Durvalumab With or Without Olaparib in Patients With Endometrial Cancers Regulatory Post Marketing Surveillance
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Endometrial Cancer. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Primary outcome measures
- Safety (adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs), serious ADRs (SADRs), unexpected AEs/ADRs) [Time frame: 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 outcome measures (1)
- Real-world Progression free survival (rwPFS) [Time frame: 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.]
Eligibility criteria
Inclusion criteria
- Patients eligible for the study drug according to the approved label in Korea
- Provision of a signed and dated written informed consent by the patient or their legally acceptable representative
Exclusion criteria
- Participation in any concurrent interventional trials during the period of the study drug treatment
- Other off-label indications according to the approved label in Korea
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Research Site — Seoul
Identifiers
NCT: NCT06995833 · D9102R00001