Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer

Official Title

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)

Summary:

A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.

Trial Description

Primary Outcome:

• Progression Free Survival (PFS)

Secondary Outcome:

• Overall Survival (OS)
• Second Progression (PFS2)
• Objective Response Rate (ORR)
• Duration of response (DoR)
• Time to first subsequent therapy (TFST)
• Time to second subsequent therapy (TSST)
• Time to discontinuation or death (TDT)
• The pharmacokinetics (PK) of durvalumab will be determined after steady state doses
• Safety and tolerability of drugs by assessment of AEs/SAEs
• The immunogenicity of durvalumab as determined by concentration of Anti-drug antibodies (ADA) to durvalumab

This Phase III study will assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer. Target patient population: Adult female patients with histologically confirmed diagnosis of epithelial endometrial carcinoma (excluding sarcomas): newly diagnosed Stage III, newly diagnosed Stage IV, or recurrent endometrial cancer

View this trial on ClinicalTrials.gov