A Study of Atezolizumab in Combination With Bevacizumab Versus Sunitinib in Participants With Untreated Advanced Renal Cell Carcinoma (RCC)

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Hoffmann-La Roche
Study ID
NCT02420821
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody — DRUG
    Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg) via intravenous (IV) infusion on Days 1 and 22 of each 42-day cycle.
  • Bevacizumab — DRUG
    Bevacizumab will be administered at a dose of 15 milligrams per kilogram (mg/kg) via IV infusion on Days 1 and 22 of each 42-day cycle.
  • Sunitinib — DRUG
    Sunitinib will be administered at a dose of 50 mg once daily, orally via capsule, on Day 1 through Day 28 of each 42-day cycle.

Study Details

This multi-center, randomized, open-label study will evaluate the efficacy and safety of atezolizumab plus bevacizumab versus sunitinib in participants with inoperable, locally advanced, or metastatic RCC who have not received prior systemic active or experimental therapy, either in the adjuvant or metastatic setting.

Key Dates

Start date
May 20, 2015
Status verified
Jan 2023
Primary completion
Feb 14, 2020
Completion
Dec 13, 2021

Study Design

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

Arms

  • Experimental: Atezolizumab + Bevacizumab
    Participants will receive both atezolizumab and bevacizumab until loss of clinical benefit, unacceptable toxicity or symptomatic deterioration attributed to disease progression, withdrawal of consent, or death, whichever occurs first.
  • Active Comparator: Sunitinib
    Participants will receive sunitinib until loss of clinical benefit, unacceptable toxicity or symptomatic deterioration attributed to disease progression, withdrawal of consent, or death, whichever occurs first.

Primary Outcome Measure

Percentage of Participants With Disease Progression as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death From Any Cause in Programmed Death-Ligand 1 (PD-L1)-Selected Population [ Time Frame: Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) ]

Locations (28)

FacilityCityStateZIPSite coordinators
University of Arizona Cancer CenterTucsonArizona85719-
University of California at Irvine Medical Center; Department of OncologyOrangeCalifornia92868-
University of CaliforniaSan FranciscoCalifornia94158-
University of Colorado; Anschutz Cancer PavilionAuroraColorado80045-
Rocky Mountain Cancer Center; Medical OncologyBoulderColorado80303-
Georgetown U; Lombardi Comp CanWashington D.C.District of Columbia20016-1468-
Lynn Cancer Institute/Boca Raton Regional HospitalBoca RatonFlorida33486-
Florida Cancer Specialists - Port CharlottePort CharlotteFlorida33980-
Florida Cancer Specialist, North RegionSt. PetersburgFlorida33705-
Piedmont Cancer Institute, PCAtlantaGeorgia30318-
The University of ChicagoChicagoIllinois60637-
Norton Cancer InstituteLouisvilleKentucky40202-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana Farber Cancer Inst.BostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02114-
Comprehensive Cancer Centers of Nevada - Eastern AvenueLas VegasNevada89169-
Hackensack University Medical CenterHackensackNew Jersey07601-
New York Oncology Hematology,P.C.-AlbanyAlbanyNew York12208-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
Oncology Hematology Care IncCincinnatiOhio45242-
Cleveland Clinic Foundation; Taussig Cancer CenterClevelandOhio44195-
Northwest Cancer Specialists, P.C.TigardOregon97223-
SCRI Tennessee Oncology ChattanoogaChattanoogaTennessee37404-
Sarah Cannon Cancer Center and Research InstituteNashvilleTennessee37203-
Vanderbilt Univ Medical CtrNashvilleTennessee37232-
Texas Oncology-Baylor Sammons Cancer CenterDallasTexas75246-
Oncology and Hematology Associates of SW Virginia-RaonokeRoanokeVirginia24014-
Seattle Cancer Care AllianceSeattleWashington98109-

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University of Arizona Cancer Center· Tucson, AZUniversity of California at Irvine Medical Center; Department of Oncology· Orange, CAUniversity of California· San Francisco, CAUniversity of Colorado; Anschutz Cancer Pavilion· Aurora, CORocky Mountain Cancer Center; Medical Oncology· Boulder, COGeorgetown U; Lombardi Comp Can· Washington D.C., DC

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