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

Description

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

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Study Overview

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Study Details

Study overview

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.

A Phase 1/2 Study of BMS-986449 Alone and in Combination With Nivolumab in Participants With Advanced Solid Tumors

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

Condition
Advanced Solid Tumors
Intervention / Treatment

-

Contacts and Locations

Los Angeles

The Angeles Clinic and Research Institute - West Los Angeles Office, Los Angeles, California, United States, 90025

New Haven

Yale New Haven Hospital-Smilow Cancer Center, New Haven, Connecticut, United States, 06510

Hackensack

Hackensack University Medical Center, Hackensack, New Jersey, United States, 07601

Hackensack

John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States, 07601

Lake Success

Northwell Health/ RJ Zuckerberg Cancer Center, Lake Success, New York, United States, 11042

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Bristol-Myers Squibb,

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2027-07-01