Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT04099251
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — BIOLOGICAL
    Specified dose on specified days
  • Placebo — OTHER
    Specified dose on specified days

Study Details

The purpose of this study is to determine the effectiveness of nivolumab adjuvant immunotherapy compared to placebo in adults and pediatric participants after complete resection of Stage IIB/C melanoma with no evidence of disease (NED) who are at high risk for recurrence.

Key Dates

Start date
Oct 28, 2019
Status verified
Mar 2026
Primary completion
Jun 28, 2022
Completion
Jun 29, 2027

Study Design

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

Arms

  • Experimental: Nivolumab
  • Placebo Comparator: Placebo

Primary Outcome Measure

Recurrence Free Survival (RFS) [ Time Frame: From randomization up to the date of first recurrence, new primary melanoma, or death (whatever the cause), whichever occurs first (up to 32 months) ]

Locations (32)

FacilityCityStateZIPSite coordinators
Local Institution - 0088BirminghamAlabama35294-3300-
Local Institution - 0126TucsonArizona85724-5024-
Local Institution - 0087SpringdaleArkansas72762-
Local Institution - 0080Los AngelesCalifornia90025-
Local Institution - 0077San FranciscoCalifornia94115-
Local Institution - 0119San FranciscoCalifornia94115-
Local Institution - 0122San JoseCalifornia95119-
Local Institution - 0109VallejoCalifornia94589-
Local Institution - 0120VallejoCalifornia94589-
Local Institution - 0121VallejoCalifornia94589-2441-
Local Institution - 0091AuroraColorado80045-
Local Institution - 0089Washington D.C.District of Columbia20057-
Local Institution - 0141AtlantaGeorgia30342-
Local Institution - 0132ChicagoIllinois60611-
Local Institution - 0135BaltimoreMaryland21237-
Local Institution - 0078BostonMassachusetts02215-
Local Institution - 0127BostonMassachusetts02215-
Local Institution - 0143BostonMassachusetts02215-
Local Institution - 0151MinneapolisMinnesota55407-
Local Institution - 0081RobbinsdaleMinnesota55407-
Local Institution - 0079OmahaNebraska68130-
Local Institution - 0093HackensackNew Jersey07601-
Local Institution - 0094New YorkNew York10016-
Local Institution - 0086CharlotteNorth Carolina28204-
Local Institution - 0099ClevelandOhio44195-
Local Institution - 0076PortlandOregon97213-
Local Institution - 0092AllentownPennsylvania18103-
Local Institution - 0031PittsburghPennsylvania15232-
Local Institution - 0148GermantownTennessee38138-
Local Institution - 0144AustinTexas78731-
Local Institution - 0085DallasTexas75246-
Local Institution - 0090FairfaxVirginia22031-

Find similar trials in Birmingham, AL

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Local Institution - 0088· Birmingham, ALLocal Institution - 0126· Tucson, AZLocal Institution - 0087· Springdale, ARLocal Institution - 0080· Los Angeles, CALocal Institution - 0077· San Francisco, CALocal Institution - 0119· San Francisco, CA

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