Endometrial CancerNCT06995833
Durvalumab With or Without Olaparib in Patients With Endometrial Cancers Regulatory Post Marketing Surveillance
An observational study of Endometrial Cancer, run by AstraZeneca at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Endometrial Cancer
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Sep 2025to 29 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
About this study
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.
Read the 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
- Conditions
- Endometrial Cancer
- Medical subject headings
- Endometrial Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs), serious ADRs (SADRs), unexpected AEs/ADRs)
To assess safety of the study drugs for patients treated with the study drugs under the approved indication in Korea
Measured: 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 (1)
Real-world Progression free survival (rwPFS)
To assess effectiveness of the study drugs for patients treated with the study drugs under the approved indication in Korea
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start19 Sep 2025
- Primary completion29 Jun 2029 (estimated)
- Study completion29 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995833
- Sponsor's protocol ID
- D9102R00001
- Status last verified
- Aug 2026
- First submitted
- 28 May 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Durvalumab With or Without Olaparib in Patients With Endometrial Cancers Regulatory Post Marketing Surveillance
- ClinicalTrials.gov ID
- NCT06995833
- Acronym / sponsor ID
- D9102R00001
- Conditions
- Endometrial Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2025 (actual)
- Primary completion
- 29 Jun 2029 (estimated)
- Study completion
- 29 Jun 2029 (estimated)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
To assess safety of the study drugs for patients treated with the study drugs under the approved indication in Korea
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer, run by AstraZeneca at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.