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Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05126342
Study type Interventional
Source AGO Research GmbH
Contact Yvonne Treffner, Dr.
Phone +49 (0) 201 959812-17
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date May 1, 2022
Completion date November 1, 2026

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