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

AstraZeneca

Status: Enrolling

Conditions: Endometrial Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT06995833

D9102R00001

Details and patient eligibility

About

Objectives of this study are to assess the safety and effectiveness of Durvalumab with or without Olaparib (hereinafter "the study drug") in a real world setting in patients who are prescribed with the study drug under the approved indication in Korea.

This is a multicenter, prospective, observational, real world treatment study. Patients treated as part of routine practice at Korean healthcare centers by investigators will be identified and considered for inclusion in the study. The period of this study is expected to run for 4 years from the approval date of the indication for this study. Approximately 50 patients are expected to be enrolled during the study.

Patient will be followed for approximately 12 months from the first dose or up to 90 days after treatment discontinuation if the study drug is administered for less than 12 months, unless they withdraw consent, are lost to follow-up or death.

Full description

Primary Objective: To assess the safety of the study drug in patients prescribed with the study drug under the approved indication(s) in Korea

Secondary Objective: To assess effectiveness of the study drug in patients prescribed with the study drug under the approved indication(s) in Korea

Exploratory Objective: To assess the safety and effectiveness of the study drug in patients prescribed with the study drug under the approved indication(s) in Korea by treatment/ MMR status

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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