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 range18 Years – 130 Years
SexFEMALE
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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.
✓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
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
✕. 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: