Study ID: FIRST
A randomized, double-blind, phase III comparison of platinum-based therapy with TSR-042 and niraparib vs. standard of care platinum-based therapy as first-line treatment of stage III or IV non-mucinous epithelial ovarian cancer.
Researchers are studying a treatment regimen in patients who have been newly diagnosed with certain types of stage 3 or 4 ovarian, fallopian tube, or peritoneal cancer — collectively referred to as ovarian cancer. Treatments being studied include the experimental intravenous drug TSR-024, an immunotherapy medication, and Zejula™ (niraparib), an FDA-approved anti-cancer oral medication.
All trial participants receive current standard of care, including chemotherapy. Patients are then randomized into three groups:
- Arm 1: Receives placebos for both medications
- Arm 2: Receives TSR-042 placebo and niraparib
- Arm 3: Receives both TSR-042 and niraparib
Participants may receive these treatments for up to three years in the absence of disease progression, toxicity, patient withdrawal or investigator decision.
Note: This trial is open only to patients of the principal investigators.
The study is open to patients for whom platinum-based neoadjuvant chemotherapy is planned. It also is open to patients with inoperable ovarian cancer and macroscopic residual disease after primary debulking surgery (PDS) and recovery from PDS.
Patients must not have mucinous, germ cell, transitional cell, or undifferentiated tumor, or low-grade or grade 1 epithelial ovarian cancer.
Other inclusion and exclusion criteria apply.
- Must have been diagnosed with high-grade non-mucinous epithelial ovarian cancer (serous, endometrial, clear cell, carcinosarcoma, and mixed pathologies) that is deemed stage III or IV
- Must agree to the treatment regimen as prescribed for the study arm into which the patient has been randomized
- Must be either postmenopausal, free from menses for more than one 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