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COMPLETEDPHASE2

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

NCT04677504•Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Considered to be eligible to receive platinum-based chemotherapy, in the investigator's judgment
•Documentation of recurrent/metastatic or locally advanced unresectable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) scans
•Histologically or cytologically confirmed diagnosis of iCCA, eCCA, or GBC
•No prior systemic therapy for advanced BTC
•At least one measurable untreated lesion (per RECIST v1.1)
•Adequate biliary drainage with no evidence of ongoing infection
•Eastern Cooperative Oncology Group Performance Status of 0 or 1
•Life expectancy of \> 3 months
•Adequate hematologic and end-organ function
•For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs
+1 more criteria

Exclusion Criteria

•Recurrent disease \<=6 months after curative surgery or \<= 6 months after the completion of adjuvant therapy
•Prior local regional therapy such as radioembolization
•Combined or mixed hepatocellular/cholangiocarcinoma
•Clinically significant hepatic encephalopathy within the 12 months prior to Day 1 of Cycle 1
•National Cancer Institute Common Terminoogy Criteria for Adverse Events Grade \>= 2 peripheral neuropathy
•Prior bleeding event due to untreated or incompletely treated esophageal and/or gastric varices within 6 months prior to Day 1 of Cycle 1
•Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of atezolizumab or within 6 months after the final dose of bevacizumab, cisplatin or gemcitabine
•Active or history of autoimmune disease or immune deficiency
•History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan
•History of malignancy other than BTC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
+12 more criteria

Locations (49)

City of Hope Cancer Center

Duarte, California, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Duke Cancer Center

Durham, North Carolina, United States

Sarah Cannon Research Institute / Tennessee Oncology

Nashville, Tennessee, United States

University of Virginia

Charlottesville, Virginia, United States

Nanfang Hospital, Southern Medical University

Guangzhou, China

Sir Run Run Shaw Hospital Zhejiang University

Hangzhou, China

Zhongshan Hospital Fudan University

Shanghai, China

Queen Mary Hospital; Dept. Of Haematology & Oncology

Hong Kong, Hong Kong

Prince of Wales Hosp; Dept. Of Clinical Onc

Shatin, Hong Kong

Key Dates

Start Date

February 23, 2021

Primary Completion Date

May 16, 2022

Completion Date

August 25, 2023

Last Updated

July 3, 2024

Enrollment

162

ACTUAL participants

Conditions

Biliary Tract Cancer

Interventions

Atezolizumab

DRUG

Bevacizumab

DRUG

Placebo

OTHER

Cisplatin

DRUG

Gemcitabine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 3, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors

Trifluridine/Tipiracil + Oxaliplatin in Participants With Advanced or Metastatic Biliary Tract Cancer

Cosiporfin Sodium for Injection Photodynamic Therapy

A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)

An Exploratory Study on the Use of Ivosidenib for the Precise Treatment of Advanced Biliary Tract Malignancies With IDH1 Mutations in the Later Line of Therapy.