Durvalumab with or without Olaparib as Maintenance Therapy after First-Line Treatment of Advanced and Recurrent Endometrial Cancer - DUO-E

Study identifier:D9311C00001

ClinicalTrials.gov identifier:NCT04269200

EudraCT identifier:2019-004112-60

CTIS identifier:N/A

Recruitment Complete

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)

Medical condition

Endometrial Neoplasms

Phase

Phase 3

Healthy volunteers

No

Study drug

olaparib, durvalumab placebo, olaparib placebo, Carboplatin, Paclitaxel

Sex

Female

Actual Enrollment

805

Study type

Interventional

Age

18 Years - 150 Years

Date

Study Start Date: 05 May 2020
Estimated Primary Completion Date: 08 Jul 2024
Estimated Study Completion Date: 14 Aug 2027

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jun 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

The Gynecologic Oncology Group (GOG) Foundation Inc, The European Network for Gynaecological Oncological Trial groups (ENGOT)

Inclusion and exclusion criteria