53
Participants
Start Date
September 29, 2017
Primary Completion Date
May 4, 2020
Study Completion Date
August 31, 2021
Niraparib
Niraparib is an orally available, potent, highly selective poly adenosine diphosphate- ribose (poly ADP-ribose) polymerase-1 (PARP-1) and PARP-2 inhibitor. It will be available as 100 milligrams (mg) capsules and will be administered as 2 X 100 mg capsules (200 mg per day) orally once daily (QD).
Pembrolizumab
Pembrolizumab is a potent and highly selective humanized monoclonal antibody (mAb) of the immunoglobulin G-4 (IgG4)/kappa isotype designed to directly block the interaction between PD-1 and its ligands (PD-L1 and PD-L2). It will be available as 50 mg lyophilized powder single-use vials or 100 mg/4 milliliters (mL) (25 mg/mL) solution in a single-dose vial. It will be administered at a dose of 200 mg intravenous (IV) using a 30-minute IV infusion
TSR-042 (Dostarlimab)
TSR-042 (Dostarlimab) is a humanized mAb of the IgG4/kappa isotype that binds with high affinity to PD-1, resulting in inhibition of binding to PD-L1 and PD-L2. It will be administered at a dose of 500 mg for every 3 weeks (Q3W) for first 4 cycles followed by 1000 mg for every 6 weeks (Q6W) for all subsequent cycles using a 30-minute IV infusion. TSR-042 (dostarlimab) will be supplied as a solution of 160 mg (20 mg/mL) or 500 mg (50 mg/mL) in a single-dose vial.
GSK Investigational Site, Buffalo
GSK Investigational Site, Durham
GSK Investigational Site, Atlanta
GSK Investigational Site, Columbus
GSK Investigational Site, Port Saint Lucie
GSK Investigational Site, Nashville
GSK Investigational Site, Toledo
GSK Investigational Site, Cleveland
GSK Investigational Site, Canton
GSK Investigational Site, Harvey
GSK Investigational Site, Tinley Park
GSK Investigational Site, Whittier
GSK Investigational Site, Tacoma
GSK Investigational Site, Kennewick
GSK Investigational Site, Boston
GSK Investigational Site, Florham Park
Tesaro, Inc.
INDUSTRY