infusion 
centers, and alleviating the travel time to clinics resulting in less disruption to patients’ 
daily lives 
− Obviating need for intravenous access (potential reduction in associated complications 
such as infections) 
− Potential to improve quality of life by reducing psychological stress and anxiety associated 
with IV therapy or treatment at an inpatient or outpatient infusion center 
• For HCPs, Nivo SC may reduce the patient chair time traditionally needed for IV therapies. 
• From the healthcare system perspective, Nivo SC may increase efficiencies for clinics, with 
reduced healthcare resource utilization for administration (no IV setup). Nivo SC has reduced 
cost of care related to physician and pharmacy preparation, and administration expenses. This 
may also lead to improved access to treatment in capacity-constrained areas or during times of 
reduced healthcare resources, as currently seen with the global coronavirus disease 2019 
(COVID-19) pandemic. 
• In addition to the above-mentioned advantages for Nivo SC, for patients, nivolumab SC 
 
could reduce the burden of treatment time, 
improve the drug administration experience, and offer flexibility and convenience. 

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930174717 2.0 
 
 
OPDIVO® (nivolumab, BMS-936558), as monotherapy or in combination with cabozantinib or 
ipilimumab and/or chemotherapy, is currently indicated for the treatment of multiple tumor types 
and lines of therapy including adjuvant treatment of melanoma.13,14 OPDIVO® is currently only 
available for administration via IV infusion. 
Bristol-Myers Squibb (BMS) is committed to improving drug delivery of immuno-oncology 
agents, including SC administration. Under Investigational New Drug 138,302, BMS is 
developing a SC formulation of high concentration nivolumab (BMS-986298) coformulated with 
a permeation enhancer (recombinant human hyaluronidase PH20 enzyme [rHuPH20] Halozyme 
Therapeutics Inc.) to offer an alternative administration route for nivolumab delivery. SC 
nivolumab can be administered via manual injection (vial and syringe) by a trained HCP. rHuPH20 
is a transiently active, locally acting permeation-enhancing enzyme, which enhances the 
permeation of large volumes of SC-administered fluid, allowing for reduced administration times 
and has been approved by the United States (US) Food and Drug Administration for use with 
other monoclonal antibodies, including HyQvia, Rituxan HYCELA, Herceptin HYLECTA, 
DARZALEX Faspro, and PHESGO™. 
The coformulated drug product (DP) nivolumab + rHuPH20 administered subcutaneously by a 
trained HCP in clinic is being formally evaluated for pharmacokinetics (PK) and efficacy 
non-inferiority compared to Nivo IV as part of another ongoing protocol, CA20967T, in 
participants with advanced/metastatic renal cell carcinoma. 
As ongoing research with nivolumab continues with new combination regimens across multiple 
tumor types and different lines of therapies, the approval of nivolumab SC, as vial & syringe 
manual injection for use in ambulatory clinic 
(would provide therapeutic 
alternatives to intravenous delivery and meet the needs of a diverse patient population across 
different lines of therapy. Once approved, the vial and syringe option for SC administration will 
provide greater convenience and flexibility for patients. 
3.1 
Study Rationale 
Overall Rationale for Protocol Amendment 01 
BMS has made a strategic decision to terminate the CA2096GE trial. This decision was not related 
to any safety concerns. Study recruitment has closed and treatment of ongoing, active participants 
will continue per Protocol Amendment 01. Changes implemented in this amendment aim to 
alleviate participant and site burden and include updates to sample collection, study procedures, 
and study design. 
3.1.1 
Research Hypotheses 
Not applicable per Protocol Amendment 01. Due to study termination, the fact that 
enrollment was stopped, and the small sample size, the study is not powered to perform 
hypothesis testing. 
Only Part 1 of the study will be subjected to statistical hypothesis testing. 

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Part 1: SC   administration of nivolumab (BMS-986298) 600 mg coformulated with rHuPH20 
will provide non-inferior PK (measured by time-averaged 
concentration over the first 28 days [Cavgd28] and minimum nivolumab serum concentration at 
steady-state [Cminss]) to IV administration of nivolumab (BMS-936558) 240 mg IV Q2W in the 
adjuvant melanoma population. 
3.2 
Background 
Melanoma accounts for less than 5% of all skin cancers; however, it causes the greatest number of 
skin cancer-related deaths worldwide.15 There were 325,000 new cases of melanoma of the skin 
diagnosed in 2020, which represented 1.7% of global cancer diagnoses.16 In the US in 2022, it is 
estimated there will be 99,780 new cases of melanoma and 7,650 deaths due to melanoma.17 
Melanoma is well-known for its ability to metastasize to virtually any organ or tissue. The most 
common initial sites of distance metastases are the non-visceral (skin, subcutaneous tissue, and 
lymph nodes), which are recurrence sites for 42% to 59% of participants in various studies. 
Visceral locations are the lung, brain, liver, gastrointestinal tract, and bone; the visceral sites are 
the initial sites of relapse in approximately 25% of all patients diagnosed with melanoma who 
experience recurrence. Early melanoma detection followed by surgical excision is usually curative. 
In contrast, advanced melanoma frequently usually has poor prognosis. 
The disease course for melanoma has fundamentally changed with the introduction of 
immunotherapies targeting the cytotoxic T lymphocyte associated antigen 4 (CTLA-4) and 
programmed death-1 (PD-1) checkpoints as well as BRAF and MEK inhibitors. Such agents have 
dramatically improved outcomes for patients with metastatic melanoma. 
In spite of these advances, opportunities exist to continue enhancing patient treatment outcomes 
and quality of life. 
3.2.1 
Adjuvant Treatment of Stage III/IV Melanoma 
CA209238, a Phase 3, randomized double-blind study evaluating Nivo IV 3 mg/kg (n = 453) 
versus ipilimumab IV 10 mg/kg (n = 453) in participants with Stage IIIB/C or Stage IV melanoma 
who were at high risk of recurrence following complete surgical resection. Participants receiving 
nivolumab had superior 12-month recurrence-free survival (RFS) rate of 70.5% (95% CI, 66.1 to 
74.5), as compared to 60.8% in participants receiving ipilimumab (95% CI, 56.0 to 65.2).18 
In CA209238, participants were included based on American Joint Committee on Cancer (AJCC) 
7th edition. AJCC 8th edition (see Appendix 9) was implemented on 01-Jan-2018. The participant 
data from CA209238 were reviewed using the new staging classification and it was determined 
that some Stage IIIB participants who were T1bN1a and T1bN2a in the 7th edition would now be 
mapped as Stage IIIA in the 8th edition, and some Stage IIIA participants would be classified as 
Stage IIIB (T3a N1–2a), suggesting IIIA participants can be considered reasonable candidates for 
trial. Furthermore, with a 4-year minimal follow-up, nivolumab monotherapy continued to show 
durable, long-term RFS benefit, and a better safety profile compared to ipilimumab. 
Most recently, data from Phase 3, randomized, double-blind study CA209915 (which included 
control arm of Nivo IV administered 480 mg every 4 weeks [Q4W]) support the activity of flat 

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prognosis and performance status in the adjuvant setting 
dose (480 mg Q4W) nivolumab with an RFS rate at 3 years of 70% (95% CI, 45 - 85) in patients 
with completely resected Stage IIIB/C/D or Stage IV melanoma.19 Treatment benefit observed 
with nivolumab 480 mg Q4W was consistent with the originally assessed Q2W weight-based dose 
in CA209238. 
Additionally, nivolumab adjuvant therapy was efficacious regardless of programmed death 
ligand-1 (PD-L1) expression status across adjuvant melanoma trials. The results from these studies 
further support the choice of adjuvant melanoma in CA2096GE. Moreover, among all the solid 
tumors, malignant melanoma occurrence is one of the highest in the younger patient populations 
and notably is the second most common cancer in young women < 30 years of age in the United 
States of America (USA).17 The younger/middle-aged patient population often have a much better 
These data supported the global approval of nivolumab IV for adjuvant treatment of melanoma. 
3.2.2 
Nivolumab Mechanism of Action 
Nivolumab (also referred to as BMS-936558, MDX1106, or ONO-4538) is a human monoclonal 
antibody (HuMAb; immunoglobulin G4 [IgG4]-S228P) that targets the programmed death-1 
(PD-1) cluster of differentiation 279 (CD279) cell surface membrane receptor. PD-1 is a negative 
regulatory molecule expressed by activated T and B lymphocytes. Binding of PD-1 to its ligands, 
programmed death ligands 1 (PD-L1) and 2 (PD-L2), results in the downregulation of lymphocyte 
activation. Inhibition of the interaction between PD-1 and its ligands promotes immune responses 
and antigen-specific T-cell responses to both foreign antigens as well as self-antigens. 
Nivolumab is expressed in Chinese hamster ovary (CHO) cells and is produced using standard 
mammalian cell cultivation and chromatographic purification technologies. The clinical study 
product is a sterile solution for parenteral administration. 
Nivolumab (OPDIVOTM) is approved for the treatment of several types of cancer in multiple 
regions including the United States (US, Dec-2014), the European Union (EU, Jun-2015), and 
Japan (Jul-2014). 
3.2.3 
Nivolumab Clinical Activity 
Beyond nivolumab activity in the adjuvant treatment of Stage III/IV melanoma, nivolumab has 
demonstrated durable responses exceeding 6 months as monotherapy in other several tumor types, 
including NSCLC, melanoma, RCC, cHL, SCLC, gastric cancer, SCCHN, urothelial cancer, HCC, 
and CRC. In confirmatory trials, nivolumab as monotherapy demonstrated a statistically 
significant improvement in OS as compared with the current standard of care in patients with 
advanced or metastatic NSCLC, unresectable or metastatic melanoma, advanced RCC, or recurrent 
or metastatic SCCHN. Details of the clinical activity in these various malignancies are provided 
in the USPI and SmPC. 

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3.2.4 
Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20) 
rHuPH20 is a glycosylated 447-amino acid single-chain recombinant human polypeptide that 
depolymerizes hyaluronan in the SC space locally at the site of injection. Hyaluronan is a repeating 
polymer of N-acetyl-glucosamine and glucuronic acid that contributes to the soluble gel-like 
component of the extracellular matrix of the skin. 
Depolymerization of hyaluronan by rHuPH20 results in a transient reduction in the viscosity of 
the gel-like phase of the extracellular matrix and increased hydraulic conductance that facilitates 
the dispersion and absorption of injected drugs (see rHuPH20 Investigator’s Brochure [IB]).20 Use 
of rHuPH20 enables the delivery of large volumes of liquid into the SC space (approximately 2 to 
20 mL), decreasing dose administration times. 

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3.3 
Benefit/Risk Assessment 
Extensive details on the safety profile of nivolumab are available in the IB and will not be repeated 
herein. 
Overall, the safety profile of nivolumab monotherapy is manageable and generally consistent 
across completed and ongoing clinical trials with no maximum tolerated dose reached at any dose 
tested up to 10 mg/kg. Most AEs were low-grade (Grade 1 to 2) with relatively few related 
high-grade (Grade 3 to 4) AEs. There was no pattern in the incidence, severity, or causality of AEs 
with respect to nivolumab dose level. 
A pattern of immune-related adverse events has been defined, for which management algorithms 
have been developed; these are provided in Appendix 7. Most high-grade events were manageable 
with the use of corticosteroids or hormone replacement therapy (endocrinopathies) as instructed 
in these algorithms. 
Additional details on the safety profile of nivolumab, including results from other clinical studies, 
are also available in the nivolumab IB (Nivo SC and Nivo IV). 
In safety data from CA2098KX, SC nivolumab showed a safety profile that was similar to the 
safety profile observed in the nivolumab monotherapy program. 
SC administration of rHuPH20 alone or in combination with biological products was generally 
well-tolerated in all clinical study populations. Most AEs were mild, transient injection site 
reactions including erythema, pain, bruising, pruritus, burning, tenderness, edema, induration, 
irritation, paresthesia, numbness, and rash. Moderate injection site reactions, which were reported 
less frequently, include burning, erythema, pain, and numbness. Mild-to-moderate headache was 
also commonly reported. 
AEs have otherwise generally reflected the adverse reaction profiles of the coadministered drug or 
have been associated with the rapid introduction of a relatively large volume of fluid into the SC 
space. The individual doses ranged from 15 U to 96,000 U of rHuPH20. It should be noted that at 
the highest single dose of 96,000 U, AEs were predominantly mild injection site reactions; there 
were no deaths, SAEs, or discontinuations due to AEs.20 
No local or systemic adverse events have been associated with positive binding or neutralizing 
rHuPH20 antibody titers in clinical trials with rHuPH20.30 

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Non-live COVID-19 vaccination is considered a simple concomitant medication within the study. 
However, the efficacy and safety of non-live vaccines (including non-live COVID-19 vaccines) in 
participants receiving BMS-986298 and BMS-936558 is unknown. 
3.3.1 
Risk Assessment 
Table 3.3.1-1: 
Risk Assessment 
 
Potential Risk of Clinical 
Significance 
Summary of 
Data/Rationale for Risk 
Mitigation Strategy 
Study Intervention(s) 
Immune-mediated AEs (eg, colitis 
diarrhea/colitis, pneumonitis, 
hepatitis, nephritis, endocrinopathy, 
rash, neurologic, AEs) 
BMS-936558 IB 
BMS-986298 IB 
Recommended IMAE management algorithms 
are included in Appendix 7 or as per 
institutional protocol/investigator discretion 
Potential Infusion-related Reaction 
BMS-936558 IB 
Please refer to Section 7.4.5 of protocol 
Potential Injection Site Reaction 
BMS-986298 IB 
Please refer to Section 7.4.5 of protocol 
Cardiovascular AEs (ie, 
myocarditis, troponin elevation) 
BMS-936558 IB 
BMS-986298 IB 
Management 
of 
myocarditis 
per 
AE 
Management Algorithm in Appendix 7 or as 
per 
institutional 
protocol/ 
investigator 
discretion 
Study Procedures 
Tumor Biopsy (eg, pain, infection) 
Not applicable 
Per 
institutional 
protocol/investigator 
discretion 
Phlebotomy (eg, pain, ecchymosis, 
bleeding, syncope) 
Not applicable 
Per 
institutional 
protocol/investigator 
discretion 

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Table 3.3.1-1: 
Risk Assessment 
 
Potential Risk of Clinical 
Significance 
Summary of 
Data/Rationale for Risk 
Mitigation Strategy 
SC Injection 
Refer to Section 3.3 
 
MRI 
Not applicable 
Per 
institutional 
protocol/investigator 
discretion 
CT 
Not applicable 
Per 
institutional 
protocol/investigator 
discretion 
Allergy to Contrast Agent (eg, 
reaction to anaphylaxis) 
Not applicable 
Prophylaxis and/or treatment per institutional 
protocol/investigator discretion 
Other (if applicable) 
Non-clinical Safety (animal studies) 
BMS-986298 IB 
Not applicable 
Abbreviations: AE, adverse event; 
 CT, computed tomography; HCP, healthcare provider; 
IB, Investigator  Brochure;  IFU,  Instructions  For  Use;  IMAE,  immune-mediated  adverse  event; 
MRI, magnetic resonance imaging; Nivo, nivolumab; SC, subcutaneous. 
 
 
3.3.2 
Benefit Assessment 
This study will also investigate recurrence-free survival in Stage III/IV completely resected 
melanoma participants. Currently, nivolumab monotherapy is an approved option for adjuvant 
treatment of melanoma in many countries. 
Despite the availability of Nivo IV, there is a need to improve patient quality of life in cancer care. 
In addition to the benefits of nivolumab to potentially improve RFS and overall survival (OS), 
participants would benefit from the use of the SC route of administration and the convenience of 
self-administration of nivolumab coformulated with rHuPH20. 
3.3.3 
Nivolumab Overall Benefit/Risk Conclusion 
The Sponsor will evaluate the benefit/risk profile of the study on an ongoing basis. This evaluation 
will be based on all available data with particular attention to 
safety trends in this 
or any other clinical study of BMS-986298 or BMS-936558 whose severity and/or frequency 
suggest that participants would be exposed to an unreasonable and significant risk of illness or 
injury. 

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4 
OBJECTIVES AND ENDPOINTS 
Per Protocol Amendment 01, PK co-primary endpoints, secondary endpoints, 
 of the 
study have been removed. Efficacy, patient-reported outcomes (PROs), and biomarker analyses 
will not be completed. Samples already collected for PK and immunogenicity assessments will be 
analyzed bioanalytically for nivolumab concentrations and anti-drug antibodies (ADAs) and 
reported as listings. Further collections for PK, ADAs, biomarkers, and PROs will be discontinued. 
Only safety assessments will be conducted. 
Table 4-1: 
Objectives and Endpoints 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: AE, adverse event; 
; BMS, Bristol-Myers Squibb Company; eCRF, electronic case 
report form; IMAE, immune-mediated adverse event; IV, intravenous; NAb, neutralizing antibody; OS, overall 
survival; Q2W, every 2 weeks; RFS, recurrence-free survival; rHuPH20, recombinant human hyaluronidase PH20 
enzyme; SAE, serious adverse event; SC, subcutaneous. 
 
The primary trial objective is to assess the safety and tolerability of 
and Nivo IV. 
Objectives 
Endpoints 
Primary 
• 
To assess the safety and tolerability of nivolumab 
SC coformulated with rHuPH20 and nivolumab 
IV 
• 
AEs/SAEs and treatment-related AEs/SAEs 
Exploratory 
• 
To assess nivolumab concentrations following 
600 mg SC 
coformulated with rHuPH20 
(Arm A) and 240 mg IV Q2W (Arm B) 
• 
Nivolumab concentrations 
• 
To assess immunogenicity of nivolumab SC 
• 
Anti-nivolumab antibodies, NAb, and titers 
• 
Anti-rHuPH20 antibodies, NAb, and titers 
coformulated  with  rHuPH20  (Arm  A)  and 
nivolumab IV (Arm B) 
• 
To assess the efficacy of nivolumab following 
600 mg SC 
coformulated 
with 
rHuPH20 (Arm A) and 240 mg IV Q2W (Arm B) 
• 
RFS (per investigator) and OS rate at 12 months 

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5 
STUDY DESIGN 
5.1 
Overall Design 
Study CA2096GE is a multicenter, open-label, Phase 3 study. Per Protocol Amendment 01, PK 
co-primary endpoints, secondary endpoints, 
 of the study have been removed. 
Efficacy, PROs, and biomarker analyses will not be completed. Samples already collected 
for PK and immunogenicity assessments will be analyzed bioanalytically for nivolumab 
concentrations and ADAs and reported as listings. Further collections for PK, ADAs, 
biomarkers, and PROs will be discontinued. Only safety assessments will be conducted. 
Therefore, the study design has been adapted to reflect the Protocol Amendment 01 changes, 
. Part 1 is no longer hypothesis-driven, but rather descriptive 
in nature (Arm A and Arm B), with the primary objective being safety and tolerability and 
exploratory objective as described in Table 4-1. 
• Arm A (n = 6): 
− 
 
 
 
• Arm B (n = 8): 
− Nivo IV (BMS-936558) 240 mg Q2W for Cycles 1 through 4. 
− Nivo IV 480 mg Q4W Cycle 5 onwards for up to total of 52 weeks. 
− All dosing will be performed in-clinic. 
 
Participants will be stratified by stage (Stage IIIA/B vs Stage IIIC/D/IV) per AJCC 8th edition 
 
 
All participants will be treated until recurrence of disease, unacceptable toxicity, participant 
withdrawal of consent, death, or a maximum of 52 weeks of treatment from first dose, whichever 
occurs first. 
 
The study design schema is presented in Figure 5.1-1. 
(BMS-986298) 600 mg 
of rHuPH20 administered 

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Figure 5.1-1: 
Study Design Schema 
 
Abbreviations: AJCC, American Joint Committee on Cancer; CNS, central nervous system; FU, follow-up; IV, 
intravenous; N, number of participants; Nivo, nivolumab; PK, pharmacokinetic, Q2W, every 2 weeks; Q4W, every 4 
weeks; RT, radiation therapy; SC, subcutaneous; vs, versus. 
a Treatment until recurrence of disease, unacceptable toxicity, participant withdrawal of consent, death, or a 
maximum of 52 weeks of treatment from first dose, whichever occurs first. 
 
5.1.1 
Screening Period 
Not applicable per Protocol Amendment 01 (enrollment closed). 
Screening will occur between Day -28 and Day -1. Participants will provide written informed 
consent to participate in the study before completing any protocol-specified procedures or 
evaluations not considered to be part of the participants’ standard care. After signing the informed 
consent form (ICF), participants will be evaluated based on the assessments outlined in the 
Schedule of Activities (Section 2, Table 2-1) and inclusion and exclusion criteria (Sections 6.1 and 
6.2, respectively) within 28 days (unless otherwise specified) prior to randomization (Part 1) 
Participants will be enrolled using Interactive Response Technology 
(IRT) on the day of consent. Each participant will be registered in to the IRT system to obtain a 
participant number. Participants who complete the Screening Period and meet the criteria for 
inclusion/exclusion will begin the Treatment Period. 
A formalin fixed, paraffin-embedded (FFPE) tumor tissue block (preferred) or a minimum of 15 
unstained slides of tumor tissue obtained from the recent resection (preferred) or an archival biopsy 
conducted within 6 months prior to enrollment, and preferably with no intervening systemic anti- 
cancer treatment between time of acquisition and enrollment, must be submitted to the central lab. 
If despite best efforts, a minimum of 15 unstained slides are not obtainable, submission of 5 
unstained slides is acceptable. Tissue availability needs to be determined during the screening 
period. It is recommended that tumor tissue be submitted during the screening period; however, it 
must be submitted no later than 14 days post-randomization/treatment assignment. Fine-needle 
aspirates or other cytology samples are not acceptable. (see Section 9.8.1 and Lab Manual for 
additional information). 

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Arm A: Participants randomized to Arm A will receive 
with rHuPH20 
5.1.2 
Treatment Period 
The Treatment Period begins at the time of randomization and will end at the beginning of the 
Follow-up Period (Follow-up Visit 1). Each cycle consists of 28 days. Treatment cycles will be 
counted from Cycle 1, Day 1 continuously regardless of dose interruptions or missed doses. 
Participants will undergo safety and efficacy assessments as defined in the Schedule of Activities 
(Section 2). Every effort should be made to schedule visits within the protocol-specified windows. 
Please refer to Sections 7.1.1 and 7.1.2 for treatment administration details. 
Results of efficacy surveillance must be reviewed by investigator and documented before dose 
administration of the next cycle. 
Participant safety will be preserved through: 
• Protocol-defined visits to the clinic 
• Phone communication with the participant (see Section 9.4.5) 
• Regular monitoring of labs and symptoms 
• Other safety reporting to the HCP by the participant or the participant’s caregiver 
• All participants will be treated until recurrence of disease, unacceptable toxicity, participant 
withdrawal of consent, death, or a maximum of 52 weeks of treatment from first dose, 
whichever occurs first. 
 
Biomarker assessments are no longer applicable per Protocol Amendment 01. 
5.1.2.1 
Randomized Study Cohort 
 
 

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Arm B: Participants randomized to Arm B will receive Nivo IV 240 mg Q2W during the 
first 4 cycles. Following Cycle 4, participants will receive Nivo IV 480 mg Q4W. All doses/visits 
will be in-clinic. 

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5.1.3 
Follow-Up Period 
Safety Follow-up will begin after the Treatment Period, when the participant has completed up to 
52 weeks of treatment or discontinues study treatment for any reason (see Section 8.1). The Safety 
Follow-up Period consists of 2 Follow-up Visits: Visit 1 (to occur 30 days [± 7 days] from date of 
last treatment dose) and Visit 2 (to occur 100 days [± 7 days] from date of last treatment dose). All 
adverse events (AEs)/serious adverse events (SAEs) (including AEs/SAEs related to severe acute 
respiratory syndrome coronavirus 2 [SARS-CoV-2]) should be collected continuously using 
National Cancer Institute (NCI) Common Technical Criteria for Adverse Events (CTCAE) version 
5 (v5) during the Safety Follow-up. 
Beyond the 100 days from the last dose of study therapy, participants will be followed for all 
drug-related AEs/SAEs until AE resolves, returns to baseline, is deemed irreversible, until the 
participant is lost to follow-up, or withdraws study consent. 
Beyond the 100 days from the last dose of study treatment, all AEs/SAEs associated with 
confirmed or suspected SARS-CoV-2 infection will be followed until resolution, until the 
condition stabilizes, until the event is otherwise explained, the event is deemed irreversible, or 
until the participant is lost to follow-up (as defined in Section 8.3). For suspected cases, 
participants should be followed until SARS-CoV-2 infection is ruled-out as per institutional policy 
on SARS-CoV-2. 
Participants who are randomized but who are never treated or who discontinue study treatment for 
any reason other than tumor recurrence should continue to have surveillance assessments until 
recurrence of disease or study discontinuation as per the Schedule of Activities, Section 2. 
Surveillance assessments should not be delayed until the planned follow-up visits. 
5.1.4 
Data Monitoring Committee and Other Committees 
Data Monitoring Committee: A safety DMC will be implemented in this study to provide safety 
oversight throughout the course of Part 1 of the study. The DMC charter will describe the 
procedures related to the committee operations in greater detail. On 26-Oct-2022, enrollment was 
paused and a total of 14 participants had been randomized. On 24-Feb-2023, the study was 
terminated with no additional participants having been randomized. As this is an open-label study, 
the Sponsor will continue the safety monitoring of remaining participants in the study. No 
subsequent DMC meeting will occur. 
Study Steering Committee: A Study Steering Committee (SSC) will be established to provide 
advisory oversight of the quality of the trial, with the objective of ensuring scientific integrity and 
the successful conduct of the CA2096GE Study. On 26-Oct-2022, enrollment was paused and a 
total of 14 participants had been randomized. On 24-Feb-2023, the study was terminated with no 
additional participants having been randomized. The Sponsor will continue to ensure the scientific 
integrity and successful conduct of the study. No SSC meeting will occur. 
5.2 
Number of Participants 
The trial has been terminated. 
14 participants 
randomized and treated in the study with 6 participants in Arm A and 8 participants in Arm B. 

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5.3 
End of Study Definition 
The start of the trial is defined as the first participant first visit. 
End of trial is defined as the last participant last visit or completion of Follow-up Visit 2. 
Study completion is defined as the final date on which data for the primary endpoint were or are 
expected to be collected, if this is not the same. 
A participant is considered to have completed the study if he/she has completed the end of trial 
(Follow-up Visit 2). 
5.4 
Scientific Rationale for Study Design 
5.4.1 
Rationale for One Year Duration of Treatment 
There is no consensus about the optimal treatment duration for patients in the adjuvant setting. For 
trials of interferon, various treatment frequencies and durations have been investigated (ranging 
between 6 months and 5 years).18,19 There is a significant geographic variability in the duration of 
interferon therapy, usually ranging between 1 and 1.5 years throughout the world. In order to 
minimize toxicity leading to discontinuation of study drug while maintaining expected efficacy of 
the study drug, the decision was reached to limit the duration of study therapy of nivolumab on 
CA2096GE to 1-year maximum duration. This is supported by data from CA209238, which was 
approved for nivolumab as adjuvant treatment of melanoma. 
5.4.2 
Rationale for Part 1 Endpoints and Non-Inferiority Margin 
Not applicable per Protocol Amendment 01. The following information refers to the original 
study design. 
PK co-primary endpoints for Part 1 of this study are Cavgd28 and Cminss. The co-primary 
endpoints would help to establish PK non-inferiority between the 2 different routes of 
administration (SC 
 and IV). The use of co-primary PK endpoints will provide data on exposure 
to nivolumab at different time points during treatment. Cavgd28 is the time-averaged concentration 
over the first 28 days of dosing and represents an early measure of exposure. The Cminss endpoint 
is a steady-state measure of exposure that can be used to assess accumulation with repeat dosing 
and as surrogate for long-term administration with 
 . Blood sampling time points have 
been selected to adequately characterize the co-primary PK endpoints (Cavgd28 and Cminss) 
while minimizing the burden to patients and HCPs. 
Non-inferiority of 
 to Nivo IV will be concluded if the lower limit of the 2-sided 90% 
CIs for the ratio of geometric means for nivolumab (SC vs IV) Cavgd28 and Cminss is not lower 
than 0.8; as this criterion is consistent with regulatory advice. 
Non-inferior PK exposures at early and late time points, particularly when the dose administration 
is given by the participant (instead of HCP), ensure effective drug levels are maintained over time 
and provide pharmacologic surrogate of disease control similar to approved Nivo IV. 

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5.4.6 
Rationale for Inclusion of Clinical Outcome Assessments/PROs (Part 1) 
Not applicable per Protocol Amendment 01. The following information refers to the original 
study design. 
The evaluation of clinical outcomes assessments (COAs) such as patient-reported outcomes 
(PROs) is an increasingly important aspect of clinical efficacy and safety in oncology trials. Such 
data provide an understanding of the impact of treatment from the participant’s perspective and 
offer insights into patient experience that may not be captured through physician reporting. 
Additionally, generic health-related quality of life (HRQoL) measures provide data needed for 
calculating utility values to inform health economic models. 
To explore overall participant self-confidence with SC injection the Self-Confidence domain of 
the Self-Injection Assessment Questionnaire (SIAQ) will be used in the Part 1 Arm A (SC arm) 
only. Participant satisfaction with route of administration (IV versus SC) will be assessed using a 
modified version of the Cancer Treatment Satisfaction Questionnaire (CTSQ), namely the 
Satisfaction with Cancer Therapy domain. The Functional Assessment of Cancer Therapy - 
General 7 item version (FACT-G7) will be used to evaluate HRQoL. The FACT-G7 has been 
shown to be a valid, reliable, and rapid measure for monitoring symptoms and concerns in 
oncology practice and research. A modified version of the Treatment Administration Satisfaction 
Questionnaire (TASQ) will be used to assess Satisfaction, Physical Impact, Psychological Impact, 
Impact on Activities of Daily Living, and Convenience between IV and SC Routes of 
Administration. The EuroQol-5 Dimension-5 Level (EQ-5D-5L) will be used for economic 
evaluations and overall health status. 
5.4.7 
Rationale for Open Label 
The expected incidence of AEs with nivolumab have been extensively studied and defined in prior 
clinical trials and are not expected to differ based on route of administration or delivery systems, 
(when not considering injection site reactions or procedure related AEs) as further demonstrated 
by the preliminary safety data from the nivolumab SC injection study, CA2098KX; therefore, an 
open-label approach is justified. In addition, the technical challenges associated with blinding 
favor the open-label design. The BMS study team will not conduct aggregate analyses by treatment 
group prior to pre-specified database locks (Sponsor blind approach). 
5.5 
Justification for Dose 

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5.5.2 
Rationale for Dosing Regimen - Intravenous (Arm B) 
Nivolumab monotherapy was originally approved as a body weight-based dose of 3 mg/kg IV 
Q2W and was recently updated to flat-dosing regimens of 240 mg Q2W or 480 mg Q4W in 
multiple indications. For this study, the selected dose of 240 mg via IV Q2W is per dose/schedule 
approved for this patient population. In addition, there is extensive PK, safety, and efficacy data 
available at this dose across multiple tumors and dosing regimens. Global development with flat 
doses of nivolumab are ongoing in a broad range of clinical trials in a variety of additional tumor 
types. Based on the aforementioned nivolumab 240 mg IV Q2W is considered an appropriate and 
globally accepted comparator to 
In relation to transition to 480 mg IV Q4W, most recently, data from the comparator arm in study 
CA209915 support that the activity of flat dose (480 mg IV Q4W) nivolumab performs similarly 
to the originally assessed 3 mg/kg IV Q2W dosing schedule in study CA209238. 
Additional details on nivolumab posologies and risk-benefit can be found in the BMS-936558 
investigator brochure. 

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5.5.4 
Rationale for Switch from Q2W to Q4W (Arm B [IV]) 
In order to mitigate participant burden, a switch from Q2W to Q4W will occur after Cycle 5 for 
participants in Arm B receiving IV nivolumab. Cycle 5 has been selected as the time for the switch 
as it was the time at which the primary endpoints in the original study design were being collected. 

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5.5.5 
Rationale for Continued Adjuvant Therapy for Participants Who Are 
Diagnosed with Melanoma in Situ During Study Treatment 
Malignant melanoma in situ (MMIS) Stage 0 includes Tis, N0, M0, demonstrates a radial growth 
phase in which the proliferation of malignant melanocytes is confined to the epidermis. Patients 
with a new Stage 0 melanoma are at minimal risk from that new tumor. The risk of death develops 
from advanced Stage IIIB/C/D or Stage IV melanoma for which they are receiving treatment 
during the clinical trial. Opdivo (nivolumab) is approved for the adjuvant treatment of adult 
patients with melanoma with involvement of lymph nodes or metastatic disease who have 
undergone complete resection. Consequently, in the absence of intolerable toxicity, patients with 
diagnosed MMIS should continue adjuvant therapy using the same dose and schedule for their 
original melanoma for a maximum of 1-year total duration starting from first dose (maximum of 
13 doses). Melanoma in situ will not be considered a new primary malignancy. 
5.5.6 
Safety/IMG with SC Nivolumab + rHuPH20 
In the Phase 1/2 CA2098KX study, the safety profile of Q2W and Q4W nivolumab SC 
monotherapy in participants with advanced/metastatic cancer was evaluated. The preliminary 
review of the study safety data showed that nivolumab SC vial and syringe across all studied doses 
was safe, tolerable, and manageable with an AE profile consistent with nivolumab when 
administered via IV. 
• Sixty-seven participants in Part A (Group 1) and Part B (Group 2, 3, 4) received 1 SC 
nivolumab dose (720 mg or 960 mg) with or without rHuPH20 followed by IV nivolumab. 
Upon selection of the dose, 28 of these participants who were still on study at the time of the 
amendment, transitioned to SC nivolumab 1,200 mg + rHuPH20 Q4W (Part C) 
• Thirty-six participants in Part D received SC nivolumab dose of 1,200 mg + rHuPH20 Q4W 
from the beginning of therapy 
• Thirty-six participants in Part E received SC nivolumab dose of 600 mg + rHuPH20 Q2W from 
the beginning of therapy 
 
Part A/B: Participants received single-dose SC nivolumab, either 720 mg (with or without 
rHuPH20) or 960 mg (with or without rHuPH20): The safety data from single-dose SC nivolumab 
followed by IV (Cycle 2+) included treatment-related AEs and SAEs previously reported within 
the Nivo IV IB with the exception of SC local reactions.34 With respect to local AEs reported with 
SC injection, the local site reactions were low incidence, of low grade, and manageable. 
Part C (transitioning to 1,200 mg + rHuPH20 from prior single-dose SC and IV): Interpretation 
of treatment-related AEs in Part C was difficult and clear attribution of systemic treatment-related 
AEs to SC nivolumab (vs IV) was not possible given switching between formulations and the long 
half-life of nivolumab. 
Of the 28 participants that transitioned from Part A/B to Part C, any Grade AEs after transitioning 
to SC nivolumab were reported in 26 (93%) participants. Treatment-related AEs were reported in 
16 (57%) participants after transitioning to Part C, all of which were Grade 1 to 2. In the majority 
of participants, low-grade treatment-related AEs were reported in the general disorders and 

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administration site conditions and skin and subcutaneous disorders SOCs. Within the general 
disorders and administration site conditions SOC, there were 3 (33.3%), 2 (33.3%), 3 (60.0%), 
and 1 (12.5%) participants that were reported with low-grade treatment-related AEs in Groups 1, 
2, 3, and 4, respectively. Within the skin and subcutaneous disorders SOC, there were 2 (22.2%), 
1 (16.7%), 0 (0.0%), and 1 (12.5%) participants that were reported with low-grade treatment- 
related AEs in Groups 1, 2, 3, and 4, respectively. No participants were reported to develop new 
or worsening Grade 3 or higher treatment-related AEs, and there were no reported 
treatment-related AEs leading to discontinuation or death. 
Part D (1,200 mg + rHuPH20): Any grade AEs were reported in all 36 participants, of these there 
were 17 (47.2%) reports of Grade 3 to 4 AEs and 4 (11.1%) reports of Grade 5 AEs. Any grade 
treatment-related AEs were reported in 28 (77.8%) participants; of these there were 6 (16.7%) 
reports of Grade 3 to 4 treatment-related AEs. Treatment-related SAEs were reported in 3 (8.3%) 
participants, all were Grade 3 to 4. In the majority of participants, treatment-related AEs were 
reported in the general disorders and administration site conditions, skin and subcutaneous 
disorders, and endocrine disorders SOCs. Within the general disorders and administration site 
conditions SOC, there were 16 (44.4%) participants that were reported with low-grade 
treatment-related AEs. Within the skin and subcutaneous disorders SOC, there were 12 (33.3%) 
participants that were reported with low-grade treatment-related AEs, of these there were 3 (8.3%) 
reports of Grade 3 to 4 treatment-related AEs. Within the endocrine disorders SOC, there were 
10 (27.8%) participants that were reported with low-grade treatment-related AEs. Of the reported 
treatment-related AEs, 4 participants (11.1%) were reported with AEs leading to treatment 
discontinuation. There was no reported treatment-related AE leading to death. No dose-related 
safety concerns were noted. Results to date suggest that SC nivolumab with rHuPH20 is safe and 
well-tolerated, which supports further clinical investigation. 
Part E (600 mg + rHuPH20): In 36 participants, any grade AEs were reported in 27 (75.0%) 
participants; of these there were 10 (27.8%) reports of Grade 3 to 4 AEs, and 1 (2.8%) report of a 
Grade 5 AE. Any grade treatment-related AEs were reported in 20 (55.6%) participants; of these 
there were 3 (8.3%) reports of Grade 3 to 4 treatment-related AEs. There was 1 (2.8%) report of a 
treatment-related SAE of Grade 3 to 4. In the majority of participants, treatment-related AEs were 
reported in the skin and subcutaneous disorders and general disorders and administration site 
conditions SOCs. Within the skin and subcutaneous disorders SOC, there were 10 (27.8%) 
participants that were reported with low-grade treatment-related AEs. Within the general disorders 
and administration site conditions SOC, there were 9 (25.0%) participants that were reported with 
low-grade treatment-related AEs. There were no reported treatment-related AEs leading to 
discontinuation or death. 
Across treatment groups, ADAs were reported with nivolumab (BMS-986298) with and without 
rHuPH20 similar to what has been reported with the IV formulation. In Part C, 15 out of 67 
participants had positive treatment-emergent ADA for nivolumab (7 out of 22 [31.8%]) 
participants in the nivolumab 720 mg with rHuPH20 group, 5 out of 18 (27.8%) participants in the 
nivolumab 720 mg without rHuPH20 group, and 3 out of 10 (30%) participants in the nivolumab 
960 mg with rHuPH20 group; there was no treatment-emergent ADAs in the 17 participants who 

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received nivolumab 960 mg without rHuPH20 group. One out of 22 (4.5%) participants in the 
nivolumab 720 mg with rHuPH20 group was classified as persistent positive ADA. In Part D, 1 
out of 26 (3.8%) participants developed treatment-emergent ADA; however, none were persistent 
positive. No neutralizing ADAs were detected in any part of the study and no association of anti- 
nivolumab antibody development with select AEs (ie, bronchospasm, hypersensitivity, infusion- 
related reactions) was reported. Data do not suggest that the presence of ADAs with SC nivolumab 
impacts clinical safety (eg, injection site or hypersensitivity reactions). Overall, the PK, safety, 
and immunogenicity data further support clinical development of additional dosing schedules 
and 600 mg Q2W) of SC 
nivolumab. 
5.6 
Clinical Pharmacology Summary 
5.6.1 
Clinical Pharmacology of Nivolumab 
Nivolumab pharmacokinetics (PK) was assessed using a population PK approach for single-agent 
nivolumab. 
Nivolumab as a single agent: The PK of single-agent nivolumab was studied in patients over a 
dose range of 0.1 to 20 mg/kg administered as a single dose or as multiple doses of nivolumab as 
a 60-minute intravenous infusion every 2 or 3 weeks. Nivolumab clearance (CL) decreases over 
time, with a mean maximal reduction (% coefficient of variation [CV%]) from baseline values of 
24.5% (47.6%) resulting in a geometric mean steady-state clearance (CLss) (CV%) of 8.2 mL/h 
(53.9%) in patients with metastatic tumors; the decrease in CLss is not considered clinically 
relevant. Nivolumab clearance does not decrease over time in patients with completely resected 
melanoma, as the geometric mean population clearance is 24% lower in this patient population 
compared with patients with metastatic melanoma at steady-state. The geometric mean volume of 
distribution at steady-state (Vss) (CV%) is 6.8 L (27.3%), and geometric mean elimination half-life 
(t1/2) is 25 days (77.5%). Steady-state concentrations of nivolumab were reached by 12 weeks 
when administered at 3 mg/kg every 2 weeks, and systemic accumulation was 3.7-fold. The 
exposure to nivolumab increases dose proportionally over the dose range of 0.1 to 10 mg/kg 
administered every 2 weeks. The predicted exposure (Cavg and Cmax) of nivolumab after a 
30-minute infusion is comparable to that observed with a 60-minute infusion. 
Specific Populations: The population PK analysis suggested that the following factors had no 
clinically important effect on the clearance of nivolumab: age (29 to 87 years), weight (35 to 160 
kg), gender, race, baseline LDH, PD-L1 expression, solid tumor type, tumor size, renal 
impairment, and mild hepatic impairment. 
Renal Impairment: The effect of renal impairment on the clearance of nivolumab was evaluated 
by a population PK analysis in patients with mild (eGFR 60 to 89 mL/min/1.73 m2), moderate 
(eGFR 30 to 59 mL/min/1.73 m2), or severe (eGFR 15 to 29 mL/min/1.73 m2) renal impairment. 
No clinically important differences in the clearance of nivolumab were found between patients 
with renal impairment and patients with normal renal function. 
Hepatic Impairment: The effect of hepatic impairment on the clearance of nivolumab was 
evaluated by population PK analyses in patients with HCC and in patients with other tumors with 

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mild hepatic impairment (total bilirubin [TB] less than or equal to the ULN and AST greater than 
ULN or TB greater than 1 to 1.5× ULN and any AST) and in HCC patients with moderate hepatic 
impairment (TB greater than 1.5 to 3× ULN and any AST). No clinically important differences in 
the clearance of nivolumab were found between patients with mild/moderate hepatic impairment. 
Full details on the clinical pharmacology aspects of nivolumab can be found in the Investigator 
Brochure and product label. 
Full details regarding approved nivolumab dosages in their associated indications may be found in 
the product label. 
5.6.2 
Clinical Pharmacology of Recombinant Human Hyaluronidase PH20 
rHuPH20 may enable coadministered therapeutics to overcome administration time and volume 
barriers to SC drug delivery. Overall, data from a number of studies suggest that rHuPH20 can 
increase the utility of SC drug administration by improving ease of administration and the PK 
profile of concurrently administered large proteins. The half-life of rHuPH20 in skin is 
< 30 minutes, and the local permeability barrier in these tissues is restored to pre-injection levels 
within 24 hours to 48 hours after injection of hyaluronidase.35,36 A study showed that rHuPH20 
was not detectable systemically in healthy volunteers and patients following SC administration at 
doses of 10,000 U and 30,000 U with a currently marketed monoclonal antibody product.37 
Another study of the PK of rHuPH20 (Halozyme Study HALO-104-104) demonstrated that plasma 
concentrations of rHuPH20 rapidly declined, with a very short t1/2 (≤ 10.4 minutes) and the plasma 
concentration became undetectable (< 0.03 ng/mL) within 1.5 hours after the end of the IV infusion 
for IV doses of 10,000 or 30,000 units of rHuPH20.38 
As of Dec-2022, 1,592 participants were exposed to HYLENEX and other rHuPH20 DPs in 
30 clinical studies conducted under Investigational New Drug 66,888 or in postmarketing Phase 4 
studies. In these studies, the maximum duration of exposure was 12 weeks, and individual doses 
ranged from 15 U to 96,000 U rHuPH20. In partnered trials with co-administered therapeutics, 
more than 9,000 participants were exposed.20 
In partnered trials, the maximum duration of participant exposure to rHuPH20 was up to 3.5 years 
(187.69 patient-years) in the combined pivotal and safety extension studies for HYQVIA® 
(Immune Globulin Infusion 10% [Human] With Recombinant Human Hyaluronidase). One 
Halozyme study evaluated rHuPH20 injected intradermally as a single agent, 28 studies evaluated 
rHuPH20 injected SC immediately prior to another agent or coadministered SC with another agent, 
and 13 studies evaluated rHuPH20 coformulated with recombinant human insulin (insulin-PH20) 
or rapid-acting insulin analogs (aspart-PH20 and lispro-PH20). One Halozyme IV dosing study 
was conducted using 10,000 U or 30,000 U of rHuPH20 in healthy volunteer participants. All but 
2 Halozyme studies were conducted in adult populations; pediatric exposure (< 18 years of age) in 
2 clinical studies included 139 participants with mild-to-moderate dehydration who received SC 
infusions of isotonic fluids. 
Across all studies, SC injections of rHuPH20 were generally well tolerated in healthy participants, 
dehydrated pediatric participants, hospice and palliative care participants, participants with type 1 

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and 2 diabetes, and participants with rheumatoid arthritis. SC injections of rHuPH20 either alone 
or co-administered with lactated Ringer’s, normal saline, co-injected drugs (morphine, ceftriaxone, 
insulin, and insulin analogues), or biologic products (immunoglobulin G and adalimumab) have 
been well tolerated in all clinical trials. Most AEs were mild, transient injection-site reactions, 
including erythema, pain, bruising, pruritus, burning, tenderness, edema, induration, irritation, 
paresthesia, numbness, and rash. Moderate injection-site reactions, which have occurred less 
frequently, included burning, erythema, pain, and numbness. Mild-to-moderate headache was also 
commonly reported. AEs in these trials have otherwise generally reflected the adverse reaction 
profiles of the co-administered drug or have been associated with the rapid introduction of a 
relatively large volume of fluid into the SC space. 
Antibodies to rHuPH20 have been evaluated in several nonclinical and clinical studies. To date, 
no clinical signs or symptoms have been associated with positive binding or neutralizing antibodies 
titers in clinical trials with rHuPH20 and no confirmed rHuPH20-neutralizing antibody activity 
has been detected. In addition to these studies, a large clinical safety database exists for rHuPH20 
as a tissue permeability enhancer co-administered with several approved products in the US and/or 
Europe (European Union), including: 
• DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj); 
• PHESGO™ (pertuzumab, trastuzumab, and hyaluronidase-zzxf; US only); 
• HYQVIA® (Immune Globulin Infusion 10% [Human] with rHuPH20); 
• Herceptin® SC/HERCEPTIN HYLECTATM (trastuzumab coformulated with rHuPH20); 
• MabThera® SC/RITUXAN HYCELA® (rituximab coformulated with rHuPH20); and 
• HYLENEX® (rHuPH20 alone; US only). 
 
6 
STUDY POPULATION 
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as 
protocol waivers or exemptions, is not permitted. 
6.1 
Inclusion Criteria 
Not applicable per Protocol Amendment 01 (as of 24-Feb-2023, enrollment in this study has 
closed). 
Participants are eligible to be included in the study only if all of the following criteria apply: 
1) Signed Written Informed Consent 
a) Participants must have signed and dated an Institutional Review Board (IRB)/Independent 
Ethics Committee (IEC)-approved written informed consent form (ICF) in accordance with 
regulatory, local, and institutional guidelines. This must be obtained before the 
performance of any protocol-related procedures that are not part of normal patient care. 
b) Participants must be willing and able to comply with scheduled visits, treatment schedule, 
laboratory testing, and other requirements of the study. 
2) Type of Participant and Target Disease Characteristics 

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a) All participants must have been diagnosed with either Stage IIIA (> 1 mm tumor in lymph 
node)/B/C/D or Stage IV melanoma by AJCC 8th edition and have histologically 
confirmed melanoma (as documented in the pathology report) that is completely surgically 
resected (free of disease) with negative margins in order to be eligible. All melanomas, 
except uveal and mucosal melanoma, regardless of primary site of disease, will be allowed. 
b) Participants are eligible if central nervous system (CNS) metastases have been resected 
and participants are neurologically stable. 
i) Prior resected CNS metastases must be without evidence of recurrence, as determined 
by magnetic resonance imaging (MRI) performed at least 4 weeks after resection is 
complete and within 28 days prior to randomization (Part 1) 
. 
ii) Participants must be off immunosuppressive doses of systemic steroids (>10 mg/day 
prednisone or equivalent) for at least 14 days prior to study drug administration and 
must have returned to neurologic baseline post-operatively. 
iii) For CNS lesion(s), a pathology report indicating that there has been complete resection 
of CNS lesion(s) will suffice as confirmation of negative margins. 
c) Complete resection must be performed within 12 weeks prior to randomization (Part 1) 
Management of residual lymph nodes after positive sentinel 
lymph node biopsy (ie, completion lymph node dissection) will be as per local standards 
and recommendations for the individual participant. 
d) All participants must have disease-free status documented by a complete physical 
examination within 14 days prior to randomization (Part 1) 
and imaging studies within 28 days prior to randomization/treatment assignment. Imaging 
studies must include computed tomography (CT) scan of the chest; CT or MRI scans of 
the abdomen, pelvis, and all known sites of resected disease; and brain MRI or CT (brain 
CT allowable if MRI is contraindicated). 
e) Participants must have an Eastern Cooperative Oncology Group (ECOG) performance 
status of ≤ 1 (Appendix 8). 
f)  
 
 
3) Age of Participant 
Participants must be ≥ 18 years of age or age of majority at the time of informed consent. 
4) Reproductive Status 
Investigators shall counsel women of child bearing potential (WOCBP) on the importance of 
pregnancy prevention, the implications of an unexpected pregnancy, and the potential of fetal 
toxicity occurring due to transmission of study intervention to a developing fetus. 
The investigator shall evaluate the effectiveness of the contraceptive method in relationship to 
the first dose of study intervention. 
Local laws and regulations may require the use of alternative and/or additional contraception 
methods. 

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a) Female Participants: 
i) Female participants must have documented proof that they are not of childbearing 
potential. 
ii) Women who are not of childbearing potential are exempt from contraceptive 
requirements. 
iii) WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 
IU/L or equivalent units of HCG) within 24 hours prior to the start of study 
intervention. An extension up to 72 hours prior to the start of study treatment is 
permissible in situations where results cannot be obtained within the standard 24-hour 
window. 
(1) If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum 
pregnancy test is required. In such cases, the participant must be excluded from 
participation if the serum pregnancy result is positive. 
iv) Additional requirements for pregnancy testing during and after study intervention are 
located in Section 2, Schedule of Activities. 
v) The investigator is responsible for review of medical history, menstrual history, and 
recent sexual activity to decrease the risk for inclusion of a woman with an early 
undetected pregnancy. 
vi) WOCBP must agree to follow instructions for method(s) of contraception defined in 
Appendix 4 and as described below and included in the ICF. 
vii) WOCBP are permitted to use hormonal contraception methods (as described in 
Appendix 4). 
viii) 
A female participant is eligible to participate if she is not pregnant or breastfeeding, 
and at least 1 of the following conditions applies: 
(1) Is not a WOCBP 
OR 
(2) Is a WOCBP and using a contraceptive method that is highly effective (with a 
failure rate of < 1% per year), with low user dependency, as described in Appendix 
4 during the intervention period and for at least 5 months after the last dose and 
agrees not to donate eggs (ova, oocytes) for the purpose of reproduction for the 
same time period 
b) Male Participants: 
No additional contraceptive measures are required to be used. 
 
6.2 
Exclusion Criteria 
Not applicable per Protocol Amendment 01 (as of 24-Feb-2023, enrollment in this study has 
closed). 
Participants are excluded from the study if any of the following criteria apply: 
1) Medical Conditions 
a) History of uveal or mucosal melanoma. 

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b) Untreated/unresected CNS metastases or leptomeningeal metastases. 
c) Participants with an active, known or suspected autoimmune disease. Participants with 
type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin 
disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or 
conditions not expected to recur in the absence of an external trigger are permitted to enroll. 
d) Participants with serious or uncontrolled medical disorder within 4 weeks prior to 
screening. 
i) Additionally, in the case of prior SARS-CoV-2 infection, acute symptoms must have 
resolved and based on investigator assessment in consultation with the Medical 
Monitor, there are no sequelae that would place the participant at a higher risk of 
receiving investigational treatment. 
e) Concurrent malignancy (present during screening) requiring treatment or history of prior 
malignancy active within 2 years prior to randomization (Part 1) 
(ie, participants with a history of prior malignancy are eligible if treatment was 
completed at least 2 years before randomization/treatment assignment and the patient has 
no evidence of disease). Participants with history of prior early stage basal/squamous cell 
skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at 
any time are also eligible. 
f) Participants with a condition requiring systemic treatment with either corticosteroids 
(> 10 mg daily prednisone equivalent) within 14 days or other immunosuppressive 
medications within 30 days of start of study treatment. Inhaled or topical steroids, and 
adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in 
the absence of active autoimmune disease. 
g) Any condition that according to investigator makes participant ineligible from participation 
in the study, including but not limited to medical (including psychological, psychiatric), or 
social conditions; or conditions that can impact ability to comply with protocol 
requirements (eg, conditions that preclude the use of IV or SC route of study drug 
administration) or that can put the participant at risk. Participants with history of self-harm 
including suicidal attempts will be excluded from the study. 
2) Prior/Concomitant Therapy 
a) Prior immunotherapy treatments for any prior malignancies are not permitted (such as, but 
not limited to anti-PD-1, anti-PD-L1, anti-PD-L2, or any other antibody or drug 
specifically targeting T-cell co-stimulation or immune checkpoint pathways). 
b) Participants treated with anti-cancer therapy directed against the resected melanoma (for 
example, but not limited to, systemic, local, radiation, and radiopharmaceuticals) except: 
i) Surgery for the melanoma lesion(s) 
ii) Adjuvant radiation therapy after neurosurgical resection for CNS lesions 
iii) Prior adjuvant interferon completed ≥ 6 months prior to randomization (Part 1) 
 
c) Treatment with complementary medications (eg, herbal supplements or traditional Chinese 
medicines) to treat the disease under study within 2 weeks prior to randomization (Part 1) 
Such medications are permitted if they are used as 
supportive care. Refer to Section 7.7.1 for prohibited therapies. 

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d) Participants currently in other interventional trials, including those for COVID-19, until 
the protocol specific washout period is achieved. If a study participant has received an 
investigational COVID-19 vaccine or other investigational product designed to treat or 
prevent COVID-19 prior to screening, enrollment must be delayed until the full dosing 
schedule of the vaccine has been completed and the biologic impact of the vaccine or 
investigational product is stabilized, unless the delay would compromise the participant’s 
health or suitability for enrollment as determined by the investigator, and in discussion 
with the BMS Medical Monitor/designee. 
e) Inability to comply with restrictions and prohibited treatments as listed in Section 7.7: 
Concomitant Therapy. 
f) Treatment with any live attenuated vaccine within 30 days of first study treatment 
(Vaccines that are not live attenuated are allowed, including COVID-19 vaccines). Details 
regarding COVID-19 vaccination are available in Section 7.7. 
3) Physical and Laboratory Test Findings 
a) Positive pregnancy test at enrollment or prior to administration of study medication. 
Note for criteria 3b to 3e: May not transfuse, use growth factors, and/or coagulation factors 
within 14 days of randomization (Part 1) 
b) White blood cell count < 2000/μL. 
c) Neutrophils < 1500/μL. 
d) Platelets < 100*103/μL. 
e) Hemoglobin < 9.0 g/dL. 
f) Blood creatinine > 2.0 × upper limit of normal (ULN), unless calculated creatinine 
clearance (CrCl) ≥ 30 mL/min (using the Cockcroft-Gault formula). 
g) Aspartate transaminase (AST) / alanine aminotransferase (ALT) > 3.0× ULN. 
h) Total bilirubin > 1.5 × ULN (except participants with Gilbert Syndrome who must have a 
total bilirubin level of < 3.0x ULN). 
i) Any positive test result for hepatitis B virus (HBV) indicating presence of virus (eg, 
Hepatitis B surface antigen [HBsAg, Australia antigen]) positive. 
j) Any positive test result for hepatitis C virus (HCV) indicating presence of active viral 
replication (detectable HCV-ribonucleic acid [RNA]). Note: Participants with positive 
HCV antibody and an undetectable HCV RNA are eligible to enroll. 
k) Known human immunodeficiency virus (HIV) positive with an AIDS defining 
opportunistic infection within the last year, or a current CD4 count < 350 cells/uL. 
Participants with HIV are eligible if: 
i) they have received antiretroviral therapy (ART) for at least 4 weeks prior to 
randomization (Part 1) 
ii) they continue on ART as clinically indicated while enrolled on study. 
iii) CD4 counts and viral load are monitored per standard of care by a local healthcare 
provider. 
NOTE: Testing for HIV must be performed at sites where mandated locally. HIV positive 
participants must be excluded where mandated locally (see Appendix 10). 

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l) Evidence of organ dysfunction or any clinically significant deviation from normal in 
physical examination, vital sign, electrocardiograms, or clinical laboratory determinations 
beyond what is consistent with the target population. 
4) Allergies and Adverse Drug Reaction 
a) History of allergy or hypersensitivity to study drug components 
b) History of life-threatening toxicity related to prior immune therapy (eg. anti-CTLA-4 or 
anti-PD-1/PD-L1 treatment or any other antibody or drug specifically targeting T-cell co- 
stimulation or immune checkpoint pathways) except those that are unlikely to re-occur with 
standard countermeasures (eg. hypothyroidism). 
5) Other Exclusion Criteria 
a) Prisoners or participants who are involuntarily incarcerated. (Note: Under certain specific 
circumstances and only in countries where local regulations permit, a person who has been 
imprisoned may be included or permitted to continue as a participant. Strict conditions 
apply, and BMS approval is required.) 
 
Eligibility criteria for this study have been carefully considered to ensure the safety of the study 
participants and that the results of the study can be used. It is imperative that participants fully 
meet all eligibility criteria. 
6.3 
Lifestyle Restrictions (Arm A Only) 
6.3.1 
Meals and Dietary Restrictions 
Not applicable. 
 
 
 
 
 
 
 
 
 
 
 
6.4 
Screen Failures 
Not applicable per Protocol Amendment 01 (enrollment closed). 
Screen failures are defined as participants who consent to participate in the clinical study but who 
are not subsequently randomized (Part 1) 
in the study/included in the analysis 
population. 
A minimal set of screen failure information is required to ensure transparent reporting of screen 
failure participants, to meet the Consolidated Standards of Reporting Trials (CONSORT) 
publishing requirements, as applicable, and to respond to queries from regulatory authorities. 

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Minimal information includes date of consent, demography, screen failure details, eligibility 
criteria, and any serious AEs. 
6.4.1 
Retesting During Screening-in Period 
Not applicable per Protocol Amendment 01 (enrollment closed). 
Participant Re-enrollment: This study permits the re-enrollment of a participant who has 
discontinued the study as a pretreatment failure (ie, participant has not been randomized/has not 
been treated). If re-enrolled, the participant must be re-consented. 
A participant who is a pre-treatment failure in Part 1 (participant has not been randomized/has not 
been treated) 
If re-enrolled, the participant must be re-consented and assigned a new participant 
number. 
Retesting of laboratory parameters and/or other assessments within any single Screening period 
will be permitted (in addition to any parameters that require a confirmatory value). 
The most current result prior to randomization (Part 1) 
is the value 
by which study inclusion will be assessed, because it represents the participant’s most current 
clinical state. 
Laboratory parameters and/or assessments that are included in Table 2-1, Screening Procedural 
Outline, and Section 9.4.4, may be repeated in an effort to find all possible well-qualified 
participants. Consultation with the Medical Monitor may be needed to identify whether repeat 
testing of any particular parameter is clinically relevant. 
Testing 
for 
asymptomatic 
SARS-CoV-2 
infection, 
for 
example 
by 
reverse 
transcriptase-polymerase chain reaction (RT-PCR) or viral antigen is not required. However, some 
participants may develop suspected or confirmed symptomatic SARS-CoV-2 infection, or be 
discovered to have asymptomatic SARS-CoV-2 infection during the screening period. In such 
cases, participants may be considered eligible for the study after meeting all inclusion/exclusion 
criteria related to active infection, and after meeting the following criteria: 
• At least 10 days (20 days for severe/critical illness) have passed since symptoms first appeared 
or positive RT-PCR or viral antigen test result 
• At least 24 hours have passed since last fever without the use of fever-reducing medications 
• Acute symptoms (eg, cough, shortness of breath) have resolved 
• In the opinion of the investigator, there are no COVID-19-related sequelae that may place the 
participant at a higher risk of receiving investigational treatment 
• Negative follow-up SARS-CoV-2 RT-PCR or viral antigen test based on institutional, local, 
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7 
STUDY INTERVENTION(S) AND CONCOMITANT THERAPY 
Study intervention is defined as any investigational intervention(s), marketed product(s), placebo, 
procedure(s), 
 intended to be administered to a study participant according to the 
study protocol. 
Study intervention includes both Investigational [Medicinal] Product (IP/IMP) and 
Non-investigational/Auxiliary [Medicinal] Product (Non-IP/Non-IMP/AxMP) as indicated in 
Table 7.1-1. 
An IP, also known as IMP in some regions, is defined a pharmaceutical form of an active substance 
or placebo being tested or used as a reference in a clinical study, including products already with 
a marketing authorization but used or assembled (formulated or packaged) differently from the 
authorized form, or used for an unauthorized indication, or when used to gain further information 
about the authorized form. 
Other medications used as support or escape medication for preventative, diagnostic, or therapeutic 
reasons, as components of the standard of care for a given diagnosis, may be considered 
as -IPs/AxMPs. 

 
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Study Interventions Administered 
Table 7.1-1: 
Study Interventions 
 
ARM Name 
Arm A 
Nivolumab SC 
Arm B 
Nivolumab IV 
Intervention Name 
Nivolumab/rHuPH20 
BMS-986298 
Nivolumab 
BMS-936558 
Type 
 
Drug 
Dose Formulation 
SC injection 
Solution for injectiona 
Dosage Level(s) 
Nivolumab 600 mg 
 
Once Q2W for up to 52 weeks 
Nivolumab 240 mg Q2W for 16 weeks (8 doses) 
Nivolumab 480 mg 
Q4W for 36 weeks (9 doses) 
Route of Administration 
SC injection 
IV infusion 
IMP and Non-IMP 
IMP 
IMP 
Sourcing 
Provided centrally by the Sponsor 
Provided centrally by the Sponsor 
Packaging and Labeling 
Study intervention will be provided in vial(s) in a carton. 
Each vial(s) and carton will be labeled as required per 
country requirement. 
Current/Former 
Name(s) or Alias(es) 
N/A - see intervention name 
Opdivo 
Abbreviations: 
 ; IMP, investigational medicinal product; IV, intravenous; N/A; not applicable; 
Q2W, every 2 weeks; Q4W, 
every 4 weeks; rHuPH20, recombinant human hyaluronidase PH20 enzyme; SC, subcutaneous; U, units. 
a “Concentrate for Solution for Infusion” is also being used for certain countries for dose formulation to align with the commercial Opdivo product. 
 
 
 
 
 
 
 
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7.1.1 
Study Treatment Details for Intravenous Administration of Nivolumab 
Participants randomized to Arm B will receive nivolumab at a dose of 240 mg over an 
approximately 30-minute IV infusion Q2W on Days 1 and 15 of the first 4 treatment cycles. 
Subsequently, participants will receive nivolumab at a dose of 480 mg over an approximately 
30-minute IV infusion Q4W on Day 1 of each treatment cycle starting at Cycle 5, Day 1 until 
disease recurrence, unacceptable toxicity, withdrawal of consent, a maximum of 52 weeks of 
treatment from first dose, death, or the end of study, whichever occurs first. If needed, flush the 
intravenous line with an appropriate amount of diluent (eg, 0.9% Sodium Chloride or 5% Dextrose 
in water) to ensure that the complete dose is administered over approximately 30 minutes. Begin 
study treatment within 3 calendar days of randomization. 
There will be no intra-participant dose escalations or reductions of nivolumab allowed. For Q2W 
dosing cycles, participants may be dosed no less than 12 days from the previous dose. The dosing 
window is ± 3 days. Premedications are not recommended for the first dose of nivolumab. 
Monitor participants carefully for infusion-site reactions during nivolumab administration and 
assess the infusion site following the infusion during Cycle 1, Days 1 and 15. If an acute infusion 
reaction is noted, manage participants according to Section 7.4.5. 
Doses of study drug(s) may be interrupted, delayed, or discontinued depending on how well the 
participant tolerates the treatment. Dosing visits are not skipped, only delayed. 
Please refer to the current Investigator Brochure and/or Pharmacy Manual for further details 
regarding storage, preparation, and administration of nivolumab. 
Care must be taken to assure sterility of the prepared solution as the product does not contain any 
antimicrobial preservative or bacteriostatic agent. 

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7.2 
Method of Study Intervention Assignment 
Before the study is initiated, designated site staff will receive log-in information and directions on 
how to access the IRT. Each participant will be assigned a unique participant number known as 
patient identification number (PID) after signing the consent. Participant’s study information and 
data will be recorded only using the patient identification number. Participant numbers will not be 
reassigned. An IRT will be employed to manage participant randomization, treatment assignment, 
and dispensation of study drug. The investigator or designee will register the participant for 
enrollment by following the enrollment procedures established by BMS. 
The following information is required for enrollment: 
• Date that informed consent was obtained 
• Year of birth 
• Gender at birth 
 
Participants who have met all eligibility criteria will be randomized in a 1:1 ratio and stratified by 
weight (< 80 kg vs ≥ 80 kg) and AJCC 8th edition staging (Stage IIIA/B vs Stage IIIC/D/IV). 

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The exact procedures for using the IRT will be detailed in the IRT manual. 
7.3 
Blinding 
This is a randomized and open-label study. It has been determined that blinding is not required to 
meet study objectives. Blinding procedures are not applicable and access to treatment assignment 
information is unrestricted. The specific treatment to be taken by a participant will be assigned 
using IRT. The site will contact the Interactive Response System prior to the start of study 
intervention administration for each participant. 
As this study is open-label, blinding is not applicable; however, the specific treatment will be 
assigned using IRT. The bioanalytical laboratory will receive treatment assignments in order to 
minimize unnecessary analysis of samples and/or to be able to determine dilutions. 
7.4 
Dosage Modification 
7.4.1 
Dose Delay Criteria for Nivolumab In-Clinic 
Dose delay criteria apply for all drug-related adverse events. Delay administration of nivolumab 
(SC AI or IV) if any of the delay criteria in Table 7.4.2-1 are met. Delay nivolumab dosing for any 
adverse event, laboratory abnormality, or intercurrent illness which, in the judgment of the 
investigator, warrants delaying the dose of study medication. 
Dose must be delayed for SARS-CoV-2 infection either confirmed or suspected. 
For participants who require delay of nivolumab, re-evaluate weekly, or more frequently, if 
clinically indicated and resume dosing when criteria to resume treatment are met. (see Section 
7.4.3). Continue efficacy surveillance per protocol even if dosing is delayed. 
No dose escalations or reductions for nivolumab are permitted. 

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Adverse Event Criteria for Delay, Resume, and Discontinue of Nivolumab 
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Drug-Related Adverse 
Event (AE) per CTCAE V5 
Severity 
Action Taken 
Clarifications, Exceptions, and Resume Criteria 
Gastrointestinal 
Colitis or Diarrhea 
Grade 2 
Delay dose 
Dosing may resume when AE resolves to baseline 
Grade 3 
Delay dose 
Dosing may resume when AE resolves to baseline 
Grade 4 
Permanently 
discontinue 
Renal 
Serum Creatinine Increased 
Grade 2 or 3 
Delay dose 
Dosing may resume when AE resolves to Grade ≤ 1 or 
baseline value 
Grade 4 
Permanently 
discontinue 
Pulmonary 
Pneumonitis 
Grade 2 
Delay dose 
Dosing may resume after pneumonitis has resolved to ≤ 
Grade 1. 
Grade 3 or 4 
Permanently 
discontinue 
Hepatic 
Aspartate aminotransferase 
(AST), alanine 
aminotransferase (ALT), or 
total bilirubin (T.bili) 
increased 
AST or ALT > 3x and ≤5x upper 
limit of normal (ULN) or T.Bili 
>1.5x and ≤3x ULN, regardless of 
baseline value 
Delay dose 
Dosing may resume when laboratory values return to 
baseline. 
AST or ALT > 5 x ULN or T. bili > 
3 x ULN, regardless of baseline 
value 
Delay dose or 
permanently 
discontinue 
In most cases of AST or ALT > 5 x ULN or T.bili >3x ULN, 
study treatment will be permanently discontinued. If the 
investigator determines a possible favorable benefit/risk ratio 
that warrants continuation of study treatment, a discussion 
between the investigator and the Medical Monitor/ designee 
must occur and approval from Medical Monitor prior to 
resuming therapy. 

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Drug-Related Adverse 
Event (AE) per CTCAE V5 
Severity 
Action Taken 
Clarifications, Exceptions, and Resume Criteria 
Concurrent AST or ALT > 3 x 
ULN and T.bili > 2 x ULN, 
regardless of baseline value 
Permanently 
discontinue 
Endocrinopathy 
Adrenal Insufficiency 
Grade 2 adrenal insufficiency 
Delay dose 
Dosing may resume after adequately controlled with 
hormone replacement. 
Grade 3 or 4 adrenal insufficiency 
or adrenal crisis 
Delay dose or 
permanently 
discontinue 
Mandatory discussion with and approval from the Medical 
Monitor needed prior to resuming therapy. If adrenal 
insufficiency resolves or is adequately controlled with 
physiologic hormone replacement, participant may not 
require discontinuation of study drug. 
Hyperglycemia 
Hyperglycemia requiring initiation 
or change in daily management 
(Grade 2 or 3) 
Delay dose 
Dosing may resume if hyperglycemia resolves to Grade ≤1 
or baseline value, or is adequately controlled with glucose- 
controlling agents. 
Grade 4 
Delay dose or 
permanently 
discontinue 
Mandatory discussion with and approval from the Medical 
Monitor needed prior to resuming therapy. If hyperglycemia 
resolves, or is adequately controlled with glucose-controlling 
agents, participant may not require discontinuation of study 
drug. 
Hypophysitis/Hypopituitarism 
Symptomatic Grade 1-3 that is also 
associated with corresponding 
abnormal lab and/or pituitary scan 
Delay dose 
Dosing may resume if endocrinopathy resolves to be 
asymptomatic, or is adequately controlled with only 
physiologic hormone replacement. 
Grade 4 
Delay dose or 
permanently 
discontinue 
Mandatory discussion with and approval from the Medical 
Monitor needed prior to resuming therapy. If endocrinopathy 
resolves or is adequately controlled with physiologic 
hormone replacement, participant may not require 
discontinuation of study drug. 
Grade 2 or 3 
Delay dose 
Dosing may resume if endocrinopathy resolves to be 
asymptomatic, or is adequately controlled with only 

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Drug-Related Adverse 
Event (AE) per CTCAE V5 
Severity 
Action Taken 
Clarifications, Exceptions, and Resume Criteria 
Hyperthyroidism or 
Hypothyroidism 
physiologic hormone replacement or other medical 
management. 
Grade 4 
Delay dose or 
permanently 
discontinue 
Mandatory discussion with and approval from the Medical 
Monitor needed prior to resuming therapy. If endocrinopathy 
resolves or is adequately controlled with physiologic 
hormone replacement or other medical management, 
participant may not require discontinuation of study drug. 
Skin 
Rash 
Grade 2 rash covering >30% body 
surface area or Grade 3 rash 
Delay dose 
Dosing may resume when rash reduces to ≤10% body 
surface area 
Suspected Stevens-Johnson 
syndrome (SJS), toxic epidermal 
necrolysis (TEN) or drug reaction 
with eosinophilia and systemic 
symptoms (DRESS) 
Delay dose 
Dosing may resume if SJS, TEN, or DRESS is ruled out and 
rash reduces to is ≤10% body surface area 
Grade 4 rash or confirmed 
SJS,TEN, or DRESS 
Permanently 
discontinue 
Neurological 
Guillain-Barre Syndrome 
(GBS) 
Any Grade 
Permanently 
discontinue 
Myasthenia Gravis (MG) 
Any Grade 
Permanently 
discontinue 
Encephalitis 
Any Grade encephalitis 
Delay dose 
After workup for differential diagnosis, (ie, infection, tumor- 
related), if encephalitis is not drug related, then dosing may 
resume when AE resolves 
Any Grade drug-related 
encephalitis 
Permanently 
discontinue 

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Drug-Related Adverse 
Event (AE) per CTCAE V5 
Severity 
Action Taken 
Clarifications, Exceptions, and Resume Criteria 
Myelitis 
Any Grade myelitis 
Delay dose 
After workup for differential diagnosis, (ie, infection, tumor- 
related), if myelitis is not drug related, then dosing may 
resume when AE resolves 
Any Grade drug-related myelitis 
Permanently 
discontinue 
Neurological (other than 
GBS, MG, encephalitis, or 
myelitis) 
Grade 2 
Delay dose 
Dosing may resume when AE resolves to baseline 
Grade 3 or 4 
Permanently 
discontinue 
Myocarditis 
Myocarditis 
Symptoms induced from mild to 
moderate activity or exertion 
Delay dose 
Dosing may resume after myocarditis has resolved 
Severe or life threatening, with 
symptoms at rest or with minimal 
activity or exertion, and/or where 
intervention indicated. 
Permanently 
discontinue 
Other Clinical AE 
Pancreatitis: 
Amylase or Lipase increased 
Grade 3 with symptoms 
Delay dose 
Note: Grade 3 increased amylase or lipase without signs or 
symptoms of pancreatitis does not require dose delay. 
Dosing may resume when participant becomes 
asymptomatic. 
Grade 4 
Permanently 
discontinue 
Uveitis 
Grade 2 uveitis 
Delay dose 
Dosing may resume if uveitis responds to topical therapy 
(eye drops) and after uveitis resolves to Grade ≤ 1 or 
baseline. If participant requires oral steroids for uveitis, then 
permanently discontinue study drug. 
Grade 3 or 4 uveitis 
Permanently 
discontinue 

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Drug-Related Adverse 
Event (AE) per CTCAE V5 
Severity 
Action Taken 
Clarifications, Exceptions, and Resume Criteria 
Other Drug-Related AE (not 
listed above) 
Grade 2 non-skin AE, except 
fatigue 
Delay dose 
Dosing may resume when AE resolves to Grade ≤ 1 or 
baseline value. 
Grade 3 AE - First occurrence 
lasting ≤ 7 days 
Delay dose 
Dosing may resume when AE resolves to Grade ≤ 1 or 
baseline value. 
Grade 3 AE- First occurrence 
lasting > 7 days 
Permanently 
discontinue 
Recurrence of Grade 3 AE of any 
duration 
Permanently 
discontinue 
Grade 4 or Life-threatening adverse 
reaction 
Permanently 
discontinue 
Other Lab abnormalities 
Other Drug-Related lab 
abnormality (not listed above) 
Grade 3 
Delay dose 
Exceptions: 
No delay required for: Grade 3 lymphopenia 
Permanent Discontinuation for: Grade 3 thrombocytopenia > 
7 days or associated with bleeding. 
Grade 4 
Permanently 
discontinue 
Exceptions: The following events do not require 
discontinuation of study drug: 
Grade 4 neutropenia ≤ 7 days 
Grade 4 lymphopenia or leukopenia 
Grade 4 isolated electrolyte imbalances/abnormalities that 
are not associated with clinical sequelae and are responding 
to supplementation/appropriate management within 72 hours 
of their onset 
Non-drug related AEs 
SARS-CoV-2 infection either 
confirmed or suspected 
N/A 
Delay Dose 
Participants with SARS-CoV-2 infection (either confirmed 
or suspected) may resume treatment after: 

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Drug-Related Adverse 
Event (AE) per CTCAE V5 
Severity 
Action Taken 
Clarifications, Exceptions, and Resume Criteria 
1) At least 10 days (20 days for severe/critical illness) have 
passed since symptoms first appeared or positive test result 
(eg, RT-PCR or viral antigen) 
2) Resolution of acute symptoms (including at least 24 hours 
passed since last fever without fever-reducing medications) 
3) Evaluation by the Investigator with confirmation that 
there are no sequelae that would place the participant at a 
higher risk of receiving investigational treatment 
4) Consultation with the BMS Medical Monitor/designee 
For suspected cases, treatment may also resume if SARS- 
CoV-2 infection is ruled-out as per institutional policy for 
testing of SARS-CoV-2 and other criteria to resume 
treatment are met. 
AEs, which in the judgement 
of investigator, require 
delaying dose 
N/A 
Delay Dose 
Infusion Reactions (manifested by fever, chills, rigors, headache, rash, pruritus, arthralgia, hypotension, hypertension, bronchospasm, or other 
allergic-like reactions.) 
Hypersensitivity reaction or 
infusion reaction 
Grade 3 or 4 
Permanently 
discontinue 
Refer to Section 7.4.5 on Treatment of Related Infusion 
Reactions 
Abbreviations: AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; BMS, Bristol-Myers Squibb; CTCAE, Common Terminology 
Criteria for Adverse Events; DRESS, drug reaction with eosinophilia and systemic symptoms; GBS, Guillain Barre syndrome; MG, myasthenia gravis; 
N/A, not applicable; RT-PCR, reverse transcriptase polymerase chain reaction; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; 
SJS, Stevens-Johnson syndrome; T.bili, total bilirubin; TEN, toxic epidermal necrolysis; ULN, upper limit of normal; v5, version 5. 

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7.4.3 
Criteria to Resume Treatment 
Participants may resume treatment with study drug if they have completed AE management 
(ie, corticosteroid taper) or are on ≤ 10 mg prednisone or equivalent, and meet the requirements 
per Table 7.4.2-1. 
Prior to re-initiating treatment in a participant with a dosing delay as defined below, the Medical 
Monitor must be consulted. 
• For Arm A, dosing delay > 6 weeks. 
• For Arm B, dosing delay > 6 weeks (Cycles 1 to 4) and > 10 weeks (Cycles 5 to 13). 
 
Continue tumor surveillance per protocol even if dosing is delayed. Continue periodic study visits 
to assess safety and laboratory studies every 4 weeks or more frequently if clinically indicated 
during such dosing delays. 
Participants with SARS-CoV-2 infection (either confirmed or suspected) may resume treatment 
after all of the following: 
• At least 10 days (20 days for severe/critical illness) have passed since symptoms first appeared 
or positive test result (eg, RT-PCR or viral antigen) 
• Resolution of acute symptoms (including at least 24 hours has passed since last fever without 
fever reducing medications) 
• Evaluation by the investigator with confirmation that there are no sequelae that would place 
the participant at a higher risk of receiving investigational treatment 
• Consultation by the Medical Monitor/designee. For suspected cases, treatment may also 
resume if SARS-CoV-2 infection is ruled-out and other criteria to resume treatment are met. 
 
For additional criteria to resume treatment for dosing of 
in the 
setting, please 
refer to Appendix 5. 
7.4.4 
Management Algorithms for Nivolumab 
Immuno-oncology (IO) agents are associated with AEs that can differ in severity and duration 
from AEs caused by other therapeutic classes. Nivolumab is considered an IO agent and the 
management algorithms in Appendix 7 provide guidance on assessing and managing the following 
groups of AEs: 
• Gastrointestinal 
• Renal 
• Pulmonary 
• Hepatic 
• Endocrinopathy 
• Skin 

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• Neurological 
• Myocarditis 
 
7.4.5 
Treatment of Related Infusion- and Injection-Reactions 
7.4.5.1 
Systemic Reactions Occurring In-clinic 
Since nivolumab contains only human immunoglobulin protein sequences, systemic 
hypersensitivity (allergic) reactions are unlikely. Although rare, if severe hypersensitivity were to 
occur, common manifestations might include fever, chills, rigors, headache, rash, pruritus, 
arthralgias, hypotension, hypertension, and/or bronchospasm. Report all Grade 3 or 4 
hypersensitivity reactions within 24 hours as an SAE. 
Treatment recommendations are provided below based on CTCAE v5 grading definitions and may 
be modified based on local treatment standards and guidelines, as appropriate: 
For Grade 1 symptoms (mild reaction; infusion/injection interruption not indicated; intervention 
not indicated): 
• Remain at bedside and monitor participant until recovery from symptoms. The following 
prophylactic premedications are recommended for future infusions and injections: 
diphenhydramine 50 mg (or equivalent) and/or acetaminophen/paracetamol 325 to 1000 mg at 
least 30 minutes before additional nivolumab administrations. 
 
For Grade 2 symptoms: (Therapy or infusion interruption indicated but responds promptly to 
symptomatic treatment (eg, antihistamines, NSAIDS, narcotics, IV fluids); prophylactic 
medications indicated for ≤ 24 hours): 
• Stop the study drug infusion/injection. Begin an IV infusion of normal saline and treat the 
participant 
with 
diphenhydramine 
50 
mg 
IV 
(or 
equivalent) 
and/or 
acetaminophen/paracetamol 325 to 1000 mg; remain at bedside and monitor participant until 
resolution of symptoms. Corticosteroid and/or bronchodilator therapy may also be 
administered as appropriate. For the participants receiving Nivo IV, if the infusion is 
interrupted, then restart the infusion at 50% of the original infusion rate when symptoms 
resolve; if no further complications ensue after 30 minutes, the rate may be increased to 100% 
of the original infusion rate. Monitor participant closely. If symptoms recur, then no further 
study medication will be administered at that visit. 
• For participants in Arm A (Nivo SC) who need to receive 2 sequential injections for a full 
dose, do not administer the second injection if symptoms are noted with the first injection, and 
follow the treatment instructions mentioned above. 
• For future infusions or injections, the following prophylactic premedications are 
recommended: diphenhydramine 50 mg (or equivalent) and/or acetaminophen/paracetamol 
325 to 1000 mg administered at least 30 minutes before nivolumab infusions or injections. If 
necessary, corticosteroids (up to 25 mg of hydrocortisone or equivalent) may be used. 

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For Grade 3 or 4 symptoms: (severe reaction, Grade 3: Prolonged (eg, not rapidly responsive to 
symptomatic medication and/or brief interruption of infusion); recurrence of symptoms following 
initial improvement; hospitalization indicated for clinical sequelae. Grade 4: Life-threatening 
consequences; urgent intervention indicated): 
• Immediately discontinue infusion/injection of study drug. Begin an IV infusion of normal 
saline and treat the participant as follows: Recommend bronchodilators, epinephrine 0.2 to 
1 mg of a 1:1000 solution for subcutaneous or intramuscular administration or 0.1 to 0.25 mg 
of a 1:10,000 solution injected slowly for IV administration, and/or diphenhydramine 50 mg 
IV with methylprednisolone 100 mg IV (or equivalent), as needed. Monitor participant until 
the investigator judges that the symptoms will not recur. Study drug will be permanently 
discontinued. Follow institutional guidelines for the treatment of anaphylaxis. Remain at 
bedside and monitor participant until recovery of the symptoms. 
• For participants in the Nivo SC arm (Arm A) who need to receive 2 sequential injections for a 
full dose, do not administer the second injection if symptoms are noted with the first injection, 
and follow the treatment instructions mentioned above. 
 
 
 
 
 
7.4.5.3 
Management of Local Infusion or Injection Site Reactions 
In the clinical experience with Nivo IV, no tissue necrosis has been observed after accidental 
extravasations 
of 
Nivo 
IV. 
The 
use 
of 
oral 
medications 
(eg, 
antihistamines, 
acetaminophen/paracetamol) and topically applied therapies such as cold packs and steroid or 
antihistamine creams or gels is allowed for the treatment of local injection reactions due to Nivo 
SC 
(eg, swelling, erythema, pain, induration, local pruritus) and infusion local site reactions 
(local inflammation, necrosis due to drug extravasation) including those related to procedures (eg, 
hematoma). Local/institutional guidelines, if available, can be followed. 
In case of late-occurring hypersensitivity symptoms (eg, appearance of a localized or generalized 
pruritus within 1 week after treatment), symptomatic treatment may be given (eg, oral 
antihistamine or corticosteroids). 

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7.5 
Preparation/Handling/Storage/Accountability 
Refer to the current version of the BMS-936558 IB for Nivo IV, the BMS-986298 IB for Nivo SC 
and the Pharmacy Manual for complete information on storage, handling, 
dispensing, and administration information. 
The IP/AxMP must be stored in a secure area according to local regulations. It is the responsibility 
of the investigator, or designee where permitted, to ensure that IP/AxMP is only dispensed to study 
participants. The IP/AxMP must be dispensed only from official study sites by authorized 
personnel according to local regulations. 
The product storage manager should ensure that the study intervention is stored in accordance with 
the environmental conditions (temperature, light, and humidity) as determined by BMS. If 
concerns regarding the quality or appearance of the study intervention arise, the study intervention 
should not be dispensed, and BMS should be contacted immediately. 
Study intervention not supplied by BMS will be stored in accordance with the package insert. 
IP/AxMP documentation (whether supplied by BMS or not) must be maintained that includes all 
processes required to ensure the drug is accurately administered. This includes documentation of 
drug storage, administration and, as applicable, storage temperatures, reconstitution, and use of 
required processes (eg, required diluents, administration sets). 
• The investigator or designee must confirm appropriate temperature conditions have been 
maintained during transit for all study intervention received and any discrepancies are reported 
and resolved before use of the study intervention. 
• The investigator, institution, or the head of the medical institution (where applicable) is 
responsible for study intervention accountability, reconciliation, and record maintenance 
(ie, receipt, reconciliation, and final disposition records). 
• Further guidance and information for the final disposition of unused study interventions are 
provided in Appendix 2. 
 
7.5.1 
Retained Samples for Bioavailability/Bioequivalence/Biocomparability 
At the time of receipt of the IP by the investigator or designee, BMS will specify the appropriate 
number of containers or units to select for retention, the conditions of sample storage, required 
duration of sample retention, and provisions for returning or disposing of the IP. When samples 
are selected, containers or units should be placed in packaging with a tamper-evident seal provided 
by BMS or sourced by the site. Package labeling should clearly identify the contents as retention 
samples and state that the IP should be stored in the restricted area with limited access. 
Additional details regarding the retention process will be provided in a Pharmacy Manual or other 
written documentation. 
7.6 
Treatment Compliance 
Study intervention compliance will be periodically monitored by drug accountability as well as 
the participant’s medical record and CRF. Drug accountability should be reviewed by the site study 

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staff at each in-clinic visit to confirm treatment compliance. Sites should discuss discrepancies 
with the participant at each on-treatment study visit. 
 
In addition, should the site identify a potential out-of-window dosing, the site must reach out to 
the participant and provide guidance on dosing, to be determined on a case-by-case basis (eg, to 
proceed immediately with dose, wait until the next dosing cycle, or delay the dose and resume 
treatment per investigator assessment). 
A record of the quantity of 
 dispensed to and administered by each participant must be 
maintained and reconciled with study intervention and compliance records. Intervention start and 
stop dates, including dates for intervention delays, will also be recorded in the CRF (in-clinic 
dosings) 
7.7 
Concomitant Therapy 
7.7.1 
Prohibited and/or Restricted Treatments 
Prohibited and/or restricted medications taken prior to study treatment administration are described 
below. Medications taken within 30 days prior to the first dose of study treatment must be recorded 
on the CRF. 
The following medications and treatments are prohibited during the study (unless utilized to treat 
a drug-related adverse event). 
• Immunosuppressive agents. 
• Immunosuppressive doses of systemic corticosteroids. Participants are permitted the use of 
topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal 
systemic absorption). Adrenal replacement steroid doses > 10 mg daily prednisone are 
permitted. A brief (less than 3 weeks) course of corticosteroids for prophylaxis (eg, contrast 
dye allergy) or for treatment of non-autoimmune conditions (eg, delayed-type hypersensitivity 
reaction caused by a contact allergen) is permitted. 
• Any concurrent systemic anti-neoplastic therapy, including any concurrent adjuvant therapy 
for melanoma or for a new malignancy. Participants who develop a new non-melanoma fully 
resectable malignancy (examples include but are not limited to in situ bladder cancer, in situ 
gastric cancer, or in situ colon cancers; in situ cervical cancers/dysplasia; or breast carcinoma 
in situ; or prostate carcinoma) during the study may continue receiving study drugs if the only 
therapy required is hormonal therapy, surgery, and/or radiation (and the surgery or radiation 
site does not overlap with a previous primary melanoma or melanoma metastasis location). 
Consultation with the Medical Monitor is required once a new malignancy is detected. 
• Any complementary medications (eg herbal supplements or traditional Chinese medicines) 
intended to treat the disease under study. Such medications are permitted if they are used as 
supportive care. 

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• Any live attenuated vaccine (eg, live COVID-19 vaccines, varicella, zoster, yellow fever, 
rotavirus, oral polio and measles, mumps, rubella [MMR]) during treatment and until 100 days 
post last dose. 
− COVID-19 vaccines that are NOT live are permitted prior to study, during the study, and 
after the last dose of nivolumab. Please contact the medical monitor with any questions 
related to COVID-19 vaccines. 
♦ The following are NOT considered live vaccines and the decision to vaccinate should 
be made by the investigator and participant: inactivated vaccines (eg, heat-killed and 
formalin-killed vaccines), subunit vaccines, toxoid vaccines, nucleic acid vaccines that 
do not encode potentially infectious virus (Pfizer/BioNTech and Moderna COVID-19 
vaccines) and replication-incompetent recombinant vector vaccines. If a study 
participant has received a live COVID-19 vaccine prior to screening, enrollment should 
be delayed until the impact of the vaccine is stabilized, UNLESS a delay would 
compromise participant health, as determined by the investigator in consultation with 
medical monitor. For COVID-19 vaccines requiring more than a single dose, the full 
series (eg, both doses of a 2-dose series) should be completed prior to enrollment when 
feasible, and when a delay in enrollment would not put the study participant at risk. 
Ideally, enrollment would occur after any acute reactions (eg, reactions occurring 
within 24 hours of vaccine administration) resolve. 
 
Supportive care for disease-related symptoms may be offered to all participants on the trial. 
7.7.2 
Other Restrictions and Precautions 
Participants are prohibited from joining another clinical trial while they are participating in this 
study. 
7.7.2.1 
Imaging Restriction and Precautions 
It is the local imaging facility’s responsibility to determine, based on participant attributes 
(eg, allergy history, diabetic history, and renal status), the appropriate imaging modality and 
contrast regimen per imaging study. Imaging contraindications and contrast risks are to be 
considered in this assessment. Participants with renal insufficiency are to be assessed as to whether 
or not they should receive contrast and if so, which contrast agent and dose is appropriate. Specific 
to MRI, participants with severe renal insufficiency (ie, estimated glomerular filtration rate [eGFR] 
< 30 mL/min/1.73 m2) are at increased risk of nephrogenic systemic fibrosis, therefore MRI 
contrast is contraindicated. In addition, participants may be excluded from MRI if they have 
tattoos, metallic implants, pacemakers, etc. This will be outlined in the image manual. 
Gentle hydration before and after IV contrast should follow local standard of care. The ultimate 
decision to perform MRI in an individual participant in this study rests with the site radiologist, 
the investigator, and standards set by the local Ethics Committee. 

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7.8 
Continued Access to Study Intervention After the End of the Study 
At the end of the study, BMS will not continue to provide BMS-supplied study intervention to 
participants/investigators unless BMS chooses to extend the study. The investigator should ensure 
that the participant receives appropriate standard of care to treat the condition under study. 
8 
DISCONTINUATION CRITERIA 
8.1 
Discontinuation From Study Intervention 
Participants MUST discontinue IP (and Non-IP/AxMP at the discretion of the investigator) for any 
of the following reasons: 
• Participant’s request to stop study intervention. Participants who request to discontinue study 
intervention will remain in the study and must continue to be followed for protocol-specified 
follow-up procedures. The only exception to this is when a participant specifically withdraws 
consent for any further contact with him/her or persons previously authorized by the participant 
to provide this information 
• Any clinical AE, laboratory abnormality, or intercurrent illness which, in the opinion of the 
investigator, indicates that continued participation in the study is not in the best interest of the 
participant 
• Termination of the study by BMS 
• Loss of ability to freely provide consent through imprisonment or involuntarily incarceration 
for treatment of either a psychiatric or physical (eg, infectious disease) illness. (Note: Under 
specific circumstances and only in countries where local regulations permit, a participant who 
has been imprisoned may be permitted to continue as a participant. Strict conditions apply, and 
BMS approval is required.) 
• Disease recurrence (local, regional, or distant) 
• Additional protocol-specified reasons for discontinuation (Section 8.1.1) 
• Pregnancy (refer to Section 9.2.5) 
• Significant noncompliance with protocol (eg, procedures, assessments, medications, etc.). The 
investigator should discuss such issues with the Medical Monitor. 
 
Refer to the Schedule of Activities for data to be collected at the time of treatment discontinuation 
and follow-up and for any further evaluations that can be completed. 
All participants who discontinue study intervention should comply with protocol-specified 
follow-up procedures as outlined in Section 2. The only exception to this requirement is when a 
participant withdraws consent for all study procedures, including post-treatment study follow-up, 
or loses the ability to consent freely (eg, is imprisoned or involuntarily incarcerated for the 
treatment of either a psychiatric or physical illness). 
If study intervention is discontinued prior to the participant’s completion of the study, the reason 
for the discontinuation must be documented in the participant’s medical records per local 
regulatory requirements in each region/country and entered on the appropriate CRF page. 

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8.1.1 
Nivolumab Discontinuation 
Nivolumab treatment must be permanently discontinued per criteria in Table 7.4.2-1 in 
Section 7.4. Discontinue nivolumab for any adverse event, laboratory abnormality, or intercurrent 
illness which, in the judgment of the investigator, presents a substantial clinical risk to the 
participant with continued nivolumab dosing. 
Any event that leads to delay in dosing from the previous dose as described in Section 7.4.3 
requires discontinuation of study treatment, with the following exceptions: 
• Dosing delays to allow for prolonged steroid tapers to manage drug-related adverse events are 
allowed. 
• Dosing delays lasting longer than those described in Section 7.4.3 that occur for non-drug- 
related reasons may be allowed if approved by the Medical Monitor (or designee). 
 
8.1.2 
Post-study Intervention Study Follow-up 
Per Protocol Amendment 01, survival follow-up is not required. Participants will be followed 
for assessment of safety through 100 days (± 7 days) after the last dose of study treatment. 
Participants will not be followed for survival. 
The following information refers to the original study design: In this study, overall survival is 
a key endpoint of the study. Post-study follow-up is of critical importance and is essential to 
preserving participant safety and the integrity of the study. Participants who discontinue study 
intervention must continue to be followed (in this study or a rollover study) for collection of 
outcome as required and in line with Section 5 until death or the conclusion of the study. 
BMS may request that survival data be collected on all treated/randomized/assigned participants 
outside of the protocol defined window as defined in Section 2. At the time of this request, each 
participant will be contacted to determine their survival status unless the participant has withdrawn 
consent for all contact or is lost to follow-up. 
Participants who discontinue study intervention may continue to be followed. 
8.2 
Discontinuation From the Study 
Participants who request to discontinue study intervention will remain in the study and must 
continue to be followed for protocol-specified follow-up procedures. The only exception to this is 
when a participant specifically withdraws consent for any further contact with him/her or persons 
previously authorized by participant to provide this information. 
• Participants should notify the investigator of the decision to withdraw consent from future 
follow-up. 
• The withdrawal of consent should be explained in detail in the medical records by the 
investigator, as to whether the withdrawal is from further treatment with study intervention 
only or also from study procedures and/or post-treatment study follow-up, and entered on the 
appropriate CRF page. 

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• In the event that vital status (whether the participant is alive or dead) is being measured, 
publicly available information should be used to determine vital status only as appropriately 
directed in accordance with local law. 
• 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. 
 
8.2.1 
Individual Discontinuation Criteria 
• A participant may withdraw completely 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. This is expected to be uncommon. Stopping study 
intervention is not considered withdrawal from the study. 
• At the time of discontinuing from the study, if possible, an early termination visit should be 
conducted, as shown in the Schedule of Activities. See the Schedule of Activities for data to 
be collected at the time of study discontinuation and follow-up and for any further evaluations 
that need to be completed. 
• The participant will be permanently discontinued both from the study intervention and from 
the study at that time. 
• 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. 
 
8.3 
Lost to Follow-up 
The following actions must be taken if a participant fails to return to the clinic for a required study 
visit: 
• All reasonable efforts must be made to locate participants to determine and report their ongoing 
status. This includes follow-up with persons authorized by the participant. 
• Lost to follow-up is defined by the inability to reach the participant after a minimum of three 
(3) documented phone calls, faxes, or emails, as well as lack of response by participant to one 
(1) registered mail letter. All attempts should be documented in the participant’s medical 
records. 
• If it is determined that the participant has died, the site will use permissible local methods to 
obtain date and cause of death. 
• If the investigator’s use of third-party representative to assist in the follow-up portion of the 
study has been included in the participant’s informed consent, then the investigator may use a 
Sponsor-retained third-party representative to assist site staff with obtaining the participant’s 
contact information or other public vital status data necessary to complete the follow-up 
portion of the study. 
• The site staff and representative will consult publicly available sources, such as public health 
registries and databases, in order to obtain updated contact information. 
• If, after all attempts, the participant remains lost to follow-up, then the last known alive date 
as determined by the investigator should be reported and documented in the participant’s 
medical records. 

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9 
STUDY ASSESSMENTS AND PROCEDURES 
• Study procedures and timing are summarized in the Schedule of Activities (see Section 2). 
• Protocol waivers or exemptions are not allowed. 
• All immediate safety concerns must be discussed with the Sponsor immediately upon 
occurrence or awareness to determine if the participant should continue or discontinue 
treatment. 
• Adherence to the study design requirements, including those specified in the Schedule of 
Activities, is essential and required for study conduct. 
• All screening evaluations must be completed and reviewed to confirm that potential 
participants meet all eligibility criteria before randomization. The investigator will maintain a 
screening log to record details of all participants screened and to confirm eligibility or record 
reasons for screening failure, as applicable. 
• Procedures conducted as part of the participant’s routine clinical management (eg, blood count) 
and obtained before signing of informed consent may be utilized for screening or baseline 
purposes provided the procedure meets the protocol-defined criteria and has been performed 
within the timeframe defined in the Schedule of Activities. 
• Perform additional measures, including non-study required laboratory tests, as clinically 
indicated or to comply with local regulations. Laboratory toxicities (eg, suspected drug induced 
liver enzyme evaluations) will be monitored during the follow-up phase via on-site/local labs 
until all study drug-related toxicities resolve, return to baseline, or are deemed irreversible. 
• Evaluate participant immediately to rule out cardiac or pulmonary toxicity if participant shows 
cardiac or pulmonary-related signs (hypoxia, abnormal heart rate or changes from baseline) or 
symptoms (eg. dyspnea, cough, chest pain, fatigue, palpitations). 
• Some of the assessments referred to in this section may not be captured as data in the eCRF. 
They are intended to be used as safety monitoring by the treating physician. Additional testing 
or assessments may be performed as clinically necessary or where required by institutional or 
local regulations. 
• Repeat or unscheduled samples may be taken for safety reasons or for technical issues with the 
samples. 
 
9.1 
Imaging Assessments 
9.1.1 
Efficacy Assessment for the Study 
Study evaluations will take place in accordance with Section 2, Schedule of Activities. 
Contrast-enhanced CT of the chest, CT/MRI of the abdomen, pelvis, and all other known and/or 
suspected sites of disease is recommended to be performed; however, imaging per local standard 
of care is allowed. 
• Imaging of extremities for resected melanomas located in the extremities is not a requirement 
and may be conducted per local standard of care. Extremity imaging should be conducted in 
the event of a suspected locoregional relapse that is not clinically unequivocal. 
• If a PET-CT was obtained within 28 days prior to randomization and the site can document 
that a CT performed as part of a PET-CT is of identical diagnostic quality to a diagnostic CT 

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(with intravenous and oral contrast), then that CT portion of the PET-CT can be used for 
eligibility assessment. 
 
Participants without a history of brain metastases should have brain imaging if clinically indicated. 
If a participant starts systemic therapy for melanoma recurrence or for a new non-melanoma tumor 
after study drug discontinuation, follow-up scans for this trial should be discontinued. 
9.1.2 
Imaging Assessment for the Study 
Images are not required to be submitted to a central imaging vendor and will not undergo blinded 
independent central review. Prior to scanning first participant, sites should review and understand 
the image acquisition guidelines and submission process as outlined in the Imaging Manual 
provided by the central imaging vendor. 
Screening and on study images should be acquired as outlined in Section 2, Schedule of Activities. 
Tumor assessments at unscheduled time points and/or at an outside institution may be performed 
if clinically indicated and should be submitted to the central imaging vendor as soon as possible. 
Unscheduled CT/MRI should be submitted to central imaging vendor. X-rays and bone scans that 
clearly demonstrate recurrence of disease, for example most commonly as unequivocal lesions that 
are unmistakably new since the prior CT/MRI, should be submitted to central imaging vendor. 
Otherwise, they do not need to be submitted centrally. 
Assessments for recurrence should preferably continue on the protocol-defined imaging schedule 
regardless if dosing is delayed or discontinued; however, imaging based on local standard of care 
is allowed. Assessment should be performed by the same investigator or designee at all time points 
and should continue until recurrence. 
• For all participants: until local, regional, or distant recurrence, or up to the 100-day safety 
follow-up (whichever comes first), loss to follow-up, withdrawal of consent, or death. 
• If a participant starts systemic therapy for melanoma recurrence or for a new non-melanoma 
tumor after study drug discontinuation, follow-up scans for this trial should be discontinued. 
 
It is recommended that the same method of assessment used at Screening should be used for on- 
study time points. CT images should be acquired with slice thickness of 5 mm or less with no 
intervening gap (contiguous). In case of contraindication for CT or MRI (including intravenous 
contrast) it is strongly recommended to adhere to the following guidance: 
• If a participant has a contraindication for CT intravenous contrast, then a non-contrast CT of 
the chest and a contrast-enhanced MRI of the abdomen, pelvis, and other known/suspected 
sites of disease should be obtained. 
• If a participant has a contraindication for both CT and MRI intravenous contrasts, a non- 
contrast CT of the chest and a non-contrast MRI of the abdomen, pelvis, and other 
known/suspected sites of disease should be obtained. 

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• If a participant has a contraindication for MRI (eg, incompatible pacemaker) in addition to 
contraindication to CT intravenous contrast, then a non-contrast CT of the chest, abdomen, 
pelvis, and other known/suspected sites of disease is acceptable. 
 
Refer to Appendix 10: Country Specific Requirements for possible exceptions. 
Other imaging may be collected per local standards, as clinically indicated. 
• Use of CT component of a PET-CT scanner: Combined modality scanning such as with 
positron emission tomography-computed tomography (PET-CT) is increasingly used in 
clinical care, and is a modality/technology that is in rapid evolution; therefore, the 
recommendations outlined here may change rather quickly with time. At present, low-dose or 
attenuation correction CT portions of a combined PET-CT are of limited use in 
anatomically -based efficacy assessments and it is therefore suggested that they should not be 
substituted for dedicated diagnostic contrast-enhanced CT scans for anatomically-based 
measurements. However, if a site can document that the CT performed as part of a PET-CT is 
of identical diagnostic quality to a diagnostic CT (with intravenous and oral contrast), then the 
CT portion of the PET-CT can be used for measurements. In this specific study, for example, 
PET-CT can be used to support assessment of disease-free status in case CT or MRI are 
inconclusive. 
 
9.1.3 
Investigator Assessment of Baseline Disease Status 
Participant eligibility must be confirmed by investigator prior to randomization. 
9.1.3.1 
Investigator Assessment of Recurrence 
The same method of assessment used at Screening is recommended to be used for on-study time 
points. Post-baseline assessments will be performed until disease recurrence as confirmed by 
investigator, death, or withdrawal from the study. 
• Tumor assessments for ongoing study treatment decisions will be completed by the 
investigator. 
• Additional imaging of potential disease sites should be performed whenever disease recurrence 
or occurrence of a secondary malignancy is suspected. 
• Brain CT or MRI with and without contrast or bone imaging during on-study treatment and 
follow-up periods should be obtained if clinically indicated. 
 
9.1.3.2 
General Considerations for Determining Recurrence 
• The goal is to identify lesions suspicious for recurrence of melanoma. If it is believed that a 
lesion is NOT malignant in nature (eg, infection, trauma), it should be noted in the medical 
records. The specified minimum size criteria should be combined with radiographic 
appearance consistent with recurrent tumor in the assessment of all suspicious lesions. 
• Non-melanoma primary cancer will be censored. 

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• Equivocal recurrence is upgraded to unequivocal recurrence (except in cases of CNS 
recurrence) by one or more of the following: 
− A subsequent scan not earlier than 4 weeks from the time when recurrence was first 
suspected demonstrates that the lesion size is ≥ 5 mm over the size previously recorded, or 
the radiographic appearance of the lesion has become consistent with tumor recurrence. If 
this occurs, the date of recurrence will be the date when the lesion was first suspected. 
− Positive histology/cytology 
• Appearance of multiple new lesions in the same time point generally constitutes unequivocal 
recurrence, even though they may be from different organs (eg, one liver lesion, one lung 
lesion, and one enlarged lymph node). 
 
Criteria for Diagnosing Recurrences is presented in Table 9.1.3.2-1. 
Table 9.1.3.2-1: 
Criteria for Diagnosing Recurrence 
 
Anatomic Sites 
Criteria 
Non-Nodal Soft 
Tissue 
Equivocal lesions include: 
• 
Solitary lesion measuring < 10 mm in LD or with radiographic appearance equivocal for 
tumor recurrence. 
Unequivocal lesions include: 
• 
One or more new lesions > 10 mm in LD with radiographic appearance consistent with 
tumor recurrence. 
• 
Positive histology/cytology. 
Bone Lesions 
Equivocal lesions include: 
• 
Solitary lesion. 
• 
Lesions identified on radionuclide bone scan. Findings on radionuclide bone scan must 
be confirmed by CT, MRI, or plain films in order to be upgraded to unequivocal. 
Unequivocal lesions include: 
• 
Two or more new lesions consistent with tumor recurrence. 
• 
Positive histology/cytology. 
Lymph Nodesa 
Normal lymph nodes are defined as < 10 mm in the SAD. 
Equivocal lymph nodes include: 
• 
Lymph nodes measuring 10–14 mm SAD with radiographic appearance consistent with 
recurrence. 
• 
Lymph nodes ≥ 15 mm SAD without radiographic appearance consistent with 
recurrence. 
Unequivocal proof of nodal recurrence includes: 
• 
One or more previously normal or equivocal lymph nodes that enlarge to ≥ 15 mm SAD 
and with radiographic appearance consistent with recurrence. 
• 
Positive histology/cytology 
Fluid Collections 
(eg, ascites, 
pleural/pericardial 
effusions) 
• 
Presence of fluid alone, without pathological confirmation, does not constitute 
equivocal or unequivocal recurrence. 
• 
Unequivocal proof of recurrence is positive pathology of malignant cells from fluid(s). 

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Table 9.1.3.2-1:    Criteria for Diagnosing Recurrence 
 
Anatomic Sites 
Criteria 
CNS 
Unequivocal recurrence is defined as any new CNS lesion of any size on CT or MRI with a 
radiographic appearance consistent with tumor recurrence. 
Abbreviations:  CNS,  central  nervous  system;  CT,  computed  tomography;  LD,  longest  diameter; 
MRI, magnetic resonance imaging; SAD, short-axis diameter. 
a For lymph node with short axis 10-15 mm, consider biopsy when lymph node is progressively enlarged as 
evidenced. 
 
9.1.3.3 
Definitions 
Recurrence is defined as the appearance of one or more new melanoma lesions (except MMIS), 
which can be local, regional, or distant in location from the primary resected site. 
Local Cutaneous Recurrence 
Local recurrence is defined as tumor regrowth within 2 cm of the surgical incision following 
definitive excision of a primary melanoma with appropriate surgical margins. Lesions must be 
unequivocal. Local cutaneous recurrence after adequate excision of the primary melanoma is 
associated with aggressive tumor biologic features and is frequently a harbinger of metastases. 
In Transit Metastasis Recurrence 
Any skin or subcutaneous metastases more than 2 cm from the primary melanoma lesion, but not 
beyond the regional lymph node. When present, in transit metastases are usually multiple, evolve 
over time, and, as previously stated, are often the harbinger of subsequent systemic disease. 
Regional Nodal Recurrences 
Regional node failure, usually at the periphery of the prior surgical procedure. Lesions must be 
unequivocal as noted in Table 9.1.3.2-1. 
Distant Recurrence 
Any distant metastases with radiographic appearance consistent with tumor recurrence or positive 
histology/cytology (typically defined as any M except for M0). Distant metastases include node 
relapses beyond the anatomical compartment of the primary melanoma basin, a nodal basin 
situated in a different anatomical compartment beyond the primary melanoma lesion, or in 2 nodal 
basins (even if contiguous; ie, 2 pelvic nodal basins, 2 mediastinal nodal basins, etc). 
Considerations for establishing distant recurrence on cross-sectional imaging: 
• CT and MRI are an important part of the work-up to establish recurrence. Contrast-enhanced 
CT and MRI are the preferred imaging modalities. See Section 9.1.1 for details. 
• Positron emission tomography (PET) alone will not be considered for the disease assessment. 
Complementary CT and/or MRI or biopsy must be performed in such cases. 
• Cytology and/or histology are mandatory to confirm recurrence in solitary or in doubtful 
lesions, cutaneous, subcutaneous, or lymph node lesions. Histological or cytological evidence 

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of recurrence should be attempted in all cases (except for brain metastases) when safe and 
clinically feasible. 
 
Clinically detected new lesions: 
• The neoplastic nature of superficial cutaneous lesions must be confirmed by 
cytology/histology. 
• Deep subcutaneous lesions and lymph node lesions should be documented by ultrasound, and 
histological/cytological evidence should be attempted. In absence of pathology report, lesion 
recurrence will be documented with a CT scan/MRI. 
• Tumor markers or auto-antibodies alone cannot be used to assess recurrence. 
 
9.1.3.4 
Date of Recurrence 
The first date when recurrence was observed is taken into account regardless of the method of 
assessment. Therefore, recurrence will be declared for any lesion when: 
• Only imaging was performed and recurrence confirmed 
• Only pathology was done and malignancy confirmed (in solitary or in doubtful lesions, 
cutaneous, subcutaneous, or lymph node lesions) 
• Both pathology and imaging were done and recurrence/malignancy confirmed. In this case, the 
date of whichever examination comes first is considered the date of recurrence. 
 
Pathology reports of biopsies confirming recurrence should be sent to a central vendor. 
Note: For documentation, the date of recurrence is the date that the pathology and/or imaging 
confirms recurrence - not the date that the information was communicated to the participant. 
9.1.4 
Health Outcomes Assessments 
Health outcomes assessment data will be collected using electronic data collection methods at 
designated times during treatment and in follow-up. If exceptional circumstances preclude the 
continued administration of measures using planned modalities, then alternate administration 
methods may be required, after consultation with Sponsor or the Sponsor’s representative. 
PRO data has been collected in Study CA2096GE. In this amendment, we are proposing to remove 
all PRO data collection in order to reduce participant and site burden now that this study is being 
stopped. The PRO data that has been collected will not be analyzed as part of the statistical analysis 
plan (SAP) due to the very limited amount of data; however, the data may be used internally at 
some point in the future to help develop PRO strategies in future clinical trials. 
9.1.4.1 
FACT-G7 (Part 1 Only) 
Not applicable per Protocol Amendment 01. The following information refers to the original 
study design. 

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The FACT-G7 is a shortened, 7-item version of the FACT-G designed to quickly and effectively 
capture the most relevant issues to cancer patients in a valid and reliable manner.39 The FACT-G7 
consists of 3 subdomains: Physical well-being, Emotional well-being, and Functional well-being. 
Item responses for all 7 items use a 5-point Likert scale (from 0 “Not at all” to 4 “Very much”). 
The questions are phrased with a recall period of “over the past 7 days.” The FACT-G7 can be 
used to rapidly assess top-rated symptoms and concerns for a broad spectrum of advanced cancers 
in clinical practice and research, as well as for quality reporting in cancer chemotherapy and 
radiation. The FACT-G7 will be completed by all participants in Part 1 of the study at every 
treatment cycle, safety follow-up, and survival follow-up (see Section 2 Schedule of Activities). 
9.1.4.2 
EQ-5D-5L (Part 1 Only) 
Not applicable per Protocol Amendment 01. The following information refers to the original 
study design. 
Participants’ reports of general health status are assessed using the EuroQoL Group’s 5-level EQ- 
5D (EQ-5D-5L) questionnaire.40 The EQ-5D-5L has 2 components: a descriptive system and a 
visual analogue scale (VAS). The EQ-5D-5L descriptive system comprises 5 dimensions: 
mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 
5 levels including no, slight, moderate, severe, and extreme or unable to. A dimension for which 
there are no problems is said to be at level 1, while a dimension for which there are extreme 
problems is said to be at level 5. Accordingly, the vectors 11111 and 55555 represent the best 
health state and the worst health state, respectively, described by the EQ-5D-5L. Altogether, the 
instrument describes 3,125 health states. Empirically derived weights can be applied to an 
individual’s responses to the EQ-5D-5L descriptive system to generate a utility index measuring 
the value to society of his or her current health. In addition, the EQ-5D-5L VAS allows respondents 
to rate their own current health on a 101-point scale ranging from best imaginable to worst 
imaginable health. 
The EQ-5D-5L has been shown to be a valid measure in a cancer patient population.41 Currently 
there are no published MIDs for EQ-5D-5L index change scores for the EQ-5D-5L in a cancer 
population; however a change of 7 points on the EQ-5D VAS score is considered clinically 
meaningful.42 All participants in Part 1 of the study will complete the EQ-5D-5L at every treatment 
cycle, safety follow-up, and survival follow-up (see Section 2 Schedule of Activities). 
9.1.4.3 
Modified CTSQ (Part 1 Only) 
Not applicable per Protocol Amendment 01. The following information refers to the original 
study design. 
The CTSQ assesses patient satisfaction and preference for cancer treatment. The original CTSQ 
contained 21 items spread across 5 domains, which was revised to a 16-item instrument measuring 
3 domains during validation: Expectations of Therapy — 5 items, Feelings about Side Effects — 
4 items, and Satisfaction with Therapy — 7 items.43 All items are scored on a 1-5 scale, with a 
value of 1 associated with the worst response and a value of 5 representing the best response with 
a recall period of past 24 hours. For each domain, if the minimum item completion standard is met, 

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the domain is scored as (mean of completed item scores - 1) × 25; otherwise, a missing value was 
assigned. The linear transformation results in a score ranging from 0 to 100 for each domain, with 
a higher score associated with the best outcome on each domain. For the purposes of the clinical 
trial, the instructions will be modified to include the terminology IV/SC, rather than IV/pills, and 
only the Satisfaction domain (7 items) of the CTSQ will be completed by all participants in Part 1 
of the study at selected time points during treatment (see Section 2 Schedule of Activities). 
9.1.4.4 
Modified TASQ (Part 1 Only) 
Not applicable per Protocol Amendment 01. The following information refers to the original 
study design. 
The TASQ was developed to assess patients’ perceptions and satisfaction with subcutaneous 
(TASQ-SC) or intravenous (TASQ-IV) treatment administration. The questionnaire has been 
validated in a cancer patient population.44 Each version of the TASQ (TASQ-IV and TASQ-SC) 
contains 19 items which comprise the 5 subdomains: Treatment satisfaction, Convenience, 
Physical impact, Psychological impact, and Impact on daily living. Although there is no specific 
recall period for either version of the TASQ, instructions provided indicate that the questionnaire 
should be completed after the most recent IV infusion or SC injection. Participants in Part 1 Arm 
B will complete the TASQ-IV and participants in Part 1 Arm A will complete the TASQ-SC. The 
questionnaire will be completed at specified time points during treatment (see Section 2, Schedule 
of Activities). 
9.1.4.5 
SIAQ (Part 1 Only) 
Not applicable per Protocol Amendment 01. The following information refers to the original 
study design. 
The SIAQ is a non-specific indication questionnaire that assesses patient overall experience with 
subcutaneous self-injection.45 The measure contains 2 parts with pre- (7 items) and post-injection 
(21 items) questionnaire. The post-injection questionnaire captures 6 main subdomains: feelings 
about injections (3 items), self-image (1 item), self-confidence (3 items), pain, and skin reactions 
during or after the injection (2 items), ease of use of the self-injection 
 (5 items), and 
satisfaction with self-injection (7 items). To reduce patient burden and avoid capturing the same 
concept multiple times using different measures, only the self-confidence subdomain will be 
completed by participants. Each of the items in the self-confidence subdomain response options 
from 1 “Not at all” to 5 “Extremely”. There is no specific recall period for the SIAQ; however the 
instructions state that the post-injection questionnaire must be answered by the participant after 
they self-inject. Therefore, if a caregiver or HCP administers the treatment, the participant would 
not complete the SIAQ. The SIAQ self-confidence subdomain will only be completed by 
participants who self-inject in Part 1 Arm A at specific time points during treatment. 
Caregivers/HCPs who administer treatment on behalf of the participant should not complete the 
SIAQ (see Section 2, Schedule of Assessments). 

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9.2 
Adverse Events 
The definitions of an AE or SAE can be found in Appendix 3. 
AEs will be reported by the participant (or, when appropriate, by a caregiver or a surrogate). 
The investigator and any qualified designees are responsible for detecting, documenting, and 
reporting 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 intervention or the study, or that caused 
the participant to discontinue before completing the study. 
Use CTCAE v5 definitions and grading for safety reporting of all AE and SAEs on the case report 
form. 
Immune-mediated adverse events (IMAEs) are AEs consistent with an immune-mediated 
mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection 
or tumor recurrence) have been ruled out. IMAEs can include events with an alternate etiology 
which were exacerbated by the induction of autoimmunity. Information supporting the assessment 
will be collected on the participant’s case report form. 
 

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Refer to Appendix 3 for SAE reporting. 
9.2.1 
Time Period and Frequency for Collecting AE and SAE Information 
All SAEs must be collected from the time of signing the consent, including those thought to be 
associated with protocol-specified procedures, and within 100 days following discontinuation of 
dosing. All AEs and SAEs, associated with confirmed or suspected SARS-CoV-2 infection must 
be collected from the date of the participant’s written consent until 100 days following 
discontinuation of dosing. 
Collect all nonserious adverse events (not only those deemed to be treatment-related) continuously 
during the treatment period and for a minimum of 100 days following discontinuation of dosing. 
The investigator must report any SAE that occurs after these time periods and that is believed to 
be related to study intervention or protocol-specified procedure (eg, a follow-up skin biopsy). 
• Medical occurrences that begin before the start of study intervention but after obtaining 
informed consent will be recorded on the appropriate section of the CRF module. 
• All SAEs will be recorded and reported to Sponsor or designee within 24 hours, as indicated 
in Appendix 3. 
• The investigator will submit any updated SAE data to the sponsor or designee within 24 hours 
of updated information being available. 
 
Investigators are not obligated to actively seek AEs or SAEs in former study participants. 
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 reasonably related to the study 
intervention or study participation, the investigator must promptly notify the Sponsor. 
The method of evaluating and assessing causality of AEs and SAEs and the procedures for 
completing and reporting/transmitting SAE reports are provided in Appendix 3. 
For participants who have been randomized or assigned to treatment and never treated with study 
drug, collect SAEs for 30 days from the date of randomization or treatment assignment. 
For participants who are enrolled but not randomized, all SAEs and AEs/SAEs related to 
SARS-CoV-2 must be collected for 30 days from the date of signing consent. 
9.2.2 
Method of Detecting AEs and SAEs 
AEs can be spontaneously reported or elicited during open-ended questioning, examination, or 
evaluation of a participant. Care should be taken not to introduce bias when collecting AEs and/or 
SAEs. Inquiry about specific AEs should be guided by clinical judgement in the context of known 
AEs, when appropriate for the program or protocol. 

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Every adverse event must be assessed by the investigator with regard to whether it is considered 
immune-mediated. For events which are potentially immune-mediated, additional information will 
be collected on the participant’s case report form. 
AEs, including SAEs, occurring during the 
 period should be collected during in-clinic 
visits and reported as early as possible (within 24 hours of learning of the SAE). 
9.2.3 
Follow-up of AEs and SAEs 
• Nonserious AEs should be followed to resolution or stabilization, or reported as SAEs if they 
become serious (see Appendix 3). 
• Follow-up is also required for nonserious AEs that cause interruption or discontinuation of 
study intervention and for those present at the end of study intervention as appropriate. 
• All identified nonserious AEs must be recorded and described on the nonserious AE page of 
the CRF (paper or electronic). Completion of supplemental CRFs may be requested for AEs 
and/or laboratory abnormalities that are reported/identified during the course of the study. 
 
All SAEs and AEs (SAEs and non-serious AEs) associated with confirmed or suspected 
SARS-CoV-2 infection will be followed until resolution, the condition stabilizes, the event is 
otherwise explained, the event is deemed irreversible, the participant is lost to follow-up (as 
defined in Section 8.3), or for suspected cases, until SARS-CoV-2 infection is ruled-out. 
Beyond 100 days from the last dose of study therapy, participants will be followed for drug-related 
AEs/SAEs until resolution, returns to baseline, or is deemed irreversible, or until the participant is 
lost to follow-up or withdraws study consent. 
Further information on follow-up procedures is given in Appendix 3. 
9.2.4 
Regulatory Reporting Requirements for SAEs 
• Prompt notification by the investigator to the Sponsor of SAEs is essential so that legal 
obligations and ethical responsibilities toward the safety of participants and the safety of a 
product under clinical investigation are met. 
• An investigator who receives an investigator safety report describing SAEs or other specific 
safety information (eg, summary or listing of SAEs) from the Sponsor will file it along with 
the Investigator’s Brochure and will notify the IRB/IEC, if appropriate according to local 
requirements. 
 
The Sponsor or designee must report AEs to regulatory authorities and ethics committees 
according to local applicable laws and regulations. A SUSAR (suspected, unexpected serious 
adverse reaction) is a subset of SAEs and must be reported to the appropriate regulatory authorities 
and investigators following local and global guidelines and requirements. 
9.2.5 
Pregnancy 
If, following initiation of the study intervention, it is subsequently discovered that a participant is 
pregnant or may have been pregnant at the time of study exposure, including during at least for 

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5 months after study product administration, the investigator must immediately notify the BMS 
Medical Monitor/designee of this event and complete and forward a Pregnancy Surveillance Form 
to the BMS designee within 24 hours of awareness of the event and in accordance with SAE 
reporting procedures described in Appendix 3. 
Follow-up information regarding the course of the pregnancy, including perinatal and neonatal 
outcome and, where applicable, offspring information, must be reported on the Pregnancy 
Surveillance Form. Protocol-required procedures for study discontinuation and follow-up must be 
performed on the participant. 
Not applicable for women not of childbearing potential (WNOCBP) - Protocol-required 
procedures for study discontinuation and follow-up must be performed on the participant. 
9.2.6 
Laboratory Test Result Abnormalities 
The following laboratory test result abnormalities should be captured on the nonserious AE CRF 
page or SAE eCRF, as appropriate. Paper forms are only intended as a back-up option when the 
electronic system is not functioning. 
• Any laboratory test result that is clinically significant or meets the definition of an SAE 
• Any laboratory test result abnormality that required the participant to have study intervention 
discontinued or interrupted 
• Any laboratory test result abnormality that required the participant to receive specific 
corrective therapy 
 
It is expected that, wherever possible, the clinical rather than laboratory term would be used by the 
reporting investigator (eg, anemia vs low hemoglobin value). 
9.2.7 
Potential Drug-Induced Liver Injury 
Wherever possible, timely confirmation of initial liver-related laboratory abnormalities should 
occur prior to the reporting of a potential DILI event. All occurrences of potential DILIs meeting 
the defined criteria must be reported as SAEs (see Section 9.2 and Appendix 3 for reporting 
details). 
Potential DILI is defined as: 
• AT (aminotransferase) (ie, ALT or AST) elevation > 3 times upper limit of normal (ULN) 
AND 
• Total bilirubin > 2 times ULN, without initial findings of cholestasis (elevated serum alkaline 
phosphatase) 
AND 
• No other immediately apparent possible causes of AT elevation and hyperbilirubinemia, 
including, but not limited to, viral hepatitis, pre-existing chronic or acute liver disease, or the 
administration of other drug(s) known to be hepatotoxic. 

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9.2.8 
Other Safety Considerations 
Any significant worsening of conditions noted during interim or final physical examinations, ECG, 
x-ray filming, or any other potential safety assessment required or not required by the protocol 
should also be recorded as a nonserious AE or SAE, as appropriate, and reported accordingly. 
9.3 
Overdose 
An overdose is defined as the accidental or intentional administration of any dose of a product that 
is considered both excessive and medically important. Overdoses that meet the regulatory 
definition of SAE will be reported as an SAE (see Appendix 3). 
Risk of intentional overdose in participants self-administering 
is minimized 
based on the following considerations: 
• CA2096GE will exclude participants with serious psychological and psychiatric disorders 
including participants with prior history of self-harm and suicidal attempts. 
• Melanoma is not included among the main cancers with higher risk of suicide. In addition, 
clinical factors associated with suicidality such as substantial pain, insomnia, fatigue, loss of 
autonomy and independence are not considered prevalent among the study population 
(adjuvant melanoma).46,47 
• The Pharmacy Manual details the required dose for Nivo 
 SC for the Q2W dosing frequency. 
 
9.4 
Safety 
Planned time points for all safety assessments are listed in the Schedule of Activities. 
9.4.1 
Physical Examinations 
Refer to Schedule of Activities, Section 2. 
9.4.2 
Vital Signs 
Refer to Schedule of Activities, Section 2. 
9.4.3 
Electrocardiograms 
Refer to Schedule of Activities, Section 2. 

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9.4.6 
Suicidal Risk Monitoring 
Not applicable. 
9.4.7 
Imaging/Other Safety Assessment 
Any incidental findings of potential clinical relevance that are not directly associated with the 
objectives of the protocol should be evaluated and handled by the study investigator as per standard 
medical/clinical judgment. 
9.5 
Pharmacokinetics 
Upon implementation of Protocol Amendment 01, sample collections for PK and ADAs are 
no longer necessary for any participant who is on study treatment. In the event samples are 
collected following implementation of Protocol Amendment 01, samples will be analyzed 
bioanalytically and reported as listings. 
The following information refers to the original study design. 
Actual times of sample collection will be used in all PK analyses. 
The nivolumab exposure measures (PK endpoints) to be assessed in the study include the 
following: 
• Cavgd28: time-averaged nivolumab serum concentration over the first 28 days 
• Cminss: trough nivolumab serum concentration at steady-state 
• Cmind28: trough nivolumab serum concentration on Day 28 
• Cmax1: maximum nivolumab serum concentration after the first dose 
• Tmax: time to Cmax1 
• Cavgss: time-averaged nivolumab serum concentration at steady-state 
• Cmaxss: maximum nivolumab serum concentration at steady-state 
 
Individual co-primary (Cavgd28 and Cminss in Part 1; Cavgd28 in 
and secondary 
(Cmind28, Cmax1, Tmax, Cavgss, and Cmaxss in Parts 1 and 2; Cminss in 
 PK endpoints 
will be determined using PPK analysis. Specifically, the structural, interindividual variability, 

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covariate, and residual error components of the previously developed combined SC and IV PPK 
model will be pre-specified and the population and individual PK parameters will be estimated 
using the data collected in this study. Individual PK exposure measures (ie, PK endpoints listed 
above) will be derived using the individual (empirical Bayes estimates) PK model parameters (eg, 
rate of absorption, bioavailability, clearance, volume of distribution) estimated by the model. The 
details of the PPK analysis will be presented in a pre-specified pharmacometrics analysis plan. 
The co-primary PK endpoints in Part 1 (Cavgd28 and Cminss) will be used for non-inferiority 
assessment as described in Section 10.4.2. 
9.5.1 
Pharmacokinetics and Anti-Drug Antibody Sample Collection and 
Processing 
Not applicable per Protocol Amendment 01. The following information refers to the original 
study design. 
A detailed schedule of PK and ADA evaluations is found in Table 9.5.1-1, Table 9.5.1-2, and Table 
9.5.1-3. Serial PK samples will be collected in all participants. All on-treatment PK time points 
are intended to align with days on which study treatment is administered. On-treatment PK samples 
are intended to be drawn relative to actual dosing days. 
Predose samples should be collected just before the administration of nivolumab (preferably within 
30 minutes). If it is known that a dose is going to be delayed, then collect the predose sample just 
prior to the delayed dose. However, if a predose sample is collected but the dose is subsequently 
delayed, an additional predose sample should not be collected. In Part 1, Arm B, the end of the 
infusion (EOI) occurs when the entire nivolumab dose in the infusion bag is administered to the 
participant. If the site infuses the drug without a flush, then collect the EOI-PK sample within 
approximately 5 minutes after EOI. If a flush is administered to clear the IV lines of the drug and 
to ensure delivery of the entire drug dose, then draw the EOI-PK sample within approximately 5 
minutes after the end of the flush. If the EOI is delayed to beyond the nominal infusion duration 
(30 minutes), the collection of the EOI-PK sample should be delayed accordingly. 
Draw blood samples from a site other than the infusion site (ie, contralateral arm) on days of 
infusion for all predose and EOI-PK samples. Please ensure accurate documentation of the time 
and date of sample collection. 
Samples will be evaluated for development of anti-drug antibodies (ADA). Samples may also be 
analyzed for neutralizing antibodies and PK samples may be used for ADA analysis in the event 
of insufficient volume, to complete immunogenicity assessment, or to follow-up on suspected 
immunogenicity-related AEs. 
Further details of sample collection, processing, and shipment will be provided in the laboratory 
procedures manual. 
Immunogenicity of nivolumab will be assessed per the SAP. PK data for rHuPH20 will not be 
collected in this study; however, immunogenicity data for rHuPH20 will be collected and may be 
analyzed and reported separately, as appropriate. 

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Table 9.5.1-1: 
Pharmacokinetic and Immunogenicity Sampling Schedule for Part 
1, Arm A (600 mg SC 
Q2W) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: ADA, anti-drug antibody 
hr, hour; IMG, immunogenicity; min, minute; PK, 
pharmacokinetic; Q2W, every 2 weeks; rHuPH20, recombinant human hyaluronidase PH20 enzyme; SC, 
subcutaneous. 
a rHuPH20 ADA predose samples on Cycle 1 Day 1 must be collected in all participants. 
b Take all predose samples for nivolumab prior to the start of the first of 2 SC nivolumab injection (preferably within 
30 minutes). If it is known that a dose is going to be delayed, then the predose sample should be collected just prior 
to the delayed dose. However, if a predose sample is collected but the dose is subsequently delayed, an additional 
predose sample should not be taken. 
c Biomarker testing will be conducted using an aliquot of PK or ADA serum sample. 
d If a participant discontinues study drug during the treatment/sampling period, move to sampling at the follow-up 
visits (Follow-up Visits 1 and 2 is 30 days and 100 days from date of last dose, respectively). 
 
 
Table 9.5.1-2: 
Pharmacokinetic and Immunogenicity Sampling Schedule for Part 
1 Arm B (240 mg IV Q2W for 4 Cycles then 480 mg IV Q4W) 
 
Study Day of Sample 
Collection 
(1 Cycle = 28 Days) 
Event 
Time Relative to 
Nivolumab Dose 
(hr:min) 
Nivolumab PK 
Serum Sample 
Nivolumab IMG 
(ADA) Serum 
Sample 
Cycle 1, Day 1 
Predosea 
0:00 
X 
X 
Study Day of Sample 
Collection 
(1 Cycle = 28 Days) 
Event 
Time Relative 
to Nivolumab 
Dose (hr:min) 
Nivolumab 
PK Serum 
Sample 
Nivolumab 
IMG (ADA) 
Serum Sample 
rHuPH20 
IMG (ADA) 
Plasma 
Samplea 
Cycle 1, Day 1 
Predoseb 
0:00 
X 
X 
X 
Cycle 1, Day 4 (± 1 day) 
72:00 
X 
Cycle 1, Day 8 (± 1 day) 
168:00 
X 
Cycle 1, Day 15 
Predoseb,c 
0:00 
X 
X 
X 
Cycle 1, Day 22 (± 1 day) 
168:00 
X 
Cycle 2, Day 1 
Predoseb,c 
0:00 
X 
X 
X 
Cycle 3, Day 1 
Predoseb 
0:00 
X 
X 
X 
Cycle 4, Day 1 
Predoseb,c 
0:00 
X 
Cycle 5, Day 1 
Predoseb 
0:00 
X 
X 
X 
Cycle 9, Day 1 
Predoseb 
0:00 
X 
X 
X 
Cycle 13, Day 1 
Predoseb 
0:00 
X 
X 
X 
Follow-up 1 and 2d 
X 
X 
X 
; 

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Table 9.5.1-2: 
Pharmacokinetic and Immunogenicity Sampling Schedule for Part 
1 Arm B (240 mg IV Q2W for 4 Cycles then 480 mg IV Q4W) 
 
Study Day of Sample 
Collection 
(1 Cycle = 28 Days) 
Event 
Time Relative to 
Nivolumab Dose 
(hr:min) 
Nivolumab PK 
Serum Sample 
Nivolumab IMG 
(ADA) Serum 
Sample 
End of infusionb 
See footnote 
X 
Cycle 1, Day 8 (± 1 day) 
168:00 
X 
Cycle 1, Day 15 
Predosea,c 
0:00 
X 
End of infusionb 
See footnote 
X 
Cycle 1, Day 22 (± 1 day) 
168:00 
X 
Cycle 2, Day 1 
Pre-dosea,c 
0:00 
X 
X 
Cycle 3, Day 1 
Predosea 
0:00 
X 
X 
Cycle 4, Day 1 
Predosea,c 
0:00 
X 
Cycle 5, Day 1 
Predosea 
0:00 
X 
X 
Cycle 9, Day 1 
Predosea 
0:00 
X 
X 
Cycle 13, Day 1 
Predosea 
0:00 
X 
X 
Follow-up 1 and 2c,d 
X 
X 
Abbreviations: ADA, anti-drug antibody; hr, hour; IMG, immunogenicity; min, minute; PK, pharmacokinetic; IV, 
intravenous; Q2W, every 2 weeks; Q4W, every 4 weeks. 
a Take all predose samples for nivolumab prior to the start of nivolumab infusion (preferably within 30 minutes). If 
it is known that a dose is going to be delayed, then the predose sample should be collected just prior to the delayed 
dose. However, if a predose sample is collected but the dose is subsequently delayed, an additional predose sample 
should not be taken. 
b Since the end of infusion-PK (EOI-PK) sample is drawn with the intent of accurately estimating the maximum 
concentration (Cmax) of the drug, draw the EOI-PK when all the study drug has been infused. If the site infuses 
drug without a flush, then collect the EOI-PK sample within approximately 5 minutes after end of infusion. If a 
flush is administered to clear the IV lines of the drug and to ensure delivery of the entire drug dose, then draw the 
EOI-PK sample within approximately 5 minutes after end of the flush. Do not draw EOI samples from the same IV 
access that the drug was administered. 
c Biomarker testing will be conducted using an aliquot of PK or ADA serum sample. 
d If a participant discontinues study drug during the treatment/sampling period, move to sampling at the follow-up 
visits (Follow-up Visits 1 and 2 is 30 days and 100 days from date of last dose, respectively). 

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9.5.2 
Pharmacokinetic and Immunogenicity Sample Analyses 
Treatment assignments will be released to the bioanalytical laboratory in order to minimize 
unnecessary analysis and/or reanalysis of PK/ADA samples. 
Concentration analyses for nivolumab will be performed by validated bioanalytical method(s). 

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Serum samples will be analyzed for nivolumab and anti-nivolumab ADAs, and plasma samples 
may be analyzed, as appropriate, for anti-rHuPH20 ADAs by validated immunoassays. Only 
samples that are positive for the presence of anti-nivolumab or anti-rHuPH20 binding antibodies 
will be analyzed as appropriate for anti-nivolumab and anti-rHuPH20 neutralizing activity. 
Bioanalytical samples designated for assessments (eg, immunogenicity, PK, or biomarker) from 
the same collection time point may be used interchangeably for analyses, if required (including, 
but not limited to, insufficient volume for complement assessment, to follow-up on suspected 
immunogenicity related AE, etc.) 
Additionally, residual bioanalytical samples will be archived and may be used for potential 
exploratory bioanalysis (including, but not limited to, analysis of drug-ADA immune complexes, 
metabolite analyses, etc) and or for additional method purposes (including, but not limited to, 
cross-validation, ADA/PK selectivity, cutpoint, etc.) 
9.6 
Immunogenicity Assessments 
Details regarding immunogenicity assessments can be found in Section 9.5.2. 
9.7 
Genetics 
Please refer to Section 9.8. 
9.8 
Biomarkers 
Not applicable per Protocol Amendment 01. The following information refers to the original 
study design. 
Serum and whole blood collected at time points indicated in Table 9.8-1 and
 may be 
used for but not limited to the measurement of deoxyribose nucleic acid (DNA) and protein 
biomarkers in the periphery. Features within the periphery have been established as 
pharmacodynamic biomarkers of nivolumab biological activity. These include increased soluble 
factors such as, but not limited to, chemokine (CXC) motif, CXC ligand-9 (CXCL9), and CXC 
ligand-10 (CXCL10). Pre- and on-treatment peripheral blood may be used to compare the 
pharmacodynamic activity between 
 and Nivo IV treatment arms. In addition to 
characterizing the pharmacodynamic activity of 
 and Nivo IV, data from these 
investigations may also be evaluated for associations with clinical efficacy and safety/toxicity 
(AE) data. To identify any potential imbalances in known prognostic factors in the tumor between 
SC 
and IV treatment arms, baseline tumor biomarkers may be compared between arms (may 
include, but are not limited to, PD-L1, tumor mutational burden [TMB], mutational status, and 
tumor inflammation). Optional tumor biopsies will also be collected upon recurrence (see Table 
9.8-1 and 
 Complete instructions on the collection, processing, handling, and 
shipment of all samples described herein will be provided in a separate Lab manual. 

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Table 9.8-1: 
Biomarker Sampling Schedule for Part 1 Arms A and B 
 
Study Day of Sample 
Collection 
(1 Cycle = 28 Days) 
Tumor 
Biopsy 
Serum 
Biomarkers 
SARS-CoV-2 
Serology 
Whole Blood DNA 
Screening 
Xa 
Cycle 1 Day 1 (Predose) 
Xb 
Xb 
X 
Cycle 1 Day 15 
Xc 
Cycle 2 Day 1 
Xc 
Cycle 4 Day 1 
Xc 
Upon recurrence (optional) 
X 
Abbreviations: DNA, deoxyribonucleic acid; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2. 
a Tissue availability must be determined during screening period. Submission of required tissue can occur during 
screening period (preferred); however, it must be submitted no later than 14 days post-randomization. 
b A single blood draw will be used for serum biomarkers and SARS CoV-2 serology. 
c Biomarker testing will be conducted using an aliquot of PK or ADA serum sample (see Table 9.5.1-1 and Table 
9.5.1-2). 

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9.8.1 
Tumor Acquisition 
Not applicable per Protocol Amendment 01. The following information refers to the original 
study design. 
Pre-treatment tumor samples are required from all participants. Sufficient, recent FFPE tumor 
tissue block, obtained from the recent resection (preferred) or from an archival biopsy conducted 
within 6 months prior to enrollment, must be submitted to the central laboratory. If an FFPE block 
is not available, a minimum of 15 unstained slides may be submitted. If despite best efforts, 
15 unstained slides are not obtainable, submission of 5 unstained slides is acceptable. Tissue 
availability needs to be determined during the screening period. It is recommended that tissue is 
submitted during the screening period; however, it must be submitted no later than 14 days post- 
randomization/treatment assignment. Biopsies should be obtained from core biopsy, punch biopsy, 
excisional biopsy, or surgical specimen. Fine-needle aspirates or other cytology samples are not 
acceptable. Preferably, participants should not have received any systemic anticancer therapy 
between time of tissue acquisition and randomization/treatment assignment. Submission of tumor 
biopsy upon recurrence is highly recommended but optional. Refer to the Laboratory Manual for 
detailed biopsy collection instructions. 
Pre-treatment tumor samples will be assessed for PD-L1 expression using the Dako PD-L1 
immunohistochemistry 28-8 pharmDx validated assay. PD-L1 stained tissue sections will be 
assessed by a pathologist, and membranous PD-L1 expression will be scored in tumor and immune 
cells if a minimum of 100 evaluable tumor cells are present. Samples with < 100 evaluable tumor 
cells or inadequate sample will be characterized as PD-L1 unevaluable. Indeterminate PD-L1 
tumor expression is defined as membrane staining that is obscured by high cytoplasmic staining 
or melanin content. To identify any potential imbalances in known prognostic factors between 
SC
 and IV treatment arms, baseline biomarkers including, but not limited to, PD-L1, TMB, 
tumor inflammation, will be descriptively compared between arms. Tumor biopsy submitted upon 
recurrence will be similarly evaluated. For TMB analysis, tumor tissue may be evaluated by 
targeted and/or whole exome or whole genome sequencing (WES). Exploratory analyses of mRNA 
may be completed using RNA isolated from tumor tissue. Targeted and/or whole transcriptome 
RNA-seq and/or similar methodologies may be used to assess gene expression signatures, such as 
but not limited, to those associated with inflammatory processes and/or immune-related signaling. 
9.8.2 
Serum 
Not applicable per Protocol Amendment 01. The following information refers to the original 
study design. 
Pre- and on-treatment serum may be assessed by enzyme-linked immunosorbent assay, seromics, 
metabolomics, and/or other relevant multiplex-based protein assay methods for immune-related 
factors that will predict for SC 
and Nivo IV benefit or AEs and to evaluate pharmacodynamic 
activity of SC
 and Nivo IV. Potential serum-based biomarkers currently under investigation 
may include, but are not limited to, levels of cytokines and chemokines. Changes from baseline in 
biomarkers will be descriptively compared between SC  and IV treatment arms. 

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Serum will be collected for potential future measurements of anti-SARS-CoV-2 antibodies by 
serology (anti-SARS-CoV-2 total or IgG) at baseline to explore potential association with safety, 
efficacy, and/or immune biomarkers. 
9.8.3 
Germline Control Whole Blood Analysis by Genomics 
Not applicable per Protocol Amendment 01. The following information refers to the original 
study design. 
Whole blood will be collected from all participants prior to treatment for genomic DNA isolation. 
Blood DNA sequencing data generated using Next Generation Sequencing technologies to enable 
WES may be used as a control in order to improve the accuracy of mutational analyses from tumor 
samples. Germline mutations from blood samples will be inferred from the WES data to consider 
somatic mutations for TMB assessment. 
9.9 
Additional Research 
Not applicable per Protocol Amendment 01. The following information refers to the original 
study design. 
This protocol will include both sample collection and residual sample storage for additional 
research (AR). 
For All US sites: 
Additional research is required for all study participants, except where prohibited by IRBs/ethics 
committees, prohibited by local laws or regulations, or academic/institutional requirements. 
Where one or more of these exceptions occurs, participation in the additional research should be 
encouraged but will not be a condition of overall study participation. 
• If the IRB/ethics committees and site agree to the mandatory additional research retention 
and/or collection, then the study participant must agree to the mandatory additional research 
as a requirement for inclusion in the study. 
• If optional participation is permitted and approved, then the study participants may opt out of 
the additional research retention and/or collection. 
 
For non-US Sites: 
Additional research is optional for all study participants, except where retention and/or collection 
is prohibited by local laws or regulations, ethics committees, or institutional requirements. 
Additional research is intended to expand the R&D capability at Bristol-Myers Squibb, and will 
support as yet undefined research aims that will advance our understanding of disease and options 
for treatment. This may also include genetic/genomic exploration aimed at exploring disease 
pathways, progression, and response to treatment etc. 

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Sample Collection and Storage 
Residual PK, immunogenicity, blood (or blood derivatives) or tumor tissue (recent, archival, or 
fresh biopsy and extracted RNA/deoxyribonucleic acid [DNA]) from tumor biopsy and biomarker 
collections (see Table 9.9-1 below) will also be retained for additional research purposes. 
Samples kept for future research will be stored at the BMS Biorepository in New Jersey, USA or 
an independent, BMS-approved storage vendor. 
The manager of these samples will ensure they are properly used throughout their usable life and 
will destroy the samples at the end of the scheduled storage period, no longer than fifteen (15) 
years after the end of the study or the maximum allowed by applicable law. 
Transfers of samples by research sponsor to third parties will be subject to the recipient’s 
agreement to establish similar storage procedures. 
Samples will be stored in a coded fashion, and no researcher will have access to the key. The key 
is securely held by the Investigator at the clinical site, so there is no direct ability for a researcher 
to connect a sample to a specific individual. 
Further details of sample collection and processing will be provided to the site in the procedure 
manual. 
Table 9.9-1: 
Residual Sample Retention for Additional Research Schedule 
 
Sample Type 
Time points for which residual samples will be retained 
PK 
All 
Immunogenicity 
All 
Serum 
All 
Tumor Biopsy 
All 
Isolated DNA/RNA 
All 
Whole blood DNA 
All 
Abbreviations: DNA, deoxyribonucleic acid; PK, pharmacokinetics; RNA, ribonucleic acid. 
 
 
9.10 
Other Assessments 
9.10.1 
Investigational Site Training 
BMS will provide quality investigational staff training prior to study initiation. Training topics 
will include but are not limited to Good Clinical Practice, AE reporting, 
study details and procedures, eCRFs, study documentation, 
informed consent, and enrollment of WOCBP. 
9.11 
Health Economics OR Medical Resource Utilization and Health 
Economics 
Not applicable per Protocol Amendment 01. The following information refers to the original 
study design. 

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Healthcare Resource Use data associated with medical encounters will be collected in the CRF by 
the investigator and study-site personnel for all participants throughout the study. Protocol- 
mandated procedures, tests, and encounters are excluded. 
The data collected may be used to conduct exploratory economic analyses and will include the 
following: 
• Number and duration of medical care encounters, including surgeries, and other selected 
procedures (inpatient and outpatient) 
• Duration of hospitalization (total days length of stay, including duration by wards; eg, intensive 
care unit) 
• Number and character of diagnostic and therapeutic tests and procedures 
• Outpatient medical encounters and treatments (including physician or emergency room visits, 
tests and procedures, and medications) 
 
10 
STATISTICAL CONSIDERATIONS 
Per Protocol Amendment 01, only safety analyses will be conducted. Summary tables and 
listings for baseline characteristics, disposition, safety, and efficacy data will be provided to 
support the Clinical Study Report (CSR). Additional summaries (as appropriate for small sample 
size) will be planned in the SAP to support study data disclosure on original study objectives. 
10.1 
Statistical Hypotheses 
Not applicable per Protocol Amendment 01. The following information refers to the original 
study design. 
Part 1 of the study will be subjected to statistical hypothesis testing. 
 
Research Hypothesis (Part 1 - Randomized Study) 
Nivolumab exposures following 
 (BMS-986298) 600 mg administered Q2W are 
non-inferior to exposures following nivolumab (BMS-936558) 240 mg IV Q2W for the adjuvant 
treatment of melanoma. 
10.2 
Sample Size Determination 
The aim of the study is to assess the safety and tolerability of 
 and Nivo IV. This has 
changed from the original protocol’s study objective of PK. Sample size calculations are not based 
on statistical considerations. There were 14 participants randomized and treated at the time of 
Protocol Amendment 01. 

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10.3 
Analysis Sets 
For the purposes of analysis, the following populations are defined: 
 
Population 
Description 
All Enrolled 
Participants 
All participants who signed an ICF and are registered into the IRT. This is the primary 
dataset for disposition. 
All Randomized 
Participants 
All participants who are randomized to any treatment group. This is the primary dataset for 
analyses of demography, protocol deviations, baseline characteristics, efficacy, and outcome 
research for the randomized part of the study. 
All Treated 
Participants 
All participants who receive at least 1 dose of nivolumab. This is the primary dataset for 
dosing and safety analyses. 
Data will be analyzed based on randomized treatment, except if a participant received the 
same incorrect treatment throughout the study, then the participant will be analyzed based on 
treatment received. 
Abbreviations: ICF, informed consent form; IRT, interactive response technology. 
 
10.4 
Statistical Analyses 
The SAP will be finalized prior to primary endpoint database lock (DBL), and it will include a 
more technical and detailed description of the statistical analyses described in this section. This 
section is a summary of the planned statistical analyses of the most important endpoints, including 
the primary endpoint. 
A description of the participant population will be included in the clinical study report, including 
subgroups of age, gender, race and other study specific populations and demographic 
characteristics. A description of participant disposition will also be included in the clinical study 
report. 
10.4.1 
General Considerations 
A summary of the planned statistical analysis is described below in subsequent paragraphs. 
10.4.2 
Primary Endpoint(s) 
Safety is the primary endpoint. See Table 10.4.2-1 for details. 

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Table 10.4.2-1: 
Primary Endpoint 
 
Primary Endpoint 
Description 
Timeframe 
• 
AEs/SAEs, 
treatment-related 
AEs/SAEs for each 
treatment group. 
• 
Incidence of all AEs/SAEs, treatment-related 
AEs/SAEs for each treatment group. 
• 
Up to 100 days after 
the last treatment of 
study intervention or 
up to discontinuation 
of study treatment. 
Abbreviations: AE, adverse event; IMAE, immune-mediated adverse event; SAE, serious adverse event. 
 
 
All safety analyses will be performed using the All Treated participants population. 
The frequency of AEs, SAEs, and treatment-related AEs/SAEs will be tabulated by treatment arm. 
IMAEs, AEs, and SAEs leading to discontinuation of study drug, infusion/injection-related AEs, 
deaths, and abnormalities in specific clinical laboratory assessments will be presented as 
listings by treatment arm. 
The safety summary will be presented by severity where applicable. Analyses will be conducted 
using the 30 and/or 100-day safety window from the day of last dose received. AEs will be coded 
using the most recent Medical Dictionary for Regulatory Activities (MedDRA) version available 
during the conduct of the study. AEs and laboratory values will be graded for severity according 
to the NCI CTCAE version 5.0. 
10.4.2.1 
Part 1 PK Co-Primary Endpoints 
Not applicable per Protocol Amendment 01. The following information refers to the original 
study design. 
 
Table 10.4.2.1-1: 
Part 1 PK Co-Primary Endpoint 
 
Co-Primary Endpoint 
Description 
Timeframe 
Time averaged nivolumab serum 
concentration over the first 28 days 
Minimum nivolumab serum 
concentration at steady-state 
 
First 28 days of treatment 
 
17 weeks after the start of treatment 
 
 
Abbreviations: Cavgd28, time averaged nivolumab serum concentration over the first 28 days; Cminss, minimum 
nivolumab serum concentration at steady-state, PK, pharmacokinetics. 
For Primary PK Endpoints analysis, a linear fixed effect model with treatment and stratification 
factors (defined in the study design) as fixed effects will be fitted to the log-transformed Cavgd28 
and Cminss for use in estimation of treatment effects and construction of CIs. To assess 
non-inferiority of 
 to Nivo IV, point estimate and the 2-sided 90% CIs for treatment 
differences on the log scale will be exponentiated to obtain estimates for ratio of geometric means 
and respective 90% CIs for Cavgd28 and Cminss on the original scale. 
Non-inferiority of 
 to Nivo IV will be concluded if the lower limit of the 2-sided 90% 
CIs for the ratio of geometric means for nivolumab Cavgd28 and Cminss is not lower than 0.8. 
Cminss 
Cavgd28 

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10.4.3 
Secondary Endpoint(s) 
Per Protocol Amendment 01, secondary endpoints 
 of the study have been removed. 
Efficacy, patient-reported outcomes (PROs), and biomarker analyses will not be completed. 
Samples already collected for PK and immunogenicity assessments will be analyzed 
bioanalytically for nivolumab concentrations and anti-drug antibodies (ADAs) and reported as 
listings. Further collections for PK, ADAs, biomarkers, and PROs will be discontinued. The 
following information refers to the original study design. 
10.4.3.1 
Part 1 Secondary Endpoint(s) 
Not applicable per Protocol Amendment 01. The following information refers to the original study 
design. 
Table 10.4.3.1-1:   Part 1 Secondary Endpoints 
 
Secondary Endpoints 
Description 
Timeframe 
Key Secondary 
Incidence of all AEs/SAEs, 
treatment-related AEs, including IMAEs, 
SAEs, AEs 
eading to discontinuation 
or death, and laboratory abnormalities for 
each treatment group 
Incidence of all AEs/SAEs, 
treatment-related AEs, including 
IMAEs, SAEs, AEs 
leading to discontinuation or 
death, and laboratory abnormalities for 
each treatment group 
Up to 100 days after the 
last treatment of study 
intervention or up to 
discontinuation of study 
treatment 
OS rate 
Time from randomization to death due 
to any cause 
Until death, up to 36 
months 
RFS (per investigator) rate 
Time between the date of 
randomization and the date of first 
recurrence (local, regional, or distant 
metastasis), new primary melanoma, or 
death (whatever the cause), whichever 
occurs first 
Until recurrence event, up 
to minimum follow-up of 
12 months from last 
participant randomized in 
the study or death 
whichever is earlier 

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Table 10.4.3.1-1:   Part 1 Secondary Endpoints 
 
Secondary Endpoints 
Description 
Timeframe 
Other Secondary 
Cmind28; Cmax1, Tmax, Cmaxss, and 
Cavgss 
Minimum nivolumab serum 
concentration at Day 28; maximum 
nivolumab serum concentration after 
the first dose; time of maximum 
nivolumab serum concentration after 
the first dose; maximum nivolumab 
serum concentration at steady-state; 
time-averaged nivolumab serum 
concentration at steady-state 
First 28 days of treatment; 
17 weeks after the start of 
treatment 
Percentage of participants who develop 
anti-nivolumab antibodies and 
neutralizing antibodies, if applicable, and 
the impact of anti-nivolumab antibodies 
on AEs, administration-related reactions, 
and events within MedDRA SMQ 
Anaphylactic reactions 
Percentage of participants who 
develop anti-nivolumab antibodies 
and neutralizing antibodies, if 
applicable, and the impact of anti- 
nivolumab antibodies on AEs, 
administration-related reactions, 
and events within MedDRA SMQ 
Anaphylactic reactions 
Up to 100 days after the 
last study treatment or up 
to discontinuation of study 
treatment 
Mean CTSQ Satisfaction domain scores 
and score change from baseline at each 
assessment time point 
Mean CTSQ Satisfaction domain scores 
and score change from baseline at each 
assessment time point 
At each assessment time 
point 
Abbreviations: AE, adverse event; Cavgss, time-averaged nivolumab serum concentration at steady-state; Cmax1, 
maximum nivolumab serum concentration after the first dose; Cmaxss, maximum nivolumab serum concentration at 
steady-state; Cmind28, minimum nivolumab serum concentration on Day 28; CTSQ, Cancer Treatment Satisfaction 
Questionnaire; IMAE, immune mediated-adverse event; MedDRA, Medical Dictionary for Regulatory Activities; OS, 
overall survival; RFS, recurrence-free survival; SAE, serious adverse event; SMQ, standard MedDRA query; Tmax, 
time to maximum nivolumab serum concentration after the first dose. 
 
The ratio of geometric means and its 90% CI of the relevant secondary PK endpoints of Cmind28, 
Cmax1, Cmaxss, and Cavgss endpoints will also be tabulated similar to the PK primary endpoint 
but will not be used for concluding non-inferiority. Medians and ranges will be presented for Tmax 
by treatment group. Summary statistics by treatment group will be provided for each nivolumab 
PK parameter together with subject listing. Geometric means and coefficients of variation will be 
presented by treatment group together with N, mean, SD, median, minimum, and maximum. 
Safety, immunogenicity, biomarkers, outcome research, and efficacy endpoints will be analyzed 
descriptively. 
RFS will be programmatically determined based on the disease recurrence date provided by the 
investigator and is defined as the time between the date of randomization and the date of first 
recurrence (local, regional, or distant metastasis), new primary melanoma (including melanoma in 
situ), or death (whatever the cause), whichever occurs first. A participant who dies without 
reported recurrence will be considered to have recurred on the date of death. For participants who 
remain alive and whose disease has not recurred, RFS will be censored on the date of last evaluable 
disease assessment. For those participants who remain alive and have no recorded post- 

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randomization disease assessment, RFS will be censored on the day of randomization. Censoring 
rules are presented in Table 10.4.3.1-2 below. 
Table 10.4.3.1-2: 
Censoring Scheme for Primary Definition of Recurrence-Free 
Survival 
 
Situation 
Date of Event or Censoring 
Outcome 
 
Recurrence  (local, regional,  distant, new 
primary melanoma, including melanoma in 
Date of first recurrence 
Event 
situ) 
Death without recurrence 
Date of death 
Event 
No baseline disease assessment 
Date of randomization 
Censored 
No on-study disease assessments and no death Date of randomization 
Censored 
No recurrence and no death 
Date of last evaluable disease assessment 
Censored 
Second 
non-melanoma 
primary 
cancer 
(excluding BCC and/or SCC) reported prior or 
on the same day of disease assessment 
Date of last evaluable disease assessment 
prior to or on the same date of diagnosis of 
second non-melanoma primary cancer 
 
Censored 
 
 
Abbreviations: BCC, basal cell carcinoma; SCC, squamous cell carcinoma. 
In Part 1, RFS distributions will be descriptively compared between treatment groups and hazard 
ratios, and corresponding 95% CIs will be estimated using a Cox proportional hazards (CPH) 
model, with treatment group as a single covariate, stratified by the protocol-specified factors. 
RFS curves will be estimated using Kaplan-Meier (K-M) product-limit methodology. Median RFS 
with 2-sided 95% CIs using the log-log transformation will be computed. 
RFS rates at 12, 18, 24, and 36 months (and yearly after depending on follow-up) with 2-sided 
95% CIs using the log-log transformation will be computed. 
For RFS, a supplemental analysis will be performed using a while on study treatment estimand 
strategy to handle the intercurrent events of start of new anticancer therapy, tumor-directed 
radiotherapy, or tumor-directed surgery (excluding basal cell carcinoma [BCC]/squamous cell 
carcinoma [SCC] removal). Under this strategy, RFS will be censored on the date of last evaluable 
disease assessment prior to or on the same date of initiation of new anticancer therapy, tumor- 
directed radiotherapy, or tumor-directed surgery (excluding BCC/SCC removal). 
For the supplemental descriptive analysis, the RFS curves will be estimated using Kaplan-Meier 
(K-M) product-limit methodology. Median RFS with 2-sided 95% CIs using the log-log 
transformation will be computed. 
OS is defined as the time from randomization to the date of death from any cause. For participants 
that are alive (ie, without documentation of death), their survival time will be censored at the date 
of last contact date (or “last known alive date”). OS will be censored at the date of randomization 
for subjects who were randomized but had no follow-up. OS will be followed continuously while 
participants are on the study drug and every 3 months via in-person or phone contact after 
participants discontinue the study drug. 

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In Part 1 OS distributions will be descriptively compared between treatment groups, hazard ratio, 
and corresponding 95% CIs will be estimated using a CPH model, with treatment group as a single 
covariate, stratified by the protocol-specified factors. 
OS curves will be estimated using K-M product-limit methodology. Median OS with 2-sided 95% 
CIs using the log-log transformation will be computed. 
OS rates at 12, 18, 24, and 36 months with 2-sided 95% CIs using the log-log transformation will 
be computed. 
All safety analyses will be performed using the All Treated participants population. Descriptive 
statistics of safety will be presented using NCI CTCAE v5 by treatment group. AEs will be coded 
using the most recent Medical Dictionary for Regulatory Activities (MedDRA) version available 
during the conduct of the study. 
Frequency distribution of treated participants with AE using the worst CTC grade will be 
presented. Participants will only be counted (1) once at the preferred term (PT) level, (2) once at 
the system organ class (SOC) level, and (3) once in the “total participant” row at their worst 
CTCAE grade, regardless of SOC or PT. 

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10.4.4 
Exploratory Endpoint(s) 
Exploratory analyses will be described in the SAP that will be finalized before the database lock. 
10.4.5 
Other Analyses 
10.4.5.1 
Exposure-Response Analyses 
Not applicable per Protocol Amendment 01. The following information refers to the original 
study design. 
Model-determined nivolumab exposures may be used for exposure-response (E-R) analyses. If 
E-R analyses are conducted, the methods and results would be reported in a separate 
pharmacometrics report. 
10.4.5.2 
Immunogenicity Analyses 
Not applicable per Protocol Amendment 01. The following information refers to the original 
study design. 
All immunogenicity analyses will be performed using the Immunogenicity Evaluable Participants 
population. 
A listing will be provided for all available immunogenicity data. A baseline ADA positive 
participant is defined as a participant with positive seroconversion detected in the last sample 
before initiation of treatment. An ADA-positive participant is a participant with at least 1 
ADA-positive sample relative to baseline after initiation of the treatment. For each drug, frequency 
distribution of baseline ADA-positive participants and ADA-positive participants after initiation 
of the treatment will be summarized. To examine the potential relationship between 

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immunogenicity and safety, a table summarizing the frequency and type of AEs of special interest 
may be explored by immunogenicity status. 
In addition, potential relationships between immunogenicity and efficacy and/or PK may also be 
explored. 
10.4.5.3 
Outcomes Research 
Not applicable per Protocol Amendment 01. The following information refers to the original 
study design. 
Unless otherwise specified in the SAP, the analysis of Outcome Research endpoints will be 
performed on the All Treated participants population and will be restricted to treated participants 
who have an assessment at baseline and at least 1 post-baseline assessment for the given 
questionnaire (where applicable). Descriptive statistics will be provided. 
10.4.5.4 
Biomarkers 
Not applicable per Protocol Amendment 01. The following information refers to the original 
study design. 
For biomarker participants, descriptive summary statistics of biomarker assessments will be 
presented at baseline and at each on-study time point described in Section 9.8, unless otherwise 
specified. 
10.4.6 
Study Analyses Timeframe 
The following DBLs will be performed: 
10.4.6.1 
Part 1 
Not applicable per Protocol Amendment 01. The following information refers to the original 
study design. 
Primary lock for Part 1 will be performed after all randomized participants in both arms have 
completed PK evaluation for the co-primary endpoints (Week 17). Subsequent database lock(s) 
will occur at 18 and 36 months after last participant is randomized (minimum follow-up of 18 and 
36 months for all randomized participants) to assess for longer safety and efficacy secondary 
endpoint of RFS. 

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10.4.6.3 
Final Analysis 
The DBL will occur approximately 100 days after the last participant last treatment or earlier as 
applicable due to participant death or lost to follow-up. 
10.5 
Interim Analyses 
Not applicable. 

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11 
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pharmacokinetics, and pharmacodynamics of recombinant human hyaluronidase PH20 
adminstered intravenously in healthy volunteers. Curr Ther Res Clin Exp 2020;93:100604. 
39 Yanez B, Pearman T, Lis CG, et al. The FACT-G7: a rapid version of the Functional 
Assessment of Cancer Therapy – General (FACT-G) for monitoring symptoms and concerns 
in oncology practice and research. Ann Oncol 2013;24:1073-8. 
40 EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. 
Health Policy 1990;16:199-208. 
41 Pickard AS, De Leon MC, Kohlmann T, et al. Psychometric comparison of the standard EQ- 
5D to a 5 level version in cancer patients. Med Care 2007;45:259-63. 
42 Pickard AS, Neary MP, Cella D. Estimation of minimally important differences in EQ-5D 
utility and VAS scores in cancer. Health Qual Life Outcomes 2007;5:70. 
43 Trask PC, Tellefsen C, Espindle D, et al. Psychometric validation of the cancer therapy 
satisfaction questionnaire. Value Health 2008;11:669-79. 

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44 Theodore-Oklota C, Humphrey L, Wiesner C, et al. Validation of a treatment satisfaction 
questionnaire in non-Hodgkin lymphoma: assessing the change from intravenous to 
subcutaneous administration of rituximab. Patient Prefer Adherence 2016;10:1767-76. 
45 Keininger D, Coteur G. Assessment of self-injection experience in patients with rheumatoid 
arthritis: psychometric validation of the Self-Injection Assessment Questionnaire (SIAQ). 
Health Qual Life Outcomes 2011;9:2. 
46  Hughes MK. Suicide screening in the oncology population. J Adv Pract Oncol 2016;7:101-4. 
47 National Comprehensive Cancer Network. NCCN Distress Management Guidelines. Version 
2.2023. 
Available 
from 
URL: 
https://www.nccn.org/docs/default-source/patient- 
resources/nccn_distress_thermometer.pdf. 

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12 
APPENDICES 

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APPENDIX 1 
ABBREVIATIONS AND TRADEMARKS 
 
Term 
Definition 
ADA 
anti-drug antibody 
AE 
adverse event 
 
 
AIDS 
acquired immunodeficiency disease 
AJCC 
American Joint Committee on Cancer 
ALT 
alanine transaminase 
AR 
additional research 
ART 
antiretroviral therapy 
AST 
aspartate transaminase 
AT 
aminotransferase 
AxMP 
Auxiliary Medicinal Product 
BCC 
basal cell carcinoma 
BLA 
biologics license application 
BMS 
Bristol-Myers Squibb 
BP 
blood pressure 
BRAF 
B-Raf proto-oncogene 
C 
cycle 
Cavgd28 
time-averaged nivolumab serum concentration on Day 28 
Cavgss 
time-averaged nivolumab serum concentration at steady-state 
CBC 
complete blood count 
CD 
cluster of differentiation 
cHL 
chronic Hodgkin's lymphoma 
CHO 
Chinese hamster ovary 
CI 
confidence interval 
CIOMS 
Council for International Organizations of Medical Sciences 
CL 
nivolumab clearance 

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Term 
Definition 
CLss 
geometric mean steady-state clearance 
Cmax1 
maximum nivolumab serum concentration after first dose 
Cmaxss 
maximum nivolumab serum concentration at steady-state 
Cmind28 
minimum nivolumab serum concentration on Day 28 
Cminss 
minimum nivolumab serum concentration at steady-state 
CNS 
central nervous system 
CONSORT 
Consolidated Standards of Reporting Trials 
COVID-19 
coronavirus 2019 
CPH 
Cox proportional hazard 
CRC 
colorectal cancer 
CRF 
case report form 
CSR 
clinical study report 
CT 
computed tomography 
CTAg 
clinical trial agreement 
CTCAE 
Common Terminology Criteria for Adverse Events 
CTLA-4 
cytotoxic T lymphocyte associated antigen 4 
CTSQ 
Cancer Treatment Satisfaction Questionnaire 
CV% 
% coefficient of variation 
CXC 
chemokine 
D 
day 
DBL 
database lock 
DILI 
drug-induced liver injury 
DMC 
Data Monitoring Committee 
DNA 
deoxyribonucleic acid 
DP 
drug product 
DPD 
dihydropyrimidine dehydrogenase 
 
 

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Term 
Definition 
DRESS 
drug reaction with eosinophilia and systemic symptoms 
 
 
ECG 
electrocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
eCRF 
electronic case report form 
EDC 
electronic data capture 
eGFR 
estimated glomerular filtration rate 
EOI 
end of infusion 
EQ-5D-5L 
EuroQol-5 Dimension-5 Level 
EQ-VAS 
EuroQol-5 Dimension-5 Level visual analogue scale 
E-R 
exposure-response 
EU 
European Union 
F 
bioavailability 
FACT-G7 
Functional Assessment of Cancer Therapy - General 7 
FDA 
Food and Drug Administration 
FFPE 
formalin-fixed paraffin embedded 
FSH 
follicle-stimulating hormone 
fT3 
free T3 
fT4 
free T4 
FU 
follow up 
GBS 
Guillain-Barre Syndrome 
GCP 
Good Clinical Practice 
HBsAg 
hepatitis B surface antigen 
HBV 
hepatitis B virus 
HCC 
hepatocellular carcinoma 
HCG 
human chronic gonadotropin 
HCP 
health care provider 

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Term 
Definition 
HCV 
hepatitis C virus 
HIPAA 
Health Insurance Portability and Accountability Act 
HIV 
human immunodeficiency virus 
HR 
hazard ratio 
HRQoL 
health-related quality of life 
HRT 
hormone replacement therapy 
HuMAb 
human monoclonal antibody 
IB 
Investigator's Brochure 
ICF 
informed consent form 
ICH 
International Council for Harmonisation 
ICMJE 
International Committee of Medical Journal Editors 
IEC 
Independent Ethics Committee 
IFU 
Instructions for Use 
IgG 
immunoglobulin 
IHC 
immunohistochemistry 
IMAE 
immune-mediated adverse event 
IMG 
immunogenicity 
IMP 
Investigational Medicinal Product 
IO 
immuno-oncology 
IP 
Investigational Product 
IRB 
Institutional Review Board 
IRT 
Interactive Response Technology 
IUS 
intrauterine hormone-releasing system 
IV 
intravenous 
Ka 
model-determined population mean absorption rate constant 
K-M 
Kaplan-Meier 
LAM 
lactational amenorrhea method 

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Term 
Definition 
LD 
longest diameter 
LDH 
lactate dehydrogenase 
LLN 
lower limit of normal 
MCB 
master cell bank 
MedDRA 
Medical Dictionary for Regulatory Activities 
MEK 
mitogen-activated protein kinase 
MG 
myasthenia gravis 
MMIS 
malignant melanoma in situ 
MMR 
measles, mumps, rubella 
MRI 
magnetic resonance imaging 
N 
number of participants 
NAb 
neutralizing antibody 
NCI 
National Cancer Institute 
Nivo 
nivolumab 
 
 
NSAID 
non-steroidal anti-inflammatory drug 
NSCLC 
non-small cell lung cancer 
OS 
overall survival 
PD-1 
programmed death-1 
PD-L1 
programmed death-ligand 1 
PD-L2 
programmed death-ligand 2 
PET-CT 
positron emission tomography-computed tomography 
PFS 
pre-filled syringe 
PK 
pharmacokinetics 
PPK 
population pharmacokinetics 
PT 
preferred term 
Q2W 
every 2 weeks 

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Term 
Definition 
Q4W 
every 4 weeks 
QoL 
quality of life 
 
 
R&D 
research and development 
RCC 
renal cell carcinoma 
RFS 
recurrence-free survival 
rHuPH20 
recombinant human hyaluronidase PH20 enzyme 
RNA 
ribonucleic acid 
RT 
radiation therapy 
RT-PCR 
reverse transcriptase-polymerase chain reaction 
SAD 
short-axis diameter 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SARS-CoV-2 
severe acute respiratory syndrome coronavirus 2 
SC 
subcutaneous 
SCC 
squamous cell carcinoma 
SCCHN 
squamous cell carcinoma of the head and neck 
SCLC 
small cell lung cancer 
SD 
standard deviation 
SIAQ 
Self-Injection Assessment Questionnaire 
SJS 
Stevens-Johnson syndrome 
SLN 
sentinel lymph node 
SmPC 
summary of product characteristics 
SMQ 
standardized MedDRA query 
SOA 
Schedule of Activities 
SOC 
system organ class 
SSC 
Study Steering Committee 

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Term 
Definition 
SUSAR 
suspected, unexpected serious adverse reaction 
T.bili 
total bilirubin 
T3 
triiodothyronine 
T4 
thyroxine 
TASQ 
Treatment Administration Satisfaction Questionnaire 
TB 
total bilirubin 
TEN 
toxic epidermal necrolysis 
TMB 
tumor mutational burden 
TRAE 
treatment-related adverse event 
TSH 
thyroid-stimulating hormone 
U 
unit 
ULN 
upper limit of normal 
US 
United States 
USA 
United States of America 
USPI 
United States prescribing information 
v5 
version 5 
VAS 
visual analogue scale 
Vss 
geometric mean volume of distribution at steady state 
WBC 
white blood cells 
WES 
whole exome syndrome 
WOCBP 
women of childbearing potential 

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APPENDIX 2 
STUDY GOVERNANCE CONSIDERATIONS 
The terms “participant” and “subject” refer to a person who has consented to participate in the 
clinical research study. Typically, the term “participant” is used in the protocol and the term 
“subject” is used in the Case Report Form (CRF). 
REGULATORY AND ETHICAL CONSIDERATIONS 
This study will be conducted in accordance with: 
• Consensus ethical principles derived from international guidelines, including the Declaration 
of Helsinki and Council for International Organizations of Medical Sciences (CIOMS) 
International Ethical Guidelines 
• Applicable International Council for Harmonisation (ICH) Good Clinical Practice (GCP) 
Guidelines 
• Applicable laws, regulations, and requirements 
 
The study will be conducted in compliance with the protocol. The protocol, any 
revisions/amendments, and the participant informed consent form (ICF) will receive 
approval/favorable  opinion  by  Institutional  Review  Board/Independent  Ethics 
Committee (IRB/IEC), and regulatory authorities according to applicable regulations prior to 
initiation of the study. 
All potential serious breaches must be reported to the Sponsor or designee immediately. A 
potential serious breach is defined as a Quality Issue (eg, protocol deviation) that is likely to affect, 
to a significant degree, one or more of the following: (1) the rights, physical safety or mental 
integrity of one or more participants; (2) the scientific value of the clinical trial (eg, reliability and 
robustness of generated data). Items (1) or (2) can be associated with either GCP regulation(s) or 
trial protocol(s). 
Personnel involved in conducting this study will be qualified by education, training, and 
experience to perform their respective tasks. 
This study will not use the services of study personnel where sanctions have been invoked or where 
there has been scientific misconduct or fraud (eg, loss of medical licensure, debarment). 
INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE 
Before study initiation, the investigator must have written and dated approval/favorable opinion 
from the IRB/IEC for the protocol, Investigator’s Brochure, product labeling information, ICF, 
participant recruitment materials (eg, advertisements), and any other written information to be 
provided to participants. 
The investigator, Sponsor, or designee should provide the IRB/IEC with reports, updates, and other 
information (eg, expedited safety reports, amendments, administrative letters) annually, or more 
frequently, in accordance with regulatory requirements or institution procedures. 
The investigator is responsible for providing oversight of the conduct of the study at the site and 
adherence to requirements of the following where applicable: 

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• ICH guidelines, 
• United States Code of Federal Regulations, Title 21, Part 50 (21CFR50) 
• European Union Directive 2001/20/EC; or 
• European Regulation 536/2014 for clinical studies (if applicable), 
• European Medical Device Regulation 2017/745 for clinical device research (if applicable), 
• the IRB/IEC 
• and all other applicable local regulations. 
 
COMPLIANCE WITH THE PROTOCOL AND PROTOCOL REVISIONS 
The investigator should not implement any deviation or change to the protocol without prior 
review and documented approval/favorable opinion of an amendment from the IRB/IEC (and, if 
applicable, also by the local Health Authority), except where necessary to eliminate an immediate 
hazard(s) to study participants. 
If a deviation or change to a protocol is implemented to eliminate an immediate hazard(s) prior to 
obtaining relevant approval/favorable opinion(s), the deviation or change will be submitted as soon 
as possible to: 
• IRB/IEC 
• Regulatory authority(ies), if applicable by local regulations (per national requirements) 
 
Documentation of approval/favorable opinion signed by the chairperson or designee of the 
IRB(s)/IEC(s) and, if applicable, also by the local Health Authority, must be sent to Bristol-Myers 
Squibb (BMS). 
If an amendment substantially alters the study design or increases the potential risk to the 
participant: (1) the ICF must be revised and submitted to the IRB(s)/IEC(s) for review and 
approval/favorable opinion; (2) the revised form must be used to obtain consent from participants 
currently enrolled in the study if they are affected by the amendment; and (3) the new form must 
be used to obtain consent from new participants prior to enrollment. 
FINANCIAL DISCLOSURE 
Investigators and sub-investigators will provide the Sponsor with sufficient, accurate financial 
information, in accordance with regulations, to allow the Sponsor to submit complete and accurate 
financial certification or disclosure statements to the appropriate Health Authorities. Investigators 
are responsible for providing information on financial interests during the course of the study and 
for 1 year after completion of the study. 
INFORMED CONSENT PROCESS 
Investigators must ensure that participants are clearly and fully informed about the purpose, 
potential risks, and other critical issues regarding clinical studies in which they volunteer to 
participate. 

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The Sponsor or designee will provide the investigator with an appropriate sample ICF, which will 
include all elements required by the ICH GCP, and applicable regulatory requirements. The sample 
ICF will adhere to the ethical principles that have their origin in the Declaration of Helsinki. 
The investigator or his/her representative must: 
• Obtain IRB/IEC written approval/favorable opinion of the written ICF and any other 
information to be provided to the participant prior to the beginning of the study and after any 
revisions are completed for new information. 
• Provide a copy of the ICF and written information about the study in the language in which 
the participant is proficient prior to clinical study participation. The language must be 
nontechnical and easily understood. 
• Explain the nature of the study to the participant and answer all questions regarding the study. 
• Inform participant that his/her participation is voluntary. Participant will be required to sign a 
statement of informed consent that meets the requirements of 21 CFR 50, local regulations, 
ICH guidelines, Health Insurance Portability and Accountability Act (HIPAA) requirements, 
where applicable, and the IRB/IEC or study center. 
• Allow time necessary for participant to inquire about the details of the study. 
 
Obtain an ICF signed and personally dated by participant and by the person who conducted the 
informed consent discussion. 
• Include a statement in participant’s medical record that written informed consent was obtained 
before 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. 
• Re-consent participant to the most current version of the ICF(s) during his/her participation in 
the study, as applicable. 
 
Revise the ICF whenever important new information becomes available that is relevant to the 
participant’s consent. The investigator, or a person designated by the investigator, should fully 
inform the participant of all pertinent aspects of the study and of any new information relevant to 
the participant’s willingness to continue participation in the study. This communication should be 
documented. 
The confidentiality of records that could identify participants must be protected, respecting the 
privacy and confidentiality rules applicable to regulatory requirements, the participant’s signed 
ICF, and, in the US, the participant’s signed HIPAA Authorization. 
The ICF must also include a statement that BMS and local and foreign regulatory authorities have 
direct access to participant records. 

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If informed consent is initially given by a participant’s legal guardian and the participant 
subsequently becomes capable of making and communicating his or her informed consent during 
the study, consent must additionally be obtained from the participant. 
BMS COMMITMENT TO DIVERSITY IN CLINICAL TRIALS 
The mission of BMS is to transform patients’ lives through science by discovering, developing, 
and delivering innovative medicines that help them prevail over serious diseases. 
BMS is committed to doing its part to ensure that patients have a fair and just opportunity to 
achieve optimal health outcomes. 
BMS is working to improve the recruitment of a diverse participant population with the goal that 
the clinical trial becomes more reflective of the real-world population and the people impacted by 
the diseases studied. 
DATA PROTECTION, DATA PRIVACY, AND DATA SECURITY 
BMS collects and processes personal data of study participants, patients, health care providers, 
and researchers for biopharmaceutical research and development to advance innovative, 
high-quality medicines that address the medical needs of patients. BMS ensures the privacy, 
protection, and confidentiality of such personal data to comply with applicable laws. To achieve 
these goals, BMS has internal policies that indicate measures and controls for processing personal 
data. BMS adheres to these standards to ensure that collection and processing of personal data are 
limited and proportionate to the purpose for which BMS collects such personal data. This purpose 
is clearly and unambiguously notified to the individual at the time of collection of personal data. In 
the true spirit of science, BMS is dedicated to sharing clinical trial information and data with 
participants, medical/research communities, the media, policy makers, and the general public. This 
is done in a manner that safeguards participant privacy and informed consent while respecting the 
integrity of national regulatory systems. Clinical trial data, health-related research, and 
pharmacovigilance activities on key-coded health data transferred by BMS across national borders 
is done in compliance with the relevant data protection laws in the country and GCP requirements. 
BMS protects Personal Information with adequate and appropriate security controls as indicated 
under the data protection laws. To align with the recommended security standards, BMS has 
adopted internal security standards and policies to protect personal data at every stage of 
its processing. 
To supplement these standards, BMS enters into Clinical Trial Agreements (CTAgs) with 
confidentiality obligations to ensure proper handling and protection of personal data by third 
parties accessing and handling personal data. 
BMS takes unauthorized access and disclosure of Personal Information very seriously. BMS has 
adopted the security standards that include National Institute of Standards and Technology 
Cybersecurity Framework for studies in the US. BMS aligns with these standards to continuously 
assess and improve its ability to protect, detect, and respond to cyber attacks and other 
unauthorized attempts to access personal data. These standards also aid in mitigating possible 

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adverse effects. Furthermore, BMS Information Technology has defined 6 principles to protect our 
digital resources and information: 
1) Responsibilities of IT Personnel 
2) Securing the BMS Digital Infrastructure 
3) Identity and Access Management 
4) External Partner Connections 
5) Cyber Threat Detection and Response 
6) Internal Cyber Incident Investigation 
 
SOURCE DOCUMENTS 
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 electronic CRF (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. 
• Definitions of what constitutes source data can be found in the Site Process and Source 
Documentation (SPSD) form. 
 
The investigator is responsible for ensuring that the source data are accurate, legible, 
contemporaneous, original, and attributable, whether the data are handwritten on paper or entered 
electronically. If source data are created (first entered), modified, maintained, archived, retrieved, 
or transmitted electronically via computerized systems (and/or any other kind of 
as part of regulated clinical trial activities, such systems must be compliant with all 
applicable laws and regulations governing use of electronic records and/or electronic signatures. 
Such systems may include, but are not limited to, electronic medical records/electronic health 
records, adverse event (AE) tracking/reporting, protocol-required assessments, and/or drug 
accountability records. 
When paper records from such systems are used in place of an electronic format to perform 
regulated activities, such paper records should be certified copies. A certified copy consists of a 
copy of original information that has been verified, as indicated by a dated signature, as an exact 
copy having all of the same attributes and information as the original. 
STUDY INTERVENTION RECORDS 
Records for study intervention (whether supplied by BMS, its vendors, or the site) must 
substantiate study intervention integrity and traceability from receipt, preparation, administration, 
and through destruction or return. Records must be made available for review at the request of 
BMS/designee or a Health Authority. 

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If 
Then 
Supplied by BMS (or its vendors): 
Records or logs must comply with applicable 
regulations and guidelines and should include: 
• amount received and placed in storage area 
• amount currently in storage area 
• label identification number or batch number 
• amount dispensed to and returned by each 
participant, 
including 
unique 
participant 
identifiers 
• amount transferred to another area/site for 
dispensing or storage 
• nonstudy disposition (eg, lost, wasted) 
• amount destroyed at study site, if applicable 
• amount returned to BMS 
• retain samples for 
bioavailability/bioequivalence/biocomparability, 
if applicable 
• dates and initials of person responsible for 
Investigational Product 
dispensing/accountability, as per the Delegation 
of Authority Form 
Sourced by site and not supplied by BMS 
or its vendors (examples include IP 
sourced from 
the 
sites stock 
or 
commercial supply or a specialty 
pharmacy) 
The investigator or designee accepts responsibility 
for documenting traceability and study treatment 
integrity in accordance with requirements applicable 
under 
law 
and 
the 
standard 
operating 
procedures/standards of the sourcing pharmacy 
BMS or its designee will provide forms to facilitate inventory control if the investigational site 
does not have an established system that meets these requirements. 
 
CASE REPORT FORMS 
An investigator is required to prepare and maintain adequate and accurate case histories designed 
to record all observations and other data pertinent to the investigation on each individual treated 
or entered as a control in the investigation. Data that are derived from source documents and 
reported on the CRF must be consistent with the source documents, or the discrepancies must be 
explained. Additional clinical information may be collected and analyzed in an effort to enhance 
understanding of product safety. CRFs may be requested for AEs and/or laboratory abnormalities 
that are reported or identified during the course of the study. 
For sites using the Sponsor or designee electronic data capture (EDC) tool, eCRFs will be prepared 
for all data collection fields except for fields specific to SAEs and pregnancy, which will be 

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reported on the electronic SAE form and Pregnancy Surveillance Form, respectively. If the 
electronic SAE form is not available, a paper SAE form can be used. Spaces may be left blank 
only in those circumstances permitted by study-specific CRF completion guidelines provided by 
the Sponsor or designee. 
The confidentiality of records that could identify participants must be protected, respecting the 
privacy and confidentiality rules in accordance with the applicable regulatory requirement(s). 
The investigator will maintain a signature sheet to document signatures and initials of all persons 
authorized to make entries and/or corrections on CRFs. 
The completed CRF and SAE/pregnancy CRFs must be promptly reviewed, signed, and dated by 
the investigator or qualified physician who is a sub-investigator and who is delegated this task on 
the Delegation of Authority Form. Sub-investigators in Japan may not be delegated the CRF 
approval task. For eCRFs, review and approval/signature is completed electronically through the 
BMS EDC tool. The investigator must retain a copy of the CRFs, including records of the changes 
and corrections. 
Each individual electronically signing eCRFs must meet Sponsor or designee training 
requirements and must only access the BMS EDC tool using the unique user account provided by 
the Sponsor or designee. User accounts are not to be shared or reassigned to other individuals. 
MONITORING 
Monitoring details describing strategy, including definition of study critical data items and 
processes (eg, risk-based initiatives in operations and quality such as risk management and 
mitigation strategies and analytical risk-based monitoring), methods, responsibilities, and 
requirements, including handling of noncompliance issues and monitoring techniques (central, 
remote, or on-site monitoring) are provided in the monitoring plan. 
Representatives of BMS must be allowed to visit all study site locations periodically to assess the 
data quality and study integrity. On site, they will review study records and directly compare them 
with source documents, discuss the conduct of the study with the investigator, and verify that the 
facilities remain acceptable. 
Certain CRF pages and/or electronic files may serve as the source documents. 
In addition, the study may be evaluated by the Sponsor or designee internal auditors and 
government inspectors who must be allowed access to CRFs, source documents, other study files, 
and study facilities. BMS audit reports will be kept confidential. 
The investigator must notify BMS promptly of any inspections scheduled by regulatory authorities 
and promptly forward copies of inspection reports to the Sponsor or designee. 
RECORDS RETENTION 
The investigator (or head of the study site in Japan) must retain all study records and source 
documents for the maximum period required by applicable regulations and guidelines, or 
institution procedures, or for the period specified by BMS or its designee, whichever is longer. 

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The investigator (or head of the study site in Japan) must contact BMS prior to destroying any 
records associated with the study. 
BMS or its designee will notify the investigator (or head of the study site in Japan) when the study 
records are no longer needed. 
If the investigator withdraws from the study (eg, relocation, retirement), the records shall be 
transferred to a mutually agreed-upon designee (eg, another investigator, study site, IRB). Notice 
of such transfer will be given in writing to BMS or its designee. 
RETURN OF STUDY TREATMENT 
BMS-936558 - NIVOLUMAB IV 
For this study, study treatments (those supplied by BMS or a vendor or sourced by the 
investigator), such as partially used study treatment containers, vials, and syringes, may be 
destroyed on site. 
 
If 
Then 
Study treatments supplied by BMS (including 
its vendors) 
Any unused study interventions supplied by 
BMS can only be destroyed after being 
inspected and reconciled by the responsible 
Study Monitor, unless study treatments 
containers must be immediately destroyed as 
required for safety, or to meet local regulations 
(eg, cytotoxics or biologics). 
Partially used study interventions and/or 
empty containers may be destroyed after 
proper reconciliation and documentation. But 
unused IMP must be reconciled by site 
monitor/Clinical Research Associate prior to 
destruction. 
If study treatments will be returned, the return 
will be arranged by the responsible Study 
Monitor. 
Study treatments sourced by site, not supplied 
by BMS (or its vendors; eg, study treatments 
sourced from the site’s stock or commercial 
supply or a specialty pharmacy) 
It 
is 
the 
investigator’s 
or 
designee’s 
responsibility to dispose of all containers 
according to the institutional guidelines and 
procedures. 
 
It is the investigator’s or designee’s responsibility to arrange for disposal of study interventions, 
provided that procedures for proper disposal have been established according to applicable federal, 
state, local, and institutional guidelines and procedures, and provided that appropriate records of 
disposal are kept. The following minimal standards must be met: 
• On-site disposal practices must not expose humans to risks from the drug. 

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• On-site disposal practices and procedures are in agreement with applicable laws and 
regulations, including any special requirements for controlled or hazardous substances. 
• Written procedures for on-site disposal are available and followed. The procedures must be 
filed with the site’s standard operating procedures and a copy provided to BMS upon request. 
• Records are maintained that allow for traceability of each container, including the date 
disposed of, quantity disposed, and identification of the person disposing the containers. The 
method of disposal (eg, incinerator, licensed sanitary landfill, or licensed waste-disposal 
vendor) must be documented. 
• Accountability and disposal records are complete, up-to-date, and available for the Study 
Monitor to review throughout the clinical trial period. 
 
It is the investigator’s or designee’s responsibility to arrange for disposal of all empty containers. 
If conditions for destruction cannot be met, the responsible Study Monitor will make arrangements 
for return of study treatments provided by BMS (or its vendors). Destruction of non-study 
treatments sourced by the site, not supplied by BMS, is solely the responsibility of the investigator 
or designee. 
 
For this study, study intervention (those supplied by BMS or its vendors) containers, vials, and 
syringes related to 
may be destroyed by the site/responsible Study Monitor or follow 
local regulations. 
Study interventions supplied by BMS or its vendors associated with any product complaints (eg, 
study intervention defect, 
 malfunction, or unsuccessful administration) will be arranged for 
return to BMS by the site/responsible Study Monitor or follow local regulations. 
STUDY AND SITE START AND CLOSURE 
The Sponsor/designee reserves the right to close the study site or to 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 intervention development 

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If the study is prematurely terminated or suspended, the Sponsor shall promptly inform the 
investigators, the IECs/IRBs, the regulatory authorities, and any contract research organization(s) 
used in the study of the reason for termination or suspension, as specified by the applicable 
regulatory requirements. The investigator shall promptly inform the participant and should assure 
appropriate participant therapy and/or follow-up. 
DISSEMINATION OF CLINICAL STUDY DATA 
In order to benefit potential study participants, patients, healthcare providers and researchers, and 
to help BMS honor its commitments to study participants, BMS will make information about 
clinical research studies and a summary of their results available to the public as per regulatory 
and BMS requirements. BMS will post study information on local, national or regional databases 
in compliance with national and international standards for disclosure. BMS may also voluntarily 
disclose information to applicable databases. 
In the European Union (EU), the summary of results and summary for laypersons will be submitted 
within 1 year of the end of trial in EU/European Economic Area and third countries. 
CLINICAL STUDY REPORT 
A Signatory Investigator must be selected to sign the Clinical Study Report (CSR). 
For each CSR related to this protocol, the following criteria will be used to select the Signatory 
Investigator: 
• External Principal Investigator designated at protocol development 
• National Coordinating Investigator 
• Study Steering Committee chair or their designee 
• Participant recruitment (eg, among the top quartile of enrollers) 
• Involvement in trial design 
• Regional representation (eg, among top quartile of enrollers from a specified region or country) 
• Other criteria (as determined by the study team) 
 
SCIENTIFIC PUBLICATIONS 
The data collected during this study are confidential and proprietary to the Sponsor or designee. 
Any publications or abstracts arising from this study must adhere to the publication requirements 
set forth in the Clinical Trial Agreement (CTAg) governing [study site or investigator] 
participation in the study. These requirements include, but are not limited to, submitting proposed 
publications to the Sponsor or designee at the earliest practicable time prior to submission or 
presentation and otherwise within the time period set forth in the CTAg. 
Scientific publications (such as abstracts, congress podium presentations and posters, and 
manuscripts) of the study results will be a collaborative effort between the study Sponsor and the 
external authors. No public presentation or publication of any interim results may be made by any 

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Principal Investigator, sub-investigator, or any other member of the study staff without the prior 
written consent of the Sponsor. 
Authorship of publications at BMS is aligned with the criteria of the International Committee of 
Medical Journal Editors (ICMJE, www.icmje.org). Authorship selection is based upon significant 
contributions to the study (ie, ICMJE criterion #1). Authors must meet all 4 ICMJE criteria for 
authorship: 
1) Substantial intellectual contribution to the conception or design of the work; or the acquisition 
of data (ie, evaluable participants with quality data), analysis, or interpretation of data for the 
work (eg, problem solving, advice, evaluation, insights and conclusion); AND 
2) Drafting the work or revising it critically for important intellectual content; AND 
3) Final approval of the version to be published; AND 
4) Agreement to be accountable for all aspects of the work in ensuring that questions related to 
the accuracy or integrity of any part of the work are appropriately investigated and resolved. 
 
Those who make the most significant contributions, as defined above, will be considered by BMS 
for authorship of the primary publication. Sub-investigators will generally not be considered for 
authorship in the primary publication. Geographic representation will also be considered. 
Authors will be listed by order of significant contributions (highest to lowest), with the exception 
of the last author. Authors in first and last position have provided the most significant contributions 
to the work. 
For secondary analyses and related publications, author list and author order may vary from 
primary to reflect additional contributions. 

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APPENDIX 3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS: 
DEFINITIONS AND PROCEDURES FOR RECORDING, 
EVALUATING, FOLLOW-UP, AND REPORTING 
ADVERSE EVENTS 
 
Adverse Event Definition: 
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a 
pre-existing medical condition in a clinical investigation participant administered study 
treatment that does not necessarily have a causal relationship with this treatment. 
An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory 
finding), symptom, or disease temporally associated with the use of study treatment, whether or 
not considered related to the study treatment. 
Events Meeting the AE Definition 
• Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or 
results from other safety assessments (eg, electrocardiograms, radiological scans, vital signs 
measurements), including those that worsen from baseline, considered clinically significant 
in the medical and scientific judgment of the investigator. Note that abnormal lab tests or 
other safety assessments should only be reported as AEs if the final diagnosis is not 
available. Once the final diagnosis is known, the reported term should be updated to be the 
diagnosis. 
• 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 intervention administration, even though 
it 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 intervention 
or a concomitant medication. Overdose, as a verbatim term (as reported by the investigator), 
should not be reported as an AE/serious adverse event (SAE) unless it is an intentional 
overdose taken with possible suicidal/self-harming intent. Such overdoses should be 
reported regardless of sequelae and should specify “intentional overdose” as the verbatim 
term. 
Events NOT Meeting the AE Definition 
• Medical or surgical procedure (eg, endoscopy, appendectomy); the condition that leads to 
the procedure is the AE. 
• Situations in which an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital). 
 
DEFINITION OF SAE 
If an event is not an AE per definition above, then it cannot be an SAE, even if serious conditions 
are met. 

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SERIOUS ADVERSE EVENTS 
 
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any 
dose: 
Results in death. 
Is life-threatening (defined as an event in which the participant was at risk of death at the time 
of the event; it does not refer to an event which hypothetically might have caused death if it were 
more severe). 
Requires inpatient hospitalization or causes prolongation of existing hospitalization (see NOTE 
below). 
NOTE: 
The following hospitalizations are not considered SAEs in Bristol-Myers Squibb (BMS) clinical 
studies: 
• A visit to the emergency room or other hospital department < 24 hours that does not result 
in admission (unless considered an important medical or life-threatening event). 
• Elective surgery, planned prior to signing consent. 
• Admissions as per protocol for a planned medical/surgical procedure. 
• Routine health assessment requiring admission for baseline/trending of health 
status (eg, routine colonoscopy). 
• Medical/surgical admission other than to remedy ill health and planned prior to entry into 
the study. Appropriate documentation is required in these cases. 
• Admission encountered for another life circumstance that carries no bearing on health status 
and requires no medical/surgical intervention (eg, lack of housing, economic inadequacy, 
caregiver respite, family circumstances, administrative reason). 
• Admission for administration of anticancer therapy in the absence of any other 
SAEs (applies to oncology protocols). 
Results in persistent or significant disability/incapacity. 
Is a congenital anomaly/birth defect. 
Is an important medical event (defined as a medical event[s] that may not be immediately life- 
threatening or result in death or hospitalization but, based upon appropriate medical and 
scientific judgment, may jeopardize the participant or may require intervention [eg, medical, 
surgical] to prevent one of the other serious outcomes listed in the definition above). Examples 
of such events include, but are not limited to, intensive treatment in an emergency room or 
for allergic bronchospasm and blood dyscrasias or convulsions that do not result in 
hospitalization. Potential drug-induced liver injury (DILI) is also considered an important 
medical event. (See Section 9.2.7 for the definition of potential DILI.) 

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Pregnancy and DILI must follow the same transmission timing and processes to BMS as used for 
SAEs. (See Section 9.2.5 for reporting pregnancies.) 
 
 
 
 
 
 
 
 
 
 
 
EVALUATING AES AND SAES 
 
Assessment of Causality 
• The investigator is obligated to assess the relationship between study intervention 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 a relationship cannot be ruled out. 
• The investigator will use clinical judgment to determine the relationship. 
• Alternative causes, such as underlying disease(s), concomitant therapy, and other risk 
factors, as well as the temporal relationship of the event to study intervention administration, 
will be considered and investigated. 
• The investigator will also consult the Investigator’s Brochure and/or product information for 
marketed products in his/her assessment. 
• 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. 
• There may be situations in which an SAE has occurred and the investigator has minimal 
information to include in the initial report to the Sponsor. However, it is very important that 
the investigator always make an assessment of causality for every event before the initial 
transmission of the SAE data to the Sponsor. 
• The investigator may change his/her opinion of causality in light of follow-up information 
and send an SAE follow-up report with the updated causality assessment. 
• The causality assessment is one of the criteria used when determining regulatory reporting 
requirements. 
 
Follow-up of AEs and SAEs 
If only limited information is initially available, follow-up reports are required. 
(Note: Follow-up SAE reports must include the same investigator term[s] initially reported.) 

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If an ongoing SAE changes in its intensity or relationship to study treatment or if new 
information becomes available, the SAE report must be updated and submitted within 24 hours 
to BMS (or designee) using the same procedure used for transmitting the initial SAE report. 
All SAEs must be followed to resolution or stabilization. 
 
REPORTING OF SAES TO SPONSOR OR DESIGNEE 
 
• SAEs, whether related or not related to study treatment, and pregnancies must be reported 
to BMS (or designee) immediately within 24 hours of awareness of the event. 
• SAEs must be recorded on the SAE Report Form. 
− The required method for SAE data reporting is through the electronic case report 
form (eCRF). 
− The paper SAE Report Form is intended only as a back-up option when the electronic 
data capture system is unavailable/not functioning for transmission of the eCRF to BMS 
(or designee). 
♦ In this case, the paper form is transmitted via email or confirmed facsimile 
transmission. 
♦ When paper forms are used, the original paper forms are to remain on site. 
• Pregnancies must be recorded on paper Pregnancy Surveillance Forms and transmitted via 
email or confirmed facsimile transmission. 
SAE Email Address: 
SAE Facsimile Number: Will be provided by local site monitor. 
SAE Telephone Contact (required for SAE and pregnancy reporting): Will be provided by local 
site monitor. 

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APPENDIX 4 
WOMEN OF CHILDBEARING POTENTIAL DEFINITIONS AND 
METHODS OF CONTRACEPTION 
Appendix 4 provides general information and definitions related to Woman of Childbearing 
Potential and methods of contraception that can be applied to most clinical trials. For information 
specific to this study regarding acceptable contraception requirements for female and male 
participants, refer to Section 6.1 of the protocol. Only the contraception methods as described in 
Section 6.1 are acceptable for this study. 
DEFINITIONS 
Woman of Childbearing Potential (WOCBP) 
A woman is considered fertile following menarche and until becoming postmenopausal unless 
permanently sterile. Permanent sterilization methods include hysterectomy, bilateral 
salpingectomy, and bilateral oophorectomy. 
Women in the following categories are not considered WOCBP: 
• Premenarchal 
• Premenopausal female with 1 of the following: 
− Documented hysterectomy 
− Documented bilateral salpingectomy 
− Documented bilateral oophorectomy 
 
Note: Documentation can come from the site personnel’s review of the participant’s medical 
records, medical examination, or medical history interview. 
• Postmenopausal female 
− A postmenopausal state is defined as 12 months of amenorrhea in a woman over age 
45 years in the absence of other biological or physiological causes. In addition, females 
under the age of 55 years must have a serum follicle-stimulating hormone (FSH) level 
> 40 mIU/mL to confirm menopause. 
 
Note: Females treated with hormone replacement therapy (HRT) are likely to have artificially 
suppressed FSH levels and may require a washout period in order to obtain a physiologic FSH 
level. The duration of the washout period is a function of the type of HRT used. Suggested 
guidelines for the duration of the washout periods for HRT types are presented below. Investigators 
should use their judgement in checking serum FSH levels. 
• 1-week minimum for vaginal hormonal products (rings, creams, gels) 
• 4-week minimum for transdermal products 
• 8-week minimum for oral products 

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Other parenteral products may require washout periods as long as 6 months. If the serum FSH 
level is > 40 mIU/mL at any time during the washout period, the woman can be considered 
postmenopausal. 
End of Relevant Systemic Exposure 
End of relevant systemic exposure is the timepoint where the Investigational Medicinal Product 
(IMP) or any active major metabolites have decreased to a concentration that is no longer 
considered to be relevant for human teratogenicity or fetotoxicity. This should be evaluated in 
context of safety margins from the no-observed-adverse-effect level or the time required for 5 half- 
lives of the IMP to pass. 
METHODS OF CONTRACEPTION 
Local laws and regulations may require use of alternative and/or additional contraception methods. 
 
Highly Effective Contraceptive Methods That Are User Dependent 
Failure rate of < 1% per year when used consistently and correctly. a 
• Combined (estrogen- and progestogen-containing) hormonal contraception associated with 
inhibition of ovulation and/or implantation. (This method of contraception can only be used 
by WOCBP participants in studies where hormonal contraception is permitted by the study 
protocol.)b 
− Oral (birth control pills) 
− Intravaginal (rings) 
− Transdermal 
• Combined (estrogen-and progestogen-containing) hormonal contraception must begin at 
least 30 days prior to initiation of study therapy. 
• 
Progestogen-only hormonal contraception associated with inhibition of ovulation. (This 
method of contraception can only be used by WOCBP participants in studies where 
hormonal contraception is permitted by the study protocol.)b 
− Oral 
− Injectable 
• Progestogen-only hormonal contraception must begin at least 30 days prior to initiation of 
study therapy. 
Highly Effective Methods That Are User Independent 
• Implantable progestogen-only hormonal contraception associated with inhibition of 
ovulation and/or implantation. (This method of contraception can only be used by WOCBP 
participants in studies where hormonal contraception is permitted by the study protocol.)b 
• Intrauterine 

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• Intrauterine hormone-releasing system (IUS). (This method of contraception can only be 
used by WOCBP participants in studies where hormonal contraception is permitted by the 
study protocol.)b,c 
• Bilateral tubal occlusion. 
• Vasectomized partner 
Having a vasectomized partner is a highly effective contraception method provided that the 
partner is the sole male sexual partner of the WOCBP and the absence of sperm has been 
confirmed. If not, an additional highly effective method of contraception should be used. 
A vasectomy is a highly effective contraception method provided that the participant is the sole 
male sexual partner of the WOCBP and the absence of sperm has been confirmed. If not, an 
additional highly effective method of contraception should be used. 
• Sexual abstinence. 
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 treatment. 
The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study 
and the preferred and usual lifestyle of the participant. 
• Continuous abstinence must begin at least 30 days prior to initiation of study therapy. 
• It is not necessary to use any other method of contraception when complete abstinence is 
elected. 
• WOCBP participants who choose complete abstinence must continue to have pregnancy 
tests, as specified in Section 2. 
• Acceptable alternate methods of highly effective contraception must be discussed in the 
event that the WOCBP participant chooses to forego complete abstinence. 
• 
Periodic abstinence (including, but not limited to, calendar, symptothermal, postovulation 
methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea 
method (LAM) are not acceptable methods of contraception for this study. 
NOTES: 
a Typical use failure rates may differ from failure rates when contraceptive methods are used consistently and 
correctly. Use should be consistent with local regulations regarding the use of contraceptive methods for 
participants in clinical studies. 
b Hormonal contraception may be susceptible to interaction with the study treatment, which may reduce the 
efficacy of the contraceptive method. Hormonal contraception is permissible only when there is sufficient 
evidence that the IMP and other study medications will not alter hormonal exposures such that contraception 
would be ineffective or result in increased exposures that could be potentially hazardous. In this case, alternative 
methods of contraception should be utilized. For information specific to this study regarding permissibility of 
hormonal contraception, refer to Sections 6.1 INCLUSION CRITERIA and 7.7.1 PROHIBITED AND/OR 
RESTRICTED TREATMENTS of the protocol. 
c IUSs are acceptable methods of contraception in the absence of definitive drug interaction studies when hormone 
exposures from 
do not alter contraception effectiveness. For information specific to this 

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study regarding permissibility of hormonal contraception, refer to .Sections 6.1 INCLUSION CRITERIA and 
7.7.1 PROHIBITED AND/OR RESTRICTED TREATMENTS of the protocol. 
 
Less Than Highly Effective Contraceptive Methods That Are User Dependent 
Failure rate of > 1% per year when used consistently and correctly. 
• Male or female condom with or without spermicide. Male and female condoms cannot be 
used simultaneously. 
• Diaphragm with spermicide. 
• Cervical cap with spermicide. 
• Vaginal sponge with spermicide. 
• Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the 
primary mechanism of action. (This method of contraception cannot be used by WOCBP 
participants in studies where hormonal contraception is prohibited.) 
Unacceptable Methods of Contraception 
• Periodic abstinence (calendar, symptothermal, postovulation methods). 
• Withdrawal (coitus interruptus). 
• Spermicide only. 
• LAM. 
 
COLLECTION OF PREGNANCY INFORMATION 
Guidance for collection of pregnancy information and outcome of pregnancy on the Pregnancy 
Surveillance Form is provided in Section 9.2.5 and Appendix 3. 

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APPENDIX 6 
PARAMETER ESTIMATES FROM PPK MODEL USED FOR 
SIMULATIONS 
Table 1: 
Parameter Estimates from the PPK Model Used For Simulations 
Parameters (Units) 
Estimate 
Fixed Effects 
CL [mL/h] 
10.8 
VC [L] 
4.01 
Q [mL/h] 
28.7 
VP [L] 
2.78 
CLBBWT 
0.6 
CLGFR 
0.12 
CLSEX 
-0.14 
CLPS 
0.17 
VCBBWT 
0.55 
VCSEX 
-0.153 
CLEMAX 
-0.292 
CLT50 
1.36 
CLHILL 
2.74 
CLRAAA 
0.0147 
CLRAAS 
-0.0731 
CLOTH 
-0.0268 
CLNSCLC 
-0.0361 
CLADJM 
-0.514 
KA 
0.0132 
F 
0.7 
Random Effects 
ω2CL [-] 
0.0965 
ω2VC [-] 
0.139 
ω2VP [-] 
0.223 
ω2EMAX [h] 
0.095 
ω2KA 
0.115 
ω2F 
0.565 
ω2CL: ω2VC 
0.0368 
ω2KA:F 
0.22 

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Table 1: 
Parameter Estimates from the PPK Model Used For Simulations 
 
Parameters (Units) 
Estimate 
 
Residual Error 
Proportional Error 
0.22 
Abbreviations: CL [mL/h], clearance milliliters per hour]); CLADJM,, effect of adjuvant melanoma on clearance; 
CLBBWT, effect of baseline body weight on clearance; CLEMAX, estimate of the maximal change in clearance; 
CLGFR, effect of estimated glomerular filtration rate on clearance; CLHILL, effect of sigmoidicity (Hill coefficient) 
on clearance; CLNSCLC, effect of non-small cell lung cancer on clearance; CLOTH, effect of other tumor types on 
clearance; CLPS, effect of performance status on clearance; CLRAAA, effect of African American race on clearance; 
CLRAAS, effect of Asian race on clearance; CLSEX, effect of sex on clearance; CLT50, time at which the change in 
clearance is 50% of the maximal change in clearance; F, bioavailability; KA, first order absorption rate constant; Q 
[mL/h], inter-compartmental clearance (milliliters per hour); VC [L], central volume of distribution (liters); VCBBWT, 
effect of baseline body weight on central volume of distribution;;VCSEX, effect of sex on central volume of 
distribution; VP [L], peripheral volume of distribution (liters); ω2CL [-], random effects for clearance; ω2CL: ω2VC, 
random effects for correlated parameters clearance and central volume of distribution; ω2EMAX [h,], random effects 
for maximal change in clearance (hours); ω2F, random effects for bioavailability; ω2KA, random effects for first order 
absorption rate constant; ω2KA:F, random effects for correlated parameters first order absorption rate constant and 
bioavailability; ω2VC [-], random effects for central volume of distribution; ω2VP [-], random effect for peripheral 
volume of distribution. 

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APPENDIX 7 
MANAGEMENT ALGORITHMS FOR STUDIES UNDER CTCAE 
VERSION 5.0 
These general guidelines constitute guidance to the Investigator and may be supplemented by 
discussions with the Medical Monitor representing the Sponsor. The guidance applies to all 
immuno-oncology agents and regimens. 
A general principle is that differential diagnoses should be diligently evaluated according to 
standard medical practice. Non-inflammatory etiologies should be considered and appropriately 
treated. 
Corticosteroids are a primary therapy for immuno-oncology drug-related adverse events. The oral 
equivalent of the recommended IV doses may be considered for ambulatory patients with 
low-grade toxicity. The lower bioavailability of oral corticosteroids should be taken into account 
when switching to the equivalent dose of oral corticosteroids. 
Consultation with a medical or surgical specialist, especially prior to an invasive diagnostic or 
procedure, is recommended. 
The frequency and severity of the related adverse events covered by these algorithms will depend 
on the immuno-oncology agent or regimen being used. 

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APPENDIX 8 
ECOG PERFORMANCE STATUS 
 
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 selfcare but unable to carry out any work activities. Up and about 
more than 50% of waking hours 
3 
Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours 
4 
Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair 
5 
Dead 
Reference: Oken MM, Creech RH, et al. Toxicity and Response Criteria of the Eastern Cooperative Oncology Group. 
Am J Clin Oncol 1982; 5: 649-655. 

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APPENDIX 9 
AJCC MELANOMA STAGING (CANCER STAGING MANUAL 
8TH EDITION) 
Definition of Primary Tumor (T) 
 
T Category 
Thickness 
Ulceration Status 
TX: primary tumor thickness cannot be 
assessed (e.g., diagnosis by curettage) 
Not applicable 
Not applicable 
T0: no evidence of primary tumor (e.g., 
unknown primary or completely regressed 
melanoma) 
Not applicable 
Not applicable 
Tis (melanoma in situ) 
Not applicable 
Not applicable 
T1 
≤1.0 mm 
Unknown or unspecified 
T1a 
<0.8 mm 
Without ulceration 
T1b 
<0.8 mm 
0.8-1.0 mm 
With ulceration 
With or without ulceration 
T2 
>1.0-2.0 mm 
Unknown or unspecified 
T2a 
>1.0-2.0 mm 
Without ulceration 
T2b 
>1.0-2.0 mm 
With ulceration 
T3 
>2.0-4.0 mm 
Unknown or unspecified 
T3a 
>2.0-4.0 mm 
Without ulceration 
T3b 
>2.0-4.0 mm 
With ulceration 
T4 
>4.0 mm 
Unknown or unspecified 
T4a 
>4.0 mm 
Without ulceration 
T4b 
>4.0 mm 
With ulceration 
 
Definition of Distant Metastasis (M) 
 
M Category 
Anatomic site 
LDH level 
M0 
No evidence of distant metastasis 
Not applicable 
M1 
Evidence of distant metastasis 
See below 
M1a 
Distant metastasis to skin, soft tissue 
including muscle, and/or non-regional 
lymph node 
Not recorded or unspecified 
M1a(0) 
Not elevated 
M1a(1) 
Elevated 
M1b 
Distant metastasis to lung with or without 
M1a sites of disease 
Not recorded or unspecified 
M1b(0) 
Not elevated 
M1b(1) 
Elevated 
M1c 
Not recorded or unspecified 
M1c(0) 
Not elevated 

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M Category 
Anatomic site 
LDH level 
M1c(1) 
Distant metastasis to non-CNS visceral 
sites with or without M1a or M1b sites of 
disease 
Elevated 
M1d 
Distant metastasis to CNS with or without 
M1a, M1b, or M1c sites of disease 
Not recorded or unspecified 
M1d(0) 
Not elevated 
M1d(1) 
Elevated 
Suffixes for M category: (0) LDH not elevated; (1) LDH elevated. No suffix is used if LDH is not recorded or is 
unspecified. 
 
Definition of Regional Lymph Node (N) 
 
N 
Category 
Number of tumor-involved regional 
lymph nodes 
Presence of in-transit, satellite, 
or microsatellite metastases 
NX 
Regional nodes not assessed (e.g., SLN biopsy not performed, 
regional nodes previously removed for another reason) 
Exception: pathological N category is not required for T1 
melanomas, use cN 
No 
N0 
No regional metastases detected 
No 
N1 
One tumor-involved node or in-transit, satellite, and/or 
microsatellite metastases with no tumor-involved nodes 
N1a 
One clinically occult (i.e., detected by SLN biopsy) 
No 
N1b 
One clinically detected 
No 
N1c 
No regional lymph node disease 
Yes 
N2 
Two or three tumor-involved nodes or in-transit, satellite, 
and/or microsatellite metastases with one tumor-involved node 
N2a 
Two or three clinically occult (i.e., detected by SLN biopsy) 
No 
N2b 
Two or three, at least one of which was clinically detected 
No 
N2c 
One clinically occult or clinically detected 
Yes 
N3 
Four or more tumor-involved nodes or in-transit, satellite, or 
microsatellite metastases with two or more tumor-involved 
nodes, or any number of matted nodes with or without in- 
transit, satellite, and/or microsatellite metastases 
N3a 
Four or more clinically occult (i.e., detected by SLN biopsy) 
No 
N3b 
Four or more, at least one of which was clinically detected, or 
presence any number of matted nodes 
No 
N3c 
Two or more clinically occult or clinically detected, and/or 
presence any number of matted nodes 
Yes 

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AJCC Prognostic Stage Groups 
Clinical (cTNM) 
Clinical stage includes microstaging of the primary melanoma and clinical/radiologic/biopsy 
evaluation for metastases. By convention, clinical staging should be used after biopsy of the 
primary melanoma, with clinical assessment for regional and distant metastases. Note that 
pathological assessment of the primary melanoma is used for both clinical and pathological 
classification. Diagnostic biopsies to evaluate possible regional and/or distant metastasis also are 
included. Note there is only one stage group for clinical Stage III melanoma. 
 
When T is.... 
And N is..... 
And M is.... 
The clinical stage is... 
Tis 
N0 
M0 
0 
T1a 
N0 
M0 
IA 
T1b 
N0 
M0 
IB 
T2a 
N0 
M0 
IB 
T2b 
N0 
M0 
IIA 
T3a 
N0 
M0 
IIA 
T3b 
N0 
M0 
IIB 
T4a 
N0 
M0 
IIB 
T4b 
N0 
M0 
IIC 
Any T, Tis 
≥N1 
M0 
III 
Any T 
Any N 
M1 
IV 
 
PATHOLOGICAL (pTNM) 
Pathological staging includes microstaging of the primary melanoma, including any additional 
staging information from the wide excision (surgical) specimen that constitutes primary tumor 
surgical treatment and pathological information about the regional lymph nodes after SLN biopsy 
or therapeutic lymph node dissection for clinically evident regional lymph node disease. 
 
When T is.... 
And N is..... 
And M is.... 
The pathological stage is... 
Tis 
N0 
M0 
0 
T1a 
N0 
M0 
IA 
T1b 
N0 
M0 
IA 
T2a 
N0 
M0 
IB 
T2b 
N0 
M0 
IIA 
T3a 
N0 
M0 
IIA 
T3b 
N0 
M0 
IIB 
T4a 
N0 
M0 
IIB 

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When T is.... 
And N is..... 
And M is.... 
The pathological stage is... 
T4b 
N0 
M0 
IIC 
T0 
N1b, N1c 
M0 
IIIB 
T0 
N2b, N2c, N3b or N3c 
M0 
IIIC 
T1a/b-T2a 
N1a-N2a 
M0 
IIIA 
T1a/b-T2a 
N1b/c or N2b 
M0 
IIIB 
T2b/T3a 
N1a-N2b 
M0 
IIIB 
T1a-T3a 
N2c or N3a/b/c 
M0 
IIIC 
T3b/T4a 
Any N >N1 
M0 
IIIC 
T4b 
N1a-N2c 
M0 
IIIC 
T4b 
N3a/b/c 
M0 
IIID 
Ant T, Tis 
Any N 
M1 
IV 
Pathological Stage 0 (melanoma in situ) and T1 do not require pathological evaluation of lymph nodes to complete 
pathological staging; use cN information to assign their pathological stage. 
Adapted from: American Joint Committee on Cancer. Melanoma of the Skin. In: Amin MB, Edge SB, Greene FL, 
et al., editors. AJCC Cancer Staging Manual. 8th ed. Chicago: Springer International Publishing AG; 2018 pp 577-8. 

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APPENDIX 10 
COUNTRY SPECIFIC REQUIREMENTS 
 
Country 
Section number and 
Title 
Original Language 
Country-specific language or 
differences 
Argentina, Czech 
Republic, 
Germany, 
Romania, and Any 
Other 
Countries 
Where Exclusion 
of HIV Positive 
Participants 
is 
Locally Mandated 
Section 
2, 
Flow 
Chart/Time 
and 
Events Schedule, 
Table 2-1: Screening 
Assessments- 
Laboratory Tests 
Add “HIV” to the list of 
laboratory tests 
Argentina, Czech 
Republic, 
Germany, 
Romania and Any 
Other 
Countries 
Where Exclusion 
of HIV Positive 
Participants 
is 
Locally Mandated 
Section 
6.2, 
Exclusion 
Criteria, 
Exclusion  criterion 
3) k) 
Known 
human 
immunodeficiency virus (HIV) 
positive with an AIDS defining 
opportunistic infection within 
the last year, or a current CD4 
count 
< 
350 
cells/uL. 
Participants with HIV are 
eligible if: 
i) 
they 
have 
received 
antiretroviral 
therapy 
(ART) for at least 4 weeks 
prior to randomization as 
clinically indicated while 
enrolled on study 
Positive test for HIV 
ii) they continue on ART as 
clinically indicated while 
enrolled on study 
iii) CD4 counts and viral load 
are monitored per standard 
of care by a local health 
care provider. 
iv) inclusion of participants 
with HIV should be based 
on Investigator clinical 
judgement 
and 
in 
consultation 
with 
the 
Medical Monitor 
NOTE: Testing for HIV must 
be performed at sites where 
mandated 
locally. 
HIV 
positive participants must be 
excluded 
where 
mandated 
locally (see Appendix 10) 
Germany 
Section 
2, 
Flow 
Chart/Time 
and 
Events Schedule, 
Contrast enhanced CT of the 
chest (if CT contrast is 
contraindicated, 
then 
non- 
contrast 
CT 
should 
be 
acquired).  CT/MRI  of  the 
abdomen, pelvis, and all other 
Contrast enhanced CT of 
the chest (if CT contrast is 
contraindicated, then non- 
contrast 
CT 
should 
be 
acquired). CT/MRI of the 
abdomen, pelvis, and all 

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Country 
Section number and 
Title 
Original Language 
Country-specific language or 
differences 
Table 2-1: Screening 
Procedural Outline 
known and/or suspected sites 
of disease, within 28 days 
prior to randomization. See 
Section 
9.1.1 
for 
further 
details. 
other 
known 
and/or 
suspected sites of disease, 
within 28 days prior to 
randomization. See Section 
9.1.1 for further details. 
MRI may be used as an 
alternative 
imaging 
modality to chest CT at 
screening, during treatment 
and in follow-up. 
Germany 
Section 
2, 
Flow 
Chart/Time 
and 
Events Schedule, 
Table 2-2: On Study 
Treatment 
Procedural 
Outline 
(Arm A) 
Table 2-3, On Study 
Treatment 
Procedural 
Outline 
(Arm B) 
Contrast enhanced CT of the 
chest, CT/MRI of the abdomen, 
pelvis, and all other known 
and/or suspected sites of disease 
should occur every 12 weeks 
(± 7 days) starting from date of 
first dose until investigator 
assessed local, regional, or 
distant recurrence (whichever 
comes first) for Stage IV 
participants and until distant 
recurrence 
for 
Stage 
III 
participants. See Section 9.1.1 
for 
further 
details. 
If 
a 
participant 
starts 
systemic 
therapy 
for 
melanoma 
recurrence, or for a new non- 
melanoma tumor after study 
drug discontinuation, follow-up 
scans for this trial should be 
discontinued. 
Contrast enhanced CT of 
the chest, CT/MRI of the 
abdomen, pelvis, and all 
other 
known 
and/or 
suspected sites of disease 
should occur every 12 
weeks (± 7 days) starting 
from date of first dose until 
investigator assessed local, 
regional, 
or 
distant 
recurrence 
(whichever 
comes first) for Stage IV 
participants and until distant 
recurrence for Stage III 
participants.  See  Section 
9.1.1 for further details. 
MRI may be used as an 
alternative 
imaging 
modality to chest CT at 
screening, during treatment 
and in follow-up. If a 
participant starts systemic 
therapy 
for 
melanoma 
recurrence, or for a new 
non-melanoma tumor after 
study drug discontinuation, 
follow-up scans for this trial 
should be discontinued. 
Germany 
Section 
2, 
Flow 
Chart/Time 
and 
Events Schedule, 
Table 2-5: Follow-up 
Assessments 
Contrast enhanced CT of the 
chest, CT/MRI of the abdomen, 
pelvis, and all other known 
and/or suspected sites of disease 
should occur every 12 weeks 
(± 7 days) starting from date of 
first dose until investigator 
assessed local, regional, or 
distant recurrence (whichever 
comes first) for Stage IV 
participants and until distant 
recurrence 
for 
Stage 
III 
participants. See Section 9.1.1 
for  further  details.  If  a 
Contrast enhanced CT of 
the chest, CT/MRI of the 
abdomen, pelvis, and all 
other 
known 
and/or 
suspected sites of disease 
should occur every 12 
weeks (± 7 days) starting 
from date of first dose until 
investigator assessed local, 
regional, 
or 
distant 
recurrence 
(whichever 
comes first) for Stage IV 
participants and until distant 
recurrence  for  Stage  III 

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Country 
Section number and 
Title 
Original Language 
Country-specific language or 
differences 
participant 
starts 
systemic 
therapy 
for 
melanoma 
recurrence, or for a new non- 
melanoma tumor after study 
drug discontinuation, follow-up 
scans for this trial should be 
discontinued. 
participants.  See  Section 
9.1.1 for further details. 
MRI may be used as an 
alternative 
imaging 
modality to chest CT at 
screening, during treatment 
and in follow-up. If a 
participant starts systemic 
therapy 
for 
melanoma 
recurrence, or for a new 
non-melanoma tumor after 
study drug discontinuation, 
follow-up scans for this trial 
should be discontinued. 
Germany 
Section 
9.1.1, 
Efficacy Assessment 
for the Study 
Contrast enhanced CT of the 
chest, CT/MRI of the abdomen, 
pelvis, and all other known 
and/or 
suspected 
sites 
of 
disease must be performed 
every 12 weeks (± 7 days) from 
date 
of 
first 
dose 
until 
investigator 
assessed 
local, 
regional, or distant recurrence 
(whichever comes first) for 
Stage IV participants and until 
distant recurrence for Stage III 
participants. 
Contrast enhanced CT of 
the chest, CT/MRI of the 
abdomen, pelvis, and all 
other 
known 
and/or 
suspected sites of disease 
must be performed every 12 
weeks (± 7 days) from date 
of 
first 
dose 
until 
investigator assessed local, 
regional, 
or 
distant 
recurrence 
(whichever 
comes first) for Stage IV 
participants and until distant 
recurrence for Stage III 
participants. MRI may be 
used 
as 
an 
alternative 
imaging modality to chest 
CT at screening, during 
treatment and in follow-up. 
France, Italy 
Section 
 8.1, 
Discontinuation 
From 
Study 
Intervention 
Add 
to 
discontinuation 
criteria 
item 
for 
discontinuation 
due 
to 
product inefficacy. 
France: 
Section 
 8.1, 
Discontinuation 
From 
Study 
Intervention 
Add 
to 
discontinuation 
criteria 
item 
for 
discontinuation 
due 
to 
severe infection. 

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Country 
Section number and 
Title 
Original Language 
Country-specific language or 
differences 
Canada 
Appendix 3, Adverse 
Evens 
Canada Phase IV AE 
reporting requirement: 
The Division 8 of the Food 
and Drug Regulations in 
Canada require that any 
cases of Unusual Failure in 
Efficacy 
occurring 
in 
Canada be reported to the 
Canadian 
Health 
Authorities in an expedited 
manner. 
Canadian sites will record 
single cases of Unusual 
Failure in Efficacy as an 
Adverse 
Event. 
This 
reporting requirement is 
specific for Canadian sites 
only. 
This AE is required to be 
reported to BMS within 24 
hours 
by 
the 
Investigator/site 
staff 
becoming aware of the 
report 
For transmission purposes, 
report this AE using the 
paper SAE form. 
For reporting information, 
refer 
to 
Appendix 
3 
Adverse 
Events 
and 
Serious Adverse Event: 
Definitions 
and 
Procedures for Recording, 
Evaluating, Follow up and 
Reporting, the section on 
Reporting  of  SAEs  to 
Sponsor or Designee. 
France 
Section 6.2, Exclusion 
Criteria, 
Exclusion criterion 3) 
m) 
Testing of DPD deficiency 
prior to treatment with 5- 
FU: not include patients 
with DPD deficiency blood 
uracil greater than or equal 
to 150ng/ml. 
France 
Table 7.4.2-1 under 
Hepatic 
Appendix 8, Hepatic 
Adverse 
Event 
Management 
Algorithm 
The 
following 
phrase 
“delay dose” is deleted and 
the 
revised 
protocol 
language will state: 
“AST or ALT > 5x ULN or 
T.bili > 3x ULN, regardless 

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Country 
Section number and 
Title 
Original Language 
Country-specific language or 
differences 
of 
baseline 
value: 
permanently discontinue”. 
The following phrases are 
deleted: 
“In most cases” and “If the 
investigator determines a 
possible 
favorable 
benefit/risk 
ratio 
that 
warrants continuation of 
study 
treatment, 
a 
discussion 
between 
the 
investigator 
and 
the 
Medical Monitor/ designee 
must occur and approval 
from Medical Monitor prior 
to resuming therapy.” 
The 
revised 
protocol 
language will state: 
“In all cases of AST or ALT 
> 5x ULN, study treatment 
will 
be 
permanently 
discontinued.” 
A footnote is added to the 
algorithm which states: 
“AST or ALT > 5x ULN or 
T.bili 
> 
3x 
ULN: 
Permanently discontinue I- 
O therapy per protocol.” 

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APPENDIX 11    PRODUCT QUALITY ISSUES 
DEFINITIONS: 
 STUDY INTERVENTION DEFECTS (IE, PRIOR TO USE OF 
AND STUDY INTERVENTION MALFUNCTIONS 
Study intervention defects may be related to component, product, or packaging and labeling issues 
prior to or during use. The list below includes, but is not limited to, descriptions of product 
complaints in these 3 categories that should be reported as a defect: 
• Component Issue: Defect in container or dosing mechanism of the investigational product (IP). 
The component defect may be damaged, missing, or broken. Component examples include the 
and the prefilled syringe housed within the 
• Product Issue (related to drug appearance, solution): Defect in the product itself. The product 
appearance has visual imperfections such as foreign particles, crystallization, discoloration, 
turbidity, insufficient volume, or anything that is not consistent to the product description in 
the IFU. 
• Packaging/Labeling Issue: Defect in the packaging or labeling of the 
 The 
packaging (carton or tamper-evident seal) or labeling defects may be damaged or unreadable, 
or the label may be missing. 
 
Study intervention malfunctions 
• An 
 (
 
malfunction is when the 
 
 appears normal during 
verification of shipment and then does not work during administration (eg, the 
activated prematurely, failed to activate, the 
stalled or did not expel the full 
volume, needle guard safety feature did not deploy, glass syringe breakage, needle bent, or 
broke upon use. 
 
REPORTING PRODUCT QUALITY ISSUES (FOR 
 and IV) 
Issues that call into question study intervention defects or study intervention 
 malfunctions 
(eg, IMP safety, purity, potency, quality, and identity [eg, evidence of suspected tampering of 
product]), 
 failed to activate, labelling issues) must be reported to the Sponsor using the 
following email: IMPQualityComplaints@bms.com within one business day and no longer than 
three calendar days (upon clinical site’s identification or time of receipt from study participants 
receiving treatment 
 ). 
This includes suspected quality issues of components co-packaged with the drug, labelling, IMP 
drug combination products, and 
In the event of a suspected product quality issue, the immediate action to be taken by the site is to 
quarantine the affected product. Do not dispose of the product unless retention presents a risk to 
personnel (eg, cytotoxic, risk of injury from broken glass or sharps). When reporting, provide as 
much product information as possible. Suspected IMP quality issues will be investigated, and a 
response will be provided back to the investigational site. 
Site staff will be asked to send back malfunctioning 
to the depot or local sponsor company 
according to local guidance/regulations.