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BMS Active Not Yet Recruiting Study icon

Active, Not Recruiting

Trial ID CA034-001  |   NCT03363776

An Investigational Immuno-Therapy Study of Experimental Medication BMS-986277 Given Alone and in Combination With Nivolumab in Epithelial Cancers

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Sorry, this study is no longer accepting new participants, but is still ongoing.
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Summary

  • Phase 1/Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

The purpose of this study is to investigate experimental medication BMS-986277 given alone and in combination with Nivolumab in patients with epithelial cancers.

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Histological or cytological confirmation of metastatic and/or unresectable metastatic colorectal, prostate, pancreatic, breast, ovarian, or urothelial carcinoma with measureable disease for solid tumors per RECIST v1.1 and for prostate carcinoma per PCWG3 - Presence of at least 2 lesions: at least one with measurable disease as defined by RECIST v1.1 for solid tumors and by PCWG3 for prostate carcinoma for response assessment; at least 1 lesion must be accessible for biopsy in addition to the target lesion - Participants must have received, and then progressed or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting, if such a therapy exists, and have been considered for all other potentially efficacious therapies prior to enrollment - ECOG performance status less than or equal to 2 Exclusion Criteria: - Participants with active central nervous system (CNS) metastases, untreated CNS metastases, or with the CNS as the only site of disease - Participants with carcinomatous meningitis - Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study treatment - Participants with active, known, or suspected autoimmune disease Other protocol defined inclusion/exclusion criteria could apply

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Combination Dose Escalation Therapy

ASSIGNED INTERVENTION
  • Biological: Nivolumab Biological: BMS-986277

Study Arms

Experimental: Combination Expansion Therapy

ASSIGNED INTERVENTION
  • Biological: Nivolumab Biological: BMS-986277

Study Arms

Experimental: Monotherapy

ASSIGNED INTERVENTION
  • Biological: BMS-986277