An Investigational Immuno-Therapy Study of Experimental Medication BMS-986242 Given in Combination With Nivolumab in Patients With Advanced Cancer

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03351231
• Collaborator: (none)
• Enrollment: 7
• Locations: 4
• Arms: 2
• Actual Duration (Months): 9
• Patients Per Site: 1.8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cancer	Drug: BMS-986242; Biological: Nivolumab	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1/2a Study of BMS-986242 Administered in Combination With Nivolumab (BMS-936558, Anti-PD-1) in Advanced Malignant Tumors
• Actual Study Start Date: Nov 27, 2017
• Actual Primary Completion Date: Aug 28, 2018
• Actual Study Completion Date: Aug 28, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose Escalation BMS-986242 administered in combination with Nivolumab	Drug: BMS-986242; Specified dose on specified days; Biological: Nivolumab; Specified dose on specified days; Other Names: BMS-936558 Anti-PD-1
Experimental: Dose Expansion BMS-986242 administered in combination with Nivolumab	Drug: BMS-986242; Specified dose on specified days; Biological: Nivolumab; Specified dose on specified days; Other Names: BMS-936558 Anti-PD-1

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Adverse Events (AE) [From initiation of study treatment until 100 days after discontinuation of study treatment]

   The primary objective to establish safety to be measured by the primary endpoint of AEs

2. Number of Participants With Serious Adverse Events (SAE) [From the date of participant's written consent until 100 days after discontinuation of nivolumab or participation in the study]

   The primary objective to establish safety to be measured by the primary endpoint of SAEs

3. Number of Participants With Dose Limiting Toxicities (DLT) [Approximately 2 years]

   The primary objective to establish safety to be measured by the primary endpoint of dose limiting toxicities

4. Number of Participants With AEs Leading to Discontinuation [Approximately 2 years]

   The primary objective to establish safety to be measured by the primary endpoint of AEs leading to discontinuation

5. Number of Deaths [Approximately 2 years]

   The primary objective to establish safety to be measured by the primary endpoint of deaths

6. Number of Participants With Laboratory Abnormalities [Approximately 2 years]

   The primary objective to establish safety to be measured by the primary endpoint of clinical laboratory test abnormalities

Secondary Outcome Measures

1. Maximum Observed Plasma Concentration (Cmax) [Approximately 2 years]

   The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0

2. Time of Maximum Observed Plasma Concentration (Tmax) [Approximately 2 years]

   The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0

3. Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] [Approximately 2 years]

   The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0

4. Area Under the Concentration-time Curve From Time Zero to Infinity [AUC(INF)] [Approximately 2 years]

   The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0

5. Trough Observed Plasma Concentration at the End of the Dosing Interval (Ctrough) [Approximately 2 years]

   The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0

6. Apparent Elimination Half-life (T-HALF) [Approximately 2 years]

   The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0

7. Apparent Total Body Clearance (CLT/F) [Approximately 2 years]

   The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0

8. Apparent Volume of Distribution at Steady State (Vss/F) [Approximately 2 years]

   The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0

9. Accumulation Index (AI) [Approximately 2 years]

   The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0. Accumulation index, calculated based on ratio of area under the curve (AUC) and Cmax at steady state to after the first dose.

10. Percent Urinary Recovery Over 24 Hours (%UR24) [Approximately 2 years]

    The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0

11. Percent Urinary Recovery Over 72 Hours (%UR72) [Approximately 2 years]

    The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0

12. Incidence of Anti-drug Antibody (ADA) to Nivolumab in Combination With BMS-986242 [Approximately 2 years]

    Baseline ADA-positive participant is defined as a participant who has a ADA detected sample at baseline. ADA-positive participant is a participant with at least 1 ADA-positive sample relative to baseline after initiation of the treatment.

13. Overall Response Rate (ORR) [Approximately 2 years]

    ORR in participants with a best overall response (BOR) of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for solid tumors

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Histologic or cytological confirmation of a malignancy that is advanced (metastatic and/or unresectable) with measureable disease per RECIST v1.1

• 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

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

• Ability to swallow tablets

• Adequate bone marrow and organ function, as defined by the protocol

Exclusion Criteria:

• Participants with known or suspected CNS metastases, untreated CNS metastases, or with the CNS as the only site of disease (patients with controlled brain metastasis allowed to enroll)

• Ocular melanoma

• Any significant acute or chronic medical illness

• Prior malignancy

• Other active malignancy requiring concurrent intervention

• Prior organ allograft or allogeneic bone marrow transplantation

• Participants with active, known, or suspected autoimmune disease

• Requirement for daily supplemental oxygen

• Uncontrolled or significant cardiovascular disease

• Pre-existing liver disease

• Gastrointestinal disease known to interfere with absorption

Other protocol defined inclusion/exclusion criteria could apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Of Alabama At Birmingham	Birmingham	Alabama	United States	35294-3300
2	Hoag Memorial Hospital Presbyterian	Los Angeles	California	United States	90033
3	USC Norris Comprehensive Cancer Center	Los Angeles	California	United States	90033
4	Local Institution	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 31, 2017

More Information

Additional Information:

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT03351231
• Other Study ID Numbers: CA024-001; 2017-003603-21
• First Posted: Nov 22, 2017
• Last Update Posted: Aug 26, 2020
• Last Verified: Aug 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Nivolumab

Study Results

Participant Flow

Pre-assignment Detail	7 participants were enrolled and 5 of those participants entered treatment; reasons for 2 participants not entering treatment were due to: 1 death; 1 participant no longer met study criteria. Note: study terminated following starting dose of BMS-986242 12.5 mg; dosing did not escalate.

Arm/Group Title	BMS-986242 12.5 mg + Nivolumab 480 mg
Arm/Group Description	2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments
Period Title: Combination Therapy Period
STARTED	5
COMPLETED	0
NOT COMPLETED	5
Period Title: Combination Therapy Period
STARTED	3
COMPLETED	0
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	BMS-986242 12.5 mg + Nivolumab 480 mg
Arm/Group Description	2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments
Overall Participants	5
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	2 40%
>=65 years	3 60%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	67.8 (7.4)
Sex: Female, Male (Count of Participants)
Female	1 20%
Male	4 80%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	5 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 20%
White	4 80%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Events (AE)
Description	The primary objective to establish safety to be measured by the primary endpoint of AEs
Time Frame	From initiation of study treatment until 100 days after discontinuation of study treatment

Outcome Measure Data

Analysis Population Description

Study terminated, data not reported due to privacy reasons

Arm/Group Title	BMS-986242 12.5 mg + Nivolumab 480 mg
Arm/Group Description	2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments
Measure Participants	5
Number [Number of participants]	NA NaN

2. Primary Outcome

Title	Number of Participants With Serious Adverse Events (SAE)
Description	The primary objective to establish safety to be measured by the primary endpoint of SAEs
Time Frame	From the date of participant's written consent until 100 days after discontinuation of nivolumab or participation in the study

Outcome Measure Data

Analysis Population Description

Study terminated, data not reported due to privacy reasons

Arm/Group Title	BMS-986242 12.5 mg + Nivolumab 480 mg
Arm/Group Description	2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments
Measure Participants	5
Number [Number of participants]	NA NaN

3. Primary Outcome

Title	Number of Participants With Dose Limiting Toxicities (DLT)
Description	The primary objective to establish safety to be measured by the primary endpoint of dose limiting toxicities
Time Frame	Approximately 2 years

Outcome Measure Data

Analysis Population Description

Study terminated, data not reported due to privacy reasons

Arm/Group Title	BMS-986242 12.5 mg + Nivolumab 480 mg
Arm/Group Description	2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments
Measure Participants	5
Number [Number of participants]	NA NaN

4. Primary Outcome

Title	Number of Participants With AEs Leading to Discontinuation
Description	The primary objective to establish safety to be measured by the primary endpoint of AEs leading to discontinuation
Time Frame	Approximately 2 years

Outcome Measure Data

Analysis Population Description

Study terminated, data not reported due to privacy reasons

Arm/Group Title	BMS-986242 12.5 mg + Nivolumab 480 mg
Arm/Group Description	2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments
Measure Participants	5
Number [Number of participants]	NA NaN

5. Primary Outcome

Title	Number of Deaths
Description	The primary objective to establish safety to be measured by the primary endpoint of deaths
Time Frame	Approximately 2 years

Outcome Measure Data

Analysis Population Description

Study terminated, data not reported due to privacy reasons

Arm/Group Title	BMS-986242 12.5 mg + Nivolumab 480 mg
Arm/Group Description	2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments
Measure Participants	5
Number [Number of deaths]	NA

6. Primary Outcome

Title	Number of Participants With Laboratory Abnormalities
Description	The primary objective to establish safety to be measured by the primary endpoint of clinical laboratory test abnormalities
Time Frame	Approximately 2 years

Outcome Measure Data

Analysis Population Description

Study terminated, data not reported due to privacy reasons

Arm/Group Title	BMS-986242 12.5 mg + Nivolumab 480 mg
Arm/Group Description	2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments
Measure Participants	5
Number [Number of participants]	NA NaN

7. Secondary Outcome

Title	Maximum Observed Plasma Concentration (Cmax)
Description	The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Time Frame	Approximately 2 years

Outcome Measure Data

Analysis Population Description

Study terminated, data not reported due to privacy reasons

Arm/Group Title	BMS-986242 12.5 mg + Nivolumab 480 mg
Arm/Group Description	2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments
Measure Participants	0

8. Secondary Outcome

Title	Time of Maximum Observed Plasma Concentration (Tmax)
Description	The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Time Frame	Approximately 2 years

Outcome Measure Data

Analysis Population Description

Study terminated, data not reported due to privacy reasons

Arm/Group Title	BMS-986242 12.5 mg + Nivolumab 480 mg
Arm/Group Description	2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments
Measure Participants	0

9. Secondary Outcome

Title	Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)]
Description	The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Time Frame	Approximately 2 years

Outcome Measure Data

Analysis Population Description

Study terminated, data not reported due to privacy reasons

Arm/Group Title	BMS-986242 12.5 mg + Nivolumab 480 mg
Arm/Group Description	2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments
Measure Participants	0

10. Secondary Outcome

Title	Area Under the Concentration-time Curve From Time Zero to Infinity [AUC(INF)]
Description	The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Time Frame	Approximately 2 years

Outcome Measure Data

Analysis Population Description

Study terminated, data not reported due to privacy reasons

Arm/Group Title	BMS-986242 12.5 mg + Nivolumab 480 mg
Arm/Group Description	2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments
Measure Participants	0

11. Secondary Outcome

Title	Trough Observed Plasma Concentration at the End of the Dosing Interval (Ctrough)
Description	The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Time Frame	Approximately 2 years

Outcome Measure Data

Analysis Population Description

Study terminated, data not reported due to privacy reasons

Arm/Group Title	BMS-986242 12.5 mg + Nivolumab 480 mg
Arm/Group Description	2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments
Measure Participants	0

12. Secondary Outcome

Title	Apparent Elimination Half-life (T-HALF)
Description	The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Time Frame	Approximately 2 years

Outcome Measure Data

Analysis Population Description

Study terminated, data not reported due to privacy reasons

Arm/Group Title	BMS-986242 12.5 mg + Nivolumab 480 mg
Arm/Group Description	2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments
Measure Participants	0

13. Secondary Outcome

Title	Apparent Total Body Clearance (CLT/F)
Description	The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Time Frame	Approximately 2 years

Outcome Measure Data

Analysis Population Description

Study terminated, data not reported due to privacy reasons

Arm/Group Title	BMS-986242 12.5 mg + Nivolumab 480 mg
Arm/Group Description	2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments
Measure Participants	0

14. Secondary Outcome

Title	Apparent Volume of Distribution at Steady State (Vss/F)
Description	The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Time Frame	Approximately 2 years

Outcome Measure Data

Analysis Population Description

Study terminated, data not reported due to privacy reasons

Arm/Group Title	BMS-986242 12.5 mg + Nivolumab 480 mg
Arm/Group Description	2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments
Measure Participants	0

15. Secondary Outcome

Title	Accumulation Index (AI)
Description	The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0. Accumulation index, calculated based on ratio of area under the curve (AUC) and Cmax at steady state to after the first dose.
Time Frame	Approximately 2 years

Outcome Measure Data

Analysis Population Description

Study terminated, data not reported due to privacy reasons

Arm/Group Title	BMS-986242 12.5 mg + Nivolumab 480 mg
Arm/Group Description	2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments
Measure Participants	0

16. Secondary Outcome

Title	Percent Urinary Recovery Over 24 Hours (%UR24)
Description	The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Time Frame	Approximately 2 years

Outcome Measure Data

Analysis Population Description

Study terminated, data not reported due to privacy reasons

Arm/Group Title	BMS-986242 12.5 mg + Nivolumab 480 mg
Arm/Group Description	2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments
Measure Participants	0

17. Secondary Outcome

Title	Percent Urinary Recovery Over 72 Hours (%UR72)
Description	The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Time Frame	Approximately 2 years

Outcome Measure Data

Analysis Population Description

Study terminated, data not reported due to privacy reasons

Arm/Group Title	BMS-986242 12.5 mg + Nivolumab 480 mg
Arm/Group Description	2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments
Measure Participants	0

18. Secondary Outcome

Title	Incidence of Anti-drug Antibody (ADA) to Nivolumab in Combination With BMS-986242
Description	Baseline ADA-positive participant is defined as a participant who has a ADA detected sample at baseline. ADA-positive participant is a participant with at least 1 ADA-positive sample relative to baseline after initiation of the treatment.
Time Frame	Approximately 2 years

Outcome Measure Data

Analysis Population Description

Study terminated, data not reported due to privacy reasons

Arm/Group Title	BMS-986242 12.5 mg + Nivolumab 480 mg
Arm/Group Description	2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments
Measure Participants	0

19. Secondary Outcome

Title	Overall Response Rate (ORR)
Description	ORR in participants with a best overall response (BOR) of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for solid tumors
Time Frame	Approximately 2 years

Outcome Measure Data

Analysis Population Description

Study terminated, data not reported due to privacy reasons

Arm/Group Title	BMS-986242 12.5 mg + Nivolumab 480 mg
Arm/Group Description	2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments
Measure Participants	0

Adverse Events

Time Frame	Adverse Events (AEs) are monitored from initiation of study treatment (monitored from participant's written consent for Serious Adverse Events) up through 100 days post-End of Treatment (EOT); Study Start of December 2017 and Study End of August 2018 (assessed approximately 1 year)
Adverse Event Reporting Description	The study will not be reported due to privacy reasons
Arm/Group Title	BMS-986242 12.5 mg + Nivolumab 480 mg
Arm/Group Description	2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments
All Cause Mortality
	BMS-986242 12.5 mg + Nivolumab 480 mg
	Affected / at Risk (%)	# Events
Total	0/5 (0%)
Serious Adverse Events
	BMS-986242 12.5 mg + Nivolumab 480 mg
	Affected / at Risk (%)	# Events
Total	0/5 (0%)
Other (Not Including Serious) Adverse Events
	BMS-986242 12.5 mg + Nivolumab 480 mg
	Affected / at Risk (%)	# Events
Total	0/5 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.