A Study to Evaluate the Use of Durvalumab in Combination With Platinum-based Chemotherapy Followe… (NCT06746116) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study to Evaluate the Use of Durvalumab in Combination With Platinum-based Chemotherapy Followed by Durvalumab With Olaparib as First-line Treatment in Advanced or Recurrent Endometrial Cancer in Spain
Spain45 participantsStarted 2024-12-30
Plain-language summary
This is a phase IIIb, interventional, single arm, multicentre study assessing the safety profile of durvalumab in combination with carboplatin-paclitaxel chemotherapy followed by durvalumab with olaparib as first-line treatment for patients with pMMR aEC as the primary endpoint.
The study will include approximately 85 patients distributed in approximately 20 sites in Spain.
The planned duration of patient recruitment is approximately 12 months. Each patient will be followed up from screening for 36 months, until end of study period, death, withdrawal from study or loss to follow-up; whichever occurs first.
Enrolment will be opened to all eligible patients treated with durvalumab in combination with carboplatin-paclitaxel chemotherapy followed by durvalumab with olaparib as first-line treatment for patients with pMMR aEC. In addition, adequate tumour tissue before study entry, stool and blood sample collected will be required for central analysis to monitor the status of relevant biomarkers.
Who can participate
Age range
18 Years – 130 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Newly diagnosed Stage III disease classified by FIGO 2023 with mesurable disease per RECIST 1.1 following surgery or diagnostic biopsy.
. Newly diagnosed Stage IV disease classified by FIGO 2023. Patients with primary cytoreduction without residual disease are allowed.
. Recurrence of disease where the potential for cure by surgery alone or in combination is poor.
.At least one, but ideally two FFPE tumour sample block must be available and must be suitable for NGS and IHC evaluation by central lab. Preferably from primary endometrial tumor, but also from metastatic site will be allowed if there is no primary tumor block available. Tumor tissue has to have no less than 30% tumoral cell and tumoral area size has to be no less than 0,5cm2.
.Eastern Cooperative Oncology Group (ECOG)/ World Health Organisation (WHO) performance status ≤ 2 at enrolment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of patients with Adverse Events
Timeframe: Time from enrollment up to at least 90 days after last dose of study treatment
1.Measured creatinine clearance (CrCL) \>51 mL/min or calculated CrCL \>51 mL/min as determined by Cockcroft-Gault (using actual body weight), a 24-hour urine test or another validated test as per local practice: Estimated CrCL = (140-age \[years\]) × weight (kg) × 0.85 (mL/min) 72 × serum creatinine (mg/dL)
Exclusion criteria
. Any unresolved toxicity National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE version 5.0) Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria. Note:
Patients with Grade ≥2 neuropathy may be included only after consultation with the study physician.
Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or olaparib may be included only after consultation with the study physician.
. Uterine sarcomas will not be allowed.
. Major surgical procedure (as defined by the investigator) within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery. Note: Local surgery of isolated lesions for palliative intent is acceptable or diagnostic staging.
. History of allogenic organ transplantation.
. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation.
. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg, colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). The following are exceptions to this criterion: