DUO-O: This phase III trial is evaluating the safety and effectiveness of various targeted therapy and chemotherapy combinations for the treatment of newly diagnosed, advanced ovarian cancerA Phase III Randomised, Double-Blind, Placebo-Controlled, Multicentre Study of Durvalumab in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib in Newly Diagnosed Advanced Ovarian Cancer Patients (DUO-O).

Exclusion

Non-epithelial ovarian cancer, borderline tumors, low grade epithelial tumors or mucinous histology

• Prior systemic anti-cancer therapy for ovarian cancer
• Inability to determine the presence or absence of a deleterious or suspected deleterious BRCA mutation
• Prior treatment with PARP inhibitor or immune mediated therapy
• Planned intraperitoneal cytotoxic chemotherapy
• Active or prior documented autoimmune or inflammatory disorders
• Patients considered a poor medical risk due to a serious, uncontrolled intercurrent illness
• Clinically significant cardiovascular disease
• Patients with known brain metastases

• History of another primary malignancy except for:

  • Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of study treatment and of low potential risk for recurrence (patients who have received prior adjuvant chemotherapy for early stage breast cancer may be eligible, provided that it was completed ≥3 years prior to registration, and that the patient remains free of recurrent or metastatic disease)
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
  • Adequately treated carcinoma in situ without evidence of disease
  • Endometrial cancer FIGO Stage IA, Grade 1 or Grade 2
• Persistent toxicities CTCAE Grade >2 caused by previous cancer therapy
• Patients with a known hypersensitivity to olaparib, durvalumab or any of the excipients of these products and to the combination/comparator agents
• Breast feeding women