NCT06746116

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Female
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of this study is to describe the safety profile of durvalumab in combination with platinum-based chemotherapy followed by durvalumab with olaparib as first-line treatment for patients with pMMR advanced or recurrent endometrial cancer. Study population: Approximately 85 eligible patients with newly diagnosed pMMR advanced or recurrent endometrial cancer (aEC) will be enrolled into the study distributed in approximately 20 sites in Spain. Study details include: * The recruitment period will be approximately 12 months. * The study duration will be approximately 48 months (12 months recruitment period + 36 months treatment and follow-up). * The median treatment duration will be approximately 13 months based on treatment duration for durvalumab + olaparib in DUO-E (22) (until objective radiological disease progression, unacceptable toxicity, consent withdrawal or death). Those patients in complete response will be allowed to discontinue durvalumab plus olaparib after completing 2 years in the maintenance phase. * The analysis for the primary objective is planned to be conducted 12 months after LSI to allow all patients have had the opportunity for 12 months of follow up, and at the end of the follow-up of the last patient up to 36 months. * The visit frequency will be: oChemotherapy Phase: every 21 days (every cycle). oMaintenance Phase: every 28 days (every cycle) Treatment: * Durvalumab + Chemotherapy phase: Durvalumab (IV) with SoC (carboplatin + paclitaxel chemotherapy: patients should receive at least 4, but preferably 6 cycles) every three weeks. * Durvalumab + Olaparib phase: durvalumab (IV) with olaparib (tablets) every four weeks until progression.

Conditions

• Advanced or Recurrent Endometrial Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-12-30
• Primary completion: 2028-11-30
• Completion: 2028-11-30
• First posted: 2024-12-24
• Last updated: 2026-04-16

Locations

24 sites across 1 country: Spain