First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Participants With Advanced Solid Tumors

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Bristol-Myers Squibb
Study ID
NCT03110107
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Advanced Cancer

Eligibility Criteria

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

Interventions

  • Ipilimumab — BIOLOGICAL
    Specified dose on specified days
  • BMS-986218 — BIOLOGICAL
    Specified dose on specified days
  • Nivolumab — BIOLOGICAL
    Specified dose on specified days

Study Details

The purpose of this study is to determine whether BMS-986218 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors.

Key Dates

Start date
May 4, 2017
Status verified
Apr 2025
Primary completion
Apr 4, 2024
Completion
Apr 4, 2024

Study Design

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

Arms

  • Experimental: Part 1A: Monotherapy (BMS-986218)
  • Experimental: Part 1B: Combination Therapy (BMS-986218 + Nivolumab)
  • Experimental: Part 2A: Monotherapy (BMS-986218 OR Ipilimumab)
  • Experimental: Part 2B: Monotherapy (BMS-986218)
  • Experimental: Part 2C: Expansion Combination Therapy (BMS-986218 + Nivolumab)
  • Experimental: Part 2D: Expansion Combination Therapy (BMS-986218 + Nivolumab)

Primary Outcome Measure

Number of Participants With Adverse Events (AEs) [ Time Frame: From first dose of study medication through 100 days following last dose of study treatment (assessed for an average of 8 months up to a max of approximately 28 months) ]

Locations (9)

FacilityCityStateZIPSite coordinators
Local Institution - 0058AtlantaGeorgia30342-
Local Institution - 0025BostonMassachusetts02215-
Local Institution - 0002HackensackNew Jersey07601-
Local Institution - 0028New BrunswickNew Jersey08009-
Local Institution - 0001New YorkNew York10032-
Local Institution - 0007New YorkNew York10065-
Local Institution - 0015MonroevillePennsylvania15146-
Local Institution - 0004PhiladelphiaPennsylvania19104-
Local Institution - 0033Sioux FallsSouth Dakota57104-

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By research site
Local Institution - 0058· Atlanta, GALocal Institution - 0025· Boston, MALocal Institution - 0002· Hackensack, NJLocal Institution - 0028· New Brunswick, NJLocal Institution - 0001· New York, NYLocal Institution - 0007· New York, NY

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