NCT04677504

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

A Phase II, Randomized, Double-Blind Placebo-Controlled Study of Atezolizumab With or Without Bevacizumab in Combination With Cisplatin Plus Gemcitabine in Patients With Untreated, Advanced Biliary Tract Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	Atezolizumab	Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.
DRUG	Bevacizumab	Bevacizumab will be administered at a dose of 15 mg/kg intravenously on Day 1 of each 21-day cycle after atezolizumab.
OTHER	Placebo	Placebo matching bevacizumab will be administered intravenously on Day 1 of each 21-day cycle after atezolizumab.
DRUG	Cisplatin	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.
DRUG	Gemcitabine	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.

Timeline

• Start date: 2021-02-23
• Primary completion: 2022-05-16
• Completion: 2023-08-25
• First posted: 2020-12-21
• Last updated: 2024-07-03
• Results posted: 2023-06-29

Locations

49 sites across 13 countries: United States, China, Hong Kong, Italy, Poland, Russia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study