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A Study of BMS-986449 With and Without Nivolumab in Participants With Advanced Solid Tumors

NCT ID: NCT05888831

Last Updated: 2025-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-06

Study Completion Date

2026-09-30

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of BMS-986449 alone and in combination with nivolumab in participants with advanced solid tumors.

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Detailed Description

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Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Escalation: BMS-986449 monotherapy

Group Type EXPERIMENTAL

BMS-986449

Intervention Type DRUG

Specified dose on specified days

Dose Escalation: BMS-986449 + nivolumab

Group Type EXPERIMENTAL

BMS-986449

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type DRUG

Specified dose on specified days

Dose Escalation: BMS-986449 monotherapy pharmacodynamic (PD) cohorts

Group Type EXPERIMENTAL

BMS-986449

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986449

Specified dose on specified days

Intervention Type DRUG

Nivolumab

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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OPDIVO® BMS-936558

Eligibility Criteria

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Inclusion Criteria

* All participants must have a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy (measurable by Response Evaluation Criteria in Solid Tumors \[RECIST\] v1.1), and have received, be refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant.

* Part 1A may have a solid malignancy of any histology.
* Part 1B is restricted to participants with Non-small cell lung cancer (NSCLC).
* Part 1C is restricted to participants with Triple-negative breast cancer (TNBC).
* Tumor biopsy must be obtained for all participants (unless medically precluded).

Exclusion Criteria

* History of Grade ≥ 3 toxicity related to prior T-cell agonist or checkpoint inhibitor therapy (eg, anti-cytotoxic T-lymphocyte-associated antigen 4 \[CTLA-4\], or anti-PD- 1/programmed death-ligand 1 \[PD-L1\] treatment, or any other antibody or drug specifically targeting T-cell co-stimulation or other immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures.
* Current or recent (within 3 months of study intervention administration) gastrointestinal disease or gastrointestinal surgery (eg, intestinal/gastric/colon resection) that could impact the absorption of study intervention.
* Any significant acute or chronic medical illness which would interfere with study intervention or follow-up in the opinion of the investigator.

Other protocol-defined criteria may apply.
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 - 0021

Los Angeles, California, United States

Site Status

Local Institution - 0007

New Haven, Connecticut, United States

Site Status

Local Institution - 0010

Hackensack, New Jersey, United States

Site Status

Local Institution - 0022

Lake Success, New York, United States

Site Status

Local Institution - 0016

Brussels, Bruxelles-Capitale, Région de, Belgium

Site Status

Local Institution - 0017

Ghent, Oost-Vlaanderen, Belgium

Site Status

Local Institution - 0002

Villejuif, Paris, France

Site Status

Local Institution - 0004

Marseille, Provence-Alpes-Côte d'Azur Region, France

Site Status

Local Institution - 0003

Bordeaux, , France

Site Status

Local Institution - 0023

Rozzano, Milano, Italy

Site Status

Local Institution - 0024

Siena, Tuscany, Italy

Site Status

Local Institution - 0026

Bergamo, , Italy

Site Status

Local Institution - 0025

Roma, , Italy

Site Status

Local Institution - 0030

Amsterdam, North Holland, Netherlands

Site Status

Local Institution - 0018

Groningen, , Netherlands

Site Status

Local Institution - 0015

Málaga, Andalusia, Spain

Site Status

Local Institution - 0013

Badalona, Barcelona [Barcelona], Spain

Site Status

Local Institution - 0012

Pamplona, Navarre, Spain

Site Status

Local Institution - 0014

Madrid, , Spain

Site Status

Local Institution - 0011

Madrid, , Spain

Site Status

Countries

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United States Belgium France Italy Netherlands Spain

Related Links

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https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT05888831.html

BMS Clinical Trial Patient Recruiting

Other Identifiers

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2023-503484-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1287-3575

Identifier Type: REGISTRY

Identifier Source: secondary_id

CA120-1001

Identifier Type: -

Identifier Source: org_study_id

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