An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread

Part of paid clinical trials in Los Angeles, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT03446040
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Advanced Cancer

Eligibility Criteria

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

Interventions

  • BMS-986258 — BIOLOGICAL
    Specified dose on specified days
  • Nivolumab — BIOLOGICAL
    Specified dose on specified days
  • rHuPH20 — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to determine whether BMS-986258 both monotherapy and in combination with Nivolumab is safe and tolerable in the treatment of advanced malignant tumors.

Key Dates

Start date
Mar 8, 2018
Status verified
Aug 2025
Primary completion
Aug 29, 2024
Completion
Aug 29, 2024

Study Design

Enrollment
92 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A Dose Escalation: BMS-986258
  • Experimental: Part A1: BMS-986258 + Recombinant human hyaluronidase PH20 (rHuPH20)
  • Experimental: Part B Dose Escalation: BMS-986258 + nivolumab
  • Experimental: Part C Cohort Expansion: BMS-986258 + nivolumab

Primary Outcome Measure

Number of Participants With Adverse Events (AEs) [ Time Frame: From first dose until 100 days after last dose of study therapy (up to approximately 78 weeks) ]

Locations (10)

FacilityCityStateZIPSite coordinators
Local Institution - 0004Los AngelesCalifornia90033-
Local Institution - 0006Los AngelesCalifornia90033-
Local Institution - 0007AuroraColorado80045-
University Of Iowa Hospitals And ClinicsIowa CityIowa52242-
Local Institution - 0018Ann ArborMichigan48109-5912-
Local Institution - 0010Grand RapidsMichigan49546-
Local Institution - 0012LebanonNew Hampshire03756-
Local Institution - 0016CincinnatiOhio45267-
Local Institution - 0005PittsburghPennsylvania15232-
Local Institution - 0002GermantownTennessee38138-

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Local Institution - 0004· Los Angeles, CALocal Institution - 0006· Los Angeles, CALocal Institution - 0007· Aurora, COUniversity Of Iowa Hospitals And Clinics· Iowa City, IALocal Institution - 0018· Ann Arbor, MILocal Institution - 0010· Grand Rapids, MI

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