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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Bristol-Myers Squibb
Study ID
NCT05407675
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BMS-986408 — DRUG
    Specified dose on specified days
  • Nivolumab — BIOLOGICAL
    Specified dose on specified days
  • Ipilimumab — BIOLOGICAL
    Specified dose on specified days
  • Platinum-doublet chemotherapy — BIOLOGICAL
    Specified dose on specified days
  • Rabeprazole — DRUG
    Specified dose on specified days

Study Details

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 Dates

Start date
Aug 2, 2022
Status verified
Sep 2025
Primary completion
Aug 22, 2024
Completion
Jul 24, 2025

Study Design

Enrollment
68 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: BMS-986408 Monotherapy
  • Experimental: Part 2: BMS-986408 in combination with nivolumab
  • Experimental: Part 2: BMS-986408 in combination with nivolumab and ipilimumab
  • Experimental: Part 2: BMS-986408 in combination with nivolumab and chemotherapy
  • Experimental: Part 2: BMS-986408 in combination with rabeprazole
  • Experimental: Part 3: BMS-986408 in combination with nivolumab
  • Experimental: Part 3: BMS-986408 in combination with nivolumab and chemotherapy

Primary Outcome Measure

Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: From first dose (Day 1) till 28 days ]

Locations (3)

FacilityCityStateZIPSite coordinators
Local Institution - 0010BostonMassachusetts02215-
Local Institution - 0001HackensackNew Jersey07601-
Local Institution - 0003HoustonTexas77030-

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Local Institution - 0010· Boston, MALocal Institution - 0001· Hackensack, NJLocal Institution - 0003· Houston, TX

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