Durvalumab with or without Olaparib for people with endometrial cancer in Korea

Durvalumab With or Without Olaparib in Patients With Endometrial Cancers Regulatory Post Marketing Surveillance

This study will see if Durvalumab, with or without Olaparib, is safe and works for people in Korea who are prescribed these drugs for endometrial cancer as part of routine care.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Sex: All
• Sponsor: AstraZeneca (industry)
• Drugs / interventions: Durvalumab
• Locations: 1 site (Seoul)
• Trial ID: NCT06995833 on ClinicalTrials.gov

What this trial studies

This is a multicenter, prospective, observational real-world study enrolling about 50 patients in Korea and following them for roughly 12 months after the first dose or up to 90 days after stopping treatment. Patients will be identified and included while receiving Durvalumab with or without Olaparib as prescribed by their treating clinicians under the approved Korean label. The primary focus is on safety monitoring, with secondary analyses of effectiveness and exploratory comparisons by treatment and mismatch repair (MMR) status. The overall study period is expected to run for four years from the product approval date in Korea.

Who should consider this trial

Good fit: Ideal candidates are adults in Korea who are prescribed Durvalumab with or without Olaparib according to the approved Korean label and who can provide informed consent.

Not a fit: Patients receiving these drugs for off-label indications, those enrolled in concurrent interventional trials, or people treated outside participating Korean centers are unlikely to gain relevant information from this observational program.

Why it matters

Potential benefit: If successful, the study could provide clinicians and patients with clearer, real-world information on the safety and effectiveness of these treatments in Korean patients with endometrial cancer.

How similar studies have performed: Some clinical trials combining PD-(L)1 inhibitors with PARP inhibitors have shown promising signals in gynecologic cancers, but robust real-world evidence specifically in endometrial cancer remains limited.

Eligibility criteria

Inclusion Criteria:

1. Patients eligible for the study drug according to the approved label in Korea
2. Provision of a signed and dated written informed consent by the patient or their legally acceptable representative

Exclusion Criteria:

1. Participation in any concurrent interventional trials during the period of the study drug treatment
2. Other off-label indications according to the approved label in Korea

Where this trial is running

Seoul

• Research Site — Seoul, South Korea (RECRUITING)

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions: Endometrial Cancer