A Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors

NCT ID: NCT03369223

Last Updated: 2025-11-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

356 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-06

Study Completion Date

2024-11-07

Brief Summary

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The purpose of this study is to determine whether BMS-986249 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors

Detailed Description

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Conditions

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Advanced Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1A: BMS-986249

Group Type EXPERIMENTAL

BMS-986249

Intervention Type BIOLOGICAL

Specified dose on specified days

Part 1B: BMS-986249 + nivolumab (nivo)

Group Type EXPERIMENTAL

BMS-986249

Intervention Type BIOLOGICAL

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Part 2A Arm C: BMS-986249 + nivo

Previously untreated unresectable stage III-IV melanoma

Group Type EXPERIMENTAL

BMS-986249

Intervention Type BIOLOGICAL

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Part 2A Arm D: ipilimumab + nivo then nivo

Previously untreated unresectable stage III-IV melanoma

Group Type EXPERIMENTAL

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Ipilimumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Part 2A Arm F: BMS-986249 + nivo

Previously untreated unresectable stage III-IV melanoma

Group Type EXPERIMENTAL

BMS-986249

Intervention Type BIOLOGICAL

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Part 2B Cohort 1: BMS-986249 + nivo

Advanced or intermediate hepatocellular carcinoma (HCC)

Group Type EXPERIMENTAL

BMS-986249

Intervention Type BIOLOGICAL

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Part 2B Cohort 2: BMS-986249 + nivo

Metastatic castration-resistant prostate cancer (CRPC)

Group Type EXPERIMENTAL

BMS-986249

Intervention Type BIOLOGICAL

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Part 2B Cohort 3: BMS-986249 + nivo

Unresectable locally advanced or metastatic triple-negative breast cancer (TNBC)

Group Type EXPERIMENTAL

BMS-986249

Intervention Type BIOLOGICAL

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Part 2A Arm A: BMS-986249 + nivo then nivo

* Previously untreated unresectable stage III-IV melanoma
* Enrollment is closed for this Arm

Group Type EXPERIMENTAL

BMS-986249

Intervention Type BIOLOGICAL

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Part 2A Arm B: BMS-986249 + nivo

* Previously untreated unresectable stage III-IV melanoma
* Enrollment is closed for this Arm

Group Type EXPERIMENTAL

BMS-986249

Intervention Type BIOLOGICAL

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Part 2A Arm E: Nivo

* Previously untreated unresectable stage III-IV melanoma
* Enrollment is closed for this Arm

Group Type EXPERIMENTAL

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Interventions

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BMS-986249

Specified dose on specified days

Intervention Type BIOLOGICAL

Nivolumab

Specified dose on specified days

Intervention Type BIOLOGICAL

Ipilimumab

Specified dose on specified days

Intervention Type BIOLOGICAL

Other Intervention Names

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Opdivo BMS-936558 Yervoy BMS-734016

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 or metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on CT/MRI for prostate cancer and have at least 1 lesion accessible for biopsy. For Part 2B participants with HCC, intermediate disease is allowed.
* Eastern Cooperative Oncology Group Performance Status of 0 or 1
* Must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to tumor type, if such a therapy exists
* Prior anti-cancer treatments such as chemotherapy, radiotherapy, or hormonal are permitted for some participants
* Willing and able to comply with all study procedures

Exclusion Criteria

* Primary central nervous system (CNS) malignancies, tumors with CNS metastases as the only site of disease or active brain metastases will be excluded
* Other active malignancy requiring concurrent intervention
* Prior organ allograft
* Active, known, or suspected autoimmune disease
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 - 0005

Aurora, Colorado, United States

Site Status

Local Institution - 0006

Denver, Colorado, United States

Site Status

Local Institution - 0017

Miami, Florida, United States

Site Status

Local Institution - 0024

Baltimore, Maryland, United States

Site Status

Local Institution - 0001

Hackensack, New Jersey, United States

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Local Institution - 0002

New York, New York, United States

Site Status

Local Institution - 0003

New York, New York, United States

Site Status

Local Institution - 0029

Cincinnati, Ohio, United States

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Local Institution - 0013

Eugene, Oregon, United States

Site Status

Local Institution - 0004

Philadelphia, Pennsylvania, United States

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Local Institution - 0008

Greenville, South Carolina, United States

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Local Institution - 0010

Austin, Texas, United States

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Local Institution - 0009

Dallas, Texas, United States

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Local Institution - 0021

Houston, Texas, United States

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Local Institution - 0016

San Antonio, Texas, United States

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Local Institution - 0011

Tyler, Texas, United States

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Local Institution - 0012

Leesburg, Virginia, United States

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Local Institution - 0007

Norfolk, Virginia, United States

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Local Institution - 0018

Vancouver, Washington, United States

Site Status

Local Institution - 0038

Buenos Aires, Distrito Federal, Argentina

Site Status

Local Institution - 0052

CABA, Distrito Federal, Argentina

Site Status

Local Institution - 0037

Buenos Aires, , Argentina

Site Status

Local Institution - 0015

North Sydney, New South Wales, Australia

Site Status

Local Institution - 0014

Adelaide, South Australia, Australia

Site Status

Local Institution - 0025

Frankston, Victoria, Australia

Site Status

Local Institution - 0047

Heidelberg, Victoria, Australia

Site Status

Local Institution - 0026

Edmonton, Alberta, Canada

Site Status

Local Institution - 0056

Ottawa, Ontario, Canada

Site Status

Local Institution - 0036

Santiago, Santiago Metropolitan, Chile

Site Status

Local Institution - 0039

Helsinki, , Finland

Site Status

Local Institution - 0030

Essen, , Germany

Site Status

Local Institution - 0035

Hamburg, , Germany

Site Status

Local Institution - 0031

Heidelberg, , Germany

Site Status

Local Institution - 0048

Milan, , Italy

Site Status

Local Institution - 0020

Napoli, , Italy

Site Status

Local Institution - 0049

Siena, , Italy

Site Status

Local Institution - 0040

Warsaw, , Poland

Site Status

Local Institution - 0045

Bucharest, , Romania

Site Status

Local Institution - 0041

Craiova, , Romania

Site Status

Local Institution - 0042

Badalona, Barcelona [Barcelona], Spain

Site Status

Local Institution - 0022

Madrid, Madrid, Comunidad de, Spain

Site Status

Local Institution - 0044

Barcelona, , Spain

Site Status

Local Institution - 0023

Madrid, , Spain

Site Status

Local Institution - 0050

Madrid, , Spain

Site Status

Local Institution - 0043

Málaga, , Spain

Site Status

Countries

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United States Argentina Australia Canada Chile Finland Germany Italy Poland Romania Spain

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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CA030-001

Identifier Type: -

Identifier Source: org_study_id

2018-000416-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

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