NCT05126342

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: AGO Research GmbH · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, non-randomized pilot study (Phase II). The aim is to obtain evidence of efficacy of niraparib and dostarlimab (TSR-042) in patients with relapsed ovarian cancer in two experimental cohorts and to generate data on PARPi (Poly(ADP-ribose)-Polymerase inhibitor) resistance and predictive biomarkers for IO (Immuno-Oncology) and PARPi.

Detailed description

In total, 100 patients are planned to be enrolled in 2 cohorts (60 patients cohort A and 40 patients cohort B). Cohort A: Recurrent ovarian-, fallopian tube, or primary peritoneal cancer with relapse after more than 6 months of PARPi maintenance therapy. Cohort B: Recurrent ovarian-, fallopian tube, or primary peritoneal cancer with relapse within 6 months of PARPi maintenance therapy. All patients must have a known status for BRCA1 and BRCA2 and one or two prior lines of chemotherapy. The last line of chemotherapy should have included platinum. Both cohorts will receive the selective PARP 1/2 inhibitor niraparib in combination with the anti-PD-1 checkpoint inhibitor dostarlimab (TSR-042) for a maximum treatment duration of 2 years. The overall objective of this study is to reveal insights in mechanisms of PARPi resistance in epithelial ovarian cancer (EOC) and to obtain preliminary evidence of the efficacy of sequential and/or simultaneous combined immuno-PARPi therapy.

Conditions

• Recurrent Ovarian Cancer
• Recurrent Fallopian Tube Cancer
• Primary Peritoneal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-11-01
• Completion: 2026-11-01
• First posted: 2021-11-19
• Last updated: 2025-04-06