Study identifier:D9311C00001
ClinicalTrials.gov identifier:NCT04269200
EudraCT identifier:2019-004112-60
CTIS identifier:N/A
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)
Endometrial Neoplasms
Phase 3
No
olaparib, durvalumab placebo, olaparib placebo, Carboplatin, Paclitaxel
Female
805
Interventional
18 Years - 150 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jun 2024 by AstraZeneca
AstraZeneca
The Gynecologic Oncology Group (GOG) Foundation Inc, The European Network for Gynaecological Oncological Trial groups (ENGOT)
No locations available
Arms | Assigned Interventions |
---|---|
Active Comparator: Arm A (control) Platinum-based chemotherapy and durvalumab placebo followed by maintenance durvalumab placebo and olaparib placebo (tablets). | Drug: durvalumab placebo Matching placebo for intravenous infusion Drug: olaparib placebo Placebo tablets to match olaparib Drug: Carboplatin Standard of care chemotherapy Drug: Paclitaxel Standard of care chemotherapy |
Experimental: Arm B (durvalumab+placebo) Platinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib placebo | Biological/Vaccine: durvalumab Durvalumab by intravenous infusion Drug: olaparib placebo Placebo tablets to match olaparib Drug: Carboplatin Standard of care chemotherapy Drug: Paclitaxel Standard of care chemotherapy |
Experimental: Arm C (durvalumab+olaparib) Platinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib. | Drug: olaparib Olaparib tablets Biological/Vaccine: durvalumab Durvalumab by intravenous infusion Drug: Carboplatin Standard of care chemotherapy Drug: Paclitaxel Standard of care chemotherapy |