Clinical trial NCT03351231
Conditions: Cancer
Sponsor: Bristol-Myers Squibb
Start date: 2017-11-27; Completion date: 2018-08-28
Enrollment: 7 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The purpose of this study is to investigate safety of experimental medication BMS-986242 and Nivolumab in patients with advanced cancers.

Detailed description:

Arms: arm 1: BMS-986242 administered in combination with Nivolumab arm 2: BMS-986242 administered in combination with Nivolumab
Interventions: intervention 1: BMS-986242 intervention 2: Nivolumab
Intervention descriptions: intervention 1: Specified dose on specified days intervention 2: Specified dose on specified days

Protocol documents:
Prot_SAP_000.pdf: 
Page:
1
Protocol Number:
CA024001
IND Number:
132183
EUDRACT Number
2017-003603-21
Date
19-Sep-2017
Revised Date:
31-Oct-2017
Clinical Protocol CA024001
A Phase 1/2a Study of BMS-986242 Administered in Combination with Nivolumab 
(BMS-936558, Anti-PD-1) in Advanced Malignant Tumors
Revised Protocol: 01
Study Director/Medical Monitor
Sophia K. Khaldoyanidi, MD, PhD
 
This document is the confidential and proprietary information of Bristol-Myers Squibb 
Company and its global affiliates (BMS). By reviewing this document, you agree to keep it 
confidential and to use and disclose it solely for the purpose of assessing whether your 
organization will participate in and/or the performance of the proposed BMS sponsored 
study. Any permitted disclosures will be made only on a confidential "need to know" basis 
within your organization or to your independent ethics committee(s). Any other use, copying, 
disclosure or dissemination of this information is strictly prohibited unless expressly 
authorized in writing by BMS. Any supplemental information (eg, amendments) that may 
be added to this document is also confidential and proprietary to BMS and must be kept in 
confidence in the same manner as the contents of this document. Any person who receives 
this document without due authorization from BMS is requested to return it to BMS or 
promptly destroy it. 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).
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IDO1 INHIBITOR
Revised Protocol No.: 01
Date: 31-Oct-2017
2
Replace all previous version(s) of the protocol with this revised protocol and please provide 
a copy of this revised protocol to all study personnel under your supervision, and archive the 
previous versions.
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Revised Protocol No.: 01
Date: 31-Oct-2017
3
DOCUMENT HISTORY
Document
Date of Issue
Summary of Change
Revised Protocol 01
31-Oct-2017
Reduced starting dose based on FDA feedback. 
Added exclusion criterion for participants with current or 
recent gastrointestinal disease
Original Protocol
19-Sep-2017
Not Applicable
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OVERALL RATIONALE FOR REVISED PROTOCOL 01:
Changes were made to the protocol to address FDA feedback.
The Revised Protocol applies to all participants.
SUMMARY OF KEY CHANGES FOR REVISED PROTOCOL 01
Section Number 
& Title
Description of Change
Brief Rationale
Table 2-1
Removed cervical cancer 
participants from the Mutational and 
Viral Status
Correction of error. No cervical 
cancer participants are in this 
study
Section 5.1 
Overall Design
Revised starting dose to 12.5 mg
Reduced starting dose based on 
FDA feedback
Section 5.1.2.1 
Part 1 Dose 
Escalation:
Revised Figure to include 12.5 mg 
dose
Reduced starting dose based on 
FDA feedback
Table 5.1.2.1-1
Added 12.5 mg dose
Reduced starting dose based on 
FDA feedback
Section 5.5.1
Dose and Schedule for BMS-986242
Reduced starting dose based on 
FDA feedback
Section 6.1 
Inclusion Criteria
Modified inclusion criterion for 
participants harboring genetic 
aberrations (e.g. BRAF, EGFR, 
ALK, HER2)
Ensure participants with genetic 
aberrations have received
appropriate standard of care 
targeted therapies prior to 
participation in this study
Section 6.2 
Exclusion 
Criterion 
Added exclusion criterion for 
participants with current or recent 
gastrointestinal disease
Per FDA feedback to assure 
gastrointestinal co-morbidities do 
not interfere with PK parameters 
of study drug 
Section 7.1 
Treatments 
Administered 
Table 7.1-1
12.5 mg dose level added
Reduced starting dose based on 
FDA feedback
Section 7.4.2 
Guidelines for 
Dose 
Modifications
Clarified guideline on dose 
modification
Defined 25 mg as the lowest dose 
level permitted for dose reduction
Section 10.1 
Sample Size 
Determination
Added statement regarding operating 
characteristics of BLRM for the 
addition of the 12.5 mg dose
To align with the addition of an 
escalation cohort.
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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.................................................................................. 
3 INTRODUCTION ..................................................................................................... 
 
 
 
 
 
 
 
 
 
 
 
 
3.3 Overall Benefit/Risk Assessment ..................................................................... 
3.3.1 Risk/Benefit for BMS-986242 .................................................................. 
3.3.2 Risk/Benefit for Combination with Nivolumab ........................................ 
3.3.3 Summary .................................................................................................. 
4 OBJECTIVES AND ENDPOINTS ........................................................................... 
5 STUDY DESIGN....................................................................................................... 
5.1 Overall Design .................................................................................................. 
5.1.1 Screening Phase ....................................................................................... 
5.1.2 Treatment Phase ...................................................................................... 
5.1.2.1 Part 1: Dose Escalation .................................................................. 
5.1.2.2 Part 2: Dose-Expansion Cohorts .................................................... 
5.1.2.3 Treatment Beyond Progression....................................................... 
5.1.2.4 Discontinuation Due to Further Progression ................................. 
5.1.3 Clinical/Safety Follow-up ........................................................................ 
5.1.4 Survival/Long-Term/Response Follow-up ............................................... 
5.1.5 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 .............................................................................................. 
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6.2 Exclusion Criteria ............................................................................................. 
6.3 Lifestyle Restrictions ........................................................................................ 
6.3.1 Meals and Dietary Restrictions ............................................................... 
6.3.2 Caffeine, Alcohol, and Tobacco ............................................................... 
6.3.3 Activity ..................................................................................................... 
6.4 Screen Failures .................................................................................................. 
6.4.1 Retesting During Screening or Lead-in Period ....................................... 
7 TREATMENT ........................................................................................................... 
7.1 Treatments Administered .................................................................................. 
7.2 Method of Treatment Assignment .................................................................... 
7.3 Blinding............................................................................................................. 
7.4 Dosage Modification ......................................................................................... 
7.4.1 Dose-limiting Toxicity .............................................................................. 
7.4.1.1 Dose-limiting Toxicities .................................................................. 
7.4.2 Guidelines for Dose Modification ............................................................ 
7.4.3 Dose Delays Due to Toxicity.................................................................... 
7.4.4 Criteria to Resume Treatment .................................................................. 
7.4.5 Guidelines for Permanent Discontinuation Secondary to Adverse Events
.....................................................................................................................
7.5 Preparation/Handling/Storage/Accountability .................................................. 
7.5.1 Retained Samples for Bioavailability/Bioequivalence ............................. 
7.6 Treatment Compliance ...................................................................................... 
7.7 Concomitant Therapy........................................................................................ 
7.7.1 Prohibited and/or Restricted Treatments................................................. 
 
 
 
 
 
7.8 Treatment After the End of the Study ............................................................... 
8 DISCONTINUATION CRITERIA ........................................................................... 
8.1 Discontinuation from Study Treatment ............................................................ 
8.1.1 Post Study Treatment Study Follow-up.................................................... 
8.2 Discontinuation from the Study ........................................................................ 
8.3 Lost to Follow-up .............................................................................................. 
9 STUDY ASSESSMENTS AND PROCEDURES ..................................................... 
9.1 Efficacy Assessments ........................................................................................ 
9.1.1 Imaging Assessment for the Study............................................................ 
9.1.2 Secondary Efficacy Assessment ............................................................... 
 
9.2 Adverse Events ................................................................................................. 
9.2.1 Time Period and Frequency for Collecting AE and SAE Information .... 
9.2.2 Method of Detecting AEs and SAEs ......................................................... 
9.2.3 Follow-up of AEs and SAEs ..................................................................... 
9.2.4 Regulatory Reporting Requirements for SAEs ......................................... 
9.2.5 Pregnancy ................................................................................................ 
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9.2.6 Laboratory Test Result Abnormalities ..................................................... 
9.2.7 Potential Drug-induced Liver Injury ....................................................... 
9.2.8 Other Safety Considerations .................................................................... 
9.3 Overdose ........................................................................................................... 
9.4 Safety ................................................................................................................ 
9.4.1 Physical Examinations ............................................................................. 
9.4.2 Vital Signs ................................................................................................ 
9.4.3 Electrocardiograms ................................................................................. 
9.4.4 Clinical Safety Laboratory Assessments .................................................. 
9.4.5 Suicidal Risk Monitoring ......................................................................... 
9.4.6 Imaging Safety Assessment ...................................................................... 
9.5 Pharmacokinetic ................................................................................................ 
9.5.1 Pharmacokinetic Assessment Following BMS-986242 Monotherapy ..... 
9.5.2 Pharmacokinetic Assessment Following Combination Treatment with 
BMS 986242 and Nivolumab ...................................................................... 
9.5.3 Pharmacokinetics: Collection and Processing ........................................ 
9.5.4 Pharmacokinetic Sample Analyses .......................................................... 
9.6 Pharmacodynamics ........................................................................................... 
9.7 Pharmacogenomics ........................................................................................... 
9.7.1 Absorption, Distribution, Metabolism, and Excretion Sampling ............. 
 
 
 
 
 
 
 
 
 
 
 
 
9.9 Health Economics OR Medical Resource Utilization and Health Economics . 
10 STATISTICAL CONSIDERATIONS .................................................................... 
10.1 Sample Size Determination ............................................................................. 
10.1.1 Dose Escalation ..................................................................................... 
10.1.2 Dose-expansion Cohort ......................................................................... 
10.2 Populations for Analyses ................................................................................ 
10.3 Statistical Analyses ......................................................................................... 
10.3.1 Efficacy Analyses ................................................................................... 
10.3.2 Safety Analyses....................................................................................... 
10.3.3 Other Analyses ....................................................................................... 
10.3.4 Interim Analyses ..................................................................................... 
 
12 APPENDICES ......................................................................................................... 
APPENDIX 1 ABBREVIATIONS AND TRADEMARKS ........................................ 
 
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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 ECOG PERFORMANCE STATUS ..................................................... 
 
APPENDIX 6 RECIST V1.1 ........................................................................................ 
 
APPENDIX 7 STATISTICAL METHODOLOGY ..................................................... 
 
APPENDIX 8 CYP3A AND CYP2B6 GUIDANCE ................................................... 
 
APPENDIX 9 MANAGEMENT ALGORITHMS FOR IMMUNO-ONCOLOGY 
AGENTS ................................................................................................................. 
 
APPENDIX 10 MEDICATIONS ASSOCIATED WITH QT PROLOGATION ........ 
 
APPENDIX 11 P-GP AND BCRP GUIDANCE ......................................................... 
 
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1
SYNOPSIS
Protocol Title: A Phase 1/2a Study of BMS-986242 Administered in Combination with 
Nivolumab (BMS-936558, Anti-PD-1) in Advanced Malignant Tumors
Study Phase:
Phase 1/2a
Rationale:
This study will consist of 2 parts, Part 1 Dose Escalation and Part 2 Dose-Expansion Cohorts.
During Part 1 the study will evaluate the safety, tolerability, pharmacokinetics (PK), and 
pharmacodynamics of escalating oral doses of BMS-986242 in combination with a flat dose of 
nivolumab. In addition, the study is expected to identify dose limiting toxicities (DLTs), the 
maximum tolerated dose (MTD) (or maximum administered dose [MAD]/alternative dose, if 
applicable) of BMS-986242 in combination with nivolumab in participants with advanced 
malignant tumors. The purpose of Part 2 of the study is to gather additional safety, tolerability, 
preliminary efficacy, PK, and pharmacodynamics information regarding BMS-986242 in 
combination with nivolumab.
Study Population:
Participants of at least 18 years of age with advanced malignant tumors.
Objectives and Endpoints:
Objectives
Endpoints
Primary
Part 1: Dose Escalation

To determine the safety, tolerability, DLTs, and 
MTD/MAD/alternative dose of BMS-986242 
administered as monotherapy (lead-in cycle) and in 
combination with nivolumab in participants with 
advanced malignant tumors

Incidence of DLTs, AEs, SAEs, AEs leading to 
discontinuation, deaths, and clinical laboratory test 
abnormalities

Additional safety endpoints include changes from 
baseline in laboratory parameters, vital signs, and 
ECGs.
Part 2: Dose-Expansion Cohort(s)

To evaluate
the safety and tolerability of 
BMS-986242 in combination with nivolumab in 
participants with advanced malignant tumors
Secondary

To 
characterize 
the 
PK 
of 
BMS-986242 
administered alone and in combination with 
nivolumab

Summary measures of selected BMS-986242 PK 
parameters, such as Cmax, Tmax, AUC(TAU), 
AUC(INF), Ctrough, T-HALF, CLT/F, Vss/F, AI, 
%UR24, %UR72, and exposure ratios of select 
BMS-986242 metabolites to BMS-986242 from 
concentration-time
data 
during 
BMS-986242 
monotherapy and BMS-986242 Ctrough during 
combination treatment.
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Objectives
Endpoints

To characterize the pharmacodynamic activity of 
BMS-986242 
administered 
alone 
and 
in 
combination with nivolumab

Summary measures of change from baseline (and/or 
percent change) for serum and tumor kynurenine 
and related metabolites

To characterize the immunogenicity of nivolumab 
when 
administered 
in 
combination 
with 
BMS-986242

Incidence of ADA to nivolumab in combination 
with BMS-986242

To assess the preliminary anti-tumor activity of 
BMS-986242 administered in combination with 
nivolumab in advanced malignant tumors

ORR in participants with a BOR of CR or PR per 
RECIST version 1.1 for solid tumors; mDOR, and 
PFSR at 6, 9, 12, and 24 months.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: %UR24 = percent urinary recovery over 24 hours; %UR72 = percent urinary recovery over 72 hours 
ADA = anti-drug antibody; AE = adverse event; AI = accumulation index; AUC(0-T) = area under the 
concentration-time curve; AUC(INF) = area under the concentration-time curve from time zero to infinity; 
AUC(TAU) = area under the concentration-time curve in 1 dosing interval; BOR = best overall response; Ceoi = 
concentrations at end of infusion; Cmax = maximum observed plasma concentration; CR = complete response; 
Ctrough = trough observed plasma concentration at the end of the dosing interval; CLT/F =  apparent total body 
clearance; DLT = dose-limiting toxicity; DOR = duration of response; mDOR = median duration of response; ECGs 
= 12-lead electrocardiograms; MAD = maximum administered dose; MR_AUC(0-T) = ratio of metabolite 
AUC(0-T) to parent AUC(0-T) corrected for molecular weight; MR_AUC(INF) = ratio of metabolite AUC(INF)
to parent AUC(INF) corrected for molecular weight; MR_AUC(TAU) = ratio of metabolite AUC(TAU) to parent 
AUC(TAU) corrected for molecular weight; MR_Cmax = ratio of metabolite Cmax to parent Cmax corrected for 
molecular weight; ORR = overall response rate; OSR = overall survival rate; PFSR = progression-free survival rate; 
PR = partial response; RECIST = Response Evaluation Criteria in Solid Tumors; SAE = serious adverse event; T-
HALF = apparent elimination half-life; Tmax = time of maximum observed plasma concentration;
Vss/F = apparent volume of distribution at steady state.
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Overall Design:
Part 1 open-label dose escalation and Part 2 dose-expansion cohort phase

To assess the short-term safety and clinical pharmacology profile of BMS-986242 
monotherapy prior to allowing participants to receive treatment in combination with nivolumab 
(see Section 3.1.2 for further details), dose escalation will start with a lead-in Cycle 0, whereby 
BMS-986242 is administered as monotherapy of 2-week duration in each dose escalation 
cohort. Decision to proceed to combination treatment with nivolumab (Cycle 1) for each 
participant in dose escalation will be determined after tolerability of the monotherapy lead-in 
is established in the 2-week Cycle 0 at each dose (see Section 5.1.2.1). The starting dose of 
BMS-986242 is 12.5 mg administered orally daily. Nivolumab will be administered at a dose 
of 480 mg intravenously (IV) Q4W. In the event the 12.5-mg dose level of BMS-986242 is 
determined to exceed the MTD in monotherapy or in combination with nivolumab, no lower 
BMS-986242 dose level will be further explored. At no point will the dose of BMS-986242 
administered in combination with nivolumab exceed doses of BMS-986242 that have been 
demonstrated previously to be safe in the monotherapy lead-in Cycle 0. In addition, a clinical 
pharmacology substudy will be conducted in which a single-dose PK, BMS-986242 exposure-
QTc relationship, and exploratory food effect of BMS-986242 will be assessed.

The study will be restricted to 6 disease types (melanoma, non-small cell lung cancer 
[NSCLC], squamous cell carcinoma of the head and neck [SCCHN], bladder urothelial 
carcinoma [BUC], renal cell carcinoma [RCC], and gastric cancer).

Upon completion of study treatment, participants will enter the Clinical/Safety Follow-up for 
at least 100 days (3 visits) after the last dose of study treatment.

After completion of the Clinical/Safety Follow-up period, participants will enter the 
Survival/Long-term Follow-up period, during which clinic visits or telephone contact every 
3 months will be performed to assess survival status up to 2 years from the last dose of study 
treatment.
Number of Participants: 
Up to 298 participants will be enrolled for this study; approximately 78 participants for Part 1 
(dose-escalation cohorts) and the clinical pharmacology substudy, and approximately 220
participants for Part 2 (dose-expansion cohorts).
Treatment Arms and Duration:
Study Treatment:
Study Treatments for CA024-001
Medication 
Potency 
IP/Non-IP 
BMS-986242-01 Film-Coated Tablet
25 mg
IP
BMS-986242-01 Film-Coated Tablet
100 mg
IP
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Study Treatments for CA024-001
Medication 
Potency 
IP/Non-IP 
Nivolumab Injection
10 mg/mL
(100 mg/vial)
IP
Abbreviations: IP = investigational product.
Figure 1-1:
Study Design Schematic
Abbreviations: AE = adverse event; CR = complete response; EOT = end of treatment; MM = Medical Monitor; 
PD = progressive disease; PI = principal investigator; PK = pharmacokinetics; PR = partial response; SD = stable 
disease.
Study Periods
Screening (up to 28 days):
Participants will sign informed consent and be evaluated for study eligibility.
Treatment Phase (consists of 104 weeks for all Parts):
In Part 1, the dose-escalation phase will start with Cycle 0, a lead-in period of 2 weeks in duration, 
during which monotherapy with BMS-986242 is administered (see Section 3.1.2 and Section 5.1.2
for further details). In both Part 1 and Part 2, each treatment cycle is 4 weeks (except Cycle 0) and 
is comprised of daily doses of BMS-986242 and 1 dose of nivolumab administered every 4 weeks 
on Day 1 of the treatment cycle. The total treatment period is 104 weeks or 26 cycles (excluding 
Cycle 0). Following every 2 treatment cycles (8 weeks), the decision to treat a participant with 
additional cycles of study treatment will be based on radiological tumor assessments (initial 
evaluation performed at baseline, end of Cycle 2, and every 8 weeks). Assessment of PR and CR 
must be confirmed at least 4 weeks following initial assessment. Tumor progression or response 
endpoints will be assessed using RECIST version 1.1 criteria for solid tumors.
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Treatment beyond progression may be allowed in select participants
with initial 
RECIST v1-defined progressive disease (PD) after discussion and agreement with the BMS
Medical Monitor that the benefit/risk assessment favors continued administration of study 
treatment (eg, participants are continuing to experience clinical benefit as assessed by the 
investigator, tolerating treatment, and do not meet treatment discontinuation criteria). See Section 
5.1.2.3 for further details. 
Clinical/Safety Follow-up Period: 
Upon completion of study treatment, participants will enter the Clinical/Safety Follow-up period.
For participants who complete all scheduled cycles of study treatment, the End-of-Treatment 
(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 study treatment, 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 (representing approximately 5 half-lives for 
nivolumab) after the last dose of study treatment. Follow-up visits should occur at Days 30, 60, 
and 100 (±10 days) after the last dose of study treatment or coinciding with the date of 
discontinuation (±10 days) if the date of discontinuation is greater than 30 days after the last dose 
of study treatment to monitor for adverse events.
Participants will be required to complete 3 Clinical/Safety Follow-up visits regardless of whether 
they start new anti-cancer therapy, except those participants who withdraw consent for study 
participation.
Survival/Long-term Follow-up: 
After completion of the Clinical/Safety Follow-up period, participants will then enter the 
Survival/Long-term Follow-up period. During this period, clinic visits or telephone contact every 
3 months will be performed to assess survival status. The duration of Survival/Long-term 
Follow-up period will be 2 years from the last dose of study treatment.
Duration of Study: 
The total duration of the study is expected to be approximately 5 years from the onset of the first 
visit of the first subject to the required Survival/Long-term Follow-up of the last subject enrolled. 
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2
SCHEDULE OF ACTIVITIES
Study assessments and procedures are presented in Table 2-1, Table 2-2, Table 2-3, Table 2-4, 
Table 2-5. 
Abbreviations used in the protocol are shown in Appendix 1.
In limited instances, scheduled events can occur outside of the indicated timeframes, but BMS 
should be notified. In the event that multiple procedures are required at a single time point, 
electrocardiograms may be obtained up to 15 minutes earlier, vital signs may be obtained up to 
10 minutes earlier or later, and clinical laboratory samples may be obtained up to 5 minutes earlier 
than the nominal time point, ensuring the pharmacokinetics samples can be collected on time.
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Table 2-1:
Screening Procedural Outline 
Procedure
Screeninga
Visit 28
Days
Day-14 
to -1 
Visit
Day-1
Visit
Notes
Eligibility Assessments
Informed Consent
X
A participant is considered enrolled only when a protocol-specific informed consent 
is signed. Obtain participant number from IRT.
Inclusion/Exclusion Criteria
X
Medical History
X
Also include any toxicities or allergy related to previous treatments. 
Prior Systemic Therapies
X
Including prior cancer treatment regimens and medications administered within 
4 weeks of dosing
Tobacco History/Status
X
Archival Tumor Tissue Samples
X
An archival, FFPE tumor tissue block or slide samples is to be provided by all 
participants, if available. One paraffin block or 15 to 20 FFPE unstained slides are to 
be identified and located prior to dosing.
Fresh Pretreatment Tumor 
Biopsy
X
Note that mandatory pre- and on-treatment biopsies will be collected at all dose 
levels. If biopsy is collected during screening, an additional pretreatment biopsy will 
not be needed. Biopsy is performed during screening in participants for whom an 
archived tumor tissue sample is unavailable. Tumor tissue is to be sent to the central 
laboratory after performing specified tests locally (see “Laboratory Tests” in this 
table below). 
Safety Assessments
Physical Examination
X
If the screening PE is performed within 24 hours prior to dosing on Day 1, then a 
single examination may count as both the screening and predose evaluation. Includes 
neurological examination.
Physical Measurements
X
Includes height and weight
ECOG Performance Status
X
See Appendix 5.
Vital Signs
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.
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Date: 31-Oct-2017
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CA024001
BMS-986242
IDO1 INHIBITOR
Table 2-1:
Screening Procedural Outline 
Procedure
Screeninga
Visit 28
Days
Day-14 
to -1 
Visit
Day-1
Visit
Notes
Oxygen Saturation
X
Pulse oximetry collected while the participant is at rest
12-lead ECG
X
ECGs should be recorded after the participant has been supine for at least 5 minutes. 
Laboratory Tests
Laboratory tests listed below must be completed within 2 weeks of Day 1 unless 
otherwise noted. 
Chemistry (Excluding LFTs)
X
Includes assessments for sodium, potassium, chloride, total serum calcium, 
magnesium, bicarbonate/carbon dioxide, phosphorus, BUN, creatinine, creatinine 
clearance, fasting glucose, total protein, albumin, amylase, lipase, uric acid, ferritin, 
LDH, HDL, and LDL.
CBC with Differential and 
Platelets
X
LFT Assessments
X
Includes AST, ALT, total bilirubin, direct bilirubin (only if total bilirubin is 
elevated), alkaline phosphatase, and GGT (only when alkaline phosphatase increases 
to ≥Grade 2)
PT/PTT
X
Urinalysis
X
Urine to be checked for protein, glucose, blood, leukocyte esterase, specific gravity, 
and pH. Microscopic examination of sediment will be done if blood, protein, or 
leukocyte esterase is positive on dipstick.
Thyroid Function Tests
X
TSH with reflex testing to free T3 and free T4 if TSH is abnormal. Results should be 
examined by the investigator or appropriate designee within 48 hours of dose 
administration.
Mutational and Viral Status
X
Document EGFR, ALK and, if available, KRAS for participants with NSCLC. 
Document BRAF for participants with melanoma.
SCCHN participants only: Sites must submit and document prior HPV status within 
28 days of dosing. See Section 9.8.1.3 and Inclusion Criteria (Section 6.1).
Serology
X
Within 28 days of dosing: hepatitis B surface antigen, hepatitis C antibody (if 
hepatitis C antibody is positive reflex to hepatitis C RNA), or hepatitis C RNA
Revised Protocol No.: 01
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CA024001
BMS-986242
IDO1 INHIBITOR
Table 2-1:
Screening Procedural Outline 
Procedure
Screeninga
Visit 28
Days
Day-14 
to -1 
Visit
Day-1
Visit
Notes
Note: Testing for HIV-1 and HIV-2 must be performed at sites where mandated by 
local requirements.
Pregnancy Test
X
X
WOCBP only at screening and within 24 hours prior to dosing. The serum 
pregnancy test may be completed on the first day of treatment provided the results are 
available before the start of study treatment.
If performed within 24 hours of dosing on Cycle 0 Day 1, then Cycle 0 Day 1 
pregnancy test is not required.
Follicle-stimulating Hormone
X
If needed to document postmenopausal status
Concomitant Medications
X
Collected during the 2 weeks prior to Cycle 1 Day 1
Clinical Complaints
X
Collected during the 2 weeks prior to Cycle 1 Day 1
Adverse Event Reporting
Monitor for Serious Adverse 
Events
X
X
X
All SAEs must be collected from the date of participant’s written consent until 
100 days after discontinuation of nivolumab or participation in the study (if the last 
scheduled visit occurs at a later time). eSAEs should be approved in the BMS EDC 
tool within 5 business days of entry.
Efficacy Assessments
Diagnostic Imaging
(Body Imaging)
X
CT with contrast is the preferred modality (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 who have not had brain imagining within 30 days of 
anticipated first study treatment 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.
a The screening period will be 28 days. 
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Date: 31-Oct-2017
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CA024001
BMS-986242
IDO1 INHIBITOR
Abbreviations: ALK = anaplastic lymphoma receptor tyrosine kinase;
ALT
=
alanine aminotransferase; AST
=
aspartate aminotransferase; 
BMS EDC = Bristol-Myers Squibb Electronic Data Capture; BUN = blood urea nitrogen; CBC = complete blood count; CRF = case report form; CT = computed 
tomography; ECG = electrocardiogram; ECOG = Eastern Cooperative Oncology Group; EGFR = epidermal growth factor receptor; eSAE = electronic serious 
adverse event; FFPE = formalin-fixed, paraffin-embedded; GGT = gamma-glutamyl transferase; HIV = human immunodeficiency virus; HPV = human 
papillomavirus; IRT = Interactive Response Technology; LDH = lactate dehydrogenase; LFT = liver function test; MRI = magnetic resonance imaging; 
NSCLC = non-small cell lung cancer; PE = physical examination; PT = prothrombin time; PTT = partial thromboplastin time; RNA = ribonucleic acid; 
SAE = serious adverse event; SCCHN = squamous cell carcinoma of the head and neck; TSH = thyroid-stimulating hormone; WOCBP = women of childbearing 
potential.
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Date: 31-Oct-2017
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CA024001
BMS-986242
IDO1 INHIBITOR
Table 2-2:
On-treatment Procedural Outline (BMS-986242 Monotherapy in Part 1 Dose Escalation)
Procedure
Cycle 0
Notes
Day 1 
Day 2
Day 8
Day 14
IRT Assignment
X
Cycle 0 Day 1 only. BMS-986242 IP assignment.
Once participant eligibility has been confirmed, IRT assignment 
can be performed within 3 days prior to first study treatment 
administration. (Discuss with Sponsor if institutional policies 
and procedures require additional lead-time.)
Complete PE
Xa
Predose. Includes neurological examination.
Symptom-directed PE
X
X
X
Predose.
Vital Signs and 
Oxygen Saturations
X
Includes 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. Pulse 
oximetry should be collected while the participant is at rest.
12-lead ECG
X
X
Collect triplicate ECG on Cycle 0 Day 1 and Cycle 0 Day 14 at 
-1 hour and 2 and 4 hours postdose. All ECG tests during Cycle 
0 will be performed in triplicates (eg, 1 ECG test equals 3 
consecutive individual 12-lead ECGs performed 5 minutes 
apart). ECGs should be performed after the participant has been 
supine for at least 5 minutes and should be completed prior to 
any PK/pharmacodynamic sample blood collections when 
assessments occur at the same time points.
Laboratory Testa,b
Chemistry (Excluding 
LFTs)
Xb
X
X
Collect predose; includes assessments for sodium, potassium, 
chloride, total serum calcium, magnesium, bicarbonate/carbon 
dioxide, phosphorus, BUN, creatinine, glucose, total protein, 
albumin, amylase, lipase, uric acid, ferritin, LDH, HDL, and 
LDL.
CBC with Differential 
and Platelets
Xb
X
X
X
Collect predose.
In addition, please collect predose on Day 4 (±1) day.
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CA024001
BMS-986242
IDO1 INHIBITOR
Table 2-2:
On-treatment Procedural Outline (BMS-986242 Monotherapy in Part 1 Dose Escalation)
Procedure
Cycle 0
Notes
Day 1 
Day 2
Day 8
Day 14
LFT Assessments
Xb
X
X
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).
Collect predose; LFTs should be repeated 4 hours postdose on 
Cycle 0 Day 14.
Pregnancy Test 
(WOCBP)
X
Serum or urine pregnancy test must be performed (urine 
pregnancy test: minimum sensitivity 25 IU/L or equivalent units 
of hCG) within 24 hours prior to administration of study 
treatment.
If pregnancy test is positive, hold all study treatment and 
perform confirmatory testing. If pregnancy is confirmed, 
permanently discontinue all study treatment and immediately 
notify the Sponsor per Section 9.2.5.
Concomitant 
Medication 
Assessments
X
X
X
X
Review prior to dosing.
Monitor for 
Nonserious Adverse 
Events
X
X
X
X
Nonserious AEs will be collected starting with the first dose of 
study treatment until 100 days after discontinuation of 
nivolumab.
Monitor for Serious 
Adverse Events
X
X
X
X
All SAEs must be collected from the date of participant’s 
written consent until 100 days after discontinuation of 
nivolumab or participation in the study (if the last scheduled 
visit occurs at a later time). eSAEs should be approved in the 
BMS EDC tool within 5 business days of entry.
Pharmacokinetic 
Assessments
See Section 9.5.3 and Table 9.5.3-1.
Performed in all participants
Immunogenicity 
Assessments
See Section 9.5.3, Section 9.8.3, and Table 9.5.3-1.
Performed in all participants
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CA024001
BMS-986242
IDO1 INHIBITOR
Table 2-2:
On-treatment Procedural Outline (BMS-986242 Monotherapy in Part 1 Dose Escalation)
Procedure
Cycle 0
Notes
Day 1 
Day 2
Day 8
Day 14
 
Additional Research
See Section 9.8.2.
Study Treatment 
Administration
Details regarding preparation and administration are provided in 
the site training materials.
BMS-986242
Administration
X
Continuous daily dosing during all cycles
BMS-986242 to be administered daily at approximately the 
same time.
Tablet Diary
X
Tablet diary must be completed with each 
administered daily dose of BMS-986242
Review tablet diary during each visit for compliance of daily 
administration of BMS-986242. Collect tablet diary at the 
completion of each cycle.
a For Cycle 0 Day 1, PE and laboratory tests do not need to be repeated if completed within the last 72 hours (for all laboratory tests).
b Participants who meet discontinuation criteria during or after Cycle 0 will have CBC with differential, platelets, and chemistry with LFTs done at the EOT and 
during the follow-up visit at 7 days.
Abbreviations: AE = adverse event; ALT = alanine aminotransferase; AST = aspartate aminotransferase; BMS EDC = Bristol-Myers Squibb Electronic Data 
Capture; BUN = blood urea nitrogen; CBC = complete blood count; ECG = electrocardiogram; EOT = end of treatment; eSAE = electronic serious adverse 
event; GGT = gamma-glutamyl transferase; hCG = human chorionic gonadotropin; IP = investigational product; IRT = Interactive Response Technology; 
LDH = lactate dehydrogenase; LFT = liver function test; PE = physical examination; SAE = serious adverse event; WOCBP = women of childbearing potential.
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Date: 31-Oct-2017
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Clinical Protocol
CA024001
BMS-986242
IDO1 INHIBITOR
Table 2-3:
On-treatment Procedural Outline (BMS-986242 + Nivolumab Part 1 Dose Escalation and Part 2 
Dose-Expansion Cohorts) 
Procedure
Cycle 1
(4 weeks)
Cycles 2 to 4
(4 weeks)
Cycles 4+ 
(4 weeks)
End of 
Treatmenta,b,c
Notes
Day 1
Day 8
Day 15 
Day 22 
Day 1 
Day15 
(±2 days)
Days
22-28
Day 1
Days
22-28
IRT Assignment
IRT Assignment
X
X
X
Once participant eligibility has 
been confirmed, IRT assignment 
can be performed within 3 days 
prior to first study treatment 
administration. (Discuss with 
Sponsor if institutional policies 
and procedures require additional 
lead-time.)
Safety Assessments
Complete PE
X
X
X
Predose. Includes neurological 
examination.
Symptom-directed 
PE
X
X
X
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Clinical Protocol
CA024001
BMS-986242
IDO1 INHIBITOR
Table 2-3:
On-treatment Procedural Outline (BMS-986242 + Nivolumab Part 1 Dose Escalation and Part 2 
Dose-Expansion Cohorts) 
Procedure
Cycle 1
(4 weeks)
Cycles 2 to 4
(4 weeks)
Cycles 4+ 
(4 weeks)
End of 
Treatmenta,b,c
Notes
Day 1
Day 8
Day 15 
Day 22 
Day 1 
Day15 
(±2 days)
Days
22-28
Day 1
Days
22-28
Vital Signs and 
Oxygen 
Saturations
X
X
X
X
X
X
X
X
Includes 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. 
Pulse oximetry should be 
collected while the participant is 
at rest.
For nivolumab, vital signs should 
be obtained prior to the infusion 
and then every 30 min (10 min) 
until 1 hour following completion 
of the infusion, except on Cycle 1 
Day 1, when vital signs will be 
obtained until 4 hours following 
completion of the infusion.
If any vital sign is abnormal 
(based upon clinician assessment) 
at the final check, the participant 
must be observed further for a 
period of time, as clinically 
indicated.
12-lead ECG
X
X
X
12-lead ECG should be recorded 
after the participant has been
supine for at least 5 minutes. A 
single ECG must be collected at 
predose on Day 1 of each cycle.
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Clinical Protocol
CA024001
BMS-986242
IDO1 INHIBITOR
Table 2-3:
On-treatment Procedural Outline (BMS-986242 + Nivolumab Part 1 Dose Escalation and Part 2 
Dose-Expansion Cohorts) 
Procedure
Cycle 1
(4 weeks)
Cycles 2 to 4
(4 weeks)
Cycles 4+ 
(4 weeks)
End of 
Treatmenta,b,c
Notes
Day 1
Day 8
Day 15 
Day 22 
Day 1 
Day15 
(±2 days)
Days
22-28
Day 1
Days
22-28
Laboratory Tests
On-study laboratory assessments (including pregnancy testing) to be done on site/locally. Laboratory assessments do not 
need to be repeated on Day 1 for Cycles 1 and onward if completed within the last 24 hours.
All laboratory assessments will be done weekly for Cycle 1 only, unless otherwise specified.
Chemistry 
(Excluding LFTs)
X
X
X
X
X
X
X
X
Predose; includes assessments for 
sodium, potassium, chloride, total 
serum calcium, magnesium, 
bicarbonate/carbon dioxide, 
phosphorus, BUN, creatinine, 
glucose, total protein, albumin, 
amylase, lipase, uric acid, 
ferritin, LDH, HDL, and LDL.
CBC with 
Differential and 
Platelets
X
X
X
X
X
X
X
X
Predose.
LFT Assessments
X
X
X
X
X
X
X
X
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)
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Clinical Protocol
CA024001
BMS-986242
IDO1 INHIBITOR
Table 2-3:
On-treatment Procedural Outline (BMS-986242 + Nivolumab Part 1 Dose Escalation and Part 2 
Dose-Expansion Cohorts) 
Procedure
Cycle 1
(4 weeks)
Cycles 2 to 4
(4 weeks)
Cycles 4+ 
(4 weeks)
End of 
Treatmenta,b,c
Notes
Day 1
Day 8
Day 15 
Day 22 
Day 1 
Day15 
(±2 days)
Days
22-28
Day 1
Days
22-28
Thyroid Function 
Tests
X
X
X
X
If collected at screening, do not 
repeat on Cycle 1 Day 1. Collect 
every 2 cycles, predose, 
beginning with Cycle 3 Day 1 
and at EOT.
To include TSH with reflex 
testing (free T3 and free T4) if 
TSH is abnormal. Results should 
be examined by the investigator 
or appropriate designee within 
48 hours of dose administration.
Pregnancy Test 
(WOCBP)
X
X
X
X
X
X
Serum or urine pregnancy test 
must be performed (urine 
pregnancy test: minimum 
sensitivity 25 IU/L or equivalent 
units of hCG) within 24 hours 
prior to administration of study 
treatment.
If pregnancy test is positive, hold 
all study treatment and perform 
confirmatory testing. If 
pregnancy is confirmed, 
permanently discontinue all study 
treatment and immediately notify 
the Sponsor per Section 9.2.5.
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Clinical Protocol
CA024001
BMS-986242
IDO1 INHIBITOR
Table 2-3:
On-treatment Procedural Outline (BMS-986242 + Nivolumab Part 1 Dose Escalation and Part 2 
Dose-Expansion Cohorts) 
Procedure
Cycle 1
(4 weeks)
Cycles 2 to 4
(4 weeks)
Cycles 4+ 
(4 weeks)
End of 
Treatmenta,b,c
Notes
Day 1
Day 8
Day 15 
Day 22 
Day 1 
Day15 
(±2 days)
Days
22-28
Day 1
Days
22-28
Adverse Event Reporting and Concomitant Medication Assessments
Concomitant 
Medication 
Assessments
X
X
X
X
X
X
X
X
X
X
Review prior to dosing.
Monitor for 
Nonserious 
Adverse Events
X
X
X
X
X
X
X
X
X
X
Nonserious AEs will be collected 
starting with the first dose of 
study treatment until 100 days 
after discontinuation of 
nivolumab.
Monitor for 
Serious Adverse 
Events
X
X
X
X
X
X
X
X
X
X
All SAEs must be collected from 
the date of participant’s written 
consent until 100 days after 
discontinuation of nivolumab or 
participation in the study (if the 
last scheduled visit occurs at a 
later time). eSAEs should be 
approved in the BMS EDC tool 
within 5 business days of entry.
Sample Collection
Pharmacokinetic 
Assessments
See Section 9.5.3 and Table 9.5.3-1.
Immunogenicity 
Assessments
See Section 9.5.3, Section 9.8.3, and Table 9.5.3-1.
 
 
Revised Protocol No.: 01
Date: 31-Oct-2017
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Clinical Protocol
CA024001
BMS-986242
IDO1 INHIBITOR
Table 2-3:
On-treatment Procedural Outline (BMS-986242 + Nivolumab Part 1 Dose Escalation and Part 2 
Dose-Expansion Cohorts) 
Procedure
Cycle 1
(4 weeks)
Cycles 2 to 4
(4 weeks)
Cycles 4+ 
(4 weeks)
End of 
Treatmenta,b,c
Notes
Day 1
Day 8
Day 15 
Day 22 
Day 1 
Day15 
(±2 days)
Days
22-28
Day 1
Days
22-28
Additional 
Research 
Sampling
See Section 9.8.2
Efficacy Assessments
Diagnostic 
Imagingd
(Body Imaging)
X
X
X
To be collected at the end of 
Cycle 2 and then every 8 weeks 
by methods used at baseline. 
Same modality/scanner should be 
used for all assessments. 
Assessed by RECIST v1.1; see 
Appendix 6. Assessment must be 
performed prior to initiating the 
next cycle of study treatment.
Brain Imagingd
X
X
X
As clinically indicated
Bone Scan 
Imagingd
X
X
X
As clinically indicated
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Clinical Protocol
CA024001
BMS-986242
IDO1 INHIBITOR
Table 2-3:
On-treatment Procedural Outline (BMS-986242 + Nivolumab Part 1 Dose Escalation and Part 2 
Dose-Expansion Cohorts) 
Procedure
Cycle 1
(4 weeks)
Cycles 2 to 4
(4 weeks)
Cycles 4+ 
(4 weeks)
End of 
Treatmenta,b,c
Notes
Day 1
Day 8
Day 15 
Day 22 
Day 1 
Day15 
(±2 days)
Days
22-28
Day 1
Days
22-28
Study Treatment 
Administration
Details regarding preparation and 
administration are provided in the 
site training materials.
BMS-986242 
Administration
X
Continuous daily dosing during all cycles
BMS-986242 to be administered 
daily at approximately the same 
time
Nivolumab 
Administration
X
X
X
For participants receiving 
nivolumab 480 mg Q4W, 
nivolumab should be dispensed at 
Day 1 of each cycle
Tablet Diary
X
Tablet diary must be completed with each 
administered daily dose of BMS-986242.
X
Review tablet diary during each 
visit for compliance of daily 
administration of BMS-986242. 
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 participant from treatment.
b For participants who complete all scheduled cycles of study treatment, the EOT visit will be the same as the last scheduled and completed on-treatment visit 
(eg, Cycle 2 Day 22), and the start of the Week 1 Clinical/Safety Follow-up visit.
c For participants who do not complete all scheduled cycles of study treatment, 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.
d To be collected at the end of Cycle 2, at the end of every 8 weeks, by methods used at baseline. Same modality/scanner should be used for all assessments. 
Assessed by RECIST v1.1; see Appendix 6. Assessment must be performed prior to initiating the next cycle of study treatment.
Abbreviations: AE = adverse event; ALT = alanine aminotransferase; AST = aspartate aminotransferase; BMS EDC = Bristol-Myers Squibb Electronic Data 
Capture; BUN = blood urea nitrogen; CBC = complete blood count; CR = complete response; ECG = electrocardiogram; EOT = end of treatment; 
eSAE = electronic serious adverse event; GGT = gamma-glutamyl transferase; hCG = human chorionic gonadotropin; IRT = Interactive Response Technology;; 
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Clinical Protocol
CA024001
BMS-986242
IDO1 INHIBITOR
LDH = lactate dehydrogenase; LFT = liver function test; PE = physical examination; Q4W = every 4 weeks; RECIST = Response Evaluation Criteria in Solid 
Tumors; SAE = serious adverse event; TSH = thyroid-stimulating hormone; WOCBP = women of childbearing potential.
Revised Protocol No.: 01
Date: 31-Oct-2017
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Clinical Protocol
CA024001
BMS-986242
IDO1 INHIBITOR
Table 2-4:
Follow-up Procedural Outline 
Procedure
Clinical/Safety Follow-up
Survival/Long-
Term Follow-up
Notes
FU 1
30 daysa
(10 days) 
FU 2
60 days 
(10 days)
FU 3
100 days 
(10 days)
All Participants;
Begins After 
Completion of
Clinical/Safety 
(2 weeks), Every 
12 weeks 
(2 weeks) Until 
2 Years After 
LAST Dose of 
Study Treatment
Response 
Follow-up
(participants
with CR, PR, 
SD)
Begins After 
Completion of 
Safety 
Follow-up 
(2 weeks) 
Until End of 
Survival 
Follow-up 
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 for 
sodium, potassium, chloride, 
total serum calcium, 
magnesium, bicarbonate/
carbon dioxide, phosphorus, 
BUN, creatinine, glucose, total 
protein, albumin, amylase, 
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Clinical Protocol
CA024001
BMS-986242
IDO1 INHIBITOR
Table 2-4:
Follow-up Procedural Outline 
Procedure
Clinical/Safety Follow-up
Survival/Long-
Term Follow-up
Notes
FU 1
30 daysa
(10 days) 
FU 2
60 days 
(10 days)
FU 3
100 days 
(10 days)
All Participants;
Begins After 
Completion of
Clinical/Safety 
(2 weeks), Every 
12 weeks 
(2 weeks) Until 
2 Years After 
LAST Dose of 
Study Treatment
Response 
Follow-up
(participants
with CR, PR, 
SD)
Begins After 
Completion of 
Safety 
Follow-up 
(2 weeks) 
Until End of 
Survival 
Follow-up 
lipase, uric acid, ferritin, LDH, 
HDL, and LDL
CBC with Differential and 
Platelets
X
X
X
Predose.
LFT Assessment
Collect at 30, 60, and 100 days following the 
last dose of BMS-986242 and/or nivolumab. For 
participants with LFT abnormalities following 
the last dose of study treatment, consider 
collecting weekly until normalized.
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)
Thyroid Function Tests
X
X
X
TSH with reflex testing to free 
T3 and free T4 if TSH is 
abnormal. Results should be 
examined by the investigator 
or appropriate designee within 
48 hours of dose 
administration.
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Table 2-4:
Follow-up Procedural Outline 
Procedure
Clinical/Safety Follow-up
Survival/Long-
Term Follow-up
Notes
FU 1
30 daysa
(10 days) 
FU 2
60 days 
(10 days)
FU 3
100 days 
(10 days)
All Participants;
Begins After 
Completion of
Clinical/Safety 
(2 weeks), Every 
12 weeks 
(2 weeks) Until 
2 Years After 
LAST Dose of 
Study Treatment
Response 
Follow-up
(participants
with CR, PR, 
SD)
Begins After 
Completion of 
Safety 
Follow-up 
(2 weeks) 
Until End of 
Survival 
Follow-up 
Pregnancy Test
X
X
X
For WOCBP; serum or urine 
pregnancy test may be 
performed (clinic urine 
pregnancy test: minimum 
sensitivity 25 IU/L or 
equivalent units of hCG).
If positive, perform 
confirmatory testing. If 
pregnancy is confirmed, 
immediately notify the 
Sponsor per Section 9.2.5.
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 treatment until 
100 days after discontinuation 
of nivolumab.
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Table 2-4:
Follow-up Procedural Outline 
Procedure
Clinical/Safety Follow-up
Survival/Long-
Term Follow-up
Notes
FU 1
30 daysa
(10 days) 
FU 2
60 days 
(10 days)
FU 3
100 days 
(10 days)
All Participants;
Begins After 
Completion of
Clinical/Safety 
(2 weeks), Every 
12 weeks 
(2 weeks) Until 
2 Years After 
LAST Dose of 
Study Treatment
Response 
Follow-up
(participants
with CR, PR, 
SD)
Begins After 
Completion of 
Safety 
Follow-up 
(2 weeks) 
Until End of 
Survival 
Follow-up 
Monitor for Serious Adverse 
Events
X
X
X
All SAEs must be collected 
from the date of participant’s 
written consent until 100 days 
after discontinuation of 
nivolumab or participation in 
the study (if the last scheduled 
visit occurs at a later time). 
eSAEs should be approved in 
the BMS EDC tool within 
5 business days of entry.
Concomitant Medication 
Assessments
X
X
X
Sample Collection
Pharmacokinetic Assessments
See Section 9.5.3 and Table 9.5.3-1.
Immunogenicity  Assessments
See Section 9.5.3, Section 9.8.3, and Table 9.5.3-1.
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Table 2-4:
Follow-up Procedural Outline 
Procedure
Clinical/Safety Follow-up
Survival/Long-
Term Follow-up
Notes
FU 1
30 daysa
(10 days) 
FU 2
60 days 
(10 days)
FU 3
100 days 
(10 days)
All Participants;
Begins After 
Completion of
Clinical/Safety 
(2 weeks), Every 
12 weeks 
(2 weeks) Until 
2 Years After 
LAST Dose of 
Study Treatment
Response 
Follow-up
(participants
with CR, PR, 
SD)
Begins After 
Completion of 
Safety 
Follow-up 
(2 weeks) 
Until End of 
Survival 
Follow-up 
Efficacy Assessments
Tumor/Response Assessments
X
X
Diagnostic imaging by method 
used at baseline. An 
unconfirmed PR or CR must 
be confirmed at least 4 weeks 
after initial assessments.
Assessed by RECIST v1.1; see 
Appendix 6.
Participants with SD/PR/CR at 
EOT visit will have imaging 
every 3 months (12 weeks) for 
the first year after the EOT 
visit and then every 6 months 
thereafter, up to 2 years after 
last study treatment (or until 
disease progression or 
withdrawal from the study).
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Table 2-4:
Follow-up Procedural Outline 
Procedure
Clinical/Safety Follow-up
Survival/Long-
Term Follow-up
Notes
FU 1
30 daysa
(10 days) 
FU 2
60 days 
(10 days)
FU 3
100 days 
(10 days)
All Participants;
Begins After 
Completion of
Clinical/Safety 
(2 weeks), Every 
12 weeks 
(2 weeks) Until 
2 Years After 
LAST Dose of 
Study Treatment
Response 
Follow-up
(participants
with CR, PR, 
SD)
Begins After 
Completion of 
Safety 
Follow-up 
(2 weeks) 
Until End of 
Survival 
Follow-up 
Assessment of Participant
Survival Status
X
Participant status will be 
assessed every 3 months 
(12 weeks) by either a clinic 
visit or telephone contact. 
New Subsequent Anti-cancer 
Therapies 
X
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 treatment 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.
Abbreviations: ADA = anti-drug antibody; AE = adverse event; ALT = alanine aminotransferase; AST = aspartate aminotransferase; BMS EDC = Bristol-Myers 
Squibb Electronic Data Capture; BUN = blood urea nitrogen; CBC = complete blood count; CR = complete response; EOT = end of treatment; eSAE = electronic 
serious adverse event; FU = follow-up; GGT = gamma-glutamyl transferase; hCG = human chorionic gonadotropin; LDH = lactate dehydrogenase; LFT = liver 
function test; PR = partial response; RECIST = Response Evaluation Criteria in Solid Tumors; SAE = serious adverse event; SD = stable disease; TSH = thyroid-
stimulating hormone; WOCBP = women of childbearing potential.
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Table 2-5:
On-treatment Procedural Outline Clinical Pharmacology Substudy
Procedure
Cycle 00
Notes
Day 1 
Day 2
Day 8a
Day 9a
Day 8 and 9 for food effect participants only
IRT Assignment
X
Xa
Cycle 00 Day 1 single-dose BMS-986242 administration under 
fasting conditions.
For food effect participants only, Cycle 00 Day 8 at selected 
dose level of BMS-986242, administered with a high-fat meal.
Once participant eligibility has been confirmed, IRT assignment 
can be performed within 3 days prior to first study treatment 
administration. (Discuss with Sponsor if institutional policies 
and procedures require additional lead-time.)
Complete PE
Xb
Predose. Includes neurological examination.
Symptom-directed PE
X
Xa,b
Xa
Predose.
Vital Signs and 
Oxygen Saturations
X
Xa,b
Includes 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. Pulse 
oximetry should be collected while the participant is at rest.
12-lead ECG (Holter)
X
Serial ECGs (reviewed by a core laboratory) will be collected 
with matching PK samples (See Table 9.5.3-2). 
12-lead continuous ECG (Holter) monitoring will be started no 
later than 1.5 hour predose and continue until at least 6.5 hours 
postdose. From these recordings, after transmission to the central 
ECG laboratory, triplicate ECGs will be extracted during a 5-
minute sampling period starting at the nominal times specified. 
Each 5-minute sampling period should be preceded by at least 10 
minutes of rest in a supine position, which will be continued until 
the end of the 5-minute sampling period.
12-lead ECG
X
For monitoring subject safety, at least 5 minutes after the end of 
triplicate ECG period at 4 hours post dose on Cycle 00 Day 1, 
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Table 2-5:
On-treatment Procedural Outline Clinical Pharmacology Substudy
Procedure
Cycle 00
Notes
Day 1 
Day 2
Day 8a
Day 9a
Day 8 and 9 for food effect participants only
the site’s standard ECG machine will be connected using dual-
snap electrodes without interrupting the Holter monitoring.
Laboratory Tests
Chemistry (Excluding 
LFTs)
Xb
Xa,b,c
X
Collect predose; includes assessments for sodium, potassium, 
chloride, total serum calcium, magnesium, bicarbonate/carbon 
dioxide, phosphorus, BUN, creatinine, glucose, total protein, 
albumin, amylase, lipase, uric acid, ferritin, LDH, HDL, and 
LDL.
CBC with Differential 
and Platelets
Xb
X
Xa,b,c
X
Collect predose.
LFT Assessments
Xb
Xa,b,c
X
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
Xa
Serum or urine pregnancy test must be performed (urine 
pregnancy test: minimum sensitivity 25 IU/L or equivalent units 
of hCG) within 24 hours prior to administration of study 
treatment.
If pregnancy test is positive, hold all study treatment and 
perform confirmatory testing. If pregnancy is confirmed, 
permanently discontinue all study treatment and immediately 
notify the Sponsor per Section 9.2.5.
Concomitant 
Medication 
Assessments
X
X
Xa
X
Review prior to dosing.
Monitor for 
Nonserious Adverse 
Events
X
X
Xa
X
Nonserious AEs will be collected starting with the first dose of 
study treatment until 100 days after discontinuation of 
nivolumab.
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Table 2-5:
On-treatment Procedural Outline Clinical Pharmacology Substudy
Procedure
Cycle 00
Notes
Day 1 
Day 2
Day 8a
Day 9a
Day 8 and 9 for food effect participants only
Monitor for Serious 
Adverse Events
X
X
Xa
X
All SAEs must be collected from the date of participant’s 
written consent until 100 days after discontinuation of 
nivolumab or participation in the study (if the last scheduled 
visit occurs at a later time). eSAEs should be approved in the 
BMS EDC tool within 5 business days of entry.
Pharmacokinetic 
Assessments
See Section 9.5.3 and Table 9.5.3-1.
On Day 1, a single dose of BMS-986242 will be administered 
under fasting condition; a 7-day washout period will follow 
during which serial PK samples with time-matched serial ECGs 
will be collected. 
For food effect participants only, on Day 8, selected dose level 
of BMS-986242 will be administered with a high-fat meal; a 
2-day washout period will follow during which serial PK 
samples will be collected.
Study Treatment 
Administration
Details regarding preparation and administration are provided in 
the site training materials.
BMS-986242
Administration
X
Xa
Abbreviations: AE = adverse event; ALT = alanine aminotransferase; AST = aspartate aminotransferase; BMS EDC = Bristol-Myers Squibb Electronic Data 
Capture; BUN = blood urea nitrogen; CBC = complete blood count; ECG = electrocardiogram; EOT = end of treatment; eSAE = electronic serious adverse 
event; GGT = gamma-glutamyl transferase; hCG = human chorionic gonadotropin; IP = investigational product; IRT = Interactive Response Technology; 
LDH = lactate dehydrogenase; LFT = liver function test; PE = physical examination; SAE = serious adverse event; WOCBP = women of childbearing potential.
a Day 8 and 9 for food effect participants only
b For Cycle 00 Day 1 and Day 8, PE and laboratory tests do not need to be repeated if completed within the last 72 hours (for all laboratory tests).
c Participants who meet discontinuation criteria during or after Cycle 00 will have CBC with differential, platelets, and chemistry with LFTs done at the EOT and 
during the follow-up visit at 7 days.
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3
INTRODUCTION
This is a dose-escalation and dose-expansion cohort study of BMS-986242, a small molecule 
inhibitor of the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme, in combination with nivolumab 
(anti-programmed cell death-1 [PD-1]), in humans with advanced malignant tumors. This study 
will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary 
efficacy of escalating oral doses of BMS-986242 in combination with a flat dose of nivolumab. In 
addition, the study is expected to identify the maximum tolerated dose (MTD)/recommended 
Phase 2 dose of BMS-986242 in combination with nivolumab to be used in the dose-expansion 
cohort phase. Part 2 (dose-expansion cohorts) will assess the preliminary efficacy of BMS-986242 
in combination with nivolumab in specific malignant disease populations and will also serve to 
generate further data to support dose optimization of the combination. The study also includes a 
clinical pharmacology substudy designed to evaluate the PK of a single dose of BMS-986242, 
exposure-QTc relationship, and the effect of food on the bioavailability of BMS-986242.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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3.3
Overall Benefit/Risk Assessment
3.3.1
Risk/Benefit for BMS-986242
There is no prior human experience with BMS-986242; therefore, clinical benefit has not been 
assessed in participants with advanced cancer. Other IDO1 inhibitors have entered human trials, 
both as monotherapy and in combination with other anti-cancer treatments (epacadostat from 
Incyte Corporation, GDC-0919 from Roche, indoximod from NewLink Genetics, and 
BMS-986205, from Bristol-Myers Squibb). Published safety information for epacadostat shows a 
favorable safety profile as monotherapy (ie, well tolerated across all dose levels, with the most 
common AEs being Grade 1 or 2 fatigue and gastrointestinal disturbances)19, suggesting no 
intrinsic risk of suggesting no intrinsic risk of severe toxicity with IDO1 blockade. The assessment 
of potential clinical benefit of BMS-986242 is based upon preclinical human xenograft model 
SKOV3, in which significant IDO1 inhibition was achieved.
In the absence of clinical studies, the assessment of the risk of side effects of BMS-986242 in 
clinical trials is based upon data from nonclinical toxicology studies in rats and dogs. In rats, 
multiple doses up to 10 mg/kg/day were well-tolerated, while single doses 20 mg/kg resulted in 
overt CNS toxicity. In dogs, the top dose studied exceeded the MTD. Clinical signs included 
vomiting, diarrhea, dehydration, and weight loss. Chronic inflammation was noted in the 
gallbladder at 100 mg/kg/day and corresponded with increases in serum GGT and ALT activity. 
The gallbladder inflammation and serum chemistry changes were reversible. CNS and respiratory 
safety pharmacology assessments were conducted as part of the pivotal 1-month oral toxicity 
studies in rats and dogs. There were no BMS-986242-related CNS signs or effects on cranial or 
spinal nerve function or respiratory function at doses up to 10 mg/kg/day in rats and up to 
100 mg/kg/day in dogs.
The nonclinical toxicity profile was used to determine the human starting dose and to develop 
appropriate exclusion criteria and safety monitoring for this study. Complete blood counts and 
chemistry test results (including liver and kidney functions) will be assessed weekly during 
monotherapy and Cycle 1 of combination and every 4 weeks (Q4W) thereafter. In addition, 
complete physical examinations (PEs) will be conducted on Day 1 of each cycle, with additional 
symptom-directed PEs at least weekly during monotherapy and Q2W for the first 12 weeks during 
combination. Participants with viral hepatitis or other liver disease, such as nonalcoholic fatty liver 
disease, will be excluded to minimize the potential for hepatotoxicity. Assays for cardiac ion 
channels did not indicate a potential for cardiovascular liability. Nevertheless, participants with 
QTc prolongation at baseline will be excluded, medications known to cause prolonged QT will be 
prohibited, and electrocardiograms (ECGs) will be monitored during the study. 
Continuous safety assessments will be utilized by the investigators and Sponsor to determine 
whether dose modification, additional safety measures, or termination of the study is required at 
any time. In addition, AEs and serious adverse events (SAEs) will be reviewed on an ongoing basis 
by the Sponsor’s Medical Monitor and Global Pharmacovigilance and Epidemiology 
representatives to monitor for any safety signals or trends. 
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As BMS-986242 is an experimental agent, it is possible that unforeseen, unknown, or 
unanticipated reactions may occur. Based on the nonclinical safety profile of BMS-986242, and 
with a 60-fold safety margin built into the planned starting dose of 25 mg daily, the potential safety 
risks are expected to be minimized. Taking a conservative approach, an initial 12.5 mg starting 
dose will be used (see Section 5.5.1). A Bayesian Logistic Regression Method (BLRM) with 
overdose control principle will be employed to ensure that safety is not compromised during dose 
escalation. This method limits the risk of exposing participants in the next cohort to an unsafe or 
toxic dose. 
3.3.2
Risk/Benefit for Combination with Nivolumab 
Nivolumab has demonstrated clinical activity in patients with advanced NSCLC, RCC, melanoma, 
and lymphomas, as well as other tumors. While preclinical testing of IDO1 inhibitors does not 
suggest that IDO inhibition alone will bring benefit to patients, it is hypothesized that inhibition 
of IDO1 will relieve the immunosuppressive milieu within the tumor, thus allowing greater depth 
of response and ultimately improved survival benefit of other therapies. Early clinical data from a 
trial of epacadostat in combination with pembrolizumab (a PD-1 inhibitor) is suggestive of the 
potential synergy between these mechanisms. The largest cohort of participants in this study was 
melanoma, in which there were 54 evaluable participants. Thirty (30) of these participants were 
responders, including 8 CRs and 22 PRs, for an ORR of 56%.43 Per the United States Prescribing 
Information for pembrolizumab, the ORR for monotherapy in advanced melanoma is 34%.
Similarly, epacadostat plus nivolumab in 40 patients with melanoma yielded an ORR of 63%.44  
In several other tumor types epacadostat combined with pembrolizumab also showed high ORRs: 
NSCLC 35% (n=40), bladder cancer 35% (n=37), SCCHN 31% (n=36), and RCC 30% (n=30).45
As a reference from the pembrolizumab prescribing information, pembrolizumab ORRs are 18%
(PD-L1 Tumor Proportion Score [TPS] ≥1% subset, n=344) for NSCLC, 21% (n=270) for bladder 
cancer, and 16% (n=174) for SCCHN. While these are different studies with slightly different 
patient populations, the data suggest that IDO1 inhibition has the potential to improve ORRs in 
tumor types that respond to PD-1 inhibition.
Nivolumab has demonstrated a manageable safety profile. Nivolumab is indicated as monotherapy 
in patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or 
metastatic melanoma. Nivolumab in combination with ipilimumab is indicated in patients with 
unresectable or metastatic melanoma. Nivolumab is also indicated in patients with metastatic 
NSCLC and progression on or after platinum-based chemotherapy, in patients with advanced RCC 
who have received prior antiangiogenic therapy, in adult patients with classical Hodgkin 
lymphoma that has relapsed or progressed, in patients with recurrent or metastatic SCCHN with 
disease progression on or after a platinum-based therapy; in patients with locally advanced or 
metastatic urothelial carcinoma, in adult and pediatric (12 years and older) patients with 
microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer that has 
progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
The overall safety experience, when used either as a monotherapy or in combination with another 
therapeutic, is based on experience in approximately 12,300 participants treated to date. There is 
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no pattern in the incidence, severity, or causality of AEs to nivolumab dose level. The most 
common AEs include fatigue, rash, pruritus, diarrhea, and nausea. Side effects of nivolumab 
therapy may include those associated with immune-mediated activation, such as pneumonitis, 
thyroiditis, and hepatitis. Most of these events resolved with immune-modulating medication. To 
mitigate risk from serious immune-mediated AEs, participant management algorithms for 
nivolumab-related AEs from prior collective nivolumab experience have been included. In 
addition, participants will have to meet a set of safety criteria in order to continue from 
monotherapy to combination treatment so that the risk of cumulative toxicity is minimized (see 
Section 5.1.2.1).
In addition, significant clinical data indicates that IDO1 inhibitors can be combined safely with 
nivolumab. Epacadostat was combined with nivolumab in 36 patients during a dose-escalation 
study with no occurrence of DLTs and in 230 additional patients in dose-expansion cohorts with 
an acceptable safety profile.44 Similarly, BMS-986205 was combined with nivolumab and 
administered to 44 patients during a dose-escalation study with DLTs occurring in 1 out of 9
participants at a dose of 100 mg QD (autoimmune hepatitis, which could be caused by PD-1 
inhibition alone) and in 1 out of 10 participants at a dose of 200 mg QD (anemia), as reported at 
the annual meeting of the American Association for Cancer Research (AACR) 2017. 46 Subsequent 
to this report, 200 mg QD BMS-986205 was determined to be the MTD, and 100 mg QD is being 
studied in Phase 2 cohorts (preliminary unpublished data).
3.3.3
Summary
Despite innovations in cancer treatment, alternative therapies are needed for participants with 
advanced cancer that has progressed or not responded to other treatments. The emerging role of 
combination immune-modulating therapies in producing deep and durable responses in a variety 
of tumor types suggests that once a pharmacologically-active dose range is reached, there may be 
a potential benefit of IDO inhibition with BMS-986242 for participants when used in combination 
with nivolumab. Preclinical safety signals were monitorable and reversible and are to be closely 
monitored in this study. This supports the evaluation of BMS-986242 as monotherapy and in 
combination with nivolumab in participants with advanced cancer who have few treatment options.
4
OBJECTIVES AND ENDPOINTS
The objective and endpoints for this study are shown in Table 4-1.
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Table 4-1:
Objectives and Endpoints
Objectives
Endpoints
Primary

Part 1: Dose Escalation

To determine the safety, tolerability, DLTs, and 
MTD/MAD/alternative dose of BMS-986242 
administered as monotherapy (lead-in cycle) and in 
combination with nivolumab in participants with 
advanced malignant tumors

Incidence of DLTs, AEs, SAEs, AEs leading to 
discontinuation, deaths, and clinical laboratory 
test abnormalities

Additional safety endpoints include changes from 
baseline in laboratory parameters, vital signs, and 
ECGs.

Part 2: Dose-Expansion Cohort(s)

To evaluate the safety and tolerability of 
BMS-986242 in combination with nivolumab in 
participants with advanced malignant tumors
Secondary

To 
characterize 
the 
PK 
of 
BMS-986242 
administered alone and in combination with 
nivolumab

Summary measures of selected BMS-986242 PK 
parameters, such as Cmax, Tmax, AUC(TAU), 
AUC(INF), Ctrough, T-HALF, CLT/F, Vss/F, 
AI, %UR24, %UR72, and exposure ratios of 
select BMS-986242 metabolites to BMS-986242 
from concentration-time
data during BMS-
986242 monotherapy and BMS-986242 Ctrough 
during combination treatment 

To characterize the pharmacodynamic activity of 
BMS-986242 
administered 
alone 
and 
in 
combination with nivolumab

Summary measures of change from baseline 
(and/or percent change) for serum and tumor 
kynurenine and related metabolites

To characterize the immunogenicity of nivolumab 
when 
administered 
in 
combination 
with 
BMS-986242

Incidence of ADA to nivolumab in combination 
with BMS-986242

To assess the preliminary anti-tumor activity of 
BMS-986242 administered in combination with 
nivolumab in advanced malignant tumors

ORR in participants with a BOR of CR or PR per 
RECIST version 1.1 for solid tumors; mDOR, 
and PFSR at 6, 9, 12, and 24 months
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table 4-1:
Objectives and Endpoints
Objectives
Endpoints

 
 
 
 
 
 
Abbreviations: %UR24 = percent urinary recovery over 24 hours; %UR72 = percent urinary recovery over 72 hours 
ADA = anti-drug antibody; AE = adverse event; AI = accumulation index; AUC(0-T) = area under the 
concentration-time curve; AUC(INF) = area under the concentration-time curve from time zero to infinity; 
AUC(TAU) = area under the concentration-time curve in 1 dosing interval; BOR = best overall response; Ceoi = 
concentrations at end of infusion; Cmax = maximum observed plasma concentration; CR = complete response; 
Ctrough = trough observed plasma concentration at the end of the dosing interval; CLT/F =  apparent total body 
clearance; DLT = dose-limiting toxicity; DOR = duration of response; mDOR = median duration of response; ECGs 
= 12-lead electrocardiograms; MAD = maximum administered dose; MR_AUC(0-T) = ratio of metabolite 
AUC(0-T) to parent AUC(0-T) corrected for molecular weight; MR_AUC(INF) = ratio of metabolite AUC(INF)
to parent AUC(INF) corrected for molecular weight; MR_AUC(TAU) = ratio of metabolite AUC(TAU) to parent 
AUC(TAU) corrected for molecular weight; MR_Cmax = ratio of metabolite Cmax to parent Cmax corrected for 
molecular weight; ORR = overall response rate; OSR = overall survival rate; PFSR = progression-free survival rate; 
PR = partial response; RECIST = Response Evaluation Criteria in Solid Tumors; SAE = serious adverse event; T-
HALF = apparent elimination half-life; Tmax = time of maximum observed plasma concentration;
Vss/F = apparent volume of distribution at steady state.
5
STUDY DESIGN
5.1
Overall Design
This is a Phase 1/2a, open-label study of BMS-986242 administered as a single agent and in 
combination with nivolumab in participants with advanced malignant tumors. The study will be 
conducted in 2 parts, dose escalation (Part 1) and dose-expansion cohorts (Part 2). In addition, a 
clinical pharmacology substudy will be conducted in which BMS-986242 single-dose PK, 
exposure-QTc relationship and exploratory food effect on BMS-986242 bioavailability will be 
assessed.
Dose escalation (Part 1) will start with a lead-in Cycle 0 (see Section 3.1.2 for details on lead-in
rationale), whereby BMS-986242 is administered as monotherapy of 2-week duration in each 
dose-escalation cohort. The decision to proceed to combination treatment with nivolumab 
(Cycle 1) for each participant in dose escalation will be determined after tolerability of the 
monotherapy lead-in is established in the 2-week Cycle 0 at each dose (see Section 5.1.2.1). The 
starting dose of BMS-986242 is 12.5 mg administered orally daily. Nivolumab will be 
administered IV at a dose of 480 mg Q4W. In the event the 12.5-mg dose level of BMS-986242 is
determined to exceed the MTD in monotherapy or in combination with nivolumab, no lower BMS-
986242 dose level will be further explored.. Please refer to Appendix 7.
Dose escalation may be stopped prior to reaching the MTD if pharmacodynamic data indicate that 
maximum inhibition of IDO1 has been achieved. In such a case, the MAD or an alternate dose 
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below the MAD will be used for the expansion cohorts. At no point will the dose of BMS-986242
administered in combination with nivolumab exceed doses of BMS-986242 that have been 
demonstrated previously to be safe in the monotherapy lead-in Cycle 0 (Section 5.1.2.1).
Participants will be enrolled per inclusion criteria in Section 6.1.
Cycle 0: Each dose-escalation cohort will start with Cycle 0, which is a 2-week BMS-986242
monotherapy lead-in. If there are no dose-limiting toxicities (DLTs) (see Section 7.4.1), 
participants will proceed to receive the combination of nivolumab and BMS-986242 (Cycle 1). 
Dose-expansion cohorts will be carried out at the dose of BMS-986242 selected from dose 
escalation in combination with nivolumab 480 mg and may represent the MTD, maximum 
administered dose (MAD), or an alternate dose for the combination. Study therapy consisting of 
BMS-986242 daily and nivolumab Q4W will be administered in 4-week cycles for up to 26 cycles. 
Participants in 6 disease-restricted populations will be enrolled as follows: melanoma, NSCLC, 
SCCHN, BUC, RCC, and gastric cancer. The dose(s) selected for cohort expansion will not exceed 
the MTD or MAD determined in dose escalation.
Participants will complete up to 4 phases of the study: Screening, Treatment, Clinical/Safety 
Follow-up, and Survival/Long-term Follow-up, as described below. The study design schematic 
is presented in Figure 5.1-1.
Figure 5.1-1:
Study Design Schematic
Abbreviations: AE = adverse event; CR = complete response; EOT = end of treatment; MM = Medical Monitor; 
PD = progressive disease; PI = principal investigator; PK = pharmacokinetics; PR = partial response; SD = stable 
disease.
5.1.1
Screening Phase
The screening phase will last for up to 28 days. The screening phase begins by establishing the 
participant’s initial eligibility and signing of the informed consent form (ICF). Participants will be 
enrolled using the Interactive Response Technology (IRT).
If a participant surpasses the 28-day window during the screening phase because of a study-related 
procedure (eg, scheduling of a tumor biopsy or waiting time for a study-related laboratory value), 
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the participant must be re-consented but does not need to be assigned a new participant
identification number. In this situation, the least amount of repeat procedures from the initial 
screening to qualify the participant while maintaining safety and eligibility under the discretion of 
the BMS Medical Monitor and investigator may be done to reduce any undue burden of procedure 
in this population.
5.1.2
Treatment Phase
The treatment phase consists of up to twenty-six 4-week treatment cycles. Each treatment cycle is 
comprised of a daily oral dose of BMS-986242 and 1 dose of nivolumab administered IV Q4W on 
Day 1 of the treatment cycle. In addition, dose escalation will start with Cycle 0, a lead-in period 
of 2-week duration, during which monotherapy with BMS-986242 is administered. The total 
treatment period is 104 weeks or 26 cycles. This is in addition to the 2-week Cycle 0.
Following every 2 treatment cycles (8 weeks), the decision to treat a participant with additional 
cycles of study treatment will be based on radiological tumor assessments (initial evaluation 
performed at baseline, end of Cycle 2, and every 8 weeks). Assessments of partial response (PR) 
and complete response (CR) must be confirmed at least 4 weeks following initial assessment. 
Tumor progression or response endpoints will be assessed using Response Evaluation Criteria in 
Solid Tumors (RECIST) v1.1 criteria for solid tumors (Appendix 6). 
Treatment beyond progression may be allowed in select participants
with initial 
RECIST v1.1-defined progressive disease (PD) after discussion and agreement with the BMS 
Medical Monitor that the benefit/risk assessment favors continued administration of study 
treatment (eg, participants are continuing to experience clinical benefit as assessed by the 
investigator, tolerating treatment, and meeting other criteria specified in Section 5.1.2.3).
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 
treatment until the first occurrence of either: 1) completion of the maximum number of cycles,
2) PD, 3) clinical deterioration suggesting that no further benefit from treatment is likely,
4) intolerability to study treatment, or 5) the participant meets criteria for discontinuation of study 
treatment as outlined in protocol Section 8. Individual participants with confirmed CR will be 
given the option to discontinue study treatment on a case-by-case basis after specific consultation 
and agreement between the investigator and BMS Medical Monitor in settings where benefit/risk 
justifies discontinuation of study treatment. 
5.1.2.1
Part 1: Dose Escalation
Six disease-restricted populations will be included in the dose-escalation part. These are 
melanoma, NSCLC, SCCHN, RCC, BUC, and gastric cancer. The dose-escalation part of the study 
will evaluate doses of BMS-986242 in combination with nivolumab based on DLTs using a BLRM 
model (for BMS-986242 monotherapy lead-in) and BLRM-copula model (for BMS-986242 in 
combination with nivolumab). The Bayesian models will be used for recommendation of the next 
dose to be investigated. BLRM (combined with copula) framework with an escalation with 
overdose control principle will be employed to ensure that safety is not compromised during dose 
escalation.
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The initial dose level of BMS-986242 will be 12.5 mg administered orally daily. After a 2-week 
period, once initial lead-in monotherapy (Cycle 0) is deemed tolerable, combination with 480 mg 
flat dose nivolumab (Cycle 1) will be initiated. 
Dose levels to be considered for the next combination cohort (with monotherapy lead-in) will be 
based on recommended monotherapy dose from BLRM and recommended combination dose from 
BLRM-copula. The lower dose from these 2 recommendations will be considered. Potential dose 
levels for dose escalation are provided in Table 5.1.2.1-1. The maximum allowable increase in 
dose will be 100%. Final dose selection for the next cohort/dose level will be made in conjunction 
with all data available from PK and pharmacodynamic assessments, and will be made after 
discussion and agreement between investigators and BMS Medical Monitor. Accordingly, 
intermediate or lower doses, or less frequent dosing of BMS-986242 may be tested if none of the 
planned doses/schedules are found to be tolerated as the lead-in phase or in combination with 
nivolumab.
Initially, approximately 4 participants will be treated at the starting dose level of BMS-986242. 
During the dose-escalation phase, once a dose level has been decided, a set of approximately 4
participants will be initially treated at that specified dose level. Increments of approximately 
3 participants will be added to each dose level depending on model recommendation and clinical 
judgment. Due to the potential for early discontinuation, additional participant(s) may be enrolled 
to ensure at least 3 evaluable participants at each dose level. 
Cohort tolerability assessment and subsequent dose recommendation may occur when 2 
DLT-evaluable participants within a cohort have completed the 6-week DLT observation period 
(see Section 7.4.1 for criteria for DLTs). DLTs occurring within the 2-week lead-in period (DLT 
observation period for monotherapy) will be used to fit the BLRM model for monotherapy. DLTs 
occurring within the 4 weeks of combination period (DLT observation period for combination) 
will be used to fit the BLRM-copula model. If a potential DLT occurring in any third evaluable 
participant does not influence the dose recommendation by BLRM (-copula), then the BLRM 
(-copula)-recommended next dose level may proceed without waiting for the third participant to 
complete the corresponding DLT observation period after discussion and agreement by the sponsor 
and investigators. The lower recommended dose from both models will be considered for the next 
dose escalation. Participants receiving 75% (11 out of 14 doses) of BMS-986242 in the 2-week 
lead-in cycle will be considered as DLT-evaluable participants for BMS-986242 monotherapy. 
Participants who receive at least 1 dose of nivolumab and have been followed at least 5 days and 
receive 75% BMS-986242 (21 out of 28 doses) in the 4-week DLT observation period for 
combination therapy will be considered as DLT-evaluable participants. Continuous re-assessment 
of dose recommendation by BLRM will be carried out at each dose level after each cohort of 
participants with consideration of all available DLT information. In order to allow additional 
safety, PK, and pharmacodynamic assessment, in Part 1 up to 12 additional participants may be 
enrolled at any dose level at or below the MTD, up to a total of 24 additional participants.
No intra-participant dose escalation is allowed, although dose modifications of BMS-986242 may 
be permitted (see Table 7.4.2-1).
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Sentinel Participant: During dose escalation, a staggered dosing (sentinel participant) approach 
will be used. In the first dose level, the first participant in both lead-in and combination will receive 
the Cycle 0 Day 1 or Cycle 1 Day 1 dose(s) of study treatment(s) and be observed for 5 days before 
additional participants in that cohort receive monotherapy or combination study treatment. In 
subsequent dose levels, a sentinel participant with a 5 day observation period will be used for 
Cycle 0 Day 1.
The dose-escalation planned dose levels for selection of the MTD/MAD/alternative dose is 
depicted in Table 5.1.2.1-1 and Figure 5.1.2.1-1.
Table 5.1.2.1-1:
Dose Escalation Schedule
Dose Level
BMS-986242
Nivolumab
1
12.5 mg
480 mg IV Q4W
2
25 mg
480 mg IV Q4W
3
50 mg
480 mg IV Q4W
4
100 mg
480 mg IV Q4W
5
200 mg
480 mg IV Q4W
6
400 mg
480 mg IV Q4W
7
600 mg
480 mg IV Q4W
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Figure 5.1.2.1-1:
Study Design Schematic - Dose Escalation
Clinical Pharmacology Substudy: 
A clinical pharmacology substudy will be conducted to characterize the PK profile of 
BMS-986242 after a single-dose administration, BMS-986242 exposure-QTc relationship and to 
evaluate of the effect of food on the bioavailability of BMS-986242. The substudy will evaluate 
selected dose levels that have already been determined to be tolerable during dose escalation.
Participants in the substudy will receive a single dose of BMS-986242 under fasting condition on 
Cycle 00 (Day 1) followed by a 7-day washout period during which serial PK samples will be 
collected (Table 9.5.3-2). Triplicate ECGs will be collected at predose and select time points 
postdose on Day 1 (with matching PK samples) to allow the assessment of the effect of 
BMS-986242 exposure on QTc intervals. All participants will then receive BMS-986242 under 
the usual dosing condition with a light meal once daily in combination with nivolumab on Cycle 1 
Day 1 and will follow all assessments as per Table 2-3. The inclusion criteria used in the dose-
escalation phase apply to participants enrolled in the clinical pharmacology substudy (Section 6.1). 
The doses to be evaluated in the substudy will be determined based on available safety, PK and
biomarker data. At least 3 doses (below, at, and above the expected dose for expansion) are 
expected to be evaluated in at least 6 evaluable participants per dose level in the substudy. 
Additional dose levels at may be evaluated if warranted.
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At a designated dose level, an exploratory food effect evaluation will be conducted. After receiving
a single dose of BMS-986242 under fasting condition on Cycle 00 (Day 1) followed by a 7-day 
washout period, participants will receive 1 dose of BMS-986242 with a high-fat meal on Day 8. 
Serial PK samples will be collected during a 2-Day washout period (Table 9.5.3-2). Participants 
will then receive BMS-986242 under the usual dosing condition with a light meal once daily in 
combination with nivolumab on Cycle 1 Day 1 and will follow all assessments as per Table 2-3. 
For the dose to be evaluated in the food effect substudy, either a higher dose would need to be 
demonstrated to be safe in the dose-escalation phase or sufficient exposure multiples should have 
been obtained following multiple doses at the same dose level. Additional doses may be evaluated 
if warranted. 
Study design schematics for the clinical pharmacology substudy are shown in Figure 5.1.2.1-2
(single-dose PK and exposure-QTc assessment) and Figure 5.1.2.1-3(food effect).
Figure 5.1.2.1-2:
Study Design Schematic for the Clinical Pharmacology Substudy
Single-dose PK and Exposure-QTc Assessment (Selected Dose Levels)
S,E
BMS-986242 Single Dose, 
Fasting
7-Day 
Washout
BMS-986242 QD, Light Meal + 
Nivolumab Q4W
Cycle 00
Day 1
Cycle 1
Day 1
S,E = screening, enrollment
Figure 5.1.2.1-3:
Food Effect Assessment (Designated Dose Group*)
Food Effect Assessment (Designated Dose Group*)
S,E
BMS-986242 
Single Dose, 
Fasting
7-Day 
Washout
BMS-986242 
Single Dose, 
High-fat Meal
2-Day 
Washout
BMS-986242 QD, 
Light Meal + 
Nivolumab Q4W
Cycle 00
Day 1
Cycle 00
Day 8
Cycle 00
Day 9
Cycle 1
Day 1
S,E = screening, enrollment
* A designated dose group from the selected dose levels will evaluated for both single-dose 
PK/exposure-QTc and food effect. One cohort of at least 6 evaluable participants will be included.
Up to approximately 78 participants are planned to be enrolled for Part 1 (dose escalation) and 
clinical pharmacology substudy: approximately 30 participants for the dose-escalation phase, with 
up to 24 additional participants in Part 1 for additional characterization of the safety, PK, and 
pharmacodynamic profile of BMS-986242, and approximately 24 participants for the clinical 
pharmacology substudy (including food effect).
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5.1.2.2
Part 2: Dose-Expansion Cohorts
The purpose of cohort expansion is to gather additional safety, tolerability, preliminary efficacy, 
PK, and pharmacodynamic information regarding BMS-986242 in combination with nivolumab.
Six disease-restricted populations will be included in the dose-expansion cohort phase. These are 
melanoma, NSCLC, SCCHN, RCC, BUC, and gastric cancer. PD-(L)1 inhibitors are an approved 
treatment option for melanoma, NSCLC, SCCHN, RCC, and BUC, and prior treatment may 
impact preliminary efficacy; thus separate cohorts (PD-(L)1 inhibitor naive or experienced) will 
be enrolled for these 5 tumor types. Approximately 20 participants will be included in each dose-
expansion cohort, for a total of approximately 220 participants in Part 2.
Continuous evaluation of toxicity events in the cohort expansions will be performed throughout 
enrollment in the expansion cohorts. If, at any time, the aggregate rate of treatment-related 
toxicities meeting DLT criteria exceeds 33% across all participants treated in cohort expansions, 
the findings will be discussed and further enrollment may be interrupted. Depending on the nature 
and grade of the toxicity and after assessing the risk/benefit ratio, a new dose(s) for all cohorts 
may be initiated at a previously tested lower dose level or at a dose level intermediate to previously 
tested lower dose levels.
5.1.2.3
Treatment Beyond Progression
A subset of participants with solid tumors treated with immunotherapy may derive clinical benefit 
despite initial evidence of PD. Participants will be permitted to continue on treatment beyond 
initial RECIST v1.1-defined PD (see Appendix 6) as long as they meet the following criteria:

Investigator-assessed clinical benefit and not having rapid disease progression

Absence of signs or symptoms indicating disease progression

Continue to meet all other study protocol eligibility criteria

Tolerance of study treatment

Stable performance status

Treatment beyond progression will not delay an imminent intervention to prevent serious 
complications of disease progression (eg, CNS metastases)

Participant provides written informed consent prior to receiving additional nivolumab and
BMS-986242 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 treatment must be documented in 
the study records. Participants will be re-consented to explain the rationale for this ongoing 
treatment.
Participants should continue to receive monitoring according to the on-treatment assessments in 
Section 9.4. Radiographic assessment by computed tomography (CT; preferred) or magnetic 
resonance imaging (MRI) described in Section 2 and in Section 9.1.1 is required when participants
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continue post-progression treatment. For participants who discontinue post-progression treatment 
with study treatment, no additional radiographic assessments will be required.
5.1.2.4
Discontinuation Due to Further Progression
Participants should discontinue study treatment 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:
For solid tumors: New lesions are considered measurable at the time of initial progression if the 
longest diameter is at least 10 mm (except for pathological lymph nodes, which must have a short 
axis of at least 15 mm).
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 initial progression event.
5.1.3
Clinical/Safety Follow-up
Upon completion of study treatment, participants will enter the Clinical/Safety Follow-up period 
(refer to Section 5.3 and Section 5.1.4 for definitions for end of treatment [EOT]). 
Participants must be followed for at least 100 days after the last dose of study treatment. Follow-up 
visits should occur at Days 30, 60, and 100 (10 days) after the last dose of study treatment 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 treatment to monitor for AEs. Participants will be required 
to complete 3 Clinical/Safety Follow-up visits regardless of whether they start a new anti-cancer
therapy, except those participants who withdraw consent for study participation.
5.1.4
Survival/Long-Term/Response Follow-up
After completion of the Clinical/Safety Follow-up period, all participants will then enter the 
Survival/Long-term Follow-up period. During this period, clinic visits or telephone contact every 
3 months will be performed to assess survival status. The duration of Survival/Long-term 
Follow-up period will be 2 years from the last dose of study treatment.
After completion of the Safety Follow-up period, participants who discontinue study with ongoing 
SD, PR, or CR at the EOT visit will enter the Response Follow-up period. These periods will occur 
simultaneously with the Survival Follow-up period for mentioned participants. During the 
Response Follow-up period (or until disease progression or withdrawal of study), these participants
will continue to have radiological and clinical tumor assessments every 12 weeks for the first year 
after the EOT visit and then every 6 months thereafter up to 2 years from the last dose of study 
treatment. Radiological tumor assessments for participants who have ongoing clinical benefit may 
continue to be collected after participants complete the survival phase of the study. 
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Participants in the Survival/Long-term Follow-up period who have progression of disease will be 
allowed to receive tumor-directed therapy as required.
5.1.5
Data Monitoring Committee and Other External Committees
BMS has elected not to use a Data Monitoring Committee for this study. In addition to the 
comprehensive safety monitoring plan outlined below, the following key points were considered 
for this decision:

This is an open-label study.

The eligibility criteria exclude participants with disease characteristics that could predispose
to higher risk of morbidity, eg, uncontrolled or significant cardiovascular disease, etc. 

Exclusion of participants with active, known, or suspected autoimmune disease also applies,
as they could be at risk for exacerbation of their condition by the administration of therapies 
that relieve immune suppression such as BMS-986242 and nivolumab.

Participants will be observed frequently for clinical evaluation and blood counts during dose 
escalation.

Well-defined discontinuation criteria are established in the protocol for individual participants 
for both safety and treatment futility with clear criteria for treatment discontinuation, dose 
delay, and toxicity management.
BMS has in place a multi-layered process for ensuring patient safety through close collaboration 
of study site investigators, the BMS study team, and the BMS GPVE-led Medical Surveillance 
Team (MST). This collaborative process constitutes the Data Safety Monitoring Plan for the study 
as detailed below:
Study safety is evaluated continuously by representatives of BMS GPVE, who operate 
independently from the clinical team and monitor safety across all BMS protocols. AEs are 
monitored continuously by GPVE. Signal detection is performed at least monthly and ad hoc 
throughout the study by the MST composed, at a minimum, of the GPVE medical safety 
assessment physician (Chairman of the MST) and GPVE single case review physician, the study 
Medical Monitor(s), the study biostatistician, and epidemiologist. The MST monitors actual or 
potential issues related to patient safety that could result in a significant change in the medical 
risk-benefit balance associated with the use of study treatments. Furthermore, investigators will be 
kept updated of important safety information, such as DLTs, during teleconferences between 
investigators and the BMS clinical team that will be held at least Q4W during dose escalation and 
at least monthly during cohort expansion. If appropriate, select safety issues may be escalated to a 
senior-level, multidisciplinary, BMS-wide Medical Review Group for further evaluation and 
action.
To support safety oversight, BMS has established ongoing processes for collection, review, 
analysis, and submission of individual AE reports and their aggregate analyses. Because this is an 
open-label study, the BMS Medical Monitor and the investigators will have access to all data 
necessary for safety evaluation.
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5.2
Number of Participants
A maximum of 298 participants may be enrolled in the study. Approximately 78 participants are 
planned to be enrolled for Part 1 (dose escalation, additional safety, PK, and PD, and clinical 
pharmacology substudy) and approximately 220 participants for Part 2 (dose-expansion cohorts).
These are discussed further in Section 5.1.2.1, Section 5.1.2.2, and Section 10.1.
5.3
End of Study Definition
The start of the trial is defined as the first visit for the first participant screened. End of trial is 
defined as the last visit scheduled or scheduled procedure shown in the Schedule of Activities for 
the last participant. Study completion is defined as the final date on which data for the primary 
endpoint was or is expected to be collected, if this is not the same. The total duration of the study 
is expected to be approximately 5 years from the onset of the first visit of the first subject to the 
required Survival/Long-term Follow-up of the last subject enrolled.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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6
STUDY POPULATION
For entry into the study, the following criteria MUST be met prior to dosing on Day 1. No 
exceptions will be granted.
6.1
Inclusion Criteria
1) Signed Written Informed Consent
a) The participant must sign the ICF prior to the performance of any study-related procedures 
that are not considered part of standard of care.
2) Type of Participant and Target Disease Characteristics
a) Participants must be at least 18 years old and have histologic or cytological confirmation 
of a malignancy that is advanced (metastatic and/or unresectable) with measureable disease 
per RECIST v1.1 (see Appendix 6).
Part 1 and Part 2:
i)
Participants must have received and then progressed or been intolerant to at least 1 
standard treatment regimen in the advanced or metastatic setting if such a therapy exists 
(1) Participants with tumor subtypes, harboring genetic aberrations that are amenable 
to targeted therapy (e.g. BRAF, EGFR, ALK, HER2) should have received the 
appropriate, standard of care therapy for their specific genetic aberration.
(2) BRAF-mutation negativemelanoma participants can be treatment-naïve, as they 
will be given concomitant nivolumab, which constitutes standard of care.
ii) The following tumor histologies will be permitted except for participants with primary 
CNS tumors or CNS metastases as the only site of active disease.
The following tumor types will be permitted:
(1) SCCHN- oral cavity, pharynx, larynx
(a) Histologically confirmed recurrent or metastatic SCCHN not amenable to local 
therapy with curative intent (surgery or radiation with or without 
chemotherapy)
(b) Documentation of p16-positive or p16-negative disease to determine HPV 
status of tumor for SCC of the oropharynx.47 Must have evidence of 
progression or recurrence within 6 months of last dose of platinum therapy in 
the adjuvant (ie, with radiation after surgery), primary (ie, with radiation),
recurrent, or metastatic setting.
(c) Radiation therapy must have been completed at least 4 weeks prior to study 
treatment administration.
(2) Bladder Urothelial Carcinoma 
(a) Evidence of metastatic or surgically unresectable transitional cell carcinoma of 
the urothelium involving the bladder, urethra, ureter or renal pelvis
(b) Progression or recurrence after treatment

With at least 1 platinum-containing chemotherapy regimen for metastatic 
or surgically unrespectable locally advanced urothelial cancer, or
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
Within 12 months of peri-operative (neo-adjuvant or adjuvant) treatment 
with a platinum agent in the setting of cystectomy for localized muscle-
invasive urothelial cancer
(3) Renal Cell Carcinoma
(a) Advanced or metastatic RCC with a clear cell component
(b) Must have received at least 1 but not more than 2 prior anti-angiogenic therapy 
regimens (including but not limited to sunitinib, sorafenib, pazopanib, axitinib, 
tivozanib, and bevacizumab) in the advanced or metastatic setting. Prior 
cytokine therapy (eg, IL-2 IFN-), vaccine therapy, or treatment with 
cytotoxics is allowed.
(c) Must have received no more than 3 total prior systemic treatment regimens in 
the advanced or metastatic setting and must have evidence of progression on or 
after the last treatment regimen received and within 6 months prior to study 
enrollment.
(4) NSCLC
(a) Histologically confirmed recurrent or metastatic NSCLC not amenable to local 
therapy with curative intent (surgery or radiation with or without 
chemotherapy)
(5) Melanoma
(a) Histologically confirmed recurrent or metastatic melanoma not amenable to 
local therapy with curative intent (surgery or radiation with or without 
chemotherapy)
(6) Gastric cancer
(a) Histologically confirmed recurrent or metastatic gastric cancer not amenable to 
local therapy with curative intent (surgery or radiation with or without 
chemotherapy)
General Inclusion Criteria:
iii) Eastern Cooperative Oncology Group (ECOG) performance status of 1
iv) Ability to swallow tablets
v) Presence of at least 1 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.
vi) Participants with prior exposure to therapy with any agent specifically targeting 
checkpoint pathway inhibition (such as anti-PD-1, anti-PD-L1, anti-PD-L2, 
anti-LAG-3, and anti-CTLA-4 antibody) are permitted after a washout period of any 
time greater than 4 weeks from the last treatment.
Note: (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 
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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 treatment.
(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).
vii)Participants with prior therapy with any agent specifically targeting T-cell 
co-stimulation pathways, such as anti-glucocorticoid-induced tumor necrosis factor 
receptor family-related gene antibody, anti-CD137, or anti-OX40 antibody, are 
permitted after a washout period of any time greater than 4 weeks from the last 
treatment.
viii)
Prior palliative radiotherapy must have been completed at least 2 weeks prior to 
first dose of study treatment. Participants with symptomatic tumor lesions at baseline 
that may require palliative radiotherapy within 4 weeks of first dose of study treatment
are strongly encouraged to receive palliative radiotherapy prior to enrollment.
ix) Participant must consent to allow the acquisition of existing formalin-fixed, 
paraffin-embedded tumor tissue, either a block or 15 to 20 unstained slides, for 
performance of correlative studies. 
x) All participants will be required to undergo mandatory pretreatment and on-treatment 
biopsies at acceptable clinical risk as judged by the investigator. 
(1) Tissue may have been collected at any time prior to first dose of study treatment.
(2) The tumor tissue specimen must be a core needle biopsy, excisional or incisional 
biopsy. Fine needle biopsies, drainage of pleural effusions with cytospins, or punch 
biopsies are not considered adequate for biomarker review and randomization. 
Biopsies of bone lesions that do not have a soft tissue component or decalcified 
bone tumor samples are also not acceptable.
(3) Biopsies cannot be collected in participants with a single measureable lesion, even 
if accessible.
xi) Adequate marrow function for participants with solid tumor histologies as defined by 
the following:
(1) White blood cells 2,000/L (stable off any growth factor within 4 weeks of first 
study treatment administration)
(2) Neutrophils 1,500/L (stable off any growth factor within 4 weeks of first study 
treatment administration)
(3) Platelets 100× 103/L (transfusion to achieve this level is not permitted within 
2 weeks of first study treatment administration)
(4) Hemoglobin 8.5 g/dL (transfusion to achieve this level is not permitted within 
2 weeks of first study treatment administration)
xii)Adequate other organ functions as defined by the following:
(1) ALT and AST 3× institutional upper limit of normal (ULN)
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(2) Total bilirubin 1.5× institutional ULN (except participants with Gilbert’s 
syndrome who must have normal direct bilirubin)
(3) Normal thyroid function, subclinical hypothyroidism (thyroid-stimulating 
hormone < 10 mIU/mL) or have controlled hypothyroidism on appropriate thyroid 
supplementation
(4) 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
(5) Ability to comply with treatment, PK, and pharmacodynamic sample collection and 
required study follow-up
3) Age and Reproductive Status
a) Males and females at least 18 years old at the time of informed consent
b) Women of childbearing potential (WOCBP) must have a negative serum or urine 
pregnancy test (urine pregnancy test: minimum sensitivity 25 IU/L or equivalent units of 
hCG) within 24 hours prior to the start of study treatment.
c) Women must not be breastfeeding.
d) WOCBP must agree to follow instructions for method(s) of contraception for the duration 
of treatment with study treatment(s) plus 5 half-lives of study treatment plus 30 days 
(duration of ovulatory cycle) for a total of 23 weeks post-treatment completion.
e) Males who are sexually active with WOCBP must agree to follow instructions for 
method(s) of contraception for the duration of treatment with study treatment plus 
5 half-lives of study treatment plus 90 days (duration of sperm turnover) for a total of 
31 weeks post treatment completion. In addition, male participants must be willing to 
refrain from sperm donation during this time. 
f)
Azoospermic males and WOCBP who are continuously not heterosexually active are 
exempt from contraceptive requirements. However WOCBP must still 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 WOCBP and male participants who are sexually active with WOCBP 
on the use of highly effective methods of contraception (see Appendix 4). Highly effective 
methods of contraception have a failure rate of < 1% when used consistently and correctly.
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. Participants with controlled brain
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metastases, however, 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 that 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 with ocular melanoma will not be allowed to enroll.
2) Medical Conditions
a) Women who are pregnant or breastfeeding
b) Any significant acute or chronic medical illness
c) A known or underlying medical condition that, in the opinion of the investigator or 
Sponsor, could make the administration of study treatment hazardous to the participants or 
could adversely affect the ability of the participant to comply with or tolerate the study
d) Any major surgery within 4 weeks of study treatment 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 treatment.
e) Participants with a prior malignancy are excluded. 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)
Other active malignancy requiring concurrent intervention
g) Prior organ allograft or allogeneic bone marrow transplantation
h) 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 4 weeks 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)
Prior exposure to BMS-986242 or other IDO inhibitor
j)
Participants with active, known, or suspected autoimmune disease. Participants with 
vitiligo, type I 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 treatment), psoriasis not requiring systemic treatment, or 
conditions not expected to recur in the absence of an external trigger are permitted to enroll.
k) Participants with a condition requiring systemic treatment with either corticosteroids 
(> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 
14 days of study treatment administration except for adrenal replacement steroid doses 
> 10 mg daily prednisone equivalent in the absence of active autoimmune disease 
i)
Note: Treatment with a short course of steroids (< 5 days) up to 7 days prior to initiating 
study treatment is permitted.
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l)
Requirement for daily supplemental oxygen
m) 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 to IV, 
pericarditis, significant pericardial effusion, or myocarditis)
vi) Cardiovascular disease-related requirement for daily supplemental oxygen therapy
n) History of any chronic hepatitis 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 C 
by PCR are eligible. History of resolved hepatitis A virus infection is not an exclusion 
criterion.
o) History of other preexisting liver disease (eg, nonalcoholic fatty liver disease)
p) Evidence of active infection 7 days prior to initiation of study treatment (does not apply 
to viral infections that are presumed to be associated with the underlying tumor type 
required for study entry)
q) Known history of testing positive for human immunodeficiency virus or known acquired 
immunodeficiency syndrome
r)
Evidence or history of active or latent tuberculosis infection, including PPD, recently 
converted to positive; chest X-ray with evidence of infectious infiltrate; and recent 
unexplained changes in fever/chill patterns
s) 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] v4.03) or baseline before administration of study treatment. 
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.
t)
Participants with a history of life-threatening toxicity related to prior immune therapy 
(eg, anti-CTLA-4 or anti-PD-1/PD-L1 treatment or any other antibody or drug specifically 
targeting T-cell co-stimulation or immune checkpoint pathways) except those that are 
unlikely to recur with standard countermeasures (eg, hormone replacement after adrenal 
crisis)
u) Concomitant use of strong inhibitors of CYP3A4 or strong inducers of CYP3A4 (see
Appendix 8)
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v) Use of non-oncology vaccines containing live virus for prevention of infectious diseases 
within 12 weeks prior to study treatment. The use of inactivated seasonal influenza 
vaccines, eg, Fluzone®, will be permitted on study without restriction.
w) Use of packed red blood cells or platelet transfusion within 2 weeks prior to the first dose 
of study treatment
x) Current or recent (within 3 months of study drug administration) gastrointestinal disease 
such as chronic or intermittent diarrhea, or uncontrolled disorders that increase the risk of 
diarrhea, such as inflammatory bowel disease, or other conditions known to interfere 
significantly with the absorption, distribution, metabolism, or excretion of drugs. 
Non-chronic conditions (eg, infectious diarrhea) that are completely resolved for at least 2 
weeks prior to starting study treatment are not exclusionary.
3) Physical and Laboratory Test Findings
a) Positive tests for hepatitis B virus surface antigen or hepatitis C ribonucleic acid (RNA). 
(Participants with positive hepatitis C antibody and negative quantitative hepatitis C by 
PCR are eligible.) Additional testing or substitute testing per institutional guidelines to rule 
out infection is permitted. 
b) Any of the following on 12-lead ECG prior to study treatment administration, confirmed 
by repeat:
i)
QRS 120 msec, except right bundle branch block
ii) QTcF 480 msec, except right bundle branch block
iii) Second or third degree heart block at Screening (Clinical Pharmacology Substudy only)
c)
History of resolved hepatitis A virus infection is not an exclusion criterion.
d) Testing for human immunodeficiency virus must be performed at sites where mandated by 
local requirements.
4) Allergies and Adverse Drug Reaction
a) History of allergy to nivolumab or related compounds
b) History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) to prior 
anti-cancer immune-modulating therapies (eg, checkpoint inhibitors and T-cell 
co-stimulatory antibodies)
5) Other Exclusion Criteria
a) Prisoners or participants who are involuntarily incarcerated (Note: Under certain specific 
circumstances, a person who has been imprisoned may be included or permitted to continue 
as a participant. Strict conditions apply, and BMS approval is required.)
b) Participants who are compulsorily detained for treatment of either a psychiatric or physical 
(eg, infectious disease) illness
c) Inability to comply with restrictions and prohibited activities/treatments as listed in 
Section 6.3
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.
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6.3
Lifestyle Restrictions
6.3.1
Meals and Dietary Restrictions
Grapefruit and Seville oranges and their juices can inhibit CYP3A4 and should not be consumed 
while on study.
BMS-986242 should be administered following a light meal. However, the participant should 
avoid heavy meals with high fat content 4 hours prior to until 4 hours after BMS-986242 dose, 
except for participants in the substudy exploring food effect.
6.3.2
Caffeine, Alcohol, and Tobacco
Not applicable.
6.3.3
Activity
Not applicable.
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/included in the analysis population. A minimal set of screen 
failure information is required to ensure transparent reporting of screen failure participants, to meet 
the Consolidated Standards of Reporting Trials 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
This study permits the re-enrollment of a participant who has discontinued the study as a screen
failure. If re-enrolled, the participant must be re-consented.
Retesting of laboratory parameters and/or other assessments within any single screening or lead-in 
period will be permitted (in addition to any parameters that require a confirmatory value).
The most current result prior to enrollment is the value by which study inclusion will be assessed, 
as it represents the participant’s most current, clinical state.
Laboratory parameters and/or assessments that are included in Table 2-1 may be repeated in an 
effort to find all possible well-qualified participants. Consultation with the Medical Monitor may 
be needed to identify whether repeat testing of any particular parameter is clinically relevant.
7
TREATMENT
Study treatment is defined as any investigational treatment(s), marketed product(s), placebo or 
medical device intended to be administered to a study participant according to the study 
randomization or treatment allocation.
Study 
treatment
includes 
both 
Investigational 
[Medicinal] 
Product 
(IP/IMP) 
and 
Non-investigational [Medicinal] Product (Non-IP/Non-IMP) and can consist of the following:
An IP, also known as IMP in some regions, is defined a pharmaceutical form of an active substance 
or placebo being tested or used as a reference in a clinical study, including products already with 
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a marketing authorization but used or assembled (formulated or packaged) differently than the 
authorized form, or used for an unauthorized indication, or when used to gain further information 
about the authorized form.
Other medications used as support or escape medication for preventative, diagnostic, or therapeutic 
reasons, as components of the standard of care for a given diagnosis, may be considered as 
non-investigational products.
Both treatments used in this open-label study qualify as IPs, as per previous text, and their 
description and storage information are described in Table 7-1.
Table 7-1:
Study Treatments
Product Description / 
Class and Dosage 
Form
Potency
IP/Non-IMP
Blinded or Open 
Label
Storage 
Conditions
BMS-986242-01 Film-
coated Tablet
25 mg
IP
Open
Per label
BMS-986242-01 Film-
coated Tablet
100 mg
IP
Open
Per label
Nivolumab Injection
10 mg/mL
(100 mg/vial)
IP
Open
Per label
7.1
Treatments Administered
Participants will be assigned to a specific dose level as listed in Section 5.1.2.1 in sequential order 
during dose escalation. 
The selection and timing of dose for each participant are as follows (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-986242
12.5-600 mg 
(dose levels 1-7)
QD
PO
Nivolumab
480 mg (flat dose)
Q4W
IV
Abbreviations: PO = per os, orally.
BMS-986242 (Part 1 and Part 2)
BMS-986242 should be administered in the morning following a light meal, approximately 
24 hours apart. On the morning of Days 1 and 14, after an overnight fast of at least 10 hours, each 
participant will receive a single oral dose of BMS-986242 within, approximately, 5 minutes of 
completing a light meal. At the time of dosing, approximately 240 mL of water will be 
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administered to the participant along with BMS-986242. Serial PK samples will be collected on 
Days 1 and 14. The time of BMS-986242 administration will be called “0” hour. A description of 
a sample light breakfast meal is provided in Table 7.1-2. 
Table 7.1-2:
Representative Light Breakfast Meal
Food Item 
Calories (kcal)
Fat (g) 
Carbohydrates (g) 
Protein (g)
2 slices of white bread
128 
1.8 
24.0 
4.0 
1 teaspoonful low-fat 
margarine
26 
2.9 
trace 
trace 
1 tablespoon jam
56 
trace 
13.8 
trace 
5 oz apple juice
71
0.2 
17.5
0.2 
5 oz skim (nonfat) milk
54 
0.3 
7.5 
5.3 
Total grams (g)
-
5.2 
62.8
9.5
Total calories (kcal)
335
47 
251 
38 
% of total calories
100 
14 
75 
11 
Source: US Department of Agriculture Nutrient Database for Standard Reference, Release 28 (September 2015)48
Clinical Pharmacology Substudy
Fasting Treatment: Following an overnight fast of at least 10 hours, participants should be 
administered BMS-986242 with approximately 240 mL of water. No food should be allowed for 
at least 4 hours postdose. Water is allowed ad libitum except for 1 hour before and 1 hour after 
drug administration.
High-fat Meal Treatments: Following an overnight fast of at least 10 hours, participants will start 
the recommended meal 30 minutes prior to administration of BMS-986242. Study participants 
should eat this meal within 30 minutes or less; however, BMS-986242 should be administered 
30 minutes after the start of the meal. BMS-986242 should be administered with approximately 
240 mL of water. No food should be allowed for at least 4 hours postdose. Water is allowed ad 
libitum except for 1 hour before and 1 hour after drug administration.
A high-fat (approximately 50% of total caloric content of the meal) and high-calorie 
(approximately 800 to 1,000 calories) meal is recommended for the high-fat test meal treatment. 
This test meal should derive approximately 150, 250, and 500 to 600 calories from protein, 
carbohydrate, and fat, respectively. A description of a sample high-fat breakfast meal is provided 
in Table 7.1-3.
Table 7.1-3:
Representative High-fat Breakfast
Food Itema
Calories (kcal)
Fat (g)
Carbohydrates (g)
Protein (g)
2 eggs fried
180
13.7
0.8
12.5
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Table 7.1-3:
Representative High-fat Breakfast
Food Itema
Calories (kcal)
Fat (g)
Carbohydrates (g)
Protein (g)
2 slices of white 
bread toasted 
128
1.8
24.0
4.0
1 tablespoon butter
102
11.5
trace
0.1
2 strips of bacon 
fried
108
8.1
0.4
7.8
4 ounces of hash 
brown potatoes
207
9.8
27.4
2.3
8 fluid ounces (237 
mL) of whole milk
149
8.0
11.7
7.7
Total grams (g)
-
52.9
64.3
34.4
Total calories 
(kcal)
874
477
257
138
% of total calories
100
55
29
16
a Substitutions in this test meal can be made as long as the meal provides a similar amount of calories from protein, 
carbohydrate, and fat and has a comparable meal volume and viscosity.
Source: US Department of Agriculture Nutrient Database for Standard Reference, Release 28 (September 2015)48
Restrictions related to food and fluid intake are described in Section 6.3.1.
Nivolumab (Part 1 and Part 2)
During combination treatment, infusion of nivolumab should start approximately 30 minutes 
following BMS-986242. Nivolumab should be infused over 30 minutes. Further details regarding 
preparation and administration will be provided separately in site/pharmacy training materials. 
Nivolumab will be administered IV as a flat dose. There will be no dose escalations or reductions 
of nivolumab allowed once assigned. There are no premedications recommended for nivolumab 
on the first cycle. If an acute infusion reaction is noted, participants should be managed according 
to Section 7.7.1.5.
7.2
Method of Treatment Assignment
During the screening visit, the investigative site will call into the enrollment option of the IRT
designated by BMS for assignment of a 5-digit participant number that will be unique across all 
sites. Enrolled participants, including those not dosed, will be assigned sequential participant
numbers starting with 00001 (eg, 00001, 00002, 00003… 00010). The participant identification 
number will ultimately be composed of the site number and participant number. For example, the 
first participant screened (ie, enrolled) at site number 1 will have a participant identification 
number of 0001 00001. Once it is determined that the participant meets the eligibility criteria 
following the screening visit, the investigator site will call the IRT within 3 days prior to the first 
study treatment administration for the participant to be assigned to a treatment group.
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During dose escalation, participants who are not evaluable for DLT determination may be 
replaced. Replacement participants will be assigned to the same treatment but will be assigned a 
new participant number.
7.3
Blinding
Not applicable.
7.4
Dosage Modification
7.4.1
Dose-limiting Toxicity
For the purpose of guiding dose escalation, DLTs will be defined based on the incidence and grade 
of AEs for which no alternate cause can be identified. 
Part 1: Cycle 0 BMS-986242 (monotherapy lead-in) will have a 2-week DLT evaluation period 
(DLT1). The combination regimen will have 4-week DLT evaluation period (DLT2). Therefore, 
the total DLT assessment period is 6 weeks. Participants may proceed from Cycle 0 to Cycle 1 at 
each cohort unless any of the following events is observed: any DLT, Grade 2 or higher immune-
related AEs considered related to BMS-986242 (eg, immune-mediated pneumonitis, colitis, 
hepatitis, nephritis, renal dysfunction) with the exception of immune-mediated hypothyroidism 
and hyperthyroidism, or Grade 2 AST and ALT elevation that does not resolve to Grade 1 within 
1 week. For Grade 2 AST and ALT elevations that resolve to Grade 1 or baseline within 1 week, 
participants can be rechallenged with BMS-986242 monotherapy for a minimum of 5 days before 
proceeding to combination with nivolumab provided there is not a recurrence of Grade 2 event.
The total DLT period is 6 weeks, and participants must have received at least 75% of the 
BMS-986242 doses and 1 dose of nivolumab with observation for a minimum of 21 days following 
the first combination treatment dose to be considered evaluable for dose escalation decisions. 
Based on the predicted human half-life of BMS-986242 of 13 hours, this interval is expected to 
cover the anticipated timeframe for the occurrence of clinically significant immediate and early-
onset AEs related to BMS-986242 monotherapy during Cycle 0 and repeat dosing of BMS-986242 
in combination with nivolumab in Cycle 1. 
The incidence of DLTs that occur within 6 weeks following the start of study treatment will guide 
dose escalation decisions. AEs will be graded according to the NCI CTCAE v4.03. For the 
purposes of participant management, study treatment-related AEs occurring at any time that meet 
the DLT definition will lead to dose interruption, dose modifications, and/or permanent 
discontinuation of study treatment as defined in Section 8. Participants who withdraw from the 
study during the DLT evaluation interval for reasons other than a DLT may be replaced at the same 
dose level. The incidence of DLT(s) during the first cycle of treatment (the DLT evaluation period) 
will be used in dose escalation decisions and to define the MTD. AEs occurring after the DLT 
period will be considered for the purposes of defining the MTD, upon agreement between the 
Sponsor/Medical Monitor and investigators, if they are determined to have no clear alternative 
cause and are not related to disease progression.
For the purpose of guiding dose escalation, DLTs are defined below based on the incidence and 
grade of AEs for which no alternate cause can be identified.
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Guidelines for management algorithms for immuno-oncology (I-O) agents and treatment of study 
treatment-related infusion reactions are provided in Sections 7.7.1.4 and 7.7.1.5, respectively.
7.4.1.1
Dose-limiting Toxicities
Dose-limiting Toxicities for DLT1 and DLT2 Periods
Nonhematologic DLT:
A. Hepatic, Nonhematologic DLT
Any of the following events will be considered a hepatic DLT:

Any Grade 3 elevation of AST, ALT, or total bilirubin

Grade 2 AST or ALT with symptomatic liver inflammation (eg, right upper quadrant 
tenderness, jaundice, pruritus)

AST or ALT > 3× ULN and concurrent total bilirubin > 2× ULN without initial findings of 
cholestasis (elevated serum alkaline phosphatase; eg, findings consistent with Hy’s law or 
Food and Drug Administration definition of potential drug-induced liver injury [DILI])*
*Note that this special category of DLT uses ULN rather than Common Toxicity Criteria Grade 
for definition.
B. Nonhepatic, Nonhematologic DLT
Any of the following events will be considered a nonhepatic, nonhematologic DLT:

Grade 2 or greater epscleritis, 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

Any Grade 3 or greater nondermatologic, nonhepatic, nonhematologic toxicity will be 
considered a DLT 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 infusion reaction that returns to Grade 1 in less than 6 hours
C. Dermatologic DLT

Grade 3 rash if no improvement (ie, resolution to Grade 1) after a 1- to 2-week infusion 
delay. Participants who have not experienced a Grade 3 study treatment-related skin AE may 
resume treatment in the presence of Grade 2 skin toxicity.
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
Grade 4 rash of any duration.
D. Hematologic DLT

Grade 4 neutropenia 5 days in duration

Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding or any requirement for 
platelet transfusion

Grade 3 febrile neutropenia for 48 hours

Grade 3 hemolysis (ie, requiring transfusion or medical intervention such as steroids)

Grade 4 anemia not explained by underlying disease


In addition to the above criteria, any toxicity that results in a participant not receiving at 
least 75% of the doses of BMS-986242 and the dose of nivolumab during the DLT evaluation 
period or causing greater than 2 weeks of dose delay will be classified as a DLT. 
7.4.2
Guidelines for Dose Modification
Participants will be monitored continuously for AEs while on study treatment. Participants will be 
instructed to notify their physician immediately for any and all AEs. The criteria presented in this 
section and Table 7.4.2-1 for dose modifications for BMS-986242 and delays are meant as general 
guidelines.
Participants will continue to receive study treatment as long as they have not had disease 
progression or study treatment-related AEs requiring dose modification as described below.

Dose modification, interruption, or delay may occur in the setting of a lower-grade AE and/or 
be more conservative than indicated in Table 7.4.2-1 based on the clinical judgment of the 
investigator and in consultation with the Sponsor/Medical Monitor.

Dose reductions of BMS-986242 should be to the previous lower dose level.

If several AEs of varying grades or severities occur simultaneously, the dose modification 
applied should be the greatest reduction applicable.

Assessment of causality (chronology, confounding factors such as disease, concomitant 
medications, diagnostic tests, and previous experience with the agent) must be determined and 
documented by the investigator prior to dose modification.

If the same AE recurs despite a dose reduction, a second dose reduction versus discontinuation 
of BMS-986242 will be discussed and agreed upon by the Sponsor/Medical Monitor and 
investigators.

No more than 2 dose reductions of BMS-986242 will be allowed per participant. If a third dose 
reduction is required, the participant must discontinue BMS-986242. Dose re-escalation after 
a dose reduction may occur in limited circumstances (such as a change in attribution of an AE) 
after discussion and agreement of the Sponsor/Medical Monitor and investigators.

Skipped doses will not be administered within the same cycle.

For an AE requiring dose modification, BMS-986242 and nivolumab should be interrupted to 
allow recovery from the AE. Re-initiation of study treatment cannot occur until AE decreases 
to ≤Grade 1 or baseline assessment. In case of delayed recovery to Grade 1 or baseline 
(except for alopecia) from treatment-related AEs that results in a delay of treatment for 
> 6 weeks, the participant will not receive additional protocol-related treatment and will be 
removed from study unless discussed and agreed upon by the Sponsor/Medical Monitor and 
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investigators that it is in the best interest of the participant to receive additional treatment with 
BMS-986242 and nivolumab (eg, if the participant has demonstrated a response to treatment).

During the DLT evaluation period, if a participant receives dose reduction and experiences a 
DLT at the lower dose, this DLT will be attributed to the highest dose level administered.

For data collection and analysis purposes, all participants will continue to be classified by the 
original treatment arm.
Table 7.4.2-1:
Dose Modifications
Dose Modification 
Criteria for Study 
Treatment-Related 
Adverse Events
BMS-986242 Monotherapy 
Modification at the Next Dose
BMS-986242 Combination 
Modification at the Next Dose 
QTcF > 500 msec 
confirmed by at least 
1 repeat ECG and at least 
60 msec above baseline
Interrupt if needed to optimize 
electrolyte management. If event 
persists after electrolyte optimization 
(including dose modification of BMS-
986242, if necessary), discontinue.
Participants may proceed to get 
nivolumab monotherapy.
Interrupt if needed to optimize 
electrolyte management. If event 
persists after electrolyte optimization 
(including dose modification of BMS-
986242, if necessary), discontinue.
However, treatment with nivolumab 
may continue after discussion between 
PI and Medical Monitor.
Any other study treatment-
related Grade 3 adverse 
event that does not meet 
permanent discontinuation 
criteria (Section 8)
Decrease 1 level of BMS-986242 (no 
lower than 25 mg).
Decrease 1 level of BMS-986242  (no 
lower than 25 mg) in combination with 
same dose of nivolumab.
Grade 2 LFT abnormalities 
that do not resolve within 
1 week
Interruption of BMS-986242
Continuation of BMS-986242 at a 
lower dose level may be considered 
after discussion with the 
Study Director/Medical Monitor.
Participants may proceed to get 
nivolumab monotherapy.
NA
Grade 2 LFT abnormalities 
that resolve in 1 week
Interrupt dosing until improvement to 
Grade 1 or baseline and resume at same 
dose. If recurrence of Grade 2 LFT 
elevations, decrease 1 level.
NA
Abbreviations: LFT = liver function test; QTcF = QT interval corrected for heart rate using Fridericia’s formula; NA
= not applicable; PI = principal investigator.
7.4.3
Dose Delays Due to Toxicity

Participants who experience a DLT must have study treatment held. Participants who are 
required to permanently discontinue both study treatments are listed in Section 8.2. In addition, 
all Grade 2 hepatic, pulmonary, renal, gastrointestinal, and neurological AEs should be 
evaluated and managed per the toxicity management algorithms for immuno-oncology agents
(see Appendix 9). Participants not meeting guidelines for permanent discontinuation will be 
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permitted to resume study treatment based on the criteria specified below in Section 7.4.4. 
Participants eligible to resume study treatment will resume study treatment at the treatment 
visit following their last received study treatment dose.

The end of cycle tumor assessments (ie, CT/MRI, positron emission tomography [PET], etc) 
will continue on an every-8-week schedule relative to the participant’s first dose regardless of 
any treatment delay incurred.
7.4.4
Criteria to Resume Treatment
Participants experiencing AEs not meeting criteria for permanent discontinuation as outlined in
Section 8.1 and Section 8.2 may resume treatment with study treatment under the following 
criteria:

Participants may resume treatment with study treatment when the study treatment-related 
AE(s) resolves to Grade 1 or baseline value with the following EXCEPTIONS:

Participants may resume treatment in the presence of Grade 2 fatigue.

Participants who have not experienced a Grade 3 study treatment-related skin AE may 
resume treatment in the presence of Grade 2 skin toxicity.

Participants with Grade 2 uveitis or eye pain or blurred vision not meeting DLT criteria 
(Section 7.4.1) must resolve to baseline prior to resuming study treatment.

Study treatment-related pulmonary toxicity, diarrhea, or colitis must have resolved to baseline 
before treatment is resumed.

Participants with study treatment-related endocrinopathies adequately controlled with only 
physiologic hormone replacement may resume treatment.

If the criteria to resume treatment are met, the participant should restart treatment at the next 
scheduled time point per protocol.

The consideration to re-initiate study treatment under these exceptions will be made on a 
case-by-case basis after considering the overall benefit/risk profile and in consultation between 
the investigator and the study Sponsor. Any AE with clinical risk will be assessed on a 
case-by-case basis with the investigator and the BMS Medical Monitor to determine the risks 
and benefits of continuing on study treatment following resolution versus discontinuing study 
treatment permanently. 

If treatment with study treatment is delayed > 6 weeks, the participant must be permanently 
discontinued from study treatment, except as specified in Section 7.4.2.
7.4.5
Guidelines for Permanent Discontinuation Secondary to Adverse 
Events
Participants will be required to permanently discontinue both study treatments for the following 
AEs:

Clinical deterioration, as assessed by the investigator

Grade 3 infusion reaction that does not return to Grade 1 in less than 6 hours

Grade 3 pneumonitis, bronchospasm, neurologic toxicity, uveitis, or myocarditis

Life-threatening skin toxicity (toxic epidermal necrolysis)
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
Any Grade 4 AE; however, an exception may be made for the following upon consultation 
between the investigator and BMS Medical Monitor:

Grade 4 electrolyte abnormalities < 72 hours in duration

Grade 4 neutropenia < 7 days in duration

Grade 4 lymphopenia

Grade 4 increase in amylase or lipase that is not associated with clinical or radiographic 
evidence of pancreatitis

Abnormal liver function tests meeting criteria for a potential DILI.

Any dosing delay lasting > 6 weeks will be cause for permanent discontinuation. Extensions 
to the period of dose delays may be granted for individual participants on a case-by-case basis 
after specific consultation and agreement between the investigator and BMS Medical Monitor 
in settings where benefit/risk may justify continued study treatment (eg, participant deriving 
clinical benefit who requires prolonged steroid taper for management of non-DLT 
immune-related AEs or experiences delays for management of a non-treatment-related AE).

Accordingly, dosing delays to allow for prolonged steroid tapers to manage study 
treatment-related AEs are allowed. Additionally, dosing delays > 6 weeks that occur for 
non-treatment-related reasons may be allowed if approved by the BMS Medical Monitor.

The consideration to re-initiate study treatment under these exceptions will be made on a 
case-by-case basis after considering the overall benefit/risk profile and in consultation between 
the investigator and the Sponsor.

Prior to re-initiating treatment in a participant with a dosing delay lasting > 6 weeks, the BMS 
Medical Monitor must be consulted.

Tumor assessments should continue per protocol even if dosing is delayed.
All participants who discontinue the IP should comply with protocol-specified follow-up 
procedures as outlined in Section 8.2. The only exception to this requirement is when a participant 
withdraws consent for all study procedures, including post-treatment study follow-up, or loses the 
ability to consent freely (eg, is imprisoned or involuntarily incarcerated for the treatment of either 
a psychiatric or physical illness).
If study 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 case report form (CRF) page.
7.5
Preparation/Handling/Storage/Accountability
The investigational product should be stored in a secure area according to local regulations. It is 
the responsibility of the investigator to ensure that investigational product is only dispensed to 
study participants. The investigational product must be dispensed only from official study sites by 
authorized personnel according to local regulations.
The product storage manager should ensure that the study treatment is stored in accordance with 
the environmental conditions (temperature, light, and humidity) as determined by BMS. If 
concerns regarding the quality or appearance of the study treatment arise, the study treatment
should not be dispensed and contact BMS immediately.
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Study treatment not supplied by BMS will be stored in accordance with the package insert.
Investigational product documentation (whether supplied by BMS or not) must be maintained that 
includes all processes required to ensure study treatment is accurately administered. This includes 
documentation of study treatment storage, administration and, as applicable, storage temperatures, 
reconstitution, and use of required processes (eg, required diluents, administration sets).
Further guidance and information for final disposition of unused study treatment are provided in 
Appendix 2 and the Study Reference Manual.
7.5.1
Retained Samples for Bioavailability/Bioequivalence
Not applicable.
7.6
Treatment Compliance
Study treatment compliance will be periodically monitored by drug accountability and review of 
dosing diary cards. Drug accountability should be reviewed by the site study staff at each visit to 
confirm treatment compliance. Sites should discuss discrepancies with the participant at each 
on-treatment study visit. 
BMS-986242 will be administered on an outpatient basis, except when participants are seen in the 
clinic for administration of nivolumab, assessment of AEs, PK sample collection, and laboratory 
evaluation. At those visits, the participant will take BMS-986242 at the clinic.
7.7
Concomitant Therapy
7.7.1
Prohibited and/or Restricted Treatments
Prohibited and/or restricted medications taken prior to study treatment administration in the study 
are described below. Medications taken within 4 weeks prior to study treatment administration 
must be recorded on the CRF.
7.7.1.1
Prohibited Therapies
A. Prior exposure to BMS-986242 or other IDO inhibitor
B. Concurrent administration of any anti-cancer therapies (investigational or approved) with the 
exception of participants in the follow-up and survival period of the study
C. Concomitant use of strong inhibitors of CYP3A4 or strong inducers of CYP3A4 (see 
Appendix 8)
D. Drugs that may prolong QT intervals are prohibited during Cycle 00 of the clinical 
pharmacological substudy. See Appendix 10 for a list of common medications associated 
with QT prolongation.
E. Immunosuppressive agents (except as stated in Section 7.7.1.3) unless they are utilized to 
treat an AE
F. Participants receiving RANK-L inhibitors or bisphosphonates are permitted as clinically 
indicated but should be avoided, if possible, prior to completion of Cycle 1.
G. Palliative radiotherapy is permitted only under certain conditions as described in Section 6.1.
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No concomitant medications (prescription, over the counter, or herbal) are to be administered 
during study unless they are prescribed for treatment of specific clinical events. Any concomitant 
therapies must be recorded on the CRF.
The investigator should contact and confirm agreement with the BMS Medical Monitor (and 
acknowledgement from the contract research organization Medical Monitor) prior to the 
administration of any concomitant medications.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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7.8
Treatment After 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.
8
DISCONTINUATION CRITERIA
8.1
Discontinuation from Study Treatment
Participants MUST discontinue IP (and non-IP at 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 specifically withdraws 
consent for any further contact with him/her or persons previously authorized by participant to 
provide this information.

Any clinical AE, laboratory abnormality, or intercurrent illness, which, in the opinion of the 
investigator, indicates that continued participation in the study is not in the best interest of the 
participant

Termination of the study by BMS

Loss of ability to freely provide consent through imprisonment or involuntarily incarceration 
for treatment of either a psychiatric or physical (eg, infectious disease) illness

Inability to comply with protocol

Discretion of the investigator

Pregnancy

Completion of study-required procedures

Documented and confirmed PD as defined by RECIST v1.1 (see Appendix 6) unless 
participant meets criteria for treatment beyond progression (Section 5.1.2.3)

Clinical deterioration while receiving active study treatment that, in the opinion of the 
investigator, indicates that continued participation in the study is not in the best interest of the 
participant

Protocol-defined reasons for discontinuation (see Section 7.4.5)
Refer to the Schedule of Activities (Section 2) for data to be collected at the time of treatment 
discontinuation and follow-up and for any further evaluations that can be completed.
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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Discontinuation of the study treatment for abnormal liver tests should be considered by the 
investigator when a participant meets the conditions outlined in Section 9.2.7.
8.1.1
Post Study Treatment Study Follow-up
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 and/or survival follow-up data as required and in line with 
Section 5.1.3 until death or the conclusion of the study.
8.2
Discontinuation from the Study
Participants who request to discontinue study treatment will remain in the study and must continue 
to be followed for protocol-specified follow-up procedures. The only exception to this is when a 
participant specifically withdraws consent for any further contact with him/her or persons 
previously authorized by the participant to provide this information. 

Participants should notify the investigator of the decision to withdraw consent from future 
follow-up in writing, whenever possible.

The withdrawal of consent should be explained in detail in the medical records by the 
investigator as to whether the withdrawal is from further treatment with study treatment only 
or also from study procedures and/or post-treatment study follow-up and entered on the 
appropriate CRF page.

In the event that vital status (whether the participant is alive or dead) is being measured, 
publicly available information should be used to determine vital status only as appropriately 
directed in accordance with local law.

If the participant withdraws consent for disclosure of future information, the Sponsor may 
retain and continue to use any data collected before such a withdrawal of consent.
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 as the inability to reach the participant after a minimum of 
3 documented phone calls, faxes, or emails as well as lack of response by the participant to one 
registered mail letter. All attempts should be documented in the participant’s medical records.

If it is determined that the participant has died, the site will use permissible local methods to 
obtain the date and cause of death.

If the investigator’s use of a third-party representative to assist in the follow-up portion of the 
study has been included in the participant’s informed consent, then the investigator may use a 
Sponsor-retained third-party representative to assist site staff with obtaining the participant’s 
contact information or other public vital status data necessary to complete the follow-up 
portion of the study. 

The site staff and representative will consult publicly available sources, such as public health 
registries and databases, in order to obtain updated contact information.

If after all attempts, the participant remains lost to follow-up, then the last known alive date as 
determined by the investigator should be reported and documented in the participant’s medical 
records.
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9
STUDY ASSESSMENTS AND PROCEDURES

Study procedures and timing are summarized in the Schedule of Activities (Section 2). 

Protocol waivers or exemptions are not allowed.

All immediate safety concerns must be discussed with the Sponsor immediately upon 
occurrence or awareness to determine if the participant should continue or discontinue 
treatment.

Adherence to the study design requirements, including those specified in the Schedule of 
Activities, is essential and required for study conduct.

All screening evaluations must be completed and reviewed to confirm that potential 
participants meet all eligibility criteria before treatment. 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
Only data for the procedures and assessments specified in this protocol should be submitted to the 
Sponsor or Designee on a CRF. Additional procedures and assessments may be performed as part 
of standard of care. Data for these assessments, however, should remain in the participant’s 
medical record and should not be provided to the Sponsor or Designee unless specifically 
requested from BMS or designee.
Disease assessment with CT and/or MRI, as appropriate, will be performed at baseline, the end of 
Cycle 2, and every 8 weeks until disease progression, at the completion of follow-up, or until 
participants withdraw from the study (every 12 weeks for the first year after the EOT visit and then 
every 6 months thereafter up to 2 years from the last dose of study treatment). Disease assessments 
at other time points may be performed if the investigator is concerned about tumor progression. 
Assessment of tumor response will be reported based on investigator assessed tumor 
measurements as defined by RECIST v1.1 (see Appendix 6) for participants with solid tumors. 
Investigators will also report the number and size of new lesions that appear while on study. The 
time point tumor assessments will be reported on the CRF based on investigators’ assessment using 
RECIST. 
9.1.1
Imaging Assessment for the Study
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.
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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.
Disease assessment with CT and/or MRI as appropriate will be performed at baseline and as 
follows:

Parts 1 and 2: end of Cycle 2 and then every 8 weeks throughout the treatment period and 
every 12 weeks for the first year after the EOT visit, and then every 6 months thereafter, up to 
2 years from the last dose of study treatment during the follow-up period.
Disease assessments at other time points may be performed as clinically indicated.
Brain Imaging
Brain imaging is only required at screening for participants with known history or symptoms of 
brain metastases and who have not had brain imaging within 30 days of anticipated first study 
treatment administration. After screening, brain imaging is required only as clinically indicated.
Bone Scan
Bone scans may be performed as clinically indicated at baseline (eg, participants with history of 
symptoms of bone metastases), but bone scans will not be considered a modality for assessment 
for measurable disease. After baseline, bone scans are required only as clinically indicated.
Imaging Modalities
For all the solid tumor types, the following imaging assessments should be performed at a 
study-specified schedule: CT of the chest, CT or MRI of the abdomen, pelvis, and other known 
sites of disease, which is also summarized Table 9.1.1-1:
Table 9.1.1-1:
Acceptable Imaging Assessment Methods for Different Anatomic 
Regions
Anatomic Region
Preferred Method
Alternative Methods
Chest, abdomen, and pelvis
Note: Scan must cover lung apices 
to diaphragm, diaphragm through 
entire liver, and to below the pubic 
symphysis
CT with IV contrast
For chest:

CT without contrast can be 
used only if the participant has 
a clinical contraindication for 
iodine-based IV contrast (eg, 
hypersensitivity, 
renal 
insufficiency)
For abdomen and pelvis:

MRI with gadolinium-based IV 
contrast is the first alternative 
method if the participant has a 
clinical contraindication for 
iodine-based IV contrast
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Table 9.1.1-1:
Acceptable Imaging Assessment Methods for Different Anatomic 
Regions
Anatomic Region
Preferred Method
Alternative Methods

CT without contrast can be 
used as the second alternative 
method only if the participant 
has a clinical contraindication 
for both contrast-enhanced CT 
and MRI.
Brain
MRI with IV contrast

CT with IV contrast is the first 
alternative 
method 
if 
IV 
gadolinium 
is 
clinically 
contraindicated. 

MRI without contrast can be 
used as a second alternative 
method if a participant has 
clinical contraindications for 
both contrast-enhanced CT and 
MRI
In all study parts, scans will be collected centrally and may be reviewed by a blinded independent 
central review at a later date or at any time during the study per Sponsor request.
9.1.2
Secondary Efficacy Assessment
The efficacy assessments will include the overall response rate (ORR) (eg, PR + CR rate), duration 
of response (DOR), and PFSR at time points (eg, 6, 9, 12, and 24 months) based on the assessment 
of tumor response using RECIST v1.1 criteria.
 
9.2
Adverse Events
The definitions of an AE or SAE can be found in Appendix 3.
AEs will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the 
participant’s legally authorized representative). 
The investigator and any designees are responsible for detecting, documenting, and reporting 
events that meet the definition of an AE or SAE and remain responsible for following up AEs that 
are serious, considered related to the study treatment or the study, or that caused the participant to 
discontinue before completing the study. 
Contacts for SAE reporting are specified in Appendix 3.
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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 
100 days after discontinuation of study treatment, at the time points 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 participant’s written consent to 
participate in the study, all SAEs, whether related or not related to study treatment, must be 
collected, including those thought to be associated with protocol-specified procedures.
All SAEs must be collected from the date of participant’s written consent until 100 days after 
discontinuation of nivolumab or participation in the study (if the last scheduled visit occurs at a 
later time).
Medical occurrences that begin before the start of study treatment but after obtaining informed 
consent will be recorded on the appropriate section of the electronic CRF.

All SAEs will be recorded and reported to the 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, or evaluation of a participant. (In order to prevent reporting bias, participants should 
not be questioned regarding the specific occurrence of one or more AEs.)
9.2.3
Follow-up of AEs and SAEs

Nonserious AEs should be followed to resolution, until the condition stabilizes, until the event 
is otherwise explained, or until the participant is lost to follow-up 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.
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After the initial AE/SAE report, the investigator is required to proactively follow each participant 
at subsequent visits/contacts. 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 by the investigator to the Sponsor of SAEs is essential so that legal 
obligations and ethical responsibilities towards the safety of participants and the safety of a 
product under clinical investigation are met.

An investigator who receives an investigator safety report describing SAEs or other specific 
safety information (eg, summary or listing of SAEs) from the Sponsor will file it along with 
the IB and will notify the institutional review board/institutional ethics committee, if 
appropriate, according to local requirements.
The Sponsor or designee will be reporting adverse events to regulatory authorities and ethics 
committees according to local applicable laws, including European Directive 2001/20/EC and 
Food and Drug Administration Code of Federal Regulations 21 CFR Parts 312 and 320. A 
Suspected, Unexpected Serious Adverse Reaction is a subset of SAEs and will be reported to the 
appropriate regulatory authorities and investigators following local and global guidelines and 
requirements.
9.2.5
Pregnancy
If, following initiation of the study treatment, it is subsequently discovered that a participant is 
pregnant or may have been pregnant at the time of study exposure, including during at least 
5 half-lives after product administration, the investigator must immediately notify the BMS 
Medical Monitor/designee of this event and complete and forward a Pregnancy Surveillance Form 
to the BMS Designee within 24 hours of awareness of the event and in accordance with SAE 
reporting procedures described in Appendix 3.
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.
Protocol-required procedures for study discontinuation and follow-up must be performed on the 
participant.
Follow-up information regarding the course of the pregnancy, including perinatal and neonatal 
outcome and, where applicable, and offspring information must be reported on the Pregnancy 
Surveillance Form.
Any pregnancy that occurs in a female partner of a male study participant should be reported to 
Sponsor or designee. In order for Sponsor or designee to collect any pregnancy surveillance 
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information from the female partner, the female partner must sign an ICF for disclosure of this 
information. Information on this pregnancy will be collected on the Pregnancy Surveillance Form.
9.2.6
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 participant to have study treatment 
discontinued or interrupted

Any laboratory test result abnormality that required the participant to receive specific 
corrective therapy
It is expected that, wherever possible, the clinical rather than laboratory term would be used by the 
reporting investigator (eg, anemia versus low hemoglobin value).
9.2.7
Potential Drug-induced Liver Injury
Wherever possible, timely confirmation of initial liver-related laboratory abnormalities should 
occur prior to the reporting of a potential DILI event. All occurrences of potential DILIs meeting 
the defined criteria must be reported as SAEs (see Section 9.2 and Appendix 3 for reporting 
details).
Potential DILI is defined as: 

AT (ALT or AST) elevation > 3×ULN
AND

Total bilirubin > 2ULN, without initial findings of cholestasis (elevated serum alkaline 
phosphatase),
AND

No other immediately apparent possible causes of AT elevation and hyperbilirubinemia, 
including, but not limited to, viral hepatitis, pre-existing chronic or acute liver disease, or the 
administration of other drug(s) known to be hepatotoxic.
9.2.8
Other Safety Considerations
Any significant worsening noted during interim or final PEs, ECG, X-ray filming, or any other 
potential safety assessment required or not required by protocol should also be recorded as a 
nonserious or serious AE, as appropriate, and reported accordingly.
9.3
Overdose
For this study, any dose of BMS-986242 greater than the assigned dose and considered both 
excessive and medically important by the investigator in consultation with the Medical Monitor 
will be considered an overdose. All occurrences of overdose must be reported as SAEs (see 
Section 9.2)
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In the event of an overdose, the investigator/treating physician should:

Contact the Medical Monitor immediately

Closely monitor the participant for AEs/SAEs and laboratory abnormalities until BMS-986242
can no longer be detected systemically (at least 7 days)

Obtain a plasma sample for PK analysis within 3 days from the date of the last dose of study 
treatment if requested by the Medical Monitor (determined on a case-by-case basis)

Document the quantity of the excess dose as well as the duration of the overdosing in the CRF
Decisions regarding dose interruptions or modifications will be made by the investigator in 
consultation with the Medical Monitor based on the clinical evaluation of the participant.
9.4
Safety
Planned time points for all safety assessments are listed in the Schedule of Activities.
9.4.1
Physical Examinations
Refer to the Schedule of Activities for timing of assessments in Section 2.
9.4.2
Vital Signs
Refer to the Schedule of Activities for timing of assessments in Section 2.
9.4.3
Electrocardiograms
Refer to the Schedule of Activities for timing of assessments in Section 2.
For the purposes of monitoring participant safety, investigators will review 12-lead ECGs per the 
protocol-specified schedule as outlined in time and events tables (see Section 2) using their site’s 
standard ECG machines.
9.4.4
Clinical Safety Laboratory Assessments
Investigators must document their review of each laboratory safety report.
A local laboratory will perform the analyses and will provide reference ranges for these tests.
Results of clinical laboratory tests performed up to Day -1 must be available prior to dosing.
The laboratory tests that will be performed for study participants are shown in Table 9.4.4-1.
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.
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Table 9.4.4-1:
Laboratory Assessments
Hematology
Hemoglobin
Hematocrit
Total leukocyte count, including differential
Platelet count
Serum Chemistry
Aspartate aminotransferase
Alanine aminotransferase
Total bilirubin
Direct bilirubin
Alkaline phosphatase
Lactate dehydrogenase
Creatinine
Blood urea nitrogen
Uric acid 
Glucose (Fasting at screening only)
Amylase
Lipase 
HDL, LDL
Total Protein
Albumin
Sodium
Potassium
Chloride
Total serum calcium
Phosphorus
Magnesium
Creatinine clearance- screening only
Bicarbonate/Carbon dioxide
Ferritin
PTT/PT
Gamma-glutamyl transferase only when alkaline phosphatase increases to Grade ≥2.
Urinalysis
Protein
Glucose
Blood
Leukocyte esterase
Specific gravity
pH
Microscopic examination (performed if blood, protein, or leukocyte esterase is present on dipstick)
Serology
Serum for hepatitis C antibody (if hepatitis C antibody is positive reflex to hepatitis C RNA) or hepatitis C RNA, 
hepatitis B surface antigen; HPV status; and HIV-1 and HIV-2 antibody. (Testing for HIV-1, HIV-2 must be 
performed at sites where mandated by local requirements)
Other Analyses
Serum or urine pregnancy test (WOCBP only) 
TSH with reflex testing to free T3 and free T4 if TSH 
is abnormal. 
FSH (if needed to document postmenopausal status)
9.4.5
Suicidal Risk Monitoring
Not applicable.
9.4.6
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. 
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9.5
Pharmacokinetic
9.5.1
Pharmacokinetic Assessment Following BMS-986242 Monotherapy 
The PK of BMS-986242 and its metabolites (if applicable) 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.
The PK parameters to be assessed for BMS-986242 and selected metabolites following single-dose 
administration in Cycle 00 and multiple-dose administration in Cycle 0 include but are not limited 
to:
Cmax
Maximum observed plasma concentration
Tmax
Time of maximum observed plasma concentration
AUC(0-T)
Area under the concentration-time curve from 0 to last observed 
collection time (clinical pharmacology substudy)
AUC(INF)
Area under the concentration-time curve from 0 extrapolated to infinity 
time (clinical pharmacology substudy only)
AUC(TAU)
Area under the concentration-time curve in 1 dosing interval
Ctrough
Trough observed plasma concentration at the end of the dosing interval
CLT/F
Apparent total body clearance
Vss/F
Apparent volume of distribution at steady-state
T-HALF
Apparent terminal phase half-life
AI
Accumulation index, calculated based on ratio of AUC and Cmax at 
steady state to after the first dose
%UR24
Percent urinary recovery over 24 hours
%UR72
Percent urinary recovery over 72 hours (clinical pharmacology 
substudy only)
In addition, the following PK parameters for select BMS-986242 metabolites may also be assessed 
if data permit:
MR_Cmax
Ratio of metabolite Cmax to parent Cmax, corrected for molecular 
weight
MR_AUC(TAU)
Ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for 
molecular weight
MR_AUC(0-T)
Ratio of metabolite AUC(0-T) to parent AUC(0-T), corrected for 
molecular weight (clinical pharmacology substudy only)
MR_AUC(INF)
Ratio of metabolite AUC(INF) to parent AUC(INF), corrected for 
molecular weight (clinical pharmacology substudy only)
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9.5.2
Pharmacokinetic Assessment Following Combination Treatment with 
BMS-986242 and Nivolumab
Plasma samples for BMS-986242 will be collected for all participants receiving combination 
treatment with BMS-986242 and nivolumab. Plasma concentration data will be tabulated using 
summary statistics. These data, together with data from the monotherapy, may also be pooled with 
other datasets for PPK analysis, which will be presented in a separate report.
Serum samples for nivolumab PK and immunogenicity assessments will be collected for all 
participants receiving combination treatment of BMS-986242 and nivolumab. End-of-infusion and 
trough concentrations will be tabulated using summary statistics. These data may also be pooled 
with other datasets for PPK analysis, which will be presented in a separate report.
9.5.3
Pharmacokinetics: Collection and Processing
Detailed sampling schedules to be followed for the assessment of PK and immunogenicity for all 
analytes in the study are provided in Table 9.5.3-1. All time points are relative to the start of 
BMS-986242 dosing. Predose samples should be taken within 30 minutes before the start of 
BMS-986242 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.
Table 9.5.3-2 lists the PK sampling and ECG collection schedules to be followed for the clinical 
pharmacology substudy (Cycle 00). Serial ECGs (reviewed by a core laboratory) will be collected 
with matching PK samples. Twelve-lead continuous ECG (Holter) will be used in the QTc 
substudy. Each ECG time point will be collected in triplicates. ECGs should be performed after 
the participant has been resting supine for at least 10 minutes and should be completed prior to any 
PK/pharmacodynamic sample blood collections when assessments occur at the same time points. 
All serial ECGs will be transmitted to a central laboratory for measurement of intervals and 
classification of ECG abnormalities. At the end of the clinical pharmacology substudy, participants 
will follow PK collection schedule after BMS-986242 + nivolumab combination treatment 
provided in Table 9.5.3-1.
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Table 9.5.3-1:
Pharmacokinetic, Anti-drug Antibody (ADA/Immunogenicity) Sampling Schedule for BMS-986242
and Nivolumab (Dose Escalation Part 1 and Dose-Expansion Cohorts Part 2)
Study Day 
of Sample 
Collection
Event
Time 
(Relative To 
BMS-986242 
Dosing)
Hour:Min
BMS-986242 
and Metabolites
Plasma Sample
BMS-986242 
Plasma Sample
(Biotransformation)
BMS-986242
and 
Metabolites 
Urine Sample
Nivolumab 
Serum Sample
Nivolumab ADA 
Sample
C0D1
Predose
00:00
01:00
X
X 
(0-8 h)
02:00
X
03:00
X
04:00
X
06:00
X
08:00
X
C0D2
Predose
00:00
X
X 
(8-24 h)
C0D8
Predose
00:00
X
C0D14
Predose
00:00
X
X
01:00
X
X
02:00
X
X
03:00
X
X
04:00
X
X
06:00
X
X
08:00
X
X
C0D15
Predosea
X
X
C1D1
Predose
00:00
X
X
X
X
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Table 9.5.3-1:
Pharmacokinetic, Anti-drug Antibody (ADA/Immunogenicity) Sampling Schedule for BMS-986242
and Nivolumab (Dose Escalation Part 1 and Dose-Expansion Cohorts Part 2)
Study Day 
of Sample 
Collection
Event
Time 
(Relative To 
BMS-986242 
Dosing)
Hour:Min
BMS-986242 
and Metabolites
Plasma Sample
BMS-986242 
Plasma Sample
(Biotransformation)
BMS-986242
and 
Metabolites 
Urine Sample
Nivolumab 
Serum Sample
Nivolumab ADA 
Sample
EOIb
01:00
X
X
02:00
X
04:00
X
C3D1
Predose
00:00
X
X
X
EOI
01:00
X
X
Every 4 
Cycles from 
C5D1
Predose
00:00
X
X
X
EOT
X
X
X
FUcc
X
X
X
Note: Each treatment cycle is 4 weeks (except Cycle 0). 
Abbreviations: ADA = anti-drug antibody; EOI = end of infusion; FU = follow-up.
a This sample should be taken 24 hours after the previous BMS-986242 dose on Cycle 0 Day 14 if Cycle 1 Day 1 does not occur on the next day after Cycle 0 
Day 14.
b This sample should be taken 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.
c Performed at the first 2 follow-up visits (up to 100 days from the EOT visit) EXCEPT for participants who have WITHDRAWN CONSENT.
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Table 9.5.3-2:
Pharmacokinetic Sampling and ECG Collection Schedule for BMS-986242 in the Clinical 
Pharmacology Substudy
Study Day of Sample 
Collection
Event
Time 
(Relative to 
BMS-986242 Dose)
Hour: Min
BMS-986242 and 
Metabolites
Plasma Sample
BMS-986242 and 
Metabolites 
Urine Sample
ECG
C00D1
Predose
-01:00
X
C00D1
Predose
-00:45
X
C00D1
Predose
-00:30
X
C00D1
Predose
00:00
01:00
X
X
(0-8 h)
01:45
X
02:00
X
02:45
X
03:00
X
03:45
X
04:00
X
06:00
X
08:00
X
C00D2
24:00
X
X
(8-24 h)
C00D3
48:00
X
X
(24-48 h)
C00D4
72:00
X
X
(48-72 h)
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Table 9.5.3-2:
Pharmacokinetic Sampling and ECG Collection Schedule for BMS-986242 in the Clinical 
Pharmacology Substudy
Study Day of Sample 
Collection
Event
Time 
(Relative to 
BMS-986242 Dose)
Hour: Min
BMS-986242 and 
Metabolites
Plasma Sample
BMS-986242 and 
Metabolites 
Urine Sample
ECG
C00D8a,b
Predose
00:00b
X
X
01:00
X
X
(0-8 h)
02:00
X
03:00
X
04:00
X
06:00
X
08:00
X
C00D9a
24:00
X
X
(8-24 h)
C00D10a
48:00,c
X
Abbreviations: ADA = anti-drug antibody; EOT = end of treatment; FU = follow-up.
a Exploratory food effect cohort only.
b For participants not in the Food Effect cohort, C00D8 predose samples should be taken approximately 168 hours after dosing on Cycle 00 Day 1 if Cycle 1 Day 
1 does not occur on the next day after Cycle 00 Day 7.
c For participants in the Food Effect cohort, this sample should be taken 48 hours after dosing on Cycle 00 Day 8 if Cycle 1 Day 1 does not occur on the next day 
of Cycle 00 Day 9.
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9.5.4
Pharmacokinetic Sample Analyses
The plasma and urine samples of BMS-986242 and select metabolites will be analyzed by 
validated liquid chromatography-mass spectrometry (LC-MS) assays, 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 and biotransformation analysis 
if the need arises and to the extent possible.
9.6
Pharmacodynamics
Details on biomarker sampling and analysis are provided in Section 9.8.
9.7
Pharmacogenomics
Details on biomarker sampling and analysis are provided in Section 9.8.
9.7.1
Absorption, Distribution, Metabolism, and Excretion Sampling
A 6-mL whole blood sample will be drawn at baseline (Cycle 0 Day 1) for potential analysis of 
deoxyribonucleic acid (DNA) variants in absorption, distribution, metabolism, and excretion 
(ADME)-related genes (see list of ADME-related genes from http://pharmaadme.org). Further 
details of blood collection and processing will be provided to the site in the procedure manual.
Details on biomarker sampling and analysis are provided in Section 9.8, Table 9.8-1, and Table 
9.8-2.
 
 
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9.9
Health Economics OR Medical Resource Utilization and Health 
Economics
Health Economics/Medical Resource Utilization and Health Economics parameters will not be 
evaluated in this study.
10
STATISTICAL CONSIDERATIONS
10.1
Sample Size Determination 
10.1.1
Dose Escalation
During the dose-escalation trial, the sample size at each dose in these arms depends on observed 
toxicity and posterior inference. 
Up to approximately 78 participants are planned to be enrolled for Part 1 (dose escalation) and 
clinical pharmacology substudy: approximately 30 participants for the dose-escalation phase, with 
up to 24 additional participants in Part 1 for additional characterization of the safety, PK, and 
pharmacodynamic profile of BMS-986242, and approximately 24 participants for the clinical 
pharmacology substudy (including food effect). Appendix 7 provides additional details for the 
operating characteristics of the BLRM for monotherapy and BLRM-copula for combination 
therapy based on doses from 25 mg; an addition of 12.5 mg is expected to provide similar operating 
characteristics..
For the food effect assessment, the sample size is not based on statistical power for comparison 
but on consideration of the precision of the estimates of geometric means of Cmax and AUC(0-T) 
of BMS-986242.
For a sample size of 6 participants, there is an 80% probability for the 90% confidence interval to 
be within 79.6% to 125.7% of the point estimate of the geometric mean for Cmax and within 
80.4% to 124.4% of the point estimate of the geometric mean for AUC(0-T). This calculation 
assumes that log(Cmax) and log(AUC[0-T]) of BMS-986242 are normally distributed with a 
standard deviation (SD) of 0.23 and 0.22, respectively, as estimated from a study of a related 
compound.
10.1.2
Dose-expansion Cohort
Dose-expansion cohorts of BMS-986242 administered in combination with nivolumab in 
6 disease-restricted populations will be included. These are melanoma, NSCLC, SCCHN, RCC, 
bladder, and gastric cancer, with separate cohorts based on prior PD-(L)1 exposure in 5 of the 
tumor types (except gastric cancer). Approximately 20 participants will be included for each dose-
expansion cohort, for a total of 220 participants for Part 2. The sample size of 20 participants per 
dose-expansion cohort is not based on statistical power for comparison but on consideration of the 
precision of the estimates for ORR proportion. A total of 20 participants are expected to provide a 
standard error of the estimate of 7% to 11% for ORR proportions between 10% and 50%.
10.2
Populations for Analyses
For purposes of analysis, the following populations are defined as follows:
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Population
Description
Enrolled 
All participants who sign informed consent and are registered into the IRT
Treated
All participants who received at least 1 dose of study treatment
Pharmacokinetic
All treated participants who have available concentration-time data from the 
participants who received any BMS-986242 or nivolumab
Immunogenicity
All treated participants who have received nivolumab and have a baseline and 
at least 1 post-treatment immunogenicity measurement
Biomarker
All treated participants who have available biomarker data
Note: Analyses of safety, extent of exposure, biomarkers, PK, efficacy, and pharmacodynamics will be based on the
treated population.
10.3
Statistical Analyses
The statistical analysis plan will be developed and finalized before database lock. Below is a 
summary of planned statistical analyses of the primary and secondary endpoints.
10.3.1
Efficacy Analyses
Listings of participant efficacy will be provided. The following efficacy analyses may be 
performed on the treated population for the final analysis, if appropriate (Table 10.3.1-1). Details 
on censoring scheme on time-to-event endpoints such as DOR for each tumor type, 
progression-free survival, and overall survival will be described in the statistical analysis plan.
Table 10.3.1-1:
Efficacy - Statistical Analyses
Endpoint
Statistical Analysis Methods
ORR
BOR for a participant will be assessed per RECIST v1.1 
for solid tumors by investigator
Estimate of ORR and corresponding 2-sided exact 
95% exact CI by the Clopper-Pearson method by 
treatment.
Median DOR
DOR for a participant with a BOR of CR or PR, defined as 
the time between the date of first response and the date of 
the first objectively documented disease progression (per 
RECIST v1.1) or death, whichever occurs first
Median DOR using the Kaplan-Meier method and 
corresponding 2-sided 95% CI using Brookmeyer 
and Crowley methodology (using log-log 
transformation) by treatment
PFSR at 6, 9, 12, and 24 months
PFS for a participant is defined as the time from the first 
dosing date to the date of first objectively documented 
disease progression or death due to any cause, whichever 
occurs first
Estimate by the Kaplan-Meier method and 
corresponding 95% CI will be derived based on 
Greenwood formula by treatment
OSR at 6, 12, and 24 months (after the last dose of study 
treatment)
OS for a participant is defined as the time from date of 
first dose of study treatment to the date of death from any 
cause
Estimate by the Kaplan-Meier method and 
corresponding 2-sided 95% CI will be derived 
based on Greenwood formula by treatment 
Note: ORR/DOR analysis may not be performed in case there are too few responses.
Abbreviations: BOR = best overall response; OS = overall survival.
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10.3.2
Safety Analyses
The safety analyses will be performed on the treated population for the final analysis (Table 10.3.2-
1). 
Table 10.3.2-1:
Safety - Statistical Analyses
Endpoint
Statistical Analysis Methods
Incidence of DLTs, AEs, SAEs, AEs leading to 
discontinuation and deaths
DLT rate by dose level, frequency distribution of treated 
participants with AE using the worst CTC grade. Participants 
will only be counted (1) once at the PT level, (2) once at the 
system organ class level, and (3) once in the ‘total 
participant’ row at their worst CTC grade, regardless of 
system organ class or PT.
AEs will be graded according to CTCAE v4.03 and coded 
using the latest version of MedDRA
Laboratory abnormalities
Laboratory shift table using the worst CTC grade on 
treatment per participant
Laboratory values will be graded according to CTCAE v4.03
Changes from baseline in laboratory parameters, 
vital signs, and ECG
Summary statistics for timepoint and change from baseline 
by time and dose.
Summary measures of parameters from posterior 
distribution of the dose-DLT profile
Summary statistics for posterior distribution parameters and 
plot of final dose-DLT curve 
Abbreviations: MedDRA = Medical Dictionary for Regulatory Activities; PT = preferred term.
Additional exposure response analyses will be performed for QTc during the clinical 
pharmacological substudy.
10.3.3
Other Analyses 
Table 10.3.3-1:
Pharmacokinetic Analyses for BMS-986242 and Nivolumab
Endpoint
Statistical Analysis Methods
BMS-986242
Cmax, AUC(TAU), AUC(0-T), 
AUC(INF), Ctrough, CLT/F, Vss/F, 
AI, %UR24, %UR72, MR_Cmax, 
MR_AUC(TAU)
Summary statistics: geometric means and coefficients of variation
Cmax, AUC(TAU), AUC(INF) (Only)
Scatter plots vs dose for each day measured; dose proportionality based 
on a power model and a CI around the power coefficient
T-HALF
Summary statistics: means and standard deviations
Tmax.
Summary statistics: medians and ranges
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Table 10.3.3-1:
Pharmacokinetic Analyses for BMS-986242 and Nivolumab
Endpoint
Statistical Analysis Methods
Ctrough and Ceoi
Summary statistics to assess attainment of steady state: geometric 
means and coefficients of variation, by treatment and by day; plots vs 
time by dose
Nivolumab
Ctrough and Ceoi
Summary statistics: geometric means and coefficients of variation, by 
treatment and by day, plots vs time by dose
Abbreviations: AI = accumulation index, calculated based on ratio of AUC and Cmax at steady state to after the first 
dose; AUC(0-T) = area under the concentration-time curve from time zero to the time of the last quantifiable 
concentration; AUC(TAU) = area under the concentration-time curve in one dosing interval; Ceoi = concentration 
at the end of infusion; CLT/F = apparent total body clearance; Cmax = maximum observed concentration; Ctrough
= trough observed plasma concentration; Tmax = time of maximum observed concentration; Vss/F = apparent 
volume of distribution at steady-state.
Geometric means and geometric mean ratios for Cmax and AUC(0-T) will be estimated for 
participants in the substudy exploring food effect. PK time-concentration data may be pooled with 
data from other studies for PPK analysis, which will be presented in a separate report.
A concentration-response analysis may be used to characterize the effects of BMS-986242 on
QTcF, based on data from the clinical pharmacology substudy QTc assessment. Additional ECG 
data and time matched concentrations may be pooled from other studies to perform an integrated 
analysis. The results of the analysis will be reported separately.
 
 
 
 
 
Table 10.3.3-3:
Immunogenicity Analyses
Endpoint
Statistical Analysis Methods
Incidence of ADA to nivolumab in combination with 
BMS-986242
Baseline ADA-positive participant is defined as a 
participant who has a ADA detected sample at 
baseline.a ADA-positive participant is a participant
with at least 1 ADA-positive sample relative to 
baseline after initiation of the treatment
Frequency distribution of baseline ADA-positive 
participants and ADA-positive participants after 
initiation of the treatment
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a Baseline sample is the last sample before initiation of the treatment
Abbreviations: ADA = anti-drug antibody.
10.3.4
Interim Analyses 
Administrative interim analysis for internal decision making or external publication purposes may 
be performed. No formal inferences requiring any adjustment to statistical significance level will 
be performed. 
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12
APPENDICES
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APPENDIX 1
ABBREVIATIONS AND TRADEMARKS
Term
Definition
ADA
anti-drug antibody
ADME
absorption, distribution, metabolism, and excretion
AE
adverse event
AI
accumulation index
ALT
alanine aminotransferase
APC
antigen-presenting cell
AST
aspartate aminotransferase
AUC
area under the concentration-time curve
AUC(0-24)
area under the concentration-time curve from time zero to 24 hours 
postdose
AUC(INF)
area under the concentration-time curve from time zero to infinity
AUC(TAU)
area under the concentration-time curve in 1 dosing interval
BCRP
breast cancer resistance protein
BLRM
Bayesian Logistic Regression Method
BMS
Bristol-Myers Squibb
BOR
best overall response
BUN
blood urea nitrogen
C24
observed plasma concentration at 24 hours
CBC
complete blood count
Ceoi
concentration at the end of infusion
CI
confidence interval
CLT/F (or CLT)
apparent total body clearance
Cmax
maximum observed plasma concentration
Cmaxss
steady-state peak concentration
CNS
central nervous system
CR
complete response
CrCl
creatinine clearance
CRF
case report form
CT
computed tomography 
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Term
Definition
CTLA-4
cytotoxic T lymphocyte-associated antigen 4
Ctrough
trough observed plasma concentration at the end of the dosing interval
CYP
cytochrome P450
DDI
drug-drug interaction
DILI
drug-induced liver injury
DLT
dose-limiting toxicity
DNA
deoxyribonucleic acid
DOR
duration of response
ECG
electrocardiogram
ECOG
Eastern Cooperative Oncology Group 
ELISA
enzyme-linked immunosorbent assay
EOI
end of infusion
EOT
end of treatment
FDG
fludeoxyglucose
FNR
false negative rate
FPR
false positive rate
FU
follow-up
GGT
gamma-glutamyl transferase
HDPE
high-density polyethylene
HNSTD
highest non-severely toxic dose
HPV
human papillomavirus
IB
Investigator Brochure
IC50
half-maximal inhibitory concentration
ICF
informed consent form
IDO1
indoleamine 2,3-dioxygenase 1
IFN
interferon-gamma
IHC
immunohistochemistry
IMP
investigational medicinal products
I-O
immuno-oncology
IP
investigational product
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Term
Definition
IV
intravenous
IRT
interactive response technology
LC-MS
liquid chromatography-mass spectrometry
LFT
liver function test
mDOR
median duration of response
MedDRA
Medical Dictionary for Regulatory Activities
miRNA
micro ribonucleic acid
MR_AUC(TAU)
ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for 
molecular weight
MR_Cmax
ratio of metabolite Cmax to parent Cmax, corrected for molecular weight
MRI
magnetic resonance imaging
MRSD
maximum recommended starting dose
MTD
maximum tolerated dose
NA
not applicable
NCI CTCAE
National Cancer Institute Common Terminology Criteria for Adverse 
Events
NHL
non-Hodgkin’s lymphoma
NOAEL
no-observed adverse effect level
NSCLC
non-small cell lung cancer
ORR
objective response rate
OS
overall survival
OSR
overall survival rate
PBMC
peripheral blood mononuclear cells
PCR
polymerase chain reaction
PD
progressive disease
PD-1
programmed cell death-1
PD-L1
programmed death receptor-ligand 1
PE
physical examination
PET
positron emission tomography
PFSR
progression-free survival rate
P-gp
P-glycoprotein
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Term
Definition
PI
principal investigator
PK
pharmacokinetic(s)
PPK
population pharmacokinetics
PO
per os, orally
PR
partial response
PT
preferred term
Q2W
every 2 weeks 
Q4W
every 4 weeks
QD
quaque die, once daily
QTcF
QT interval corrected for heart rate using Fridericia’s formula
RCC
renal cell carcinoma
RECIST
Response Evaluation Criteria in Solid Tumors
SAE
serious adverse event
SD
stable disease
SCCHN
squamous cell carcinoma of the head and neck
SD
stable disease
SNP
single nucleotide polymorphism
STD10
severely toxic dose to 10%
TCGA
The Cancer Genome Atlas
TDO
tryptophan 2,3-dioxygenase
Teff
effector T cells
T-HALF
apparent elimination half-life
Tmax
time of maximum observed plasma concentration
tMLR
tolerogenic mixed lymphocyte reaction
Treg
regulatory T cells
TSH
thyroid-stimulating hormone
UGT1A1
uridine diphosphate glucuronosyltransferase 1A1
ULN
upper limit of normal
%UR24
percent urinary recovery over 24 hours
%UR72
percent urinary recovery over 72 hours
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Term
Definition
US
United States
VS
vital signs
Vss/F (or Vss)
apparent volume of distribution at steady state
WBC
white blood cell
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:

Good Clinical Practice (GCP), as defined by the International Council on Harmonisation 
(ICH)

the ethical principles underlying European Union Directive 2001/20/EC

United States Code of Federal Regulations, Title 21, Part 50 (21CFR50) 

applicable local requirements
The study will be conducted in compliance with the protocol. The protocol and any amendments 
and the participant informed consent will receive approval/favorable opinion by Institutional 
Review Board/Independent Ethics Committee (IRB/IEC) and regulatory authorities according to 
applicable local regulations prior to initiation of the study.
All potential serious breaches must be reported to the Sponsor or designee immediately. A serious
breach is a breach of the conditions and principles of GCP in connection with the study or the 
protocol, which is likely to affect, to a significant degree, the safety or physical or mental integrity 
of the subjects of the study or the scientific value of the study.
Personnel involved in conducting this study will be qualified by education, training, and 
experience to perform their respective tasks.
This study will not use the services of study personnel where sanctions have been invoked or where 
there has been scientific misconduct or fraud (eg, loss of medical licensure, debarment). 
INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE
Before study initiation, the investigator must have written and dated approval/favorable opinion 
from the IRB/IEC for the protocol, 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 copy of the Investigator Brochure or product labeling 
information 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 institutional 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 subinvestigators will provide the Sponsor with sufficient, accurate financial 
information in accordance with local regulations to allow the Sponsor to submit complete and 
accurate financial certification or disclosure statements to the appropriate health authorities. 
Investigators are responsible for providing information on financial interests during the course of 
the study and for 1 year after completion of the study.
INFORMED CONSENT PROCESS
Investigators must ensure that subjects are clearly and fully informed about the purpose, potential 
risks, and other critical issues regarding clinical studies in which they volunteer to participate. 
In situations where consent cannot be given to subjects, their legally acceptable representatives (as 
per country guidelines) are clearly and fully informed about the purpose, potential risks, and other 
critical issues regarding clinical studies in which the participant volunteers to participate. 
The sponsor or designee will provide the investigator with an appropriate (i.e., Global or Local) 
sample informed consent form, which will include all elements required by ICH, GCP, and 
applicable regulatory requirements. The sample informed consent form will adhere to the ethical 
principles that have their origin in the Declaration of Helsinki.
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Investigators must:

Provide a copy of the consent form and written information about the study in the language 
in which the participant is most proficient prior to clinical study participation. The language 
must be non-technical and easily understood. 

Allow time necessary for participant or participant’s legally acceptable representative to 
inquire about the details of the study.

Obtain an informed consent signed and personally dated by the participant or the 
participant’s legally acceptable representative and by the person who conducted the 
informed consent discussion. 

Obtain the IRB/IEC’s written approval/favorable opinion of the written informed consent 
form and any other information to be provided to the subjects, prior to the beginning of the 
study, and after any revisions are completed for new information.
If informed consent is initially given by a participant’s legally acceptable representative or legal 
guardian, and the participant subsequently becomes capable of making and communicating his or 
her informed consent during the study, consent must additionally be obtained from the participant.
Revise the informed consent whenever important new information becomes available that is 
relevant to the participant's consent. The investigator, or a person designated by the investigator, 
should fully inform the participant or the participant’s legally acceptable representative or legal 
guardian, of all pertinent aspects of the study and of any new information relevant to the 
participant's willingness to continue participation in the study. This communication should be 
documented. 
The confidentiality of records that could identify subjects must be protected, respecting the privacy 
and confidentiality rules applicable to regulatory requirements, the subjects’ signed ICF, and, in 
the US, the subjects’ signed HIPAA Authorization.
The consent form must also include a statement that BMS and regulatory authorities have direct 
access to participant records. 
Subjects unable to give their written consent (eg, because of stroke 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 participant become capable, he or she should personally sign and 
date the consent form as soon as possible. The explicit wish of a participant who is unable to give 
his or her written consent, but who is capable of forming an opinion and assessing information to 
refuse participation in, or to be withdrawn from, the clinical study at any time should be considered 
by the investigator.
The rights, safety, and well-being of the study subjects are the most important considerations and 
should prevail over interests of science and society.
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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 treatment integrity and traceability from receipt, preparation, administration, and through 
destruction or return. Records must be made available for review at the request of BMS/designee 
or a Health Authority.
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If
Then
Supplied by BMS (or its vendors):
Records or logs must comply with applicable 
regulations and guidelines and should include:

amount received and placed in storage 
area

amount currently in storage area

label identification number or batch 
number

amount dispensed to and returned by each 
participant, including unique participant
identifiers

amount transferred to another area/site for 
dispensing or storage

nonstudy disposition (eg, 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 site’s stock or commercial supply or a 
specialty pharmacy)
The 
investigator 
or 
designee 
accepts 
responsibility for documenting traceability and 
study drug integrity in accordance with 
requirements applicable under law and the 
SOPs/standards of the sourcing pharmacy.   
These records should include:

label identification number or batch 
number 

amount dispensed to and returned by each 
participant, including unique participant
identifiers

dates and initials of person responsible for 
Investigational Product 
dispensing/accountability, as per the 
Delegation of Authority Form
BMS or designee will provide forms to facilitate inventory control if the investigational site does not have an 
established system that meets these requirements.
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CASE REPORT FORMS
An investigator is required to prepare and maintain adequate and accurate case histories designed 
to record all observations and other data pertinent to the investigation on each individual treated 
or entered as a control in the investigation. Data that are derived from source documents and 
reported on the CRF must be consistent with the source documents or the discrepancies must be 
explained. Additional clinical information may be collected and analyzed in an effort to enhance 
understanding of product safety. CRFs may be requested for AEs and/or laboratory abnormalities 
that are reported or identified during the course of the study.
For sites using the Sponsor or designee electronic data capture 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 an 
electronic SAE form is not available, a paper SAE form can be used. Spaces may be left blank 
only in those circumstances permitted by study-specific CRF completion guidelines provided by 
the Sponsor or designee.
The confidentiality of records that could identify 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, including SAE/pregnancy CRFs, must be promptly reviewed, signed, and 
dated by the investigator or qualified physician who is a subinvestigator and who is delegated this 
task on the Delegation of Authority Form. Subinvestigators in Japan may not be delegated the CRF 
approval task. For electronic CRFs, review and approval/signature is completed electronically 
through the BMS electronic data capture tool. The investigator must retain a copy of the CRFs 
including records of the changes and corrections.
Each individual electronically signing electronic CRFs must meet Sponsor or designee training 
requirements and must only access the BMS electronic data capture tool using the unique user 
account provided by the Sponsor or designee. User accounts are not to be shared or reassigned to 
other individuals
MONITORING
Sponsor or designee representatives will review data centrally to identify potential issues to 
determine a schedule of on-site visits for targeted review of study records. 
Representatives of BMS must be allowed to visit all study site locations periodically to assess the 
data quality and study integrity. On site, they will review study records and directly compare them 
with source documents, discuss the conduct of the study with the investigator, and verify that the 
facilities remain acceptable. Certain CRF pages and/or electronic files may serve as the source 
documents.
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In addition, the study may be evaluated by Sponsor or designee internal auditors and government 
inspectors who must be allowed access to CRFs, source documents, other study files, and study 
facilities. BMS audit reports will be kept confidential.
The investigator must notify BMS promptly of any inspections scheduled by regulatory authorities 
and promptly forward copies of inspection reports to the Sponsor or designee.
RECORDS RETENTION
The investigator (or head of the study site in Japan) must retain all study records and source 
documents for the maximum period required by applicable regulations and guidelines, or 
institutional 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.
If the investigator withdraws from the study (eg, relocation, retirement), the records shall be 
transferred to a mutually agreed upon designee (eg, another investigator, study site, IRB). Notice 
of such transfer will be given in writing to BMS or 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 site’s stock 
or commercial supply or a specialty pharmacy)
It 
is 
the 
investigator’s 
or 
designee’s 
responsibility to dispose of all containers 
according to the institutional guidelines and 
procedures.
It is the investigator’s or designee’s responsibility to arrange for disposal, provided that procedures 
for proper disposal have been established according to applicable federal, state, local, and 
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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, eg, incinerator, licensed sanitary landfill, or licensed waste 
disposal vendor, must be documented.

Accountability and disposal records are complete, up-to-date, and available for the Medical 
Monitor to review throughout the clinical trial period.
It is the investigator’s or designee’s responsibility to arrange for disposal of all empty containers.
If conditions for destruction cannot be met, the responsible Medical Monitor will make 
arrangements for return of study treatments provided by BMS (or its vendors). Destruction of 
nonstudy treatments sourced by the site, not supplied by BMS, is solely the responsibility of the 
investigator or designee.
CLINICAL STUDY REPORT AND PUBLICATIONS
A Signatory Investigator must be selected to sign the clinical study report. 
For this protocol, the Signatory Investigator will be the Study Steering Committee chair or their 
designee.
The data collected during this study are confidential and proprietary to the Sponsor or designee. 
Any publications or abstracts arising from this study must adhere to the publication requirements
set forth in the clinical trial agreement governing the study site’s or the investigator’s participation 
in the study. These requirements include, but are not limited to, submitting proposed publications 
to the Sponsor or designee at the earliest practicable time prior to submission or presentation and 
otherwise within the time period set forth in the clinical trial agreement.
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APPENDIX 3
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS: 
DEFINITIONS AND PROCEDURES FOR RECORDING, 
EVALUATING, FOLLOW UP AND REPORTING
ADVERSE EVENTS
Adverse Event Definition:
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a 
preexisting medical condition in a clinical investigation participant administered study drug 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 drug, whether or not 
considered related to the study drug.
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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 participant was at risk of death at the time 
of the event; it does not refer to an event which hypothetically might have caused death if it 
were more severe)
Requires inpatient hospitalization or causes prolongation of existing hospitalization. The 
following hospitalizations are not considered SAEs in BMS clinical studies: 
o
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)
o
elective surgery, planned prior to signing consent
o
admissions as per protocol for a planned medical/surgical procedure
o
routine health assessment requiring admission for baseline/trending of health 
status (e.g., routine colonoscopy)
o
medical/surgical admission other than to remedy ill health and planned prior to 
entry into the study. Appropriate documentation is required in these cases
o
admission encountered for another life circumstance that carries no bearing on 
health status and requires no medical/surgical intervention (eg, lack of housing, 
economic inadequacy, caregiver respite, family circumstances, administrative 
reason)
o
admission for administration of anticancer therapy in the absence of any other 
SAEs (applies to oncology protocols)
Results in persistent or significant disability/incapacity or substantial disruption of the ability to 
conduct normal life functions
Results in a congenital anomaly/birth defect
Is an important medical event (defined as a medical event[s] that may not be immediately life-
threatening or result in death or hospitalization but, based upon appropriate medical and 
scientific judgment, may jeopardize the participant or may require intervention [eg, medical, 
surgical] to prevent one of the other serious outcomes listed in the definition above). Examples 
of such events include, but are not limited to, intensive treatment in an emergency room or at 
home for allergic bronchospasm and blood dyscrasias or convulsions that do not result in 
hospitalization. Potential drug-induced liver injury (DILI) is also considered an important 
medical event. (See Section 9.2.7 for the definition of potential DILI.) 
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Suspected transmission of an infectious agent (eg, pathogenic or nonpathogenic) via the study 
treatment is an SAE. 
Although pregnancy, overdose, cancer, and potential DILI are not always serious by regulatory 
definition, these events must be handled as SAEs. (See Section 9.2.5 for reporting pregnancies.)
Any component of a study endpoint that is considered related to study therapy should be reported 
as an SAE (eg, death is an endpoint, if death occurred due to anaphylaxis, anaphylaxis must be 
reported).
EVALUATING AES AND SAES
Assessment of Causality
The causal relationship to study drug is determined by a physician and should be used to 
assess all AEs. The causal relationship can be one of the following:
Related: There is a reasonable causal relationship between study drug 
administration and the AE.
Not related: There is not a reasonable causal relationship between study drug 
administration and the AE. 
The term "reasonable causal relationship" means there is evidence to suggest a causal 
relationship. 
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 drug or if new 
information becomes available, the SAE report must be updated and submitted within 24 
hours to BMS (or designee) using the same procedure used for transmitting the initial SAE 
report.
All SAEs must be followed until resolution, until the condition stabilizes, until the event is 
otherwise explained, or until the participant is lost to follow-up.
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REPORTING OF SAES TO SPONSOR OR DESIGNEE

SAEs, whether related or not related to study drug, and pregnancies must be 
reported to BMS (or designee) within 24 hours of awareness of the event.

SAEs must be recorded on the SAE Report Form; pregnancies on a Pregnancy 
Surveillance Form (electronic or paper forms).

The preferred method for SAE data reporting collection is through the eCRF.

The paper SAE/pregnancy surveillance forms are only intended as a back-up option 
when the eCRF system is not functioning.
o
In this case, the paper forms are to be transmitted via email or confirmed 
facsimile (fax) transmission to:
SAE Email Address: Refer to Contact Information list.
SAE Facsimile Number: Refer to Contact Information list.
For studies capturing SAEs through electronic data capture (EDC), electronic submission 
is the required method for reporting. In the event the electronic system is unavailable for 
transmission, paper forms must be used and submitted immediately. When paper forms are 
used, the original paper forms are to remain on site.
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 postmenopausal unless 
permanently sterile. Permanent sterilization methods include hysterectomy, bilateral 
salpingectomy, and bilateral oophorectomy.
Women in the following categories are not considered WOCBP:

Premenarchal

Premenopausal 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 

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.
*Females treated with hormone replacement therapy are likely to have artificially suppressed FSH 
levels and may require a washout period in order to obtain a physiologic FSH level. The duration 
of the washout period is a function of the type of hormone replacement therapy used. The durations
of the washout period below are suggested guidelines and the investigators should use their 
judgement in checking serum FSH levels. 

1 week minimum for vaginal hormonal products (rings, creams, gels)

4 week minimum for transdermal products

8 week minimum for oral products
Other parenteral products may require washout periods as long as 6 months. If the serum FSH 
level is > 40 mIU/ml at any time during the washout period, the woman can be considered 
postmenopausal.
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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, as approximately 5 half-lives after the end of study 
treatment, plus 30 days.
Local laws and regulations may require use of alternative and/or additional contraception methods.
Highly Effective Contraceptive Methods That Are User Dependent 
Failure rate of < 1% per year when used consistently and correctly.a

Combined (estrogen- and progestogen-containing) hormonal contraception associated with 
inhibition of ovulationb

oral 

intravaginal 

transdermal 

Progestogen-only hormonal contraception associated with inhibition of ovulationb

oral 

injectable 
Highly Effective Contraceptive Methods That Are User Independent 

Implantable progestogen-only hormonal contraception associated with inhibition of 
ovulation b

Intrauterine device (IUD)c

Intrauterine hormone-releasing system (IUS)c

Bilateral tubal occlusion

Vasectomized partner 
A vasectomized partner is a highly effective contraception method provided that the partner is 
the sole male sexual partner of the WOCBP and the absence of sperm has been confirmed. If 
not, an additional highly effective method of contraception should be used. 

Sexual abstinence 
Sexual abstinence is considered a highly effective method only if defined as refraining from 
heterosexual intercourse during the entire period of risk associated with the study drug. The 
reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and 
the preferred and usual lifestyle of the participant.

It is not necessary to use any other method of contraception when complete abstinence 
is elected. 

WOCBP participants who choose complete abstinence must continue to have pregnancy 
tests, as specified in Section 2. 
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Acceptable alternate methods of highly effective contraception must be discussed in the event 
that the WOCBP participants chooses to forego complete abstinence.
NOTES:
a Typical use failure rates may differ from those when used consistently and correctly. Use should be consistent with 
local regulations regarding the use of contraceptive methods for participants participating in clinical studies.
b Hormonal contraception may be susceptible to interaction with the study drug, which may reduce the efficacy of 
the contraceptive method. Hormonal contraception is permissible only when there is sufficient evidence that the 
IMP and other study medications will not alter hormonal exposures such that contraception would be ineffective or 
result in increased exposures that could be potentially hazardous. In this case, alternative methods of contraception 
should be utilized. 
c Intrauterine devices and intrauterine hormone releasing systems are acceptable methods of contraception in the 
absence of definitive drug interaction studies when hormone exposures from intrauterine devices do not alter 
contraception effectiveness.
Less Than Highly Effective Contraceptive Methods That Are User Dependent 
Failure rate of > 1% per year when used consistently and correctly.

Male or female condom with or without spermicide.  Male and female condoms cannot be 
used simultaneously.

Diaphragm with spermicide

Cervical cap with spermicide

Vaginal Sponge with spermicide

Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the 
primary mechanism of action
Unacceptable Methods of Contraception

Periodic abstinence (calendar, symptothermal, post-ovulation methods)

Withdrawal (coitus interruptus)

Spermicide only

Lactation amenorrhea method (LAM)
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 the end of relevant 
systemic exposure defined as approximately 5 half-lives after the end of treatment plus an 
additional 90 days. 
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
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 approximately 5 half-
lives after the end of treatment in the male participant plus an additional 90 days.

Male participants with 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 approximately 5 half-lives after the end of treatment plus an 
additional 90 days. 

Refrain from donating sperm for the duration of the study treatment and for approximately 
5 half-lives after the end of treatment plus an additional 90 days.
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 3 for Adverse Events and Serious 
Adverse Events: Definitions and Procedures for Recording, Evaluating, Follow Up and Reporting.
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APPENDIX 5
ECOG PERFORMANCE STATUS
ECOG PERFORMANCE STATUS
0
Fully active, able to carry on all pre-disease performance without restriction
1
Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or 
sedentary nature, eg, light house work, office work
2
Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about 
more than 50% of waking hours
3
Capable of only limited selfcare. Confined to bed or chair more than 50% of waking hours
4
Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair
5
Dead
 
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APPENDIX 6
RECIST V1.1
1
ASSESSMENT OF OVERALL TUMOR BURDEN AND MEASURABLE 
DISEASE
Only subjects with measurable disease at baseline should be included in protocols where 
objective tumor response is the primary endpoint. In studies where the primary endpoint is tumor 
progression (either time to progression or proportion with progression at a fixed date), the 
protocol must specify if entry is restricted to those with measurable disease or whether subjects 
having non-measurable disease only are also eligible.
To assess objective response or future progression, it is necessary to estimate the overall tumor
burden at baseline and use this as a comparator for subsequent measurements. Measurable 
disease is defined by the presence of at least 1 measurable tumor lesion. When computed 
tomography (CT) scans have slice thickness greater than 5 mm, the minimum size for a 
measurable lesion should be twice the slice thickness.
At baseline, tumor lesions/lymph nodes will be categorized as measurable or non-measurable as 
follows.
1.1
Measurable Lesions
Measurable lesions must be accurately measured in at least 1 dimension (longest diameter in the 
plane of the measurement to be recorded) with the following minimum size:

10 mm by CT/magnetic resonance imaging (MRI) scan (CT/MRI scan slice thickness no 
greater than 5 mm)

10 mm caliper measurement by clinical exam (lesions that cannot be accurately measured 
with calipers should be recorded as non-measurable)

20 mm by chest x-ray

Malignant lymph nodes: To be considered pathologically enlarged and measurable, a lymph 
node must be 15 mm in short axis when assessed by CT scan (CT scan slice thickness 
recommended to be no greater than 5 mm). At baseline and in follow-up, only the short axis 
will be measured and followed.
1.2
Non-measurable Lesions

All other lesions, including small lesions (longest diameter < 10 mm or pathological lymph 
nodes with 10 to < 15 mm short axis), as well as truly non-measurable lesions. 

Lesions considered truly non-measurable include the following: leptomeningeal disease, 
ascites, pleural or pericardial effusion, inflammatory breast disease, lymphangitic 
involvement of skin or lung, or abdominal masses/abdominal organomegaly identified by 
physical exam that is not measurable by reproducible imaging techniques.  
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1.3
Special Considerations Regarding Lesion Measurability
1.3.1
Bone Lesions

Bone scan, positron emission tomography (PET) scan, or plain films are not considered 
adequate imaging techniques to measure bone lesions. However, these techniques can be 
used to confirm the presence or disappearance of bone lesions. 

Lytic bone lesions or mixed lytic-blastic lesions, with identifiable soft tissue components, that 
can be evaluated by cross-sectional imaging techniques such as CT or MRI can be considered 
as measurable lesions if the soft tissue component meets the definition of measurability 
described above.

Blastic bone lesions are non-measurable.
1.3.2
Cystic Lesions

Lesions that meet the criteria for radiographically defined simple cysts should not be 
considered as malignant lesions (neither measurable nor non-measurable) because they are, 
by definition, simple cysts. 

“Cystic lesions” thought to represent cystic metastases can be considered as measurable 
lesions if they meet the definition of measurability described above. However, if non-cystic 
lesions are present in the same subject, these are preferred for selection as target lesions.
1.3.3
Lesions with Prior Local Treatment
Tumor lesions situated in a previously irradiated area, or in an area subjected to other 
loco-regional therapy, are usually not considered measurable unless there has been demonstrated 
progression in the lesion. 
1.4
Specifications by Methods of Measurements
1.4.1
Measurement of Lesions
All measurements should be recorded in metric notation (mm). All baseline evaluations should 
be performed as close as possible to the treatment start and never more than 30 days before the 
beginning of the treatment.
1.4.2
Method of Assessment
The same method of assessment and the same technique should be used to characterize each 
identified and reported lesion at baseline and during follow-up. Imaging-based evaluation should 
always be done rather than clinical examination unless the lesion(s) being followed cannot be 
imaged but are assessable by clinical exam.
1.4.2.1
CT/MRI Scan 
CT/MRI is the best currently available and reproducible method to measure lesions selected for 
response assessment. Measurability of lesions on CT/MRI scan is based on the assumption that 
CT/MRI slice thickness is 5 mm or less. When CT scans have slice thickness greater than 5 mm, 
the minimum size for a measurable lesion should be twice the slice thickness.
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1.4.2.2
Chest X-ray 
Chest CT is preferred over chest x-ray, particularly when progression is an important endpoint, 
since CT is more sensitive than x-ray, particularly in identifying new lesions. However, lesions 
on chest x-ray may be considered measurable if they are clearly defined and surrounded by 
aerated lung.
1.4.2.3
Clinical Lesions 
Clinical lesions will only be considered measurable when they are superficial and 10 mm in 
diameter as assessed using calipers. For the case of skin lesions, documentation by color 
photography, including a ruler to estimate the size of the lesion, is suggested. As previously 
noted, when lesions can be evaluated by both clinical exam and imaging, imaging evaluation 
should be undertaken because it is more objective and may also be reviewed at the end of the 
study.
1.4.2.4
Ultrasound 
Ultrasound is not useful in the assessment of lesion size and should not be used as a method of 
measurement. If new lesions are identified by ultrasound in the course of the study, confirmation 
by CT or MRI is advised. 
1.4.2.5
Endoscopy and Laparoscopy
The utilization of these techniques for objective tumor evaluation is not advised.
1.4.2.6
Tumor Markers 
Tumor markers alone cannot be used to assess objective tumor response.
2
BASELINE DOCUMENTATION OF “TARGET” AND “NON-TARGET”
LESIONS
2.1
Target Lesions
When more than 1 measurable lesion is present at baseline, all lesions up to a maximum of 
5 lesions total (and a maximum of 2 lesions per organ) representative of all involved organs 
should be identified as target lesions and will be recorded and measured at baseline. 
Target lesions should be selected on the basis of their size (lesions with the longest diameter), be 
representative of all involved organs, and should lend themselves to reproducible repeated
measurements.
A sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) for all target 
lesions will be calculated and reported as the baseline sum diameters. If lymph nodes are to be 
included in the sum, then as noted below, 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.
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2.1.1
Lymph Nodes
Lymph nodes merit special mention because they are normal anatomical structures that may be 
visible by imaging even if not involved by tumor. Pathological nodes that are defined as 
measurable and may be identified as target lesions must meet the criterion of a short axis of 
15 mm by CT scan. Only the short axis of these nodes will contribute to the baseline sum. 
Nodes that have a short axis < 10 mm are considered non-pathological and should not be 
recorded or followed.
2.2
Non-target Lesions
All other lesions (or sites of disease), including pathological lymph nodes, should be identified as 
non-target lesions and should also be recorded at baseline. Measurements are not required, and 
these lesions should be followed as “present,” “absent,” or, in rare cases, “unequivocal 
progression.” 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”).
3
TUMOR RESPONSE EVALUATION
3.1
Evaluation of Target Lesions
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes 
(whether target or non-target) must have reduction in short axis to < 10 mm.
Partial Response (PR):  At least a 30% decrease in the sum of diameters of target lesions,
taking as reference the baseline sum diameters.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, 
taking as reference the smallest sum on study (this includes the baseline sum if that is the 
smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an 
absolute increase of at least 5 mm. (Note: the appearance of 1 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.
3.1.1
Special Notes on the Assessment of Target Lesions
3.1.1.1
Lymph Nodes
Lymph nodes merit special mention because they are normal anatomical structures that may be 
visible by imaging even if not involved by tumor. Pathological nodes that are defined as 
measurable and may be identified as target lesions must meet the criterion of a short axis of 
15 mm by CT scan. Only the short axis of these nodes will contribute to the baseline sum. 
Nodes that have a short axis < 10 mm are considered non-pathological and should not be 
recorded or followed.
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3.1.1.2
Target Lesions That Become “Too Small to Measure”
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). If the radiologist is 
able to provide an actual measurement, that should be recorded, even if it is below 5 mm.
However, when such a lesion becomes difficult to assign, an exact measure then is as follows:

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. (Note: In case of a lymph node believed to be present and 
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 CT slice thickness). 
3.1.1.3
Target 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. 

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.”
3.2
Evaluation of Non-target Lesions
While some non-target lesions may actually be measurable, they need not be measured and 
instead should be assessed only qualitatively at the time points specified in the protocol. 
CR: Disappearance of all non-target lesions and normalization of tumor marker level. All lymph 
nodes must be non-pathological in size (< 10 mm short axis).
Non-CR/Non-PD: Persistence of 1 or more non-target lesion(s) and/or maintenance of tumor 
marker level above the normal limits.
PD: Unequivocal progression of existing non-target lesions. (Note: The appearance of 1 or more 
new lesions is also considered progression.)
3.2.1
Special Notes on the Assessment of Non-target Lesions
The concept of progression of non-target disease requires additional explanation as follows.
3.2.1.1
When the Subject Also Has Measurable Disease

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 the presence of 
SD or PR in the target disease, the overall tumor burden has increased sufficiently to merit 
discontinuation of therapy. 

A modest “increase” in the size of 1 or more non-target lesions is usually not sufficient to 
quality for unequivocal progression status. 
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3.2.1.2
When the Subject Has Only Non-measurable Disease

To achieve “unequivocal progression” on the basis of the non-target disease, there must be an 
overall level of substantial worsening such that the overall tumor burden has increased 
sufficiently to merit discontinuation of therapy. 

A modest “increase” in the size of 1 or more non-target lesions is usually not sufficient to 
qualify for unequivocal progression status. 

Because worsening in non-target disease cannot be easily quantified (by definition: if all 
lesions are non-measurable), a useful test that can be applied when assessing subjects for 
unequivocal progression is to consider if the increase in overall disease burden based on the 
change in non-measurable disease is comparable in magnitude to the increase that would be 
required to declare PD for measurable disease, ie, an increase in tumor burden representing 
an additional 73% increase in “volume” (which is equivalent to a 20% increase diameter in a 
measurable lesion). Examples include an increase in a pleural effusion from “trace” to 
“large,” an increase in lymphangitic disease from localized to widespread, or may be 
described in protocols as “sufficient to require a change in therapy.”

If “unequivocal progression” is seen, the subject should be considered to have had overall PD
at that point. 
3.2.1.3
Tumor Markers
Tumor markers alone cannot be used to assess objective tumor responses. If markers are initially 
above the upper normal limit, however, they must normalize in order for a subject to be 
considered as having attained a CR. 
3.3
New Lesions
The appearance of new malignant lesions denotes disease progression. The finding of a new 
lesion should be unequivocal, ie, not attributable to differences in scanning technique, change in 
imaging modality, or findings thought to represent something other than tumor (for example, 
some “new” bone lesions may be simply healing or flare of pre-existing lesions). This is 
particularly important when the subject’s baseline lesions show PR or CR. For example, necrosis 
of a liver lesion may be reported on a CT scan report as a new cystic lesion, which it is not.
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 subject who has visceral disease at baseline and, while on study, has a CT or MRI brain scan 
ordered that reveals metastases. The subject’s brain metastases are considered to be evidence of 
PD even if he/she did not have brain imaging at baseline.
For example, if a new lesion is equivocal because of its small size, continued therapy and 
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.
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4
RESPONSE CRITERIA
4.1
Time Point Response
A response assessment should occur at each time point specified in the protocol. 
For subjects who have measurable disease at baseline, Table 4.1-1 provides a summary of the 
overall response status calculation at each time point.
Table 4.1-1:
Time Point Response: Subjects 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; NE = not evaluable; PD = progressive disease; PR = partial response; SD = stable disease.
4.1.1
Missing Assessments and Not Evaluable Designation
When no imaging/measurement is done at all at a particular time point, the subject is not 
evaluable (NE) at that time point. If only a subset of lesion measurements is made at an 
assessment, the case is also considered NE at that time point, unless a convincing argument can 
be made that the contribution of the individual missing lesion(s) would not have changed the 
assigned time point response.
4.1.2
Confirmation Scans
Verification of Response: Confirmation of PR and CR is required at least 4 weeks later to 
ensure that the responses identified are not the result of measurement error.
4.2
Best Overall Response: All Time Points
The best overall response is determined once all the data for the subject are known. It is the best 
response recorded from the start of the study treatment until objectively documented progression 
per RECIST Criteria or subsequent cancer therapy, whichever happens first, taking into account 
any requirement for confirmation. The subject’s best overall response assignment will depend on 
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the findings of both target and non-target disease and will also take into consideration the 
appearance of new lesions. 
Best response is defined as the best response across all time points with subsequent confirmation. 
CR or PR may be claimed only if the criteria for each are met at a subsequent time point as 
specified in the protocol (generally 4 weeks later). 
In this circumstance, the best overall response can be interpreted as specified in Table 4.2-1. 
When SD is believed to be the best response, it must meet the protocol-specified minimum time 
from baseline. Measurements must have met the SD criteria at least once after study entry at a 
minimum interval (in general, not less than 6 weeks).
Table 4.2-1:
Best Overall Response When Confirmation of CR and PR Is Required
Overall Response
Best Overall Response
First Time Point
Subsequent Time Point
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
PR
SD
SD
PR
PD
SD provided minimum criteria for 
SD duration met, otherwise, PD
PR
NE
SD provided minimum criteria for 
SD duration met, otherwise NE
NE
NE
NE
CR = complete response; NE = not evaluable; PD = progressive disease; PR = partial response; SD = stable disease.
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 (because disease must have reappeared after CR). 
Best response would depend on whether the minimum duration for SD was met. However, sometimes CR may be 
claimed when subsequent scans suggest that small lesions were likely still present and in fact the subject 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.
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4.3
Duration of Response
4.3.1
Duration of Overall Response
The duration of overall response is measured from the time measurement criteria are first met for 
CR/PR (whichever is first recorded) until the first date that recurrent disease or PD is objectively 
documented (taking as reference for PD the smallest measurements recorded on study).
The duration of overall CR is measured from the time measurement criteria are first met for CR 
until the first date that recurrent disease is objectively documented.
4.3.2
Duration of Stable Disease
SD is measured from the start of the treatment (in randomized trials, from date of randomization) 
until the criteria for progression are met, taking as reference the smallest sum on study (if the 
baseline sum is the smallest, this is the reference for calculation of PD).
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APPENDIX 7
STATISTICAL METHODOLOGY
STATISTICAL DETAILS FOR BAYESIAN LOGISTIC REGRESSION METHOD (BLRM 
AND BLRM-COPULA) MODEL AND PRIORS FOR DOSE ESCALATION
1
MODEL SETUP FOR BMS-986242 MONOTHERAPY (LEAD IN)
1.1
Monotherapy Methodology Description 
An adaptive 2-parameter Bayesian Logistic Regression Method (BLRM) model guided by the 
escalation with overdose control (EWOC) principle1,2,3 will be used to guide the dose escalation 
of BMS-986242 in the monotherapy lead-in phase and to provide dose recommendation during 
dose escalation. 
The BLRM will be fitted on the dose-limiting toxicity (DLT) data during the first 2 weeks of 
treatment accumulated throughout the dose escalation to model the dose-toxicity relationship of 
BMS-986242 in the monotherapy lead-in phase. 
The dose-toxicity relationship for BMS-986242 monotherapy is assumed to follow a logistic 
model:
݈݋݃݅ݐ(݌௜) = ݈݋݃(ߙଵ) + ߚଵ݈݋݃(݀ଵ௜݀ଵ
∗
൘),
where ݌௜is the probability of toxicity at dose level ݀ଵ௜. Note that the ߙଵand ߚଵparameters are 
assumed positive and ݀ଵ
∗is the reference dose for BMS-986242 (please refer to the meaning of 
ߙଵand ߚଵin Section 1.2.1 for detailed implementation).
1.2
Prior Specification for BMS-986242 Monotherapy
The Bayesian approach requires the specification of prior distributions for model parameters,
which include parameters (ߙଵ, ߚଵ) for BMS-986242. The prior distributions for BMS-986242
single-agent activity were derived using a weakly informative prior, as well as discussion with the 
Bristol-Myers Squibb (BMS) clinical team.
Derivation of prior distribution of these parameters is provided in the following subsections.
1.2.1
Prior Derivation for BMS-986242 Parameters (࢒࢕ࢍ(ࢻ૚), ࢒࢕ࢍ(ࢼ૚))
A weakly informative prior will be used for parameters (ߙଵ, ߚଵ) for BMS-986242 to reflect the 
potential of the different toxicities of BMS-986242 and allow for considerable prior uncertainty.
Further details are provided below.
Weakly Informative Prior

The median DLT rate at the reference dose (BMS-986242 at 600 mg QD) was assumed to be 
30%, that is, mean (log(ߙଵ)) = logit (0.3) = log(0.3/(1-0.3)) = -0.847.

A doubling in dose was assumed to double the odds of DLT, that is, mean(log(ߚଵ)) = 0.
The standard deviation of log(ߙଵ) was set to 1.53 using the following steps:

If the toxicity probability range was set to be [1%, 99%], then the toxicity interval would be 
logit (0.99)-logit (0.01) = 9.19.
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
To cover 99.7% of the variance, the toxicity interval will cover 6*standard deviation (SD)
(log(ߙଵ)), which gives us SD (log(ߙଵ)) = 9.19/6 = 1.53.
Correspondingly, the standard deviation of log(ߚଵ) was set to 1, which allows for considerably
larger prior uncertainty for the dose toxicity.
1) The correlation between log(ߙଵ) and log(ߚଵ) was set to 0.
2) log(ߙଵ) and log(ߚଵ) follow a bivariate normal distribution.
Table 1:
Prior Distribution for Model Parameters for BMS-986242
Parameter
Means
Standard Deviations
Correlation
log(ߙଵ), log(1)
(-0.847, 0)
(1.53, 1)
0
2
MODEL SETUP FOR BMS-986242 AND NIVOLUMAB COMBINATION
2.1
Methodology Description for Combination Therapy
Toxicity profiles of both BMS-986242 monotherapy and nivolumab monotherapy will be 
incorporated to develop the combination model framework. A copula-type model will be used to 
cover all general combination cases, including additive and synergistic effects. The combination 
of the 2 treatments will be explored using a Bayesian hierarchical model by utilizing the toxicity 
profiles of the single agents as prior marginal profiles for the combination. The following copula-
type model4 will be used to describe the probability ݌௜௝of toxicity when dose level ݅of agent A 
and dose level ݆of agent B are administered in combination:
݌௜௝= 1 −݁ݔ݌(−൤{−݈݋݃(1 −݌௜
௠)}
ଵఊభ
ൗ
+ ൛−݈݋݃(1 −ݍ௝
௡)ൟ
ଵఊభ
ൗ൨
ఊభ
),
where ݌௜is the prespecified best guess toxicity probability for agent A, ݍ௝is the prespecified best 
guess toxicity probability for agent B, ݉and ݊characterize the individual drug effect, and 
ߛଵcharacterizes the drug-drug interactive effect.
The joint toxicity framework models the toxicity rates of both agents as well as their interaction 
effects in a 7-parameter hierarchical model, where each monotherapy dose-toxicity relationship 
will be characterized by a 2-parameter BLRM model (see Section 1.1). There are 3 additional 
parameters for the copula-type model, 1 for each agent (݉and ݊) as well as 1 for the interaction 
term (ߛଵ). A dose-toxicity surface will be characterized for different dose combinations of these 2
agents.
As there are currently no historical data or prior knowledge to indicate how much information is 
to be borrowed for each of the single agents, parameters ݉and ݊are both set to be 1, meaning 
borrowing 100% of the information from the 2 agents. The above formula is then simplified into 
a 5-parameter model as follows:
݌௜௝= 1 −݁ݔ݌(−൤{−݈݋݃(1 −݌௜)}
ଵఊభ
ൗ
+ ൛−݈݋݃൫1 −ݍ௝൯ൟ
ଵఊభ
ൗ൨
ఊభ
.
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Since only a fixed nivolumab dose (480 mg) will be used in the BMS-986242 and nivolumab 
combination, this surface will be simplified into a 2-dimensional dose-toxicity curve. Posteriors 
for the corresponding 5 parameters (2 logistic regression parameters [ߙଵ, ߚଵ] for BMS-986242 and 
2 logistic regression parameters [ߙଶ, ߚଶ] for nivolumab, as well as 1 interaction parameter for the 
copula-type model [ߛଵ, which will be discussed in detail in the following section]) will be fitted
into the in-house developed model. It implements the above-described theoretical setup.
2.2
Prior Specification for Combination Therapy
2.2.1
Marginal Prior for BMS-986242
Posterior information on log(1) and log(1) from the monotherapy Lead in will be used as 
marginal BMS-986242 prior for combination with nivolumab. This prior information is not 
prespecified and will be continuously updated when additional DLT information from the 
monotherapy is available. In the simulation (see Section 3, the prior of BMS-986242 as described 
in Section 1.2.1 (Table 1) is used for illustration purposes because no real-time DLT data are 
available at this time.
2.2.2
Marginal Prior Derivation for Nivolumab Parameters (log(2), log(2))
Similar to BMS-986242 monotherapy in the monotherapy phase, the logistic model for nivolumab 
is as follows:
݈݋݃݅ݐ൫ݍ௝൯= ݈݋݃(ߙଶ) + ߚଶ݈݋݃(݀ଶ௝
݀ଶ
∗
൘
), 
where ݍ௝is the probability of toxicity at dose level ݀ଶ௝. Note that the ߙଶܽ݊݀ߚଶparameters are 
assumed positive, and ݀ଶ
∗is the reference dose for nivolumab.
The toxicity profile of nivolumab has been studied in several studies. A bivariate normal prior for 
the nivolumab model parameters (log(2), log(2)) was obtained by extracting a posterior of 
nivolumab using DLT and safety data from the Study CA209003, which is used later as the meta-
analytical-predictive (MAP) prior for nivolumab. 
The MAP prior for the model parameters (log(2), log(2)) was obtained in the following steps.
First, a prior distribution for nivolumab was developed:

The median DLT rate at the reference dose (3 mg/kg every 2 weeks) was assumed to be 10%, 
that is, mean (log(2)) = logit(1/10) = log(1/9) = -2.197.

A doubling in dose was assumed to double odds of DLT, that is, mean(log(2)) = 0.

The standard deviation of log(2) was set to 2, and the standard deviation of log(2) to 1, which 
allows for considerable prior uncertainty for the dose-toxicity profile.

The correlation between log(2) and log(2) is assumed to be 0 (assuming independence of 
log(2) and log(2)).

In addition, heterogeneity between the historical study and current study was incorporated 
using a meta-analytic predictive approach by defining between-trial standard deviations 1 and 
2 for log(2) and log(2), respectively. The between-trial variability is assumed to be 
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moderate. Therefore, 1 and 2 were set to follow a log-normal distribution, with mean 
log(0.25) and log(0.125), respectively, with a common standard deviation log(2)/1.96.
With this prior, the clinical trial data below (Table 2) were used to generate the posterior for 
nivolumab, which is then used as the MAP prior for this study (Table 3).
Table 2:
Data From Single-agent Nivolumab (Study CA209003)
Dose of Nivolumab (mg/kg)
Every 2 Weeks
No. of DLTs/No. of Evaluable Participants in the Escalation 
Phase
0.1
0/3
0.3
0/3
1
0/3
3
0/3
10
1/6
Abbreviation: DLT = dose limiting toxicity.
Table 3:
Marginal Prior Distribution for Model Parameters for Nivolumab 
(ie, Posterior from MAP Method)
Parameter
Means
Standard Deviations
Correlation
log(2), log(2)
(-3.269, -0.152)
(1.186, 0.771)  
-0.369
Note: Nivolumab prior information was based on a milligram-per-kilogram dosing instead of flat dosing. If real PK 
data from this study show difference from the milligram-per-kilogram assumption, the nivolumab prior will be 
revisited and modified accordingly.
2.2.3
Prior for Interaction Parameters for Joint Toxicity of BMS-986242 and 
Nivolumab Combination
A gamma prior distribution for the interaction parameter γଵis derived to reflect the current 
uncertainty about the toxicity profile of the combination of BMS-986242 and nivolumab. Although 
no PK drug-drug interaction is expected, the possibility of a significant positive interaction 
between BMS-986242 and nivolumab cannot be totally excluded. The interaction parameter γଵ
was chosen accordingly but with a degree of uncertainty to allow for the possibility that the 
interaction may be positive or negative. Therefore, the following assumptions are made for the 
interaction parameter:

γଵfollows a gamma distribution and with a mean centered at 1.1, which means the combination 
of 2 agents is likely to have only a small synergistic effect.

The 97.5 percentile of γ1 is log(3), that is, a 3-fold increase in odds of DLT due to the 
interaction over independence at the starting dose of the combination.
This model assigns the highest probability to there being small synergistic interaction and also 
allows for the potential of larger synergism of the toxic profiles. It also does not completely ignore 
the possibility of antagonism because there is a 40% prior probability that γଵis less than 1.
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3
DECISION RULE FOR DOSE ESCALATION AND SIMULATION
Dose escalation recommendations for BMS-986242 monotherapy and in combination with 
nivolumab will be based on the inference from the Bayesian posterior and the probability that the 
true DLT rate for each dose lies in 1 of the following categories:

[0%, 16%) under-dosing

[16%, 33%) targeted toxicity

[33%, 100%] excessive toxicity
These boundaries are similar to the toxicity boundaries used by a rule-based design (ie, 3 + 3 
design) in that a minimum is set at 16% (about 1 in 6) DLT rate and a maximum at 33% (about 2
in 6) DLT rate. Following the principle of EWOC, dose recommendations for the next cohort will 
be based on the Bayesian model after DLT information becomes available during the DLT period, 
accounting for all of the available data from the administered doses, and the candidate doses are 
the ones fulfilling the overdose criterion that there is less than 25% (for monotherapy) and 35% 
(for combination therapy) chances of excessive toxicity. Only the candidate doses will be 
considered for the next cohort. While the Bayesian model will use DLT information from the DLT 
period only, clinical assessment will take into consideration of the totality of available data 
including PK/Pharmacodynamics from all treated participants.
The MTD is the highest administered dose not expected to cause DLT in more than 33% of the 
treated participants during the DLT period. The final recommended MTD/RP2D will be based on 
the recommendation from the BLRM/BLRM-copula, and on an overall assessment of all available 
safety, PK/Pharmacodynamic, and efficacy data.
3.1
Simulation Parameters 
One thousand trial simulations were used for each scenario. All simulations were run using EAST 
6.3.1® software for BLRM model for BMS-986242 monotherapy and in-house developed code via 
R and Openbugs for BLRM-copula method for BMS-986242 in combination with nivolumab. The 
number of participants to be treated in each cohort in a specific dose level and the stopping rules 
used to declare MTD are defined as:

Fixed cohort size: 3

Probability of overdosing: < 25% for BLRM and 35% for BLRM-Copula

Probability of achieving the target toxicity: > 50%

Maximum number of participants treated: 30

Minimum number of participants treated at a given dose level in order to declare MTD: 6

Maximum number of participants at a dose:12
The provisional dose levels for BMS-986242 monotherapy are 25 mg through 600 mg. For the 
combination therapy, nivolumab is fixed at 480 mg flat dose for Q4W.
3.2
Operating Characteristics
Section 3.2.1 demonstrates operating characteristics of BLRM for monotherapy and Section 3.2.2
demonstrates operating characteristics of BLRM-copula for combination therapy accounting for 
joint toxicity of the combination therapy.
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3.2.1
Operating Characteristics of BLRM for Monotherapy
Three scenarios were investigated by selecting (1) dose-DLT relationship derived by prior, (2) 
narrow safety window in order to explore how EWOC limits the risk of exposing participants from
a toxic dose level, and (3) all doses above the target toxicity (Table 4).
Table 4:
Simulation Results of BLRM for Monotherapy
Scenario
BMS-
986242
Dose
(mg)
25
50
100
200
400
600
MTD 
not 
selected 
(%)
Fitted 
MTD
Toxicity 
Observed 
(%)
Avg
# Pts
By Prior
% DLT
2
4
7
13
22
30
0.2
598.8
17.6
18.4
% 
MTD
0
0
2.6
25.9
46.5
24.7
# Pts
3.1
0.2
0.8
4.2
6.6
3.5
# DLTs
0.0
0.0
0.0
0.1
1.3
1.2
Narrow 
Safety 
Window
% DLT
2
4
7
13
22
60
0.4
546.6
19.6
18.3
% 
MTD
0.2
0.3
1.7
29.7
62.9
4.8
# Pts
3.1
0.2
0.9
4.7
7.3
2.1
# DLTs
0.1
0.0
0.0
0.6
1.6
1.3
All High
% DLT
40
50
60
70
75
80
86.1
28.7
54.8
7.7
% 
MTD
8.8
3.9
1
0.2
0
0
# Pts
4.6
1.5
0.7
0.3
0.6
0
# DLTs
1.8
0.7
0.4
0.2
0.4
0
Note: % DLT = true DLT rate; % MTD = proportion of the dose selected as the MTD; # Pts = average number of 
participants by adjusting for skipped dose level where the true toxicity rate is below the target rate; # DLTs =
average number of DLTs by adjusting for skipped dose level where the true toxicity rate is below the target rate; 
Fitted MTD = fitted MTD at 33% as the target toxicity rate; % toxicity observed = average proportion of DLTs 
given the doses were tried
Doses with true target toxicity within the target toxicity interval [16%, 33%)
Abbreviations: Pts = participants. 
The average sample size was no more than 20 participants. The results for the scenarios of narrow 
safety window and all high show how the EWOC principle limits the risk of exposing participants 
from a toxic dose level. Overall, the scenarios illustrated above demonstrate that the model 
performs well in the hypothetical scenarios investigated by correctly identifying the MTD at least 
62% of the time while limiting participants from receiving excessive/unacceptable toxic dose 
levels.
3.2.2
Operating Characteristics of BLRM-copula for Combination Therapy
Three hypothetical scenarios were investigated: (1) additive joint toxicity; (2) toxicity rates 25% 
higher than the additive scenario; (3) toxicity rates 50% higher than the additive scenario (Table 
5).
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Table 5:
Simulation Results of BLRM-Copula for Combination
Scenario
BMS-
986242
Dose
25
50
100
200
400
600
MTD not 
selected 
(%)
Fitted 
MTD
Toxicity 
Observed 
(%)
Avg
# Pts
Additive
% DLT
12
14
17a
23a
32a
40
10
464.7
24.3
19.5
% MTD
2.7
5.7
23.6
24.6
23.6
9.8
# Pts
3.6
3.2
4.7
3.6
2.4
2.2
#DLT
0.5
0.4
0.7
0.8
0.7
0.9
25% 
Higher
% DLT
15
18a
21a
29a
40
50
14.1
357.2
27.7
17.7
% MTD
5.5
8.7
26.4
29.8
12.9
2.6
# Pts
3.8   3.2
4.5
3.5
1.7
1.1
#DLT
0.6
0.6
0.9
0.9
0.7
0.6
50% 
Higher
% DLT
18a
21a
26a
34
48
60
21.8
291.7
31.7
15.5
% MTD
7.9
10.7
29.5
24.5
5.4
0.2
# Pts
3.9
3.2
4.1
2.8
0.9
0.6
#DLT
0.7
0.7
1.0
0.9
0.5
0.3
a Doses with true target toxicity within the target toxicity interval [16%, 33%)
Note: % DLT = true DLT rate; % MTD = proportion of the dose selected as the MTD; #DLT = average number of 
DLTs; MTD not selected = dose was below lowest dose or above highest dose; Fitted MTD = fitted MTD at 33% as 
the target toxicity rate; Toxicity observed = Average proportion of DLTs out of all simulated trials; # Pts = average 
number of participants
The average sample size was around 20 participants. The results show how the EWOC principle 
limits the risk of exposing participants from unacceptable toxic dose levels. Overall, the scenarios 
illustrated above demonstrate that the model performs well by correctly identifying the MTD 
ranging from 49% to 72% in the hypothetical scenarios investigated while limiting participants 
from receiving unacceptable toxic dose levels.
4
INTERIM MONITORING CASE STUDY TO ILLUSTRATE PROVISION OF 
DOSE RECOMMENDATIONS DURING DOSE ESCALATION
In order to provide a comprehensive view of the dynamics of the models, different hypothetical 
scenarios exploring different possibilities are examined. For the simplicity of illustration purposes, 
a static cohort size of 3 subjects is applied for dose level 25 mg. This cohort size could vary during 
the actual clinical trial, and the BLRM (-Copula) models are designed to fit various different cohort 
sizes, adaptively. In general, there are many possible scenarios for a specific dose level, especially 
with a monotherapy lead-in followed by combination treatment. For example, there could be 0, 1,
2, or 3 DLTs observed in the monotherapy lead-in period, and similarly 0, 1, 2, or 3 DLTs observed 
in the combination period. 
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During interim monitoring, posterior probabilities will be updated when there is new DLT 
information available. The following two visualization plots will be produced to reflect the real 
time dose-DLT relationship, to quantify benefit (in the form of target dosing) and risk (in the form 
of overdosing and underdosing) during the model’s recommendation process, and to facilitate 
clinical team’s interpretation of the model recommendations for the final decision making:

Dose-DLT profile for the doses ranging between 0 mg and 600 mg (Figure 1).

Stacking histograms displaying predictive probabilities on DLT rates classified into 3 different 
categories (Underdosing, Target Dosing and Overdosing) (Figure 2).
Figure 1: 
An Example of Updated Dose-DLT Profile After Incorporating Prior 
Information and DLT Information at 25 mg (0/3 DLTs in 
Monotherapy Lead-in and 0/3 DLTs in Combination at 25 mg for 
BMS-986242)
Interpretation and usage of Figure 1:
Figure 1 is a snapshot of an updated dose-DLT profile with DLT information available at dose 
level 25 mg after the combination period (assuming there was no DLT in either monotherapy lead-
in or combination period). The dose-DLT profile is captured with a continuous dose spectrum 
ranging from 0 mg through 600 mg, which is a slice of the dose-DLT surface of the combination 
of two drugs with nivolumab fixed at 480 mg. For each dose within the range, there is a 
corresponding distribution of the predicted DLT rates calculated from the posterior samples of the 
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model parameters. This figure will be updated each time new DLT information becomes available
from different dose levels.
In Figure 1, there are 3 different quantiles (2.5%, 50%, and 97.5%) plotted to characterize the 
current trend of the toxicity profile (as shown by the 50% quantile), as well as the variation of the 
dose-DLT profile (as shown by the 2.5% quantile and the 97.5% quantile), according to the 
accumulation of DLT data from all previous and current dose levels. The toxicity boundaries (0.16 
and 0.33) are illustrated in two horizontal lines to benchmark the way in which the dose-DLT 
profile is trending. 
Intermediate dose levels can be identified using different boundary cutoffs. For example, using the 
50% quantile curve (green highlight), which represents the nearly average DLT distribution for 
each dose level, 350 mg could be a potential intermediate dose level corresponding to the lower 
pre-specified DLT rate boundary of 0.16, and 600 mg could be a fitted MTD dose level associated 
with the upper boundary of 0.33.
Moreover, if all of the current pre-specified doses are considered intolerable (overdosing 
probabilities > 0.35 for combination therapy, for example, a case not shown on the current Figure 
1), the model will recommend to stop the current dose level, and the clinical team can leverage the 
current updated dose-DLT curve to pinpoint a new dose, which is lower than pre-specified lowest 
dose (25 mg) by using the DLT rate boundaries.
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Figure 2:
An Example of Updated Stacking Histogram After Incorporating 
Prior Information and DLT Information at 25mg (0/3 DLTs at 
Monotherapy Lead-in and 0/3 DLTs at Combination) to Classify 
Predicted DLT Rates into 3 Categories (Underdosing, Target Dosing,
and Overdosing)
Interpretation and usage of Figure 2:
Figure 2 is a snapshot of stacking histogram with DLT information available at dose level 25 mg
after combination period (assuming there was no DLT in either monotherapy lead-in or
combination period). This figure will be updated each time new DLT information becomes 
available in different dose levels.
When recommending the next dose level, the model will first exclude doses that are intolerable 
(with overdosing probabilities ≥35% or ≥25% for combination and monotherapy respectively). 
Among those qualified candidate doses that are considered “tolerable”, the model will select the 
dose that maximizes the probability of being within the target toxicity range (DLT rate of 16% up 
to 33%). 
As illustrated in Figure 2, when there is 0 DLT observed out of 3 subjects for the dose level 25 mg
in both monotherapy lead-in and combination, the distribution of predicted DLT rates will be 
characterized into possibilities falling into 3 different categories. Some dose levels for 
BMS-986242 might be excluded according to the higher-than-cutoff overdosing probabilities (eg,
600mg, > 35%). Among the remainder of tolerable dose levels, the BLRM (-Copula) model 
recommends the dose that maximizes the probability of being within the target dosing interval. 
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Therefore, the model’s recommendation would be to escalate to 400 mg, which is associated with 
the highest target dosing probability of 27% compared with that of other dose levels.
Similarly (although not shown on Figure 2), according to the rules specified above, the model 
could possibly recommend to de-escalate to a lower dose level than current treated dose level, 
extend the current dose level, or even to stop and identify a new dose level lower than 25 mg, the 
lowest pre-specified dose level. Please refer to description of Figure 1 for details on how to specify 
the new dose levels.
4.1
Example of the BLRM Using BMS-986242 Monotherapy Dose Escalation 
According to safety consideration and clinical judgement, dose level 25 mg is recommended as 
the starting dose for BMS-986242 monotherapy. With the current BMS-986242 prior specified in 
the Section 1.2.1 the following flow chart illustrates possible scenarios (the model’s 
recommendations) after dose level 25mg using available DLT information in Figure 3.
Figure 3:
Hypothetical Scenarios for BMS-986242 Dose Escalation After Dose 
Level 25mg Based on BLRM (-Copula) Model
 
 
 
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APPENDIX 8
CYP3A 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 AUC or 20-50% 
Decrease in CL
CYP3A
Boceprevir, clarithromycin, 
conivaptan, grapefruit juice,d
indinavir, itraconazole, 
ketoconazole,
lopinavir/ritonavir,
mibefradil,e nefazodone, 
nelfinavir, posaconazole, 
ritonavir, saquinavir,
telaprevir, telithromycin,
voriconazole
Amprenavir, aprepitant,
atazanavir, ciprofloxacin,
darunavir/ritonavir, 
diltiazem, erythromycin, 
fluconazole, fosamprenavir, 
grapefruit juice,d imatinib, 
verapamil
Alprazolam, amiodarone, 
amlodipine, atorvastatin, 
bicalutamide, cilostazol, 
cimetidine, cyclosporine, 
fluoxetine, fluvoxamine, 
ginkgo,f goldenseal,f
isoniazid, nilotinib, oral 
contraceptives, ranitidine, 
ranolazine,
tipranavir/ritonavir, 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 sensitive substrate for 
that CYP by equal to 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 CYP by 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.
Abbreviations: AUC = area under the concentration-time curve; CL = clearance; 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
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.
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,c cisapride,c
cyclosporine, dihydroergotamine, 
ergotamine, fentanyl, pimozide, 
quinidine, sirolimus, tacrolimus,
terfenadinec
CYP2B6
Bupropion, efavirenz
Please note that this is not an exhaustive list.
a Sensitive CYP substrates refers to drugs whose plasma AUC values have been shown to increase 5-fold or higher 
when co-administered with a known CYP inhibitor.
b CYP substrates with narrow therapeutic range refers 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
MANAGEMENT ALGORITHMS FOR IMMUNO-ONCOLOGY 
AGENTS
These general guidelines constitute guidance to the Investigator and may be supplemented by 
discussions with the Medical Monitor representing the Sponsor. The guidance applies to all 
immuno-oncology (I-O) agents and regimens.
A general principle is that differential diagnoses should be diligently evaluated according to 
standard medical practice. Non-inflammatory etiologies should be considered and appropriately 
treated.
Corticosteroids are a primary therapy for I-O drug-related adverse events. The oral equivalent of 
the recommended intravenous doses may be considered for ambulatory patients with low-grade 
toxicity. The lower bioavailability of oral corticosteroids should be taken into account when 
switching to the equivalent dose of oral corticosteroids.
Consultation with a medical or surgical specialist, especially prior to an invasive diagnostic or 
therapeutic procedure, is recommended. 
The frequency and severity of the related adverse events covered by these algorithms will depend 
on the I-O agent or regimen being used.
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APPENDIX 10
MEDICATIONS ASSOCIATED WITH QT PROLOGATION
The list below is not 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 11
P-GP AND BCRP GUIDANCE
The list below is not meant to be all inclusive. Please consult individual drug labels for further 
information. Additional information is also available at:
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, irinotecan, 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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