Platinum-based Therapy + Dostarlimab + Niraparib for Ovarian Cancer
(FIRST Trial)

Recruiting in Palo Alto (17 mi)

+251 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Tesaro, Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?Ovarian cancer is a heterogeneous disease, characterized by complex molecular and genetic changes. The high expression of vascular endothelial growth factor (VEGF) receptor, programmed death receptor ligands 1 (PD-L1) expression, and deoxyribonucleic acid (DNA) damage in ovarian tumors provide several targets for treatment and maintenance of disease response. Given the unmet medical need of participants with advanced or metastatic ovarian cancer, this study design will enable investigators to provide participants with current SOC for ovarian cancer for the duration of the study. This is a global, multicenter, randomized, double-blind, controlled Phase 3 study that will primarily compare the progression-free survival (PFS) for participants receiving dostarlimab with SOC chemotherapy +/- bevacizumab followed by niraparib and dostarlimab maintenance +/- bevacizumab versus participants receiving SOC with chemotherapy followed by niraparib maintenance. This comparison will be investigated in participants of newly diagnosed stage III or IV advanced non-mucinous epithelial ovarian cancer participants and also to compare PFS of all participants with Stage III or IV high-grade non-mucinous epithelial ovarian cancer treated with platinum-based combination therapy, dostarlimab (TSR-042), and niraparib to SOC platinum-based combination therapy. The currently recommended SOC therapy for the first line treatment of Stage III or IV ovarian cancer is the combination of paclitaxel and carboplatin, with or without concurrent and maintenance bevacizumab. Participants will receive SOC during the chemotherapy Run-In period (cycle 1) before randomization to study treatment (cycle 2). Concurrent bevacizumab use must be determined prior to randomization at cycle 2.

Eligibility Criteria

This trial is for women aged 18+ with advanced non-mucinous epithelial ovarian cancer (Stage III/IV). They must be postmenopausal, surgically sterilized, or use contraception. Eligible participants should have an ECOG score of 0 or 1, can take oral meds, and have normal blood pressure or controlled hypertension. They cannot join if they've had recent major surgery, uncontrolled medical issues, immunodeficiency, certain past cancers within specific time frames, active hepatitis B/C or autoimmune diseases.

Inclusion Criteria

I can provide a specific tissue sample for cancer testing.

I have Stage IV cancer and may have surgery or chemotherapy planned.

I have advanced ovarian, fallopian tube, or peritoneal cancer.

+14 more

Exclusion Criteria

You have active hepatitis B or C.

My cancer is of a specific type (mucinous, germ cell, transitional cell, or undifferentiated).

My ovarian cancer is at an early stage (low-grade or Grade 1).

+17 more

Participant Groups

The study compares the effectiveness of platinum-based therapy combined with TSR-042 (dostarlimab) and niraparib versus standard chemotherapy in treating ovarian cancer. It's a global Phase 3 trial focusing on progression-free survival rates. Participants will receive standard care initially before being randomly assigned to either the new drug combination or continued standard treatment.

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Participants receiving SOC+dostarlimab+niraparibExperimental Treatment3 Interventions

Participants in this arm will receive SOC in cycle 1 (each cycle is of 21 days) followed by SOC with chemotherapy treatment dostarlimab, and maintenance treatment of +/-bevacizumab with niraparib and dostarlimab

Group II: Participants receiving SOC+niraparibActive Control3 Interventions

Participants in this arm will receive SOC in cycle 1 (each cycle is of 21 days) followed by SOC with chemotherapy treatment dostarlimab placebo from cycles 2 to 6 and maintenance treatment of +/- bevacizumab with niraparib and dostarlimab placebo

Group III: Participants receiving SOC+placeboPlacebo Group3 Interventions

Participants in this arm will receive SOC (carboplatin+paclitaxel+/-bevacizumab) in cycle 1 (each cycle is of 21 days) followed by SOC with chemotherapy treatment with dostarlimab placebo from cycles 2 to 6 and maintenance treatment of +/-bevacizumab along with niraparib placebo and dostarlimab placebo

Dostarlimab (TSR-042) is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Jemperli for: