A Study of BMS-986416 With and Without Nivolumab in Select Solid Tumors

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Bristol-Myers Squibb
Study ID
NCT04943900
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

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

Interventions

  • BMS-986416 — DRUG
    Specified dose on specified days
  • Nivolumab — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to evaluate the safety, tolerability, drug effects, drug levels and preliminary antitumor activity of BMS-986416 when administered alone and in combination with Nivolumab in participants with select advanced solid tumors.

Key Dates

Start date
Aug 9, 2021
Status verified
Apr 2025
Primary completion
Feb 27, 2025
Completion
Feb 27, 2025

Study Design

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

Arms

  • Experimental: Part 1A: Monotherapy (BMS-986416)
  • Experimental: Part 1B: Combination Therapy (BMS-986416 + Nivolumab)

Primary Outcome Measure

Incidence of Adverse Events (AEs) [ Time Frame: Up to 100 days after the last treatment of study intervention(s) ]

Locations (6)

FacilityCityStateZIPSite coordinators
Local Institution - 0006AtlantaGeorgia30322-
Local Institution - 0005BaltimoreMaryland21287-
Local Institution - 0002HackensackNew Jersey07601-
Local Institution - 0013ClevelandOhio44106-1716-
Local Institution - 0003PittsburghPennsylvania15232-
Local Institution - 0004HoustonTexas77030-

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