A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers

February 4, 2026 updated by: Bristol-Myers Squibb

A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers

The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
281

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

  • Name: First line of the email MUST contain NCT # and Site #.

Study Locations

  • Australia
      • Ballarat Central, Australia, VIC 3350
        • Local Institution - 0091
    • New South Wales
      • Wollstonecraft, New South Wales, Australia, 2065
        • Local Institution - 0088
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Local Institution - 0096
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Local Institution - 0090
      • Melbourne, Victoria, Australia, 3004
        • Local Institution - 0095
    • Western Australia
      • Perth, Western Australia, Australia, 6009
        • Local Institution - 0097
  • Belgium
      • Brussels, Belgium, 1200
        • Local Institution - 0037
      • Ghent, Belgium, 9000
        • Local Institution - 0036
      • Kortrijk, Belgium, 8500
        • Local Institution - 0082
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Local Institution - 0030
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Local Institution - 0029
      • Victoria, British Columbia, Canada, V8R 6V5
        • Local Institution - 0078
    • Ontario
      • Toronto, Ontario, Canada, M5G 1Z5
        • Local Institution - 0020
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution - 0055
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • Local Institution - 0056
  • France
      • Nantes, France, 44000
        • Local Institution - 0085
      • Paris, France, 75010
        • Local Institution - 0068
      • Toulouse, France, 31059
        • Local Institution - 0102
      • Villejuif, France, 94800
        • Local Institution - 0069
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, France, 13385
        • Local Institution - 0067
  • Germany
      • Berlin, Germany, 12200
        • Local Institution - 0034
      • Hamburg, Germany, 20251
        • Local Institution - 0053
    • Baden-Wurttemberg
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Local Institution - 0054
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55131
        • Local Institution - 0052
  • Italy
      • Forlì, Italy, 47014
        • Local Institution - 0043
      • Milan, Italy, 20132
        • Local Institution - 0042
      • Napoli, Italy, 80131
        • Local Institution - 0027
      • Rozzano-milano, Italy, 20089
        • Local Institution - 0026
  • Poland
      • Krakow, Poland, 31-115
        • Local Institution - 0071
      • Warsaw, Poland, 02-781
        • Local Institution - 0077
  • Spain
      • Madrid, Spain, 28034
        • Local Institution - 0045
      • Madrid, Spain, 28040
        • Local Institution - 0022
      • Madrid, Spain, 28050
        • Local Institution - 0023
      • Málaga, Spain, 29010
        • Local Institution - 0044
      • Pamplona, Spain, 31008
        • Local Institution - 0021
      • Santiago de Compostela, Spain, 15706
        • Local Institution - 0047
  • Sweden
      • Lund, Sweden, 221 85
        • Local Institution - 0049
  • Switzerland
      • Lausanne, Switzerland, 1011
        • Local Institution - 0040
      • Sankt Gallen, Switzerland, 9007
        • Local Institution - 0041
      • Zurich, Switzerland, 8091
        • Local Institution - 0039
  • United Kingdom
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M20 4BX
        • Local Institution - 0024
    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G12 0YN
        • Local Institution - 0083
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2TH
        • Local Institution - 0019
  • United States
    • Arkansas
      • Springdale, Arkansas, United States, 72762
        • Local Institution - 0059
    • California
      • Los Angeles, California, United States, 90033
        • Local Institution - 0099
    • Colorado
      • Lakewood, Colorado, United States, 80228
        • Local Institution - 0007
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Local Institution - 0087
      • Atlanta, Georgia, United States, 30342
        • Local Institution - 0100
      • Marietta, Georgia, United States, 30060
        • Local Institution - 0101
    • Maryland
      • Columbia, Maryland, United States, 21044
        • Local Institution - 0012
      • Lutherville, Maryland, United States, 21093
        • Local Institution - 0003
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Local Institution - 0060
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Local Institution - 0004
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Local Institution - 0076
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Local Institution - 0005
      • New Brunswick, New Jersey, United States, 08903
        • Local Institution - 0032
    • New York
      • New York, New York, United States, 10032
        • Local Institution - 0002
      • New York, New York, United States, 10029
        • Local Institution - 0025
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Local Institution - 0028
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Local Institution - 0017
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Local Institution - 0001
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Local Institution - 0009
    • Texas
      • Austin, Texas, United States, 78705
        • Local Institution - 0011
      • Dallas, Texas, United States, 75246
        • Local Institution - 0010
      • Fort Worth, Texas, United States, 76104-3927
        • Local Institution - 0014
      • Houston, Texas, United States, 77030
        • Local Institution - 0018
      • San Antonio, Texas, United States, 78240
        • Local Institution - 0006
      • Tyler, Texas, United States, 75702
        • Local Institution - 0013
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Local Institution - 0058
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Local Institution - 0015
      • Norfolk, Virginia, United States, 23502
        • Local Institution - 0008

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1
  • At least 1 lesion accessible for biopsy
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1

Exclusion Criteria:

  • Participants with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll)
  • Participants with active, known or suspected autoimmune disease
  • Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
  • Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)
  • Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy

Other protocol defined inclusion/exclusion criteria could apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1A: BMS-986253 + nivolumab
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: BMS-986253
Specified dose on specified days
Experimental: Part 1B: BMS-986253 + nivolumab
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: BMS-986253
Specified dose on specified days
Experimental: Part 1C: BMS-986253 + nivolumab + ipilimumab
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • YERVOY
Drug: BMS-986253
Specified dose on specified days
Experimental: Part 2A: BMS-986253 + nivolumab + ipilimumab
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • YERVOY
Drug: BMS-986253
Specified dose on specified days
Placebo Comparator: Part 2B: Placebo + nivolumab + ipilimumab
Other: Placebo
Specified dose on specified days
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • YERVOY

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants Experiencing Adverse Events (AEs) - Part 1
Time Frame: From first dose up to 100 days after last dose (up to 65 months)

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.

This endpoint was prespecified in the protocol to include only participants in Part 1.
From first dose up to 100 days after last dose (up to 65 months)
Number of Participants Experiencing Serious Adverse Events (SAEs) - Part 1
Time Frame: From first dose up to 100 days after last dose (up to 65 months)

A serious adverse event is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.

This endpoint was prespecified in the protocol to include only participants in Part 1.
From first dose up to 100 days after last dose (up to 65 months)
Number of Participants Experiencing Dose Limiting Toxicities (DLTs) - Part 1
Time Frame: From first dose up to 100 days after last dose (up to 65 months)

Dose-Limiting Toxicities (DLTs) are effects of a treatment that are serious enough to prevent an increase in dose of that treatment, as advised by the Dose Review Team. DLTs will be defined based on the incidence, intensity, and duration of AEs that are possibly related to study treatment. DLTs will include gastrointestinal, hepatic, hematologic, dermatologic, and other AEs.

This endpoint was prespecified in the protocol to include only participants in Part 1.
From first dose up to 100 days after last dose (up to 65 months)
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation - Part 1
Time Frame: From first dose up to 100 days after last dose (up to 65 months)

Number of participants with any grade adverse events (AEs) leading to discontinuation of study treatment. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

This endpoint was prespecified in the protocol to include only participants in Part 1.
From first dose up to 100 days after last dose (up to 65 months)
Number of Participants Who Died - Part 1
Time Frame: From first dose up to 100 days after last dose (up to 65 months)
The number of participants who died due to any cause are summarized. This endpoint was prespecified in the protocol to include only participants in Part 1.
From first dose up to 100 days after last dose (up to 65 months)
Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 1
Time Frame: From first dose up to 30 days after last dose (up to 63 months)

Laboratory results were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Laboratory tests are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.

This endpoint was prespecified in the protocol to include only participants in Part 1.
From first dose up to 30 days after last dose (up to 63 months)
Objective Response Rate (ORR) - Part 2
Time Frame: From the date of the first dose to the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurred first (up to approximately 22 months)
Objective Response Rate per blinded independent central review (BICR) is the percentage of participants who have a confirmed complete or partial best overall response (BOR) among participants who have measurable disease at baseline. Complete Response (CR) is defined as 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) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Baseline was defined as evaluations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations. This endpoint was prespecified in the protocol to include only participants in Part 2.
From the date of the first dose to the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurred first (up to approximately 22 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) - Part 1
Time Frame: From the date of the first dose to the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurred first (up to approximately 74 months)
Objective Response Rate per investigator is the percentage of participants who have a confirmed complete or partial best overall response (BOR) among participants who have measurable disease at baseline. Complete Response (CR) is defined as 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) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Baseline was defined as evaluations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations. This endpoint was prespecified in the protocol to include only participants in Part 1.
From the date of the first dose to the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurred first (up to approximately 74 months)
Duration of Response (DOR) - Part 1
Time Frame: From the date of the first dose to the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurred first (up to approximately 74 months)

DOR for a participant with a best overall response (BOR) of CR or PR is defined as the date of first response up to the date of the first objectively documented tumor progression by the investigator per RECIST v1.1 or death, whichever occurs first. Analysis computed using Kaplan-Meier method.

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 during the study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of at least 5 mm.

This endpoint was prespecified in the protocol to include only participants in Part 1.
From the date of the first dose to the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurred first (up to approximately 74 months)
Maximum Concentration (Cmax) - Part 1
Time Frame: Cycle 1 Day 1

Cmax is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered and before the administration of a second dose.

1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)
Cycle 1 Day 1
AUC(0-T)-Area Under Curve From Time Zero up to Last Quantifiable Concentration - Part 1
Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Cycle 1 Day 1

AUC (0-T) represents the observed exposure to a drug (area under the concentration curve) from first exposure until the last quantifiable concentration. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.

1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)
0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Cycle 1 Day 1
AUC(TAU)-Area Under Curve in 1 Dosing Interval - Part 1
Time Frame: Cycle 1 Day 1

Area under the concentration-time curve in 1 dosing interval. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.

1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)
Cycle 1 Day 1
Observed Serum Concentration at the End of a Dosing Interval (Ctau) - Part 1
Time Frame: Cycle 1 Day 1

BMS-986253 observed serum concentration at the end of a dosing interval (Ctau). Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.

1 cycle=28 days for all Arms/Groups except Cycles 1 and 2 (1 cycle=42 days) in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group
Cycle 1 Day 1
Total Body Clearance (CLT) - Part 1
Time Frame: Cycle 1 Day 1

Clearance is the rate of elimination of BMS-986253 from the blood calculated as the rate of elimination divided by serum concentration. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.

1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)
Cycle 1 Day 1
Average Serum Concentration Over a Dosing Interval (Css-avg) - Part 1
Time Frame: Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1

BMS-986253 Average concentration over a dosing interval (\[AUC(TAU)/tau\] (Css-avg) at steady state. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.

1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)

Note: C2D1, C3D1, C4D1 were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.
Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1
AUC Accumulation Index (AI_AUC) - Part 1
Time Frame: Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1

AUC Accumulation Index is defined as the ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.

1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)

Note: C2D1, C3D1, C4D1 were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.
Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1
Cmax Accumulation Index (AI_Cmax) - Part 1
Time Frame: Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1

BMS-986253 Cmax accumulation index (AI_Cmax). Ratio of an exposure measure at steady state to that after the first dose. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.

1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)

Note: C2D1, C3D1, C4D1 were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.
Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1
Ctau Accumulation Index (AI_Ctau) - Part 1
Time Frame: Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1

Ctau is the observed serum concentration at the end of a dosing interval. Ctau accumulation index (AI_Ctau) is the ratio of an exposure measure at steady state to that after the first dose. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint. Ctau was reported on non-compartmental analysis day, which is on Cycle 1 Day1, Cycle 2 Day 1, Cycle 3 Day 1, or Cycle 4 Day 1 based on data available.

1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)

Note: C2D1, C3D1, C4D1 were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.
Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1
Effective Elimination (T-HALFeff) - Part 1
Time Frame: Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1

BMS-986253 effective elimination (T-HALFeff) that explains the degree of accumulation observed for a specific exposure measure. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.

1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)

Note: C2D1, C3D1, C4D1 were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.
Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1
Time to Maximum Concentration (Tmax) - Part 1
Time Frame: Cycle 1 Day 1

Tmax is defined as the time it takes for a drug to reach the maximum concentration (Cmax) after administration of a drug.

1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)
Cycle 1 Day 1
Serum Trough Concentration (Ctrough) - Part 1
Time Frame: C1D15, C1D29, C2D1, C2D9, C2D15, C3D1, C4D1, C4D15, C5D1, C7D1, C9D1, C10D1, C14D1, C20D1, and C26D1

A serum trough concentration (Ctrough) is the concentration reached by a drug immediately before the next dose is administered. Serum trough concentrations (Ctrough) of BMS-986253 will be summarized with descriptive statistics by treatment and visit.

1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)

Note: The timepoints listed were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.
C1D15, C1D29, C2D1, C2D9, C2D15, C3D1, C4D1, C4D15, C5D1, C7D1, C9D1, C10D1, C14D1, C20D1, and C26D1
Number of Participants With Anti-Drug Antibodies (ADA) - Part 1
Time Frame: C1D1, C1D2, C1D8, C1D15, C1D22, C2D1, C2D2, C2D8, C2D15, C3D1, C4D1, C4D2, C4D8, C4D15, C4D22, C5D1, C9D1, C14D1, C20D1, C26D1, C32D1, C38D1, 30-day follow-up, 100-day follow-up

Blood samples were evaluated for development of Anti-Drug Antibody (ADA) by a validated electrochemiluminescent (ECL) immunoassay. Baseline is defined as first dose.

ADA-positive subject: A subject with at least one ADA positive-sample relative to baseline at any time after initiation of treatment.

Persistent Positive (PP): ADA-positive sample at 2 or more consecutive time points, where the first and last ADA-positive samples are at least 16 weeks apart

Not PP-Last Sample Positive: Not persistent positive with ADA-positive sample at the last sampling time point

Other Positive: Not persistent positive but some ADA-positive samples with the last sample being negative

Neutralizing Positive: At least one ADA-positive sample with neutralizing antibodies detected

ADA-negative subject: A subject with no ADA-positive sample after the initiation of treatment.

1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)
C1D1, C1D2, C1D8, C1D15, C1D22, C2D1, C2D2, C2D8, C2D15, C3D1, C4D1, C4D2, C4D8, C4D15, C4D22, C5D1, C9D1, C14D1, C20D1, C26D1, C32D1, C38D1, 30-day follow-up, 100-day follow-up
Change From Baseline in Interleukin 8 (IL-8)- Part 1
Time Frame: C1D2, C1D8, C1D15, C1D22, C1D29, C1D36, C2D1, C2D2, C2D8, C2D15, C2D22, C2D29, C3D1, C3D2, C3D8, C4D1, C4D2, C4D8, C4D15, C4D22, C5D1, C7D1, C8D1, C9D1, C10D1, C11D1, C14D1, C16D1, C17D1, C20D1, C23D1, C26D1, at last dose, and 100 days post last dose

Change from baseline in IL-8 measured in pg/mL. Baseline is defined as first dose.

1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)

Note: Some timepoints were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.
C1D2, C1D8, C1D15, C1D22, C1D29, C1D36, C2D1, C2D2, C2D8, C2D15, C2D22, C2D29, C3D1, C3D2, C3D8, C4D1, C4D2, C4D8, C4D15, C4D22, C5D1, C7D1, C8D1, C9D1, C10D1, C11D1, C14D1, C16D1, C17D1, C20D1, C23D1, C26D1, at last dose, and 100 days post last dose
Progression Free Survival (PFS) - Part 2
Time Frame: From the date of the first dose to the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurred first (up to approximately 22 months)

Progression free survival (PFS) is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression by BICR or death due to any cause, whichever is earlier.

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. The appearance of one or more new lesions is also considered progression.

This endpoint was prespecified in the protocol to include only participants in Part 2.
From the date of the first dose to the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurred first (up to approximately 22 months)
Number of Participants Experiencing Adverse Events (AEs) - Part 2
Time Frame: From first dose up to 100 days after last dose (up to 25 months)

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.

This endpoint was prespecified in the protocol to include only participants in Part 2.
From first dose up to 100 days after last dose (up to 25 months)
Number of Participants Experiencing Serious Adverse Events (SAEs) - Part 2
Time Frame: From first dose up to 100 days after last dose (up to 25 months)
A serious adverse event is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.
From first dose up to 100 days after last dose (up to 25 months)
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation - Part 2
Time Frame: From first dose up to 100 days after last dose (up to 25 months)
Number of participants with any grade adverse events (AEs) leading to discontinuation of study treatment. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
From first dose up to 100 days after last dose (up to 25 months)
Number of Participants Who Died - Part 2
Time Frame: From first dose up to 100 days after last dose (up to 25 months)
The number of participants who died due to any cause are summarized.
From first dose up to 100 days after last dose (up to 25 months)
Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 2
Time Frame: From first dose up to 30 days after last dose (up to 23 months)

Laboratory results were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Laboratory tests are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.

This endpoint was prespecified in the protocol to include only participants in Part 2.
From first dose up to 30 days after last dose (up to 23 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 12, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 26, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 4, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA027-002
  • 2023-509061-20 (Registry Identifier: EU Trial Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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