ACTIVE_NOT_RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-06-06

Study Completion:2026-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05888831

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Principal Investigator

Bristol-Myers Squibb

STUDY_DIRECTOR

Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 0021

Los Angeles, California, 90025

United States

Local Institution - 0007

New Haven, Connecticut, 06510

United States

Local Institution - 0010

Hackensack, New Jersey, 07601

United States

Local Institution - 0022

Lake Success, New York, 11042

United States

Collaborators and Investigators

Sponsor: Bristol-Myers Squibb

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-06

Study Completion Date2026-09-30

Study Record Updates

Study Start Date2023-06-06

Study Completion Date2026-09-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Advanced Solid Tumors