A Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Bristol-Myers Squibb
Study ID
NCT03369223
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Advanced Cancer

Eligibility Criteria

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

Interventions

  • BMS-986249 — BIOLOGICAL
    Specified dose on specified days
  • Nivolumab — BIOLOGICAL
    Specified dose on specified days
  • Ipilimumab — BIOLOGICAL
    Specified dose on specified days

Study Details

The purpose of this study is to determine whether BMS-986249 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors

Key Dates

Start date
Dec 6, 2017
Status verified
Nov 2025
Primary completion
Nov 7, 2024
Completion
Nov 7, 2024

Study Design

Enrollment
356 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1A: BMS-986249
  • Experimental: Part 1B: BMS-986249 + nivolumab (nivo)
  • Experimental: Part 2A Arm C: BMS-986249 + nivo
    Previously untreated unresectable stage III-IV melanoma
  • Experimental: Part 2A Arm D: ipilimumab + nivo then nivo
    Previously untreated unresectable stage III-IV melanoma
  • Experimental: Part 2A Arm F: BMS-986249 + nivo
    Previously untreated unresectable stage III-IV melanoma
  • Experimental: Part 2B Cohort 1: BMS-986249 + nivo
    Advanced or intermediate hepatocellular carcinoma (HCC)
  • Experimental: Part 2B Cohort 2: BMS-986249 + nivo
    Metastatic castration-resistant prostate cancer (CRPC)
  • Experimental: Part 2B Cohort 3: BMS-986249 + nivo
    Unresectable locally advanced or metastatic triple-negative breast cancer (TNBC)
  • Experimental: Part 2A Arm A: BMS-986249 + nivo then nivo
    * Previously untreated unresectable stage III-IV melanoma * Enrollment is closed for this Arm
  • Experimental: Part 2A Arm B: BMS-986249 + nivo
    * Previously untreated unresectable stage III-IV melanoma * Enrollment is closed for this Arm
  • Experimental: Part 2A Arm E: Nivo
    * Previously untreated unresectable stage III-IV melanoma * Enrollment is closed for this Arm

Primary Outcome Measure

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) - Part 1 A and 1 B [ Time Frame: From first dose until 100 days after last dose of study therapy (up to approximately 38 weeks) ]

Locations (19)

FacilityCityStateZIPSite coordinators
Local Institution - 0005AuroraColorado80045-
Local Institution - 0006DenverColorado80218-
Local Institution - 0017MiamiFlorida33176-
Local Institution - 0024BaltimoreMaryland21287-
Local Institution - 0001HackensackNew Jersey07601-
Local Institution - 0002New YorkNew York10032-
Local Institution - 0003New YorkNew York10065-
Local Institution - 0029CincinnatiOhio45219-
Local Institution - 0013EugeneOregon97401-
Local Institution - 0004PhiladelphiaPennsylvania19104-
Local Institution - 0008GreenvilleSouth Carolina29605-
Local Institution - 0010AustinTexas78705-1165-
Local Institution - 0009DallasTexas75246-
Local Institution - 0021HoustonTexas77030-
Local Institution - 0016San AntonioTexas78240-
Local Institution - 0011TylerTexas75702-
Local Institution - 0012LeesburgVirginia20176-
Local Institution - 0007NorfolkVirginia23502-
Local Institution - 0018VancouverWashington98684-

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By research site
Local Institution - 0005· Aurora, COLocal Institution - 0006· Denver, COLocal Institution - 0017· Miami, FLLocal Institution - 0024· Baltimore, MDLocal Institution - 0001· Hackensack, NJLocal Institution - 0002· New York, NY

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