For Healthcare Professionals

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

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About the study

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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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION 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.

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

EXCLUSION CRITERIA

Exclusion Criteria:

  1. 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.
  2. 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.
  3. 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.

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 855-907-3286Email iconEmail Study Center

Study Details


Contition

Advanced Solid Tumors

Age

18+

Phase

PHASE1/PHASE2

Participants Needed

100

Est. Completion Date

Jul 1, 2027

Treatment Type

INTERVENTIONAL


Sponsor

Bristol-Myers Squibb

ClinicalTrials.gov NCT Identifier

NCT05888831

Study Number

CA120-1001

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