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

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study ID
NCT04679064
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Niraparib — DRUG
    PARP-inihibitor
  • Dostarlimab — DRUG
    PD-1 inihibitor
  • Pegylated liposomal doxorubicin — DRUG
    Chemotherapy drug
  • Paclitaxel — DRUG
    Chemotherapy drug
  • Gemcitabine — DRUG
    Chemotherapy drug
  • Topotecan — DRUG
    Chemotherapy drug
  • Bevacizumab — DRUG
    Chemotherapy drug

Study Details

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

Key Dates

Start date
Dec 1, 2020
Status verified
Sep 2020
Primary completion
Jan 1, 2025
Completion
Jan 1, 2025

Study Design

Enrollment
427 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Phisician's choice of standard chemotherapy
    Chemotherapy at physician's choice between Pegylated Liposomal Doxorubicin 40 mg/mq iv q 28 Weekly Paclitaxel 80 mg/mq d 1,8,15 q 28 Gemcitabine 1000 mg/mq d 1,8,15 q 28 Topotecan 1.25 mg/mq day 1-5 q 21 +/- Bevacizumab at defined scehedule
  • Experimental: Niraparib+Dostarlimab
    Dostarlimab 500 mg q 3W for the fist 4 cycles, 1000 mg q 6W thereafter + Niraparib 300 mg or 200 mg if platelet count \<150,000 /μL and/or body weight \<77kg QD po q 28

Primary Outcome Measure

Overall Survival [ Time Frame: 4 years ]

Central Contacts

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