An Investigational Immunotherapy Study of BMS-986301 Alone or in Combination With Nivolumab, and Ipilimumab in Participants With Advanced Solid Cancers

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Bristol-Myers Squibb
Study ID
NCT03956680
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Cancers

Eligibility Criteria

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

Interventions

  • BMS-986301 — DRUG
    Specified dose on specified days
  • Nivolumab — BIOLOGICAL
    Specified dose on specified days
  • Ipilimumab — BIOLOGICAL
    Specified dose on specified days

Study Details

The main purpose of this study is to characterize the safety, tolerability, dose limiting toxicities, best route of administration, maximum tolerated dose, maximum administered dose, or alternative dose of BMS-986301 alone or in combination with nivolumab and ipilimumab in participants with cancers that have failed to respond to T cell checkpoint inhibiting antibodies.

Key Dates

Start date
Mar 26, 2019
Status verified
Feb 2025
Primary completion
Apr 17, 2024
Completion
Apr 24, 2024

Study Design

Enrollment
54 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1A Group 1: BMS-986301 Monotherapy Intramuscular (IM)
  • Experimental: Part 1A Group 2: BMS-986301 Monotherapy Intratumoral (I-TUMOR) Sub-study
  • Experimental: Part 1A Group 3: BMS-986301 Monotherapy Intravenous (IV) Sub-study
  • Experimental: Part 1B Group 4: Systemic BMS-986301 + Nivolumab + Ipilimumab
  • Experimental: Part 1B Group 5: I-TUMOR BMS-986301 + Nivolumab + Ipilimumab

Primary Outcome Measure

Incidence of dose-limiting toxicity (DLTs) [ Time Frame: Cycle 1 (28 days) ]

Locations (4)

FacilityCityStateZIPSite coordinators
Local Institution - 0003ChicagoIllinois60637-
Local Institution - 0005St LouisMissouri63110-
Local Institution - 0006PittsburghPennsylvania15232-1305-
Local Institution - 0002NashvilleTennessee37232-

Find similar trials in Chicago, IL

By research site
Local Institution - 0003· Chicago, ILLocal Institution - 0005· St Louis, MOLocal Institution - 0006· Pittsburgh, PALocal Institution - 0002· Nashville, TN

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