A Study to Evaluate the Efficacy and Safety of Novel Treatment Combinations in Participants With Ovarian Cancer

Summary

This study will evaluate the efficacy and safety of niraparib and novel treatment combinations of niraparib as described within each cohort-specific supplement in participants with ovarian, fallopian tube, or primary peritoneal cancer. Cohort A (single arm) includes participants with recurrent ovarian cancer. Cohort B will not be initiated. Cohort C (randomized-2 arms) includes participants with newly diagnosed ovarian cancer.

Timeline

Start

2018-11-15

Primary completion

2024-06-28

Completion

2025-03-31

Publications

• Liu JF, Gaillard S, Wahner Hendrickson AE, Yeku O, Diver E, Gunderson Jackson C, Arend R, Ratner E, Samnotra V, Gupta D, Chung J, Zhang H, Compton N, Baines A, Bacque E, Liu X, Felicetti B, Konecny GE. Niraparib, Dostarlimab, and Bevacizumab as Combination Therapy in Pretreated, Advanced Platinum-Resistant Ovarian Cancer: Findings From Cohort A of the OPAL Phase II Trial. JCO Precis Oncol. 2024 May;8:e2300693. doi: 10.1200/PO.23.00693.
• Belotte J, Felicetti B, Baines AJ, YoussefAgha A, Rojas-Espaillat L, Ortiz AG, Provencher D, Vazquez RM, Cortijo LG, Zeng X. Comparing niraparib versus platinum-taxane doublet chemotherapy as neoadjuvant treatment in patients with newly diagnosed homologous recombination-deficient stage III/IV ovarian cancer: study protocol for cohort C of the open-label, phase 2, randomized controlled multicenter OPAL trial. Trials. 2024 May 4;25(1):301. doi: 10.1186/s13063-024-08142-5.

Drugs

Indications