Conditions: Melanoma Skin Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 20
Healthy volunteers: no

Brief summary:
The purpose of this study is to see if BMS-986205 combined with nivolumab, compared to nivolumab by itself, is more effective in treating Melanoma that has spread or is unable to be removed by surgery, and has not previously been treated

Detailed description:

Arms:
arm 1: Specified dose on specified day

Participants will no longer receive BMS-986205 Placebo arm 2: Specified dose on specified day.

Participants have the option to discontinue BMS-986205, and continue nivolumab monotherapy, at investigator discretion

Interventions: intervention 1: BMS-986205 intervention 2: Nivolumab intervention 3: Placebo
Intervention descriptions: intervention 1: specified dose on specified day intervention 2: Specified dose on specified day intervention 3: Specified dose on specified day

Protocol document:
Prot_000.pdf: 
Page:
1
Protocol Number:
CA017055
EX-US
Non-IND
IND Number:
128,331
EUDRACT Number:
2017-002499-14
Date:
28-Aug-2017
Revised Date:
25-Oct-2018
Clinical Protocol CA017055
A Phase 3, Randomized, Double-blind Study of BMS-986205 Combined with Nivolumab versus 
Nivolumab in Participants with Metastatic or Unresectable Melanoma that is Previously 
Untreated
Revised Protocol 02
Incorporates Administrative Letters: 01 and 02
Study Director/Medical Monitor
Bruce Fischer, MD
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 
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IDO1 inhibitor
Revised Protocol No.: 02
2
Date: 25-Oct-2018
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. All other rights reserved. References to BMS in this protocol may apply 
to partners to which BMS has transferred obligations, eg, a Contract Research Organization 
(CRO).
Replace all previous version(s) of the protocol with this revised protocol and please provide 
a copy of this revised protocol to all study personnel under your supervision, and archive the 
previous versions.
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IDO1 inhibitor
Revised Protocol No.: 02
3
Date: 25-Oct-2018
DOCUMENT HISTORY
Document
Date of Issue
Summary of Change
Revised Protocol 02
25-Oct-2018
Revised Protocol incorporates the Administrative Letters 01 
and 02, clarifies typographical errors in the Revised 
Protocol 01 and incorporates clarifications on prohibited 
treatments, Appendices 03 and 05 of the BMS Protocol 
Model Document
Administrative Letter 02
09-Aug-2018
The purpose of this administrative letter is to clarify some 
typographical errors that occurred during the formatting of 
the Revised Protocol 01.
Administrative Letter 01
03-Aug-2018
This letter serves to clarify the language in the 
contraceptive appendix. A vasectomized partner is 
considered a highly effective method of contraception for 
WOCBP participants in this study. An additional note is 
added to reinforce that, vasectomized males receiving 
BMS-986205 must still use a synthetic or latex condom to 
prevent exposure in partners who are WOCBP or pregnant.
Revised Protocol 01
13-Jun-2018
To close the enrollment into the study, and to remove 
collection of efficacy assessments. In addition, safety 
collections were updated.
Original Protocol
28-Aug-2017
Not applicable
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IDO1 inhibitor
OVERALL RATIONALE FOR REVISED PROTOCOL 02:
 
 
.
SUMMARY OF KEY CHANGES FOR REVISED PROTOCOL 02
Section Number & 
Title
Description of Change
Brief Rationale
Cover Page
Change of  Medical Monitor.
N/A
Appendix 03 -
Adverse events and 
serious adverse 
events: Definitions 
and procedures for 
recording, evaluating, 
follow up and 
reporting
The Restructured Protocol Model 
Document Appendix 3 was rolled 
out on March 28 included changes 
in order to clarify our policy 
relative to the collection of disease 
related events. Those Appendix 3 
changes were made in error and 
are now clarified.
 
 
Appendix 04-Women 
of Childbearing 
Potential; 
Contraceptive 
Guidance for Female 
Participants of Child 
Bearing Potential
An additional note is added to 
reinforce that, vasectomized males 
receiving BMS-986205 must still 
use a synthetic or latex condom to 
prevent exposure in partners who 
are WOCBP or pregnant.
 
 
 
Appendix 05 -
 
 
 
 
 
 
 
 
Section 7 – Table 7-1
BMS-986205-04 50or100mg is 
Unblinded.
 
Section 7-1.2, 
Nivolumab Dosing
Total infusion volume is 160mL.
 
Section 7.7.1, 
Prohibited treatments
Any live / attenuated vaccine is 
prohibited during study treatment 
and within 100 days post last dose.
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TABLE OF CONTENTS 
TITLE PAGE ................................................................................................................ 
DOCUMENT HISTORY .............................................................................................. 
OVERALL RATIONALE FOR REVISED PROTOCOL 02: ..................................... 
SUMMARY OF KEY CHANGES FOR REVISED PROTOCOL 02 ......................... 
TABLE OF CONTENTS .............................................................................................. 
1 SYNOPSIS ................................................................................................................. 
2 SCHEDULE OF ACTIVITIES.................................................................................. 
3 INTRODUCTION ..................................................................................................... 
 
 
 
 
 
 
 
 
4 OBJECTIVES AND ENDPOINTS ........................................................................... 
5 STUDY DESIGN....................................................................................................... 
5.1 Overall Design .................................................................................................. 
5.1.1 Data Monitoring Committee and Other External Committees ................ 
5.2 Number of Participants ..................................................................................... 
5.3 End of Study Definition .................................................................................... 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6 STUDY POPULATION ............................................................................................ 
6.1 Inclusion Criteria .............................................................................................. 
6.2 Exclusion Criteria ............................................................................................. 
6.3 Lifestyle Restrictions ........................................................................................ 
6.4 Screen Failures .................................................................................................. 
6.4.1 Retesting During Screening or Lead-In Period ....................................... 
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7 TREATMENT ........................................................................................................... 
7.1 Treatments Administered .................................................................................. 
7.1.1 BMS-986205 Dosing ................................................................................ 
7.1.2 Nivolumab Dosing ................................................................................... 
7.2 Method of Treatment Assignment .................................................................... 
7.3 Blinding............................................................................................................. 
7.4 Dosage Modification ......................................................................................... 
7.4.1 Nivolumab Dose Modifications ................................................................ 
7.4.2 BMS-986205 Dose Modifications ............................................................ 
7.4.3 Dose Delay (BMS-986205 and Nivolumab) ............................................ 
7.4.4 Criteria to Resume Treatment (BMS-986205 and Nivolumab) ............... 
7.4.5 Management Algorithms for Immuno-Oncology Agents ......................... 
7.4.6 Detection of Methemoglobinemia ............................................................ 
7.5 Preparation/Handling/Storage/Accountability .................................................. 
7.5.1 Retained Samples for Bioavailability / Bioequivalence ........................... 
7.6 Treatment Compliance ...................................................................................... 
 
 
 
 
 
 
 
 
 
 
 
7.8 Treatment After the End of the Study ............................................................... 
8 DISCONTINUATION CRITERIA ........................................................................... 
8.1 Discontinuation from Study Treatment ............................................................ 
8.1.1 BMS-986205 and Nivolumab Dose Discontinuation ............................... 
8.1.2 BMS-986205 Dose Discontinuation ........................................................ 
8.1.3 Treatment Beyond Progression ................................................................ 
8.1.3.1 Rationale ......................................................................................... 
8.1.3.2 Criteria Required for Treatment Beyond Progression ................... 
8.1.4 Post-Study Treatment Study Follow-up ................................................... 
8.2 Discontinuation from the Study ........................................................................ 
8.3 Lost to Follow-Up ............................................................................................. 
9 STUDY ASSESSMENTS AND PROCEDURES ..................................................... 
 
 
 
 
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 ......................................................... 
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9.2.3 Follow-up of AEs and SAEs ..................................................................... 
9.2.4 Regulatory Reporting Requirements for SAEs ......................................... 
9.2.5 Adverse Events of Special Interest ........................................................... 
9.2.6 Pregnancy ................................................................................................ 
9.2.7 Laboratory Test Result Abnormalities ..................................................... 
9.2.8 Potential Drug Induced Liver Injury (DILI) ............................................ 
9.2.9 Other Safety Considerations .................................................................... 
9.3 Overdose ........................................................................................................... 
9.4 Safety ................................................................................................................ 
9.4.1 Clinical Safety Laboratory Assessments .................................................. 
9.4.2 Imaging Safety Assessment ...................................................................... 
 
 
 
 
 
 
 
 
 
 
 
10 STATISTICAL CONSIDERATIONS .................................................................... 
10.1 Sample Size Determination ............................................................................. 
10.2 Populations for Analyses ................................................................................ 
10.3 Statistical Analyses ......................................................................................... 
 
10.3.2 Safety Analyses....................................................................................... 
 
 
 
 
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 PERFORMANCE STATUS SCALES ................................................. 
APPENDIX 7 AJCC MELANOMA STAGING (CANCER STAGING MANUAL 
8TH EDITION) ....................................................................................................... 
 
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APPENDIX 12 RESPONSE EVALUATION CRITERIA IN SOLID TUMORS 
GUIDELINES (VERSION 1.1) WITH BMS MODIFICATIONS ........................ 
 
 
  
APPENDIX 16 REVISED PROTOCOL SUMMARY OF CHANGE HISTORY ...... 
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1
SYNOPSIS
Protocol Title: A Phase 3, Randomized, Double-blind Study of BMS-986205 Combined with 
Nivolumab versus Nivolumab in Participants with Metastatic or Unresectable Melanoma 
that is Previously Untreated
Study Phase: 3
 
 
 
 
 
 
 
 
 
 
 
 
Study Population:
The study population consists of adult (18 years of age, or age of majority) participants with 
unresectable or metastatic melanoma that is previously untreated who have not received prior 
systemic therapy for their disease. Enrollment in this study was closed on 19-Apr-2018. 
Key Inclusion Criteria:

Histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the American 
Joint Committee on Cancer (AJCC) Staging Manual (8th edition) 

Treatment-naïve participants (ie, no prior systemic anticancer therapy for unresectable or 
metastatic melanoma). Note that prior adjuvant or neoadjuvant melanoma therapy is permitted 
in the setting of completely resected disease if it was completed at least 6 months prior to 
randomization, and all related adverse events (AEs) have either returned to baseline or 
stabilized.

At least one measurable lesion by computed tomography (CT) or magnetic resonance imagery 
(MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria

Tumor tissue (biopsy or surgical specimen, where applicable) from an unresectable or 
metastatic site of disease must be provided for biomarker analyses. In order to be randomized, 
a participant must be classified as PD-L1 positive (1% tumor cell membrane staining) vs
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PD-L1 negative (< 1% tumor cell membrane staining)/PD-L1 indeterminate (tumor cell 
membrane scoring hampered by high cytoplasmic staining or melanin content). If an 
insufficient amount of tumor tissue from an unresectable or metastatic site is available prior to 
the start of the screening phase, then a fresh biopsy will be required during the screening phase
for performance of biomarker analyses.

Participants must have known BRAF V600 mutation status or consent to BRAF V600 mutation 
testing per local institutional standards during the Screening Period and have results of BRAF 
testing available prior to randomization. Participants with indeterminate BRAF status or with 
BRAF status not documented prior to randomization are not permitted to randomize to a 
treatment arm.

Prior radiotherapy must have been completed at least 2 weeks prior to study treatment 
administration.

Participants must be able to swallow pills intact.
Key Exclusion Criteria:

Women who are pregnant or breastfeeding

Active brain metastases or leptomeningeal metastases. Participants with brain metastases are 
eligible if these have been treated and there is no magnetic resonance imagery (MRI) evidence 
of progression for at least 8 weeks after treatment is complete and within 28 days prior to first 
dose of study treatment administration. 

Uveal or ocular melanoma

Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg 
daily prednisone equivalent) or other immunosuppressive medications within 14 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.

Participants with a personal or family (ie, in a first-degree relative) history of cytochrome b5 
reductase deficiency (previously called methemoglobin reductase deficiency) or other diseases 
that put them at risk of methemoglobinemia. All participants will be screened for 
methemoglobin levels prior to randomization.

Participants with a history of glucose 6-phosphate dehydrogenase (G6PD) deficiency or other 
congenital or autoimmune hemolytic disorders. All participants will be screened for G6PD 
levels prior to randomization.

Prior treatment with an anti-PD-1 (except if given as adjuvant or neoadjuvant therapy for 
melanoma), anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody (except if given as adjuvant or 
neoadjuvant therapy for melanoma), or any other antibody or drug specifically targeting T-cell 
costimulation or immune checkpoint pathways

Prior treatment with BMS-986205 or any other IDO1 inhibitors
Objectives and Endpoints:
As of 19-Apr-2018 enrollment in this study was closed and only safety assessments will be 
collected. No analyses of efficacy, quality of life/patient reported outcomes, pharmacokinetics, or
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health resource utilization, are planned. Previously collected biomarker specimens may be 
analyzed, but no formal analyses are planned. 
Overall Design:
This is a Phase 3, randomized, study of BMS-986205 in combination with nivolumab versus 
nivolumab monotherapy in adult and adolescent participants with unresectable or metastatic 
melanoma that is previously untreated. (This study was originally double blind with respect to 
BMS-986205 but was unblinded with Revised Protocol 01.)

A pre-treatment tumor sample to determine PD-L1 status is required to be submitted from all 
participants prior to randomization. The sample must be obtained within 3 months prior to 
enrollment from a metastatic tumor lesion or from an unresectable primary tumor lesion; the 
tumor sample must be taken from a site of disease that has not been previously irradiated. In 
addition, no intervening treatment may have been administered between the time of
biopsy/surgery and randomization.

Participants must have a documented BRAF status prior to randomization. 

Depending on the treatment arm, the participant will receive BMS-986205 plus nivolumab or 
nivolumab monotherapy for up to 104 weeks (approximately 2 years) of study treatment. 
Under Revised Protocol 01, BMS-98205 Placebo will not be administered to Arm B 
participants, and investigators have the option of continuing on nivolumab monotherapy in 
participants assigned to Arm A (nivolumab + BMS986205). 

One cycle of treatment is defined as 4 weeks. Treatment will continue until investigator-
assessed disease progression per RECIST v1.1 criteria, unacceptable toxicity, withdrawal of 
consent/assent, or completion of 104 weeks of treatment, whichever occurs first. Treatment 
beyond initial progression is permitted if the participant has investigator-assessed clinical 
benefit, is tolerating study treatment (see Sections 8.1.1 and 8.1.3.2 of the protocol), and has 
not yet completed 104 weeks of study treatment.

On-study tumor assessments will follow the schedule of the local standard of care.
Number of Participants: 
As of 19-April-2018 enrollment into this study was closed. 
Treatment Arms and Duration:
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Study treatment: 
Study Drug for CA017055
Medication 
Potency 
IP/Non-IP 
BMS-936558-01
(Nivolumab) Solution for 
Injection
100 mg (10 mg/mL)
IP
BMS-986205-04
100 mg
IP
BMS-986205-04
50 mg
IP
The original study design schematic is presented in Figure 1-1. Under Revised Protocol 01 the 
study is closed to enrollment and is no longer double blind. 
Figure 1-1:
Study Schematic
Note: As of Revised Protocol 01, treatment will no longer be blinded, and participants in Arm B will no longer 
receive BMS-986205 Placebo. Participants in Arm A, have the option to discontinue BMS-986205, and continue 
nivolumab monotherapy, at investigator discretion. 
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During the treatment phase, participants will receive:

In Arm A: BMS-986205 100 mg PO QD and Nivolumab 480 mg IV Q4W for a maximum of 
104 weeks. Under Revised Protocol 01 investigators have the option of continuing participants 
on nivolumab monotherapy.

In Arm B: BMS-986205 Placebo PO QD and Nivolumab 480 mg IV Q4W for a maximum of 
104 weeks. Under Revised Protocol 01 BMS-986205 Placebo should not be administered.
Dose reductions are not permitted for nivolumab. One dose reduction is permitted for 
BMS-986205, from a 100 mg QD tablet to a 50 mg QD tablet. No re-escalation is permitted after 
dose reduction. BMS-986205 tablets must be taken by mouth, and swallowed whole and intact. 
Crushing, chewing, dissolving, and other alterations to the formulation or route of administration 
are not permitted.
Doses of BMS-986205 and nivolumab should be delayed due to treatment-related AEs described 
in Section 7.4.3 of the protocol. Treatment-related AEs resulting in permanent discontinuation of 
study treatment are described in Section 8 of the protocol. Treatment may be prematurely 
discontinued due to unacceptable toxicity, withdrawal of consent, disease progression, or 
completion of treatment cycles, whichever occurs first. A Data Monitoring Committee (DMC) will 
provide independent oversight of safety, study conduct and efficacy of the study treatments.
Duration:
As of 19-Apr-2018, enrollment in the study was closed. Participants currently enrolled in the study 
may continue to receive treatment until progression, unacceptable toxicity, withdrawal of consent, 
or 104 weeks from the first dose of nivolumab. 
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2
SCHEDULE OF ACTIVITIES
Table 2-1:
Screening Procedural Outline (CA017055) 
Per Revised Protocol 01 enrollment in the study is closed. Participants in screening who have not been randomized at the time of enrollment closure 
(19-Apr-2018) will not start study treatment and should be screen failed (see Section 3.1.1).
Procedurea
Screening
Visit
Notes
(All windows are based on calendar days)
Eligibility Assessments
Informed Consent
X
Register in Interactive Response system (IRT) to obtain participant number
Inclusion/Exclusion Criteria
X
Must be confirmed prior to randomization
Medical History
X
All medical history relevant to the disease under study. Include concomitant 
medications, prior cancer therapy, American Joint Committee on Cancer 
(AJCC) stage, and BRAF mutation status. Glucose-6-phosphate dehydrogenase 
(G6PD) deficiency history, and cytochrome b5 reductase deficiency history.
For participants without BRAF mutation status documented at screening, they 
must consent to BRAF mutation testing at this time and BRAF mutation results 
must be available prior to randomization. 
Tumor Tissue Samples
X
All participants must have tumor tissue available, either recent archival sample 
(obtained within 3 months prior to enrollment from a site not previously 
irradiated and with no intervening treatment between time of acquisition and 
enrollment) or a fresh pre-treatment biopsy obtained during the screening 
period. Tissue may be from a core biopsy, punch biopsy, excisional biopsy or 
surgical specimen; fine needle aspiration and other cytology samples are not 
acceptable. Sufficient quantities must be available: a block or, optimally, at least 
20 slides is requested, with a minimum of 10 slides required.  
In order to be randomized, a participant must have quantifiable PD-L1 
expression (1% [positive] or < 1% [negative] tumor cell membrane staining) 
or be classified as PD-L1 indeterminate. See Section 5.1.
The analytical laboratory must provide IRT with confirmation of the related 
results prior to randomization.
Please refer to Section 9.8.1 for additional information.
Body Imaging
X
Contrast enhanced computed tomography (CT) of the chest, contrast-enhanced 
CT (or magnetic resonance imagery [MRI] with and without contrast) of the 
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Table 2-1:
Screening Procedural Outline (CA017055) 
Per Revised Protocol 01 enrollment in the study is closed. Participants in screening who have not been randomized at the time of enrollment closure 
(19-Apr-2018) will not start study treatment and should be screen failed (see Section 3.1.1).
Procedurea
Screening
Visit
Notes
(All windows are based on calendar days)
abdomen, pelvis, and all known sites of disease within 28 days prior to 
randomization. See Section 9.1.
Brain Imaging
X
For participants with a history or clinical symptoms of brain metastasis an MRI 
brain with and without gadolinium is required at Screening within 28 days prior 
to randomization. See Section 9.1. 
Other Imaging (eg, Bone Scan)
X
As clinically indicated. See Section 9.1.
Safety Assessments
Targeted Physical Examination, Measurements, Vital 
Signs, and Performance Status
X
Height, weight, and ECOG Performance Status (See Appendix 6), blood 
pressure (BP), heart rate (HR), temperature. Must be collected within 14 days 
prior to randomization. Vital signs must be obtained at the screening visit and 
within 3 calendar days prior to first dose.
Oxygen saturation
X
Oxygen saturation by pulse oximetry at rest within 14 days prior to 
randomization. 
Assessment of Signs and Symptoms
X
Within 14 days prior to randomization
 
Serious Adverse Events (SAEs) Assessment
X
SAEs collected from time of consent
ECG
X
At rest
Laboratory Tests
Complete Blood Count (CBC) with differential, 
methemoglobin levels, G6PD levels, Chemistry, 
Endocrine, Viral, , C-reactive protein, Urinalysis
X
For all except viral testing: must be performed within 14 days prior to 
randomization. 
Methemoglobin levels to be assessed on arterial or venous blood sample or by 
co-oximetry (performed locally).
For viral testing and C-reactive protein: must be performed within 28 days prior 
to randomization.
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Table 2-1:
Screening Procedural Outline (CA017055) 
Per Revised Protocol 01 enrollment in the study is closed. Participants in screening who have not been randomized at the time of enrollment closure 
(19-Apr-2018) will not start study treatment and should be screen failed (see Section 3.1.1).
Procedurea
Screening
Visit
Notes
(All windows are based on calendar days)
For HIV: testing at sites where locally mandated; see Appendix 13.
For full list of assessments, see Section 9.4.1.
Pregnancy Test (WOCBP only)
X
Serum or urine pregnancy test (minimum sensitivity equivalent units 25IU/L or 
equivalent units of HCG) to be done at screening visit and repeated within 24 
hours prior to first dose of study treatment
a 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 treatment 
physician. Additional testing or assessments may be performed as clinically necessary or where required by institutional or local regulations.
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IDO1 inhibitor
Table 2-2:
On-study Assessments (CA017055)
Procedurea
BMS-986205 PO once daily (QD) + Nivolumab 480 mgb, IV (Arm A) every 4 
weeks (Q4W)
OR 
Nivolumab 480 mg IV(Arm B) Q4W (Per Revised Protocol 01, no BMS-
986205 Placebo will be given)
Notesc
Cycle 1 (Day 1)
Cycle 1
(Day 14 3 
days)
Cycle 2 and subsequent on-treatment 
visits (Day 1 3 days)
(1 Cycle = 4 Weeks)
Treat until progression, unacceptable 
toxicity, or completion of 104 weeks of 
therapy
Study Treatment
Randomize
X
First dose to be administered within 3 
calendar days following randomization.
IRT Drug Assignment
X
X
Administer Study 
Treatment
X
X
First dose to be administered within 3 
calendar days following randomization. 
Advise participants on dosing of 
BMS-986205 with a meal.
After the first nivolumab infusion, 
subjects should be monitored per 
local/institutional guidelines. If no such 
guidelines exist, an observation period 
of 2 hours after the end of the nivolumab 
infusion is suggested.
Dispense BMS-986205 
and Pill Diary
On C1D7 3 
days: contact by 
telephone to 
ensure 
compliance with 
BMS-986205 
X
Review pill diary during each visit for 
compliance of daily administration of 
BMS-986205. Collect pill diary at the 
completion of each cycle for participants 
receiving BMS-986205.
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BMS-986205
IDO1 inhibitor
Table 2-2:
On-study Assessments (CA017055)
Procedurea
BMS-986205 PO once daily (QD) + Nivolumab 480 mgb, IV (Arm A) every 4 
weeks (Q4W)
OR 
Nivolumab 480 mg IV(Arm B) Q4W (Per Revised Protocol 01, no BMS-
986205 Placebo will be given)
Notesc
Cycle 1 (Day 1)
Cycle 1
(Day 14 3 
days)
Cycle 2 and subsequent on-treatment 
visits (Day 1 3 days)
(1 Cycle = 4 Weeks)
Treat until progression, unacceptable 
toxicity, or completion of 104 weeks of 
therapy
dosing 
requirements 
Safety Assessments
Targeted Physical 
Examination, 
Measurements, Vital 
Signs, and Performance 
Status
X
X
See note
Weight, BP, HR, temperature, and 
ECOG status prior to each dose. 
Targeted physical examination to be 
performed only as clinically indicated 
within 3 calendar days prior to dosing.
Oxygen Saturation
X
X
X
Oxygen saturation by pulse oximetry or 
co-oximetry at rest prior to dosing.
Adverse Events (AEs) 
Assessments (including 
SAEs)
Continuously
Record at each visit
ECG
X
X
See note
At rest. C1D1 and C1D14: Pre-dose for 
all participants, and 4 hours post dose
for participants receiving BMS-986205. 
For Cycle 2 and beyond: Pre-dose, as 
clinically indicated, including if 
concomitant medications which may 
prolong the QTc interval are added.
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Table 2-2:
On-study Assessments (CA017055)
Procedurea
BMS-986205 PO once daily (QD) + Nivolumab 480 mgb, IV (Arm A) every 4 
weeks (Q4W)
OR 
Nivolumab 480 mg IV(Arm B) Q4W (Per Revised Protocol 01, no BMS-
986205 Placebo will be given)
Notesc
Cycle 1 (Day 1)
Cycle 1
(Day 14 3 
days)
Cycle 2 and subsequent on-treatment 
visits (Day 1 3 days)
(1 Cycle = 4 Weeks)
Treat until progression, unacceptable 
toxicity, or completion of 104 weeks of 
therapy
 
Laboratory Tests
CBC with differential, 
Chemistry panel, Thyroid 
testing
Methemoglobin (only for 
participants receiving 
BMS-986205)
X
CBC only
X
For full list of laboratory assessments to 
be performed within 3 calendar days 
prior to dosing, assessments, see Section 
9.4.1.
For participants receiving BMS-986205: 
Methemoglobin should be assessed 
locally on arterial or venous blood 
sample or by co-oximetry once each 
treatment cycle, and as clinically 
indicated based on symptoms (all 
participants) (See Section 7.7.4)
Also measure TSH starting at C2D1, and 
every 8 weeks/2 cycles thereafter. If 
TSH abnormal, reflex to free T3, and T4 
at those measurement time points.
Pregnancy Test (WOCBP 
only)
X
X
A negative pregnancy test should be 
documented within 24 hours prior to 
start of each dose of nivolumab.
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Table 2-2:
On-study Assessments (CA017055)
Procedurea
BMS-986205 PO once daily (QD) + Nivolumab 480 mgb, IV (Arm A) every 4 
weeks (Q4W)
OR 
Nivolumab 480 mg IV(Arm B) Q4W (Per Revised Protocol 01, no BMS-
986205 Placebo will be given)
Notesc
Cycle 1 (Day 1)
Cycle 1
(Day 14 3 
days)
Cycle 2 and subsequent on-treatment 
visits (Day 1 3 days)
(1 Cycle = 4 Weeks)
Treat until progression, unacceptable 
toxicity, or completion of 104 weeks of 
therapy
 
 
 
 
 
 
 
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Table 2-2:
On-study Assessments (CA017055)
Procedurea
BMS-986205 PO once daily (QD) + Nivolumab 480 mgb, IV (Arm A) every 4 
weeks (Q4W)
OR 
Nivolumab 480 mg IV(Arm B) Q4W (Per Revised Protocol 01, no BMS-
986205 Placebo will be given)
Notesc
Cycle 1 (Day 1)
Cycle 1
(Day 14 3 
days)
Cycle 2 and subsequent on-treatment 
visits (Day 1 3 days)
(1 Cycle = 4 Weeks)
Treat until progression, unacceptable 
toxicity, or completion of 104 weeks of 
therapy
 
 
 
 
a If a dose is delayed, the procedures scheduled for that same time point (except tumor assessments) should also be delayed to coincide with when that time point’s 
dosing actually occurs.
b Per Revised Protocol-01, investigators have the option of discontinuing participants in Arm A from BMS-986205 treatment and continuing nivolumab treatment. 
c 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.
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Table 2-3:
Follow-up Procedural Outline (CA017055)
Procedure
Follow-Upa
Visits 1 and 2
Survival Follow-
Up Visits (not 
applicable per 
Revised Protocol 
01)
Notesb
Safety Assessments
Targeted Physical Examination, 
Measurements, Vital Signs, and 
Performance Status
X
Weight, BP, HR, temperature, and ECOG status. Targeted physical 
examination to be performed only as clinically indicated.
AEs Assessment (including SAEs)
Continuously
Record at each visit
 
Pregnancy Test (WOCBP only)
X
Serum or urine pregnancy test must be performed (urine pregnancy test: 
minimum sensitivity 25 IU/L or equivalent units of hCG) 
Laboratory Tests
CBC with differential, Chemistry 
panel, Thyroid testing
X01-yes
X02 - if 
toxicities are 
present
For full list of assessments, see Section 9.4.1.
 
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Table 2-3:
Follow-up Procedural Outline (CA017055)
Procedure
Follow-Upa
Visits 1 and 2
Survival Follow-
Up Visits (not 
applicable per 
Revised Protocol 
01)
Notesb
 
 
a Participants must be followed for at least 100 days after last dose of study treatment. Follow-up visit #1 should occur 30 days from the last dose (7 days) or 
can be performed on the date of discontinuation if that date is greater than 42 days from the last dose. Follow-up visit #2 occurs approximately 100 days (7 
days) from last dose of study treatment. Both follow-up visits should be conducted in person. No follow-up visit is required for participants who screen fail. 
b 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.
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4
OBJECTIVES AND ENDPOINTS
Not applicable per Revised Protocol 01. Only safety assessments will be conducted. No analyses 
of efficacy, quality of life/patient reported outcomes, pharmacokinetics, or health resource 
utilization, are planned. Previously collected biomarker samples may be analyzed, but no further 
collections are planned with this revised protocol.
5
STUDY DESIGN
See Section 3.1.1for updates on Study Design as per Revised Protocol 01. 
5.1
Overall Design
The original design was a Phase 3, randomized, double-blind study of BMS-986205 in 
combination with nivolumab versus nivolumab monotherapy in adult (18 years of age and older, 
or age of majority) participants with unresectable or metastatic melanoma that is previously 
untreated. As of 19-Apr-2018, enrollment in the study was closed (see Section 3.1.1).
Participants must have unresectable Stage III or Stage IV melanoma, per the 8th edition of the 
American Joint Committee on Cancer (AJCC) Staging Manual30 (See Appendix 7), and must not 
have received prior systemic therapy for the treatment of unresectable or metastatic melanoma. 
Prior adjuvant or neoadjuvant therapy in participants with previously completely resected disease 
that has now recurred is permitted if this therapy was completed at least 6 months prior to 
randomization. 
The study design schematic is presented in Figure 5.1-1. 
Figure 5.1-1:
Study Design Schematic
Note: As of Revised Protocol 01, treatment will no longer be blinded, and participants in Arm B will no longer 
receive BMS-986205 Placebo. Participants in Arm A, have the option to discontinue BMS-986205, and continue 
nivolumab monotherapy, at investigator discretion.
A pre-treatment tumor sample to determine PD-L1 status is required to be submitted from all 
participants prior to randomization. The sample must be obtained within 3 months prior to 
enrollment from a metastatic tumor lesion or from an unresectable primary tumor lesion. The 
tumor sample must be taken from a site of disease which has not been previously irradiated. In 
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addition, no intervening treatment may have been administered between the time of biopsy/surgery 
and randomization. Pre-treatment tumor tissue biopsy specimens in the form of a paraffin-
embedded block or, optimally, at least 20 unstained slides, will be requested; a minimum of 
10 slides is required. The pre-treatment tumor sample must be a core biopsy, punch biopsy, 
excisional biopsy, or surgical specimen; fine needle aspiration samples and cytology samples are 
not acceptable. If sufficient tissue is not available from within 3 months prior to enrollment, then 
a fresh biopsy will be required during the screening period. Samples will be submitted to the 
analytical laboratory for PD-L1 testing. The analytical laboratory must provide IRT with 
confirmation of the related results prior to randomization. 
Participants must have a documented BRAF status prior to randomization. Those participants 
enrolling in this study without documented results must have testing performed locally and results 
(wild type or mutant) be available prior to randomization. Participants with indeterminate or 
unknown BRAF status results will not be permitted to randomize to a treatment arm.
During the treatment phase, adult participants will receive:

Arm A: BMS-986205 100 mg PO QD and Nivolumab 480 mg IV Q4W for up to 104 weeks 
(approximately 2 years). Under Revised Protocol 01 investigators have the option of 
continuing participants on nivolumab monotherapy.

Arm B: Nivolumab 480 mg IV Q4W for up to 104 weeks (approximately 2 years). Under 
Revised Protocol 01 BMS-986205 Placebo should not be administered.
One cycle of treatment is defined as 4 weeks. 
Dose reductions will be not be allowed for nivolumab; dose reductions will be permitted for 
BMS-986205 if the participant is an adult or an adolescent receiving 100 mg tablets. See 
Section 7.4.2 for more information.
Per Revised Protocol 01 tumor assessments should be conducted per the timing of the local 
standard of care. 
Treatment beyond initial investigator-assessed Response Evaluation Criteria in Solid Tumors
(RECIST) v1.1-defined progression (see Appendix 12) is permitted if the participant has 
investigator-assessed clinical benefit, is tolerating study treatment, and has not yet completed 
104 weeks of study treatment (Section 8.1.1 and Section 8.1.3).
5.1.1
Data Monitoring Committee and Other External Committees
Not Applicable per Revised Protocol 01. 
5.2
Number of Participants
As of 19-April-2018 enrollment into this study was closed (see Section 3.1.1). 
5.3
End of Study Definition
The start of the trial is defined as the first visit for the first participant screened. As of Revised 
Protocol 01, study completion is defined as the final date on which data is collected for this study. 
The total duration of the study will be determined by the last follow-up visit for the last subject to 
stop treatment. 
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6
STUDY POPULATION
For entry into the study, the following criteria MUST be met.
6.1
Inclusion Criteria
Per Revised Protocol 01, enrollment in the current study has been stopped as of 19-Apr-2018. 
Male participants continuing treatment should follow the updated contraceptive guidance 
below (and in Appendix 4). 
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1) Signed Written Informed Consent
a) Participants must have signed and dated an IRB/IEC approved written informed consent 
form in accordance with regulatory 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.
c) For adolescent participants unable to give their written consent, in accordance with local 
regulations, one or both parents, a guardian, or a legally acceptable representative must be 
informed of the study procedures and must document permission by signing the informed 
consent form approved for the study prior to clinical study participation. Each participant 
must be informed about the nature of the study to the extent compatible with his or her 
understanding. Should a participant become capable or reach the age of majority, his or her 
consent should be obtained as soon as possible. The explicit wish of a participant who is a 
minor or unable to give his or her written consent, but who is capable of forming an opinion 
and assessing information to refuse participation in, or to be withdrawn from, the clinical 
study at any time should be considered by the investigator. Minors who are judged to be of 
an age of reason as determined by local requirements should also give their assent. The 
assent should be documented based on local requirements. Continued assent should be 
documented when important new information becomes available that is relevant to the 
participant’s assent.
2) Type of Participant and Target Disease Characteristics
a) Eastern Cooperative Oncology Group (ECOG) performance status of 1 (see Appendix 6)
b) Histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the American 
Joint Committee on Cancer (AJCC) Staging Manual (8th edition) (see Appendix 7)
c) Treatment-naïve participants (ie, no prior systemic anticancer therapy for unresectable or 
metastatic melanoma). Note that prior adjuvant or neoadjuvant melanoma therapy is 
permitted in the setting of completely resected disease if it was completed at least 6 months 
prior to randomization, and all related AEs have either returned to baseline or stabilized.
d) At least one measurable lesion by computed tomography (CT) or magnetic resonance 
imagery (MRI) per RECIST v1.1 criteria (see Appendix 12)
e) Tumor tissue (biopsy or surgical specimen, where applicable) from an unresectable 
primary tumor or from a metastatic site of disease must be provided for biomarker analyses. 
The tumor sample must be obtained from a site of disease that has not been previously 
irradiated. In order to be randomized, a participant must be classified as PD-L1 positive 
(1% tumor cell membrane staining) vs PD-L1 negative (< 1% tumor cell membrane 
staining)/PD-L1 indeterminate (tumor cell membrane scoring hampered by high 
cytoplasmic staining or melanin content). If an insufficient amount of tumor tissue from an 
unresectable or metastatic site is available from prior to the start of the screening phase, 
then a fresh biopsy will be required during the screening phase for performance of 
biomarker analyses. PD-L1 expression will be determined using the Dako PD-L1 IHC 28-
8 pharmDx assay
i)
Either a recent archival sample obtained within 3 months prior to enrollment (with no 
intervening treatment between time of acquisition and enrollment) or a fresh 
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pre-treatment biopsy is to be submitted as a formalin-fixed, paraffin-embedded (FFPE) 
tissue block or unstained tumor tissue sections (optimally at least 20 slides, but a 
minimum of 10 slides required), with an associated pathology report, to the analytical 
laboratory for inclusion. The analytical laboratory must provide IRT with confirmation 
of receipt of the related results prior to randomization. Biopsy should be excisional, 
incisional, or core needle. Fine needle aspiration or cytology specimens are not 
acceptable for submission.
f)
Participants must have known BRAF V600 mutation status prior to enrollment or consent 
to BRAF V600 mutation testing per local institutional standards during the Screening 
Period and have results of BRAF testing available prior to randomization. Participants with 
indeterminate or BRAF status not reported prior to randomization are not permitted to 
randomize to a treatment arm.
g) Prior radiotherapy must have been completed at least 2 weeks prior to study treatment 
administration.
h) Participants must be able to swallow pills intact. 
i)
Participant Re-enrollment: This study permits the re-enrollment of a participant who has 
discontinued the study as a pre-treatment failure (ie, participant has not been randomized) 
after obtaining agreement from the Medical Monitor/designee prior to re enrolling a 
participant. If re-enrolled, the participant must be re-consented.
3) Age and Reproductive Status
a) Males and females, ages 12 years or older, except where local regulations and/or 
institutional policies do not allow for participants < 18 years of age (pediatric population) 
to participate. For those sites, the eligible participant population is 18 years of age, or age 
majority.
b) Women of childbearing potential (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 treatment.
c) Women must not be breastfeeding
d) Women of childbearing potential (WOCBP) must agree to follow instructions for 
method(s) of contraception (see Appendix 4) for the duration of treatment with study 
treatment plus 5 months after the last dose of study treatment (ie, 30 days [duration of 
ovulatory cycle] plus the time required for nivolumab to undergo approximately 
5 half-lives).
e) Males who are receiving BMS-986205, and are sexually active with WOCBP, must agree 
to use a male synthetic or latex condom during sexual activity for the duration of treatment 
with study treatment plus 7 months after the last dose of the study treatment (ie, 90 days 
[duration of sperm turnover] plus the time required for nivolumab to undergo 
approximately 5 half-lives). Males receiving nivolumab monotherapy must agree to use 
contraception (see Appendix 4) for the duration of treatment with study treatment plus 7 
months after the last dose of the study treatment (ie, 90 days [duration of sperm turnover] 
plus the time required for nivolumab to undergo approximately 5 half-lives). These critera 
apply to azoospermic males as well. In addition, male participants must be willing to refrain 
from sperm donation during this time. 
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f)
WOCBP who are continuously not heterosexually active are also exempt from 
contraceptive requirements, and still must undergo pregnancy testing as described in this 
section.
Investigators shall counsel WOCBP, and male participants who are sexually active with WOCBP, 
on the importance of pregnancy prevention and the implications of an unexpected pregnancy. 
Investigators shall advise on the use of highly effective methods of contraception (Appendix 4) 
which have a failure rate of < 1% when used consistently and correctly. Hormonal contraceptives 
are not highly effective methods of contraception for participants in this study who are 
WOCBP receiving BMS-986205.
6.2
Exclusion Criteria
Per Revised Protocol 01, enrollment in the current study was closed on 19-Apr-2018.
1) Medical Conditions
a) Women who are pregnant or breastfeeding
b) Active brain metastases or leptomeningeal metastases. Participants with brain metastases 
are eligible if these have been treated and there is no magnetic resonance imagery (MRI) 
evidence of progression for at least 8 weeks after treatment is complete and within 28 days 
prior to first dose of study treatment administration. 
c) Uveal or ocular melanoma
d) Participants with 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.
e) Participants with a condition requiring systemic treatment with either corticosteroids 
(> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 
14 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.
f)
Participants with a personal or family (ie, in a first-degree relative) history of cytochrome 
b5 reductase deficiency (previously called methemoglobin reductase deficiency) or other 
diseases that put them at risk of methemoglobinemia. All participants will be screened for 
methemoglobin levels prior to randomization.
g) Participants with a history of G6PD deficiency or other congenital or autoimmune 
hemolytic disorders. All participants will be screened for G6PD deficiency prior to 
randomization using quantitative or qualitative levels per local standard of care.  
Interpretation of G6PD assay results to ensure no deficiency is present should also be per 
local standard of care, including with consultation of appropriate medical subspecialists, 
as needed..
h) Participants with serious or uncontrolled medical disorders
i)
Prior malignancy active within the previous 3 years except for locally curable cancers that 
have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder 
cancer, or carcinoma in situ of the prostate, cervix, or breast
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2) Prior/Concomitant Therapy
a) Prior treatment with an anti-PD-1 (except if given as adjuvant or neoadjuvant therapy for 
melanoma), anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody (except if given as adjuvant 
or neoadjuvant therapy for melanoma), or any other antibody or drug specifically targeting 
T-cell costimulation or immune checkpoint pathways 
b) Prior treatment with BMS-986205 or any other IDO1 inhibitors
c) Treatment with botanical preparations (eg, herbal supplements or traditional Chinese 
medicines) intended for general health support or to treat the disease under study within 
2 weeks prior to randomization.
3) Physical and Laboratory Test Findings
a) WBC < 2000/L
b) Neutrophils < 1500/L
c) Platelets < 100x 103/L
d) Hemoglobin < 9.0 g/dL (transfusion to achieve this level is not permitted within 2 weeks 
of this laboratory assessment)
e) Serum creatinine > 1.5x ULN or calculated creatinine clearance (CLcr) < 40 mL/min (using 
the Cockcroft-Gault formula):
Female CLcr = (140- age in years) x weight in kg x 0.85
72 x serum creatinine in mg/ dL
Male CLcr = (140- age in years) x weight in kg x 1.00
72 x serum creatinine in mg/ dL
f)
AST or ALT > 3.0x ULN
g) Total bilirubin > 1.5x ULN (except participants with Gilbert Syndrome who must have a 
total bilirubin level of < 3.0x ULN)
h) Any positive test result for hepatitis B virus or hepatitis C virus indicating presence of 
virus, eg, Hepatitis B surface antigen (HBsAg, Australia antigen) positive, or Hepatitis C 
antibody (anti-HCV) positive (except if HCV-RNA negative)
i)
Known history of positive test for human immunodeficiency virus (HIV) or known 
acquired immunodeficiency syndrome (AIDS). Note: Testing for HIV must be performed 
at sites where mandated locally.
j)
Quantitative or qualitative G6PD assay results suggesting underlying G6PD deficiency
k) Blood methemoglobin > ULN, assessed in an arterial or venous blood sample or by 
co-oximetry 
l)
Positive pregnancy test at enrollment or prior to administration of study medication
4) Allergies and Adverse Drug Reaction
a) History or presence of hypersensitivity or idiosyncratic reaction to methylene blue 
b) History of allergy or hypersensitivity to any study treatment components
5) Other Exclusion Criteria
a) Prisoners or participants who are involuntarily incarcerated. Note: under certain specific 
circumstances a person who has been imprisoned may be included or permitted to continue 
as a participant. Strict conditions apply and BMS approval is required.
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b) Participants who are compulsorily detained for treatment of either a psychiatric or physical 
(eg, infectious disease) illness
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
Not applicable. No restrictions are required.
6.4
Screen Failures
Screen failures are defined as participants who consent to participate in the clinical study but are 
not subsequently randomized. 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. Minimal information includes date of consent, demography, screen 
failure details, eligibility criteria, and any SAEs.
6.4.1
Retesting During Screening or Lead-In Period
Participant Re-enrollment: This study permits the re-enrollment of a participant who has 
discontinued the study as a pre-treatment failure (ie, participant has not been randomized). If 
re-enrolled, the participant must be re-consented.
Retesting of laboratory parameters and/or other assessments within the screening period will be 
permitted (in addition to any parameters that require a confirmatory value).
The most current result prior to Randomization is the value by which study inclusion will be 
assessed, as it represents the participant’s most current clinical state.
Laboratory parameters and/or assessments that are included in Table 2-1, Screening Procedural 
Outline, may be repeated in an effort to find all possible well-qualified participants. Consultation 
with the Medical Monitor/designee may be needed to identify whether repeat testing of any 
particular parameter is clinically relevant.
7
TREATMENT
Study treatment is defined as any investigational treatment(s), marketed product(s), placebo or 
medical device intended to be administered to a study participant according to the study 
randomization or treatment allocation.
An investigational product, also known as investigational medicinal product in some regions, is 
defined as 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 than the authorized form, or used for an 
unauthorized indication, or when used to gain further information about the authorized form.
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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 
non-investigational products.
Investigational products (IP) used in this trial are provided in Table 7-1. There are no 
non-investigational products in this study.
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Table 7-1:
Study treatments for Study CA017055
Product Description / Class 
and Dosage Form
Potency
IP/Non-IP
Blinded or Open 
Label
Packaging / 
Appearance
Storage Conditions
(per label)
BMS-936558-01
(Nivolumab) Solution for 
Injectiona
100 mg (10 mg/mL)
IP
Open Label
Vial
Refer to the label on container 
and/or pharmacy manual
BMS-986205-04
100 mg
IP
Unblindedb
Tablet
Refer to the label on container 
and/or pharmacy manual
BMS-986205-04
50 mg
IP
Unblindedb
Tablet
Refer to the label on container 
and/or pharmacy manual
a May be labeled as “Nivolumab” or “BMS-936558-01 Solution for Injection”
b Per Revised Protocol 01, treatment assignment will be unblinded and participants in Arm B will be discontinued from BMS-986205 Placebo. Participants in 
Arm A, may at the discretion of the investigator, discontinue BMS-986205, and continue on nivolumab monotherapy.
Abbreviations: NA = not applicable; IP = investigational product
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7.1
Treatments Administered
The selection and timing of dose for each participant is presented in Table 7.1-1.
Study treatments will be dispensed at the study visits as listed in Schedule of Activities (Section 2). 
Table 7.1-1:
Selection and Timing of Dose
Per Revised Protocol 01, treatment assignment will be unblinded and participants in Arm 
B will be discontinued from BMS-986205 Placebo. Participants in Arm A, may at the 
discretion of the investigator, discontinue BMS-986205, and continue on nivolumab 
monotherapy.
Study Treatment
Unit dose 
strength(s)/Dosage 
level(s)
Dosage formulation
Frequency of 
Administration
Route of 
Administration
Nivolumab 
480 mg
Solution for injection/ 
every 4 weeks
IV
BMS-986205 
100 mg
Tablet/once daily
PO
Abbreviations: NA=not applicable; PO=by mouth; IV=intravenous
7.1.1
BMS-986205 Dosing
Per Revised Protocol 01, treatment assignment will be unblinded and participants in Arm B
will be discontinued from BMS-986205 Placebo. Participants in Arm A, may at the discretion 
of the investigator, discontinue BMS-986205, and continue on nivolumab monotherapy.
For participants in Arm A that continue on BMS-986205, a bottle of BMS-986205 should be 
dispensed at each Day 1 visit within a cycle. Participants should be instructed that BMS-986205 
should be administered once a day (approximately 24 hours apart) following a meal. The tablet 
must administered by mouth, swallowed whole, and not be crushed, chewed, dissolved or altered 
in any way.
Participants in Arm A that continue taking BMS-986205 should be provided with pill diaries at 
each visit and instructed to record intake of BMS-986205 in the diary after each daily 
administration.
BMS-986205 will be administered on an out-patient basis. Additional information on study drug 
preparation, handling and administration can be found in the Pharmacy Manual.
Participants should receive BMS-986205 until progression, unacceptable toxicity, withdrawal of 
consent by the participant, or completion of 104 weeks of treatment, whichever occurs first. 
Participants should begin study treatment within 3 calendar days of randomization. 
Doses of BMS-986205 may be modified, interrupted or discontinued depending on how well the 
participant tolerates the treatment (See Section 7.4.2 [modification], Section 7.4.3 [delay], and 
Section 8.1.1 [discontinuation]). If the dose of BMS-986205 is reduced, escalation will not be 
permitted. Skipped doses during interruptions should not be administered within the same cycle.
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If nivolumab dosing is delayed for reasons other than study drug toxicity (eg, administrative issues, 
holidays, etc), BMS-986205 dosing should continue uninterrupted.
For details on prepared drug storage, preparation, and administration, please refer to the 
BMS-986205 IB and/or pharmacy binder. The selection and timing of dose for each participant is 
provided in Table 7.1-1.
7.1.2
Nivolumab Dosing
Participants 18 years of age and older, or age of majority, should receive nivolumab at a dose of 
480 mg as a 30-minute infusion on Day 1 of each treatment cycle until progression, unacceptable 
toxicity, withdrawal of consent/assent, or completion of 104 weeks of treatment, whichever occurs 
first. 
Participants should begin study treatment within 3 calendar days of randomization
The dose of BMS-986205 (for participants in Arm A that continue receiving BMS-986205) should 
be given before the dose of nivolumab, but specific timing is not required. Participants should 
begin study treatment within 3 calendar days of randomization.
There will be no dose escalations or reductions of nivolumab allowed. For Q4W dosing cycles, 
participants may be dosed within a 3 day window. For this dosing cycle, participants may be 
dosed no less than 25 days and no more than 31 days between doses. In extenuating circumstances 
in which the participant cannot make the dosing schedule within the 3-day window, the BMS 
Medical Monitor/designee should be contacted.
Premedication is not recommended for the first dose of nivolumab.
Participants should be carefully monitored for infusion reactions during nivolumab administration. 
After the first nivolumab infusion, subjects should be monitored per local/institutional guidelines.  
If no such guidelines exist, an observation period of 2 hours after the end of the nivolumab infusion 
is suggested.
If an acute infusion reaction is noted, participants should be managed according to Section 7.7.5.
Doses of nivolumab may be interrupted, delayed, or discontinued depending on how well the 
participant tolerates the treatment. Dosing visits are not skipped, only delayed.
Nivolumab Injection, 100 mg/10 mL (10 mg/mL) is to be administered as an IV infusion through 
a 0.2-micron to 1.2-micron pore size, low-protein binding in-line filter at the protocol-specified 
doses. It is not to be administered as an IV push or bolus injection. When the dose is based on 
participant’s weight (ie, mg/kg), nivolumab injection can be infused undiluted (10 mg/mL) or 
diluted with 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP to protein 
concentrations as low as 0.35 mg/mL. When the dose is fixed (eg, 480 mg flat dose), nivolumab 
injection can be infused undiluted or diluted so as not to exceed a total infusion volume of 160 mL. 
Nivolumab infusion must be promptly followed by a saline flush to clear the line. Instructions for 
dilution and infusion of nivolumab injection will be provided in the pharmacy binder. 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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Nivolumab infusions are compatible with polyvinyl chloride (PVC) or polyolefin containers and 
infusion sets, and glass bottles.
Additional information on study drug preparation, handling and administration can be found in the 
Pharmacy Manual.
The selection and timing of dose for each participant is provided in Table 7.1-1.
7.2
Method of Treatment Assignment
As of 19-Apr-2018, enrollment in the study has been closed. 
All participants will be centrally randomized using an Interactive Response Technology (IRT). 
Before the study is initiated, each user will receive log-in information and directions on how to 
access the IRT. After the participant’s initial eligibility is established and informed consent has 
been obtained, the participant must be enrolled into the study by calling an IRT to obtain the 
participant number. Every participant who signs the informed consent form must be assigned a 
participant number in IRT. 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
Once enrolled in IRT, enrolled participants who have met all eligibility criteria will be ready to be 
randomized through the IRT. The following information is required for participant randomization:

Participant number 

Year of birth 

PD-L1 status (PD-L1 positive vs PD-L1 negative/indeterminate) entered by vendor ; PD-L1 
expression will be determined using the Dako PD-L1 IHC 28-8 pharmDx assay.

BRAF V600 mutational status

M Stage at screening (see Appendix 7)
Participants meeting all eligibility criteria will be randomized in a 1:1 ratio and stratified by PD-L1 
status, BRAF status, and AJCC M stage as described below:

PD-L1 status

PD-L1 positive (1% tumor cell membrane staining in a minimum of 100 evaluable tumor 
cells) vs

PD-L1 negative (< 1% tumor cell membrane staining in a minimum of 100 evaluable tumor 
cells)/indeterminate (tumor cell membrane scoring hampered by high cytoplasmic staining 
or melanin content)
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
BRAF status

BRAF V600 mutation positive vs

BRAF V600 wild type

AJCC M stage at screening (See Appendix 7)

M0/M1any(0) vs 

M1any(1)
Note: participants whose PD-L1 status is indeterminate/not evaluable will be classified with 
participant where PD-L1 expression is < 1%. 
The randomization procedures will be carried out via permuted blocks within each stratum, defined 
by combination of PD-L1 status (positive, 1%, negative/indeterminate), BRAF V600 mutational 
status (BRAF mutation positive, BRAF wild type), and M Stage (M0/M1any[0], M1any[1]). The 
exact procedures for using the IRT will be detailed in the IRT manual.
7.3
Blinding
Per Revised Protocol 01, the study will be unblinded (see Section 3.1.1).
7.4
Dosage Modification
7.4.1
Nivolumab Dose Modifications
No dose modifications for nivolumab are permitted.
7.4.2
BMS-986205 Dose Modifications
A dose reduction of BMS-986205 is defined as a change from a 100 mg QD tablet to a 50 mg QD 
tablet. 
Doses of BMS-986205 should be reduced for the following AEs attributable to study therapy that 
do not otherwise meet criteria for discontinuation:

Grade 3 fatigue, nausea, vomiting, or anemia related to study treatment

Methemoglobin 15%

Clinically significant elevations in methemoglobin (generally 10%, with a normal hemoglobin 
level51) with any associated Grade 3 AE (hypoxia, dyspnea, confusion, etc.) attributable to 
sustained elevations of methemoglobin and not attributable to another etiology

QTcF > 500 msec confirmed by at least 1 repeat ECG and at least 60 msec above baseline (See 
Appendix 9)
Dose modification and interruption of BMS-986205 may occur in the setting of lower grade AEs 
and/or be more conservative than indicated above based on the clinical judgment of the 
investigator and in consultation with the BMS Medical Monitor/designee. For an AE requiring 
dose modification, BMS-986205 should be delayed to allow improvement of the AE, even if the 
AE does not otherwise meet criteria for dose delay (Section 7.4.3).
Re-escalation of BMS-986205 will not be permitted once the dose of BMS-986205 has been 
reduced for a participant.
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Only one dose reduction is permitted. The participant must discontinue study treatments if a 
subsequent dose reduction of BMS-986205 is required (see Section 8.1.1).
7.4.3
Dose Delay (BMS-986205 and Nivolumab)
BMS-986205 and nivolumab administration should be delayed for the following:

Grade 2 non-skin, drug-related AE, with the exception of fatigue, nausea, vomiting and anemia

Grade 2 drug-related creatinine, AST, ALT and/or Total Bilirubin abnormalities

Grade 3 skin, drug-related AE

Grade 3 drug-related fatigue, nausea, vomiting, and anemia

Grade 3 drug-related laboratory abnormality, with the following exceptions: 

Grade 3 lymphopenia or asymptomatic amylase or lipase elevations do not require dose 
delay

Grade 3 AST, ALT, Total Bilirubin will require dose discontinuation (see Section 8.1.1)

Any AE, laboratory abnormality, or intercurrent illness which, in the judgment of the 
investigator, warrants delaying the dose of study medication
In addition, only BMS-986205 should be delayed for the following:

Methemoglobin 15%

Clinically significant elevations in methemoglobin (generally 10% with a normal hemoglobin 
level51) with any associated Grade 3 AE (hypoxia, dyspnea, confusion, etc.) attributable to 
sustained elevations of methemoglobin and not attributable to another etiology

QTcF > 500 msec confirmed by at least 1 repeat ECG and at least 60 msec above baseline (See 
Appendix 9)
Appendix 14 presents the above criteria in tabular format. 
If nivolumab dosing is delayed for reasons other than study drug toxicity (eg, administrative issues, 
holidays, etc), BMS-986205 dosing should continue uninterrupted.
Participants may continue to receive nivolumab during dose delays of BMS-986205for elevations 
of methemoglobin and associated events, as well as QTcF prolongations.
For participants with methemoglobin elevations with associated Grade 3 AEs, if contribution of 
nivolumab to the associated AE cannot be ruled out (eg, a participant with dyspnea in whom 
pneumonitis has not yet been ruled out), nivolumab dosing should be delayed as well. See 
Section 7.7.4 for management of methemoglobinemia.
If BMS-986205 dosing is delayed, dose reduction may be necessary. See Section 7.4.2.
If dosing is resumed after a delay, BMS-986205 may be resumed as soon as the criteria to resume 
treatment are met (see Section 7.4.4). Nivolumab should be resumed as soon as possible after 
criteria to resume treatment are met, but may be resumed later than BMS-986205 given the 
differences in each drug’s administration.
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Participants who require delay of any study treatment should be re-evaluated weekly or more 
frequently if clinically indicated and resume dosing when re-treatment criteria are met.
7.4.4
Criteria to Resume Treatment (BMS-986205 and Nivolumab)
Participants may resume treatment with study treatments when the drug-related AE(s) resolve to 
Grade 1 or baseline value, with the following exceptions:

Participants may resume treatment in the presence of Grade 2 fatigue.

Participants who have not experienced a Grade 3 drug-related skin AE may resume treatment 
in the presence of Grade 2 skin toxicity.

For participants with Grade 2 AST, ALT and/or Total Bilirubin abnormalities, dosing may 
resume when laboratory values return to baseline and management with corticosteroids, if 
needed, is complete.

Participants with combined AST/ALT AND total bilirubin values meeting discontinuation 
parameters (Section 8.1.1) should have treatment permanently discontinued. 

Drug-related pulmonary toxicity, diarrhea or colitis must have resolved to baseline before 
treatment is resumed. Participants with persistent Grade 1 pneumonitis after completion of a 
steroid taper over at least 1 month may be eligible for retreatment if discussed with and 
approved by BMS Medical Monitor/designee.
Participants with drug-related endocrinopathies adequately controlled with only physiologic 
hormone replacement may resume treatment after consultation with the BMS Medical 
Monitor/designee. Adrenal insufficiency requires discontinuation regardless of control with 
hormone replacement.
For participants who have BMS-986205 held for elevations of methemoglobin, dosing may resume 
when the methemoglobin levels have decreased to below the institutional ULN and any associated 
AEs have resolved to Grade 1 or baseline value. Dose modification of BMS-986205 should be 
considered when resuming after a delay (see Section 7.4.2).
 
 
 
 
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7.4.6
Detection of Methemoglobinemia
BMS-986205 may produce a p-chloroaniline metabolite. P-chloroaniline has been associated with 
the production of methemoglobin. Symptoms of methemoglobinemia are related to the lack of 
oxygen delivery to tissues and are proportional to the fraction of methemoglobin, as described 
below for participants with normal hemoglobin levels. 
Symptoms associated with elevations of methemoglobin are as follows:

0% to 10% - Usually asymptomatic

10% to 20% - Cyanosis without other symptoms

20% to 50% - Headache, dyspnea, lightheadedness (possibly syncope), weakness, confusion, 
palpitations, chest pain

50% to 70% - Coma, seizures, arrhythmias; acidosis

> 70% - Usually death
Note that participants with anemia may experience symptoms at lower methemoglobin percentages 
than listed above, depending on the degree of anemia. 
Increasing levels of methemoglobin may confound the results of standard pulse oximeters, with 
values of around 85% reported consistently as methemoglobin levels increase, regardless of the 
true oxygen saturation.
When methemoglobinemia is suspected, part of the diagnostic work-up includes evaluation for 
other disorders that can present with a similar clinical picture, including cardiac and pulmonary 
disease. A fresh peripheral blood sample (either venous or arterial) should be sent for evaluation 
of methemoglobin levels; methemoglobin levels may vary with storage of blood.  
In this study methemoglobin testing will be performed at screening, at each cycle (for BMS-
986205
treated participants only), and as clinically indicated. For management of 
methemoglobinemia, see Section 7.7.4.
7.5
Preparation/Handling/Storage/Accountability
For nivolumab, refer to the current version of the IB and/or Pharmacy Manual for complete 
storage, handling, dispensing, and infusion information.
Similarly, for BMS-986205, refer to the current version of the IB and/or Pharmacy Manual for 
complete storage, handling, and dispensing information.
The investigational products should be stored in a secure area according to local regulations. It is 
the responsibility of the investigator to ensure that investigational products are only dispensed to 
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study participants. The investigational products must be dispensed only from official study sites 
by authorized personnel according to local regulations.
The product storage manager should ensure that the study treatments are 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 treatments arise, do not dispense the 
study treatment and contact BMS immediately.
Study treatment not supplied by BMS will be stored in accordance with the package insert.
Investigational product documentation (whether supplied by BMS or not) must be maintained that 
includes all processes required to ensure 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).
Further guidance and information for final disposition of unused study treatments are provided in 
Appendix 2.
7.5.1
Retained Samples for Bioavailability / Bioequivalence
Not applicable.
7.6
Treatment Compliance
Treatment compliance of nivolumab will be monitored by drug accountability as well as the 
participant’s medical record and eCRF. 
Treatment compliance of BMS-986205 will be monitored by drug accountability, as well as by 
recording BMS-986205 administration in the participant pill diary (as applicable), medical record, 
and eCRF. Participants should bring all drug containers to each study visit for drug reconciliation. 
The pill diary should be reviewed at each clinic visit and submitted at the end of each cycle, as 
applicable.
 
 
 
 
 
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7.8
Treatment After the End of the Study
At the conclusion of the study, participants who continue to demonstrate clinical benefit will be 
eligible to receive BMS-supplied study treatment for the maximum treatment duration specified 
in Section 7.1. Study treatment will be provided via an extension of the study, a rollover study 
requiring approval by responsible health authority and ethics committee, or through another 
mechanism at the discretion of BMS. See Section 5.4.2 for more information.
BMS reserves the right to terminate access to BMS supplied study treatment if any of the following 
occur: a) the study is terminated due to safety concerns; b) the development of BMS-986205 is 
terminated for other reasons, including but not limited to lack of efficacy and/or not meeting the 
study objectives; c) the participant can obtain medication from a government-sponsored or private 
health program. In all cases BMS will follow local regulations.
8
DISCONTINUATION CRITERIA
8.1
Discontinuation from Study Treatment
Participants MUST discontinue investigational product (and non-investigational product at the 
discretion of the investigator) for any of the following reasons:

Participant’s request to stop study treatment. Withdrawal of consent/assent may be requested 
by participants, parents, guardians, or legally acceptable representatives, in accordance with 
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local regulations. The wishes of minor participants to withdraw their assent should also be 
respected. Participants who request to discontinue study treatment 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

Additional protocol-specified reasons for discontinuation (Section 8.1.1)

Documented investigator-assessed progression as defined by RECIST v1.1 (see Appendix 12) 
unless participant meets criteria for treatment beyond progression
In the case of pregnancy, the investigator must immediately notify the Sponsor or designee of this 
event. In most cases, the study treatment will be permanently discontinued in an appropriate 
manner (eg, dose tapering if necessary for participant safety). Please contact the Sponsor or 
designee within 24 hours of awareness of the pregnancy. If the investigator determines a possible 
favorable benefit/risk ratio that warrants continuation of study treatment, a discussion between the 
investigator and the Sponsor or designee must occur.
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 treatment 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 (ie, is imprisoned or involuntarily incarcerated for the treatment of either 
a psychiatric or physical illness).
The assessment for discontinuation of nivolumab should be made separately from the assessment 
made for discontinuation of BMS-986205. Although there is overlap among the discontinuation 
criteria, if discontinuation criteria are met for BMS-986205 but not for nivolumab, treatment with 
nivolumab may continue if BMS-986205 is discontinued. If a participant discontinues nivolumab, 
they must also discontinue BMS-986205.
If a participant receiving nivolumab/BMS-986205 combination meets criteria for discontinuation 
and investigator is unable to determine whether the event is related to both or one study drug, the 
participant should discontinue both nivolumab and BMS-986205 and be taken off the treatment 
phase of the study.
If study treatment 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 and entered on the 
appropriate eCRF page.
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8.1.1
BMS-986205 and Nivolumab Dose Discontinuation
BMS-986205 and nivolumab treatment should be permanently discontinued for the following:

Any occurrence of serotonin syndrome

Any Grade 2 drug-related uveitis, eye pain or blurred vision that does not respond to topical 
therapy and does not improve to Grade 1 severity within the time frame permitted for dose 
delays OR requires systemic treatment 

Any event requiring more than 1 dose reduction of BMS-986205 (see Section 7.4.2), except 
for those related to methemoglobinemia or QTc prolongations, which require only 
discontinuation of BMS-986205 alone; subjects may continue to receive nivolumab in these 
situations (see also Section 8.1.2)

Any drug-related event requiring 10 mg per day or greater prednisone or equivalent for more 
than 12 weeks, except for adrenal replacement steroid dose >10mg. 

Immune-mediated encephalitis of any grade

Any Grade 3 non-skin, drug-related AE lasting > 7 days, or recurs with the following 
exceptions for laboratory abnormalities, diarrhea, colitis, neurologic toxicity, drug-related 
uveitis, pneumonitis, bronchospasm, hypersensitivity reactions, infusion reactions, and 
endocrinopathies:

Grade 3 drug-related diarrhea, colitis, neurologic toxicity, uveitis, pneumonitis, 
bronchospasm, myocarditis, hypersensitivity reaction, or infusion reaction of any 
duration requires discontinuation

Grade 3 drug-related endocrinopathies, adequately controlled with only physiologic 
hormone replacement do not require discontinuation. Adrenal insufficiency requires 
discontinuation regardless of control with hormone replacement. 

Grade 3 drug-related laboratory abnormalities do not require treatment discontinuation 
except:
Grade 3 drug-related thrombocytopenia > 7 days or associated with bleeding requires 
discontinuation
Any drug-related liver function test (LFT) abnormality that meets the following criteria 
require discontinuation:
o
Grade 3 drug-related AST, ALT or Total Bilirubin requires discontinuation*
o
Concurrent AST or ALT > 3 x ULN and total bilirubin > 2x ULN
* In most cases of Grade 3 AST or ALT elevation, study treatment(s) will be permanently 
discontinued. If the investigator determines a possible favorable benefit/risk ratio that 
warrants continuation of study treatment(s), a discussion between the investigator and the 
BMS Medical Monitor/designee must occur.

Any Grade 4 drug-related AE or laboratory abnormality (including but not limited to 
creatinine, AST, ALT, or Total Bilirubin), except for the following events which do not require 
discontinuation:

Grade 4 neutropenia 7 days

Grade 4 lymphopenia or leukopenia or asymptomatic amylase or lipase
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
Isolated Grade 4 electrolyte imbalances/abnormalities that are not associated with clinical 
sequelae and are corrected with supplementation/appropriate management within 3 
calendar days of their onset

Grade 4 drug-related endocrinopathy AEs, such as, hyper- or hypothyroidism, or glucose 
intolerance, which resolve or are adequately controlled with physiologic hormone 
replacement (corticosteroids, thyroid hormones) or glucose-controlling agents, 
respectively, may not require discontinuation after discussion with and approval from the 
BMS Medical Monitor/designee. 

Any AE, laboratory abnormality, or intercurrent illness which, in the judgment of the 
investigator, presents a substantial clinical risk to the participant with continued BMS-986205 
and nivolumab dosing

Any event that leads to delay in dosing of nivolumab lasting > 10 weeks from the previous 
dose requires discontinuation, with the following exceptions:

Dosing delays to allow for prolonged steroid tapers to manage drug-related AEs are 
allowed. 

Dosing delays lasting > 10 weeks from the previous dose that occur for non-drug-related 
reasons may be allowed if approved by the BMS Medical Monitor/designee. 

Any event requiring 10 mg per day or greater prednisone or equivalent for more than 12 weeks 
except for adrenal replacement steroid dose >10mg
Prior to re-initiating treatment in a participant with a dosing delay lasting > 10 weeks, the BMS 
Medical Monitor/designee must be consulted. Tumor assessments should continue as per protocol 
even if dosing is delayed. Periodic study visits to assess safety and laboratory studies should also 
continue every 4 weeks or more frequently if clinically indicated during such dosing delays.
Participants who are discontinued from nivolumab, must also discontinue BMS-986205. 
8.1.2
BMS-986205 Dose Discontinuation
The following events require discontinuation of BMS-986205 only; nivolumab may continue to 
be administered unless other events occur that would require delay or discontinuation of nivolumab 
as described in Sections 7.4.3 and 8.1.1. 

Any event requiring more than 1 dose reduction of BMS-986205

Any AE, laboratory abnormality, or intercurrent illness which, in the judgment of the 
investigator, presents a substantial clinical risk to the participant with continued BMS-986205 
dosing

For participants who delay BMS-986205 but continue nivolumab (see Section 7.4.3), any dose 
delay of BMS-986205 lasting > 10 weeks will result in the discontinuation of both 
BMS-986205 only. 

Per Revised Protocol 01, participants are permitted to discontinue BMS-986205, and continue 
nivolumab at investigator discretion (see Section 3.1.1)

Any occurrence of serotonin syndrome
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8.1.3
Treatment Beyond Progression 
 
 
 
 
 
 
 
 
 
 
 
 
 
8.1.3.2
Criteria Required for Treatment Beyond Progression
Participants will be permitted to continue study treatment beyond initial RECIST v1.1-defined PD 
(see Appendix 12), assessed by the investigator, as long as they meet the following criteria:

Investigator-assessed clinical benefit

Tolerance of study treatment

Stable performance status

Treatment beyond progression will not delay an imminent intervention to prevent serious 
complications of disease progression (eg, CNS metastases).

Participant provides written informed consent prior to receiving additional study treatment. All 
other elements of the main consent including description of reasonably foreseeable risks or 
discomforts, or other alternative treatment options will still apply.
A radiographic assessment/ scan should be performed within 8 weeks of initial investigator-
assessed progression to determine whether there has been a decrease in the tumor size or continued 
PD. The assessment of clinical benefit should be balanced by clinical judgment as to whether the 
participant is clinically deteriorating and unlikely to receive any benefit from continued study 
treatment.
If the investigator feels that the participant continues to achieve clinical benefit by continuing 
treatment, the participant should remain on the trial and continue to receive monitoring according 
to the Schedule of Activities (Section 2).
For the participants who continue study therapy beyond progression, further progression is defined 
as an additional 10% increase in tumor burden with a minimum 5 mm absolute increase from time 
of initial PD. This includes an increase in the sum of diameters of all target lesions and/ or the 
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diameters of new measurable lesions compared to the time of initial PD. All study treatment should 
be discontinued permanently upon documentation of further progression.
New lesions are considered measurable at the time of initial progression if the longest diameter is 
at least 10 mm (except for pathological lymph nodes which must have a short axis of at least 
15 mm). Any new lesion considered non-measurable at the time of initial progression may become 
measurable and therefore included in the tumor burden if the longest diameter increases to at least 
10 mm (except for pathological lymph nodes which must have a short axis of at least 15 mm). In 
situations where the relative increase in total tumor burden by 10% is solely due to inclusion of 
new lesions which become measurable, these new lesions must demonstrate an absolute increase 
of at least 5 mm.
8.1.4
Post-Study Treatment Study Follow-up
Per Revised Protocol 01, overall survival follow up is not required. 
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 treatment must continue to be followed for collection of 
outcome and/or survival follow-up data as required and in line with Section 2 until death or the 
conclusion of the study.
BMS may request that survival data be collected on all treated/randomized participants outside of 
the protocol-defined window (Table 2-3). At the time of this request, each participant will be 
contacted to determine their survival status unless the participant has withdrawn consent for all 
contacts or is lost to follow-up.
8.2
Discontinuation from the Study
Participants who request to discontinue study treatment 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 in writing, whenever possible.

The withdrawal of consent/assent should be explained in detail in the medical records by the 
investigator, as to whether the withdrawal is from further treatment with study treatment only 
or also from study procedures and/or post treatment study follow-up, and entered on the 
appropriate CRF page.

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/assent.
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8.3
Lost to Follow-Up

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
documented phone calls, faxes, or emails as well as lack of response by participant to one 
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 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 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.
9
STUDY ASSESSMENTS AND PROCEDURES

Study procedures and timing are summarized in the Schedule of Activities (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.
Additional measures, including non-study required laboratory tests, should be performed 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 treatment-related toxicities resolve, return to baseline, or are deemed 
irreversible.
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If a participant shows pulmonary-related signs (hypoxia, fever) or symptoms (eg. dyspnea, cough, 
and fever) consistent with possible pulmonary AEs, the participant should be immediately 
evaluated to rule out pulmonary toxicity, according to the suspected pulmonary toxicity 
management algorithm in the BMS-936558 (Nivolumab) IB. In addition, blood methemoglobin 
levels should be evaluated to rule out methemoglobinemia (see Section 7.4.6) and CBC measured 
to rule out anemia in participants with dyspnea.
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.
This study will consist of three phases: screening, treatment, and follow-up.
Screening Phase:

Begins by establishing the participant’s initial eligibility and signing of the informed consent 
form (ICF).
Treatment Phase:

Begins with the randomization request to the IRT. The participant is randomly assigned to 
either the BMS-986205 + nivolumab arm or the BMS-986205 Placebo + nivolumab arm. (Per 
Revised Protocol 01, BMS-986205 Placebo will not be administered in this study. Participants 
in Arm B, may discontinue BMS-986205 and continue treatment with nivolumab 
monotherapy). 

Ends when the participant is discontinued from study therapy or completes 104 weeks of study 
therapy. For a complete list of reasons for treatment discontinuation, see Section 8.1.
Follow-Up Phase

Begins when the decision to discontinue a participant from study therapy is made (no further 
treatment with study therapy) or when 104 weeks of study therapy has been completed, and 
ends when follow-up data have been collected for all participants (Section 8.1.4).
 
 
 
 
 
 
 
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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, surrogate, or the 
participant's legally authorized representative). 
The investigator and any designees are responsible for detecting, documenting, and reporting 
events that meet the definition of an AE or SAE and remain responsible for following up AEs that 
are serious, considered related to the study treatment or the study, or that caused the participant to 
discontinue before completing the study. 
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 progression) 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.
Contacts for SAE are reporting specified in Appendix 3.
9.2.1
Time Period and Frequency for Collecting AE and SAE Information
The collection of non-serious AE information should begin at initiation of study treatment at the 
time points specified in the Schedule of Activities (Section 2). Non-serious AE information should 
also be collected from the start of a placebo lead-in period or other observational period intended 
to establish a baseline status for the participants.
Section 5.6 in the IBs for BMS-986205 and nivolumab represents the Reference Safety 
Information to determine expectedness of SAEs for expedited reporting. Following the 
participant’s written consent/assent to participate in the study, all SAEs, whether related or not 
related to study treatment, must be collected, including those thought to be associated with 
protocol-specified procedures.
All SAEs must be collected that occur during the screening period and within 100 days of the last 
dose of study treatment, except in cases where a study participant has started a new anti-neoplastic 
therapy. However, any SAE occurring after the start of a new treatment that is suspected to be 
related to study treatment by the investigator will be reported.
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For participants assigned to treatment and never treated with study treatment, SAEs should be 
collected for 30 days from the date of randomization. 
The investigator must report any SAE that occurs after these time periods and that is believed to 
be related to study treatment or protocol-specified procedure.

Medical occurrences that begin before the start of study treatment but after obtaining informed 
consent will be recorded on the appropriate section of the eCRF section.

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 within 24 hours of this 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 
treatment 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.
9.2.2
Method of Detecting AEs and SAEs
All nonserious adverse events (not only those deemed to be treatment-related) should be collected 
continuously during the treatment period and for a minimum of 100 days following discontinuation 
of study treatment. 
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 can be spontaneously reported or elicited during open-ended questioning, examination, or 
evaluation of a participant. (In order to prevent reporting bias, participants should not be 
questioned regarding the specific occurrence of one or more AEs).
9.2.3
Follow-up of AEs and SAEs

Non-serious 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 non-serious AEs that cause interruption or discontinuation of 
study treatment and for those present at the end of study treatment as appropriate.

All identified non-serious AEs must be recorded and described on the non-serious 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.
After the initial AE/SAE report, the investigator is required to proactively follow each participant 
at subsequent visits/contacts. All SAEs, and non-serious AEs of special interest (as defined in 
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Section 9.2.5 and Appendix 15) will be followed until resolution, until the condition stabilizes, 
until the event is otherwise explained, or until the participant is lost to follow-up (as defined in 
Section 8.3).
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 towards 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.
Sponsor or designee will be reporting AEs to regulatory authorities and ethics committees 
according to local applicable laws including European Directive 2001/20/EC and FDA Title 21 
Code of Federal Regulations (CFR) Parts 312 and 320. A SUSAR (Suspected, Unexpected Serious 
Adverse Reaction) is a subset of SAEs and will be reported to the appropriate regulatory authorities 
and investigators following local and global guidelines and requirements.
9.2.5
Adverse Events of Special Interest
Adverse events of special interest (AEOSI) have been defined for this protocol which require 
expedited reporting by the investigator of these adverse events to BMS. These are:

Hemophagocytic lymphohistiocytosis (HLH; also known as histiocytosis haematophagic)

Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome
These AEOSI, whether related or not related to study drug, must be reported to BMS or designee 
within 24 hours of awareness of the event. These AEOSI are medically important events and are 
therefore considered SAEs. The reporting system for SAEs should be used (see Section 9.2.4 and 
Appendix 3).  
As both HLH and DRESS syndrome may both pose diagnostic challenges due to varying clinical 
manifestations and signs and symptoms that may overlap with other clinical events.  To assist 
investigators in identifying constellations of clinical symptoms that may be consistent with one of 
these diagnoses, standardized scoring criteria are provided in Appendix 15. Formal evaluation and 
documentation of diagnostic scores based on these systems is not required; investigators should 
use their best clinical judgement as informed by these provided criteria to determine if a subject 
has experienced one of these AEOSI.
9.2.6
Pregnancy
If, following initiation of the study treatment, it is subsequently discovered that a participant is 
pregnant or may have been pregnant at the time of study exposure, including during at least 
5 half-lives after product administration, the investigator must immediately notify the BMS
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Medical Monitor/designee of this event and complete and forward a Pregnancy Surveillance Form 
to BMS Designee within 24 hours of awareness of the event and in accordance with SAE reporting 
procedures described in Appendix 3.
In most cases, the study treatment will be permanently discontinued in an appropriate manner 
(eg, dose tapering if necessary for participant safety). Please call the BMS Medical 
Monitor/designee within 24 hours of awareness of the pregnancy.
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.
Any pregnancy that occurs in a female partner of a male study participant should be reported to 
Sponsor or designee. In order for Sponsor or designee to collect any pregnancy surveillance 
information from the female partner, the female partner must sign an informed consent form for 
disclosure of this information. Information on this pregnancy will be collected on the Pregnancy 
Surveillance Form.
9.2.7
Laboratory Test Result Abnormalities
The following laboratory test result abnormalities should be captured on the non-serious AE CRF 
page or SAE Report Form electronic, 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 treatment 
discontinued or delayed/ 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 versus low hemoglobin value).
9.2.8
Potential Drug Induced Liver Injury (DILI)
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 drug induced liver injury is defined as:
1) ALT or AST elevation > 3 times upper limit of normal (ULN)
AND
2) Total bilirubin > 2 times ULN, without initial findings of cholestasis (elevated serum alkaline 
phosphatase), 
AND
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3) No other immediately apparent possible causes of aminotransferase elevation and 
hyperbilirubinemia, including, but not limited to, viral hepatitis, preexisting chronic or acute 
liver disease, or the administration of other drug(s) known to be hepatotoxic.
9.2.9
Other Safety Considerations
Any significant worsening noted during interim or final physical examinations, ECG, x-ray 
filming, any other potential safety assessment required or not required by protocol should also be 
recorded as a non-serious or serious AE, 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 meeting the regulatory definition 
of SAE must be reported as an SAE (see Section 9.2.4 for reporting details).
In the event of an overdose the investigator/treating physician should:
1) Contact the Medical Monitor/designee immediately
2) Closely monitor the participant for AEs/SAEs and laboratory abnormalities
3) Document the quantity of the excess dose as well as the duration of the overdosing in the CRF.
Decisions regarding dose interruptions or modifications will be made by the investigator in 
consultation with the Medical Monitor/designee based on the clinical evaluation of the participant.
9.4
Safety
Planned time points for all safety assessments are listed in the Schedule of Activities. Safety 
assessments include AEs, physical examinations, vital signs, performance status, oxygen 
saturation, ECGs, assessment of signs and symptoms, laboratory tests, and pregnancy tests as 
outlined in the Schedule of Activities.
9.4.1
Clinical Safety Laboratory Assessments
Laboratory assessments are listed in Table 9.4.1-1.

Investigators must document their review of each laboratory safety report.

All clinical safety laboratory assessments will be performed locally per the Schedule of 
Activities (Section 2).
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Table 9.4.1-1:
Laboratory Assessment Panels
Hematology
Hemoglobin
Hematocrit
Total leukocyte count, including differential
Platelet count
Methemoglobin - screening for all participants, each 
treatment cycle for BMS-986205-treated 
participants, and then as clinically indicated for all 
participants
G6PD levels - screening only
Serum Chemistry
Aspartate aminotransferase (AST)
Alanine aminotransferase (ALT)
Total bilirubin
Alkaline phosphatase (ALP)
Gamma-glutamyl transferase (only when alkaline 
phosphatase is Grade 2)
Albumin
Lactate dehydrogenase (LDH)
Uric acid
TSH (reflex to free T3 and T4 if abnormal) 
Sodium
Potassium
Chloride
Calcium
Phosphate
Magnesium
Creatinine
Creatinine clearance (CLcr) - screening only
Blood Urea Nitrogen (BUN) or Serum Urea Level
Glucose
Urinalysis (at screening)
Protein
Glucose
Blood
Leukocyte esterase
Specific gravity
pH
Serology (at screening)
Serum for hepatitis C antibody (if Hepatitis C antibody 
is positive reflex to hepatitis C RNA) or hepatitis C 
RNA, hepatitis B surface antigen, HIV-1 and HIV-2 
antibodies. (Testing for HIV-1 and HIV-2 must be 
performed at sites where mandated by local 
requirements)
Other Analyses
Pregnancy test (women of child-bearing potential 
[WOCBP] only, Section 2).
Follicle stimulating hormone (FSH) screening -only 
required to confirm menopause in women < age 55 (if 
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Table 9.4.1-1:
Laboratory Assessment Panels
needed to document postmenopausal status as defined 
in Appendix 4)
9.4.2
Imaging 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 per standard 
medical/clinical judgment. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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10
STATISTICAL CONSIDERATIONS
Per Revised Protocol 01, efficacy analysis will not be conducted (see Section 3.1.1 and the updated 
Schedule of Activities in Section 2). 
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10.1
Sample Size Determination 
Per Revised Protocol 01 this section is not applicable. 
The sample size is calculated in order to compare PFS between participants randomized to receive 
BMS-986205 with nivolumab vs nivolumab monotherapy. The number of events required is 
simulated based on results from Study CA209067; this simulation resulted in a median PFS of 
6.9 months for nivolumab monotherapy and 11.8 months for BMS-986205 with nivolumab 
therapy, incorporating 35% of participants with durable response in the combined groups, and a 
non-proportional hazard resulting in an effective hazard ratio (HR) of approximately 0.73.
Based on these assumptions, the study requires at least 365 PFS events to ensure approximately 
85% power to detect an HR of 0.73 with an overall type I error of 0.05 (two-sided). Approximately 
700 participants will be randomized to the 2 treatment arms in a 1:1 ratio. While follow-up for the 
primary PFS endpoint is planned to occur when 365 participants have had a PFS event, the follow-
up for the primary PFS endpoint can also be terminated 9 months after the randomization of the 
last participant if the 365th event has not occurred (e.g. slow arrival of events close to but less than 
365 that suggest a higher than expected long-term response rate). Predictions for enrollment and 
follow-up are based on an estimation of approximately 12 months for enrollment and 7 months of 
follow-up after the end of enrollment. Various patterns of enrollment were assessed from uniform 
enrollment to enrollment of 25% of participants in the first half of enrollment and 75% in the 
second half of enrollment.
Follow-up for the overall survival (OS) endpoint is planned to occur when 330 participants have 
had an OS event. If the 330th event has not occurred at 24 months after randomization of the last 
participant, then the follow-up time can be terminated 24 months after the randomization of the 
last participant. A total of 330 OS events would provide approximately 90% power to detect an 
overall HR of approximate 0.70 with a type I error of 0.05 (two-sided).
10.2
Populations for Analyses
Per Revised Protocol 01, efficacy analysis will not be conducted (see Section 3.1.1 and the updated 
Schedule of Activities in Section 2). 
For purposes of analysis, the following populations are defined:
Population
Description
Enrolled Participants
All participants who sign informed consent and were registered 
into IRT
Randomized
All participants who are randomized to any treatment group. 
Treated
All participants who received at least one dose of any study 
medication.
Safety
All randomized participants who take at least 1 dose of double-
blind study treatment. Data in this data set will be analyzed based 
on randomized treatment, except in the following case:
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Population
Description

If a participant received the same incorrect treatment 
throughout the study, then the participant will be analyzed 
based on the treatment received.
10.3
Statistical Analyses
A description of the participant population will be included in a statistical output report, including 
subgroups of age, gender and race.
Per Revised Protocol 01, efficacy analysis will not be conducted (see Section 3.1.1 and the 
updated Schedule of Activities in Section 2). 
 
10.3.2
Safety Analyses
All safety analyses will be performed on the Safety Population. 
Endpoint
Statistical Analysis Methods
Primary
Safety analyses will be performed in all treated participants. Descriptive 
statistics of safety will be presented using National Cancer Institute (NCI) 
Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 by 
treatment group. All on-study AEs, treatment-related AEs, SAEs, and 
treatment-related SAEs will 
be tabulated using worst grade per 
NCI CTCAE v 4.03 criteria by system organ class and preferred term. On-
study lab parameters including hematology, chemistry, liver function, and renal 
function will be summarized using worst grade NCI CTCAE v 4.03 criteria.
Exploratory
Additional safety analyses will be described in the SAP finalized before 
database lock.
 
 
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10.3.4
Interim Analyses 
No interim analyses are planned. 
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12
APPENDICES
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APPENDIX 1
ABBREVIATIONS AND TRADEMARKS
Term
Definition
ADA
anti-drug antibody
ADME
absorption-distribution-metabolism-excretion
AE
adverse event
AIDS
acquired immunodeficiency syndrome
AJCC
American Joint Committee on Cancer
ALT
alanine aminotransferase
ALP
alkaline phosphatase
AST
aspartate aminotransferase
AUC
area under the concentration-time curve
BICR
Blinded Independent Central Review
BMS
Bristol-Myers Squibb
BOR
best overall response
BP
blood pressure
BUN
blood urea nitrogen
Ca++
calcium
Cavgss
average concentration at steady state
CBC
complete blood count
CFR
Code of Federal Regulations 
CI
confidence interval
C1-
chloride
CL
clearance
CLcr
creatinine clearance
Cmaxss
maximum observed concentration at steady state
Cminss
minimum observed concentration at steady state
CMV
cytomegalovirus
CNS
Central nervous system
CONSORT
Consolidated Standards of Reporting Trials
CR
Complete Response
CRF
Case Report Form, paper or electronic
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Term
Definition
CRO
Contract Research Organization
CT
Computed tomography
CTCAE
Common Terminology Criteria for Adverse Events
CTLA-4
cytotoxic T-lymphocyte-associated protein-4
CYP
cytochrome p-450
DLBCL
diffuse large B-cell lymphoma
DDI
drug-drug interaction
DILI
drug-induced liver injury
DMC
Data Monitoring Committee
DNA
deoxyribonucleic acid
DOOR
duration of objective response
DTIC
Dacarbazine (5-(3,3 dimethyl-l-triazeno)-imidazole-4-carboxamide) 
ECG
electrocardiogram
ECOG
Eastern Cooperative Oncology Group
eCRF
Electronic Case Report Form
EDTA
ethylene diamine tetra-acetic acid
ELISA
enzyme-linked immunosorbent assay
EOI
end of infusion
EORTC-QLQ-
C30
European Organization for Research and Treatment of Cancer Quality of 
Life Questionnaire
eGFR
estimated glomerular filtration rate
ePRO
electronic patient-reported outcome
EQ-5D-3L
EuroQoL 5-dimensions 3-levels (quality of life questionnaire)
FDA
Food and Drug Administration
FDG
fluorodeoxyglucose
FFPE
formalin fixed paraffin-embedded
FISH
fluorescent in situ hybridization
FSH
follicle stimulating hormone
G6PD
glucose 6-phosphate dehydrogenase
GCP
Good Clinical Practice
HBsAg
hepatitis B surface antigen
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Term
Definition
HBV
hepatitis B virus
HCG
human chorionic gonadotropin
HCV
hepatitis C virus
HIV
Human Immunodeficiency Virus
HL
Hodgkin Lymphoma
HPV
human papilloma virus
HR
heart rate
HRT
hormone replacement therapy
IB
Investigator Brochure
ICH
International Conference on Harmonisation 
IDO1
indoleamine-1,2-dioxygenase 1 (enzyme)
IEC
Independent Ethics Committee
IFN
interferon 
IHC
immunohistochemistry
IL
interleukin 
IMAE
immune-mediated adverse event
IMP
investigational medicinal product
IO
Immuno-oncology
IP
investigational products
IRB
Institutional Review Board
IRT
Interactive Response Technology
IU 
international units
IV
intravenous
K+
potassium
LDH
lactate dehydrogenase
LFT
liver function test
MID
minimal important difference
MLR 
mixed lymphocyte reaction
mmHg
millimeters of mercury
MRI
magnetic resonance imaging
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Term
Definition
MTD
maximum tolerated dose
Na+
sodium
NA
not applicable
NSCLC
non-small cell lung cancer
ORR
objective response rate
OS
overall survival
PBMC
peripheral blood mononuclear cells
PCR
polymerase chain reaction
PD
pharmacodynamics
PD-1
programmed cell death protein-1
PET
positron emission tomography
PFS
progression-free survival
PK
pharmacokinetics
PO
per os (by mouth route of administration)
PPK
population pharmacokinetics
PR
Partial Response
QD, qd
quaque die, once daily
RCC
renal cell carcinoma
RECIST
Response Evaluation Criteria in Solid Tumors
RNA
ribonucleic acid
SAE
serious adverse event
SD
standard deviation
SNP
single nucleotide polymorphism
SUSAR
Suspected, unexpected serious adverse reaction
TCR
T-cell receptor
TIL
tumor infiltrating lymphocyte
TMB
tumor mutational burden
Treg
regulatory T-cell
TSH
thyroid stimulating hormone
TTR
time to objective response
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Term
Definition
ULN
upper limit of normal
VAS
visual analog scale
Vss
volume of distribution at steady state
WNOCBP
women not of childbearing potential
WOCBP
women of childbearing potential
WPAI(:GH)
Work Productivity and Activity Impairment (:General Health) 
questionnaire
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APPENDIX 2
STUDY GOVERNANCE CONSIDERATIONS
The term ‘Participant’ is used in the protocol to refer to a person who has consented to participate 
in the clinical research study.  The term ‘Subject’ used in the eCRF is intended to refer to a person 
(Participant) who has consented to participate in the clinical research study.
REGULATORY AND ETHICAL CONSIDERATIONS
GOOD CLINICAL PRACTICE
This study will be conducted in accordance with:

Good Clinical Practice (GCP), 

as defined by the International Council on Harmonisation (ICH)

in accordance with the ethical principles underlying European Union Directive 2001/20/EC

United States Code of Federal Regulations, Title 21, Part 50 (21CFR50) 

applicable local requirements.
The study will be conducted in compliance with the protocol. The protocol and any amendments 
and the participant informed consent will receive approval/favorable opinion by Institutional 
Review Board/Independent Ethics Committee (IRB/IEC), and regulatory authorities according to 
applicable local regulations prior to initiation of the study.
All potential serious breaches must be reported to Sponsor or designee immediately. A serious
breach is a breach of the conditions and principles of GCP in connection with the study or the 
protocol, which is likely to affect, to a significant degree, the safety or physical or mental integrity 
of the subjects of the study or the scientific value of the study.
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 (e.g., 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, consent form, participant recruitment materials (e.g., 
advertisements), and any other written information to be provided to subjects. The investigator or 
BMS should also provide the IRB/IEC with a copy of the Investigator Brochure or product labeling 
information to be provided to subjects and any updates. 
The investigator, Sponsor or designee should provide the IRB/IEC with reports, updates and other 
information (e.g., expedited safety reports, amendments, and administrative letters) according to 
regulatory requirements or institution procedures.
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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 local health authority) except where necessary to eliminate an immediate 
hazard(s) to study subjects. 
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 for 

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 local health authority must be sent to BMS.
If an amendment substantially alters the study design or increases the potential risk to the 
participant: (1) the consent form 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 subjects 
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 subjects prior to enrollment.
If the revision is done via an administrative letter, investigators must inform their IRB(s)/IEC(s).
FINANCIAL DISCLOSURE
Investigators and sub-Investigators will provide the Sponsor with sufficient, accurate financial 
information in accordance with local 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 subjects are clearly and fully informed about the purpose, potential 
risks, and other critical issues regarding clinical studies in which they volunteer to participate. 
In situations where consent cannot be given to subjects, their legally acceptable representatives (as 
per country guidelines) are clearly and fully informed about the purpose, potential risks, and other 
critical issues regarding clinical studies in which the participant volunteers to participate. 
Sponsor or designee will provide the investigator with an appropriate (i.e., Global or Local) sample
informed consent form which will include all elements required by ICH, GCP and applicable
regulatory requirements. The sample informed consent form will adhere to the ethical principles 
that have their origin in the Declaration of Helsinki.
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Investigators must:

Provide a copy of the consent form and written information about the study in the language in 
which the participant is most proficient prior to clinical study participation. The language must 
be non-technical and easily understood. 

Allow time necessary for participant or participant's legally acceptable representative to 
inquire about the details of the study.

Obtain an informed consent signed and personally dated by the participant or the participant's 
legally acceptable representative and by the person who conducted the informed consent 
discussion. 

Obtain the IRB/IEC’s written approval/favorable opinion of the written informed consent form 
and any other information to be provided to the subjects, prior to the beginning of the study, 
and after any revisions are completed for new information.
If informed consent is initially given by a participant’s legally acceptable representative or 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.
Revise the informed consent 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 or the participant's legally acceptable representative or legal 
guardian, 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 subjects must be protected, respecting the privacy 
and confidentiality rules applicable to regulatory requirements, the subjects' signed ICF and, in the 
US, the subjects’ signed HIPAA Authorization.
The consent form must also include a statement that BMS and regulatory authorities have direct 
access to participant records. 
For minors, according to local legislation, one or both parents or a legally acceptable representative 
must be informed of the study procedures and must sign the informed consent form approved for 
the study prior to clinical study participation. The explicit wish of a minor, who is capable of 
forming an opinion and assessing this information to refuse participation in, or to be withdrawn 
from, the clinical study at any time should be considered by the investigator. 
Minors who are judged to be of an age of reason must also give their written assent.
The rights, safety, and well-being of the study subjects are the most important considerations and 
should prevail over interests of science and society.
SOURCE DOCUMENTS
The Investigator is responsible for ensuring that the source data are accurate, legible, 
contemporaneous, original and attributable, whether the data are hand-written on paper or entered 
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electronically. If source data are created (first entered), modified, maintained, archived, retrieved, 
or transmitted electronically via computerized systems (and/or any other kind of electronic 
devices) 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/health records (EMRs/EHRs), 
adverse event tracking/reporting, protocol required assessments, and/or drug accountability 
records).
When paper records from such systems are used in place of 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 TREATMENT RECORDS
Records for study treatments (whether supplied by BMS, its vendors, or the site) must substantiate 
study treatment 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 (e.g., lost, wasted) 

amount destroyed at study site, if 
applicable

amount returned to BMS

retain samples for 
bioavailability/bioequivalence, 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 drug integrity in accordance with 
requirements applicable under law and the 
SOPs/standards of the sourcing pharmacy.
BMS or 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.
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For sites using the Sponsor or designee electronic data capture tool, electronic CRFs will be 
prepared for all data collection fields except for fields specific to SAEs and pregnancy, which will 
be reported on the electronic SAE form and Pregnancy Surveillance form, respectively.  If 
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 
Sponsor or designee. 
The confidentiality of records that could identify subjects 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, SAE/pregnancy CRFs, must be promptly reviewed, signed, and dated by the 
investigator or qualified physician who is a subinvestigator and who is delegated this task on the 
Delegation of Authority Form. Subinvestigators in Japan may not be delegated the CRF approval 
task For electronic CRFs, review and approval/signature is completed electronically through the 
BMS electronic data capture tool. The investigator must retain a copy of the CRFs including 
records of the changes and corrections.
Each individual electronically signing electronic CRFs must meet Sponsor or designee training 
requirements and must only access the BMS electronic data capture tool using the unique user 
account provided by Sponsor or designee. User accounts are not to be shared or reassigned to other 
individuals
MONITORING
Sponsor or designee representatives will review data centrally to identify potential issues to 
determine a schedule of on-site visits for targeted review of study records. 
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 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 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 designee, whichever is longer. The 
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investigator (or head of the study site in Japan) must contact BMS prior to destroying any records 
associated with the study.
BMS or 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 (e.g., relocation, retirement), the records shall be 
transferred to a mutually agreed upon designee (e.g., another investigator, study site, IRB). Notice 
of such transfer will be given in writing to BMS or designee. 
RETURN OF STUDY TREATMENT
For this study, study treatments (those supplied by BMS, 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 treatments 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 (e.g., 
cytotoxics or biologics).
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) (examples include 
study treatments sourced from the sites 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, 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.

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 SOPs 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 
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method of disposal, i.e., 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 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.
CLINICAL STUDY REPORT AND PUBLICATIONS
A Signatory Investigator must be selected to sign the clinical study report. 
For this protocol, the Signatory Investigator will be selected as appropriate based on the following 
criteria:

External Principal Investigator designated at protocol development

National Coordinating Investigator 

Study Steering Committee chair or their designee

Participant recruitment (e.g., among the top quartile of enrollers)

Involvement in trial design

Regional representation (e.g., among top quartile of enrollers from a specified region or 
country)

Other criteria (as determined by the study team)
The data collected during this study are confidential and proprietary to Sponsor or designee. Any 
publications or abstracts arising from this study must adhere to the publication requirements set 
forth in the clinical trial agreement (CTA) governing [Study site or Investigator] participation in 
the study. These requirements include, but are not limited to, submitting proposed publications to 
Sponsor or designee at the earliest practicable time prior to submission or presentation and 
otherwise within the time period set forth in the CTA.
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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 
preexisting medical condition in a clinical investigation participant administered study treatment
and 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, ECG, 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/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).
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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.
SERIOUS ADVERSE EVENTS
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 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 (e.g., 
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 (e.g., 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)
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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 [e.g., 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 at 
home for allergic bronchospasm; 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.) 
Pregnancy and potential drug induced liver injury (DILI) must follow the same transmission timing 
and processes to BMS as used for SAEs (see section 9.2.5 for reporting pregnancies).
Any component of a study endpoint that is considered related to study therapy should be reported 
as SAE (e.g., death is an endpoint, if death occurred due to anaphylaxis, anaphylaxis must be 
reported).
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 (IB) 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 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 Sponsor.

The investigator may change his/her opinion of causality in light of follow-up information
and send a SAE follow-up report with the updated causality assessment.

The causality assessment is one of the criteria used when determining regulatory reporting 
requirements.
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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.) 
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 eCRF.

The paper SAE Report Form is only intended as a back-up option when the electronic 
data capture (EDC) 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 (fax) 
transmission
When paper forms are used, the original paper forms are to remain on site

Pregnancies must be recorded on a paper Pregnancy Surveillance Form and transmitted via 
email or confirmed facsimile (fax) transmission 
SAE Email Address: Refer to Contact Information list.
SAE Facsimile Number: Refer to Contact Information list.
SAE Telephone Contact (required for SAE and pregnancy reporting): Refer to Contact 
Information list
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APPENDIX 4
WOMEN OF CHILDBEARING POTENTIAL DEFINITIONS AND 
METHODS OF CONTRACEPTION
DEFINITIONS
Woman of Childbearing Potential (WOCBP)
A woman is considered fertile following menarche and until becoming post-menopausal 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.
CONTRACEPTION GUIDANCE FOR FEMALE PARTICIPANTS OF CHILD BEARING 
POTENTIAL
One of the highly effective methods of contraception listed below is required during study duration 
and until the end of relevant systemic exposure, defined as 5 months after the end of study 
treatment.*
Note: Hormone-based contraceptives are not considered highly effective methods of 
contraception for WOCBP participants receiving BMS-986205 in this study.
Highly Effective Contraceptive Methods That Are User Dependent 
Failure rate of <1% per year when used consistently and correctlya

Not for participants receiving BMS-986205: Combined (estrogen- and progestogen-
containing) hormonal contraception associated with inhibition of ovulationb

oral 

intravaginal 

transdermal 
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
Not for participants receiving BMS-986205: Progestogen-only hormonal contraception 
associated with inhibition of ovulationb

oral 

injectable 
Highly Effective Methods That Are User Independent

Not for participants receiving BMS-986205: Implantable progestogen-only hormonal 
contraception associated with inhibition of ovulation b

Not for participants receiving BMS-986205: Hormonal methods of contraception 
including oral contraceptive pills containing a combination of estrogen and progesterone,
vaginal ring, injectables, implants and intrauterine hormone-releasing system (IUS) b

Intrauterine device (IUD)

Bilateral tubal occlusion

Vasectomized partner 
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. 

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 drug. 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.

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 participants chooses to forego complete abstinence 
NOTES: 
a Typical use failure rates may differ from those when used consistently and correctly. Use should be consistent 
with local regulations regarding the use of contraceptive methods for participants participating in clinical studies. 
b Hormonal contraception may be susceptible to interaction with the study drug, which may reduce the efficacy of 
the contraceptive method.  Due to the potential interaction with study drug(s), these are only considered highly 
effective methods for female partners of male subjects participating in this study. Hormonal contraception should 
not be used by female participants of child-bearing potential.
Unacceptable Methods of Contraception*

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
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
Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the 
primary mechanism of action

Periodic abstinence (calendar, symptothermal, post-ovulation methods)

Withdrawal (coitus interruptus).

Spermicide only

Lactation amenorrhea method (LAM)
* Local laws and regulations may require use of alternative and/or additional contraception 
methods.
CONTRACEPTION GUIDANCE FOR MALE PARTICIPANTS WITH PARTNER(S) OF 
CHILD BEARING POTENTIAL.
Male participants with female partners of childbearing potential are eligible to participate if they 
agree to the following during the treatment and until the end of relevant systemic exposure.

Inform any and all partner(s) of their participation in a clinical drug study and the need to 
comply with contraception instructions as directed by the investigator.

Male participants are required to use a latex or synthetic male condom during each episode of 
sexual activity for study duration and until end of relevant systemic exposure defined as 7 
months after the end of study treatment. This applies even if the participant has undergone a 
successful vasectomy.

Female partners of males participating in the study to consider use of effective methods of 
contraception until the end of relevant systemic exposure, defined as 7 months after the end of 
treatment in the male participant.

Male participants with a pregnant or breastfeeding partner must agree to remain abstinent from 
penile vaginal intercourse or use a latex or synthetic male condom during each episode of 
sexual activity during the treatment and until 7 months after the end of study treatment. 

Refrain from donating sperm for the duration of the study treatment and until 7 months after 
the end of study treatment.
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 the Appendix for Adverse Events and Serious 
Adverse Events Definitions and procedures for Evaluating, Follow-up and Reporting
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APPENDIX 6
PERFORMANCE STATUS SCALES
STATUS
SCALES
STATUS
KARNOFSKY
ZUBROD-ECOG-
WHO
Normal, no complaints; no evidence of 
disease
100
0
Normal activity
Able to carry on normal activities. Minor 
signs or symptoms of disease
90
0
Normal activity with effort; some signs or 
symptoms of disease
80
1
Symptoms, but fully 
ambulatory
Cares for self. Unable to carry on normal 
activity or to do active work
70
1
Requires occasional assistance, but able to 
care for most of his personal needs
60
2
Symptomatic, but in 
bed < 50% of the day
Requires considerable assistance and 
frequent medical care
50
2
Disabled. Requires special care and 
assistance
40
3
Symptomantic. Needs 
to be in bed > 50% of 
the day, but not 
bedridden
Severely disabled. Hospitalization 
indicated although death not imminent
30
3
Very sick. Hospitalization necessary. 
Active supportive treatment necessary
20
4
Unable to get out of 
bed
Moribund. Fatal processess progressing 
rapidly
10
4
Dead
0
5
Dead
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APPENDIX 7
AJCC MELANOMA STAGING (CANCER STAGING MANUAL 
8TH EDITION)
[From AJCC Cancer Staging Manual, 8th Edition. Amin MB, Edge S, Greene F, Byrd DR, 
Brookland RK, Washington MK, et al. editors. Springer International Publishing. 2017 (pages 
577 & 578)]
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
With ulceration
0.8-1.0 mm
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
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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
Distant metastasis to non-CNS visceral 
sites with or without M1a or M1b sites of 
disease
Not recorded or unspecified
M1c(0)
Not elevated
M1c(1)
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.
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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
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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
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.
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APPENDIX 12
RESPONSE EVALUATION CRITERIA IN SOLID TUMORS 
GUIDELINES (VERSION 1.1) WITH BMS MODIFICATIONS
1
EVALUATION OF LESIONS
Solid tumors will be evaluated using Response Evaluation Criteria In Solid Tumors version 1.1 
(RECIST 1.1) guideline with BMS modifications.1
At baseline, tumor lesions/lymph nodes will be categorized as measurable or non-measurable as 
follows:
1.1
Measurable
Tumor lesions: Must be accurately measured in at least one dimension (longest diameter in the 
plane of measurement is to be recorded) with a minimum size of:
10 mm by CT/MRI scan (scan slice thickness no greater than 5 mm), or 2x slice thickness if 
greater than 5mm.
Malignant lymph nodes: To be considered pathologically enlarged and measurable, a lymph node 
must be 15 mm in short axis when assessed by CT/MRI scan (scan slice thickness recommended 
to be no greater than 5 mm).
Lymph nodes merit special mention since they are normal anatomical structures which may be 
visible by imaging even if not involved by tumor. Pathological nodes which are defined as 
measurable and may be identified as target lesions must meet the criterion of a short axis of 
15 mm by CT/MRI scan. Only the short axis of these nodes will contribute to the baseline sum. 
The short axis of the node is the diameter normally used by radiologists to judge if a node is 
involved by solid tumor. Nodal size is normally reported as two dimensions in the plane in which 
the image is obtained (for CT scan this is almost always the axial plane; for MRI the plane of 
acquisition may be axial, sagittal or coronal). The smaller of these measures is the short axis. For 
example, an abdominal node which is reported as being 20 mm x 30 mm has a short axis of 20 mm 
and qualifies as a malignant, measurable node. In this example, 20 mm should be recorded as the 
node measurement. All other pathological nodes (those with short axis 10 mm but < 15 mm) 
should be considered non-target lesions. Nodes that have a short axis < 10 mm are considered 
non-pathological and should not be recorded or followed.
Note: Lesions on X-Ray are not to be selected as Target or Non-Target Lesions.
1.2
Non-Measurable
All other lesions are considered non-measurable, including small lesions (longest diameter 
< 10mm or pathological lymph nodes with 10 to < 15 mm short axis) as well as truly 
non-measurable lesions. Lesions considered truly non-measurable include: leptomeningeal 
disease, inflammatory breast disease, lymphangitic involvement of skin or lung, abdominal 
masses/abdominal organomegaly identified by physical exam that is not measurable by 
reproducible imaging techniques.
Note: Lesions on X-Ray are not to be selected as Target or Non-Target Lesions.
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1.3
Special considerations regarding lesion measurability
1.3.1
Bone lesions

Bone scan, PET scan and plain films are not considered adequate imaging techniques to 
measure bone lesions. However, these techniques can be used to confirm the presence or 
disappearance of bone lesions. 

Lytic bone lesions or mixed lytic-blastic lesions, with identifiable soft tissue components, that 
can be evaluated by cross sectional imaging techniques such as CT or MRI can be considered 
as measurable lesions if the soft tissue component meets the definition of measurability 
described above.

Blastic bone lesions are non-measurable.
1.4
Baseline Documentation Of ‘Target’ And ‘Non-Target’ Lesions
When more than one measurable lesion is present at baseline all lesions up to a maximum of five 
lesions total (and a maximum of two lesions per organ) representative of all involved organs should 
be identified as target lesions and will be recorded and measured at baseline (this means in 
instances where patients have only one or two organ sites involved a maximum of two and four 
lesions respectively will be recorded).
Note: A maximum of two lesions can be selected per organ system. For example, a maximum of 
two lung lesions can be selected (selected from one lung or one lesion from each). A maximum of 
two lymph nodes can be selected at baseline, as the lymphatic system is considered one organ.
Target lesions should be selected on the basis of their size (lesions with the longest diameter), be 
representative of all involved organs, but in addition should be those that lend themselves to 
reproducible repeated measurements. It may be the case that, on occasion, the largest lesion does 
not lend itself to reproducible measurement in which circumstance the next largest lesion which 
can be measured reproducibly should be selected.
A sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) for all target 
lesions will be calculated and reported as the baseline sum diameters. If lymph nodes are to be 
included in the sum, then as noted above, only the short axis is added into the sum. The baseline 
sum diameters will be used as reference to further characterize any objective tumor regression in 
the measurable dimension of the disease.
All other lesions (or sites of disease) including pathological lymph nodes should be identified as 
non-target lesions and should also be recorded at baseline. Measurements are not required and 
these lesions should be followed as ‘present’, ‘absent’, or in rare cases ‘unequivocal progression’ 
(more details to follow). In addition, it is possible to record multiple non-target lesions involving 
the same organ as a single item on the case record form (eg, ‘multiple enlarged pelvic lymph nodes’ 
or ‘multiple liver metastases’).
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2.
RESPONSE CRITERIA
2.1
Evaluation of Target Lesions

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes 
(whether target or non-target) must have reduction in short axis to < 10 mm.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, 
taking as reference the baseline sum diameters.

Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, 
taking as reference the smallest sum on study (this includes the baseline sum if that is the 
smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate 
an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also 
considered progression).

Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to 
qualify for PD, taking as reference the smallest sum diameters while on study.

Not Evaluable (NE): If one or more target lesions cannot be measured or adequately assessed 
as either fully resolved or too small to measure (due to missing or poor quality images), and 
the sum of diameters of the remaining measured target lesions (if any) has not increased 
sufficiently to meet Progressive Disease as defined above. 
2.1.1
Special Notes on the Assessment of Target Lesions
2.1.1.1
Lymph nodes
Lymph nodes identified as target lesions should always have the actual short axis measurement 
recorded (measured in the same anatomical plane as the baseline examination), even if the nodes 
regress to below 10 mm on study. This means that when lymph nodes are included as target lesions, 
the ‘sum’ of lesions may not be zero even if complete response criteria are met, since a normal 
lymph node is defined as having a short axis of < 10 mm. Case report forms or other data collection 
methods may therefore be designed to have target nodal lesions recorded in a separate section 
where, in order to qualify for CR, each node must achieve a short axis < 10 mm. For PR, SD and 
PD, the actual short axis measurement of the nodes is to be included in the sum of target lesions.
2.1.1.2
Target lesions that become ‘too small to measure’
While on study, all lesions (nodal and non-nodal) recorded at baseline should have their actual 
measurements recorded at each subsequent evaluation, even when very small (eg, 2 mm). 
However, sometimes lesions or lymph nodes which are recorded as target lesions at baseline 
become so faint on CT scan that the radiologist may not feel comfortable assigning an exact 
measure and may report them as being ‘too small to measure’. When this occurs it is important 
that a value be recorded on the case report form. If it is the opinion of the radiologist that the lesion 
has likely disappeared, the measurement should be recorded as 0 mm. If the lesion is believed to 
be present and is faintly seen but too small to measure, a default value of 5 mm should be assigned
as the reference diameter. (Note: It is less likely that this rule will be used for lymph nodes since 
they usually have a definable size when normal and are frequently surrounded by fat such as in the 
retroperitoneum; however, if a lymph node is believed to be present and is faintly seen but too 
small to measure, a default value of 5 mm should be assigned in this circumstance as well). This 
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default value is derived from the 5 mm CT slice thickness (but should not be changed with varying 
CT slice thickness). The measurement of these lesions is potentially non-reproducible, therefore 
providing this default value will prevent false responses or progressions based upon measurement 
error. To reiterate, however, if the radiologist is able to provide an actual measure, that should be 
recorded, even if it is below 5 mm.
2.1.1.3
Lesions that split or coalesce on treatment
When non-nodal lesions ‘fragment’, the longest diameters of the fragmented portions should be 
added together to calculate the target lesion sum. Similarly, as lesions coalesce, a plane between 
them may be maintained that would aid in obtaining maximal diameter measurements of each 
individual lesion. If the lesions have truly coalesced such that they are no longer separable, the 
vector of the longest diameter in this instance should be the maximal longest diameter for the 
‘coalesced lesion’.
2.2
Evaluation of Non-Target Lesions
This section provides the definitions of the criteria used to determine the tumor response for the 
group of non-target lesions. While some non-target lesions may actually be measurable, they need 
not be measured and instead should be assessed only qualitatively at the time points specified in 
the protocol.

Complete Response (CR): Disappearance of all non-target lesions. All lymph nodes must be 
non-pathological in size (< 10mm short axis). 

Non-CR/Non-PD: Persistence of one or more non-target lesion(s)

Progressive Disease (PD): Unequivocal progression of existing non-target lesions.
2.2.1
Special Notes on Assessment of Progression of Non-Target Disease
The concept of progression of non-target disease requires additional explanation as follows:
2.2.1.1
When the patient also has measurable disease
In this setting, to achieve ‘unequivocal progression’ on the basis of the non-target disease, there 
must be an overall level of substantial worsening in non-target disease such that, even in presence 
of SD or PR in target disease, the overall tumor burden has increased sufficiently to merit 
discontinuation of therapy A modest ‘increase’ in the size of one or more non-target lesions is 
usually not sufficient to qualify for unequivocal progression status. Pleural effusions, pericardial 
effusions and ascites will not be followed as target or non-target lesions and will not contribute to 
response or progression. The designation of overall progression solely on the basis of change in 
non-target disease in the face of SD or PR of target disease will therefore be extremely rare.
2.2.1.2
When the patient has only non-measurable disease
This circumstance arises in some trials when it is not a criterion of study entry to have measurable 
disease. The same general concepts apply here as noted above, however, in this instance there is 
no measurable disease assessment to factor into the interpretation of an increase in non-measurable 
disease burden. Because worsening in non-target disease cannot be easily quantified (by definition: 
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if all lesions are truly non-measurable) a useful test that can be applied when assessing patients for 
unequivocal progression is to consider if the increase in overall disease burden based on the change 
in non-measurable disease is comparable in magnitude to the increase that would be required to 
declare PD for measurable disease: ie, an increase in tumor burden representing an additional 73% 
increase in ‘volume’ (which is equivalent to a 20% increase diameter in a measurable lesion). 
Examples include, an increase in lymphangitic disease from localized to widespread, or may be 
described as ‘sufficient to require a change in therapy’. If ‘unequivocal progression’ is seen, the 
patient should be considered to have had overall PD at that point. While it would be ideal to have 
objective criteria to apply to non-measurable disease, the very nature of that disease makes it 
impossible to do so; therefore the increase must be substantial.
2.2.2
New Lesions
The appearance of new malignant lesions denotes disease progression; therefore, some comments 
on detection of new lesions are important. There are no specific criteria for the identification of 
new radiographic lesions; however, the finding of a new lesion should be unequivocal: ie, not 
attributable to differences in scanning technique, change in imaging modality or findings thought 
to represent something other than tumor (for example, some ‘new’ bone lesions may be simply 
healing or flare of pre-existing lesions). This is particularly important when the patient’s baseline 
lesions show partial or complete response. For example, necrosis of a liver lesion may be reported 
on a CT scan report as a ‘new’ cystic lesion, which it is not.
NOTE: Fluid collections (pleural effusions, pericardial effusions, and ascites) will not be 
considered new lesions and will not contribute to response or progression. In the event a new fluid 
collection is seen on a post-baseline imaging exam, a comment may be made, but the appearance 
of a new fluid collection alone should not result in an assessment of Progressive Disease (PD). A 
lesion identified on a follow-up study in an anatomical location that was not scanned at baseline 
is considered a new lesion and will indicate disease progression. An example of this is the patient 
who has visceral disease at baseline and while on study has a CT or MRI brain ordered which 
reveals metastases. The patient’s brain metastases are considered to be evidence of PD even if 
he/she did not have brain imaging at baseline. A lesion identified on Chest X-Ray that was not 
present in prior CT can be considered a new lesion and will result in Progressive Disease (PD).
If a new lesion is equivocal, for example because of its small size, continued follow-up evaluation 
will clarify if it represents truly new disease. If repeat scans confirm there is definitely a new 
lesion, then progression should be declared using the date of the initial scan. While FDG-PET 
response assessments need additional study, it is sometimes reasonable to incorporate the use of 
FDG-PET scanning to complement CT scanning in assessment of progression (particularly 
possible ‘new’ disease). New lesions on the basis of FDG-PET imaging can be identified according 
to the following algorithm:
1. Negative FDG-PET at baseline, with a positive FDG-PET at follow-up is a sign of PD based 
on a new lesion.
2. No FDG-PET at baseline and a positive FDG-PET at follow-up: If the positive FDG-PET at 
follow-up corresponds to a new site of disease confirmed by CT, this is PD. If the positive 
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FDG-PET at follow-up is not confirmed as a new site of disease on CT, additional follow-up 
CT scans are needed to determine if there is truly progression occurring at that site (if so, the 
date of PD will be the date of the initial abnormal FDG-PET scan). If the positive FDG-PET 
at follow-up corresponds to a pre-existing site of disease on CT that is not progressing on the 
basis of the anatomic images, this is not PD.
2.3
Response Assessment
2.3.1
Evaluation of Best Overall Response
The best overall response is the best response recorded from the start of the study treatment until 
disease progression or the last response recorded, taking into account any requirement for 
confirmation and censoring rules regarding subsequent therapy. The patient’s best overall response
assignment will depend on the findings of both target and non-target disease and will also take into 
consideration the appearance of new lesions. Furthermore, depending on the nature of the study 
and the protocol requirements, it may also require confirmatory measurement.
2.3.2
Time Point Response
At each protocol specified time point, a response assessment occurs. Table 2.3.2-1 provides a 
summary of the overall response status calculation at each time point for patients who have 
measurable disease at baseline. When patients have non-measurable (therefore non-target) disease 
only, Table 2.3.2-2 is to be used. 
Table 2.3.2-1:
Time Point Response: Patients With Target (± Non-Target) Disease
Target Lesions
Non-Target Lesions
New Lesions
Overall Response
CR
CR
No
CR
CR
Non-CR/non-PD
No
PR
CR
Not evaluated
No
PR
PR
Non-PD or not all 
evaluated
No
PR
SD
Non-PD or not all 
evaluated
No
SD
Not all evaluated
Non-PD
No
NE
PD
Any
Yes or No
PD
Any
PD
Yes or No
PD
Any
Any
Yes
PD
CR = complete response, PR = partial response, SD = stable disease, PD = progressive disease and NE = inevaluable
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Table 2.3.2-2:
Time Point Response: Patients with Non-target Disease Only
Non-Target Lesions
New Lesions
Overall Response
CR
No
CR
Non-CR/non-PD
No
Non-CR/non-PDa
Not all evaluated
No
NE
Unequivocal PD
Yes or No
PD
Any
Yes
PD
CR = complete response, PD = progressive disease and NE = inevaluable
a Non-CR/non-PD is preferred over SD for non-target disease since SD is increasingly used as endpoint for 
assessment of efficacy in some trials so to assign this category when no lesions can be measured is not advised.
2.3.3
Best Overall Response 
Best response determination of complete or partial response requires confirmation: Complete or 
partial responses may be claimed only if the criteria for each are met at a subsequent time point of 
4 weeks (28 days) later. In this circumstance, the best overall response can be interpreted as in 
Table 2.3.3-1. When SD is believed to be best response, it must meet the protocol specified 
minimum time from the date of first treatment or randomization date.
For example, if the first scheduled follow-up imaging visit is Week 6 (± 7 days) for a particular 
protocol, a Best Response of SD can only be made after the subject is on-study for a minimum of 
6 weeks (42 days) minus 7 days, for an absolute minimum time on-study of 35 days from the 
reference start date (reference date is considered Day 1 on study).  If the subject is not on-study 
for at least this amount of time, any tumor assessment indicating stable disease before this time 
period will have a Best Response of NE unless PD is identified.
Special note on response assessment: When nodal disease is included in the sum of target lesions 
and the nodes decrease to ‘normal’ size (< 10 mm), they may still have a measurement reported 
on scans. This measurement should be recorded even though the nodes are normal in order not to 
overstate progression should it be based on increase in size of the nodes. As noted earlier, this 
means that patients with CR may not have a total sum of ‘zero’ on the case report form (CRF).
Table 2.3.3-1:
Best Overall Response (Confirmation of CR and PR Required)
Overall Response 
First Time Point
Overall Response 
Subsequent Time Point
Best Overall Response
CR
CR
CR
CR
PR
SD, PD OR PRa
CR
SD
SD provided minimum criteria for SD duration met, otherwise, 
PD
CR
PD
SD provided minimum criteria for SD duration met, otherwise, 
PD
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Table 2.3.3-1:
Best Overall Response (Confirmation of CR and PR Required)
Overall Response 
First Time Point
Overall Response 
Subsequent Time Point
Best Overall Response
CR
NE
SD provided minimum criteria for SD duration met, otherwise, 
NE
PR
CR
PR
PR
PR
PR
PR
SD
SD
PR
PD
SD provided minimum criteria for SD duration met, otherwise, 
PD
PR
NE
SD provided minimum criteria for SD duration met, otherwise, 
NE
NE
NE
NE
CR = complete response, PR = partial response, SD = stable disease, PD = progressive disease, and 
NE = inevaluable
a If a CR is truly met at first time point, then any disease seen at a subsequent time point, even disease meeting PR 
criteria relative to baseline, makes the disease PD at that point (since disease must have reappeared after CR). Best 
response would depend on whether minimum duration for SD was met. However, sometimes ‘CR’ may be claimed 
when subsequent scans suggest small lesions were likely still present and in fact the patient had PR, not CR at the 
first time point. Under these circumstances, the original CR should be changed to PR and the best response is PR.
2.3.4
Confirmation Scans
Verification of Response: To be assigned a status of CR or PR, changes in tumor measurements 
must be confirmed by consecutive or subsequent repeat assessments that should be performed no 
less than 28 days after the criteria for response are first met. Subsequent documentation of a CR 
may provide confirmation of a previously identified CR even with an intervening NE or PR (e.g., 
CR NE CR or CR PR CR). Subsequent documentation of a PR may provide confirmation of a
previously identified PR even with an intervening NE or SD (e.g., PR NE PR or PR SD PR). 
However, only one (1) intervening time point will be allowed between PR/CRs for confirmation.
Verification of Progression: Progression of disease should be verified in cases where progression 
is equivocal. If repeat scans confirm PD, then progression should be declared using the date of the 
initial scan. If repeat scans do not confirm PD, then the subject is considered to not have 
progressive disease.
1 Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumors:
revised RECIST guideline (version 1.1). Eur J Cancer 2009; 45: 228-47.
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APPENDIX 16
REVISED PROTOCOL SUMMARY OF CHANGE HISTORY
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Summary of key changes for Revised Protocol 01
Section Number & Title
Description of Change
Brief Rationale
Section 2, Table 2-1, 
Screening Procedural Outline
Note added to title indicating that 
enrollment was stopped, and any 
consented 
but 
non-randomized 
patients should be screen failed. 
 
 
Section 2, Table 2-2, On-study 
Assessments

 
 
 
 
. 

Allowing for co-oximetry to 
be used for oxygen saturation.

Increase 
frequency 
of 
methemoglobin 
assessments 
for participants treated with 
BMS-986205 

 
 
 
 
 
 
 
 
Table 2-3, Follow-up 
Procedural Outline 

Survival visits removed. 

Pregnancy testing for WOCBP 
added

 
 
 

Footnote added specifying no 
follow-up visits required for 
participants who screen fail.
 
 
 
Section 3.1.1, Change Per 
Revised Protocol 01
 
 
 
 
Section 6.1, Inclusion Criteria
Contraceptive guidance updated. 
 
 
 
 
Section 7.1.2 Nivolumab 
Dosing
Guidance regarding monitoring for 
infusion reactions added. 
Information provided for sites that do no 
 
 
 
 
 
 
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Summary of key changes for Revised Protocol 01
Section Number & Title
Description of Change
Brief Rationale
 
 
 
 
 
 
 
 
 
 
 
.
Section 7.7.2 Other 
Restrictions and Precautions 
Precautions regarding the 
development of and monitoring of 
serotonin syndrome added.
 
 
 
 
Section 8.1.1 BMS-986205 
and Nivolumab Dose 
Discontinuation
Updated to contain the most recent 
criteria for nivolumab in 
combination with BMS-986205.
 
 
.
Section 8.1.2 BMS-986205 
Dose Discontinuation
Updated to specify events that 
require discontinuation of BMS-
986205. 
Section 9.1.1
Imaging schedule updated to local 
standard of care. 
Updated with note that images will 
not be submitted to BIRC. 
 
 
Section 9.2.5 Adverse Event 
of Special Interest 
Added section regarding the 
adverse events of special interest. 
Section 9.3 Overdose
Updated reporting requirements. 
 
 
 
 
  
 
 
Section 10, Statistical 
considerations
Updated to indicate that efficacy 
analyses will not be conducted.
 
 
 
 
 
 
 
 
 
 
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Summary of key changes for Revised Protocol 01
Section Number & Title
Description of Change
Brief Rationale
 
Appendix 15
Adverse events of special interest
Guidance added to aid investigators in 
identifying adverse events of special 
interest. 
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SAP_001.pdf: 
Official Title of Study: 
A Phase 3, Randomized, Double-blind Study of BMS-986205 Combined with Nivolumab versus 
Nivolumab in Participants with Metastatic or Unresectable Melanoma that is Previously 
Untreated 
 
NCT Number: NCT03329846 
 
Document Date (Date in which document was last revised): July 23, 2020 
 


STATISTICAL ANALYSIS PLAN
FOR SYNOPTIC CLINICAL STUDY REPORT
A PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY OF BMS-986205 COMBINED 
WITH NIVOLUMAB VERSUS NIVOLUMAB IN PARTICIPANTS WITH METASTATIC 
OR UNRESECTABLE MELANOMA THAT IS PREVIOUSLY UNTREATED
PROTOCOL(S) CA017055
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2
TABLE OF CONTENTS
STATISTICAL ANALYSIS PLAN FOR SYNOPTIC CLINICAL STUDY REPORT ...............1
TABLE OF CONTENTS............................................................................................................2
LIST OF FIGURES ....................................................................................................................4
2
STUDY DESCRIPTION ..........................................................................................6
2.1
Study Design ............................................................................................................6
2.2
Treatment Assignment..............................................................................................7
2.3
Blinding and Unblinding...........................................................................................9
2.4
Protocol Amendments...............................................................................................9
2.5
Data Monitoring Committee .....................................................................................9
3
OBJECTIVES ..........................................................................................................9
3.1.1
Safety........................................................................................................................9
4
ENDPOINTS..........................................................................................................10
5
SAMPLE SIZE AND POWER...............................................................................10
6
STUDY PERIODS, TREATMENT REGIMENS AND POPULATIONS 
FOR ANALYSES ..................................................................................................10
6.1
Study Periods..........................................................................................................10
6.1.1
Baseline Period ......................................................................................................10
6.1.2
Post Baseline Period...............................................................................................10
6.2
Treatment Regimens...............................................................................................11
6.3
Populations for Analyses ........................................................................................11
7
STATISTICAL ANALYSES..................................................................................11
7.1
General Methods ....................................................................................................11
7.2
Study Conduct........................................................................................................11
7.2.1
Participant Disposition...........................................................................................11
7.2.2
Demographic and Baseline Characteristics ............................................................12
7.2.3
Medical History......................................................................................................12
7.2.4
Prior Therapy.........................................................................................................12
7.3
Extent of Exposure .................................................................................................12
7.3.2
Subsequent Anti-Cancer Therapy............................................................................12
7.5
Safety.....................................................................................................................12
7.5.1
Deaths ....................................................................................................................12
7.5.2
Serious Adverse Events...........................................................................................12
7.5.3
Adverse Events Leading to Discontinuation of Study Therapy.................................13
7.5.4
Adverse Events .......................................................................................................13
7.5.5
Laboratory Parameters...........................................................................................13
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CONVENTIONS....................................................................................................13
10
CONTENT OF REPORTS .....................................................................................14
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LIST OF FIGURES
Figure 2.1-1:
Study Design Schematic...........................................................................6
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2
STUDY DESCRIPTION
2.1
Study Design
This is a Phase 3, randomized, double-blind study of BMS-986205 in combination with nivolumab 
versus nivolumab in combination with BMS-986205 placebo in adult (18 years of age and older, 
or age of majority) and adolescent (≥12 years of age, where locally acceptable; otherwise ≥18 
years of age) participants with unresectable or metastatic melanoma that is previously untreated. 
This study is double-blinded with respect to BMS-986205; BMS-986205 Placebo PO QD will be 
administered in combination with nivolumab administered IV Q4W in the nivolumab monotherapy 
arm. Participants must have unresectable Stage III or Stage IV melanoma, per the 8th edition of 
the American Joint Committee on Cancer (AJCC) Staging Manual2, and must not have received 
prior systemic therapy for the treatment of unresectable or metastatic melanoma. Prior adjuvant or 
neoadjuvant therapy in participants with previously completely resected disease that has now 
recurred is permitted if this therapy was completed at least 6 months prior to randomization.
The study design schematic in adults and adolescents is presented in Figure 2.1-1. 
Figure 2.1-1:
Study Design Schematic
A pre-treatment tumor sample to determine PD-L1 status is required to be submitted from all 
participants prior to randomization. The sample must be obtained within 3 months prior to 
enrollment from a metastatic tumor lesion or from an unresectable primary tumor lesion. The 
tumor sample must be taken from a site of disease which has not been previously irradiated. In 
addition, no intervening treatment may have been administered between the time of biopsy/surgery
and randomization. Pre-treatment tumor tissue biopsy specimens in the form of a paraffin-
embedded block or, optimally, at least 20 unstained slides, will be requested; a minimum of 10 
slides is required. The pre-treatment tumor sample must be a core biopsy, punch biopsy, excisional 
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biopsy, or surgical specimen; fine needle aspiration samples and cytology samples are not 
acceptable. If sufficient tissue is not available from within 3 months prior to enrollment, then a 
fresh biopsy will be required during the screening period. Samples will be submitted to the 
analytical laboratory for PD-L1 testing. The analytical laboratory must provide IRT with 
confirmation of the related results prior to randomization. 
Participants must have a documented BRAF mutational status prior to randomization. Those 
participants enrolling in this study without known results must have testing performed locally and 
results (wild type or mutant) be available prior to randomization. Participants with indeterminate 
or unknown BRAF mutational status results will not be permitted to be randomized in the study.
During the treatment phase, participants will receive:
•
Arm A: BMS-986205 100 mg PO QD and Nivolumab 480 mg IV Q4W for up to 104 weeks 
(approximately 2 years)
•
Arm B: BMS-986205 Placebo PO QD and Nivolumab 480 mg IV Q4W for up to 104 weeks 
(approximately 2 years)
Dose reductions will be not be allowed for nivolumab; dose reductions will be permitted for 
double-blind BMS-986205 (or matching placebo) if the participant is an adult or an adolescent 
receiving 100mg tablets. No dose reductions for BMS-986205 (or matching placebo) will be 
allowed for adolescent participants receiving 50 mg tablets.
Treatment beyond initial investigator-assessed Response Evaluation Criteria in Solid Tumors
(RECIST) v1.1-defined progression is permitted if the participant has investigator-assessed 
clinical benefit, is tolerating study treatment, and has not yet completed 104 weeks of study 
treatment.
2.2
Treatment Assignment
All participants will be centrally randomized using an Interactive Response Technology (IRT). 
Before the study is initiated, each user will receive log-in information and directions on how to 
access the IRT. After the participant’s initial eligibility is established and informed consent has 
been obtained, the participant must be enrolled into the study by calling an IRT to obtain the
participant number. Every participant who signs the informed consent form must be assigned a 
participant number in IRT. 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
Once enrolled in IRT, enrolled participants who have met all eligibility criteria will be ready to be 
randomized through the IRT. The following information is required for participant randomization:
•
Participant number 
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•
Year of birth 
•
PD-L1 status (PD-L1 positive vs. PD-L1 negative/indeterminate) entered by vendor
•
BRAF V600 mutational status
•
M (Metastatic) Stage at screening 
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Participants meeting all eligibility criteria will be randomized in a 1:1 ratio and stratified by PD-L1 
status, BRAF status, and AJCC M stage as described below:
•
PD-L1 status
−
PD-L1 positive (≥1% tumor cell membrane staining in a minimum of 100 evaluable tumor 
cells) vs.
−
PD-L1 negative (< 1% tumor cell membrane staining in a minimum of 100 evaluable tumor 
cells) / indeterminate (tumor cell membrane scoring hampered by high cytoplasmic 
staining or melanin content)
•
BRAF mutational status
−
BRAF V600 mutation positive vs.
−
BRAF V600 wild type
•
AJCC M stage at screening
−
M0/M1a(0)/M1b(0) vs.
−
M1a(1)/M1b(1)/M1c(any)/M1d(any)
The randomization procedures will be carried out via permuted blocks within each stratum, defined 
by combination of PD-L1 status (positive, negative/indeterminate), BRAF V600 mutational status 
(BRAF 
mutated, 
BRAF 
wild
type), 
and 
M 
Stage 
(M0/M1a(0)/M1b(0), 
M1a(1)/M1b(1)/M1c(any)/M1d[any]). The exact procedures for using the IRT will be detailed in 
the IRT manual.
2.3
Blinding and Unblinding
Treatment allocation will be unblinded upon approval of Revised Protocol 01 and a list of 
treatment assignments for each subject will be provided to each site with randomized subjects.
2.4
Protocol Amendments
Revised Protocol 01 on 13-Jun-2018.
2.5
Data Monitoring Committee
NA.
3
OBJECTIVES
Not applicable per Revised Protocol 01.
3.1.1
Safety
Safety will be analyzed through the incidence of deaths, adverse events, serious adverse events, 
adverse events leading to discontinuation, adverse events leading to dose modification, and 
specific laboratory abnormalities (worst grade) in each treatment arm. Toxicities will be graded 
using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events 
(CTCAE) version 4.03. 
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4
ENDPOINTS
 
 
 
 
 
5
SAMPLE SIZE AND POWER
NA.
6
STUDY PERIODS, TREATMENT REGIMENS AND POPULATIONS FOR 
ANALYSES
6.1
Study Periods
6.1.1
Baseline Period
Baseline evaluations or events will be defined as evaluations or events that occur before the date 
and time of the first dose of study treatment. Evaluations on the same date and time of the first 
dose of study treatment will be considered as baseline evaluations. For subjects who are 
randomized but not treated, baseline evaluation will be defined as those that occur before the date 
and time of randomization.
In cases where the time (onset time of event or evaluation time and dosing time) is missing or not 
collected, the following definitions will apply:
•
Pre-treatment AEs will be defined as AEs with an onset date prior to but not including the day
of the first dose of study treatment
•
Baseline evaluations (laboratory tests, pulse oximetry and vital signs) will be defined as
evaluations with a date on or prior to the day of first dose of study treatment
If there are multiple valid assessments, the assessment that is closest to day (and time if collected) 
of the first dose of study treatment will be used as the baseline in the analyses. If multiple 
assessments are collected at the same date (and time if collected), the assessment with the latest 
database entry date (and time if collected) will considered as baseline. 
6.1.2
Post Baseline Period
On-treatment AEs will be defined as AEs with an onset date-time on or after the date-time of the 
first dose of study treatment (or with an onset date on or after the day of first dose of study 
treatment if time is not collected or is missing). An AE will be counted as on-treatment if the event 
occurred within 30 days (or 100 days depending on analysis) of the last dose of study treatment. 
On-treatment evaluations (laboratory tests, pulse oximetry, and vital signs) will be defined as 
evaluations taken after the day (and time, if collected and not missing) of first dose of study 
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treatment. An evaluation will be counted as on-treatment if it occurred within a safety window of 
30 days (or 100 days depending on analysis) of the last dose of study treatment.
Late emergent drug-related AEs will be defined as drug-related AEs with an onset date greater 
than 100 days after the last dose of study treatment in subjects who are off study treatment.
6.2
Treatment Regimens
The treatment group “as randomized” will be retrieved from the IRT system.
•
Arm A: BMS-986205 100 mg PO QD and Nivolumab 480mg IV Q4W 
•
Arm B: BMS-986205 Placebo PO QD and Nivolumab 480mg IV Q4W 
The treatment group “as treated” will be the same as the arm as randomized by IRT. However, if 
a participant received the incorrect drug for the entire period of treatment, the participant’s 
treatment group will be defined as the incorrect drug the participant actually received.
6.3
Populations for Analyses
•
Enrolled participants: All participants who signed informed consent and were registered into 
IRT.
•
All treated participants: All participants who received at least one dose of any study 
medication, including placebo doses.
•
All randomized participants: All participants who are randomized to any treatment group.
•
PK: All randomized participants with available serum time-concentration data.
7
STATISTICAL ANALYSES
7.1
General Methods
Unless otherwise noted, the bulleted titles in the following subsections describe tabulations of 
discrete variables, by the frequency and proportion of subjects falling into each category, grouped 
by treatment (with total). Percentages given in these tables will be rounded and, therefore, may not 
always sum to 100%. 
Continuous variables will be summarized by treatment group (with total, as needed) using the 
mean, standard deviation, median, quartiles, minimum and maximum values, unless specified 
otherwise.
7.2
Study Conduct
7.2.1
Participant Disposition
Pre-Randomized (Before Double-blind Period) Subject Status and Subject Status on treatment will 
be summarized. A participant listing for all randomized participants will be provided showing the 
participant’s randomization date, first and last dosing date, off treatment date and reason for going 
off-study treatment. Information regarding off-study reason will be included if available.
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7.2.2
Demographic and Baseline Characteristics
Listings will be provided for demographic characteristics (including age, race and gender) for all 
treated participant.
7.2.3
Medical History
Not applicable (not required for a synoptic CSR)
7.2.4
Prior Therapy
Not applicable (not required for a synoptic CSR)
7.3
Extent of Exposure
A listing of study medication received will be provided for all treated participants. 
7.3.2
Subsequent Anti-Cancer Therapy
Not applicable (not required for a synoptic CSR)
 
 
7.5
Safety
The safety analysis will be presented in all treated participants, unless otherwise specified.
7.5.1
Deaths
A list of death will be provided for all enrolled participants.
7.5.2
Serious Adverse Events
Serious adverse events will be summarized by treatment group:
•
Overall summary of SAEs by worst CTC grade (any grade, grade 3-4, grade 5) presented by 
SOC/PT.
•
Overall summary of drug-related SAEs by worst CTC grade (any grade, grade 3-4, grade 5) 
presented by SOC/PT.
All analyses will be conducted using the 30-day safety window. 
A by-subject SAE listing will be provided for the “enrolled subjects” population.
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7.5.3
Adverse Events Leading to Discontinuation of Study Therapy
A list of adverse events leading to discontinuation of study therapy will be provided for all treated 
participants.
7.5.4
Adverse Events
Adverse events will be summarized by treatment group.
The following analyses will be conducted using the 30 days safety window:
•
Overall summary of any AEs by worst CTC grade (1, 2, 3, 4, 5, not reported, total) presented
by SOC/PT. 
•
Overall summary of drug-related AEs by worst CTC grade (any grade, grade 3-4, grade 5) 
presented by SOC/PT.
A by-subject AE listing will be provided. 
7.5.5
Laboratory Parameters
Laboratory parameters including hematology, serum chemistry, liver function, and renal function
in SI units will be summarized using worst grade by treatment group for all treated participants. 
A by-subject listing of these laboratory parameters will be provided.
 
 
 
9
CONVENTIONS
The following conventions may be used for imputing partial dates for analyses requiring dates:
For missing and partial adverse event onset dates, imputation will be performed using the Adverse 
Event Domain Requirements Specification3. 
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For death dates, the following conventions will be used for imputing partial dates:
•
If only the day of the month is missing, the 1st of the month will be used to replace the missing 
day. The imputed date will be compared to the last known date alive and the maximum will be 
considered as the death date.
•
If the month or the year is missing, the death date will be imputed as the last known date alive.
•
If the date is completely missing but the reason for death is present the death date will be 
imputed as the last known date alive.
For date of progression, the following conventions will be used for imputing partial dates:
•
If only the day of the month is missing, the 1st of the month will be used to replace the missing 
day*.
•
If the day and month are missing or a date is completely missing, it will be considered as 
missing.
* In cases where the date of death is present and complete, the imputed progression date will be 
compared to the date of death. The minimum of the imputed progression date and date of death 
will be considered as the date of progression.
For other partial/missing dates, the following conventions may be used:
•
If only the day of the month is missing, the 15th of the month will be used to replace the 
missing day.
•
If both the day and the month are missing, “July 1” will be used to replace the missing 
information.
•
If a date is completely missing, it will be considered as missing.
The following conversion factors will be used to convert days to months or years: 1 month =
30.4375 days and 1 year = 365.25 days.
Duration (e.g., time from first diagnosis to first dosing date, duration of response, and time to 
response) will be calculated as follows:
Duration = (Last date - first date + 1)
All statistical analyses will be carried out using SAS (Statistical Analysis System software, SAS 
Institute, North Carolina, USA) unless otherwise noted.
10
CONTENT OF REPORTS
All analyses described in this SAP will be included in the Clinical Study Report(s) except where 
otherwise noted. Refer to the Data Presentation Plan for mock-ups of all tables and listings.
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