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

NCT05888831 | Active Not Recruiting Phase 1 FDA Drug

• 3 other identifiers: CA120-10012023-503484-42U1111-1287-3575
• Study Type: interventional
• Target: 100
• Locations: 6 countries
• Sites: 20

Brief Summary

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.

Conditions

Advanced Solid Tumors

Keywords

BMS-986449; Nivolumab; Cancer; Solid Tumors; Non-Small Cell Lung Cancer (NSCLC); Triple Negative Breast Cancer (TNBC)

Outcome Measures

Primary Outcomes (5)

• Number of participants with Dose-Limiting Toxicities (DLTs)

  Up to approximately 4 years

• Number of participants with Adverse Events (AEs)

  Up to approximately 4 years

• Number of participants with Serious Adverse Events (SAEs)

  Up to approximately 4 years

• Number of participants with AEs leading to discontinuation

  Up to approximately 4 years

• Number of deaths

  Up to approximately 4 years

Secondary Outcomes (3)

• Maximum observed plasma concentration (Cmax)

  Up to approximately 4 years

• Time of maximum observed concentration within a dosing interval (Tmax)

  Up to approximately 4 years

• Area under the concentration-time curve within a dosing interval (AUC[TAU])

  Up to approximately 4 years

Study Arms (3)

Dose Escalation: BMS-986449 monotherapy

EXPERIMENTAL

Drug: BMS-986449

Dose Escalation: BMS-986449 + nivolumab

EXPERIMENTAL

Drug: BMS-986449; Drug: Nivolumab

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

EXPERIMENTAL

Drug: BMS-986449

Interventions

BMS-986449 DRUG

Specified dose on specified days

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

Nivolumab DRUG

Specified dose on specified days

Also known as: OPDIVO®, BMS-936558

Dose Escalation: BMS-986449 + nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (20)

Local Institution - 0021

Los Angeles, California, 90025, United States

Location

Local Institution - 0007

New Haven, Connecticut, 06510, United States

Location

Local Institution - 0010

Hackensack, New Jersey, 07601, United States

Location

Local Institution - 0022

Lake Success, New York, 11042, United States

Location

Local Institution - 0016

Brussels, Bruxelles-Capitale, Région de, 1200, Belgium

Location

Local Institution - 0017

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Local Institution - 0002

Villejuif, Paris, 94800, France

Location

Local Institution - 0004

Marseille, Provence-Alpes-Côte d'Azur Region, 13273, France

Location

Local Institution - 0003

Bordeaux, 33076, France

Location

Local Institution - 0023

Rozzano, Milano, 20089, Italy

Location

Local Institution - 0024

Siena, Tuscany, 53100, Italy

Location

Local Institution - 0026

Bergamo, 24127, Italy

Location

Local Institution - 0025

Roma, 00168, Italy

Location

Local Institution - 0030

Amsterdam, North Holland, 1066 CX, Netherlands

Location

Local Institution - 0018

Groningen, 9713 GZ, Netherlands

Location

Local Institution - 0015

Málaga, Andalusia, 29010, Spain

Location

Local Institution - 0013

Badalona, Barcelona [Barcelona], 08916, Spain

Location

Local Institution - 0012

Pamplona, Navarre, 31008, Spain

Location

Local Institution - 0014

Madrid, 28040, Spain

Location

Local Institution - 0011

Madrid, 28050, Spain

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Neoplasms; Carcinoma, Non-Small-Cell Lung; Triple Negative Breast Neoplasms

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Breast Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 5, 2023
• Study Start: June 6, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

IT (4); NL (2); ES (5); US (4); BE (2); FR (3)