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

NCT04269200 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 805

Last updated 2025-12-23

Study results available
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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.

Conditions

  • Endometrial Neoplasms

Interventions

DRUG

olaparib

Olaparib tablets

BIOLOGICAL

durvalumab

Durvalumab by intravenous infusion

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

Sponsors & Collaborators

  • The Gynecologic Oncology Group (GOG) Foundation Inc

    collaborator UNKNOWN

  • The European Network for Gynaecological Oncological Trial groups (ENGOT)

    collaborator UNKNOWN

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Shannon N. Westin, MD, MPH, FACOG · The University of Texas MD Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
150 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-05
Primary Completion
2024-07-08
Completion
2027-04-01
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • China
  • Colombia
  • Estonia
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • India
  • Israel
  • Japan
  • Lithuania
  • Mexico
  • Poland
  • Russia
  • Singapore
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04269200 on ClinicalTrials.gov