Trial on NIraparib-TSR-042 (Dostarlimab) vs Physician's Choice CHEmotherapy in Recurrent, Ovarian, Fallopian Tube or Primary Peritoneal Cancer Patients Not Candidate for Platinum Retreatment
NCT04679064 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 427
Last updated 2021-08-27
Summary
Randomized phase 3 trial evaluating niraparib plus dostarlimab vs chemotherapy at physician's choice in the treatment of recurrent ovarian, fallopian tube or primary peritoneal cancer patients for which platinum is not an option
Conditions
Interventions
- DRUG
-
Niraparib
PARP-inihibitor
- DRUG
-
Dostarlimab
PD-1 inihibitor
- DRUG
-
Pegylated liposomal doxorubicin
Chemotherapy drug
- DRUG
-
Chemotherapy drug
- DRUG
-
Chemotherapy drug
- DRUG
-
Topotecan
Chemotherapy drug
- DRUG
-
Chemotherapy drug
Sponsors & Collaborators
- collaborator INDUSTRY
-
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-01
- Primary Completion
- 2025-01-01
- Completion
- 2025-01-01
Countries
- Italy
Study Locations
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