Study to Estimate Efficacy of Combining Dostarlimab and Niraparib in Relapsed EOC After Treatment With PARPi

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

November 1, 2023

Primary Completion Date

November 1, 2024

Study Completion Date

November 1, 2026

Conditions
Recurrent Ovarian CancerRecurrent Fallopian Tube CancerPrimary Peritoneal Cancer
Interventions
DRUG

Niraparib

Niraparib starting dose of study treatment will be based upon the patient's baseline body weight and baseline platelet count. Patients with a baseline body weight ≥77 kg and baseline platelet count ≥150 x 10\^9/L may start with niraparib 300 mg (3 x 100 mg capsules) daily unless the dose has not already been reduced to 200 mg in a prior treatment line. Patients with a baseline body weight \<77 kg or a baseline platelet count \<150 x 10\^9/L will be administered niraparib 200 mg (2 x 100 mg capsules) daily.

DRUG

Dostarlimab

Dostarlimab (TSR-042) is administered 500 mg iv Q3W for the first 12 weeks. For the remainder of the study dostarlimab (TSR-042) is administered 1000 mg iv Q6W.

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

AGO Research GmbH

INDUSTRY