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Active, Not Recruiting

First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Participants With Advanced Solid Tumors - CA022-001

Updated: 2 January, 2024   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
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/Phase 2

    Phase

  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Part 1A: Monotherapy (BMS-986218)
Biological: BMS-986218
Experimental: Part 1B: Combination Therapy (BMS-986218 + Nivolumab)
Biological: Nivolumab, BMS-986218
Experimental: Part 2A: Monotherapy (BMS-986218 OR Ipilimumab)
Biological: BMS-986218, Ipilimumab
Experimental: Part 2B: Monotherapy (BMS-986218)
Biological: BMS-986218
Experimental: Part 2C: Expansion Combination Therapy (BMS-986218 + Nivolumab)
Biological: Nivolumab, BMS-986218
Experimental: Part 2D: Expansion Combination Therapy (BMS-986218 + Nivolumab)
Biological: Nivolumab, BMS-986218

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) - Eastern Cooperative Oncology Group Performance Status of 0 or 1 - Participants must have received, and then progressed, relapsed, or been intolerant to at least 2 standard treatment regimens with proven survival benefit in the advanced or metastatic setting according to tumor type, if such a therapy exists - Advanced stage cutaneous melanoma who have received standard therapies with proven survival benefit including prior immunotherapy with an anti-programmed cell death 1 (anti-PD-1) or anti-programmed death ligand 1 (anti-PD-L1) (For Part 2A) - Non-small cell lung cancer (NSCLC) (adenocarcinoma or squamous cell carcinoma) who have received standard therapies with proven survival benefit including prior immunotherapy with an anti-PD-1 or anti-PD-L1 (For Parts 2B & 2C) - Microsatellite Stable Colorectal Cancer (MSS CRC) who have received standard therapies with proven survival benefit (Part 2D) Exclusion Criteria: - Participants with primary CNS malignancies, or tumors with CNS metastases as the only site of disease, will be excluded - Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy - Prior anti-cancer treatments such as chemotherapy, radiotherapy, hormonal, or immunotherapy (including anti-PD-1/PD-L1) are permitted Other protocol-defined inclusion/exclusion criteria apply

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