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

Conditions

• Advanced or Recurrent Endometrial Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 130 Years

Healthy Volunteers

Not accepted

Interventions

• Durvalumab + Chemotherapy phase — DRUG
  Durvalumab (IV) with SoC (carboplatin + paclitaxel chemotherapy: patients should receive at least 4, but preferably 6 cycles) every three weeks.
• Durvalumab + Olaparib phase — DRUG
  durvalumab (IV) with olaparib (tablets) every four weeks until progression.

Study Details

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.

Key Dates

Start date

Dec 30, 2024

Status verified

Apr 2026

Primary completion

Nov 30, 2028

Completion

Nov 30, 2028

Study Design

Enrollment

45 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Single Arm
  Durvalumab + Chemotherapy (chemotherapy phase) plus Durvalumab + Olaparib (maintenence phase)

Primary Outcome Measure

Number of patients with Adverse Events [ Time Frame: Time from enrollment up to at least 90 days after last dose of study treatment ]