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

Sponsor
AGO Research GmbH
Study ID
NCT05126342
Phase
PHASE2
Status
Withdrawn

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Niraparib — DRUG
    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.
  • Dostarlimab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Nov 1, 2023
Status verified
Apr 2025
Primary completion
Nov 1, 2024
Completion
Nov 1, 2026

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
    Recurrent ovarian-, fallopian tube, or primary peritoneal cancer with relapse after more than 6 months of PARPi maintenance therapy.
  • Experimental: Cohort B
    Recurrent ovarian-, fallopian tube, or primary peritoneal cancer with relapse within 6 months of PARPi maintenance therapy.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: At week 16 of treatment ]

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