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

NCT ID: NCT03400332

Last Updated: 2025-07-25

Study Results

Results available

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

281 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-12

Study Completion Date

2025-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part 1A: BMS-986253 + nivolumab

Group Type EXPERIMENTAL

BMS-986253

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Part 1B: BMS-986253 + nivolumab

Group Type EXPERIMENTAL

BMS-986253

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Part 1C: BMS-986253 + nivolumab + ipilimumab

Group Type EXPERIMENTAL

BMS-986253

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Ipilimumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Part 2A: BMS-986253 + nivolumab + ipilimumab

Group Type EXPERIMENTAL

BMS-986253

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Ipilimumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Part 2B: Placebo + nivolumab + ipilimumab

Group Type PLACEBO_COMPARATOR

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Ipilimumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Placebo

Intervention Type OTHER

Specified dose on specified days

Interventions

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BMS-986253

Specified dose on specified days

Intervention Type DRUG

Nivolumab

Specified dose on specified days

Intervention Type BIOLOGICAL

Ipilimumab

Specified dose on specified days

Intervention Type BIOLOGICAL

Placebo

Specified dose on specified days

Intervention Type OTHER

Other Intervention Names

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BMS-936558 Opdivo BMS-734016 YERVOY

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0059

Springdale, Arkansas, United States

Site Status

Local Institution - 0099

Los Angeles, California, United States

Site Status

Local Institution - 0007

Lakewood, Colorado, United States

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Local Institution - 0087

Atlanta, Georgia, United States

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Local Institution - 0100

Atlanta, Georgia, United States

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Local Institution - 0101

Marietta, Georgia, United States

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Local Institution - 0012

Columbia, Maryland, United States

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Local Institution - 0003

Lutherville, Maryland, United States

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Local Institution - 0060

Boston, Massachusetts, United States

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Local Institution - 0004

Ann Arbor, Michigan, United States

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Local Institution - 0076

Omaha, Nebraska, United States

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Comprehensive Cancer Centers Of Nevada

Las Vegas, Nevada, United States

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Local Institution - 0005

Hackensack, New Jersey, United States

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Local Institution - 0032

New Brunswick, New Jersey, United States

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Local Institution - 0025

New York, New York, United States

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Local Institution - 0002

New York, New York, United States

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Local Institution - 0028

Oklahoma City, Oklahoma, United States

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Local Institution - 0017

Eugene, Oregon, United States

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Local Institution - 0001

Pittsburgh, Pennsylvania, United States

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Local Institution - 0009

Greenville, South Carolina, United States

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Local Institution - 0011

Austin, Texas, United States

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Local Institution - 0010

Dallas, Texas, United States

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Local Institution - 0014

Fort Worth, Texas, United States

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Local Institution - 0018

Houston, Texas, United States

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Local Institution - 0006

San Antonio, Texas, United States

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Local Institution - 0013

Tyler, Texas, United States

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Local Institution - 0058

Salt Lake City, Utah, United States

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Local Institution - 0015

Fairfax, Virginia, United States

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Local Institution - 0008

Norfolk, Virginia, United States

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Local Institution - 0088

Wollstonecraft, New South Wales, Australia

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Local Institution - 0096

Adelaide, South Australia, Australia

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Local Institution - 0090

Melbourne, Victoria, Australia

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Local Institution - 0095

Melbourne, Victoria, Australia

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Local Institution - 0097

Perth, Western Australia, Australia

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Local Institution - 0091

Ballarat Central, , Australia

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Local Institution - 0037

Brussels, , Belgium

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Local Institution - 0036

Ghent, , Belgium

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Local Institution - 0082

Kortrijk, , Belgium

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Local Institution - 0030

Edmonton, Alberta, Canada

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Local Institution - 0029

Vancouver, British Columbia, Canada

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Local Institution - 0078

Victoria, British Columbia, Canada

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Local Institution - 0020

Toronto, Ontario, Canada

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Local Institution - 0055

Toronto, Ontario, Canada

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Local Institution - 0056

Montreal, Quebec, Canada

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Local Institution - 0067

Marseille, Bouches-du-Rhône, France

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Local Institution - 0085

Nantes, , France

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Local Institution - 0068

Paris, , France

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Local Institution - 0102

Toulouse, , France

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Local Institution - 0069

Villejuif, , France

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Local Institution - 0054

Tübingen, Baden-Wurttemberg, Germany

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Local Institution - 0052

Mainz, Rhineland-Palatinate, Germany

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Local Institution - 0034

Berlin, , Germany

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Local Institution - 0053

Hamburg, , Germany

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Local Institution - 0043

Forlì, , Italy

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Local Institution - 0042

Milan, , Italy

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Local Institution - 0027

Napoli, , Italy

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Local Institution - 0026

Rozzano-milano, , Italy

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Local Institution - 0071

Krakow, , Poland

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Local Institution - 0077

Warsaw, , Poland

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Local Institution - 0045

Madrid, , Spain

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Local Institution - 0022

Madrid, , Spain

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Local Institution - 0023

Madrid, , Spain

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Local Institution - 0044

Málaga, , Spain

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Local Institution - 0021

Pamplona, , Spain

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Local Institution - 0047

Santiago de Compostela, , Spain

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Local Institution - 0049

Lund, , Sweden

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Local Institution - 0040

Lausanne, , Switzerland

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Local Institution - 0041

Sankt Gallen, , Switzerland

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Local Institution - 0039

Zurich, , Switzerland

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Local Institution - 0024

Manchester, Greater Manchester, United Kingdom

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Local Institution - 0083

Glasgow, Lanarkshire, United Kingdom

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Local Institution - 0019

Birmingham, West Midlands, United Kingdom

Site Status

Countries

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United States Australia Belgium Canada France Germany Italy Poland Spain Sweden Switzerland United Kingdom

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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2023-509061-20

Identifier Type: REGISTRY

Identifier Source: secondary_id

CA027-002

Identifier Type: -

Identifier Source: org_study_id

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