A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following Nephrectomy

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Hoffmann-La Roche
Study ID
NCT03024996
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Atezolizumab 1200 mg IV infusion q3w
  • Placebo — OTHER
    Placebo matching to atezolizumab q3w

Study Details

This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of atezolizumab versus placebo in participants with RCC who are at high risk of disease recurrence following nephrectomy.

Key Dates

Start date
Jan 3, 2017
Status verified
Jul 2023
Primary completion
May 3, 2022
Completion
Dec 8, 2022

Study Design

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

Arms

  • Experimental: Atezolizumab
    Participants will receive atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurs first).
  • Placebo Comparator: Placebo
    Participants will receive placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurs first).

Primary Outcome Measure

Investigator-assessed Disease-Free Survival (DFS) [ Time Frame: From baseline up to first occurence of event by investigator assessment (up to approximately 64 months) ]

Locations (45)

FacilityCityStateZIPSite coordinators
Mayo Clinic- ScottsdaleScottsdaleArizona85259-
City of Hope National Medical CenterDuarteCalifornia91010-
City of Hope, Antelope ValleyLancasterCalifornia93534-
UCLA Urology; UrologyLos AngelesCalifornia--
University of California Irvine Medical CenterOrangeCalifornia92868-
City of Hope-South PasadenaSouth PasadenaCalifornia91030-
City of Hope; UplandUplandCalifornia91786-
University of Colorado Cancer CenterAuroraColorado80045-
Yale School of MedicineNew HavenConnecticut06510-
Florida Cancer Specialists-Broadway, Fort MyersFort MyersFlorida33908-
University of FloridaGainesvilleFlorida32607-
Univ of Miami, School of Med; Hem/OncMiamiFlorida33136-
Moffitt Cancer CenterTampaFlorida33612-
Emory Uni - Winship Cancer Center; Hematology/OncologyAtlantaGeorgia30322-
The University of Chicago Biological Sciences; Dept. of Medicine, Section of Hematology/OncologyChicagoIllinois60637-
Loyola University Medical Center, Cardinal Bernardin Cancer CenterMaywoodIllinois60151-
Norton Cancer InstituteLouisvilleKentucky40202-
Ochsner Clinic FoundationNew OrleansLouisiana70121-
Tulane Uni Health Sciences CenterNew OrleansLouisiana70112-
Chesapeake Urology Research AssociatesTowsonMaryland21204-
Mayo Clinic - RochesterRochesterMinnesota55905-
Garden State UrologyWhippanyNew Jersey--
New York Oncology Hematology at Albany Medical CenterAlbanyNew York12208-
Bellevue HospitalNew YorkNew York10016-
Laura and ISAAC Perlmutter Cancer Center at NYU Langone.New YorkNew York10016-
Mount SInai Medical CenterNew YorkNew York10029-
University of Rochester Medical Center; UrologyRochesterNew York14642-
SUNY Upstate Medical UniversitySyracuseNew York13210-
University of North Carolina at Chapel HillChapel HillNorth Carolina27514-
Levine Cancer InstituteCharlotteNorth Carolina28204-
Cleveland Clinic Foundation; Hematology and OncologyClevelandOhio44195-
Fairview Hospital; Cleveland Clinic Cancer CenterClevelandOhio44111-
Hillcrest Hospital; Hirsch Cancer CenterMayfield HeightsOhio44124-
University of Oklahoma; Stephenson Oklahoma Canc CtrOklahoma CityOklahoma73104-
Oregon Health & Science UniPortlandOregon97239-
Fox Chase Cancer Center; Hematology/OncologyPhiladelphiaPennsylvania19111-
Sanford Cancer Cnt Onco ClinicSioux FallsSouth Dakota57104-
Erlanger Health SystemsChattanoogaTennessee37403-
Urology Associates of Kingsport, P.C.KingsportTennessee37660-
Sarah Cannon Research InstituteNashvilleTennessee37203-
Vanderbilt University Medical Center; Vanderbilt UniversityNashvilleTennessee37232-
University of Texas Southwestern Medical CenterDallasTexas75390-
MD Anderson Cancer CenterHoustonTexas77030-4095-
University of Utah; Huntsman Cancer HospitalSalt Lake CityUtah84112-
West Virginia University Hospitals IncMorgantownWest Virginia26056-

Find similar trials in Scottsdale, AZ

By condition
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By specialty
OncologyUrology
By research site
Mayo Clinic- Scottsdale· Scottsdale, AZCity of Hope National Medical Center· Duarte, CACity of Hope, Antelope Valley· Lancaster, CAUCLA Urology; Urology· Los Angeles, CAUniversity of California Irvine Medical Center· Orange, CACity of Hope-South Pasadena· South Pasadena, CA

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