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A Study to Evaluate the Use of Durvalumab in Combination With Platinum-based Chemotherapy Followed by Durvalumab With Olaparib as First-line Treatment in Advanced or Recurrent Endometrial Cancer in Spain

NCT06746116 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-04-16

No results posted yet for this study

Summary

This is a phase IIIb, interventional, single arm, multicentre study assessing the safety profile of durvalumab in combination with carboplatin-paclitaxel chemotherapy followed by durvalumab with olaparib as first-line treatment for patients with pMMR aEC as the primary endpoint.

The study will include approximately 85 patients distributed in approximately 20 sites in Spain.

The planned duration of patient recruitment is approximately 12 months. Each patient will be followed up from screening for 36 months, until end of study period, death, withdrawal from study or loss to follow-up; whichever occurs first.

Enrolment will be opened to all eligible patients treated with durvalumab in combination with carboplatin-paclitaxel chemotherapy followed by durvalumab with olaparib as first-line treatment for patients with pMMR aEC. In addition, adequate tumour tissue before study entry, stool and blood sample collected will be required for central analysis to monitor the status of relevant biomarkers.

Conditions

  • Advanced or Recurrent Endometrial Cancer

Interventions

DRUG

Durvalumab + Chemotherapy phase

Durvalumab (IV) with SoC (carboplatin + paclitaxel chemotherapy: patients should receive at least 4, but preferably 6 cycles) every three weeks.

DRUG

Durvalumab + Olaparib phase

durvalumab (IV) with olaparib (tablets) every four weeks until progression.

Sponsors & Collaborators

  • Apices Soluciones S.L.

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-12-30
Primary Completion
2028-11-30
Completion
2028-11-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

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 NCT06746116 on ClinicalTrials.gov