A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Hoffmann-La Roche
Study ID
NCT03434379
Phase
PHASE3
Status
Completed

Conditions

  • Carcinoma, Hepatocellular

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Atezolizumab will be administered by IV, 1200 mg on day 1 of each 21 day cycle
  • Bevacizumab — DRUG
    Bevacizumab will be administered by IV, 15 mg/kg on day 1 of each 21 day cycle
  • Sorafenib — DRUG
    Sorafenib will be administered by mouth, 400 mg twice per day, on days 1-21 of each 21-day cycle

Study Details

This study will evaluate the efficacy and safety of atezolizumab in combination with bevacizumab compared with sorafenib in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have received no prior systemic treatment.

Key Dates

Start date
Mar 15, 2018
Status verified
Sep 2023
Primary completion
Aug 31, 2020
Completion
Nov 17, 2022

Study Design

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

Arms

  • Experimental: Atezolizumab + Bevacizumab
    Participants will receive Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator
  • Active Comparator: Sorafenib
    Participants will receive Sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator

Primary Outcome Measure

Overall Survival (OS) in the Global Population [ Time Frame: From randomization to death from any cause up to the clinical cut off date (CCOD) of 29Aug2019 (up to approximately 18 months) and 31Aug2020 (up to approximately 30 months) ]

Locations (21)

FacilityCityStateZIPSite coordinators
St. Josephs Hospital and Medical CenterPhoenixArizona85260-
City of HopeDuarteCalifornia91010-
Uni of California - San Diego; Cancer Center & Dept of MedicineLa JollaCalifornia92093-
Kaiser Permanente Northern CaliforniaNovatoCalifornia94589-
University of California Irvine Medical CenterOrangeCalifornia92868-
Kaiser Permanente Sacramento Medical CenterSacramentoCalifornia95825-
California Pacific Medical CenterSan FranciscoCalifornia94115-
Kaiser Permanente - San Francisco Medical CenterSan FranciscoCalifornia94118-
University of California Los AngelesSanta MonicaCalifornia90404-
Kaiser Permanente - Walnut CreekWalnut CreekCalifornia94596-
Banner MD Anderson Cancer CenterGreeleyColorado85234-
Georgetown UniversityWashington D.C.District of Columbia20007-
Moffitt Cancer CenterTampaFlorida33612-
Massachusetts General HospitalBostonMassachusetts02114-
Henry Ford Health SystemDetroitMichigan48202-
Washington University; Wash Uni. Sch. Of MedSt LouisMissouri63110-
University of New Mexico Comprehensive Cancer CenterAlbuquerqueNew Mexico87102-
Laura and ISAAC Perlmutter Cancer Center at NYU Langone.New YorkNew York10016-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
M.D Anderson Cancer Center; Uni of Texas At HoustonHoustonTexas77030-
Swedish Cancer Inst.SeattleWashington98104-

Find similar trials in Phoenix, AZ

By research site
St. Josephs Hospital and Medical Center· Phoenix, AZCity of Hope· Duarte, CAUni of California - San Diego; Cancer Center & Dept of Medicine· La Jolla, CAKaiser Permanente Northern California· Novato, CAUniversity of California Irvine Medical Center· Orange, CAKaiser Permanente Sacramento Medical Center· Sacramento, CA

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