158
Participants
Start Date
July 28, 2015
Primary Completion Date
October 2, 2019
Study Completion Date
October 2, 2019
Atezolizumab
Participants will receive atezolizumab at a fixed dose of 1200 milligrams (mg) via intravenous (IV) infusion on Day 1 of each 21-day cycle with the exception of biopsy cohort A, where atezolizumab administration will start on Cycle 2 Day 1.
GDC-0919
Participants will receive GDC-0919 by mouth (PO) twice daily (BID), specifically every 12 hours. During the dose-escalation stage, the first cohort will receive GDC-0919 at a starting dose of 50 mg PO BID. Dosing will commence on Day -1 for Cycle 1 and follow subsequent 21-day (Days 1 to 21) dosing cycles. The dose will be modified based upon evaluation of DLTs, with single dose escalations not to exceed 2.5-fold of the previous dose. The proposed dosages for evaluation are 50, 100, 200, 400, 600, and 1000 mg PO BID. During the expansion stage, selected solid tumor types will be treated at the MTD or MAD as determined during the dose-escalation stage.
Samsung Medical Center, Seoul
Memorial Sloan Kettering Cancer Center, New York
Hopital Nord AP-HM, Marseille
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore
Hospital Universitario HM Sanchinarro-CIOCC, Madrid
H. Lee Moffitt Cancer Center and Research Inst., Tampa
Sarah Cannon Research Institute, Nashville
Hospital Clinico Universitario de Valencia, Valencia
HonorHealth Research Institute - Bisgrove, Scottsdale
The Angeles Clinic and Research Institute, Santa Monica Office, Santa Monica
Institut Gustave Roussy, Villejuif
University of Colorado, Aurora
Yale Cancer Center, New Haven
Beth Israel Deaconess Medical Center, Boston
Dana Farber Cancer Institute, Boston
Seoul National University Hospital, Seoul
Asan Medical Center - Oncology, Seoul
Hospital Universitari Vall d'Hebron, Barcelona
Lead Sponsor
Genentech, Inc.
INDUSTRY