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

Updated: 1 December, 2020   |   ClinicalTrials.gov

Print Friendly Summary

Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1


  • Gender(s)

  • 18+

    Age Range

  • 5


  • Recruiting

Treatment Options

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

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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 could apply

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

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