243
Participants
Start Date
April 6, 2016
Primary Completion Date
May 31, 2021
Study Completion Date
May 31, 2021
5-FU
5-FU (400 mg/m\^2) will be administered as an IV bolus, followed by 2400 mg/m\^2 by continuous IV infusion over 46 (± 1) hours, q2w.
Atezolizumab
Participants will receive atezolizumab in a flat dose of 1200 mg q3w (Arm A, Group E2, and Arm F) or 840 mg q2w (Arm B, Arm C, and Groups E1 and E3).
Bevacizumab
Participants will receive bevacizumab at 15 mg/kg q3w (Arm A and Group F1) or 10 mg/kg q2w (Arm B).
Gemcitabine
Gemcitabine will be administered according to the local prescribing information. The starting dose-level of gemcitabine (1000 mg/m\^2) will be administered intravenously over 35 (± 5) minutes on Days 1, 8, and 15 of each 28-day cycle (3-weeks-on/1-week-off schedule).
Leucovorin
Leucovorin 200 mg/m\^2 L-isomer form or 400 mg/m\^2 D,L-racemic form will be administered IV over 120 (± 15) minutes, q2w.
Nab-Paclitaxel
Nab-Paclitaxel will be administered according to the local prescribing information. The starting dose-level of nab-paclitaxel (125 mg/m\^2) will be administered intravenously over 35 (± 5) minutes on Days 1, 8, and 15 of each 28-day cycle (3-weeks-on/1-week-off schedule).
Oxaliplatin
Oxaliplatin 85 mg/m\^2 will be administered IV over 120 (± 5) minutes q2w.
Capecitabine
Capecitabine may be administered after 6 months at the discretion of the investigator (range of 650-1000 mg/m\^2) twice daily on Days 1-4 of a 21-day cycle.
Cisplatin
Cisplatin will be administered as 80 mg/m\^2 IV over 120 minutes q3w (Group E2).
Taipei Veterans General Hospital, Taipei
Auckland City Hospital, Auckland
Austin Hospital, Heidelberg
Monash Medical Centre Clayton, Clayton
National Taiwan University Hospital, Taipei
Columbia University Medical Center, New York
Seoul National University Bundang Hospital, Seongnam-si
Georgetown University Medical Center, Washington D.C.
UNC Lineberger Comprehensive Cancer Center, Chapel Hill
Duke Cancer Institute, Durham
Sarah Cannon Research Inst., Nashville
China Medical University Hospital, North Dist.
Medical College of Wisconsin, Milwaukee
Mayo Clinic, Rochester
National Cheng Kung University Hospital, Tainan City
University of Colorado Hospital, Aurora
Stanford Cancer Institute; Hematology, Palo Alto
The 81st Hospital of P.L.A., Nanjing
Yale School of Medicine, New Haven
Massachusetts General Hospital, Boston
Dana Farber Cancer Institute, Boston
National Cancer Center Hospital East, Chiba
Yokohama City University Medical Center, Kanagawa
Kanagawa Cancer Center, Kanagawa
The Cancer Institute Hospital of JFCR, Tokyo
Seoul National University Hospital, Seoul
Severance Hospital, Seoul
Asan Medical Center, Seoul
Samsung Medical Center, Seoul
Chang Gung Medical Foundation - LINKOU; Dept of Cardiology, Taoyuan
Hoffmann-La Roche
INDUSTRY