An Investigational Immunotherapy Study of BMS-986301 Alone or in Combination With Nivolumab, and Ipilimumab in Participants With Advanced Solid Cancers

About the study

The main purpose of this study is to characterize the safety, tolerability, dose limiting toxicities, best route of administration, maximum tolerated dose, maximum administered dose, or alternative dose of BMS-986301 alone or in combination with nivolumab and ipilimumab in participants with cancers that have failed to respond to T cell checkpoint inhibiting antibodies.

Who can take part

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

INCLUSION CRITERIA

Inclusion Criteria:

Histologically or cytologically confirmed advanced unresectable/metastatic malignancy of the squamous cell carcinoma of the head and neck (HNSCC), non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC), triple negative breast cancer (TNBC), and urothelial carcinoma (UCC), that are refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant
Must have experienced radiographically documented progressive disease on or after the most recent therapy
Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial

EXCLUSION CRITERIA

Exclusion Criteria:

Primary central nervous system (CNS) malignancy
Other active malignancy requiring concurrent intervention
Uncontrolled or significant cardiovascular disease

Other protocol defined inclusion/exclusion criteria apply

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.

Study’s details

Contition

Advanced Solid Cancers

Age (in years)

18+

Phase

Phase 1

Participants needed

190

Est. Completion Date

Nov 28, 2025

Treatment type

Interventional

Sponsor

Bristol-Myers Squibb

ClinicalTrials.gov identifier

NCT03956680

Study number

CA046006

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