A Study of Atezolizumab in Combination With Cabozantinib Compared to Cabozantinib Alone in Participants With Advanced Renal Cell Carcinoma After Immune Checkpoint Inhibitor Treatment

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Hoffmann-La Roche
Study ID
NCT04338269
Phase
PHASE3
Status
Terminated

Conditions

  • Carcinoma, Renal Cell

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Atezolizumab 1200 mg will be administered at a fixed dose on Day 1 of each 21-day cycle by IV infusion every 3 weeks.
  • Cabozantinib — DRUG
    Cabozantinib 60 mg (three 20-mg tablets) administered orally once daily.

Study Details

This is a Phase III, multicenter, randomized, open-label study designed to evaluate the efficacy and safety of atezolizumab given in combination with cabozantinib versus cabozantinib alone in participants with inoperable, locally advanced, or metastatic renal cell carcinoma (RCC) who experienced radiographic tumor progression during or after Immune Checkpoint Inhibitor (ICI) treatment in the metastatic setting.

Key Dates

Start date
Jul 28, 2020
Status verified
Feb 2026
Primary completion
Jan 3, 2023
Completion
Mar 24, 2025

Study Design

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

Arms

  • Experimental: Atezo+Cabo
    Participants will receive atezolizumab every 3 weeks on Day 1 of each 21-day cycle (1 cycle=21 days) plus oral tablets of cabozantinib every day.
  • Active Comparator: Cabozantinib
    Participants will receive cabozantinib every day.

Primary Outcome Measure

Progression Free Survival (PFS) as Assessed by an Independent Review Facility (IRF) (IRF-PFS) According to RECIST v1.1 [ Time Frame: From randomization to the first occurrence of PD according to RECIST v1.1, or death from any cause, whichever occurred first (up to 2 years 5 months) ]

Locations (24)

FacilityCityStateZIPSite coordinators
University of ArizonaTucsonArizona85724-5030-
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
UC San Diego Health SystemLa JollaCalifornia92093-
UCLALos AngelesCalifornia90095-
University of ColoradoAuroraColorado80045-
Rocky Mountain Cancer Center - DenverLittletonColorado80120-
Woodlands Medical Specialists, P.A.PensacolaFlorida32503-
Moffitt Cancer CenterTampaFlorida33612-
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimoreMaryland21287-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Minnesota Oncology HematologyMinneapolisMinnesota55404-
Comprehensive Cancer Centers of Nevada (CCCN) - Central ValleyLas VegasNevada89169-
Memorial Sloan Kettering - MonmouthMiddletownNew Jersey07748-
Memorial Sloan Kettering BergenMontvaleNew Jersey07645-
New York Oncology Hematology,P.C.-AlbanyAlbanyNew York12208-
Mount Sinai Medical CenterNew YorkNew York10029-
SUNY Upstate Medical UniversitySyracuseNew York13210-
Montefiore Medical CenterThe BronxNew York10461-
Duke University Medical CenterDurhamNorth Carolina27710-
Cleveland ClinicClevelandOhio44195-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Texas Oncology - Central SouthAustinTexas78731-
University Of UtahSalt Lake CityUtah84108-
Virginia Cancer Specialists - GainsvilleGainesvilleVirginia20155-

Find similar trials in Tucson, AZ

By research site
University of Arizona· Tucson, AZCity of Hope Comprehensive Cancer Center· Duarte, CAUC San Diego Health System· La Jolla, CAUCLA· Los Angeles, CAUniversity of Colorado· Aurora, CORocky Mountain Cancer Center - Denver· Littleton, CO

Related Studies