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Active, Not Recruiting

A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers - CA027-002

Updated: 15 July, 2024   |   ClinicalTrials.gov

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CONSIDERING THIS TRIAL?
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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/Phase 2

    Phase

  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Part 1A: BMS-986253 + nivolumab
Drug: BMS-986253 Biological: Nivolumab
Experimental: Part 1B: BMS-986253 + nivolumab
Drug: BMS-986253 Biological: Nivolumab
Experimental: Part 1C: BMS-986253 + nivolumab + ipilimumab
Drug: BMS-986253 Biological: Nivolumab, Ipilimumab
Experimental: Part 2A: BMS-986253 + nivolumab + ipilimumab
Drug: BMS-986253 Biological: Nivolumab, Ipilimumab
Placebo Comparator: Part 2B: Placebo + nivolumab + ipilimumab
Biological: Nivolumab, Ipilimumab Other: Placebo

Key Eligibility Criteria

Inclusion Criteria: - Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1 - At least 1 lesion accessible for biopsy - Eastern Cooperative Oncology Group Performance Status of 0 or 1 Exclusion Criteria: - Participants with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll) - Participants with active, known or suspected autoimmune disease - Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration - Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS) - Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy Other protocol defined inclusion/exclusion criteria could apply

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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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