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  • NCT03956680

Active, Not Recruiting

An Investigational Immunotherapy Study of BMS-986301 Alone or in Combination With Nivolumab, and Ipilimumab in Participants With Advanced Solid Cancers - CA046-006

Updated: 25 April, 2023   |   ClinicalTrials.gov

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CONSIDERING THIS TRIAL?
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Trial Details

  • Phase 1

    Phase

  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Part 1A Group 1: BMS-986301 Monotherapy Intramuscular (IM)
Drug: BMS-986301 Biological: Ipilimumab, Nivolumab
Experimental: Part 1A Group 2: BMS-986301 Monotherapy Intratumoral (I-TUMOR) Sub-study
Drug: BMS-986301 Biological: Ipilimumab, Nivolumab
Experimental: Part 1A Group 3: BMS-986301 Monotherapy Intravenous (IV) Sub-study
Drug: BMS-986301 Biological: Ipilimumab, Nivolumab
Experimental: Part 1B Group 4: Systemic BMS-986301 + Nivolumab + Ipilimumab
Drug: BMS-986301 Biological: Ipilimumab, Nivolumab
Experimental: Part 1B Group 5: I-TUMOR BMS-986301 + Nivolumab + Ipilimumab
Drug: BMS-986301 Biological: Ipilimumab, Nivolumab

Key Eligibility 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: - Primary central nervous system (CNS) malignancy - Other active malignancy requiring concurrent intervention - Uncontrolled or significant cardiovascular disease Other protocol defined inclusion/exclusion criteria apply

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