Conditions: Advanced Cancer
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 12
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine safety and effectiveness of experimental medication BMS-986205 in combination with Nivolumab in patients with cancers that are advanced or have spread.

Detailed description:

Arms:
arm 1: 2 week BMS-986205 monotherapy lead in followed by BMS-986205 + Nivo combination therapy

Interventions: intervention 1: BMS-986205 intervention 2: Nivolumab
Intervention descriptions: intervention 1: Specified Dose on Specified Day intervention 2: Specified Dose on Specified Day

Protocol document:
Prot_000.pdf: 
Page: 1
Protocol Number: CA017076
IND Number: N/A
EX-US Non-IND
EUDRACT Number: N/A
Date: 26-Feb-2018
Revised Date: 10-Oct-2018
Clinical Protocol CA017076
A Phase 1/2 Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and 
Tolerability of BMS-986205 Alone and in Combination with Nivolumab in Chinese Patients 
with Advanced Malignant Solid Tumors
Revised Protocol 01
Study Director/Medical Monitor
24-hr Emergency Telephone Number
Bristol-Myers Squibb Research and Development
1717 West Nanjing Road
Shanghai 200040, P.R. China
Approved 2.0
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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 participatein and/or the performance of the proposed BMS sponsored 
study. Any permitted disclosures will be made only on a confidential "need to know" basis 
within your organization or to your independent ethics committee(s). Any other use, copying, 
disclosure or dissemination of this information is strictly prohibited unless expressly 
authorized in writing by BMS. Any supplemental information (eg, amendments) that may 
be added to this document is also confidential and proprietary to BMS and must be kept in 
confidence in the same manner as the contents of this document. Any person who receives 
this document without due authorization from BMS is requested to return it to BMS or 
promptly destroy it. 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).


Clinical Protocol
CA017076
BMS-986205
IDO1 inhibitor
Revised Protocol No.: 01
Date:10-Oct-2018
2
Approved 2.0
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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.


Clinical Protocol
CA017076
BMS-986205
IDO1 inhibitor
Revised Protocol No.: 01
Date:10-Oct-2018
3
DOCUMENT HISTORY
Document
Date of Issue
Summary of Change
Revised Protocol 01
10-Oct-2018
Incorporated changes to align this protocol with the current 
standards of the BMS-986205 and nivolumab programs and 
enhance subject safety across the protocol
Information about Reticulocyte counts and haptoglobin 
monitoring at baseline and reflex when methemoglobin is 
elevated over ULNwas added
Exclusion criteria was updated to exclude participants with 
prior exposure to anti-PD-1, anti-PDL-1 therapy was 
updated
Information on the serotonin syndrome as a possible class 
effect of IDO1 inhibitors and additional exclusion criteria 
and dose discontinuation criteria to reflect this possibility
Information about smoking and CYP1A2 was added to 
other restrictions and precautions and other sections
Administrative changes, minor clarifications, typographical 
corrections, and updates for consistency were made
Updated notes and provided clarification in the procedure 
outline and across the protocol
Original Protocol
26-Feb-2018
Not applicable
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Clinical Protocol
CA017076
BMS-986205
IDO1 inhibitor
OVERALL RATIONALE FOR REVISED PROTOCOL 01:
The primary reasons for these changesbelow were to align this protocol with the current standards 
of the BMS-986205 and nivolumab programs and enhance subject safety.
SUMMARY OF KEY CHANGES FOR REVISED PROTOCOL 01
Section Number & Title
Description of Change
Brief Rationale
Table 2-1: Screening 
Procedural Outline 
(CA017076)
Updated notes to clarify that 
Vital signs must be obtained 
at the screening visit and 
prior to randomization or first 
dose must be obtained prior 
to performing any screening 
procedures
Updated text for clarity
Table 2-1: Screening 
Procedural Outline 
(CA017076)
Updated notes to clarify that 
G6PD Deficiency Testing 
will not be done locally
Updated text for clarity
Table 2-1: Screening 
Procedural Outline 
(CA017076)
Updated frequency and notes 
to clarify that methemoglobin 
levels to be assessed on 
arterial or venous blood 
sample
Updated text for clarity
Table 2-1: Screening 
Procedural Outline 
(CA017076)
Updated notes to clarify that 
Reticulocyte counts and 
haptoglobin will be done at 
baseline and reflex when 
methemoglobin is elevated 
over ULN)
Updated text for clarity
Table 2-2:
On-Treatment:  
BMS-986205 Monotherapy 
(One 14-Day Cycle) 
Procedure Outline 
(CA017076)
Updated notes to delete “For 
Day 2, only collect predose if 
elevated either 2 or 4 hours 
postdose evaluation on Day 1. 
Predose on Day 4 (± 1 day)”.
Updated text forclarity
Table 2-2:
On-Treatment:  
BMS-986205 Monotherapy 
(One 14-Day Cycle) 
Procedure Outline 
(CA017076)
Updated notes about CBC 
with Differential and Platelets 
to clarify that additional 
samples to be collected as 
clinically indicated
Updated text for clarity
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Clinical Protocol
CA017076
BMS-986205
IDO1 inhibitor
SUMMARY OF KEY CHANGES FOR REVISED PROTOCOL 01
Section Number & Title
Description of Change
Brief Rationale
Table 2-4: Follow-Up 
Procedure Outline 
(CA017076)
Updated notes about CBC 
with Differential and Platelets 
to clarify that additional 
samples to be collected as 
clinically indicated
Updated text for clarity
5.1Overall Design
Deleted the statement 
“Participants who have not 
experienced a Grade 3 drug-
related skin AE may resume 
treatment in the presence of 
Grade 2 skin toxicity”.
Updated text for clarity
5.1Overall Design
Clarified that treatmentmay 
continue from Cycle 0 (2 
weeks) until 50 weeks disease 
progression, or withdrawal of 
consent.
Updated text for clarity
5.1Overall Design
Screening
Removed text “If a 
participant surpasses the 28-
day window during the 
screening phase due to a 
study-relatedprocedure (eg, 
waiting time for a study-
related laboratory value),the 
participant must be re-
consented but does not need 
Updated for consistency 
purposes
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Clinical Protocol
CA017076
BMS-986205
IDO1 inhibitor
SUMMARY OF KEY CHANGES FOR REVISED PROTOCOL 01
Section Number & Title
Description of Change
Brief Rationale
to be assigned a new 
identificationnumber. In this 
situation, the least amount of 
repeat procedures from the 
initial screening to qualifythe 
participant, while maintaining 
safety and eligibility under 
the discretion of the BMS 
medicalmonitor and 
investigator, may be done to 
reduce any undue burden of 
procedures in this subject
population”.
6.1Inclusion Criteria2f
Exclusion criteria was 
modified to exclude 
“Participants with prior 
exposure to therapy with any 
agent specifically targeting 
checkpoint pathway 
inhibition other than PD-1 or 
PD-L1 (such as anti-PD-1, 
anti-PDL-1)”
New requirement based on 
evolving data
6.1Inclusion Criteria3f
Modified the exclusion 
criteria to include “in 
addition, male subjects must 
be willing to refrain from 
sperm donation during this 
time”.
Updated text for clarity
6.2Exclusion Criteria2b
Added the exclusion criteria 
“Participants must not have a 
prior history of serotonin 
syndrome”
New requirement based on 
evolving data
6.2Exclusion Criteria3b
Added that “Participants with 
prior exposure to anti PD-1 or 
anti-PDL1 therapy must be 
excluded”
New requirement based on 
evolving data
6.2Exclusion Criteria3c
Updated that participants 
must not use any strong 
New requirement based on 
evolving data
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Clinical Protocol
CA017076
BMS-986205
IDO1 inhibitor
SUMMARY OF KEY CHANGES FOR REVISED PROTOCOL 01
Section Number & Title
Description of Change
Brief Rationale
inhibitors of CYP1A2in 
addition to CYP3A4
7.1.1BMS-986205 
Administration
Clarified that BMS-986205 
100 mg oral daily dose must 
be administered with a meal 
at approximately the same 
time each day. .
Updated text for clarity
7.4.4 Guidelines for 
Permanent Discontinuation of 
BMS-986205 and Nivolumab
Added that “Any occurrence 
of serotonin syndromeshould 
result in discontinuation of 
BMS-986205 only.”
Deleted “any event requiring 
more than 1 dose reduction of 
BMS-986205”.
New requirement based on 
evolving data
7.4.4 Guidelines for 
Permanent Discontinuation of 
BMS-986205 and Nivolumab
Clarified thatfor participants 
who delay BMS-986205 but 
continue nivolumab, any dose 
delay of BMS 986205 lasting 
>10 weeks will result in the 
discontinuation of BMS-
986205, but not nivolumab 
treatment.
Updated text for clarity
7.4.7 Treatment of 
Methemoglobinemia
Associated with BMS-
986205
Added a new section
Added to align with the 
program level safety updates
7.7.1 Prohibited and/or 
Restricted Treatments
Updated Prohibited and/or 
Restricted Treatmentsto 
include strong inhibitors of 
CYP1A2and strong inducers 
of CYP1A2
New requirement based on 
evolving data
7.7.2 Other Restrictions and 
Precautions
Restricted therapies are not 
prohibited but are not 
recommended; Investigators 
should consider possible 
benefit/risk implications of 
enrolling and treating 
participants in whom the 
Added to align with the 
program level updates
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Clinical Protocol
CA017076
BMS-986205
IDO1 inhibitor
SUMMARY OF KEY CHANGES FOR REVISED PROTOCOL 01
Section Number & Title
Description of Change
Brief Rationale
following are clearly 
medically indicated.
Added the following 
text:about smoking 
restriction:
Concurrent smoking 
(tobacco, marijuana, etc.) 
may induce CYP1A2 and 
decrease the systemic 
exposure of BMS-986205.
Caution is warranted when 
consuming marijuana by 
means other than smoking as 
it may lead to increased 
exposure of BMS-986205 
through interaction with 
metabolic enzymes.
8 Discontinuation Criteria
Added text about serotonin 
syndrome
New requirement based on 
evolving data
9.2.6 Pregnancy
Updated section to clarify 
that “If the Investigator 
determines a possible 
favorable benefit-risk ratio 
that warrants continuation”
Added to align with the 
program level updates
Table 9.5.2-1: 
Pharmacokinetic, Anti-Drug 
Antibody (ADA) for BMS-
986205 and Nivolumab
Removed C0D1 predose row 
and changed frequency of 
metabolite urine sample 
collection 
Updated based on evolving 
data
Table 9.5.2-1: 
Pharmacokinetic, Anti-Drug 
Antibody (ADA) for BMS-
986205 and Nivolumab
Updated follow-up 
information
Updated based on evolving 
data
Appendix 8
Updated list added
Updated to a newer version
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Clinical Protocol
CA017076
BMS-986205
IDO1 inhibitor
SUMMARY OF KEY CHANGES FOR REVISED PROTOCOL 01
Section Number & Title
Description of Change
Brief Rationale
All
Minor formatting and 
typographical corrections
Minor, therefore have not 
been summarized
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TABLE OF CONTENTS 
TITLE PAGE 
................................................................................................................ 
DOCUMENT HISTORY 
.............................................................................................. 
OVERALL RATIONALE FOR REVISED PROTOCOL 01: 
..................................... 
SUMMARY OF KEY CHANGES FOR REVISED PROTOCOL 01 
......................... 
TABLE OF CONTENTS 
.............................................................................................. 
1 SYNOPSIS 
................................................................................................................. 
2 SCHEDULE OF ACTIVITIES.................................................................................. 
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 
....................................... 
7 TREATMENT 
........................................................................................................... 
7.1 Treatments Administered 
.................................................................................. 
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7.1.1 BMS-986205 Administration ................................................................... 
7.1.2 Nivolumab Administration 
....................................................................... 
7.2 Method of Treatment Assignment 
.................................................................... 
7.4 Dosage Modification 
......................................................................................... 
7.4.1 Guidelines For Dose Modification 
.......................................................... 
7.4.2 Dose Delay due to Toxicity 
...................................................................... 
7.4.3 Criteria to Resume Treatment of BMS-986205 and Nivolumab 
.............. 
7.4.4 Guidelines for Permanent Discontinuation of BMS-986205 and 
Nivolumab
 ...................................................................................................
 
7.4.5 Management Algorithms for Immuno-Oncology Agents 
......................... 
7.4.6 Management of Treatment-Related Hematological Adverse Events and 
Detection of Methemoglobinemia 
............................................................... 
7.4.7 Treatment of Methemoglobinemia Associated with BMS-986205 
........... 
7.5 Preparation/Handling/Storage/Accountability 
.................................................. 
7.5.1 Retained Samples for Bioavailability/Bioequivalence 
............................. 
7.6 Treatment Compliance 
...................................................................................... 
7.6.1 Treatment of Drug-Related Infusion Reactions 
....................................... 
7.7 Concomitant Therapy........................................................................................ 
7.7.1 Prohibited and/or Restricted Treatments................................................. 
7.7.2 Other Restrictions and Precautions 
......................................................... 
7.7.3 Permitted Therapy ................................................................................... 
7.7.3.1 Palliative Local Therapy................................................................. 
7.8 Treatment After the End of the Study 
............................................................... 
8 DISCONTINUATION CRITERIA 
........................................................................... 
8.1 Discontinuation from Study Treatment ............................................................ 
8.1.1 Poststudy Treatment Study Follow-up 
..................................................... 
8.1.2 Treatment Beyond Progression 
................................................................ 
8.1.3 Discontinuation due to Further Progression (Confirmed Progression).. 
8.1.4 Assessment Schedule for Participants with Post Progression Treatment
.....................................................................................................................
8.2 Discontinuation from the Study 
........................................................................ 
8.3 Lost to Follow-Up 
............................................................................................. 
9 STUDY ASSESSMENTS AND PROCEDURES 
..................................................... 
9.1 Efficacy Assessments 
........................................................................................ 
9.2 Adverse Events ................................................................................................. 
9.2.1 Time Period and Frequency for Collecting AE and SAE Information .... 
9.2.2 Method of Detecting AEs and SAEs 
......................................................... 
9.2.3 Follow-up of AEs and SAEs 
..................................................................... 
9.2.4 Regulatory Reporting Requirements for SAEs 
......................................... 
9.2.6 Pregnancy 
................................................................................................ 
9.2.7 Laboratory Test Result Abnormalities 
..................................................... 
9.2.8 Potential Drug Induced Liver Injury ....................................................... 
9.2.9 Other Safety Considerations 
.................................................................... 
9.3 Overdose 
........................................................................................................... 
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69
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69
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70
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73
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9.4 Safety Assessment ............................................................................................ 
9.4.1 Clinical Safety Laboratory Assessments 
.................................................. 
9.4.2 Imaging Safety Assessment 
...................................................................... 
9.5 Pharmacokinetics and Immunogenicity 
............................................................ 
9.5.1 Pharmacokinetic Assessment following Monotherapy of BMS-986205 
.. 
9.5.2 Pharmacokinetic Assessment following Combination Therapy of BMS-
986205 and Nivolumab 
............................................................................... 
9.6 Pharmacodynamics 
........................................................................................... 
10 STATISTICAL CONSIDERATIONS .................................................................... 
10.1 Sample Size Determination 
............................................................................. 
10.2 Populations for Analyses 
................................................................................ 
10.3 Statistical Analyses 
......................................................................................... 
10.3.1 Efficacy Analyses 
................................................................................... 
10.3.2 Safety Analyses....................................................................................... 
10.3.3 Pharmacokinetic Analyses 
..................................................................... 
10.3.4 Immunogenicity Analyses 
....................................................................... 
10.3.5 Other 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 5 RESPONSE EVALUATION CRITERIA IN SOLID TUMORS 
GUIDELINES (VERSION 1.1) WITH BMS MODIFICATIONS 
........................ 
APPENDIX 6 ECOG PERFORMANCE STATUS 
..................................................... 
APPENDIX 7 MANAGEMENT ALGORITHMS 
....................................................... 
APPENDIX 8 CYP3A4, CYP1A2 AND CYP2B6 GUIDANCE ................................ 
APPENDIX 9 MEDICATIONS ASSOCIATED WITH QT PROLOGATION 
.......... 
APPENDIX 10 P-GP AND BCRP GUIDANCE 
......................................................... 
APPENDIX 11 AGENTS KNOWN TO CAUSE METHEMOGLOBINEMIA 
.......... 
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IDO1 inhibitor
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Clinical Protocol
CA017076
BMS-986205
IDO1 inhibitor
1
SYNOPSIS
Protocol Title:A Phase 1/2 Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, 
and Tolerability of BMS-986205 Alone and in Combination with Nivolumab in ChinesePatients 
with Advanced Malignant Solid Tumors
Study Phase:  1/2
Study Population:
The study population includes adult Chinese participants with advanced malignant solid tumors.
Key Inclusion Criteria:
Participants must have histologic or cytological confirmation of a malignancy (solid tumor) 
that is advanced (metastatic and/or unresectable) with measureable disease per Response 
Evaluation Criteria in Solid Tumors (RECIST)v1.1. 
Participants must have received, and then progressed or been intolerant to at least one 
standard treatment regimen in the advanced or metastatic setting, if such a therapy exists. 
Participants who refuse or are ineligible for standard therapy will be allowed to enroll 
provided refusal/ineligibility is documented.
Participants must have an Eastern Cooperative Oncology Groupperformance status of ≤ 1.
Participants must present with at least one lesion with measurable disease as defined by 
RECIST v1.1 for solid tumors for response assessment. Participants with lesions in a 
previously irradiated field as the sole site of measurable disease will be permitted to enroll 
provided the lesion(s) have demonstrated clear progression and can be measured 
accurately.
Participants with prior exposure to therapy with any agent specifically targeting checkpoint 
pathway inhibition other than PD-1 or PD-L1(such as anti-PDL-2, anti-lymphocyte 
activation gene 3 [LAG-3], and anti-cytotoxic Tlymphocyte-associated antigen 4 [CTLA]
antibody) are permitted after a washout period of any time greater than 4 weeks from the 
last treatment. Participants with prior therapy with any agent specifically targeting T-cell 
costimulation pathwayssuch as anti-glucocorticoid-induced tumor necrosis factor receptor 
(TNFR)family related gene antibody, 
anti-CD137, anti-OX40 antibody, 
are permitted after 
a washout period of any time greater than 4 weeks from the last treatment.
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Clinical Protocol
CA017076
BMS-986205
IDO1 inhibitor
o Participants who experienced prior Grade 1 to 2 checkpoint therapy-related 
immune-mediated adverse events (AEs)must have confirmed recovery from these 
events at the time of study entry, other than endocrinopathies treated with 
supplementation, as documented by resolution of all related clinical symptoms, 
abnormal findings on physical examination, and/or associated laboratory 
abnormalities. Where applicable, these participants must also have completed 
steroid tapers for treatment of these AEs by a minimum of 14 days prior to 
commencing treatment with study drug.
o Eligibility of participants with prior ≥ Grade 3 checkpoint therapy-related immune 
AEs, will be considered on a case-by-case basis after discussion with the Medical 
Monitor (eg, asymptomatic isolated Grade 3 lipase elevations without clinical or 
radiological features of pancreatitis will be permitted to enroll).
Prior palliative radiotherapy must have been completed at least 2 weeks prior to first dose 
of study drug. Participants with symptomatic tumor lesions at baseline that may require 
palliative radiotherapy within 4 weeks of first dose of study drug are strongly encouraged 
to receive palliative radiotherapy prior to enrollment.
Women must not be pregnant or breastfeeding.
Key Exclusion Criteria:
Participants with knownor suspected central nervous system (CNS) metastases, untreated 
CNS metastases, or withthe CNS as the only site of disease are excluded. However, 
participants with controlledbrain metastases will be allowed to enroll. Controlled brain 
metastases are defined as noradiographic progression for at least 4 weeks following 
radiation and/or surgical treatment(or 4 weeks of observation if no intervention is clinically 
indicated), and off of steroids forat least 2 weeks, and no new or progressive neurological 
signs and symptoms. Please note: Squamous cell carcinoma of the head and neck 
(SCCHN)participants with direct extension of tumor through the base of skull will not be 
excluded, as they are considered distinct from hematogenously spread parenchymal brain 
metastasis.
Participants must not have ocular melanoma.
Participants must not have a prior history of serotonin syndrome.
Participants must not have a personal or family history or presence of cytochrome b5 
reductase deficiency, or other diseases that putsthem at risk of methemoglobinemia.
Participants must not have a history of or current G6PD deficiency (quantitative or 
qualitative assessments will be checked during screening). Participants must also not have 
any other congenital or autoimmune hemolytic disorders. If participant has history of 
transient acquired hemolytic anemia, discuss with Medical Monitor for study eligibility.
Participants must not have a history or presence of hypersensitivity or idiosyncratic 
reaction to methylene blue.
Participantswith a prior malignancy are excluded (except non-melanoma skin cancers, and 
in situ cancers such as the following:  bladder, colorectal, cervical/dysplasia, melanoma, or 
breast). Participants with other second malignancies diagnosed more than 2 years ago who 
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Clinical Protocol
CA017076
BMS-986205
IDO1 inhibitor
have received therapy with curative intent with no evidence of disease during the interval 
who are considered by the investigator to present a low risk for recurrence will be eligible.
Participants must not have other active malignancy requiring concurrent intervention.
Participants must not have prior organ allograft or allogeneic bone marrow transplantation.
Participants must not have any anti-cancer therapy (eg, chemotherapy, biologics, vaccines, 
or hormonal treatment) including investigational drugswithin 4 weeks prior to the first 
dose of study drug administration, except for non-cytotoxic therapies, for which at least 
4weeks or 5 half-lives (whichever is shorter) must have elapsed between last dose and first 
treatment with any study drugs; if 5 half-lives is shorter than 4 weeks, agreement with the 
Medical Monitor must be obtained.
Participants with prior exposure to anti PD-1 or anti-PDL1 therapy must be excluded.
Participants must not have had prior therapy with an IDO inhibitor.
Participants must not have active, known, or suspected autoimmune disease. Participants 
with vitiligo, type 1 diabetes mellitus, residual hypothyroidism due to autoimmune 
condition only requiring hormone replacement, euthyroid participants with a history of 
Grave’s disease (participants with suspected autoimmune thyroid disorders must be 
negative for thyroglobulin and thyroid peroxidase antibodies and thyroid stimulating 
immunoglobulin prior to first dose of study drug), psoriasis not requiring systemic 
treatment, or conditions not expected to recur in the absence of an external trigger are 
permitted to enroll.
Objectives and Endpoints:
Objectives
Endpoints
The primary objective of this study is to 
characterize the pharmacokinetics (PK) and 
assess the safety and tolerability of 
BMS-986205 administered alone and in 
combination with nivolumab in Chinese 
participants with advanced malignant tumors.
PK parameters,incidence of 
AEs, serious adverse events 
(SAEs), AEs leading to 
discontinuation, deaths, and 
laboratory abnormalities
The secondary objectives of this study are:
To characterize the pharmacodynamic activity 
of BMS-986205 administered alone and in 
combination with nivolumab.
To characterize the immunogenicity of 
nivolumab when administered in combination 
with BMS-986205.
To investigate the preliminary anti-tumor 
activity of BMS-986205 administered in 
combination with nivolumab in advanced 
malignant tumors.
Incidence of anti-drug 
antibodies (ADA) to 
nivolumab; measurement of 
serum kynurenine and 
tryptophan levels
Overall response rate (ORR), 
best overall response (BOR) 
and duration of response (DOR) 
as assessed per RECIST v1.1 by 
investigator
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Clinical Protocol
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BMS-986205
IDO1 inhibitor
Overall Design:
This is a Phase 1/2, open-label study of BMS-986205 administered as a monotherapy and in 
combination with nivolumab in participants with advanced malignant solid tumors.
Treatment will start with a 2-week monotherapy lead-in (Cycle 0) whereby BMS-986205 100 mg 
oral daily dose must be administered with a meal at approximatelythe same time each day.
Participants will then proceed toreceive the combination of nivolumab and BMS-986205. 
Nivolumab will be administered at a dose of 480 mg intravenously (IV)every 4weeks (Q4W).
Number of Participants: 
A sample size of 12 PK evaluable subjects is proposed for this study.
Treatment Arms and Duration:
Study Treatments for CA017076
Medication 
Potency 
IP/Non-IP 
BMS-986205
50 or 100 mg
IP
Nivolumab
Solution for Injection
10 mg/ml
(100-mg/vial)
IP
The study design schematic is presented below:
Study Design Schematic
Participants will complete up to 3 phases of the study:  Screening, Treatment, and Clinical/Safety 
Follow-up, as described below.
Screening:  The screening phase will last for up to 28 days. Screening begins by establishing the 
participant’s initial eligibility and signing the informed consent form (ICF).
Treatment:  The treatment phase consists of the 2-week monotherapy lead-in (Cycle 0) and up to 
twelve 4-week combination therapy cycles for a total study treatment period up to 50 weeks. 
Dosing regimens for each phase are as follows:
Lead-in:  single oral daily dose of BMS-986205 for two weeks
Screening
28 Days
Follow-Up
30, 60, 100 Days
BMS-986205
100mg POQD
Cycle 0
(2-week lead-in)
Cycle 1-12
(4-week cycles)
BMS-986205100mg POQD
+
Nivolumab 480 mg IV Q4W
Approved 2.0
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Date: 10-Oct-2018
16


Clinical Protocol
CA017076
BMS-986205
IDO1 inhibitor
Combination Therapy:  single oral daily dose of BMS-986205 and one dose of nivolumab
administered intravenously Q4W on Day 1 of each treatment cycle up to 12 cycles. 
Clinical/Safety Follow-Up:  Upon completion or termination of therapy, all participants will enter 
the Clinical/SafetyFollow-Up period. Participants must be followed for at least 100 days after the 
last dose of study therapy or 30 days if participant only received BMS-986205.
Dose Modifications:
The sponsor will carefully review the totality of the safety data observed among the 12 Chinese 
patients treated with nivolumab and BMS-986205. If such review suggests that the risk profile of 
the treatment regimen deviates significantly from that observed among non-Chinese patients 
treated with this same regimen, then consideration will be given to studying a lower dose of 
BMS-986205 in combination with nivolumab or enrolling additional Chinese patients to confirm 
the safety of the protocol defined treatment regimen.
Approved 2.0
v
Revised Protocol No.: 01
Date: 10-Oct-2018
17


Clinical Protocol
CA017076
BMS-986205
IDO1 inhibitor
2
SCHEDULEOF ACTIVITIES
Study assessments and procedures are presented in Table 2-1, Table 2-2, Table 2-3,Table 2-4and
in limited instances, scheduled events can occur outside of the indicated timeframesafter 
consultation with the BMS medicalmonitor/designeeon a case by case basis.
In the event that multiple procedures are required at a single timepoint, the following is a list of 
procedures from highest priority to low:1) pharmacokinetic (PK) sampling, 2) electrocardiogram 
(ECG), and 3) clinical labs.
Approved 2.0
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Revised Protocol No.: 01
Date: 10-Oct-2018
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Clinical Protocol
CA017076
BMS-986205
IDO1 inhibitor
Table 2-1:
Screening Procedural Outline (CA017076)
Procedure
D-28 to D-1 
D-14 to D-1
Notes
Eligibility Assessments
Informed Consent
X
A participantis considered enrolled only when a protocol specific 
informed consent is signed.
Inclusion/Exclusion Criteria
X
See Section 6.
Medical History
X
Include any toxicities or allergiesrelated to previous treatmentsas well
as any history of cytochrome b5 reductase deficiency or G6PD 
deficiency,if known.
Prior Systemic Therapies
X
Includes all prior cancer treatment regimens.
Tobacco History/Status
X
Safety Assessments
Physical Examination (PE)
X
If the screening PE is performed within 24 hours prior to dosing on Day 
1,then a single exam may count as both the screening and predose 
evaluation.
Physical Measurements
X
Includes height andweight.
ECOG Performance Status
X
ECOG Performance Status (Appendix 6).Performance Status must be 
obtained at the screening visit and prior to randomization or first dose
Vital Signs
X
Includes body temperature, respiratory rate, and seated blood pressure 
and heart rate. Blood pressure and heart rate should be measured after 
the participanthas been resting quietly for at least 5 minutes. Consider 
alternate position(s) for vital sign collection.Vital signs must be 
obtained at the screening visit and prior to randomization or first dose
Oxygen Saturation
X
Pulse oximetry collected at rest.
Electrocardiograms(ECGs)
X
12-lead ECGs should be recorded after the participanthas been supine 
for at least 5 minutes. 
Concomitant Medication Use
X
X
Collect during the 2 weeks prior to Cycle 0 Day 1.
Laboratory Tests
Approved
2.0
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Revised Protocol No.: 01
Date: 10-Oct-2018
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Clinical Protocol
CA017076
BMS-986205
IDO1 inhibitor
Table 2-1:
Screening Procedural Outline (CA017076)
Procedure
D-28 to D-1 
D-14 to D-1
Notes
Chemistry (Excluding Liver Function 
Test LFTs))
X
Includes assessments for sodium, potassium, chloride, total serum 
calcium,magnesium, bicarbonate/carbon dioxide, phosphorus, blood 
urea nitrogen(BUN), creatinine,creatinine clearance, C-reactive 
protein, fasting glucose, total protein, albumin, amylase, lipase,uric 
acid, ferritin, and lactase dehydrogenase (LDH).
G6PD Deficiency Testing
X
Methemoglobin
X
Methemoglobin levels to be assessed on arterial or venous blood sample
Reticulocyte counts andhaptoglobin
X
At baseline and reflex when methemoglobin is elevated over upper limit 
of normal [ULN]). Additional samples as clinically indicated.
CBC with Differential and Platelets
X
Includes hemoglobin, hematocrit, platelet count, and total leukocyte 
count including differential.
LFT Assessments
X
Includes aspartate aminotransferase (AST) and alanine aminotransferase 
(ALT), total bilirubin, direct bilirubin (only if total bilirubin is 
elevated), alkaline phosphatase, and gamma-glutamyl transferase(GGT) 
(only when alkaline phosphatase increases to Grade 2).
PT/aPTT/INR
X
Urinalysis
X
Refer to Table 9.4.1-1
Thyroid Function Tests
X
TSH with free thyroxine (T4) and triiodothyronine (T3)
Serology
X
Refer to Table 9.4.1-1
Pregnancy Test
X
Women of childbearing potential (WOCBP)only at screening and 
within 24 hours prior to dosing. 
Follicle Stimulating Hormone (FSH)
X
If needed to document postmenopausal status as defined in Appendix 4.
Adverse Event Reporting
Monitor for Serious Adverse Events 
X
X
Allserious adverse events(SAEs)must be collected from the date of 
subject’s written consent until 100 days post discontinuation of 
nivolumab(or 30 days if participant only received BMS-986205),or 
participant’s participation in the study if the last scheduled visit occurs 
Approved
2.0
v
Revised Protocol No.: 01
Date: 10-Oct-2018
20


Clinical Protocol
CA017076
BMS-986205
IDO1 inhibitor
Table 2-1:
Screening Procedural Outline (CA017076)
Procedure
D-28 to D-1 
D-14 to D-1
Notes
at a later time. SAEs reported in the BMS EDC tool should be approved 
within 5 business days of entry.
Baseline Efficacy Assessments
Diagnostic Imaging
X
Computed tomography (CT)with contrast is the preferred modality 
(Magnetic resonance imaging [MRI]if CT is not feasible). Assessment 
should include the chest/abdomen/pelvis at a minimum; and should 
include other anatomic regions as indicated by individual participant 
disease histories.
Brain Imaging
X
Brain imaging (CT/MRI) is only required for participants with known 
history or symptoms of brain metastases and have not had brain 
imagining within 30 days of anticipated first study drug administration.
Bone Scan
X
As clinically indicated (eg, participants with history of symptoms of 
bone metastases), but bone scans will not be considered a modality for 
assessment for measurable disease.
Approved
2.0
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Revised Protocol No.: 01
Date: 10-Oct-2018
21


Clinical Protocol
CA017076
BMS-986205
IDO1 inhibitor
Table 2-2:
On-Treatment:  BMS-986205 Monotherapy (One 14-Day Cycle) Procedure Outline (CA017076)
Procedure
Cycle 0
D1
Cycle 0
D2
Cycle 0
D8
Cycle 0
D14
Notes
Admit to Clinical Facility
X
X
For the purpose of PK sample collection, participants will be admitted to 
the clinical facility prior to dosingon C0D1 and C0D14. Participants will 
remain at the clinicalfacility until after the dosing on the following day.
Participants who are continuing treatment in Cycle 1 after completion of 
C0D14 will remain at the clinical facility until after dosing on C1D2.
Complete Physical Examination 
(PE)
Xa
Predose.
Symptom-DirectedPE
X 
X 
X
Predose.
Vital Signs andOxygen 
Saturations
X
X 
X
Includes temperature, seated blood pressure, and heart rate. Blood 
pressure and heart rate should be measured after the subject has been 
seated quietly for at least 5 minutes.
12-lead ECG
X
X
Collect single ECGs on C0D1 and C0D14 at -1 hour pre-dose and 2 and 
4 hours postdose. ECGs should be performed after the subject has been 
resting supine for at least 5 minutes and should be completed prior to any 
PK/PD sample blood collections when assessments occur at the same 
time points.
Laboratory Testsb
Chemistry
(Excluding LFTs)
Xa
X 
X
Predose; includes assessments for sodium, potassium,chloride, total 
serum calcium, magnesium,bicarbonate/carbon dioxide, phosphorus, 
BUN,creatinine, c-reactive protein, glucose, total protein, albumin, 
amylase,lipase, and LDH.
Methemoglobin
X
X 
X
Pre-dose on Day 1, 8 and 14; if elevated,see Section 7.4.6.
Additional samples as clinically indicated.
Reticulocyte counts, 
haptoglobinand LDH
X
X 
X
Reflex when methemoglobin is elevated over ULN. Additional samples 
as clinically indicated.
CBCwith Differential and 
Platelets
Xa
X 
X
Collect predose.
additional samples to be collected as clinically indicated
Predose on Day 4 (± 1 day).
Approved
2.0
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Revised Protocol No.: 01
Date: 10-Oct-2018
22


Clinical Protocol
CA017076
BMS-986205
IDO1 inhibitor
Table 2-2:
On-Treatment:  BMS-986205 Monotherapy (One 14-Day Cycle) Procedure Outline (CA017076)
Procedure
Cycle 0
D1
Cycle 0
D2
Cycle 0
D8
Cycle 0
D14
Notes
LFT Assessments
Xa
X 
X
Collect predose.
Includes AST, ALT, total bilirubin, direct bilirubin (only if total bilirubin 
is elevated), alkaline phosphatase, and GGT (only when alkaline 
phosphatase is increased to ≥ Grade 2).
Pregnancy Test
(WOCBP)
X
Serum or urine pregnancy test must be performed (urine pregnancy test: 
minimum sensitivity 25IU/L or equivalent units of hCG) within 24 
hours prior to administration of study drug.
If pregnancy test is positive, hold all study drugs and perform 
confirmatory testing. If pregnancy is confirmed, permanently discontinue 
all study drugs and immediately notify sponsor per Section 9.2.5.
ConcomitantMedication
Assessments
X
Review prior to dosing.
Monitor for Nonserious 
AdverseEvents
X
Nonserious AEs will be collected starting with the first dose of study 
drug and through 100 days after completion of study drugs (or 30 days if 
subject only received BMS-986205).
Monitor for Serious Adverse 
Events
X
All SAEs must be collected from the date of participant’s written consent 
until 100 days post last dose of study drugs (or 30 days if participant only 
received BMS-986205) or participant’s participation in the study if the 
last scheduled visit occurs at a later time. SAEs reported in the BMS 
EDC tool should be approved within 5business days of entry.
Pharmacokinetic (PK) 
Assessments
X
See Section 9.5.1and. Table 9.5.2-1.
Performed in all subjects.
Urine for p-Chloroaniline
X 
X
See Section 9.5.1.
Urine (0 to 24 hours) collection start after first dose.
An approximately 50 mL aliquot of each urine collection (0 to 8 hours, 8 
to 24 hours) will be frozen for shipment.
Approved
2.0
v
Revised Protocol No.: 01
Date: 10-Oct-2018
23


Clinical Protocol
CA017076
BMS-986205
IDO1 inhibitor
Table 2-2:
On-Treatment:  BMS-986205 Monotherapy (One 14-Day Cycle) Procedure Outline (CA017076)
Procedure
Cycle 0
D1
Cycle 0
D2
Cycle 0
D8
Cycle 0
D14
Notes
Study Drug Administration
Dispense
BMS-986205
X
BMS-986205 should be dispensed to participants at Day 1 of Cycle 0.
BMS-986205 Administration
Daily
BMS-986205 administration must be performed daily. BMS-986205 
must be administered with a meal at approximately the same time each 
day. Dosing and associated meal should occur at the site on days when 
serial PK is collected.
Pill Diary
Daily
Pill diary should be provided to participants at Day 1 of Cycle 0.
Pill diary must be completed with each administered daily dose of BMS-
986205.
Review pill diary during each visit for compliance of daily 
administration of BMS-986205. Collect pill diary at the completion of 
each cycle.
a C0D1 physical exam and laboratory tests do not need to be repeated if completed within the last 3 days (for all laboratory tests).
b Subjects who meet discontinuation criteria during or after Cycle 0 will have complete blood count (CBC)with differential, platelets, methemoglobin levels, and 
chemistry with LFTsdone at the EOT and during the follow-up visit at 7 days.
Approved
2.0
v
Revised Protocol No.: 01
Date: 10-Oct-2018
24


Clinical Protocol
CA017076
BMS-986205
IDO1 inhibitor
Table 2-3:
On-Treatment:  BMS-986205 + Nivolumab (Multiple 4-Week Cycles) Procedure Outline (CA017076)
Procedure
Cycle 1 (4 weeks)
Cycle 2-12(4-weekcycles)
End of 
Treatmenta,b,c
Notes
D1 
D8
D15
(±2 days)
D22
(±2 days)
D1
D15
(±2 days) D22-28
Admit to Clinical 
Facility
X
For the purpose of PK sample 
collection, participants will be 
admitted to the clinical facility prior 
to dosingon C1D1. Participants will 
remain at the clinical facility until 
after the dosing onthe following day.
SeeTable 9.5.2-1.
Safety Assessments
CompletePhysical 
Examination(PE)
X
X
Predose.
Symptom-DirectedPE
X
X
X
Predose.
Vital Signs(VS)and 
Oxygen Saturations
X 
X 
X 
X 
X 
X
X
Predose. Includes temperature, seated 
blood pressure, andheart rate. Blood 
pressure and heart rate should be
measured after the participant has 
been seated quietly forat least 5 
minutes.
For nivolumab, VS should be 
obtained prior to theinfusion and then 
every 30min (10min) until 1hour
following completion of the infusion, 
except on C1D1 when VS will be 
obtained until 4hours following
completion of the infusion.
If any vital sign isabnormal (based 
upon clinicianassessment) at the final 
time point of each visit, theparticipant 
must be observed further for a period 
of time, as clinically indicated.
Approved
2.0
v
Revised Protocol No.: 01
Date: 10-Oct-2018
25


Clinical Protocol
CA017076
BMS-986205
IDO1 inhibitor
Table 2-3:
On-Treatment:  BMS-986205 + Nivolumab (Multiple 4-Week Cycles) Procedure Outline (CA017076)
Procedure
Cycle 1 (4 weeks)
Cycle 2-12(4-weekcycles)
End of 
Treatmenta,b,c
Notes
D1 
D8
D15
(±2 days)
D22
(±2 days)
D1
D15
(±2 days) D22-28
12-lead ECG
X
X
12-lead ECGs shouldbe recorded
after the subject has been supine forat 
least 5minutes. ECGs must be
collected predose on Day 1 of each 
cycle.
Laboratory Tests
Laboratory tests must be performed within 3 days and results reviewed prior to dosing of nivolumabat Day 1 of each cycle, unless 
otherwise specified.
All laboratory testing will be done weekly for Cycle 1 only, unless otherwise specified.
Chemistry (Excluding 
LFTs)
X 
X 
X 
X 
X 
X
X
Predose; includes assessments for 
sodium, potassium,chloride, total 
serum calcium, magnesium, 
phosphorus,BUN, creatinine,c-
reactive protein,glucose, total protein, 
albumin, amylase,lipase, and LDH.
Methemoglobin
X 
X 
X 
X 
X
X
Collect predose.
Starting with C2D1, collect every 
cycleand as clinically indicated..
Methemoglobin levels to be assessed 
on arterial or venous blood sample.
.
Reticulocyte counts,  
haptoglobin and LDH
X 
X 
X 
X 
X
X
Reflex when methemoglobin is 
elevated over ULN. Additional 
samples as clinically indicated.
CBC withDifferential 
andPlatelets
X 
X 
X 
X 
X 
X
X
Predose.
Approved
2.0
v
Revised Protocol No.: 01
Date: 10-Oct-2018
26


Clinical Protocol
CA017076
BMS-986205
IDO1 inhibitor
Table 2-3:
On-Treatment:  BMS-986205 + Nivolumab (Multiple 4-Week Cycles) Procedure Outline (CA017076)
Procedure
Cycle 1 (4 weeks)
Cycle 2-12(4-weekcycles)
End of 
Treatmenta,b,c
Notes
D1 
D8
D15
(±2 days)
D22
(±2 days)
D1
D15
(±2 days) D22-28
LFT Assessments
X 
X 
X 
X 
X 
X
X
Predose; includes AST, ALT, total
bilirubin, direct bilirubin (only iftotal 
bilirubin is elevated), alkaline
phosphatase, and GGT (only when
alkaline phosphatase is increasedto 
Grade 2).
Thyroid Function Tests
X
See 
notes 
(every 
2 
cycles)
X
Collect every 2cycles, predose, 
beginning withC3D1 and at the end 
oftreatment.
To include TSH with reflex testing to
free T3 and free T4 if TSH abnormal.
Results should be examined by the
investigator or appropriate designee
within 48 hours of dose 
administration.
Pregnancy Test
(WOCBP)
X
X
X
Serum or urine pregnancy test must be 
performed (urinepregnancy test: 
minimum sensitivity 25IU/L or
equivalent units of hCG) within 24 
hours prior toadministration of 
nivolumab.
If pregnancy test is positive, hold all 
study drugs andperform confirmatory 
testing. If pregnancy is confirmed,
permanently discontinue all study 
drug and immediately notify sponsor 
per Section9.2.5.
Approved
2.0
v
Revised Protocol No.: 01
Date: 10-Oct-2018
27


Clinical Protocol
CA017076
BMS-986205
IDO1 inhibitor
Table 2-3:
On-Treatment:  BMS-986205 + Nivolumab (Multiple 4-Week Cycles) Procedure Outline (CA017076)
Procedure
Cycle 1 (4 weeks)
Cycle 2-12(4-weekcycles)
End of 
Treatmenta,b,c
Notes
D1 
D8
D15
(±2 days)
D22
(±2 days)
D1
D15
(±2 days) D22-28
Adverse Event Reporting and Concomitant Medication Assessments
Concomitant 
Medication 
Assessments
X 
X 
X 
X 
X 
X 
X
X
Review prior to dosing.
Monitor for 
Nonserious Adverse 
Events
X
Nonserious AEs will be collected 
starting with the firstdose of study 
drug and through 100 days post last 
dose ofstudy drugs.
Monitor for Serious 
Adverse Events
X
All SAEs must be collected from the
date of subject’s written consent until
100 days postdiscontinuation of
nivolumab or subject’s participation
in the study if the last scheduled visit
occurs at a later time. SAEsreported 
in BMS EDCshouldbe approved 
within 5business days of entry.
Sample Collection
PK/ADAAssessments
X
Performed in all subjects.
See Section9.5.2.
Pharmacodynamic 
Assessments
X
Performed in all subjects.
See Section 9.6.
Approved
2.0
v
Revised Protocol No.: 01
Date: 10-Oct-2018
28


Clinical Protocol
CA017076
BMS-986205
IDO1 inhibitor
Table 2-3:
On-Treatment:  BMS-986205 + Nivolumab (Multiple 4-Week Cycles) Procedure Outline (CA017076)
Procedure
Cycle 1 (4 weeks)
Cycle 2-12(4-weekcycles)
End of 
Treatmenta,b,c
Notes
D1 
D8
D15
(±2 days)
D22
(±2 days)
D1
D15
(±2 days) D22-28
Efficacy Assessments
Diagnostic Imaging
X
X
To be collected at the end of Cycle 2 
and then every 8weeks (± 1 week), by 
methods used at baseline. See Section 
9.1and Section9.4.2.Same 
modality/scanner should be used for 
all assessments. Assessed by RECIST 
v1.1; see Appendix 5. Assessment 
must be performed prior to initiating 
the next cycle of treatment.
Brain Imaging
X
As clinically indicated; see Section 
9.1and Section9.4.2.
Bone Scan Imaging
X
As clinically indicated; see Section 
9.1and Section9.4.2.
Study Drug Administration
Dispense
BMS-986205
X
X
BMS-986205 should be dispensed to 
participants at Day1 of each cycle.
BMS-986205 
Administration
X
Daily
BMS-986205 administration must be 
performed daily.
BMS-986205 must be administered 
with a meal at approximately the same 
time each day.Dosing and associated 
meal should occur at the site on days 
when serial PK is collected.
Nivolumab 
Administration
X
X
Nivolumab should be administeredat 
Day 1 of each cycle.
Approved
2.0
v
Revised Protocol No.: 01
Date: 10-Oct-2018
29


Clinical Protocol
CA017076
BMS-986205
IDO1 inhibitor
Table 2-3:
On-Treatment:  BMS-986205 + Nivolumab (Multiple 4-Week Cycles) Procedure Outline (CA017076)
Procedure
Cycle 1 (4 weeks)
Cycle 2-12(4-weekcycles)
End of 
Treatmenta,b,c
Notes
D1 
D8
D15
(±2 days)
D22
(±2 days)
D1
D15
(±2 days) D22-28
Pill Diary
X
Daily
X
Pill diary should be provided to 
participants at Day 1 of each cycle.
Pill diary must be completed with 
each administered daily dose of BMS-
986205. Review pill diary during each 
visit for compliance ofdaily 
administration of BMS-986205. 
Collect pill diary at the completion of 
each cycle and EOT.
a EOT is defined as the visit where decision is made to discontinue the subject from treatment.
b For subjects who complete all scheduled cycles of therapy, the EOT visit will be the same as the last scheduled and completedon-treatment visit (eg, Cycle 2
Day 22) and the start of the Week 1 Clinical/Safety Follow-Up visit.
c For subjects who do not complete all scheduled cycles of therapy, the EOT visitwill be the most recent on-treatment visit (with all available safety and response
data) and does not need to be repeated, and will be considered the start of the Week 1 Clinical/Safety Follow-Up visit.
Approved
2.0
v
Revised Protocol No.: 01
Date: 10-Oct-2018
30


Clinical Protocol
CA017076
BMS-986205
IDO1 inhibitor
Table 2-4:
Follow-Up Procedure Outline (CA017076)
Procedure
Clinical Safety Follow-Upa
Notes
FU 1 
30 days
(10 days)
FU 2
60 days
(10 days)
FU 3
100 days
(10 days)
Safety Assessments
Symptom-Directed 
Physical Examination
X
X
X
Vital Signs
X
X
X
Includes body temperature, seated blood pressure, and 
heart rate.Blood pressure and heart rate should be 
measured after the participant has been seated quietly 
for at least 5 minutes.
Laboratory Tests
Chemistry (Excluding 
LFTs)
X
X
X
Includes assessments forsodium, potassium, chloride,
total serum calcium,magnesium,bicarbonate/carbon 
dioxide,phosphorus, BUN, creatinine,glucose, total 
protein, albumin,amylase, lipase, and LDH.
Methemoglobin
X
X
X
Only to be drawn if above ULN at last assessment; not 
requiredduring follow up. 
Reticulocyte count, LDH, 
and haptoglobin
X
X
X
Reflex when methemoglobin is elevated over ULN. 
Additional samples as clinically indicated.
CBC with Differential and
Platelets
X
X
X
Additional samples as clinically indicated.
LFT Assessment
X
X
X
Forparticipants with LFT abnormalities following the 
lastdose of study drug, consider collecting weekly 
until normalized.
Includes AST, ALT, totalbilirubin, direct bilirubin 
(onlyif total bilirubin is elevated),alkaline 
phosphatase, andGGT (only when alkaline
phosphatase is increased to Grade 2).
Approved
2.0
v
Revised Protocol No.: 01
Date: 10-Oct-2018
31


Clinical Protocol
CA017076
BMS-986205
IDO1 inhibitor
Table 2-4:
Follow-Up Procedure Outline (CA017076)
Procedure
Clinical Safety Follow-Upa
Notes
FU 1 
30 days
(10 days)
FU 2
60 days
(10 days)
FU 3
100 days
(10 days)
Thyroid Function Tests
X
X
X
To include TSH with reflex testing (free T3 and free 
T4).
Pregnancy Test
X
X
X
For WOCBP; serum or urine pregnancy test may be 
performed(clinic urine pregnancy test: minimum 
sensitivity 25 IU/L orequivalent units of hCG).
If positive, perform confirmatory testing. If pregnancy 
is confirmed, immediately notify sponsor per 
Section9.2.5.
Adverse Event Reporting and Concomitant Medication Assessments
Monitor for Nonserious 
Adverse Events
X
X
X
Nonserious AEs will be collected starting with the first 
dose of study drug and through 100 days post last dose 
of study drugs (or 30 days if participant only received 
BMS-986205).
Monitor for Serious 
Adverse Events
X
X
X
All SAEs must be collected from the date of 
participant’s writtenconsent until 100 post last dose of 
study drugs (or 30 days ifparticipant only received 
BMS-986205) or participant’sparticipation in the 
study if the last scheduled visit occurs at a latertime. 
SAEs reported in the BMS EDC should be approved 
within 5 business days of entry.
Concomitant Medication 
Assessments
X
X
X
Sample Collection
PK/ADA Assessments
X
X
See Section 9.5.2.
Efficacy Assessments
Approved
2.0
v
Revised Protocol No.: 01
Date: 10-Oct-2018
32


Clinical Protocol
CA017076
BMS-986205
IDO1 inhibitor
Table 2-4:
Follow-Up Procedure Outline (CA017076)
Procedure
Clinical Safety Follow-Upa
Notes
FU 1 
30 days
(10 days)
FU 2
60 days
(10 days)
FU 3
100 days
(10 days)
Tumor/Response 
Assessments
Xb
Diagnostic imaging by method used at baseline, an 
unconfirmed PR orCR must be confirmed at least 4 
weeks after initial assessments.
New Subsequent Anti-
Cancer Therapies
X
X
X
Any new anti-cancer therapies (including surgery and 
radiotherapy) will be recorded.
a Follow-up visits at Days 30, 60, and 100 (10 days) should occur after the last dose of study drugs (or at Day 30 if participant only received BMS-986205) or
should coincide with the date of discontinuation 10 days if date of discontinuation is greater than 30 days after the last dose to monitor for adverse events.
b Only participants who have not discontinued study treatment for progressive disease.
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4
OBJECTIVES AND ENDPOINTS
Table 4-1:
Objectives and Endpoints
Objectives
Endpoints
The primary objective of this study is to characterize the PK and assess 
the safety and tolerability of BMS-986205 administered aloneand in 
combination with nivolumabin Chinese participants with advanced 
malignant tumors.
PK parameters Incidence of 
AEs, SAEs, AEs leading to 
discontinuation, deaths, and 
laboratory abnormalities
The secondaryobjectives of this study are:
To characterize the pharmacodynamicactivity of BMS-986205 
administered alone and in combination with nivolumab.
To characterize the immunogenicity of nivolumab when administered in 
combination with BMS-986205.
To investigate the preliminary anti-tumor activity of BMS-986205 
administered in combination with nivolumab in advanced malignant 
tumors.
Incidence of anti-drug 
antibodies (ADA)to 
nivolumab; measurement of 
serum kynurenine and 
tryptophan levels
ORR,best overall response 
(BOR)and duration of 
response (DOR) asassessed 
per Response Evaluation 
Criteria in Solid Tumors 
(RECIST)v1.1 by 
investigator
5
STUDY DESIGN
5.1
Overall Design
This is a Phase 1/2, open-label study of BMS-986205 administered as a monotherapy and in 
combination with nivolumab in participants with advanced malignant solid tumors.
Treatment will start with a 2-week monotherapy lead-in (Cycle 0) whereby 
BMS-986205 100 mg oral daily dose must be administered with a meal at approximately the same 
time each day.
Participants will then proceed toreceive the combination of nivolumab and BMS-986205. 
Nivolumab will be administered at a dose of 480 mg IV Q4W. 
Cycle 0
Participants will start with Cycle 0, which is a 2-week BMS-986205monotherapy lead-in, with a 
100-mg oral daily dose. Participants whohave received at least 75% of doses in Cycle 0 will be 
eligible to proceed to receive the combination of nivolumab and BMS-986205 (Cycle 1).
The following AEs will prohibit a participant from proceeding to combination withnivolumab 
(Cycle 1):
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Grade 2 or higher immune-related AEs (irAEs) considered related to BMS-986205 
(eg,immune-mediated pneumonitis, colitis, hepatitis, nephritis, and renal dysfunction) with 
the exception of immune-mediated hypothyroidism and hyperthyroidism
Grade 2 AST and ALT elevations that do not resolve to Grade 1 or baseline within 1 week
Grade 3 elevation of AST, ALT, or total bilirubin that persists for 7 days
Grade 2 AST or ALT elevation with symptomatic liver inflammation (eg, right upper quadrant 
tenderness, jaundice, pruritus)
AST or ALT > 3× upper limit of normal (ULN) and concurrent total bilirubin > 2× ULN 
without initial findings of cholestasis (elevated serum alkaline phosphatase, eg, findings 
consistent with Hy’s law or FDA definition of potential drug-induced liver injury [DILI])
Grade 2 or greater episcleritis, uveitis, or iritis
Any other Grade 2 eye pain or blurred vision that does not respond to topical therapy and does 
not improve to Grade 1 severity within 2 weeks OR requires systemic treatment
Grade 3 or greater uveitis, pneumonitis, bronchospasm, neurologic toxicity, hypersensitivity 
reaction, or infusion reaction of any duration requires discontinuation
Any Grade 3 or greater non-dermatologic, non-hepatic, non-hematologic toxicity with the 
following specific EXCEPTIONS:
Grade 3 or Grade 4 electrolyte abnormalities that are not complicated by associatedclinical 
adverse experiences, last less than 48 hours and either resolve spontaneouslyor respond to 
conventional medical intervention
Grade 3 nausea, vomiting, or diarrhea that lasts less than 48 hours, and either resolves 
spontaneously or responds to conventional medical intervention
Isolated Grade 3 elevation of amylase or lipase not associated with clinical orradiographic 
evidence of pancreatitis
Isolated Grade 3 fever not associated with hemodynamic compromise (eg, hypotension,
clinical or laboratory evidence of impaired end-organ perfusion)
Grade 3 endocrinopathy that is well-controlled by hormone replacement
Grade 3 tumor flare (defined as pain, irritation, or rash that localizes to site of knownor 
suspected tumor)
Grade 3 fatigue
Grade 3 rash if no improvement (ie, resolution to ≤ Grade 1) after a 1-to 2-week dose delay. 
Grade 4 rash of any duration
Methemoglobin levels 15% and study-drug related
Grade 4 neutropenia 5 days in duration and study-drug related
Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding (study-drug related), 
or any requirement for platelet transfusion (study-drug related) 
Grade 3 febrile neutropenia for 48 hours, study-drug related
Grade 3 hemolysis (ie, requiring transfusion or medical intervention such as steroids), study-
drug related
Grade 4 anemia not explained by underlying disease (study-drug related)
The study design schematic is presented inFigure 5.1-1.
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Figure 5.1-1:
Study Design Schematic
Treatmentmay continue from Cycle 0 (2 weeks) until 50 weeks(or up to a total maximum of 98 
weeks if applicable), disease progression, or withdrawal of consent.
Inaddition, cohort may be expanded in this study to gather additional safety, tolerability, PK, 
pharmacodynamics, and preliminary efficacy information regarding BMS-986205 in combination 
with nivolumab in certain tumor type(s).
Participants will complete up to 3 phases of the study:  Screening, Treatment, and Clinical/Safety 
Follow-up, as described below.
Screening
The screening phase will last for up to 28 days. Screening begins by establishing theparticipant’s 
initial eligibility and signing the informed consent form (ICF).
Treatment
The treatment phase consists of the 2-week monotherapy lead-in (Cycle 0) and up to twelve 4-week 
combination therapy cycles. The 2-week lead-in treatment consists of a single oral daily dose of 
BMS-986205. The combination therapy cycles are comprised of an oral daily dose of 
BMS-986205 and one dose of nivolumabadministered intravenously Q4W on Day 1 of each 
treatment cycle up to 12 cycles. Total study treatment period is up to 50 weeks.
Following every two combination therapy treatment cycles (8 weeks) starting with Cycle 1, the 
decision to treat aparticipant with additional cycles of study therapy will be based on radiological 
tumor assessments(initial evaluation performed at baseline, end of Cycle 2, and every 8 weeks). 
Assessments ofPR and CR must be confirmed at least 4weeks following initial assessment. 
Tumor progression or response endpoints will be assessed using RECIST v1.1 criteria for solid 
tumors (Appendix 5).
Treatment beyond progression may be allowed in select participants with initial RECIST v1.1
disease progression (PD) after discussion and agreement with the BMS medical monitor (with 
proper documentation in the Trial Master File) that thebenefit/risk assessment favors continued 
administration of study therapy (eg, participants arecontinuing to experience clinical benefit as 
assessed by the investigator, tolerating treatment, and meeting other criteria specified in 
Section8.1.2).
Screening
28 Days
Follow-Up
30, 60, 100 Days
BMS-986205
100mg POQD
Cycle 0
(2-week lead-in)
Cycle 1-12
(4-week cycles)
BMS-986205100mg POQD
+
Nivolumab 480 mg IV Q4W
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Participants with a response of stable disease (SD), PR, or CR at the end of a given cycle will
continue to the next treatment cycle. Participants will generally be allowed to continue study
therapy until the first occurrence of either: 1) completion of the maximum number of 12 cycles; 2)
PD; 3) clinical deterioration suggesting that no further benefit from treatment is likely; 4)
intolerability to therapy; or 5) the participant meets criteria fordiscontinuation of study therapy as
outlined in Section 7.4.4. Individual participants with confirmed CR will be given theoption to 
discontinue study therapy on a case-by-case basis after specific consultation andagreement 
between the investigator and BMS medical monitor in settings where benefit/riskjustify 
discontinuation of study therapy.
In all parts of this study, all participants will be treated for 48 weeks of BMS-986205 in 
combinationwith nivolumab unless criteria for study drug discontinuationare met earlier 
(Section7.4.4).Allparticipants completing approximately 48 weeks of combination study therapy
with ongoing disease control (CR, PR, or SD) may be eligible for an additional 48 weeks of study
therapy at the originally assigned dose regimen beyond theinitial 48 weeks, on a case-by-case 
basis, after careful evaluation and discussion with the BMSmedical monitor to determine whether 
the benefit/risk ratio supports administration of furtherstudy drug. Subjects whose last assessment 
of theinitial 48-week period shows PD will also be eligible to continue to additional cycles if they 
arestill deriving clinical benefit, as per the guidance of treatment beyond progression 
(Section8.1.2). Upon completion of 48 weeks of combination treatment (or up to a maximum of 
96 weeks if applicable), allsubjects will enter the Clinical/Safety Follow-Up period.
Clinical/Safety Follow-Up
Upon completion of 48 weeks of combination treatment(or up to a maximum of 96 weeks if 
applicable), all participants will enter the Clinical/SafetyFollow-Up period after the decision is 
made to discontinue the participant from treatment (eg, atend of treatment [EOT]).
For participants who complete all scheduled cycles of therapy, the EOT visit will be the same as
the last scheduled and completed on-treatment visit, and the start of the Week 1 Clinical/Safety
Follow-Up visit. For participants who do not complete all scheduled cycles of therapy, the EOT
visit will be the most recent on-treatment visit (with all available safety and response data) and
does not need to be repeated, and will be considered the start of the Week 1 Clinical/Safety 
Follow-Upvisit.
Participants who discontinue the treatment phase will enter the Clinical/Safety Follow-Up period.
Participants must be followed for at least 100 days after the last dose of study therapy or 30 days 
if participant only received BMS-986205. Follow-up visits should occur at Days 30, 60, and 100
(10 days) after the last dose of study therapy or should coincide with the date of discontinuation
(10 days) if date of discontinuation is greater than 30 days after the last dose of study therapy to
monitor for AEs. All participants will be required to complete one (if participant only received 
BMS-986205) or three Clinical/Safety Follow-Up visits regardless of whether they start a new 
anti-cancertherapy, except those participants who withdraw consent for study participation.
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5.1.1
Data Monitoring Committee and Other External Committees
Not applicable.
5.2
Number of Participants
A sample size of 12 PK evaluable subjects is proposed for thisstudy. Based onpreliminary PK 
results from Study CA017003 cohorts 25 to 200 mg, assuming the inter-subjectcoefficient of 
variation (CV)for AUC24 is 42%, a sample size of 12 PK evaluable subjects will be sufficient for 
the pointestimates of the mean PK parameter to fall within 80% to125% of the true value, with 
91%confidence level. Assuming the inter-subject CV for Cmax is 29%, a sample size of 12 PK
evaluable subjects will be sufficient for the point estimates of the mean PK parameter to fall within
80% to125% of the true value, with 98% confidence level. Twelve subjects will provide 90%
probability of observing at least 1occurrence of a specific AE that would occur with an18%
incidence in the population. If a participant discontinuesbefore or at Cycle 1 Day 1, an additional 
patient will be enrolled to ensure 12 PK evaluable participants are to be enrolled in this study.
5.3
End ofStudy Definition
The start of the trial is defined as first visit for first participant screened. End of trial is defined as 
the last visit or scheduled procedure shown in the Schedule of Activities for the last participant. 
Study completion is defined asthe final date on which data for the primary endpoint was or is 
expected to be collected, if this is not the same.
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6 
STUDY POPULATION
For entry into the study (prior to C0D1), the following criteria MUST be met.
6.1
Inclusion Criteria
1) Signed Written Informed Consent
a) The participant must sign and date an IRB/IEC-approved ICF prior to the performance of 
any study related proceduresthat are not considered part of standard of care.
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2) Type of Participant and Target Disease Characteristics
a) Participants must have histologic or cytological confirmation of a malignancy(solid tumor)
that is advanced (metastatic and/or unresectable) with measureable disease per RECIST 
v1.1 (see Appendix 5). 
b) Participants must have received, and then progressed or been intolerant to at least one
standard treatment regimen in the advanced or metastatic setting, if such a therapy exists. 
Participants who refuse or are ineligible for standard therapy will be allowed to enroll 
provided refusal/ineligibility is documented.
c) Participants must have an Eastern Cooperative Oncology Group performance status of ≤ 1.
d) Participants must be able to swallow pills or capsules.
e) Participants must present withat least one lesion with measurable disease as defined by 
RECIST v1.1 for solid tumors for response assessment. Participants with lesions in a 
previously irradiated field as the sole site of measurable disease will be permitted to enroll 
provided the lesion(s) have demonstrated clear progression and can be measured 
accurately.
f) Participants with prior exposure to therapy with any agent specifically targeting checkpoint 
pathway inhibitionother than PD-1 or PD-L1(such as;anti-PDL-2, anti-lymphocyte 
activation gene 3 [LAG-3], and anti CTLA-4 antibody) are permitted after a washout 
period of any time greater than 4weeks from the last treatment. Participants with prior 
therapy with any agent specifically targeting T-cell costimulation pathways such as anti-
glucocorticoid-induced tumor necrosis factor receptor (TNFR)family related gene 
antibody, anti-CD137, anti-OX40 antibody, are permitted after a washout period of any 
time greater than 4 weeks from the last treatment.
i) Participants who experienced prior Grade 1 to 2 checkpoint therapy-related immune-
mediated AEs must have confirmed recovery from these events at the time of study 
entry, other than endocrinopathies treated with supplementation, as documented by 
resolution of all related clinical symptoms, abnormal findings on PE, and/or associated 
laboratory abnormalities. Where applicable, these participants must also have 
completed steroid tapers for treatment of these AEs by a minimum of 14 days prior to 
commencing treatment with study drug.
ii)Eligibility of participants with prior ≥ Grade 3 checkpoint therapy-related immune 
AEs, will be considered on a case-by-case basis after discussion with the medical 
monitor (eg, asymptomatic isolated Grade 3 lipase elevations without clinical or 
radiological features of pancreatitis will be permitted to enroll).
g) Prior palliative radiotherapy must have been completed at least 2 weeks prior to first dose 
of study drug. Participants with symptomatic tumor lesions at baseline that may require 
palliative radiotherapy within 4 weeks of first dose of study drug are strongly encouraged 
to receive palliative radiotherapy prior to enrollment.
h) Participants must have blood methemoglobin levels within the ULN.
i) Participants must have adequate marrow function for participants with solid tumor 
histologies as defined by the following:
White blood cells(WBC) ≥ 2000/μL (stable off any growth factor within 4 weeks of 
first study drug administration)
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Neutrophils ≥1500/μL (stable off any growth factor within 4 weeks of first study drug 
administration)
Platelets ≥ 100× 103/μL (transfusion to achieve this level is not permitted within 2weeks 
of first study drug administration)
Hemoglobin ≥ 8.5 g/dL (transfusion to achieve this level is not permitted within 2 weeks 
of first study drug administration)
j) Participants must have adequate other organ function as defined by the following:
i) ALT and AST ≤ 3×institutional ULN
ii)Total bilirubin ≤ 1.5× institutionalULN (except participants with Gilbert’s Syndrome 
who must have normal direct bilirubin)
iii)Normal thyroid function, subclinical hypothyroidism (thyroid-stimulating hormone 
[TSH] < 10 mIU/mL) or have controlled hypothyroidism on appropriate thyroid 
supplementation
iv)Serum creatinine ≤ 1.5× ULN or creatinine clearance (CrCl) ≥ 40 mL/min (measured 
using the Cockcroft-Gault formula below):
Female CrCl = (140 -age in years) × weight in kg × 0.85
72 × serum creatinine in mg/dL
Male CrCl =(140 -age in years) × weight in kg × 1.00
72× serum creatinine in mg/dL
k) Ability to comply with treatment, PK and pharmacodynamic sample collection, and 
required study follow-up.
l) Life expectancy 3months.
3) Age and Reproductive Status
a) Participants must be male and female, age ≥ 18 years at the time of informed consent.
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 notbe pregnant or breastfeeding.
d) WOCBP must agree to follow instructions for method(s) of contraception(Appendix 4)for 
the duration of treatment with study treatment(s) plus 5 months (approximately 23 weeks) 
post-treatment completion.
e) Males who are sexually active with WOCBP must agree to follow instructions for 
method(s) of contraception (Appendix 4) for the duration of treatment with study 
treatment(s) plus an additional 7 months (approximately 31 weeks) post-treatment 
completion. In addition, maleparticipants must be willing to refrain from sperm donation 
during this time.
f) Males who are sexually active with WOCBP must agree to use a condom (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). In addition, male subjects must be 
willing to refrain from sperm donation during this time. This criteria applies to azoospermic 
males as well.
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g) WOCBP who are continuously not heterosexually active are also exempt from 
contraceptive requirements, but 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)
that have a failure rate of < 1% when used consistently and correctly.It is important to note that 
contraceptive methods thatrely on hormones are not considered highly effective for subjects 
receiving BMS-986205.
6.2
Exclusion Criteria
1) Target Disease Exceptions
a) Participants with known or suspected CNS metastases, untreated CNS metastases, or with
the CNS as the only site of disease are excluded. However, participants with controlled
brain metastases will be allowed to enroll. Controlled brain metastases are defined as no
radiographic progression for at least 4 weeks following radiation and/or surgical treatment
(or 4 weeks of observation if no intervention is clinically indicated), and off of steroids for
at least 2 weeks, and no new or progressive neurological signs and symptoms. Please note:
SCCHN participants with direct extension of tumor through the base of skull will not be 
excluded, as they are considered distinct from hematogenously spread parenchymal brain 
metastasis.
b) Participants must not have ocular melanoma.
2) Medical History and Concurrent Disease
a) Participants must not have a personal or family history or presence of cytochrome b5 
reductase deficiency, or other diseases that puts them at risk of methemoglobinemia.
b) Participants must not have a prior history of serotonin syndrome.
c) Participants must not have a history of or current G6PD deficiency (quantitative or 
qualitative assessments will be checked during screening). Participants must also not have 
any other congenital or autoimmune hemolytic disorders.If participant has historyof 
transient acquired hemolytic anemia, discuss with medical monitor for study eligibility.
d) Participants must not have a history or presence of hypersensitivity or idiosyncratic 
reaction to methylene blue.
e) Participants with a prior malignancy are excluded(except non-melanoma skin cancers, and 
in situ cancers such as the following: bladder, colorectal, cervical/dysplasia, melanoma, or 
breast). Participants with other second malignancies diagnosed more than 2 years ago who 
have received therapy with curative intent with no evidence of disease during the interval 
who are considered by the investigator to present a low risk for recurrence will be eligible.
f) Participants must not have other active malignancy requiring concurrent intervention.
g) Participants must not have prior organ allograft or allogeneic bone marrow transplantation.
h) Participants must not have any anti-cancer therapy (eg, chemotherapy, biologics, vaccines, 
or hormonal treatment) including investigational drugs within 4 weeks prior to the first 
dose of study drug administration, except for non-cytotoxic therapies, for which at least 
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4weeks or 5 half-lives (whichever is shorter) must have elapsed between last dose and first 
treatment with any study drugs; if 5 half-lives is shorter than 4 weeks, agreement with the 
Medical Monitor must be obtained.
i) Participants must not have had prior therapy with an IDO inhibitor.
j) Participants must not have active, known,or suspected autoimmune disease. Participants 
with vitiligo, type 1 diabetes mellitus, residualhypothyroidism due to autoimmune 
condition only requiring hormone replacement, euthyroid participants with a history of 
Grave’s disease (participants with suspected autoimmune thyroid disorders must be 
negative for thyroglobulin and thyroid peroxidase antibodies and thyroid stimulating 
immunoglobulin prior to first dose of study drug), psoriasis not requiring systemic 
treatment, or conditions not expected to recur in the absence of an external trigger are 
permitted to enroll.
k) Participants must not have a condition requiring systemic treatment with either 
corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive 
medications within 14 days of study drug administration.
Note: Treatment with a short course of steroids (< 5 days) up to 7 days prior to initiating 
study drug is permitted.
l) Participants must not require daily supplemental oxygen.
m) Participants must not have uncontrolled or significant cardiovascular disease including, but 
not limited to, any of the following:
i) Myocardial infarction or stroke/transient ischemic attack within the past 6 months.
ii)Uncontrolled angina within the past 3 months.
iii)Any history of clinically significant arrhythmias (such as ventricular tachycardia, 
ventricular fibrillation, or Torsades de pointes).
iv)QT interval corrected for heart rate using Fridericia’s formula (QTcF) prolongation
480 msec.
v) History of other clinically significant heart disease (eg, cardiomyopathy, congestive 
heart failure with New York Heart Association functional classification III-IV, 
pericarditis, significant pericardial effusion, or myocarditis).
vi)Cardiovascular disease-related requirement for daily supplemental oxygen therapy.
n) Participants must not have a history of any chronic hepatitis as evidenced by:
i) Positive test for hepatitis B surface antigen.
ii)Positive test for qualitative hepatitis C viral load (by polymerase chain reaction [PCR]).
Note: Participants with positive hepatitis C antibody and negative quantitative hepatitis 
Cby PCR are eligible. History of resolved hepatitis A virus infection is not an exclusion 
criterion.
o)Participants must not have a history of other preexisting liver disease (eg, nonalcoholic 
fatty liver disease [NAFLD]).
p) Participants must not have significant gastrointestinal disease, or other conditions known
to interfere significantly with the absorption of oral medication. Contact BMS medical 
monitor/designee if needed.
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q) Participants must not have active interstitial lung disease/pneumonitis or with a history of 
interstitial lung disease/pneumonitis requiringsteroids.
r) Participants must not show evidence of active infection ≤7 days prior to initiation of study 
drug therapy (does not apply to viral infections that are presumed to be associatedwith the 
underlying tumor type required for study entry). 
s) Participants must not have a known history of testing positive for human 
immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
Note: Testing for HIV must be performed at site.
t)Participants must not show evidence or history of active or latent tuberculosis infection 
including PPD recently converted to positive; chest x-ray with evidence of infectious 
infiltrate; and recentunexplained changes in fever/chill patterns.
u) Participants must not have had any major surgery within 4 weeks of study-drug 
administration. Participants must have recovered from the effects of major surgery or 
significant traumatic injury at least 14 days before the first dose of study drug.
v) All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must 
have resolved to Grade 1 (National Cancer Institute Common Terminology Criteria for 
Adverse Events [NCI CTCAE]v5.0) or baseline before administration of study drug. 
Participants with toxicities attributed to prior anti-cancer therapy that are not expected to 
resolve and result in long lasting sequelae, such as neuropathy after platinum based therapy, 
are permitted to enroll.
w) Participants must not have a history of life-threatening toxicity related to prior immune 
therapy (eg, anti-CTLA-4 or anti-PD-1/PDL-1 treatment or any other antibody or drug 
specifically targeting T-cell co-stimulation or immune checkpoint pathways).
x) Participants must not have aknown or underlying medical condition that, in the opinion of 
the investigator or sponsor, could make the administration of study drug hazardous to the 
participants, or could adversely affect the ability of the participant to comply with or 
tolerate the study.
3) Prior/Concomitant Therapy
a) Participants must be able to comply with restrictions and prohibited treatments as listed in 
Section 7.7,Concomitant Therapy.
b) Participants with prior exposure to anti PD-1 or anti-PDL1 therapy must be excluded.
c) Participants must not use any strong inhibitors of CYP3A4and/or CYP1A2or strong 
inducers of CYP3A4and/or CYP1A2(see Appendix 8).
d) Participants must not use non-oncology vaccines containing live virus for prevention of 
infectious diseases within 12 weeks prior to study drug. The use of inactivated seasonal 
influenza vaccines will be permitted on study without restriction.
e) Participants must not use packed red blood cells or have a platelet transfusion within 
2weeks prior to the first dose of study drug.
f) Prior Traditional Chinese Medicines (TCMs) are not prohibited;however, prior TCMs with 
anti-cancer claims should be stopped for at least 14 days prior to dosing. Prior use of TCMs 
isnot considered prior-line of therapy.
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4) Physical and Laboratory Test Findings
a) Participants must not exhibit any of the following on a 12-lead ECG prior to study drug 
administration, confirmed by repeat:
i) QRS ≥ 120 msec, except right bundle branch block
ii)QTcF ≥ 480 msec, except right bundle branch block
5) Allergies and Adverse Drug Reaction
a) Participants must not have a history of allergy to any of the study treatment components.
b) Participants must not have a history of any significant drug allergy (such as anaphylaxis or 
hepatotoxicity) to prior anticancer immune-modulating therapies(for example, checkpoint 
inhibitors and T cell costimulatory antibodies).
6) Other Exclusion Criteria
a) Prisoners or participants who are involuntarily incarceratedare excluded from the study. 
(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.)
b) Participants who are compulsorily detained for treatment of either a psychiatric or physical 
(eg, infectious disease) illnessare excluded from the study.
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
LifestyleRestrictions
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 entered in the study. Aminimal 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, and to respond to queries from regulatory
authorities. Minimal information includes date of consent, demography, screen failure details,
eligibility criteria, and any serious AEs.
6.4.1
Retesting During Screening or Lead-In Period
Participant Re-enrollment: This study permits the re-enrollment of a participant that has
discontinued the study as a pre-treatment failure (ie, participant has not been treated). If 
re-enrolled,the participant must be re-consented.Retesting of laboratory parameters and/or other 
assessments within any single screening periodwill be permitted (in addition to any parameters 
that require a confirmatory value).The most current result prior to treatment is the value by which 
study inclusion will beassessed, as it represents the participant’s most current, clinical state.
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Laboratory parameters and/or assessments that are included in Table 2-1may be repeated in an 
effort to find all possible well-qualified participants. Consultation with the medical monitor may 
be needed to identify whether repeat testing of any particular parameter is clinically relevant.
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 treatment 
allocation.
Study treatment includes Investigational [Medicinal] Product (IP/IMP) and can consist of the
following:
BMS-986205
Nivolumab
Product description and storage information are described in Table 7-1. Preparation, 
administration,and storage instructions will be provided separately.An IP, also known as IMPin 
some regions, isdefined a pharmaceutical form of an active substance or placebo being tested or 
used as a referencein a clinical study, including products already with a marketing authorization 
but used orassembled (formulated or packaged) differently than the authorized form, or used for 
anunauthorized indication, or when used to gain further information about the authorized form.
Other medications used as support or escape medication for preventative, diagnostic, or therapeutic
reasons, as components of the standard of care for a given diagnosis, may be considered as nonIP. 
Not applicable for this study.
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Table 7-1:
Study Treatments for CA017076
Product Description / 
Class and Dosage 
Form
Potency
IP/Non-IMP
Blinded or Open 
Label
Packaging / 
Appearance
Storage Conditions
(per label)
BMS-986205
100mg
IP
Open Label
Tablet
Refer to the label on 
container and/or 
pharmacy manual
BMS-986205
50mg
IP
Open Label
Tablet
Refer to the label on 
container and/or 
pharmacy manual
Nivolumab
Solution for Injection
10mg/mL
(100-mg/vial)
IP
Open Label
Vial
Refer to the label on 
container and/or 
pharmacy manual
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7.1
Treatments Administered
The selection and timing of dose for each participant is shown in Table 7.1-1:
Table 7.1-1: 
Selection and Timing of Dose
Study Treatment
Unit dose 
strength(s)/Dosage 
level(s)
Dosage formulation
Frequency of 
Administration
Route of Administration
BMS-986205
100 mg/tablet
1 tablet/daily
Oral
Nivolumab
480 mg
Solution for injection/
every 4 weeks
IV
7.1.1
BMS-986205Administration
A bottle of BMS-986205 should be dispensed to participants at Day 1 of each cycle. 
BMS-986205 is administered as a tablet. The tablet must be administered by mouth, swallowed 
whole, and not be crushed, chewed, dissolved,or altered in any way. BMS-986205 100 mg oral 
daily dose must be administered with a meal at approximately the same time each day.On the 
morning of Cycle 0 Days 1 and 14, and Cycle 1 Day 1when serial PK samples are collected, after
fasting for at least 10 hours, each participant will receive a single oral dose of BMS-986205 within
approximately 5 minutes of completing a meal. At the time of dosing, approximately 240 mLof 
water will be administered to the participant along with BMS-986205. The time of BMS-986205
administration will be called “0” hour.
7.1.2
NivolumabAdministration
During combination therapy, infusion of nivolumab should start approximately 30 minutes
following BMS-986205. Nivolumab should be infused over 30 minutes. Further details regarding
preparation and administration will be provided separately in site/pharmacy materials.Restrictions 
related to food and fluid intake are described in Section 7.7.2.
7.2
Method of Treatment Assignment
Enrolled participants, including those not dosed, will be assigned sequential participant numbers 
starting with 00001 (eg, 00001, 00002, 00003.... 00010). Those enrolled participants meeting 
inclusion and exclusion criteria will be eligible to be dosed.
7.4
Dosage Modification
The sponsor will carefully review the totality of the safety data observed among the 12 Chinese 
patients treated with nivolumab and BMS-986205. If such review suggests that the risk profile of 
the treatment regimen deviates significantly from that observed among non-Chinese patients 
treated with this same regimen, then consideration will be given to studying a lower dose of 
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BMS-986205 in combination with nivolumab or enrolling additional Chinese patients to confirm 
the safety of the protocol defined treatment regimen.
7.4.1
Guidelines For Dose Modification
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 
level
42) 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 after consultation with the BMS Medical Monitor and should be well documented. 
For an AE requiringdose modification, BMS-986205 should be interrupted to allow improvement 
of the AE, even ifthe AE does not otherwise meet criteria for dose delay (Section 7.4.2).
Re-escalation of BMS-986205 will not be permitted once the dose of BMS-986205 has been
reduced for a participant.
Only one dose reduction is permitted. The participant must discontinue study treatments if a
subsequent dose reduction of BMS-986205 is required (see Section 7.4.4).
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.
Premedications are not recommended for the first dose of nivolumab.
7.4.2
DoseDelay due to Toxicity
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 3drug-related skin AE
Grade 3 drug-related fatigue, nausea, vomiting, diarrhea, and anemia
Grade 3 drug-related laboratory abnormality, with the following exceptions:
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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 7.4.4)
Any AE, laboratory abnormality, or intercurrent illness that, in the judgment of the 
investigator, warrants delaying the dose of study medication(should consult the BMS medical 
monitor and should be well documented)
In addition, only BMS-986205should be delayed for the following:
Methemoglobin ≥15%
Clinically significant elevations in methemoglobin (generally 10% with a normal hemoglobin 
level
42) 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).
Participants may continue to receive nivolumab during dose delays of BMS-986205 for 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
Section7.4.6for management of methemoglobinemia.
If BMS-986205 dosing is delayed, dose reduction may be necessary,see Section 7.4.1.
If dosing is resumed after a delay, BMS-986205 may be resumed as soon as the criteria to resume
treatment are met (see Section 7.4.3). 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.
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.
The end of cycle tumor assessments (ie, CT/MRI, etc.) will continue as scheduled regardless of 
any treatment delay incurred.
7.4.3
Criteria to Resume Treatmentof BMS-986205 and Nivolumab
Participants may resume treatment with study treatments when the drug-related AE(s) resolve to
Grade 1 orbaseline 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.
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Participants with combined AST/ALT AND total bilirubin values meeting discontinuation 
parameters (Section 7.4.4) 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 ULNand 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 7.4.1).
7.4.4
Guidelines for Permanent Discontinuationof BMS-986205 and 
Nivolumab
BMS-986205 and nivolumab treatment should be permanently discontinued for the following:
Any occurrence of serotonin syndromeshould result in discontinuation of BMS-986205 only.
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 Grade 3 non-skin, drug-related AE lasting > 7 days or that recurs, with the following 
exceptions for laboratory abnormalities, drug-related uveitis, pneumonitis, bronchospasm, 
neurologic toxicity, hypersensitivity reactions, infusion reactions, and endocrinopathies:
Grade 3 drug-related uveitis, pneumonitis, bronchospasm, neurological toxicity,
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 lasting 7 days or associated with bleeding 
requires discontinuation
Grade 3 drug-related AST, ALT,or total bilirubin requires discontinuation*
Concurrent AST or ALT > 3 x ULN and total bilirubin > 2 x 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:
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Grade4 neutropenia 7 days
Grade 4 lymphopenia or leukopenia or asymptomatic amylase or lipase
Isolated Grade 4 electrolyte imbalances/abnormalities that are not associated with clinical 
sequelae and are corrected with supplementation/appropriate management within 48 hours
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 dose administration> 10 weeks from the previous dose requires 
discontinuation, with the following exceptions:
Dose administrationdelays to allow for prolonged steroid tapers to manage drug-related 
AEs are allowed.
Dose administrationdelays 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.
Prior to re-initiating treatment in a participant with a dose 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 Q4Wor more frequently if clinically indicated during such dosing delays.
For participants who delay BMS-986205 but continue nivolumab, any dose delay of 
BMS-986205 lasting >10 weeks will result in the discontinuation of BMS-986205, but not
nivolumabtreatment.
All participants who discontinue IPshould comply with protocol-specifiedfollow-up procedures 
as outlined in Section 2. The only exception to this requirement is when aparticipant withdraws 
consent for all study procedures including post-treatment study follow-upor loses the ability to 
consent freely (eg, is imprisoned or involuntarily incarcerated for thetreatment of either a 
psychiatric or physical illness).
If study drug 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 case report form (CRF)page.
7.4.5
Management Algorithms for Immuno-Oncology Agents
Immuno-oncology (IO)agents are associated with AEs that can differ in severity and duration 
from AEs caused byother therapeutic classes. Nivolumab and BMS-986205 are considered IO 
agents in this protocol.Early recognition and management of AEs associated with IO agents may 
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mitigate severe toxicity.Management algorithms have been developed from extensive experience 
with nivolumab to assist investigatorsin assessing and managing the following groups of AEs:
gastrointestinal
renal
pulmonary
hepatic
endocrinopathies
skin
neurological
The clinical nature of AEs noted 
with BMS-986205 will determine the role of the above algorithms
for use in toxicities related to its use in this study.The algorithms recommended for utilization in 
this protocol are included in Appendix 7.
7.4.6
Management of Treatment-Related Hematological Adverse Eventsand 
Detection of Methemoglobinemia
 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.
For management of methemoglobinemia, see Section 7.4.6. Testing is done at screening and as 
clinically indicated.
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7.4.7
Treatment of Methemoglobinemia Associated with BMS-986205
The following management recommendations are intended as guidelines for the Investigator and 
may be modified based on institutional practices or local standard of care, as appropriate. See 
Section 7.4.6for guidance on detection of methemoglobinemia.
Initial care includes supportive measures and the administration of supplemental oxygen. In mild 
cases, recovery often occurs simply by interrupting the administration of the offending medication. 
Concomitant medication lists should be reviewed for medications other than the study treatment 
that can cause methemoglobinemia (see Appendix 10).
Further treatment of methemoglobinemiais generally indicated when the methemoglobin level is 
above 20% or is associated with symptoms.
Intravenous methylene blue is the first-line antidotal agent and works by restoring the oxygen 
carrying capacity of hemoglobin by reduction of methemoglobin from its oxidized state. It is given 
as a 1% solution at a dose of 1 to 2 mg/kg. Most participants require only 1 dose, and symptoms 
should resolve within 1 hour. Methylene blue may confound the interpretation of methemoglobin 
levels detected by co-oximetry; alternative methods should be used after treatment with methylene 
blue if methemoglobin level monitoring is required. Methylene blue should be used with caution 
in participants with concurrent use of serotonergic psychiatric medications, as this could increase 
the risk of serotonin syndrome.
Exchange transfusion and hyperbaric oxygen treatment are second-line options for participants 
with severe methemoglobinemia whose condition does not respond to methylene blue or who 
cannot be treated with methylene blue. Participant transfer should occur when life-threatening 
methemoglobinemia that is refractory to treatment occurs in a facility that cannot provide the 
appropriate critical care.
7.5
Preparation/Handling/Storage/Accountability
The IPshould be stored in a secure area according to local regulations. It is the responsibility of 
the investigator to ensure that IPis only dispensed to study participants. The IPmust be dispensed 
only from official study sites by authorized personnel according to local regulations.
The product storage manager should ensure that the study treatmentis 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 treatmentarise, the study treatment
should not be dispensed and BMS should be contactedimmediately.
Study treatmentnot supplied by BMS will be stored in accordance with the package insert.
Documentation for IP(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).
Refer to the current IBs for BMS-986205 and nivolumab for complete storage, handling, and 
dispensing information.
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7.5.1
Retained Samples for Bioavailability/Bioequivalence
Not applicable.
7.6
Treatment Compliance
At scheduled PK sample collection as well as laboratory evaluation days, BMS-986205 and 
associated meal will beadministered to the participant in the clinical facility. At all other times 
throughout the study, BMS-986205 will be administered on an out-participant basis, except when 
participants are seen in theclinical facility for administration of nivolumab, assessment of AEs, 
and laboratory evaluation. Trained medical personnel will dispense BMS-986205 to the 
participants. Treatment compliance will bemonitored by drug accountability, as well as by 
recording BMS-986205 administration in theparticipant pill diary, medical record, and CRF. 
Participants should bring all drug containers for BMS-986205 toeach study visit for drug 
reconciliation.
7.6.1
Treatment of Drug-Related Infusion Reactions
Because nivolumab contains only human immunoglobulin protein sequences, it is unlikely to be
immunogenic and induce infusion or hypersensitivity reactions. However, if such a reaction were
to occur, it might manifest with fever, chills, rigors, headache, rash, pruritus, arthralgias, hypo-or
hypertension, bronchospasm, or other symptoms. All Grade 3 or4 infusion reactions should be
reported within 24 hours to the BMS medical monitor and reportedas an SAE if criteria are met.
Infusion reactions should be graded according to NCI CTCAE v5.0guidelines.
Treatment recommendations are provided below and may be modified based on local treatment
standards and guidelines as appropriate:
For Grade 1 symptoms:Mild reaction; infusion interruption not indicated; intervention not
indicated.
Remain at bedside and monitor participant until recovery from symptoms. The following
prophylactic premedications are recommended for future infusions: diphenhydramine 50 mg (or
equivalent) and/or acetaminophen 325 to 1000 mg at least 30 minutes before additional study drug
administrations.
For Grade 2 symptoms:Moderate reaction requires therapy or infusion interruption but responds
promptly to symptomatic treatment (eg, antihistamines, nonsteroidal anti-inflammatory drugs,
narcotics, corticosteroids, bronchodilators, IV fluids); prophylactic medications indicated for 
24hours.
Stop the nivolumab infusion, begin an IV infusion of normal saline, and treat the participant
with diphenhydramine 50 mg IV (or equivalent) and/or acetaminophen 325 to 1000 mg
(acetaminophen); monitor participant until resolution of symptoms.
Bronchodilator or corticosteroid therapy may also be administered as appropriate.
The infusion may be restarted at 50% of the original infusion rate when symptoms resolve;if 
no further complications ensue after 30 minutes, the rate may be increased to 100% ofthe 
original infusion rate. Monitor participant closely.
The amount of study drug infused must be recorded on the CRF.
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If symptoms recur, then no further nivolumab, as the casemay be, will be administered atthat 
visit.
The following prophylactic premedications are recommended for future infusions:
diphenhydramine 50 mg (or equivalent) and/or acetaminophen 325 to 1000 mg
(acetaminophen) should be administered at least 30 minutes before additional nivolumab
administrations. If necessary, corticosteroids (up to 25 mg of SoluCortef or equivalent)may 
be used.
Late-occurringsymptoms:
In the case of late-occurring hypersensitivity symptoms (eg, appearance of a localized or
generalized pruritus within 1 week after treatment), symptomatic treatment may be given (eg, oral
antihistamine or corticosteroids).
For Grade 3 or Grade 4 symptoms:Severe reaction; Grade 3: prolonged (eg, not rapidly
responsive to symptomatic medication and/or brief interruption of infusion); recurrence of
symptoms following initial improvement; hospitalization indicated for other clinical sequelae (eg,
renal impairment, pulmonary infiltrates); Grade 4: life-threatening;pressor or ventilatory support
indicated.
Immediately discontinue study drug infusion. Begin an IV infusionof normal saline and treat the
participant as follows: recommend bronchodilators, epinephrine 0.2 to 1 mg of a 1:1,000 solution
for subcutaneous administration or 0.1 to 0.25 mg of a 1:10,000 solution injected slowly for IV
administration, and/or diphenhydramine 50 mg IV with methylprednisolone 100 mg IV (or
equivalent), as needed. Participant should be monitored until the investigator is comfortable that
the symptoms will not recur. Study drug will be permanently discontinued. Investigators should
follow their institutional guidelines for the treatment of anaphylaxis. Remain at bedside and
monitor participant until recovery from symptoms. In the case of late-occurring hypersensitivity
symptoms (eg, appearance of a localized or generalized pruritus within 1 week after treatment),
symptomatic treatment may be given (eg, oral antihistamine, or corticosteroids).
7.7
Concomitant Therapy
7.7.1
Prohibited and/or Restricted Treatments
Prohibited and/or restricted medications taken prior to study drug administration in the study are 
described below:
Prior exposure to BMS-986205 or other IDO inhibitor.
Concurrent administration of any anti-cancer therapies (investigational or approved) with the 
exception of participants in the follow up of the study.
Concomitant use of strong inhibitors of CYP3A4 and/or CYP1A2or strong inducers of 
CYP3A4and/or CYP1A2(seeAppendix 8).
Immunosuppressive agents (except as stated in Section 7.7.3), unless they are utilized totreat 
an AE.
Palliative radiotherapy is permitted only under certain conditions as described in Section6.1.
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Use of any medicinal herbal preparations within 2 weeks of the first dose of study drug and 
during study treatment unless prescribed by a treating physician.
Avoid co-administration of TCMs with nivolumab and BMS-986205, unless with sponsor 
approval. TCMs with anti-cancer claims should be stopped for at least 14 days prior to dosing.
Medications taken within 2 weeks prior to study drug administration must be recorded on the CRF.
Any concomitant therapies must be recorded on the CRF.
7.7.2
Other Restrictions and Precautions
Restricted therapies are not prohibited but are not recommended; Investigators should consider 
possible benefit/risk implications of enrolling and treating participants in whom the following are 
clearly medically indicated:
Grapefruit and Seville oranges and their juices can inhibit CYP3A4 and should not be 
consumed while on study.
Concurrent use of moderate inhibitors or inducers of CYP3A4and/or CYP1A2may affect the 
systemicexposure of BMS-986205. The BMS medical monitor should be consulted prior to 
use.See Appendix 8for a list of CYP3A4and/or CYP1A2modulators.
Concurrent smoking (tobacco, marijuana, etc.) may induce CYP1A2 and decrease the systemic 
exposure of BMS-986205.
Caution is warranted when consuming marijuana by means other than smoking as it may lead 
to increased exposure of BMS-986205 through interaction with metabolic enzymes.
Caution is warranted when administering BMS-986205 to participants taking drugs thatare 
highly dependent on CYP3A4 or CYP2B6 for metabolism. See Appendix 8for a listof 
sensitive CYP3A4 and CYP2B6 substrates.
Caution is warranted when administering BMS-986205 to participants taking drugs thatmay 
be associated with QT prolongation. See Appendix 9for a list of commonmedications 
associated with QT prolongation.
Caution is warranted when administering BMS-986205 to participants taking drugs that are 
subject toextensive intestinal efflux by P-gp/BCRP. See Appendix 10for a list of common P-
gp/BCRP substrates.
In vitro solubility data indicate that BMS-986205 has decreased solubility with increasingpH. 
Until further data are available, participants should try to avoid taking proton pumpinhibitors. 
H2 antagonists and short-acting antacid agents, such as Maalox®or TUMS®,may be taken,
but it is recommended that these not be taken 4 hours before or 4 hours after dosing of
BMS-986205.
Caution is warranted when using other agents known to cause methemoglobinemia (see
Appendix 11). Dapsone, topical anesthetics, and antimalarial drugs are the most likelyagents 
and thus these drugs should only be used after discussion with the StudyDirector/Medical 
Monitor.
The development of serotonin syndrome has been associated with exposure to another 
investigational agent that inhibits the IDO1 enzyme. No case of serotonin syndrome has been 
observed with administration of BMS-986205. Given the possibility of a class effect, there is a 
theoretical risk that BMS-986205 could causean increase in serotonin levels in the brain that might 
trigger serotonin syndrome when administered in combination with serotonergic agents or 
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tryptophan supplements. Use caution and monitor for symptoms of serotonin syndrome in 
participants receiving concurrent serotonergic psychiatric medications and/or tryptophan 
supplements.
7.7.3
Permitted Therapy
Participants are permitted the use of topical, ocular, intra-articular, intranasal, and inhalational 
corticosteroids (with minimal systemic absorption). Treatment with a short course of steroids 
(< 5 days) up to 7 days prior to initiating study drug is permitted. A brief course of 
corticosteroids for prophylaxis (eg, contrast dye allergy) or for treatment of nonautoimmune 
conditions (eg, delayed-type hypersensitivity reaction caused by a contact allergen) is 
permitted.
Inhaled or intranasal corticosteroids (with minimal systemic absorption may be continued if 
the participant is on a stable dose) are permitted in the absence of active autoimmune disease.
Nonabsorbed intra-articular steroid injections will be permitted.
Immunosuppressive agents and the use of systemic corticosteroids are permitted in the context 
of treating AEs. Participants receiving corticosteroids for treatment of drug-related AEs must 
be at < 10 mg/day prednisone or equivalent prior to re-initiation of study drug.Participants 
may continue to receive HRT.
Participants receiving RANK-L inhibitors or bisphosphonates are permitted as clinically 
indicated but should be avoided, if possible, prior to completion of Cycle 1.
7.7.3.1
Palliative Local Therapy
Palliative and supportive care for disease-related symptoms may be offered to all participants on
the trial. Limitedradiation therapy or surgery to control isolated lesions is permitted for 
participants who haveinvestigator-assessed clinical benefit following consultation with the BMS 
Medical Monitor.
Participants should not receive study drug during radiation as the potential for overlapping
toxicities with radiotherapy and BMS-986205, or combinationof BMS-986205 and nivolumab is
currently not known. Anecdotal data suggest that radiotherapy administered to participants while
receiving nivolumab therapy is tolerable. However, because concurrent radiotherapy and
immunotherapies in cancer have not been formally evaluated, in cases where palliative
radiotherapy is required for a tumor lesion, then BMS-986205 alone or BMS-986205 in
combination with nivolumab should be withheld for at least 1 week before, during, and 1 week
after radiation. Participants should be closely monitored for any potential toxicity during and after
receiving radiotherapy, and AEs related to radiotherapy should resolve to Grade 1 prior to
resuming study drug.
7.8
TreatmentAfter the End of the Study
At the end of the study, BMS will not continue to provide BMS supplied study treatment to 
participants/investigators unless BMS chooses to extend the study. The investigator should ensure
that the participant receives appropriate standard of care to treat the condition under study.
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8
DISCONTINUATION CRITERIA
8.1
Discontinuation from Study Treatment
Participants MUST discontinue IP (and non-IPat the discretion of the investigator) for any of the 
following reasons:
Participant’s request to stop study treatment. 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 specificallywithdraws 
consent for any further contact with him/her or persons previously authorizedby participant to 
provide this information
Any clinical AE, laboratory abnormality or intercurrent illness which, inthe opinion of the 
investigator, indicates that continued participation in the study is not inthe best interest of the 
participant
Termination of the study by BMS
Loss of ability to freely provide consent through imprisonment or involuntarilyincarceration 
for treatment of either a psychiatric or physical (eg, infectious disease) illness 
Inability to comply with protocol
Discretion of the investigator
Pregnancy
Completion of study required procedures
Documented and confirmed disease progression as defined by RECIST v1.1 (see Appendix5) 
unless participant meets criteria for treatment beyond progression (Section 8.1.2)
Clinical deterioration while receiving active study therapy that in the opinion of the
investigator indicates that continued participation in the study is not in the best interest ofthe 
participant
Protocol-defined reasons for discontinuation (see Section 7.4.4and Section 8.2)
In the case of pregnancy, the investigator must notify within 24 hours of awareness of the 
pregnancy, the BMS medical monitor/designee of this event. In the event a female participant 
becomes pregnant during this clinical trial, the study treatment must be discontinued immediately. 
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 within 24 
hours of awareness of the pregnancy. Refer to Section 9.2.6.
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).
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 CRF page.
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8.1.1
Poststudy Treatment Study Follow-up
In this study, safety and tolerability of BMS-986205 administrated as monotherapy and in 
combination with nivolumab is a key endpoint of the study. Poststudy 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 for at least 100 days after the last dose of study therapy.
8.1.2
Treatment Beyond Progression
A subset of participants with solid tumors treated with immunotherapy mayderive clinical benefit 
despite initial evidence of PD. Participants will be permitted to continue on treatment beyond
initial RECIST v1.1 (see Appendix 5) defined PD, as long as they meet the following criteria:
Investigator-assessed clinical benefit, and not having rapid disease progression;
Continue to meet all other study protocol eligibility criteria;
Tolerance of study drug;
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 any additional nivolumab 
and/or BMS-986205 treatment, using an ICF describing any reasonably foreseeable risks or 
discomforts, or other alternative treatment options.
The assessment of clinical benefit should take into account whether the participant is clinically 
deteriorating and unlikely to receive further benefit from continued treatment. All decisions to 
continue treatment beyond initial progression must be discussed with the BMS medical monitor 
and an assessment of the benefit/risk of continuing with study drug must be documented in the 
study records. Participants will be re-consented to explain the rationale for this ongoing treatment.
8.1.3
Discontinuation due to Further Progression (Confirmed Progression)
Participants should discontinue study drug upon further evidence of further progression, defined 
as an additional 10% or greater increase in tumor burden volume from time of initial progression
(including all target lesions and new measurable lesions).
The tumor burden volume from time of initial progression should be used as the reference baseline 
for comparison with the post progression assessment.
Any new lesion considered non-measurable at the time of initial progression may become 
measurable and therefore must be included in the tumor burden measurement as follows:
New lesions are considered measurable at the time of initial progression if the longest diameter is 
at least 10 mm.
For statistical analyses that include the investigator-assessed progression date, participants who 
continue treatment beyond initial investigator-assessed, RECIST v1.1 -defined progression will be 
considered to have investigator-assessed PD at the time of the initialprogression event.
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8.1.4
Assessment Schedule for Participants with Post Progression Treatment
Participants should continue to receive monitoring according to the on-treatment assessments in 
Section 9.1. Radiographic assessment by CT(preferred) or MRI described in Section 9.1is 
required when participants continue post progression treatment. For participants who discontinue 
post progression treatment with study drug, no additional radiographic assessments will be 
required.
8.2
Discontinuation from the Study
Participants who request to discontinue study treatmentwill 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 withhim/her or persons 
previously authorized by participantto provide this information. 
Participants should notify the investigator of the decision to withdraw consent from future 
follow-upin writing, whenever possible.
The withdrawal of consent should be explained in detail in the medical records by the 
investigator, as to whether the withdrawal is from further treatment with study treatmentonly 
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.
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 participantto one 
registered mail letter. All attempts should be documented in the participant’s medical records.
If it is determined that the participanthas died, the site will use permissible local methods to 
obtain date andcause 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.
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9
STUDY ASSESSMENTS AND PROCEDURES
Study assessments,procedures, and timingare presented in Table 2-1,Table 2-2,Table 2-3,
andTable 2-4.
Allimmediate safety concerns must bediscussed 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 dosing. 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.
9.1
Efficacy Assessments
Disease assessment with CT and/or MRI as appropriate will be performed at baseline, end of Cycle
2 and every 8 weeks during study treatment until disease progression, at the completion of follow-
up,or until participants withdraw from the study. Assessment of tumor response will be reported
by the investigator for appropriate populations of participants as defined by RECIST v1.1 (see
Appendix 5). At the sponsor’s discretion, scans and measurements may be collected centrally to
be reviewed by independent radiologists using RECIST v1.1, or other criteria at a later date, or at
any time duringthe study.
Changes in tumor measurements and tumor responses will be assessed by the investigator using
RECIST criteria. Investigators will also report the number and size of new lesions that appear
while on study. The tumor assessment time points will bereported on the CRF based on
investigators’ assessment using RECIST criteria. Please refer to Appendix 5for specifics of 
RECIST v1.1 criteria to be utilized in this study.
Body Imaging
CT with contrast is the preferred modality (MRI if CT is not feasible). Assessment should include
the chest/abdomen/pelvis at a minimum; and other known/suspected sites of disease should be 
performed.These assessments will be performed at the end of Cycle 2 and then every 8 weeks 
(1week) during study treatment until disease progression, at the completion of follow-up,or 
until participants withdraw from the study.
Disease assessments at other time points may be performed as clinically indicated.
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Brain Imaging
Brain imaging is only required at screening for subjects with known history or symptoms of brain
metastases and who have not had brain imaging within 30 days of anticipated first study drug
administration). After screening, brain imaging is required only as clinically indicated.
Bone Scan
Bone scansmay be performed as clinically indicated at baseline (eg, subjects with history of
symptoms of bone metastases), but bone scans will not be considered a modality for assessment
for measurable disease. After baseline, bone scansare required only as clinically indicated.
Imaging Modalities
For all subjects, the following imaging assessments should be performed atstudy-specified 
schedule: CT of the chest, CT or MRI of the abdomen, pelvis, and other knownsites of disease.
CT scans should be acquired with slice thickness of 5 mm or less with no intervening gap 
(continuous).
Should a participant have a contraindication for CT IV contrast, a non-contrast CT of the chest 
and a contrast enhanced MRI of the abdomen and pelvis and other sites of disease may be 
obtained. MRIs should be acquired with slice thickness of 5 mm or less with nogap 
(continuous).
Should a participant have contraindication for both MRI and CT intravenous contrasts, a non-
contrast CT of the chest and a non-contrast MRI of the abdomen, pelvis, and other 
known/suspected sites of disease should be obtained.
Positron emission tomography (PET)alone will not be considered for the disease assessment. 
Complementary CT and/orMRI or biopsy must be performed in such cases.
Note: Use of CT component of a PET/CT scanner: Combined modality scanning, such aswith 
fluorodeoxyglucose (FDG)-PET/CT, is increasingly used in clinical care and is a 
modality/technology thatis in rapid evolution; therefore, the recommendations outlined here 
may change ratherquickly with time. At present, low-dose or attenuation correction CT 
portions of acombined FDG-PET/CT are of limited use in anatomically-based efficacy 
assessments,and it is, therefore, suggested that they should not be substituted for dedicated 
diagnosticcontrast enhanced CT scans for anatomically-based RECIST v1.1 measurements
(Appendix 5).However, if a site can document that the CT performed as part of a FDG-
PET/CT is ofidentical diagnostic quality to a diagnostic CT (with IV and oral contrast), then 
the CTportionof the FDG-PET/CT can be used for RECIST v1.1 measurements. Note, 
however,that the FDG-PET portion of the CT introduces additional data which may bias an
investigator if it is not routinely or serially performed.
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). 
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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 studyprocedure, or that caused the 
participant to discontinue before completing the study. 
Contacts for SAE reporting specified in Appendix 3.
9.2.1
Time Period and Frequency for Collecting AE and SAE Information
The collection of nonserious AE information should begin at initiation of study treatment until the 
timepoints specified in the Schedule of Activities (Section 2). Nonserious 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.
Sections 5.6.1 and 5.6.2 in the IB represent the Reference Safety Information to determine
expectedness of SAEs for expedited reporting. Following the subject’s written consent to
participate in the study, all SAEs, whether related or not related to study drug, 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 discontinuation of dosing
and for 30 days post discontinuation of study drug for subjects not receiving combination therapy.
If applicable, SAEs must be collected that relate to any later protocol-specified procedure (eg, a
follow-up skin biopsy).
The investigator must report any SAE that occurs after these time periods and that is believed to
be related to study drug or protocol-specified procedure.
Medical occurrences that beginbefore the start of study treatment but after obtaining informed 
consent will be recorded on the appropriate section of the eCRF.
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
Adverse events can be spontaneously reported or elicited during open-ended questioning, 
examination, orevaluation of a participant. Care should be taken not to introduce bias when 
collecting AE and/or SAEs. Inquiry about specific AEs should be guided by clinical judgement in 
the context of known AEs, when appropriate for the program or protocol.
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9.2.3
Follow-up of AEs and SAEs
Nonserious AEs should be followed to resolution or stabilization, or reported as SAEs if they 
become serious (see Appendix 3).
Follow-up is also required for nonserious AEs that cause interruption or discontinuation of 
study treatment and for those present at the end of study treatment as appropriate.
All identified nonserious AEs must be recorded and described on the nonserious AE page of 
the CRF (paper or electronic). Completion of supplemental CRFs may be requested for AEs 
and/or laboratory abnormalities that are reported/identified during the course of the study.
All SAEs 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 bythe 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 ordesignee will be reporting adverse events to regulatory authorities and ethics 
committees according to local applicable laws including European Directive 2001/20/EC and FDA 
Code of Federal Regulations 21 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.
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9.2.6
Pregnancy
If, following initiation of the IP, it is subsequently discovered that a studysubject is pregnant or 
may have been pregnant at the time of study exposure, including during atleast 5 half-lives + 30 
days after nivolumab administration (for a total of 23 weeks post-treatmentcompletion), the 
investigator must notifythe BMS medical monitor/designee of thisevent and complete and 
forward a Pregnancy Surveillance Form to the BMS designee within24hours of awareness of the 
event and in accordance with SAE reporting procedures described in Section 9.2.1.
If the Investigator determines a possible favorable benefit-risk ratio that warrants continuation of 
study treatment, or reinitiation of study treatment, a discussion between the Investigator and the 
BMS Medical Monitor/designee must occur. If, for whatever reason, the pregnancy has ended, 
confirmed by negative serum pregnancy test, treatment may be resumed (at least 3 weeks and not 
greater than 6 weeks after the pregnancy has ended), following approvals of 
participant/Sponsor/IRB/EC, as applicable.
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 
the sponsor or designee. In order for the sponsor or designee to collect any pregnancy surveillance 
information from the female partner, the female partner must sign an ICFfor 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 nonserious AE CRF 
page or electronic SAE Report Form,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 participantto have study treatment
discontinued or interrupted
Any laboratory test result abnormality that required the participantto 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
Wherever possible, timely confirmation of initial liver-related laboratory abnormalities should 
occur prior to the reporting of a potential drug-induced liver injury (DILI)event. All occurrences 
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of potential DILIs, meeting the defined criteria, must be reported as SAEs (see Section 9.2.1for 
reporting details).
Potential DILIis defined as: 
1) Aminotransferase (AT)(ALT or AST) elevation > 3xULN
AND
2) Total bilirubin > 2xULN, without initial findings of cholestasis (elevated serum alkaline 
phosphatase),
AND
3) No other immediately apparent possible causes of AT elevation and hyperbilirubinemia, 
including, but not limited to, viral hepatitis, pre-existing chronic or acute liver disease, or the 
administration of other drug(s) known to be hepatotoxic.
9.2.9
Other Safety Considerations
Any significant worsening noted during interim or final physical examinations, ECG, x-ray 
filming, or any other potential safety assessment required or not required by protocol should also 
be recorded as a nonserious AE 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. All occurrences of overdose must be 
reported as an SAE (see Section 9.2.1).
9.4
SafetyAssessment
Planned time points for all safety assessments are listed in the Schedule of Activities.
AEs will be assessed continuously during the study and for 100 days after the last dose of 
nivolumab. AEs will be evaluated according to the NCI CTCAE v5.0and should be followed per 
requirements in Section 9.2.1and Section 9.2.2. AEs will be coded using the most current version 
of Medical Dictionary for Regulatory Activities (MedDRA) and reviewed for potential 
significance and importance. Participants should be followed until all treatment-related AEs have 
recovered to baseline or are deemed irreversible by the investigator.
9.4.1
Clinical Safety Laboratory Assessments
Investigators must document their review of each laboratory safety report.
A central/local laboratory will perform the analyses and will provide reference ranges for these 
tests.
Results of clinical laboratory tests performed on Day -1 must be available prior to dosing.Table 
9.4.1-1lists the clinical laboratory tests that will be performed.
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Table 9.4.1-1:
Clinical Laboratory Assessments
Hematology
Hemoglobin
Hematocrit
Total leukocyte count, including differential
Platelet count
Methemoglobin
Reticulocyte counts and haptoglobin (at baseline and reflex when methemoglobin is elevated over ULN)
PT/aPTT/INR
G6PD, quantitative or qualitative -screening only
Serum Chemistry
Aspartate aminotransferase (AST)
Alanine aminotransferase (ALT)
Total bilirubin
Direct bilirubin(only if total bilirubin is elevated)
Alkaline phosphatase
GGT only when alkaline phosphatase is abnormal 
Lactate dehydrogenase (LDH)
Creatinine
Blood urea nitrogen (BUN)
Amylase
Lipase
C-reactive protein
Total protein
Albumin
Sodium
Potassium
Chloride
Total serum calcium
Phosphorus
Magnesium
Bicarbonate/carbon dioxide
Uric acid -screening only 
Glucose -Fastingat screening only
Creatinine clearance (CrCl)-screening only
Ferritin -screening only
Urinalysis(at screening)
Protein
Glucose
Blood
Leukocyte esterase
Specific gravity
pH
Microscopic examination of sediment will be done if blood, protein, or leukocyte esterase is positive on dipstick.
Other
24 hour urine collection for testing of p-chloroaniline
Serology
Serum for hepatitis C antibody (if Hepatitis C antibody is positive reflex to hepatitis C RNA),hepatitis B surface 
antigen, HIV-1, HIV-2 antibody.
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Table 9.4.1-1:
Clinical Laboratory Assessments
Other Analyses
Pregnancy test(WOCBP only)
TSH with free T3 and free T4 at screening and TSH with reflex to free T3 and free T4 as applicable on treatment 
phase
FSH (if needed to document postmenopausal status as defined in Appendix 4)
Results of all laboratory tests required by this protocol must be provided to BMS, either recorded 
on the laboratory pages of the CRF or by another mechanism as agreed upon between the 
investigator and BMS (eg, provided electronically). If the units of a test result differ from those 
printed on the CRF, the recorded laboratory values must specify the correct units. Any abnormal
laboratory test result considered clinically significant by the investigator must be recorded on the 
appropriate AE page of the CRF (see Section 9.2.4).
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 as per standard 
medical/clinical judgment. 
9.5
Pharmacokineticsand Immunogenicity
Pharmacokinetics of BMS-986205
 will be derived from plasma 
concentration versus time and urinary excretion data. Individual participant PK parameter values 
will be derived by noncompartmental methods by a validated PK analysis program. Actual times 
will be used for the analyses. 
9.5.1
Pharmacokinetic Assessment following Monotherapy of BMS-986205 
The PK parameters to be assessed for BMS-986205 following multiple dose administration in 
Cycle 0 during the dose escalation phase may include but not limited to: 
Cmax
Maximum observed plasma concentration
Tmax
Time of maximum observed plasma concentration
Ctrough
Trough observed plasma concentration
AUC(TAU)
Area under the concentration-time curve in one dosing interval
CLT/F 
Apparent total body clearance 
Vss/F
Apparent volume of distribution at steady-state 
AI 
Accumulation index, calculated based on ratio of AUC(TAU) and 
Cmax at steady state to after the first dose 
T-HALF(eff, AUC)
Effective elimination half-life that explains the degree of AUC accumulation observed  
%UR24 
Percent urinary recovery over 24 hours 
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9.5.2
Pharmacokinetic Assessment following Combination Therapy of BMS-
986205 and Nivolumab
Plasma samples for BMS-986205 will be collected for all participants receiving combination 
treatment of BMS-986205 and nivolumab. PK will be assessed for BMS-986205 when in 
combination of nivolumab (Cycle 1 Day 1).
Serum samples for nivolumab PK and immunogenicity assessments will be collected for all 
participants receiving combination treatment of BMS-986205 and nivolumab. End-of-infusion
(Ceoi)and trough (Ctrough) concentrations will be tabulated using summary statistics. These data 
may also be pooled with other datasets for population PK analysis, which will be presented in a 
separate report.
Detailed sampling schedules to be followed for the assessment of PK and immunogenicity for all 
analytes in the study are provided in Table 9.5.2-1. All time points are relative to the start of 
BMS-986205 dosing. Predose samples should be taken within 30 minutes before the start of 
BMS-986205 administration. Nivolumab end-of-infusion samples should be taken just prior to the 
end of infusion (preferably within 2 minutes). 
Further details of sample collection, processing, and shipment will be provided in the laboratory 
procedures manual. On-treatment PK samples are intended to be drawn relative to actual dosing 
days; if a dose occurs on a different day within the cycle due to delays or minor schedule 
adjustments, PK samples should be adjusted accordingly.
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Table 9.5.2-1:
Pharmacokinetic, Anti-Drug Antibody (ADA) for BMS-986205 and 
Nivolumab
Study Day of 
Sample 
Collection
Event
Time
(Relative To 
BMS-986205 
Dose)
Hour: Min
BMS-986205
 
 
Plasma 
Sample
BMS-986205 
 
Urine 
Sample
Nivolumab 
Serum 
Sample 
Nivolumab 
ADA Sample
Cycle 0
C0D1
1:00
X
X
0-8 h
2:00
X
3:00
X
4:00
X
6:00
X
8:00
X
C0D2
predose
0:00
X
X
8-24 h
C0D8
predose
0:00
X
C0D14
predose
0:00
X
1:00
X
2:00
X
3:00
X
4:00
X
6:00
X
8:00
X
C0D15a
predose
X
Cycle 1
C1D1
predoseb
0:00
X
X
X
EOIc
1:00
X
X
2:00
X
3:00
X
4:00
X
6:00
X
8:00
X
C1D2
predose
X
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Table 9.5.2-1:
Pharmacokinetic, Anti-Drug Antibody (ADA) for BMS-986205 and 
Nivolumab
Study Day of 
Sample 
Collection
Event
Time
(Relative To 
BMS-986205 
Dose)
Hour: Min
BMS-986205
 
 
Plasma 
Sample
BMS-986205 
 
Urine 
Sample
Nivolumab 
Serum 
Sample 
Nivolumab 
ADA Sample
Cycle 3
C3D1
predose
0:00
X
X
X
EOI
1:00
X
X
2:30 –4:00
X
Cycle 5+
Every 4 
Cycles
from C5D1
predose
0:00
X
X
X
EOI
1:00
X
X
EOT and FU
EOT
X
X
X
FU-1
X
X
X
FU-2
X
X
X
a This sample should be taken 24 hours after the previous BMS-986205 dose on Cycle 0 Day 14 if Cycle 1 Day 1 
does not occur on the next day of Cycle 0 Day 14.
b This sample should be taken24 hours after the previous BMS-986205 dose on Cycle 0 Day 14 if Cycle 1 Day 1 
occurs on the next day of Cycle 0 Day 14.
c EOI samples should be taken immediately prior to stopping the nivolumab infusion (preferably within 2 minutes 
prior to the end of infusion). If the end of infusion is delayed to beyond the nominal infusion duration, the collection 
of this sample should also be delayed accordingly.
The plasma and urine samples of BMS-986205 
 will be analyzed by 
validated 
 liquid chromatography-mass spectrometry (LC-MS) assaysas applicable, 
and serum samples of nivolumab and anti-nivolumab antibody will be analyzed by validated 
immunoassays. In addition, plasma samples will be archived for potential additional metabolite
analysis, if the need arises and to the extent possible.Treatment assignments will be released to 
the bioanalytical laboratory in order to minimize unnecessary analysis of samples.
9.6
Pharmacodynamics
Pharmacodynamic analysis will be performed on serum by measuringkynurenine and tryptophan 
levels pre and postdose of BMS-986205 and nivolumab
 
.Serum will be collected at the time points specified in Table 9.6-1. 
 
 
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Table 9.6-1: 
Pharmacodynamic Serum Collection to Measure Kynurenine and 
Tryptophan Levels Pre-and Postdose of BMS-986205 and 
Nivolumab
Study Day of Sample Collected
Events
Serum Sample
C1D1
Predose
X
C1D1
Postdose (at 6hours)
X
C1D2
Predose
X
Disease Progression
--
X
10
STATISTICAL CONSIDERATIONS
10.1
Sample Size Determination 
The sample size for this study is not based on statistical power, but based on consideration of the 
precision of the estimate of geometric means of Cmax and AUC of BMS-986205. 
 
 
 
 
 
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10.2
Populations for Analyses
For purposes of analysis, the following populations are defined:
Population
Description
All Enrolled Participants
All participants who sign informed consent.
All Treated Participants
All enrolled participants who take at least onedose of study 
treatment.
Pharmacokinetic 
Population
The PK data set includes all available concentration-time data 
from the participants who received any BMS-986205 or 
nivolumab.
Evaluable 
Pharmacokinetic 
Population
Participants who have adequate PK profiles and have no protocol 
deviations considered to affect the PK assessments. All available 
derived PK parameter values will be included in the PK data set 
and reported, but only participants with evaluable PK will be 
included in the summary statistics.
Immunogenicity
The immunogenicity data set consists of all available 
immunogenicitydata from the participants who receive nivolumab 
and have a baseline and at least one post-treatment 
immunogenicity measurement.
10.3
Statistical Analyses
The statistical analysis plan will be developed and finalized before database lock and will describe 
the selection of participants to be included in the analyses, and procedures for accounting for 
missing, unused, and spurious data. Below is a summary of planned statistical analyses of the 
primary and secondary endpoints.
A description of the participant population will be included in the statistical output reported, 
including subgroups of ageandgender.
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10.3.1
Efficacy Analyses
Endpoint
Statistical Analysis Methods
ORR
ORR is defined as the total number of participants 
whose BOR is either a CR or PR divided bythe 
total number of participants in the population of 
interest. To describe the anti-tumor activity of 
BMS-986205 in combination with nivolumab, 
ORR will be calculated. ORR and corresponding 
2-sided exact 95% CI by the Clopper and Pearson 
method will be provided by treatment, and/or dose 
level and tumor type (if appropriate).
BOR, DOR 
BOR: defined as the best response designation 
over the study as a whole, recorded between the 
dates of first dose until the last tumor assessment 
prior to subsequent therapy. CR or PR 
determinations included in the BOR assessment 
must be confirmed by a second scan performed no 
less than 4 weeks after the criteria for response are 
first met. For those participants who have surgical 
resection, only presurgical tumor assessments will 
be considered in the determination of BOR. Listing 
of tumor measurements will be provided by 
subject. Individual participant’s BOR will be listed 
based on RECIST v1.1 for solid tumors. DOR, 
computed for all treated participants with a BOR 
of CR or PR, is defined as the time between the 
date of first response and the date of disease 
progression or death, whichever occurs first. 
Median DOR and corresponding 2 sided 95% CI 
may be reported by treatment, and/or dose level 
and tumor type (if appropriate). DOR will be 
analyzedusing the Kaplan-Meier method.
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10.3.2
Safety Analyses
All safety analyses for treated participantswill be performed on the Safety Sample.
Endpoint
Statistical Analysis Methods
The occurrence of non-serious AEs, SAEs, 
AEs leading to discontinuation or death
All AEs will be listed and summarized by system 
organ class and preferred term for all treated 
participantsand coded according to the most 
current version of Medical Dictionary for 
Regulatory Activities (MedDRA). Listing will 
presented for deaths.
Clinical laboratory tests, vital sign 
measurements, ECGs,
and physical 
examinations; and marked abnormalities in 
clinical laboratory test results
Vital signs, ECGs, and laboratory test results will 
be listed and summarized by time point. Any 
significant physical examination findings and 
marked abnormal clinical laboratory test results 
will be listed. ECGrecordings will be evaluated by 
the investigator and abnormalities, if present, will 
be listed.
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10.3.3
PharmacokineticAnalyses 
Endpoint
Statistical Analysis Methods
BMS-986205
Cmax, AUCtau, CLT/F, Vss/F
Summary statistics:geometric means and 
coefficients of variation
BMS-986205
T-HALF(eff, AUC)
Summary statistics:  means and SD
BMS-986205
Tmax
Summary statistics: medians and ranges
BMS-986205
Ctrough
Summary statistics to assess attainment of steady 
state: geometric means andcoefficients of 
variation; plots vs time by dose
BMS-986205 %UR
List will be presented for %UR. Plots of 
individual cumulative percent of dose recovered 
in urine versus end of interval time. Mean plots of 
cumulative percent of dose recovered in urine 
versus end of interval time
Nivolumab end of infusion(Ceoi), 
Ctrough Summary statistics
10.3.4
Immunogenicity Analyses
The immunogenicity will be assessed by the frequency of positive ADAto nivolumab. A listing 
of all available immunogenicity data will be provided by treatment, dose, and immunogenicity 
status. The frequency of participants with a baseline and/or at least one positive ADA assessment 
of nivolumab will be summarized. 
10.3.5
Other Analyses
The population pharmacokinetics analysis and pharmacodynamic analyses will be presented 
separately from the main clinical study report.
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12 
APPENDICES
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APPENDIX 1
ABBREVIATIONS AND TRADEMARKS
Term
Definition
ADA
anti-drug antibodies
AE
adverse event
AIDS
acquired immunodeficiency syndrome
ALT
alanine aminotransferase
aPTT
activated partial thromboplastin time
AST
aspartate aminotransferase
AUC
area under the concentration-timecurve
BCRP
breast cancer resistance protein
BID
twice daily
BOR
best overall response
BUN
blood urea nitrogen
CBC
complete blood count
CI
confidence interval
Cmax
maximum observed concentration
CNS
central nervous system
CONSORT
Consolidated Standards ofReporting Trials
CR
complete response
CrCl
creatinine clearance
CRF
case report form
CT
computed tomography
CTCAE
Common Terminology Criteria for Adverse Events
CTLA
cytotoxic T lymphocyte-associated antigen 4
CV
coefficient of variation
CV%
geometric mean
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Term
Definition
DILI
drug-induced liver injury
DOR
duration ofresponse
ECG
electrocardiogram
ECOG
Eastern Cooperative Oncology Group
EDC
electronic data capture
EMH
extramedullaryhematopoiesis
EOT
end of treatment
FDG
fluorodeoxyglucose
FSH
follicle stimulating hormone
FU
follow-up
GGT
gamma-glutamyl transferase
HIV
human immunodeficiency virus
IB
Investigator’s Brochure
ICF
informed consent form
IDO1
indoleamine 2,3-dioxygenase 1
IO
Immuno-oncology
IP
investigational product
irAEs
immune-related AEs
IV
intravenous
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Term
Definition
LAG-3
lymphocyte activation gene 3
LC-MS
liquid chromatography-mass spectrometry
LDH
lactate dehydrogenase
LFTs
liver function tests
MedDRA
Medical Dictionary for Regulatory Activities
MRI
magnetic resonance imaging
NAFLD
nonalcoholic fatty liver disease
NCI
National Cancer Institute
ORR
overall response rate
PCR
polymerase chain reaction
PD
disease progression
PD1
programmed cell death 1
PDL-1
programmed death receptor-ligand 1
PE
physical examination
PET
positron emission tomography
P-gp
P-glycoprotein
PK
pharmacokinetics
PO
orally
PPK
population PK
PR
partial response
PT
prothrombin time
Q2W
every 2 weeks
Q4W
every 4 weeks
QD
once daily
QTcF
Fridericia’s-corrected QT interval
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Term
Definition
RBC
red blood cell
RECIST
Response Evaluation Criteria in Solid Tumors
SAEs
serious adverse events
SCCHN
squamous cell carcinoma of the head and neck
SD
standard deviation (statistics)
SD
stable disease
TCMs
Traditional Chinese Medicines
T-HALF
terminal phase half-life
Tmax
time of maximum observed plasma concentration
TNFR
tumor necrosis factor receptor
TSH
thyroid-stimulating hormone
ULN
upper limit of normal
US
United States
VS
vital signs
Vss
volume of distribution at steady state
WBC
white blood cells
WOCBP
women of childbearing potential
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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:
Consensus ethical principles derived from international guidelines including the Declaration 
of Helsinki and Council for International Organizations of Medical Sciences (CIOMS) 
International Ethical GuidelinesGood 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 participantinformed consent will receive approval/favorable opinion by Institutional 
Review Board/Independent Ethics Committee (IRB/IEC), and regulatory authorities according to 
applicable local regulationsprior to initiation of the study.
All potential serious breaches must be reported toSponsor 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 (eg, loss of medical licensure, debarment). 
INSTITUTIONAL REVIEWBOARD/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 
(eg,advertisements), and any other written information to be provided to subjects. The investigator 
or BMS should also provide the IRB/IEC with a copyof 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 (eg, 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
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 yearafter 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 situationswhere 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 participantvolunteers to participate. 
Sponsor or designee will provide the investigator with an appropriate (ie, 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 participantis most proficient prior to clinical study participation. The language must 
be non-technical and easily understood. 
Allow time necessary for participantor participant's legally acceptable representative to 
inquire about the details of the study.
Obtain an informed consent signed and personally dated by the participantor 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 participantsubsequently 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 participantor 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 beprotected, 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 participantrecords. 
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.
Subjects unable to give their written consent (e.g., stroke or subjects with or severe dementia) may 
only be enrolled in the study with the consent of a legally acceptable representative. The participant
must also be informed about the nature of the study to the extent compatible with his or her 
understanding, and should this participantbecome capable, he or she should personally sign and 
date the consent formas soon as possible. The explicit wish of a participantwho is unable to give 
his or her written consent, but who is capable of forming an opinion and assessing information to 
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refuse participation in, or to be withdrawn from, the clinical study at any time should be considered 
by the investigator.
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 
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 treatmentintegrity 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 treatmentintegrity in accordance with 
requirements applicable under law and the 
SOPs/standards of thesourcing 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 designeeelectronic 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 CRFcompletion 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 
taskFor 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 designeetraining 
requirements andmust 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
Representatives of BMS must be allowed to visit all studysite 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
In addition, the study may be evaluated by Sponsoror designeeinternal 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 
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.
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If the investigator withdraws from the study (eg, relocation, retirement), the records shall be 
transferred to a mutually agreed upon designee (eg, anotherinvestigator, 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 (eg, 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 
method of disposal, ie, incinerator, licensed sanitary landfill, or licensed waste disposal vendor 
must be documented.
Accountability and disposal recordsare complete, up-to-date, and available for the Monitor to 
review throughout the clinical trial period.
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It is the investigator’s or designee’s responsibility to arrange for disposal of all empty containers.
If conditions for destruction cannot be met theresponsible 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
For this single site protocol, the Principal Investigator for the site will sign the clinical study report.
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 (CTAg) 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 CTAg.
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APPENDIX 3
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS: 
DEFINITIONS AND PROCEDURES FORRECORDING, 
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 participantadministered 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 anincrease 
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 NOTMeeting 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 notan AE per definition above, then it cannot be an SAE even if serious conditions 
are met.
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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 participantwas 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)
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 orresult in death or hospitalization but, based upon appropriate medical and 
scientific judgment, may jeopardize the participantor 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 9.2.7for 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).
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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 mustdocument 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 beforethe 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.
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 treatmentor 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.
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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 monthsafter the end of study 
treatment.*
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Highly EffectiveMethods That Are User Independent
Non-hormonal intrauterine devices(IUDs)such as ParaGard

Bilateral tubal occlusion
Vasectomizedpartner 
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 necessaryto use any other method of contraception when complete abstinence is 
elected. 
WOCBP participantswho 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 participantschooses to forego complete abstinence 
Unacceptable Methods of Contraception*
Combined (estrogen-and progestogen-containing) hormonal contraception associated with 
inhibition of ovulation(oral,intravaginal, or transdermal)
Progestogen-only hormonal contraception associated with inhibition of ovulation (oral or 
injectable)
Implantable progestogen-only hormonal contraception associated with inhibition of 
ovulation
Hormonal methods of contraception including oral contraceptive pills containing a 
combination of estrogen and progesterone,vaginal ring, injectables, implantsand 
intrauterine hormone-releasing system (IUS)and hormonal IUDs
Male or female condom with or without spermicide. Male and female condoms cannot be 
used simultaneously
Diaphragm with spermicide
Cervical cap with spermicide
Vaginal Sponge with spermicide
Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the 
primary mechanism of action
Periodic abstinence (calendar, symptothermal, post-ovulation methods)
Withdrawal(coitus interruptus).
Spermicide only
Lactation amenorrhea method (LAM)
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* 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 condom for study duration and until end of relevant 
systemic exposuredefined as 7 monthsafter the end of study treatment.
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 participantswith a pregnant or breastfeeding partner must agree to remain abstinent from 
penile vaginal intercourse or use a male condom during each episode of penile penetration 
during the treatment and until 7 monthsafter theend 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 5
RESPONSE EVALUATION CRITERIA IN SOLID TUMORS 
GUIDELINES(VERSION 1.1) 
1
EVALUATION OF LESIONS
Solid tumors will be evaluated using Response Evaluation Criteria InSolid Tumors version 1.1 
(RECIST1.1)guideline 
.
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) witha minimum size of:
10 mm by CT/MRIscan (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/MRIscan (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 
15mm by CT/MRIscan. 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 20mm 
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 notconsidered 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 identifiablesofttissuecomponents, that 
can be evaluated by cross sectional imaging techniques such as CT or MRI can be considered 
as measurable lesions if the softtissuecomponentmeets 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 fornodal 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 atbaseline. 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 a20% 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 absoluteincrease 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 
default value is derived from the 5 mm CT slice thickness (but should not be changed with varying 
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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, evenif 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 bemeasurable, 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 (<10mmshort 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 ofnon-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: 
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 thechange 
in non-measurable disease is comparable in magnitude to the increase that would be required to 
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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 shouldbe 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. NegativeFDG-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 isPD. If the positive 
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 
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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 
confirmationand 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 2.3.2-1provides 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 2.3.2-2is 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
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
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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
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 CRand PR Required)
Overall Response 
First Time Point
Overall Response 
Subsequent Time Point
BestOverall 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
CR
NE
SD provided minimum criteria for SD duration met, otherwise, 
NE
PR
CR
PR
PR
PR
PR
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Table 2.3.3-1:
Best Overall Response (Confirmation of CRand PR Required)
Overall Response 
First Time Point
Overall Response 
Subsequent Time Point
BestOverall Response
PR
SD
SD
PR
PD
SD provided minimum criteria for SD duration met, otherwise, 
PD
PR
NE
SD provided minimum criteria for SD durationmet, 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 subsequentrepeat assessments that should be performed no 
less than 28days after the criteria for response are first met. Subsequent documentation of a CR 
may provide confirmation of apreviously identified CR even with an intervening NEor PR(eg, 
CR NE CRor CR PR CR).Subsequent documentation of a PR may provide confirmation of a
previously identified PR even with an intervening NE or SD (eg, PR NE PR or PR SD PR). 
However, only one (1) intervening time point will be allowed between PR/CRsfor 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.
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APPENDIX 6
ECOG PERFORMANCE STATUS
ECOG PERFORMANCE STATUS
0
Fully active, able to carry on all pre-disease performance without restriction
1
Restricted in physically strenuous activity but ambulatory and able to carry out 
work of a light or sedentary nature, eg, light house work, office work
2
Ambulatory and capable of all selfcare but unable to carry out anywork 
activities. Up and about more than 50% of waking hours
3
Capable of only limited selfcare, confined to bed or chair more than 50% of 
waking hours
4
Completely disabled. Cannot carry on any selfcare. Totally confined to bed or 
chair
5
Dead
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APPENDIX 7
MANAGEMENTALGORITHMS
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APPENDIX 8
CYP3A4, CYP1A2 AND CYP2B6 GUIDANCE
The lists below are not meant to be all inclusive. Please consult individual drug labels for further 
information. Additional information is also available at:
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteractio
nsLabeling/ucm093664.htm
Table 1:
Classification of In Vivo Inhibitors of CYP Enzymes
CYP 
Enzymes
Strong Inhibitorsa
5-fold Increase in AUC
or> 80% Decrease in CL
Moderate Inhibitorsb
2 but < 5-fold Increase 
in AUC or 50-80% 
Decrease in CL
Weak Inhibitorsc
1.25 but < 2-fold Increase in 
AUCor20-50% Decrease in 
CL
CYP3A
Boceprevir, clarithromycin, 
conivaptan, grapefruit juice,d
indinavir, itraconazole, 
ketoconazole, lopinavir/ritonavir, 
mibefradil,enefazodone, 
nelfinavir, posaconazole, 
ritonavir, saquinavir, telaprevir, 
telithromycin, voriconazole
Amprenavir, aprepitant, 
atazanavir, ciprofloxacin, 
darunavir/ritonavir, 
diltiazem, erythromycin, 
fluconazole, 
fosamprenavir, grapefruit 
juice,dimatinib, 
verapamil
Alprazolam, amiodarone, 
amlodipine, atorvastatin, 
bicalutamide, cilostazol, 
cimetidine, cyclosporine, 
fluoxetine, fluvoxamine, 
ginkgo,fgoldenseal,fisoniazid, 
nilotinib, oral contraceptives, 
ranitidine, ranolazine, 
tipranavir/ritonavir, zileuton
CYP1A2
ciprofloxacin, enoxacin,
fluvoxamine
g,zafirlukast
methoxsalen, mexiletine, 
oral contraceptives
acyclovir, allopurinol, 
cimetidine, peginterferon alpha-
2a, piperine, zileuton
Please note that this is not an exhaustive list.
a A strong inhibitor for a specific CYP is defined as an inhibitor that increases the AUC of a substrate for that CYP 
by equal or more than 5-fold.
b A moderate inhibitor for a specific CYP is defined as an inhibitor that increases the AUC of a sensitive substrate 
for that CYPby less than 5-fold but equal to or more than 2-fold.
c A weak inhibitor for a specific CYP is defined as an inhibitor that increases the AUC of a sensitive substrate for 
that CYP by less than 2-fold but equal to or more than 1.25-fold.
d The effect of grapefruit juice varies widely among brands and is concentration, dose, and preparation dependent. 
Studies have shown that it can be classified as a “strong CYP3A inhibitor” when a certain preparation was used 
(eg, high dose, double strength) or as a “moderate CYP3A inhibitor” when another preparation was used (eg, low 
dose, single strength).
e Withdrawn from the United States market because of safety reasons.
f Herbal product.
gStrong inhibitor of CYP1A2 and CYP2C19, and moderate inhibitor of CYP2D6 and CYP3A
Abbreviations: AUC = area under the concentration-time curve; CYP = cytochrome P450.
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Table 2:
Classification of In Vivo Inducers of CYP Enzymes
CYP 
Enzymes
Strong Inducers
80% Decrease in AUC
Moderate Inducers
50-80% Decrease in AUC
Weak Inducers
20-50% Decrease in AUC
CYP3A
Avasimibe,a
carbamazepine, phenytoin, 
rifampin, St. John’s wortb
Bosentan, efavirenz, 
etravirine, modafinil, 
nafcillin
Amprenavir, aprepitant, 
armodafinil, echinacea,c
pioglitazone, prednisone, 
rufinamide
CYP1A2
Phenytoind, rifampine, 
ritonavirf, smoking, 
teriflunomide
Please note that this is not an exhaustive list.
a Not a marketed drug.
b The effect of St. John’s wort varies widely and is preparation dependent.
c Herbal product.
dStrong inducer of CYP3A and moderate inducer of CYP1A2, CYP2C19.
eStrong inducer of CYP2C19, CYP3A, and moderate inducer of CYP1A2, CYP2B6, CYP2C8, 
CYP2C9.
f Strong inducer of CYP2C19 and moderate inducer of CYP1A2, CYP2B6, CYP2C9.
Abbreviations: AUC = area under the concentration-time curve; CYP = cytochrome P450.
Table 3:
Examples of Sensitive In Vivo CYP Substrates and CYP 
Substrates with Narrow Therapeutic Range
CYP 
Enzymes
Sensitive Substratesa
Substrates with Narrow 
Therapeutic Rangeb
CYP3A
Alfentanil, aprepitant, budesonide, buspirone, conivaptan, 
darifenacin, darunavir, dasatinib, dronedarone, eletriptan, 
eplerenone, everolimus, felodipine, indinavir, fluticasone, 
lopinavir, lovastatin, lurasidone, maraviroc, midazolam, 
nisoldipine, quetiapine, saquinavir, sildenafil, simvastatin, 
sirolimus, tolvaptan, tipranavir, triazolam, vardenafil
Alfentanil, astemizole,ccisapride,c 
cyclosporine, dihydroergotamine, 
ergotamine, fentanyl, pimozide, 
quinidine, sirolimus, tacrolimus,
terfenadine
c
CYP2B6
Bupropion, efavirenz
Please note that this is not an exhaustive list.
a Sensitive CYP substratesrefers to drugs whose plasma AUC values have been shown to increase 5-fold or higher 
when co-administered with a known CYP inhibitor.
b CYPsubstrates with narrow therapeutic rangerefers to drugs whose exposure-response relationship indicates that 
small increases in their exposure levels by the concomitant use of CYP inhibitors may lead to serious safety 
concerns (eg, Torsades de Pointes).
c Withdrawn from the United States market because of safety reasons.
Abbreviations: AUC = area under the concentration-time curve; CYP = cytochrome P450.
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APPENDIX 9
MEDICATIONS ASSOCIATED WITH QT PROLOGATION
The listbelowisnot meant to be all inclusive. Please consult individual drug labels for further 
information.
quinidine, procainamide, disopyramide,
amiodarone, sotalol, ibutilide, dofetilide,
erythromycins, clarithromycin,
chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide,
cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone,
halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
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APPENDIX 10
P-GP AND BCRPGUIDANCE
The list below isnot meant to be all inclusive. Please consult individual drug labels for further 
information. Additional information is also available at:
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteractio
nsLabeling/ucm080499.htm
Table 1:
Examples of In Vivo Substrates for Selected Transporters
Transporter
Gene
Substrate
P-gp
ABCB1
Aliskiren, ambrisentan, colchicine, dabigatran etexilate, 
digoxin, everolimus, fexofenadine, imatinib, lapatinib, 
maraviroc, nilotinib, posaconazole, ranolazine, saxagliptin, 
sirolimus, sitagliptin, talinolol, tolvaptan, topotecan
BCRP
ABCG2
Methotrexate, mitoxantrone, imatinib, irrinotecan, lapatinib, 
rosuvastatin, sulfasalazine, topotecan
Please note that this is not an exhaustive list.
Abbreviations: BCRP = breast cancer resistance protein; P-gp = P-glycoprotein.
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APPENDIX 11
AGENTS KNOWN TO CAUSE METHEMOGLOBINEMIA
Acetanilid
p-Amino salicylic acid
Aniline, aniline dyes
Benzene derivatives
Clofazimine
Chlorates
Chloroquine
Diaminodiphenylsulfone
Local anesthetic agents 
Benzocaine 
Lidocaine 
Prilocaine 
Menadione
Metoclopramide
Methylene blue*
Naphthoquinone
Naphthalene
Nitrites 
Amyl nitrite 
Farryl nitrite 
Sodium nitrite 
Nitroglycerin 
Nitric oxide 
Nitrobenzene
Paraquat
Phenacetin
Phenazopyridine
Primaquine
Rasburicase
Resorcinol
Sulfonamides
While methylene blue is a recognized treatment for methemoglobinemia, it is an agent with oxidant potential (and 
may worsen the clinical situation)since in individuals with glucose-6-phosphate dehydrogenase deficiency,it induces 
acute hemolysis that can further decrease oxygen delivery to the tissues. Paradoxically, in high doses,methylene blue 
can also increase methemoglobinemia.
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SAP_001.pdf: 
STATISTICAL ANALYSIS PLAN
FOR CLINICAL STUDY REPORT
A PHASE 1/2 STUDY TO EVALUATE THE PHARMACOKINETICS, 
PHARMACODYNAMICS, SAFETY, AND TOLERABILITY OF BMS-986205 ALONE 
AND IN COMBINATION WITH NIVOLUMAB IN CHINESE PATIENTS WITH 
ADVANCED MALIGNANT SOLID TUMORS
PROTOCOL CA017076
VERSION # 1.0
DATE: 06-Oct-2021
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Statistical Analysis Plan
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2
TABLE OF CONTENTS
STATISTICAL ANALYSIS PLAN FOR CLINICAL STUDY REPORT ...................................1
TABLE OF CONTENTS............................................................................................................2
LIST OF TABLES......................................................................................................................5
LIST OF FIGURES ....................................................................................................................5
2
STUDY DESCRIPTION ..........................................................................................6
2.1
Study Design ............................................................................................................6
2.2
Treatment Assignment............................................................................................10
2.3
Blinding and Unblinding.........................................................................................10
2.4
Protocol Amendments.............................................................................................10
3
OBJECTIVES ........................................................................................................10
3.1
Primary...................................................................................................................10
3.2
Secondary...............................................................................................................10
4
ENDPOINTS..........................................................................................................10
4.1
Efficacy Endpoints .................................................................................................11
4.1.1
Objective Response Rate.........................................................................................11
4.1.2
Duration of Response .............................................................................................11
4.2
Safety Endpoints.....................................................................................................11
4.3
Other Endpoints......................................................................................................11
4.3.1
Pharmacokinetics ...................................................................................................11
4.3.3
Immunogenicity ......................................................................................................12
4.3.5
Pharmacodynamics ................................................................................................12
5
SAMPLE SIZE AND POWER...............................................................................12
6
STUDY PERIODS, TREATMENT REGIMENS AND POPULATIONS 
FOR ANALYSES ..................................................................................................13
6.1
Study Periods..........................................................................................................13
6.2
Treatment Regimens...............................................................................................15
6.3
Populations for Analyses ........................................................................................15
7
STATISTICAL ANALYSES..................................................................................15
7.1
General Methods ....................................................................................................15
7.1.1
Adverse Events, Serious Adverse Events, Multiple events, Select Adverse 
Events, 
 and Immune-Mediated Adverse 
Events.....................................................................................................................16
7.1.1.3
Immune-Mediated Adverse Events (US Submission)................................................17
7.1.2
Laboratory Tests.....................................................................................................17
7.1.3
Immunogenicity data ..............................................................................................18
7.2
Study Conduct........................................................................................................18
7.3
Study Population ....................................................................................................18
7.3.1
Subject Disposition.................................................................................................18
7.3.2
Demographics and Other Baseline Disease Characteristics....................................19
7.3.3
Medical History......................................................................................................20
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3
7.3.4
Prior Therapy Agents .............................................................................................20
7.3.5
Physical Examinations............................................................................................20
7.3.6
Baseline Physical Measurements ............................................................................20
7.4
Extent of Exposure .................................................................................................20
7.4.1
Administration of Study Therapy.............................................................................21
7.4.2
Modifications of Study Therapy ..............................................................................21
7.4.2.1
Dose Delays ...........................................................................................................21
7.4.2.2
Infusion Interruptions and Rate Changes................................................................22
7.4.2.3
Dose Escalations ....................................................................................................22
7.4.2.4
Dose Reductions.....................................................................................................22
7.4.2.5
Dose Discontinued..................................................................................................22
7.4.3
Concomitant Medications.......................................................................................22
7.4.3.1
Immune modulating medication..............................................................................23
7.4.3.2
Subsequent Cancer Therapy ...................................................................................23
7.5
Efficacy..................................................................................................................23
7.5.1
Analysis of Objective Response Rate.......................................................................23
7.5.2
Duration of Response .............................................................................................23
7.6
Safety.....................................................................................................................23
7.6.1
Deaths ....................................................................................................................24
7.6.2
Serious Adverse Events...........................................................................................24
7.6.3
Adverse Events Leading to Discontinuation of Study Therapy.................................24
7.6.4
Adverse Events Leading to Dose Modification........................................................24
7.6.5
Adverse Events .......................................................................................................24
7.6.6
Select Adverse Events (EU/ROW Submissions) .......................................................25
7.6.6.1
Incidence of Select AE ............................................................................................25
7.6.7
Immune-Mediated Adverse Events (US Submission)................................................25
7.6.9
Multiple Events.......................................................................................................26
7.6.10
Laboratory Parameters...........................................................................................26
7.6.10.1
Hematology ............................................................................................................26
7.6.10.2
Serum Chemistry ....................................................................................................26
7.6.10.3
Electrolytes.............................................................................................................26
7.6.10.4
Methemoglobin.......................................................................................................26
7.6.10.5
Additional Analyses................................................................................................27
7.6.11
Vital Signs and Pulse Oximetry...............................................................................27
7.6.12
Electrocardiograms................................................................................................27
7.6.13
Physical Measurements ..........................................................................................28
7.6.14
Immunogenicity Analysis ........................................................................................28
7.6.15
Pregnancy ..............................................................................................................28
7.7
Pharmacokinetics....................................................................................................28
7.7.1
Pharmacokinetic Concentrations............................................................................29
7.7.2
Pharmacokinetic Parameters..................................................................................29
7.7.3
PK Analysis of Urinary recovery data.....................................................................29
7.8
Pharmacodynamics.................................................................................................30
8
CONVENTIONS....................................................................................................30
8.1
General...................................................................................................................30
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8.2
Pharmacokinetic Summaries...................................................................................31
9
CONTENT OF REPORTS .....................................................................................32
10
DOCUMENT HISTORY........................................................................................32
APPENDIX 1
MISSING AND PARTIAL RADIOTHERAPY AND SURGERY 
DATES IMPUTATION ALGORITHMS ...............................................33
APPENDIX 2
IMMUNOGENICITY ANALYSIS
 
.........................................................................................35
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LIST OF TABLES
Table 4-1:
Objectives and Endpoints .......................................................................10
Table 6.2-1:
Treatment Regimen Information.............................................................15
Table 7.4.1-1:
Administration of study therapy: definition of parameters.......................21
Table 10-1:
Document History ..................................................................................32
LIST OF FIGURES
Figure 2.1-1:
Study Schematic.......................................................................................8
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2
STUDY DESCRIPTION
2.1
Study Design
This is a Phase 1/2, open-label study of BMS-986205 administered as a monotherapy and in 
combination with nivolumab in participants with advanced malignant solid tumors.
Treatment will start with a 2-week monotherapy lead-in (Cycle 0) whereby BMS-986205 100 mg 
oral daily dose must be administered with a meal at approximately the same time each day.
Participants will  then  proceed  to  receive  the  combination  of  nivolumab  and  BMS-986205. 
Nivolumab will be administered at a dose of 480 mg IV Q4W.
Cycle 0
Participants will start with Cycle 0, which is a 2-week BMS-986205 monotherapy lead-in, with a 
100-mg oral daily dose. Participants who have received at least 75% of doses in Cycle 0 will be 
eligible to proceed to receive the combination of nivolumab and BMS-986205 (Cycle 1).
The following AEs will prohibit a participant from proceeding to combination with nivolumab 
(Cycle 1):
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•
Grade 2 or higher immune-related AEs  (irAEs)  considered  related  to  BMS-986205 (eg, 
immune-mediated pneumonitis, colitis, hepatitis, nephritis, and renal dysfunction) with the 
exception of immune-mediated hypothyroidism and hyperthyroidism
•
Grade 2 AST and ALT elevations that do not resolve to Grade 1 or baseline within 1 week
•
≥Grade 3 elevation of AST, ALT, or total bilirubin that persists for ≥7 days
•
Grade 2 AST or ALT elevation with symptomatic liver inflammation (eg, right upper quadrant 
tenderness, jaundice, pruritus)
•
AST or ALT > 3× upper limit of normal (ULN) and concurrent total bilirubin > 2× ULN 
without initial findings of cholestasis (elevated serum alkaline phosphatase, eg, findings 
consistent with Hy’s law or FDA definition of potential drug-induced liver injury [DILI])
•
Grade 2 or greater episcleritis, uveitis, or iritis
•
Any other Grade 2 eye pain or blurred vision that does not respond to topical therapy and does 
not improve to Grade 1 severity within 2 weeks OR requires systemic treatment
•
Grade 3 or greater uveitis, pneumonitis, bronchospasm, neurologic toxicity, hypersensitivity 
reaction, or infusion reaction of any duration requires discontinuation
•
Any Grade 3 or greater non-dermatologic, non-hepatic, non-hematologic toxicity with the 
following specific EXCEPTIONS:
-
Grade 3 or Grade 4 electrolyte abnormalities that are not complicated by associated clinical 
adverse experiences, last less than 48 hours and either resolve spontaneously or respond 
to conventional medical intervention
-
Grade 3 nausea, vomiting, or diarrhea that lasts less than 48 hours, and either resolves 
spontaneously or responds to conventional medical intervention
-
Isolated Grade 3 elevation of amylase or lipase not associated with clinical or radiographic 
evidence of pancreatitis
-
Isolated Grade 3 fever not associated with hemodynamic compromise (eg, hypotension, 
clinical or laboratory evidence of impaired end-organ perfusion)
-
Grade 3 endocrinopathy that is well-controlled by hormone replacement
-
Grade 3 tumor flare (defined as pain, irritation, or rash that localizes to site of known or 
suspected tumor)
-
Grade 3 fatigue
•
Grade 3 rash if no improvement (ie, resolution to ≤Grade 1) after a 1- to 2-week dose delay.
•
Grade 4 rash of any duration
•
Methemoglobin levels ≥15% and study-drug related
•
Grade 4 neutropenia ≥5 days in duration and study-drug related
•
Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding (study-drug related), 
or any requirement for platelet transfusion (study-drug related)
•
Grade ≥3 febrile neutropenia for 48 hours, study-drug related
•
Grade ≥3 hemolysis (ie, requiring transfusion or medical intervention such as steroids), study-
drug related
•
Grade 4 anemia not explained by underlying disease (study-drug related) 
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A schematic of the study is provided in Figure 2.1-1.
Figure 2.1-1:
Study Schematic
Treatment may continue from Cycle 0 (2 weeks) until 50 weeks (or up to a total maximum of 98 
weeks if applicable), disease progression, or withdrawal of consent.
In addition, cohort may be expanded in this study to gather additional safety, tolerability, PK, 
pharmacodynamics, and preliminary efficacy information regarding BMS-986205 in combination 
with nivolumab in certain tumor type(s).
Participants will complete up to 3 phases of the study: Screening, Treatment, and Clinical/Safety 
Follow-up, as described below.
Screening
The screening phase will last for up to 28 days. Screening begins by establishing the participant’s 
initial eligibility and signing the informed consent form (ICF).
Treatment
The treatment phase consists of the 2-week monotherapy lead-in (Cycle 0) and up to twelve 4-
week combination therapy cycles. The 2-week lead-in treatment consists of a single oral daily dose 
of BMS-986205. The combination therapy cycles are comprised of an oral daily dose of BMS-
986205 and one dose of nivolumab administered intravenously Q4W on Day 1 of each treatment 
cycle up to 12 cycles. Total study treatment period is up to 50 weeks.
Following every two combination therapy treatment cycles (8 weeks) starting with Cycle 1, the 
decision to treat a participant with additional cycles of study therapy will be based on radiological 
tumor assessments (initial evaluation performed at baseline, end of Cycle 2, and every 8 weeks). 
Assessments of PR and CR must be confirmed at least 4 weeks following initial assessment. Tumor 
progression or response endpoints will be assessed using RECIST v1.1 criteria for solid tumors 
(Appendix 5 in protocol).
Treatment beyond progression may be allowed in select participants with initial RECIST v1.1 
disease progression (PD) after discussion and agreement with the BMS medical monitor (with 
proper documentation in the Trial Master File) that the benefit/risk assessment favors continued 
administration of study therapy (eg, participants are continuing to experience clinical benefit as 
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assessed by the investigator, tolerating treatment, and meeting other criteria specified in in protocol 
Section 8.1.2).
Participants with a response of stable disease (SD), PR, or CR at the end of a given cycle will 
continue to the next treatment cycle. Participants will generally be allowed to continue study 
therapy until the first occurrence of either: 1) completion of the maximum number of 12 cycles; 2) 
PD; 3) clinical deterioration suggesting that no further benefit from treatment is likely; 4) 
intolerability to therapy; or 5) the participant meets criteria for discontinuation of study therapy as 
outlined in protocol Section 7.4.4. Individual participants with confirmed CR will be given the 
option to discontinue study therapy on a case-by-case basis after specific consultation and 
agreement between the investigator and BMS medical monitor in settings where benefit/risk justify 
discontinuation of study therapy.
In all parts of this study, all participants will be treated for 48 weeks of BMS-986205 in 
combination with nivolumab unless criteria for study drug discontinuation are met earlier (protocol 
Section 7.4.4). All participants completing approximately 48 weeks of combination study therapy 
with ongoing disease control (CR, PR, or SD) may be eligible for an additional 48 weeks of study 
therapy at the originally assigned dose regimen beyond the initial 48 weeks, on a case-by-case 
basis, after careful evaluation and discussion with the BMS medical monitor to determine whether 
the benefit/risk ratio supports administration of further study drug. Subjects whose last assessment 
of the initial 48-week period shows PD will also be eligible to continue to additional cycles if they 
are still deriving clinical benefit, as per the guidance of treatment beyond progression (protocol 
Section 8.1.2). Upon completion of 48 weeks of combination treatment (or up to a maximum of 
96 weeks if applicable), all subjects will enter the Clinical/Safety Follow-Up period.
Clinical/Safety Follow-Up
Upon completion of 48 weeks of combination treatment (or up to a maximum of 96 weeks if 
applicable), all participants will enter the Clinical/Safety Follow-Up period after the decision is 
made to discontinue the participant from treatment (eg, at end of treatment [EOT]).
For participants who complete all scheduled cycles of therapy, the EOT visit will be the same as 
the last scheduled and completed on-treatment visit, and the start of the Week 1 Clinical/Safety 
Follow-Up visit. For participants who do not complete all scheduled cycles of therapy, the EOT 
visit will be the most recent on-treatment visit (with all available safety and response data) and 
does not need to be repeated, and will be considered the start of the Week 1 Clinical/Safety Follow-
Up visit.
Participants who discontinue the treatment phase will enter the Clinical/Safety Follow-Up period. 
Participants must be followed for at least 100 days after the last dose of study therapy or 30 days 
if participant only received BMS-986205. Follow-up visits should occur at Days 30, 60, and 100 
(± 10 days) after the last dose of study therapy or should coincide with the date of discontinuation 
(± 10 days) if date of discontinuation is greater than 30 days after the last dose of study therapy to 
monitor for AEs. All participants will be required to complete one (if participant only received 
BMS-986205) or three Clinical/Safety Follow-Up visits regardless of whether they start a new 
anti-cancer therapy, except those participants who withdraw consent for study participation.
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2.2
Treatment Assignment
The subject must be enrolled into the study after the subject’s eligibility is established and 
informed consent has been obtained. The study treatments include BMS-986205 and BMS-936558 
(nivolumab). Subjects will be treated at dose level as specified in Section 2.1.
2.3
Blinding and Unblinding
This is an open-label study.
2.4
Protocol Amendments
This analysis plan reflects Revised Protocol 01, dated 18-Oct-2018.
3
OBJECTIVES
3.1
Primary
The primary objective of this study is to characterize the PK and assess the safety and tolerability 
of BMS-986205 administered alone and in combination with nivolumab in Chinese participants 
with advanced malignant tumors.
3.2
Secondary
•
To characterize the pharmacodynamic activity of BMS-986205 administered alone and in 
combination with nivolumab.
•
To characterize the immunogenicity of nivolumab when administered in combination with 
BMS-986205.
•
To investigate the preliminary anti-tumor activity of BMS-986205 administered in 
combination with nivolumab in advanced malignant tumors.
4
ENDPOINTS
Endpoints to address the objectives in Section 3 are reflected in Table 4-1.
Table 4-1:
Objectives and Endpoints
Objectives
Endpoints
•
The primary objective of this study is to characterize the PK 
and assess the safety and tolerability of BMS-986205
administered alone and in combination with nivolumab in 
Chinese participants with advanced malignant tumors.
•
PK parameters; Incidence of AEs, SAEs, 
AEs leading to discontinuation, deaths, 
and laboratory abnormalities.
The secondary objectives of this study are:
•
To characterize the pharmacodynamic activity of BMS-
986205 administered alone and in combination with 
nivolumab.
•
To characterize the immunogenicity of nivolumab when 
administered in combination with BMS-986205.
•
To investigate the preliminary anti-tumor activity of BMS-
986205 administered in combination with nivolumab in 
advanced malignant tumors.
•
Incidence of anti-drug antibodies (ADA) 
to nivolumab; measurement of serum 
kynurenine and tryptophan levels.
•
ORR, best overall response (BOR) and 
duration of response (DOR) as assessed 
per Response Evaluation Criteria in 
Solid Tumors (RECIST) v1.1 by 
investigator.
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4.1
Efficacy Endpoints
4.1.1
Objective Response Rate
Objective Response Rate (ORR) is defined as the number of treated subjects who achieve a best 
response of confirmed complete response (CR) or confirmed partial response (PR) based on 
investigator assessments (using RECIST v1.1 criteria) divided by the number of all treated
subjects. 
Best Overall Response (BOR) is defined as the best response, as determined by the investigator, 
recorded between the date of first dose and the date of objectively documented progression per 
RECIST v1.1 criteria or the date of subsequent therapy (including tumor-directed radiotherapy and 
tumor-directed surgery), whichever occurs first. For subjects without documented progression or 
subsequent therapy, all available response designations will contribute to the BOR determination. 
Confirmation of response is required at least 4 weeks after the initial response.
4.1.2
Duration of Response
Duration of Response (DOR) is defined as the time between the date of first confirmed documented 
response (CR or PR) to the date of the first documented tumor progression as determined by the 
investigator (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first. Subjects 
who start subsequent therapy without a prior reported progression will be censored at the last 
evaluable tumor assessments prior to initiation of the subsequent anticancer therapy. Subjects who 
die without a reported prior progression will be considered to have progressed on the date of their 
death. Subjects who neither progress nor die, DOR will be censored on the date of their last 
evaluable tumor assessment. DOR will be evaluated for responders (confirmed CR or PR) only.
4.2
Safety Endpoints
The assessment of safety will be based on the incidence of adverse events (AEs), serious adverse 
events (SAEs), adverse events leading to discontinuation, adverse events leading to dose 
modification (i.e. dose delay/reduction), select adverse events (select AEs) for EU/ROW
Submissions, immune-mediated AEs (IMAEs) for US Submission, 
 
 and deaths. The use of immune modulating concomitant medication will be also 
summarized. In addition clinical laboratory tests, and immunogenicity (i.e. development of anti-
drug antibody) will be analyzed.
4.3
Other Endpoints
4.3.1
Pharmacokinetics
PK will be determined from BMS-986205/select metabolites plasma and urine for %UR24 and 
nivolumab serum concentrations. Samples will be collected to characterize pharmacokinetics and 
to explore exposure-safety and exposure-efficacy relationships. 
Selected BMS-986205 parameters, such as Cmax, Tmax, AUC(TAU), Ctrough, T-HALF(T-
HALFeff_AUC), CLT/F, Accumulation index (AI), %UR24, and selected BMS-986205 
metabolites parameters, such as Cmax, Tmax, AUC(TAU), Ctrough, %UR24, MR_Cmax, 
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MR_AUC(TAU),
will be assessed
from concentration-time data during BMS-986205 
monotherapy and combination phase (Part 1 and Part 2).
End-of-infusion (Ceoi) and trough (Ctrough) concentrations for nivolumab will be assessed during 
combination phase (Part 2).
PK parameters will be provided by the CPAR group.
4.3.3
Immunogenicity
Serum samples collected for anti-drug antibodies against nivolumab will be analyzed by a 
validated immunogenicity assay. 
In addition, ad hoc serum samples designated for pharmacokinetic assessments may also be used 
for immunogenicity analysis if required (e.g., insufficient volume for complete immunogenicity 
assessment or to follow up on suspected immunogenicity related AE).
Further details on immunogenicity 
 definitions, population for analyses 
and endpoints are described in APPENDIX 2.
4.3.5
Pharmacodynamics
Change from baseline for serum kynurenine and tryptophan and corresponding percent change 
from baseline will be assessed.
5
SAMPLE SIZE AND POWER
The sample size for this study is not based on statistical power, but based on consideration of the 
precision of the estimate of geometric means of Cmax and AUC of BMS-986205. Based on 
preliminary PK results from Study CA017003 cohorts 25 mg to 200 mg, assuming the inter-subject 
CV for AUC24 is 42%, a sample size of 12 PK evaluable subjects will be sufficient for the point 
estimates of the mean PK parameter to fall within 80% to 125% of the true value, with 91% 
confidence level. Assuming the inter-subject CV for Cmax is 29%, a sample size of 12 PK
evaluable subjects will be sufficient for the point estimates of the mean PK parameter to fall within 
80% to 125% of the true value, with 98% confidence level. Twelve subjects will provide 90% 
probability of observing at least one occurrence of a specific AE that would occur with an 18% 
incidence in the population.
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6
STUDY PERIODS, TREATMENT REGIMENS AND POPULATIONS FOR 
ANALYSES
6.1
Study Periods
•
Baseline period:
−
Baseline evaluations or pre-treatment events will be defined as evaluations or events that 
occur before the date and time of the first dose of study treatment. Evaluations (laboratory
tests, pulse oximetry, vital signs) on the same date and time of the first dose of study 
treatment will be considered as baseline evaluations. Events (AEs) on the same date and 
time of the first dose of study treatment will not be considered as pre-treatment events.
−
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, vital signs) will be defined as 
evaluations with a date (and time if collected) on or prior to the date of first dose of 
study treatment.
−
If there are multiple valid observations in the baseline period, then the latest non missing 
observation will be used as the baseline in the analyses. If multiple observations exist on 
the latest collection date (and time if collected), the record with the latest data entry date 
and time will be used. If multiple observations exist on the latest collection date (and time 
if collected) and data entry date and time, then the first observation is used as baseline, 
unless otherwise specified.
•
For nivolumab Anti-Drug Antibody (ADA), the baseline record ofIDO1 inhibitor
immunogenicity (IMG) evaluation must be less than the date and time of the first
NivolumabIDO1 inhibitor dose date and time.
•
Post baseline period:
−
On-treatment AEs will be defined as AEs with an onset date and time on or after the date 
and 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). For subjects who are off 
study treatment, AEs will be included if event occurred within a safety window of 100 days 
after the last dose of study treatment if a participant received BMS-986205 + NIVO (or 30 
days after the last dose of study treatment if a participant received only BMS-986205). No 
“subtracting rule” will be applied when an AE occurs both pre-treatment and post-
treatment with the same preferred term and grade.
−
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 treatment. For subjects who are off study treatment, evaluations should be within a 
safety window of 100 days after the last dose of study treatment if a participant received 
BMS-986205 + NIVO (or 30 days after the last dose of study treatment if a participant 
received only BMS-986205).
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•
Post baseline period by phase:
−
Mono lead-in period starts with the first dose of BMS986205 and end prior to first dose of 
nivolumab.
♦Mono lead-in AEs will be defined as AEs with an onset date and time on or after the 
date and time of the first dose of initial mono study treatment (or with an onset date on 
or after the day of first dose of initial mono study treatment if time is not collected or 
is missing) and prior to the date-time of the first dose of nivolumab (or with an onset 
date prior to the day of first dose of nivolumab if time is not collected or is missing). 
For subjects who discontinue during Mono lead in, AEs will be included if event 
occurred within a safety window of 30 days after the last dose of BMS-986205 initial 
mono study treatment.  No “subtracting rule” will be applied when an AE occurs both 
pre-treatment and post-treatment with the same preferred term and grade.
♦Mono lead-in evaluations (laboratory tests, pulse oximetry and vital signs) will be 
defined as evaluations taken after the day and time of the first dose of initial mono 
study treatment (or with a start date after the day of first dose of initial mono study 
treatment if time is not collected or is missing) and prior to the date-time of the first 
dose of nivolumab (or with a start date on or prior to the day of first dose of 
nivolumab if time is not collected or is missing). For subjects who discontinue during 
Mono lead in, evaluations will be included if evaluation is taken within a safety 
window of 30 days after the last dose of BMS-986205 initial mono study treatment.
−
Combination Treatment Period starts with the first dose date-time of initial nivolumab.
♦Combination treatment AEs will be defined as AEs with an onset date and time on or 
after the date and time of the first dose of nivolumab (or with an onset date on or after 
the day of first dose of nivolumab if time is not collected or is missing). For subjects 
who are off study treatment, AEs will be included if event occurred within a safety 
window of 100 days after the last dose of study treatment.
♦Combination 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 nivolumab. For subjects who are off treatment, evaluations 
will be included if evaluation is taken within 100 days of the last dose of study 
medication.
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6.2
Treatment Regimens
Refer to Table 6.2-1 for treatment regimens explored in this trial:
Table 6.2-1:
Treatment Regimen Information
Phase
Treatment Regimen Description
Lead-in
BMS-986205 100 mg PO QD
Combination 
BMS-986205 100 mg PO QD + Nivolumab 480 mg IV Q4W
6.3
Populations for Analyses
•
Enrolled subjects Population: All subjects who signed the informed consent form and obtained 
a subject number.
•
Treated subjects Population: All enrolled subjects who received at least one dose of any study 
treatment.
•
Pharmacokinetic Population: All enrolled subjects who received at least one dose of any study 
treatment and have any available concentration-time data.
•
Evaluable Pharmacokinetic Population: A subset of the PK Population, defined as all subjects 
who have adequate PK profiles or have at least one evaluable PK parameter. All available 
derived PK parameter values will be included in the PK data set and reported, but only 
participants with evaluable PK will be included in the summary statistics.
•
Immunogenicity Population: All enrolled subjects who received at least one dose of nivolumab 
and have a baseline and at least one post-treatment immunogenicity measurement.
Unless otherwise specified, the safety analyses will include all treated subjects.
Unless otherwise specified, the efficacy analyses will include all treated subjects.
7
STATISTICAL ANALYSES
All analyses will be performed in SAS using version 9.3 or higher and S-Plus for some figures.
7.1
General Methods
Unless otherwise noted, discrete variables will be tabulated by the frequency and proportion of 
subjects falling into each category, grouped by treatment. Percentages given in these tables will be 
rounded to the first decimal and, therefore, may not always sum to 100%. Percentages less than 
0.1 will be indicated as ‘< 0.1’. Continuous variables will be summarized using the mean, standard 
deviation, median, minimum, and maximum values.
Time-to-event variables (e.g., time-to resolution) will be analyzed using the Kaplan-Meier 
technique. When specified, the median will be reported along with 95% CI using Brookmeyer and 
Crowley method1 (using log-log transformation for constructing the confidence intervals2).
The conventions to be used for imputing missing and partial dates for analyses requiring dates are 
described in Section 8.
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7.1.1
Adverse Events, Serious Adverse Events, Multiple events, Select 
Adverse Events, 
 and Immune-Mediated 
Adverse Events
Drug-related AEs are those events with relationship to study drug “Related”, as recorded on the 
CRF. If the relationship to study drug is missing, the AE will be considered as drug-related. 
Serious adverse events consist of AEs deemed serious by the Investigator and flagged accordingly 
in the CRF and clinical database.
Adverse events leading to study drug discontinuation are AEs with action taken regarding study 
drug(s) = “Drug Withdrawn”. 
Adverse events leading to dose delay are AEs with action taken regarding study drug(s) = “Dose 
Delayed”.
Adverse events leading to dose reduction are AEs with action taken regarding study drug(s) = 
“Dose Reduced”.
Adverse events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), 
and the most recent version of the dictionary at the time of the database lock will be used. Adverse 
event results will be graded for severity using the NCI Common Terminology Criteria for Adverse 
Events (CTCAE) and the version of the criteria specified in the protocol will be used.
In the AE summary tables, unless otherwise specified, subjects will be counted only once at the 
Preferred Term (PT), only once at the System Organ Class (SOC), and only once at subject level 
for the counting of total number of subjects with an AE. The AE tables will be sorted by the SOCs 
and then PTs. SOC will be ordered by descending frequency overall and then alphabetically. PTs 
will be ordered within SOC by descending frequency overall and then alphabetically. The sorting 
will be done based on the ‘Any Grade’ column.
Unless otherwise specified, the AE summary tables will be restricted to on-treatment events 
regardless of the causality.
Analyses that take into account the multiple occurrences of a given adverse event will be conducted 
(see Section 7.6.9). To prepare these analyses, the CRF data will be processed according to 
standard BMS algorithms3 in order to collapse adverse event records into unique records based on 
the preferred term.
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7.1.1.3
Immune-Mediated Adverse Events (US Submission)
In order to further characterize AEs of special clinical interest, analysis of immune-mediated AEs 
(IMAE) will be conducted. IMAEs are specific events (or groups of PTs describing specific events) 
that include pneumonitis, diarrhea/colitis, hepatitis, nephritis/renal dysfunction, rash, endocrine 
(adrenal insufficiency, hypothyroidism/thyroiditis, hypothyroidism, thyroiditis, hyperthyroidism, 
diabetes mellitus, and hypophysitis), and other specific events, considered as potential immune-
mediated events by investigator that meet the definition summarized below: 
•
those occurring within 100 days of the last dose
•
regardless of causality
•
treated with immune-modulating medication (of note, endocrine AEs such as adrenal 
insufficiency, hypothyroidism/thyroiditis, hypothyroidism, thyroiditis, hyperthyroidism, 
diabetes mellitus, and hypophysitis are considered IMAEs regardless of immune-modulating 
medication use, since endocrine drug reactions are often managed without immune-modulating 
medication)
•
with no clear alternate etiology based on investigator assessment, or with an immune-mediated 
component
The list of MedDRA preferred terms used to identify IMAEs is revisited quarterly and updated 
accordingly. The preferred terms used for the selection at the time of the database lock by 
categories will be provided.
7.1.2
Laboratory Tests
Clinical laboratory parameters (hematology, serum chemistry and electrolytes) will be evaluated.
Laboratory tests will be graded using the NCI Common Terminology Criteria, and the most recent 
version of the criteria at the time of the database lock will be used.
Clinical laboratory data will be first analyzed using International System of Units (SI). 
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Analyses will be repeated using US conventional units.
In the laboratory summary tables, unless otherwise specified, subjects will be counted only once 
for each lab parameter according to their worst on treatment CTC grade (worst being the highest 
CTC grade). The laboratory tables and listings will be sorted by laboratory category, laboratory 
subcategory and laboratory test code sequence number.
7.1.3
Immunogenicity data
Blood samples for nivolumab immunogenicity analysis will be collected according to the protocol 
schedule. Samples will be evaluated for development of Anti-Drug Antibody (ADA) by a validated 
electrochemiluminescent (ECL) immunoassay.
7.2
Study Conduct
Non-programmable relevant eligibility and on-treatment, as well as significant (both 
programmable and/or non-programmable) protocol deviations will be reported through 
 listings.
Enrollment by country and site will be summarized and listed for all enrolled subjects.
A by-subject listing of batch numbers for all treated subjects will be provided.
7.3
Study Population
Analyses in this section will be tabulated for all treated subjects, unless otherwise specified.
7.3.1
Subject Disposition
Subject Pre-treatment Status
The total number of subjects enrolled (entering or not entering treatment period) will be presented 
along with the reason for not entering treatment period. This analysis will be performed on the all 
enrolled subjects population only.
Reason for not entering treatment period will be derived from subject status CRF page.
A by-subject listing including the above information will also be provided for all enrolled subjects.
Subject Phase Status 
Number of ongoing, completed and discontinued subjects along with discontinuation reason and 
next expected study phase will be summarized on the all treated subjects population for the 
following:
•
Mono lead-in
•
Combination
•
Follow-up (excluding next expected study phase)
Reason for discontinuation will be derived from subject status CRF page.
A by-subject listing including the above information will also be provided for all treated subjects.
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Subject Completion Status
Number of subjects of the following along with discontinuation reason will be summarized on the 
all treated subjects population:
•
Ongoing
•
Completed the study
•
Discontinued the study
•
Reason for discontinuation will be derived from subject status CRF page.
A by-subject listing including the above information will also be provided for all treated subjects.
7.3.2
Demographics and Other Baseline Disease Characteristics
The following demographic and baseline disease characteristics will be summarized and listed:
•
Age (continuous)
•
Age categorization (< 65, ≥65)
•
Sex (Male vs. Female)
•
Race (White, Black or African American, Asian, American Indian or Alaska Native, Native
Hawaiian or Other Pacific Islander, Asian Indian, Chinese, Japanese, Malay, Asian Other,
Other)
•
Height
•
Baseline Weight
•
Baseline ECOG performance status
•
Smoking History (Current/Former, Never Smoked - listed only)
•
Disease characteristics (listed only):
•
Tumor type
•
For Melanoma: stage and disease classification at initial diagnosis; stage and disease 
classification at study entry
•
For NSCLC: stage, disease classification and cell type at initial diagnosis; stage and disease 
classification at study entry
•
For RCC: stage and cell type at initial diagnosis; stage and disease classification at study entry
•
For Bladder Cancer: stage, disease classification, location and minor histological variants at 
initial diagnosis; stage, disease classification and location at study entry
•
For CRC: stage, disease classification, cell type and location at initial diagnosis; stage and
disease classification at study entry
•
For SCLC: stage and cell type at initial diagnosis; stage and disease classification at study entry
•
For Breast Cancer: stage, disease classification and cell type at initial diagnosis; stage and 
disease classification at study entry
•
For Pancreatic Cancer: stage and cell type at initial diagnosis; stage and disease classification 
at study entry
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•
For Hepatocellular Carcinoma: stage and cell type at initial diagnosis; stage at study entry
•
For Head and Neck: stage, cell type and location at initial diagnosis; stage at study entry
•
For Gastric Cancer: stage at initial diagnosis; disease classification and cell type at study entry
•
For Esophageal Cancer: stage at initial diagnosis; disease classification, cell type and location 
at study entry
•
For Gastroesophageal Junction: stage at initial diagnosis; disease classification and cell type at 
study entry
•
For Other Solid Tumors: stage and cell type at initial diagnosis; stage and disease classification
at study entry
7.3.3
Medical History
A by-subject listing of general medical history for all treated subjects will be provided.
7.3.4
Prior Therapy Agents
Prior systemic cancer therapy (regimen setting, number of regimen, line of therapy, best response 
to latest regimen etc.) will be summarized and listed by subject.
Prior radiotherapy (Yes/No) and prior surgery (Yes/No) will be summarized and listed by subject.
7.3.5
Physical Examinations
Subjects with abnormal baseline physical examination will be listed by subject.
7.3.6
Baseline Physical Measurements
Baseline physical measurements will be listed by subject.
7.4
Extent of Exposure
Listings will include all available exposure data. Analyses will be performed on all treated 
subjects, unless otherwise specified.
The treatment period consists of two phases: 
•
2 weeks of monotherapy lead-in (Cycle 0) during which single oral daily dose of BMS-986205
monotherapy is administered daily, and
•
48 weeks of combination therapy whereby each treatment cycle is 4 weeks and is comprised 
of daily doses of BMS-986205 and 1 dose of nivolumab administered every 4 weeks on Day 
1 of the treatment cycle up to 12 cycles.
All participants completing approximately 48 weeks of combination study therapy with ongoing 
disease control (CR, PR, or SD) may be eligible for an additional 48 weeks of study therapy at the 
originally assigned dose regimen beyond the initial 48 weeks.
The cycle start date will correspond to the dosing date. Extent of Exposure will be assessed 
separately for the 2-week lead in period for mono BMS-986205 and the drugs in combination.
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7.4.1
Administration of Study Therapy 
The following parameters will be summarized (descriptive statistics) by phase and study therapy:
•
Number of doses received
•
Cumulative dose (mg) = the sum of all actual doses that a subject received
•
Duration of study therapy (weeks) 
•
Dose intensity (mg/weeks) = cumulative dose (mg) / duration of therapy (weeks)
•
Relative dose intensity (%) 
•
Relative dose intensity (%) using the following categories: < 50%; 50 - < 70%; 70 - < 90%; 
90 - < 110%; ≥110%
Exposure parameter derivation for each treatment are shown in Table 7.4.1-1.
Table 7.4.1-1:
Administration of study therapy: 
definition of parameters
Parameter
BMS-986205
Nivolumab
Dosing schedule 
per protocol
100 mg QD
480 mg Q4W
Cumulative Dose
(mg)
Cum dose (mg) is sum of the doses (mg) administered to a subject during the treatment 
period.
Duration of study 
therapy (week)
(Last dose date - Start dose date + 1) / 7
(Last dose date - Start dose date + 28) / 7
Dose intensity 
(mg/week)
Cum dose (mg) / Duration of Therapy (week)
Relative dose 
intensity (%)
[Dose Intensity / (100 × 7)] × 100
[Dose Intensity /(480 / 4)] × 100
A by-subject listing of dosing of study medications (record of study medication, infusion details, 
and dose changes) and a by-subject listing of exposure parameters (number of doses, duration of 
therapy, cumulative dose, dose intensity, and relative dose intensity) will be also provided.
7.4.2
Modifications of Study Therapy
7.4.2.1
Dose Delays
Each BMS-986205 and nivolumab may be delayed. 
A dose of nivolumab will be considered as actually delayed if the delay is exceeding 3 days (i.e. 
greater than or equal to 4 days from scheduled dosing date) for nivolumabIDO1 inhibitor. 
BMS-986205 is administered as a tablet daily. A dose of BMS-986205 will be considered as 
actually delayed (interrupted) if BMS-986205 was not administrated for at least 1 day. Interruption 
means the continuous oral dosing was stopped or held for a period of time prior to resuming. 
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All study drugs must be delayed until treatment can resume. Reason for dose delay will be retrieved 
from CRF dosing pages.
The following parameters will be summarized by study drug:
•
Number of subjects with at least one dose delayed, the number of dose delays per subject, the 
reason for dose delay and the length of dose delay.
7.4.2.2
Infusion Interruptions and Rate Changes
Each nivolumab infusion can be interrupted and/or the IV infusion rate can be reduced. This 
information will be retrieved from CRF dosing pages.
The following parameters will be summarized:
•
Number of subjects with at least one dose infusion interruption, the reason for interruption, 
and the number of infusion interruptions per subject.
•
Number of subjects with at least one IV infusion rate reduction, the reason for reduction and 
the number of infusion with IV rate reduction per subject.
7.4.2.3
Dose Escalations
Dose escalations (within subject) are not permitted for nivolumab. 
7.4.2.4
Dose Reductions
Dose reductions (within subject) are not permitted for nivolumabIDO1 inhibitor. 
Number of subjects with at least one dose reduction, the reason for dose reduction, and the number 
of dose reductions per subject will be summarized for BMS-986205 only.
7.4.2.5
Dose Discontinued
Number of subjects with dose discontinued along with the reason will be summarized by study 
drug.
7.4.3
Concomitant Medications
Concomitant medications, defined as medications other than study medications which are taken at 
any time on-treatment (i.e. on or after the first day of study therapy and within 100 days following 
the last dose of study therapy), will be coded using the UMC WHO Drug Global Dictionary.
A by-subject listing of concomitant medications will be provided..
Prior medications, defined as non-study medications with a start date before consent date, and 
current medications, defined as non-study medications with a start date before the first date of 
study medication and stop date after consent date, will be coded using the UMC WHO Drug Global 
Dictionary. 
A by-subject listing of prior/current medications will be provided..
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7.4.3.1
Immune modulating medication 
Immune modulating concomitant medications are medications entered on an immune modulating 
medication form or available from the most current pre-defined list of immune modulating 
medications. The list of anatomic class, therapeutic class and generic name used for the selection 
at the time of the database lock will be provided.
A by-subject listing of concomitant immune modulating medications will be provided.
7.4.3.2
Subsequent Cancer Therapy
A by-subject listing of subsequent cancer therapy (systemic anti-cancer therapy, radiotherapy and 
surgery) will be produced for all treated subjects.
7.5
Efficacy
Analyses in this section will be tabulated for all treated subjects, unless otherwise specified.
7.5.1
Analysis of Objective Response Rate
One of the objectives of the study is to estimate the ORR per investigator among all treated
subjects. ORR with corresponding 2-sided 95% CI based on the Clopper and Pearson4 method will 
be presented.
The number and percentage of subjects in each category of BOR per investigator (complete 
response [CR], partial response [PR], stable disease [SD], progressive disease [PD], or unable to 
determine [UTD]) will be presented. Estimates of response rate, along with its exact two-sided 
95% CI by Clopper and Pearson5 will be presented.
A by-subject listing of best overall response will be presented including best overall response per 
investigator and dates of CR/PR/progression. 
A by-subject listing of lesion evaluations per investigator will be presented.
A by-subject listing of per time point tumor response per investigator will be also presented.
7.5.2
Duration of Response
Duration of response (DOR) will also be evaluated for subjects who achieved confirmed PR or 
CR. The DOR will be estimated using the Kaplan-Meier (KM) product limit method and will be 
displayed graphically. A table will be produced presenting number of events, number of subjects 
involved, medians, and 95% CIs for the medians. Median values of DOR, along with two-sided 
95% CI will be computed based on a log-log transformation method. 
A by-subject listing will be presented including best response, duration of response, whether the 
subject was censored for duration of response, and, if so, the reason. 
7.6
Safety
Analyses in this section will be tabulated for all treated subjects by phase (monotherapy lead-in, 
combination) and overall, unless otherwise specified.
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7.6.1
Deaths
Deaths will be summarized:
•
All deaths, reasons for death.
•
Deaths within 100 days of last dose received, reasons for death.
A by-subject listing of deaths will be provided for the all enrolled subjects population.
7.6.2
Serious Adverse Events
Serious adverse events will be summarized :
•
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.
A by-subject SAE listing will be provided for the “enrolled subjects” population.
7.6.3
Adverse Events Leading to Discontinuation of Study Therapy
AEs leading to discontinuation will be summarized:
•
Overall summary of AEs leading to discontinuation by worst CTC grade (any grade, grade 
3-4, grade 5) presented by SOC/PT.
•
Overall summary of drug-related AEs leading to discontinuation by worst CTC grade (any 
grade, grade 3-4, grade 5) presented by SOC/PT.
A by-subject AEs leading to discontinuation listing will be provided.
7.6.4
Adverse Events Leading to Dose Modification
AEs leading to dose delay/reduction will be summarized:
•
Overall summary of AEs leading to dose delay/reduction by worst CTC grade (any grade, 
grade 3-4, grade 5) presented by SOC/PT.
•
Overall summary of related AEs leading to dose delay/reduction by worst CTC grade (any 
grade, grade 3-4, grade 5) presented by SOC/PT.
A by-subject AEs leading to dose delay/reduction listing will be provided.
7.6.5
Adverse Events
Adverse events will be summarized:
•
Overall summary of any AEs by worst CTC grade (1, 2, 3, 4, 5, not reported, total) presented 
by SOC/PT.
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•
Overall summary of any AEs that required immune modulating medication by worst CTC 
grade (any grade, grade 3-4, grade 5) presented by SOC/PT.
•
Overall summary of drug-related 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. A by-subject listing of any AE requiring immune 
modulating medications will also be provided.
7.6.6
Select Adverse Events (EU/ROW Submissions)
Unless otherwise specified, analyses will be performed by select AE category. Analyses will also 
be repeated by subcategory of endocrine events.
7.6.6.1
Incidence of Select AE
Select AEs will be summarized for each category/subcategory:
•
Overall summaries of any select AEs by worst CTC grade (any grade, grade 3-4, grade 5) 
presented by Category or Subcategory/PT.
•
Overall summaries of any drug-related select AEs by worst CTC grade (any grade, grade 3-4, 
grade 5) presented by Category or Subcategory/PT.
•
Overall summaries of any serious select AEs by worst CTC grade (any grade, grade 3-4, grade 
5) presented by Category or Subcategory /PT.
•
Overall summaries of drug-related serious select AEs by worst CTC grade (any grade, grade 
3-4, grade 5) presented by Category or Subcategory /PT.
•
Overall summaries of any select AEs leading to discontinuation by worst CTC grade (any 
grade, grade 3-4, grade 5) presented by Category or Subcategory /PT.
•
Overall summaries of drug-related select AEs leading to discontinuation by worst CTC grade
(any grade, grade 3-4, grade 5) presented by Category or Subcategory /PT.
•
Summary of frequency of unique select AEs by Category.
A by-subject select AE listing will be provided.
7.6.7
Immune-Mediated Adverse Events (US Submission)
A by-subject listing of IMAEs will be provided. For new studies which collect investigator 
assessment of potential IMAE data, a by-subject listing of AEs considered as immune-mediated 
events per investigator but not qualified for IMAEs definition will also be provided.
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7.6.9
Multiple Events
A listing displaying the unique instances of all AEs, i.e., after duplicates have been eliminated and 
overlapping and contiguous occurrences of the same event (i.e. same PT) have been collapsed will 
be provided.
7.6.10
Laboratory Parameters
The analysis population for each laboratory test is restricted to treated subjects who underwent that 
laboratory test. Laboratory tests (in addition to the tests specified below) with CTC criteria 
collected in the specific studies may also be included in the summaries.
7.6.10.1
Hematology
The following will be summarized as worst CTC grade on-treatment per subject and as shift table 
of worst on-treatment CTC grade compared to baseline CTC grade per subject: hemoglobin (HB), 
platelets, white blood counts (WBC), absolute neutrophils count (ANC) and lymphocyte count 
(LYMPH). 
A by-subject listing of these laboratory parameters will be provided.
7.6.10.2
Serum Chemistry
The following will be summarized as worst CTC grade on-treatment per subject and as shift table 
of worst on-treatment CTC grade compared to baseline CTC grade per subject: ALT, AST, 
alkaline phosphatase (ALP), total bilirubin and creatinine. 
A by-subject listing of these laboratory parameters will be provided.
7.6.10.3
Electrolytes
The following will be summarized as worst CTC grade on-treatment per subject and as shift table 
of worst on-treatment CTC grade compared to baseline CTC grade per subject: sodium (high and 
low), potassium (high and low), calcium (high and low), magnesium (high and low), and Glucose 
Serum (fasting hyperglycemia and hypoglycemia regardless of fasting status).
A by-subject listing of these laboratory parameters will be provided.
7.6.10.4
Methemoglobin
The number of subjects with highest methemoglobin post baseline >10% will be summarized.
A by-subject listing of these subjects will be provided.
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7.6.10.5
Additional Analyses
In addition, further analyses on specific laboratory parameters will be performed:
Abnormal Hepatic Function Test
The number of subjects with the following laboratory abnormalities from on-treatment evaluations 
will be summarized:
•
ALT or AST > 3 x ULN, > 5 x ULN, > 10 x ULN and > 20 x ULN
•
Total bilirubin > 1.5 x ULN and > 2 x ULN
•
Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN
•
Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN
A by-subject listing of these specific abnormalities will be provided.
Abnormal Thyroid Function Test
The number of subjects with the following laboratory abnormalities from on-treatment evaluations 
will be summarized:
•
TSH value > ULN and
−
with baseline TSH value ≤ULN
−
with at least one FT3/FT4 test value < LLN within 2-week window after the abnormal TSH 
test
−
with all FT3/FT4 test values ≥ LLN within 2-week window after the abnormal TSH test
−
with FT3/FT4 missing within 2-week window after the abnormal TSH test
•
TSH < LLN and
−
with baseline TSH value ≥LLN
−
with at least one FT3/FT4 test value > ULN within 2-week window after the abnormal 
TSH test
−
with all FT3/FT4 test values ≤ULN within 2-week window after the abnormal TSH test
−
with FT3/FT4 missing within 2-week window after the abnormal TSH test
A by-subject listing of these specific abnormalities will be provided.
7.6.11
Vital Signs and Pulse Oximetry
Vital signs will be summarized by timepoint.
Vital signs and pulse oximetry (i.e. % oxygen saturation) collected on the CRF will be provided 
in separate listings.
7.6.12
Electrocardiograms
All of the available ECG parameter values from each subject will be included in the ECG data set. 
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Baseline values are defined as the last recorded values prior to the first dosing. For ECG parameters 
such as heart rate (HR), QT, QRS, QTcB, QTcF and PR, summary measures (n, mean, standard 
deviation, median, minimum, and maximum) will be provided.
A by-subject listing of all ECG measures and a listing of abnormal ECG interpretations will be 
provided.
7.6.13
Physical Measurements
Physical measurements will be listed by subject.
7.6.14
Immunogenicity Analysis
Further details on immunogenicity 
 definitions, population for analyses 
and endpoints are described in APPENDIX 2. 
Incidence of ADA
Number (%) of subjects will be reported for the following parameters based on Evaluable Subjects.
•
Baseline ADA-positive
•
ADA-positive
−
Persistent Positive (PP)
−
Not PP-Last Sample Positive
−
Other positive
−
Neutralizing Positive
•
ADA-negative
A listing of all ADA assessments will be provided. A separate listing of ADA assessments of 
nivolumab for subjects with neutralizing positive will also be provided.
Clinical implications 
Clinical implications of nivolumab immunogenicity will be primarily focused on subjects with 
persistent ADA-positive relative to ADA-negative. Subjects with any ADA-positive samples after 
initiation of treatment (relative to baseline) may be used to explore clinical implications. Effect of 
immunogenicity on safety will be explored by examining the type of AEs 
 such 
as hypersensitivity/infusion reaction. Individual subject’s safety profile will be examined and 
described based on a listing. Clinical implications on efficacy will also be explored similarly. 
Association between trough concentrations of nivolumab and ADA assessments may be explored, 
as needed.
7.6.15
Pregnancy
A by-subject listing of pregnancy tests results will be provided for treated female subjects.
7.7
Pharmacokinetics  
The BMS-986205 and nivolumab concentration data obtained in this study will also be combined 
with data from other studies in the clinical development program to develop a population PK 
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model. This model will be used to evaluate the effects of intrinsic and extrinsic covariates on the 
PK of BMS-986205 and nivolumabIDO1 inhibitor. In addition, exposure-response analyses with 
selected efficacy and safety endpoints may be conducted. Results of population PK and exposure 
response-analyses will be reported separately. 
7.7.1
Pharmacokinetic Concentrations
Analyses for this section will be provided by the CPAR group. Summary statistics and listings will 
be provided for the following pharmacokinetic concentrations by treatment, cycle, study day and 
time on the BMS-986205 and nivolumab PK Subjects.  
•
Plasma concentrations of BMS-986205 and select metabolites
•
Serum concentrations of nivolumab
Plots of the individual and mean concentration profile vs. time by cycle/study day for BMS-986205
and select metabolites will be provided.
A by-subject listing of BMS-986205/select metabolites plasma and nivolumab serum 
concentrations will be provided.
7.7.2
Pharmacokinetic Parameters
Summary statistics will be provided for all individual PK parameters by treatment, cycle, study 
day and time where data is available. Geometric means and coefficients of variation will be 
presented for the selected following PK parameters for BMS-986205 or corresponding 
metabolites: Cmax, AUC(TAU), CLT/F, Ctrough, AI, %UR24, MR_AUC(TAU) and MR_Cmax. 
Mean and standard deviation will be presented for T-HALF(T-HALFeff_AUC). Median, 
minimum, and maximum will be presented for Tmax. Drug accumulation indices (AI) is defined 
as the ratio of AUC(TAU) and Cmax at steady state to after the first dose. Effective T-Half, which 
will be caluclated only if AI >1,  is defined as following:
Effective T െHalf ൌ݀݋ݏ݅݊݃݅݊ݐ݁ݎݒ݈ܽ∗݈݋݃ሺ2ሻ
݈݋݃ሺ
ܣܫ
ܣܫെ1ሻ
Plot of geometric mean with 90% CI of Ctrough vs. study day and cycle will be presented to assess 
if steady state is reached.
Summary statistics will be provided for the following PK parameters for nivolumab: Ctrough, 
Ceoi.
A by-subject listing of BMS-986205/select metabolites and nivolumab PK parameters will be 
provided.
7.7.3
PK Analysis of Urinary recovery data
Urinary recovery data of BMS-986205/select metabolites will be listed if available.
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7.8
Pharmacodynamics
Summary statistics of change from baseline for serum kynurenine and tryptophan and 
corresponding percent change from baseline (C1D1) will be summarized by timepoint.
Line graphs summarizing the mean of absolute and relative (change from baseline and percent 
change from baseline) values by timepoint will be produced.  
8
CONVENTIONS
8.1
General
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 Specification6
•
For missing and partial adverse event resolution dates, imputation will be performed as follows 
(these conventions may change):
−
If only the day of the month is missing, the last day of the month will be used to replace 
the missing day. If the imputed date is after the death date or the last known alive date, then 
the latest known alive date or death date is considered as the resolution date. 
−
If the day and month are missing or a date is completely missing, it will be considered as 
missing.
•
Missing and partial non-study medication domain dates will be imputed using the derivation 
algorithm described in 4.1.3 of BMS Non-Study Medication Domain Requirements 
Specification7.
•
Missing and partial radiotherapy and surgery dates will be imputed using algorithm described 
in APPENDIX 1.
•
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 alive date 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 alive 
date. 
−
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 other partial/missing dates, the following conventions were 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: 
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1 month = 30.4375 days and 1 year = 365.25 days.
Duration (e.g. time-to onset, time-to resolution) will be calculated as follows:
Duration = (Last date - first date + 1)
Last known alive date will be defined based on all appropriate dates collected on the CRF.
All statistical analyses will be carried out using SAS (Statistical Analysis System software, SAS 
Institute, North Carolina, USA) unless otherwise noted.
8.2
Pharmacokinetic Summaries
In-text Tables
For in-text pharmacokinetic tables, coefficient of variation (%CV) will be reported as integers. For 
other statistics except for standard deviations, values of 100 or higher will be presented as integers, 
values of 10 - < 100 will be displayed to one decimal place, and values of 1 - < 10 will be displayed 
to two decimal places. Values less than 1 will be displayed to three decimal places. Ratios will 
also be displayed to three decimal places. Standard deviations will be reported to a precision of 1 
decimal place more than the mean.
Handling of Non-Quantifiable Concentrations
For the summaries of PK concentration-time data, concentrations that are less than the lower limit 
of quantification (LLOQ) should be displayed as “< LLOQ” in the listings and be treated as 
missing in summary tables and plots. For the purpose of calculating PK parameters, other than 
Ctrough, pre-dose concentrations that are less than LLOQ and concentrations prior to the first 
quantifiable concentration that are less than LLOQ will be set to zero, and all other concentrations 
less than LLOQ will be set to missing. Summary statistics for Ctrough concentrations will be 
calculated by imputing values less than LLOQ as ½ * LLOQ.
All available PK concentration-time data and derived pharmacokinetic parameter values will be 
included in the PK data set and listed accordingly.
Treatment of Outliers
Individual PK concentrations, if deemed to be anomalous, may be excluded from the analysis 
following a review of available documentation (e.g., bioanalytical report, clinical data). Any such 
exclusion will be clearly listed in the study report along with justification for exclusion.
Entire PK concentration-time profiles for a subject may be excluded following review of available 
documentation (e.g., bioanalytical report, clinical data). However, results of analysis with and 
without the excluded profiles may be presented in the study report. Any such exclusion will be 
clearly listed in the study report along with justification for exclusion.
PK Exclusions
PK Analysis, Reporting, and Exclusion criteria should follow the BMS PK Harmonization 
document Version 4.0.
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9
CONTENT OF REPORTS
The complete list of analyses contributing to the clinical study report and other possible analyses 
will be given in the Data Presentation Plan.
10
DOCUMENT HISTORY
Table 10-1:
Document History
Version 
Number
Author(s)
Description
1.0
Original Issue
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APPENDIX 1
MISSING AND PARTIAL RADIOTHERAPY AND SURGERY 
DATES IMPUTATION ALGORITHMS
Procedures – Imputation Rules. 
If reported procedure start date is a full valid date then set start date equal to the date part of 
procedure start date. 
In case of partial date use imputation rules described below: 
•
If only day is missing then 
−
If month and year of procedure match month and year of first dose date then impute as date 
of first dose; 
−
If month and year of procedure don't match month and year of first dose date then impute 
as first day of that month and year. 
•
If both day and month are missing, then impute as maximum between 01JAN of the year and 
date of the first dose; 
•
If date is completely missing or invalid then leave missing. 
Note: Imputation is not applicable to data where start date is not collected (for example "PRIOR 
RADIOTHERAPY" CRF). Set start date to missing in this case. 
If reported end date is a full valid date then set end date equal to the date part of the reported end 
date. 
In case of partial date use imputation rules described below: 
•
If reported end date is partial then set end date equal to the last possible reported end date based 
on the partial entered reported end date. 
•
If reported end date is missing, continuing, unknown or invalid then set end date equal to the 
most recent database extraction date. 
If end date was imputed then compare end date to the death date or last known alive date if subject 
is not dead. If posterior then end date should be imputed to death date (or last known alive date if 
subject not dead). 
Note: Imputation of partial dates only applies to data entered on "RADIOTHERAPY” CRF page. 
For other CRF pages in case of partial dates set end date to missing.  
Surgeries – Imputation Rules. 
If reported surgery date is a full valid date then set start date equal to the date part of surgery date. 
In case of partial date, use one of the two imputation rules described below: 
A. For data collected on "PRIOR SURGERY RELATED TO CANCER" CRF page: 
•
If only day is missing then impute as the first day of the month; 
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•
If both day and month are missing then then impute as 01JAN of the year; 
•
If date is completely missing or invalid then leave missing. 
B. For data collected on other CRF pages (deemed to be on-treatment/subsequent surgeries): 
•
If only day is missing then 
−
If month and year of surgery match month and year of first dose date then impute the 
missing date as the date of first dose; 
−
If month and year of surgery don't match month and year of first dose date then impute as 
first day of that month and year; 
•
If both day and month are missing then impute as maximum between 01JAN of the year and 
date of the first dose; 
•
If date is completely missing or invalid then leave missing. 
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APPENDIX 2
IMMUNOGENICITY ANALYSIS
 
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Immunogenicity Endpoints
A fundamental metric that informs clinical immunogenicity interpretation is the incidence of ADA 
in a study or across comparable studies. ADA incidence is defined as the proportion of the study 
population found to have seroconverted or boosted their pre-existing ADA during the study period.
Terms and Definitions
Validated ADA test methods enable characterization of samples into ADA-positive vs. ADA-
negative. To classify the ADA status of a subject using data from an in vitro test method, each 
sample from the subject is categorized based on the following definitions:
Sample ADA Status:
•
Baseline ADA-positive sample: ADA is detected in the last sample before initiation of 
treatment
•
Baseline ADA-negative sample: ADA is not detected in the last sample before initiation of 
treatment
•
ADA-positive sample: After initiation of treatment, (1) an ADA detected (positive 
seroconversion) sample in a subject for whom ADA is not detected at baseline, or (2) an ADA 
detected sample with ADA titer to be at least 4-fold or greater (≥) than baseline positive titer
•
ADA-negative sample: After initiation of treatment, ADA not positive sample relative to 
baseline
Next, using the sample ADA status, subject ADA status is defined as follows:
Subject ADA Status:
•
Baseline ADA-positive subject: A subject with baseline ADA-positive sample
•
ADA-positive subject: A subject with at least one ADA positive-sample relative to baseline 
at any time after initiation of treatment
1) Persistent Positive (PP): ADA-positive sample at 2 or more consecutive time points, where 
the first and last ADA-positive samples are at least 16 weeks apart
2) Not PP-Last Sample Positive: Not persistent positive with ADA-positive sample at the last 
sampling time point
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3) Other Positive: Not persistent positive but some ADA-positive samples with the last sample 
being negative
4) Neutralizing Positive: At least one ADA-positive sample with neutralizing antibodies detected
•
ADA-negative subject: A subject with no ADA-positive sample after the initiation of 
treatment.
(Note: 16 weeks was chosen based on a long half-life of IgG4.)
Population for Analyses
Analysis of immunogenicity data will be based on ADA evaluable subjects defined as all treated 
subjects with baseline and at least 1 post-baseline immunogenicity assessment. Analysis dataset 
and data listing will include all available ADA samples. However, subject-level ADA status will 
be defined based on only adequate samples (e.g., excluding 1-hour post-infusion samples when 
clearly indicated).
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