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

Sponsor: Bristol-Myers Squibb

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03400332

Patient View

This study evaluates BMS-986253 with Nivolumab or Nivolumab plus Ipilimumab in advanced solid tumors. Eligible participants must have a confirmed advanced solid tumor, measurable disease per RECIST v1.1, at least one biopsy-accessible lesion, and an ECOG status of 0 or 1. Interventions include specified doses of BMS-986253, Nivolumab, Ipilimumab, or a placebo.

Patient Parameters

Program Overview

The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.

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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