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A Randomized, Double-Blind, Phase 3 Comparison of Platinum-Based Therapy with TSR-042 And Niraparib Versus Standard of Care Platinum-Based Therapy as First-Line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer

Clinical Trial Details

The study is open to patients with inoperable ovarian cancer, patients who have macroscopic residual disease at the end of the primary debulking surgery (PDS) and have recovered from PDS and patients for whom platinum-based combination neoadjuvant chemotherapy (NACT) is planned. The primary objectives of this study are: 

  • To compare the progression-free survival (PFS) of programmed death-ligand 1 (PD-L1) positive patients with Stage III or IV high-grade nonmucinous epithelial ovarian cancer treated with platinum-based combination therapy, dostarlimab, and niraparib to standardof-care (SOC) platinum-based combination therapy. 
  • To compare the PFS of all patients with Stage III or IV high-grade nonmucinous epithelial ovarian cancer treated with platinum-based combination therapy, dostarlimab, and niraparib to standard of care platinum-based combination therapy.
Key Eligibility: 
  • Female, ≥18 years of age
  • Postmenopausal, free from menses for more than 1 year, surgically sterilized, or willing to use highly effective contraception to prevent pregnancy or must agree to abstain from activities that could result in pregnancy throughout the study, starting with enrollment through 180 days after the last dose of study treatment
  • Confirmed diagnosis of high-grade nonmucinous epithelial ovarian (serous, endometrioid, clear cell, carcinosarcoma, and mixed pathologies), fallopian tube, or primary peritoneal cancer that is Stage III or IV 
  • Patients with Stage IV disease 
  • No low-grade or Grade 1 epithelial ovarian cancer
  • No active central nervous system metastases, carcinomatous meningitis, or both
  • No diagnosis and/or treatment with any therapy for invasive cancer less than 5 years from study enrollment
  • Not pregnant or lactating 

Study contact by location

Upper East Side - Manhattan

Contact(s)

Nadine Nicholson
(505) 730-4200
nan2023@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

194020124

ClinicalTrials.gov:

NCT03602859

Sponsor:

3000-03-005/ENGOT-OV44

Status

Open to Enrollment

Age Group

Adult

Sponsor