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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06995833

Enrollment

Registered

2025-05-30

Start date

2025-09-19

Completion date

2029-06-29

Last updated

2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer

Brief summary

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.

Detailed 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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
Safety (adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs), serious ADRs (SADRs), unexpected AEs/ADRs)	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.	To assess safety of the study drugs for patients treated with the study drugs under the approved indication in Korea

Secondary

Measure	Time frame	Description
Real-world Progression free survival (rwPFS)	Data obtained up until progression, or the last evaluable assessment (up to 12 month +/- 30 days) in the absence of progression, will be included in the assessment of rwPFS.	To assess effectiveness of the study drugs for patients treated with the study drugs under the approved indication in Korea

Countries

South Korea

Contacts

CONTACTAstraZeneca Clinical Study Information Center

information.center@astrazeneca.com1-877-240-9479

Outcome results