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

Titre officiel

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)

Sommaire:

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.

Description de l'essai

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

Voir cet essai sur ClinicalTrials.gov

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