An Investigational Immuno-therapy Study of BMS-986205 Combined With Nivolumab, Compared to Nivolumab by Itself, in Patients With Advanced Melanoma

Part of paid clinical trials in Los Angeles, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT03329846
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • BMS-986205 — DRUG
    specified dose on specified day
  • Nivolumab — BIOLOGICAL
    Specified dose on specified day
  • Placebo — DRUG
    Specified dose on specified day

Study Details

The purpose of this study is to see if BMS-986205 combined with nivolumab, compared to nivolumab by itself, is more effective in treating Melanoma that has spread or is unable to be removed by surgery, and has not previously been treated

Key Dates

Start date
Nov 30, 2017
Status verified
Jun 2021
Primary completion
Jul 2, 2020
Completion
Jul 2, 2020

Study Design

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

Arms

  • Active Comparator: Nivolumab + Placebo
    Specified dose on specified day Participants will no longer receive BMS-986205 Placebo
  • Experimental: Nivolumab + BMS-986205
    Specified dose on specified day. Participants have the option to discontinue BMS-986205, and continue nivolumab monotherapy, at investigator discretion

Primary Outcome Measure

Number of Participants Experiencing Adverse Events [ Time Frame: From first dose to 30 days following last dose (up to approximately 25 months) ]

Locations (6)

FacilityCityStateZIPSite coordinators
Angeles Clinic and Research InstituteLos AngelesCalifornia90025-
University Of ColoradoAuroraColorado80045-
Mount Sinai Comprehensive Cancer CenterMiami BeachFlorida33140-
University Of ChicagoChicagoIllinois60637-
Oregon Health & Science UniversityPortlandOregon97239-
Local InstitutionSeattleWashington98109-

Find similar trials in Los Angeles, CA

By condition
MelanomaSkin cancer
By specialty
OncologySkin cancerDermatology
By research site
Angeles Clinic and Research Institute· Los Angeles, CAUniversity Of Colorado· Aurora, COMount Sinai Comprehensive Cancer Center· Miami Beach, FLUniversity Of Chicago· Chicago, ILOregon Health & Science University· Portland, ORLocal Institution· Seattle, WA

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