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
Why is the FIRST study being done?
More treatment options have become available for women with advanced ovarian cancer in recent years. Early laboratory and clinical studies suggest that combining a DNA damage repair inhibitor (i.e. niraparib), with an immune checkpoint inhibitor (i.e. TSR-042), whether or not in combination with a VEGF inhibitor (i.e. bevacizumab) may provide a better outcome for the patient. FIRST is assessing this combination against the current standard of care in first line Ovarian Cancer.
- A histologically confirmed diagnosis of Stage 3 or 4, high-grade, non-mucinous epithelial ovarian cancer (serous, endometrial, clear cell, carcinosarcoma, and mixed pathologies)
- Those with Stage 4 disease are eligible (including those with inoperable disease with plans to receive a neo-adjuvant treatment).
- 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.
- Must have adequately recovered from previous major surgery
- Must not have clinically significant cardiovascular disease, hepatitis B or hepatitis C or be immunocompromised
- Must not have been diagnosed and/or treated with any therapy for invasive cancer less than 5 years from study enrollment
HOW DO I KNOW IF THE FIRST TRIAL IS RIGHT FOR ME?
The best next step is to contact the research site that would be the most convenient for you in order to discuss your medical history and whether the FIRST clinical trial would be a good fit.
To find sites in your area, contact: firstname.lastname@example.org or use the form above.
To find additional information on FIRST see: clinicaltrials.gov