Tesaro is recruiting for its Phase 2 trial testing its therapy Zejula (niraparib) plus Avastin (bevacizumab, Genentech) as a maintenance therapy for women with advanced ovarian cancer who achieved at least a partial response after platinum-based chemotherapy plus Avastin.
The study — called OVARIO (NCT03326193) — is looking for 90 patients, regardless of their BRCA mutation or homologous recombination deficiency (HRD) status, with advanced (stage 3b and 4) epithelial ovarian, fallopian tube, or peritoneal cancer.
Information on enrollment can be found here.
The trial detail’s will be presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in the poster, “OVARIO: The phase 2, single-arm, open-label study of maintenance therapy with niraparib + bevacizumab in patients with advanced ovarian cancer following response on frontline platinum-based chemotherapy.”
Trial participants are required to have achieved complete response (be cancer free), partial response, or no evidence of disease after the front-line platinum-based chemotherapy.
Participants will receive a combination of Zejula and Avastin. Zejula will be given as a pill every day in 21-day cycles. Avastin will be administered intravenously on the first day of each cycle for up to 15 months. Patients will be treated continuously until disease progression or unacceptable toxicity.
Zejula’s dose will be chosen according to the patient’s body weight and/or platelet count. Patients weighing 170 pounds or more with a platelet count of 150,000 per microliter (μL) or more will receive 300 mg daily. Patients who weigh less than 170 pounds or with a platelet count of below 150,000 per μL will receive 200 mg daily.
Avastin will be delivered as a 15 mg per kg body weight dose every three weeks for up to 15 months.
The study’s main objective is to assess the proportion of patients who are alive and whose disease has not progressed 18 months after starting treatment, a measure called 18-month progression-free survival.
Additional — or secondary — goals include progression-free survival at six and 12 months; overall survival; time to first subsequent therapy; safety; and tolerability.
Zejula, developed by Tesaro, is approved in the U.S. and Europe as a maintenance therapy for ovarian cancer, with or without BCRA mutations, in women who have shown a complete or partial response to platinum-based chemotherapy.
The U.S. Food and Drug Administration is currently reviewing Genentech‘s supplemental Biologics License Application (sBLA) for Avastin in combination with chemotherapy, as a front-line treatment for women with advanced ovarian cancer. The FDA’s decision is expected by June 25, 2018.
Avastin is approved as treatment for women with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with chemotherapy.
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