“Study of Niraparib and TSR-042 in Recurrent Endometrial Cancer”
This is a phase 2 study of investigational drug niraparib and TSR-042 in patients with advanced/recurrent endometrial cancer. The purpose of this study is to determine whether blocking a protein called poly (ADP-ribose) polymerase (PARP) with niraparib provides clinical benefit in patients with recurrent endometrial cancer, as well as to explore the possible impact of phosphatase and tensin homolog (PTEN) loss (loss of function of the PTEN gene) on blocking PARP with niraparib.
Drug - Niraparib
200 or 300 mg daily PO, for 21 day cycle
Drug - TSR-042
500 mg once intravenously on day 1 of cycle (From cycle 1-4 followed by 1000 mg intravenously every 6 weeks for maximum of 2 yrs)
A Phase II, Open Label Study of the Poly(ADP-ribose) Polymerase Inhibitor Niraparib in Monotherapy or in Combination With Anti-PD1 Inhibitor TSR-042 in Recurrent Endometrial Cancer