Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Nektar Therapeutics
Study ID
NCT04410445
Phase
PHASE3
Status
Terminated

Conditions

  • Melanoma
  • Melanoma (Skin)
  • Melanoma Stage III
  • Melanoma Stage IV

Eligibility Criteria

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

Interventions

  • Bempegaldesleukin — BIOLOGICAL
    Specified dose on specified days
  • Nivolumab — BIOLOGICAL
    Specified dose on specified days

Study Details

The main purpose of this study is to compare the efficacy of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIA/B/C/D, or Stage IV cutaneous melanoma who are at high risk for recurrence.

Key Dates

Start date
Jul 27, 2020
Status verified
Mar 2023
Primary completion
Sep 22, 2022
Completion
Sep 22, 2022

Study Design

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

Arms

  • Experimental: Combination of bempegaldesleukin (NKTR-214) + nivolumab
    Arm A: Participants will receive bempegaldesleukin (NKTR-214) IV in combination with nivolumab every 3 weeks.
  • Active Comparator: Nivolumab
    Arm B: Participants will receive nivolumab IV alone every 4 weeks.

Primary Outcome Measure

Recurrence-free Survival (RFS) by Blinded Independent Central Review (BICR) of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone. [ Time Frame: Up to 21 months ]

Locations (62)

FacilityCityStateZIPSite coordinators
Honor HealthScottsdaleArizona85258-
Banner MD Anderson Cancer CenterLittle RockArkansas72205-
Kaiser Foundation Hospital, Inpatient PharmacyAnaheimCalifornia92805-
Kaiser PermanenteFontanaCalifornia92335-
St. Joseph Heritage HealthcareFullertonCalifornia92835-
Hematology Oncology Medical Group of Orange County, Inc.OrangeCalifornia92868-
University of California IrvineOrangeCalifornia92868-
Emad Ibrahim, MD, IncRedlandsCalifornia92373-
Kaiser PermanenteRiversideCalifornia92505-
Southern California Permanente Medical GroupRiversideCalifornia92505-
San Francisco Oncology AssociatesSan FranciscoCalifornia94115-
California Cancer Associates for Research and ExcellenceSan MarcosCalifornia92069-
Kaiser PermanenteSan MarcosCalifornia92078-
Angeles Clinic and Research InstituteSanta MonicaCalifornia90404-
John Wayne Cancer InstituteSanta MonicaCalifornia90404-
Rocky Mountain Cancer Centers (Littleton) - USORAuroraColorado80012-
University of Colorado - Cancer Center - PPDSAuroraColorado80045-
MedStar Georgetown University HospitalWashington D.C.District of Columbia20007-
Orlando Health Cancer InstituteLongwoodFlorida32750-
Rush University Medical CenterChicagoIllinois60612-
Goshen Center For Cancer CareGoshenIndiana46526-
University of KentuckyLexingtonKentucky40536-
Ochsner Clinic FoundationNew OrleansLouisiana70121-
Massachusetts General HospitalBostonMassachusetts02114-
Mayo Clinic - PINRochesterMinnesota55905-
Washington University School of MedicineSt LouisMissouri63110-
Frontier Cancer Center and Blood InstituteBillingsMontana59102-
Nebraska Cancer SpecialistsOmahaNebraska68130-
Nebraska Methodist HospitalOmahaNebraska68130-
University of Nebraska Medical CenterOmahaNebraska68198-
Hackensack University Medical CenterHackensackNew Jersey07601-
Atlantic Health SystemMorristownNew Jersey07960-
Columbia University Medical Center - PINNew YorkNew York10021-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
NYU Langone Medical CenterNew YorkNew York10016-
University of North Carolina at Chapel HillChapel HillNorth Carolina32750-
Duke Cancer InstituteDurhamNorth Carolina27710-
The Cleveland Clinic FoundationClevelandOhio44195-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
Oregon Health and Science UniversityPortlandOregon97216-
Providence Cancer Institute, Franz ClinicPortlandOregon97213-
Lehigh Valley Physician Group (LVPG) - Hematology OncologyAllentownPennsylvania18103-
Penn State Milton S Hershey Medical CenterHersheyPennsylvania17033-
Jefferson University HospitalPhiladelphiaPennsylvania19107-
H Lee Moffitt Cancer Center and Research InstitutePittsburghPennsylvania15232-
Hillman Cancer CenterPittsburghPennsylvania15232-
Prisma Health Cancer InstituteGreenvilleSouth Carolina29605-
SCRI Tennessee Oncology ChattanoogaChattanoogaTennessee37404-
University of Tennessee Medical CenterKnoxvilleTennessee37920-
SCRI Tennessee Oncology NashvilleNashvilleTennessee37203-
Vanderbilt University Medical CenterNashvilleTennessee37232-
Department of Pharmacy Investigational Drug ServicesDallasTexas75235-
Texas Oncology (Loop) - USORDallasTexas75246-
University of Texas Southwestern Medical CenterDallasTexas75390-
MD Anderson Cancer CenterHoustonTexas77030-
Utah Cancer Specialists (Salt Lake City)Salt Lake CityUtah90603-
University of Virginia Cancer CenterCharlottesvilleVirginia22903-
Inova Schar Cancer InstituteFairfaxVirginia22031-
Blue Ridge Cancer Care - USORRoanokeVirginia24014-
Seattle Cancer Care AllianceSeattleWashington98109-
Northwest Medical SpecialtiesTacomaWashington98405-
University of WisconsinMadisonWisconsin53792-

Find similar trials in Scottsdale, AZ

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Honor Health· Scottsdale, AZBanner MD Anderson Cancer Center· Little Rock, ARKaiser Foundation Hospital, Inpatient Pharmacy· Anaheim, CAKaiser Permanente· Fontana, CASt. Joseph Heritage Healthcare· Fullerton, CAHematology Oncology Medical Group of Orange County, Inc.· Orange, CA

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