A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Hoffmann-La Roche
Study ID
NCT02450331
Phase
PHASE3
Status
Terminated

Conditions

  • Carcinoma, Transitional Cell

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Atezolizumab will be administered at a dose of 1200 milligrams (mg).

Study Details

This Phase III, open-label, randomized, multicenter study is to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with observation in participants with muscle-invasive UC who are at high risk for recurrence following resection. Eligible participants were randomized by a 1:1 ratio into atezolizumab group or control group.

Key Dates

Start date
Oct 5, 2015
Status verified
May 2023
Primary completion
Nov 30, 2019
Completion
Jun 14, 2022

Study Design

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

Arms

  • Experimental: Atezolizumab
    Participants will receive intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
  • No Intervention: Observation
    Participants will undergo observation starting on Day 1 for 16 cycles (up to 1 year).

Primary Outcome Measure

Disease-Free Survival (DFS), as Assessed by Investigator [ Time Frame: Randomization up to first occurrence of DFS event (up to approximately 50 months) ]

Locations (41)

FacilityCityStateZIPSite coordinators
HonorHealth Research Institute - Pima - Virginia G. Piper Cancer Care NetworkScottsdaleArizona85258-
UCLALos AngelesCalifornia90024-
USC Norris Cancer CenterLos AngelesCalifornia90033-
Stanford University Medical CenterPalo AltoCalifornia94304-
University Of ColoradoAuroraColorado80045-
The Urology Center of ColoradoDenverColorado80211-
Yale Cancer Center; Medical OncologyNew HavenConnecticut06520-
Northwestern University Feinberg School Of MedicineChicagoIllinois60611-
University of Chicago; Hematology/OncologyChicagoIllinois60637-
University of Iowa Hospital & Clinic; Division of Hematology/OncologyIowa CityIowa52242-
Albert B. Chandler Medical Center; University of KentuckyLexingtonKentucky40536-
Norton Cancer InstituteLouisvilleKentucky40202-
Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21287-
Chesapeake Urology Research AssociatesTowsonMaryland21204-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana Farber Cancer Inst.BostonMassachusetts02115-
Massachusetts General Hospital.BostonMassachusetts2114-
University Of MichiganAnn ArborMichigan48109-
Henry Ford Health SystemDetroitMichigan48202-
Karmanos Cancer InstituteDetroitMichigan48201-
MSK @Basking RidgeBasking RidgeNew Jersey07920-
Saint Barnabas Medical Center Cancer CenterLivingstonNew Jersey07039-
Memorial Sloan-Kettering Cancer CenterCommackNew York11725-
Columbia University Medical CenterNew YorkNew York10032-
Laura and ISAAC Perlmutter Cancer Center at NYU Langone.New YorkNew York10016-
Levine Cancer InstituteCharlotteNorth Carolina28204-
Duke Cancer CenterDurhamNorth Carolina27710-
Wake Forest University Baptist Medical CenterWinston-SalemNorth Carolina27157-
Cleveland ClinicClevelandOhio44106-
Fairview Hospital; Cleveland Clinic Cancer CenterClevelandOhio44111-
The Ohio State University Wexner Medical CenterColumbusOhio43212-
Cleveland CL N Coast Cancer CrSanduskyOhio44870-
Abramson Cancer Center; Univ of PennsylvaniaPhiladelphiaPennsylvania19104-
Fox Chase-Temple Cancer CenterPhiladelphiaPennsylvania19111-
Kimmel Cancer Center Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
Miriam HospitalProvidenceRhode Island02906-
University of Texas SouthwesternDallasTexas75390-8897-
Baylor College of Medicine; GastroenterologyHoustonTexas77030-
University of Texas Health Science Center at San AntonioSan AntonioTexas78229-
University of VirginiaCharlottesvilleVirginia22906-
Seattle Cancer Care AllianceSeattleWashington98109-

Find similar trials in Scottsdale, AZ

By research site
HonorHealth Research Institute - Pima - Virginia G. Piper Cancer Care Network· Scottsdale, AZUCLA· Los Angeles, CAUSC Norris Cancer Center· Los Angeles, CAStanford University Medical Center· Palo Alto, CAUniversity Of Colorado· Aurora, COThe Urology Center of Colorado· Denver, CO

Related Studies