29
Participants
Start Date
April 27, 2017
Primary Completion Date
August 11, 2020
Study Completion Date
August 11, 2020
Atezolizumab
Atezolizumab 1200 mg (equivalent to an average body weight-based dose of 15 milligrams per kilogram \[mg/kg\]) will be administered by IV infusion once every 3 weeks, corresponding to a 21-day treatment cycle. Participants will receive atezolizumab starting on Cycle 1, Day 1. Participants deriving clinical benefit will be allowed to continue on study treatment until the absence of unacceptable toxicity or compelling evidence of disease progression.
Rucaparib
The starting dosage level of rucaparib for Part 1 is 400 mg PO BID during a 21-day treatment cycle. During Part 1, the rucaparib doses were increased up to a maximum of 600 mg PO BID using a standard 3 + 3 dose escalation. RP2D was identified as 600 mg BID. During Part 2 of the study, rucaparib will be dosed at the RP2D determined in Part 1. Participants in Part 1 of the study will receive rucaparib starting on Cycle 1, Day 1. During Part 2, participants will receive rucaparib monotherapy during a 21-day run-in period. After completion of the rucaparib run-in period and the first on-treatment biopsy between Days 15 and 21 of the run-in period, participants will begin Cycle 1, Day 1 of the rucaparib. Participants deriving clinical benefit will be allowed to continue on study treatment until the absence of unacceptable toxicity or compelling evidence of disease progression.
Peter Maccallum Cancer Centre, Melbourne
Clínica Universidad de Navarra, Pamplona
Centre Leon Berard, Lyon
Centre Hospitalier Lyon Sud; Service d'Oncologie Médicale, Pierre-Bénite
Gustave Roussy, Villejuif
Hospital Universitario Vall d'Hebron, Barcelona
La Paz University Hospital, Madrid
Royal Marsden Hospital - London, London
University College London Hospitals NHS Foundation Trust - University College Hospital, London
Lancashire Teaching Hospitals NHS Foundation Trust, Preston
Royal Marsden NHS Foundation Trust, Sutton
Hoffmann-La Roche
INDUSTRY