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 (3000-03-005/ENGOT-OV44)

Purpose

To compare the progression-free survival (PFS) of patients with Stage III or IV ovarian cancer treated with platinum-based therapy, TSR-042, and niraparib to standard-of-care (SOC) platinum-based therapy.

Criteria

Patients must be at least 18 years old and have a diagnosis of high-grade non-mucinous epithelial ovarian cancer that is Stage III or IV.

All patients with Stage IV disease are eligible.

Patients must have normal blood pressure (BP) or adequately treated and controlled hypertension

Patients must be able to take oral medication

You Cannot:

 Can’t have low-grade or Grade 1 epithelial ovarian cancer.                                                

Can’t have a bowel obstruction Can’t have been diagnosed and/or treated with any therapy for invasive cancer within 5 years, completed adjuvant chemotherapy less than 3 years from enrollment, or completed adjuvant hormonal therapy less than 4 weeks from enrollment. Patients with definitively treated noninvasive malignancies such as cervical carcinoma in situ, ductal carcinoma in situ, Grade 1 or 2, Stage I endometrial cancer, or nonmelanomatous skin cancer are allowed.                                                

Can’t be    immunocompromised                                                

Can’t have active hepatitis B or hepatitis C

Details

All patients will be treated with standard of care chemotherapy per the physician judgement for first 6 cycles of treatment. Patients will receive Paclitaxel, Carboplatin and TSR-042 (study medication) infusions every 21 days.  Patients may or may not be prescribed Bevacizumab every 21 days.  The study medication (TSR-042) is an immunotherapy medication and not chemotherapy. After the 1st cycle is completed the patient will then be prescribed TSR-042 infusions every 6 weeks and Niraparib capsules



Interested in more information on clinical research? Contact WK Physician Network Clinical Research at 318-212-8613

Interested in more information? Contact Us:

Destin Black, M.D., Principal Investigator
Gynecologic Oncology Associates
(318) 212-8727

IRB: WIRB
IRB Number:
Trial Type: NA
Sponsor: Tesaro