Overview

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

Status:
Not yet recruiting
Trial end date:
2027-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bristol-Myers Squibb
Treatments:
Nivolumab
Criteria
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.