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BMS Active Not Yet Recruiting Study icon

Active, Not Recruiting

Trial ID CA099-003  |   NCT05407675

A Study to Evaluate the Safety and Tolerability of BMS-986408 Alone and in Combination With Nivolumab or Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors

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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 primary purpose of this study is to characterize the safety profile of BMS-986408 as monotherapy and in combination with nivolumab or nivolumab and ipilimumab to establish the maximum tolerated dose (MTD). The Recommended Phase 2 Dose (RP2D) that optimizes the pharmacokinetic/pharmacodynamic (PK/PD) relationship of BMS-986408 will also be determined.

Key Eligibility Criteria

Inclusion Criteria: - Participants with a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy of any histology measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 - Participants who have received, been refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant - Participants with melanoma should have documentation of mutation status for B-type Raf proto-oncogene (BRAF) and neuroblastoma ras viral oncogene homolog (NRAS) - Participants must have experienced radiographically documented progressive disease on or after the most recent therapy Exclusion Criteria: - An active, known or suspected autoimmune disease - Conditions requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment - Current or recent gastrointestinal disease or gastrointestinal surgery that could impact the absorption of study drug - Untreated central nervous system (CNS) metastases or leptomeningeal metastasis Other protocol-defined inclusion/exclusion criteria apply

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Part 1: BMS-986408 Monotherapy

ASSIGNED INTERVENTION
  • Drug: BMS-986408

Study Arms

Experimental: Part 2: BMS-986408 in combination with nivolumab

ASSIGNED INTERVENTION
  • Biological: Nivolumab
  • Drug: BMS-986408

Study Arms

Experimental: Part 2: BMS-986408 in combination with nivolumab and chemotherapy

ASSIGNED INTERVENTION
  • Biological: Platinum-doublet chemotherapy, Nivolumab
  • Drug: BMS-986408

Study Arms

Experimental: Part 2: BMS-986408 in combination with nivolumab and ipilimumab

ASSIGNED INTERVENTION
  • Drug: BMS-986408
  • Biological: Ipilimumab, Nivolumab

Study Arms

Experimental: Part 2: BMS-986408 in combination with rabeprazole

ASSIGNED INTERVENTION
  • Drug: BMS-986408, Rabeprazole

Study Arms

Experimental: Part 3: BMS-986408 in combination with nivolumab

ASSIGNED INTERVENTION
  • Biological: Nivolumab
  • Drug: BMS-986408

Study Arms

Experimental: Part 3: BMS-986408 in combination with nivolumab and chemotherapy

ASSIGNED INTERVENTION
  • Biological: Platinum-doublet chemotherapy, Nivolumab
  • Drug: BMS-986408

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