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

PHASE2CompletedINTERVENTIONAL
Enrollment

162

Participants

Timeline

Start Date

February 23, 2021

Primary Completion Date

May 16, 2022

Study Completion Date

August 25, 2023

Conditions
Biliary Tract Cancer
Interventions
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.

Trial Locations (49)

100

National Taiwan Uni Hospital; Dept of Oncology, Taipei

13496

CHA Bundang Medical Center, Gyeonggi-do

20089

Istituto Clinico Humanitas - Humanitas Cancer Center, Rozzano

22903

University of Virginia, Charlottesville

27710

Duke Cancer Center, Durham

28034

Hospital Ramon y Cajal; Servicio de Oncologia, Madrid

31008

Complejo Hospitalario de Navarra; Servicio de Oncologia, Pamplona

32005

Complejo Hospitalario de Orense; Servicio de Oncologia, Ourense

34000

Sunpasitthiprasong Hospital; Oncology and/or Hematology, Ubon Ratchathani

34010

Koc Universitesi Hastanesi; T?bbi Onkoloji, Zeyt?nburnu

35128

IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II, Padua

37203

Sarah Cannon Research Institute / Tennessee Oncology, Nashville

40002

Srinagarind Hospital; Medical Oncology Unit, Khon Kaen

40139

"Azienda Ospedaliero Universitaria di Bologna; Istituto di Ematologia Lorenzo e Ariosto Seragnoli", Bologna

44280

Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department, Malatya

50009

Hospital Universitario Miguel Servet; Servicio Oncologia, Zaragoza

50200

Maharaj Nakorn Chiang Mai Hosp; Oncology Unit, Chiang Mai

61018

SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU, Kharkiv

61070

?Kharkov Regional Oncology Center, Kharkiv

80100

Fondazione Pascale; U.O. Sperimentazioni Cliniche, Napoli

91010

City of Hope Cancer Center, Duarte

111123

"SBIH Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM", Moskva

112201

Taipei Veterans General Hospital; Department of Oncology, Taipei

115478

"FSBI National Medical Research Center of Oncology N.N. Blokhin?", Moscow

119991

First Moscow State Medical University n.a. I.M. Sechenov, Moscow

197758

GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology), Saint Petersburg

200032

Zhongshan Hospital Fudan University, Shanghai

310016

Sir Run Run Shaw Hospital Zhejiang University, Hangzhou

510515

Nanfang Hospital, Southern Medical University, Guangzhou

02114

Massachusetts General Hospital, Boston

Unknown

Queen Mary Hospital; Dept. Of Haematology & Oncology, Hong Kong

Prince of Wales Hosp; Dept. Of Clinical Onc, Shatin

41-902

SP ZOZ Wojewódzki Szpital Specjalistyczny nr 4; Oddzial Onkologii Klinicznej, Bytom

80-214

Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii, Gdansk

75-581

Szpital Wojewódzki im. Miko?aja Kopernika; Oddzia? Dzienny Chemioterapii, Koszalin

02-034

NIO im Marii Sklodowskiej-Curie; Klinika Onkologii i Radioterapii, Warsaw

53-413

Dolno?l?skie Centrum Onkologii; Oddzia? Onkologii Klinicznej i Chemioterapii, Wroc?aw

463-707

Seoul National University Bundang Hospital, Seongnam-si

03080

Seoul National University Hospital, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

08035

Hospital Universitari Vall d'Hebron; Oncology, Barcelona

01130

Adana Ac?badem Hospital Oncology Department, Adana

06520

Memorial Ankara Hastanesi, Ankara

03126

"SI Shalimov National Institute of Surgery and Transplantation of Nat.Acad of Med.Sci of Ukraine", Kyiv

G12 0YN

Beatson West of Scotland Cancer Centre, Glasgow

NW3 2QS

Royal Free Hospital, London

OX3 7LJ

Churchill Hospital, Oxford

SM2 5PT

Royal Marsden Hospital (Sutton), Sutton

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT04677504 - A Study of Atezolizumab With or Without Bevacizumab in Combination With Cisplatin Plus Gemcitabine in Patients With Untreated, Advanced Biliary Tract Cancer | Biotech Hunter | Biotech Hunter