Clinical trial NCT06995833: Durvalumab With or Without Olaparib in Patients With Endometrial Cancers Regulatory Post Marketing Surveillance
Official title: Durvalumab With or Without Olaparib in Patients With Endometrial Cancers Regulatory Post Marketing Surveillance
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Endometrial Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2025-05-30
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be enrolled by a total surveillance method. In principle, patients treated with study drugs in accordance with local prescribing information are eligible for enrollment in this study. Each patient must meet all of the inclusion criteria and none of the exclusion criteria. Investigators should enroll the patients who initiate or are receiving treatment with study drugs after the contract date.

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

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

Primary outcomes:
measure: Safety (adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs), serious ADRs (SADRs), unexpected AEs/ADRs)
timeFrame: 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.
Secondary outcomes:
measure: Real-world Progression free survival (rwPFS)
timeFrame: 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.
Other outcomes:
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