NCT07690540 DETERMINANTS OF IMMUNOTHERAPY EFFICACY IN ENDOMETRIAL CANCER
| NCT ID | NCT07690540 |
| Status | Recruiting |
| Phase | — |
| Sponsor | European Institute of Oncology |
| Condition | Endometrial Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 510 participants |
| Start Date | 2026-04-14 |
| Primary Completion | 2029-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 510 participants in total. It began in 2026-04-14 with a primary completion date of 2029-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In recent years, the introduction of immune checkpoint inhibitors (ICI) in combination with chemotherapy has significantly changed the management of advanced and recurrent Endometrial Cancer (EC). Despite these advances, responses to immunotherapy remain heterogeneous. Not all patients with mismatch repair-deficient (dMMR) tumors derive durable benefit, while a subset of mismatch repair-proficient (pMMR) tumors may respond. In addition, ICI treatment is associated with relevant costs and immune-related toxicities, highlighting the need for improved patient selection. To date, no validated predictive biomarkers beyond mismatch repair (MMR) status are available, reflecting limited understanding of the biological mechanisms underlying sensitivity and resistance to immunotherapy in EC. This study aims to assess and integrate molecular and epigenetic features to identify prognostic and predictive biomarkers of immunotherapy response in endometrial cancer, and to explore their functional relevance using patient-derived experimental models.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years * Histologically confirmed advanced or recurrent endometrial carcinoma or carcinosarcoma * No prior treatment with immune checkpoint inhibitors * Availability of paired fresh-frozen and FFPE tumor samples * Provision of written informed consent for participation in translational research Exclusion Criteria: * Refusal or inability to provide informed consent by the patient or legal representative * Mesenchymal tumors or epithelial tumors of non-endometrial origin (e.g., ovarian cancer) * Active treatment with immunomodulatory agents at the time of sample collection (e.g., immunotherapy for autoimmune disease) * Known positivity for HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV)
Contact & Investigator
Ilaria Betella
PRINCIPAL INVESTIGATOR
European Institute of Oncology
Frequently Asked Questions
Who can join the NCT07690540 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Endometrial Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07690540 currently recruiting?
Yes, NCT07690540 is actively recruiting participants. Contact the research team at ilaria.betella@ieo.it for enrollment information.
Where is the NCT07690540 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT07690540 clinical trial?
NCT07690540 is sponsored by European Institute of Oncology. The principal investigator is Ilaria Betella at European Institute of Oncology. The trial plans to enroll 510 participants.
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