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Recruiting

An Investigational Immuno-therapy Study of BMS-986207 Given Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Solid Cancers That Are Advanced or Have Spread - CA020-002

Updated: 10 May, 2021   |   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

  • 3

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Part 1A: Dose Escalation Monotherapy (BMS-986207)
Drug: BMS-986207
Experimental: Part 1B: Dose Escalation Combination Therapy (BMS-986207 + nivolumab)
Biological: Nivolumab Drug: BMS-986207
Experimental: Part 1C: Triplet Cohort (BMS-986207 + nivolumab + ipilimumab)
Biological: Ipilimumab Drug: BMS-986207 Biological: Nivolumab
Experimental: Part 2A: Expansion Monotherapy (BMS-986207)
Drug: BMS-986207
Experimental: Part 2B: Expansion Combination Therapy (BMS-986207 + nivolumab)
Biological: Nivolumab Drug: BMS-986207
Experimental: Part 2C: Triplet Expansion (BMS-986207 + nivolumab + ipilimumab)
Drug: BMS-986207 Biological: Ipilimumab Biological: Nivolumab

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Participant must consent for pretreatment and on treatment tumor biopsy samples - For Part 1C tumor biopsies are optional - Nonsmall cell lung cancer (NSCLC) without prior treatment in the advanced or metastatic setting (Part 2C) - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Must have received, and progressed or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting (Part 1A, 1B and 1C) - Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria; radiographic tumor assessment performed within 28 days before randomization Exclusion Criteria: - Primary central nervous system (CNS) disease, or tumors with CNS metastases as the only site of disease. Controlled brain metastases will be allowed to enroll - Other active malignancy requiring concurrent intervention - Uncontrolled/significant heart disease - History of chronic hepatitis [except for hepatocellular carcinoma (HCC)] - Active, known, or suspected autoimmune disease Other protocol defined inclusion/exclusion criteria apply

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