An Investigational Immuno-therapy Study of Nivolumab Combined With Ipilimumab Compared to Nivolumab by Itself After Complete Surgical Removal of Stage IIIb/c/d or Stage IV Melanoma

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Bristol-Myers Squibb
Study ID
NCT03068455
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • 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 an investigational immunotherapy Nivolumab, when combined with Ipilimumab, is more effective than Nivolumab by itself, in delaying the return of cancer in patients who have had a complete surgical removal of stage IIIb/c/d or stage IV Melanoma

Key Dates

Start date
Apr 11, 2017
Status verified
Aug 2021
Primary completion
Jun 12, 2020
Completion
Feb 2, 2021

Study Design

Enrollment
1,844 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: nivolumab + ipilimumab
    Specified Dose on Specified Days
  • Experimental: nivolumab
    Specified Dose on Specified Days

Primary Outcome Measure

Recurrence-free Survival (RFS) - All Randomized Participants [ Time Frame: From randomization to Primary Completion Date (up to approximately 3 years) ]

Locations (33)

FacilityCityStateZIPSite coordinators
University of Arizona Cancer CenterTucsonArizona85724-
The Angeles Clinic & Research InstituteLos AngelesCalifornia90025-
California Pacific Medical CenterSan FranciscoCalifornia94115-
University Of ColoradoAuroraColorado80045-
Georgetown University Med CtrWashington D.C.District of Columbia20007-
Mount Sinai Comprehensive Cancer CenterMiami BeachFlorida33140-
UF Health Cancer Center at Orlando HealthOrlandoFlorida32806-
H. Lee Moffitt Cancer CenterTampaFlorida33612-
Winship Cancer InstituteAtlantaGeorgia30322-
Northwestern UniversityChicagoIllinois60611-
University Of ChicagoChicagoIllinois19123-
Oncology Specialists, S.C.Park RidgeIllinois60068-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Mass General HospitalBostonMassachusetts02114-
University Of Michigan Health SystemAnn ArborMichigan48109-5848-
Virginia Piper Cancer InstituteMinneapolisMinnesota55407-
Mayo Clinic RochesterRochesterMinnesota55905-
Washington University School Of MedicineSt LouisMissouri63110-
Memorial Sloan Kettering NassauNew YorkNew York10065-
NYU Langone Medical CenterNew YorkNew York10016-
Carolinas Med CtrCharlotteNorth Carolina28204-
Duke University Medical CenterDurhamNorth Carolina27710-
Oregon Health & Science UniversityPortlandOregon97239-
Providence Cancer Center Oncology And Hematology CarePortlandOregon97213-
St. Luke's University Health NetworkEastonPennsylvania18045-
Local InstitutionNashvilleTennessee37232-
Texas Oncology Sammons Cancer CenterDallasTexas75246-
Md Anderson Can CntHoustonTexas77030-4009-
Huntsman Cancer InstituteSalt Lake CityUtah84112-
University Of Virginia Health SystemCharlottesvilleVirginia22908-
Inova Melanoma and Skin Cancer CenterFairfaxVirginia55905-
University Of Washington Cancer Care AllianceSeattleWashington98109-1023-

Find similar trials in Tucson, AZ

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
University of Arizona Cancer Center· Tucson, AZThe Angeles Clinic & Research Institute· Los Angeles, CACalifornia Pacific Medical Center· San Francisco, CAUniversity Of Colorado· Aurora, COGeorgetown University Med Ctr· Washington D.C., DCMount Sinai Comprehensive Cancer Center· Miami Beach, FL

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