A Study of Atezolizumab With or Without Bevacizumab in Combination With Cisplatin Plus Gemcitabine in Patients With Untreated, Advanced Biliary Tract Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT04677504
Phase
PHASE2
Status
Completed

Conditions

  • Biliary Tract Cancer

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.
  • Bevacizumab — DRUG
    Bevacizumab will be administered at a dose of 15 mg/kg intravenously on Day 1 of each 21-day cycle after atezolizumab.
  • Placebo — OTHER
    Placebo matching bevacizumab will be administered intravenously on Day 1 of each 21-day cycle after atezolizumab.
  • Cisplatin — DRUG
    Cisplatin will be administered intravenously at a dose of 25 mg/m\^2 on Days 1 and 8 of each 21-day cycle for Cycles 1-8.
  • Gemcitabine — DRUG
    Gemcitabine will be administered intravenously at a dose of 1000 mg/m\^2 on Days 1 and 8 of each 21-day cycle for Cycles 1-8.

Study Details

This study will evaluate the efficacy and safety of atezolizumab with bevacizumab in combination with cisplatin and gemcitabine(CisGem), compared with atezolizumab in combination with CisGem, in participants with advanced biliary tract cancer (BTC) who have not received prior systemic therapy. Treatment will consist of a chemotherapy combination phase followed by a cancer immunotherapy (CIT)/placebo phase.

Key Dates

Start date
Feb 23, 2021
Status verified
Jun 2024
Primary completion
May 16, 2022
Completion
Aug 25, 2023

Study Design

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

Arms

  • Experimental: Arm A: Atezo+Bev+CisGem, followed by Atezo+Bev
    Participants will receive atezolizumab intravenously on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, and clinical status. Participants will receive bevacizumab intravenously on Day 1 of each 21-day cycle. Participants will receive cisplatin intravenously followed by gemcitabine on Days 1 and 8 of each 21-day cycle for Cycles 1-8.
  • Active Comparator: Arm B: Atezo+PBO+CisGem, followed by Atezo+PBO
    Participants will receive atezolizumab intravenously on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, and clinical status. Participants will receive placebo matching bevacizumab intravenously on Day 1 of each 21-day cycle. Participants will receive cisplatin intravenously followed by gemcitabine on Days 1 and 8 of each 21-day cycle for Cycles 1-8.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Randomization to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first)(up to approximately 14 months) ]

Locations (5)

FacilityCityStateZIPSite coordinators
City of Hope Cancer CenterDuarteCalifornia91010-
Massachusetts General HospitalBostonMassachusetts02114-
Duke Cancer CenterDurhamNorth Carolina27710-
Sarah Cannon Research Institute / Tennessee OncologyNashvilleTennessee37203-
University of VirginiaCharlottesvilleVirginia22903-

Find similar trials in Duarte, CA

By research site
City of Hope Cancer Center· Duarte, CAMassachusetts General Hospital· Boston, MADuke Cancer Center· Durham, NCSarah Cannon Research Institute / Tennessee Oncology· Nashville, TNUniversity of Virginia· Charlottesville, VA

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