A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination with Durvalumab Followed by Maintenance Durvalumab with or without Olaparib in Patients with Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E)

• Female age 18 or greater
• Histologicall confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcoma, are allowed
• Disease in one of the following categories
  • Newly diagnosed Stage III disease (with measurable disease following surgery or biopsy)
  • Newly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy)
  • Recurrence of disease where the potential for cure by surgery alone or in combination is poor
• Naive to first line systemic anti-cancer treatment.  For patients with recurrent disease only, prior chemo is allowed only if administered in the adjuvant setting and there is at least 12 months from the date of the last dose of chemo to the date of subsequent relapse
• ECOG PS 0-1
• No CNS disease
• No prior treatment with PARP inhibitors or immunotherapy

• Primary
  • PFS
• Secondary
  • OS
  • PFS2
  • ORR
  • DoR
  • TFST
  • TSST
  • TDT
  • PK
  • Safety