Predictive biomarkers for immunotherapy in endometrial cancer
Official title: INVESTIGATING DETERMINANTS OF IMMUNOTHERAPY EFFICACY IN ENDOMETRIAL CANCER: A MULTIDIMENSIONAL APPROACH IN A UNIQUE POPULATION (iDEA PROJECT)
Run by European Institute of Oncology · NCT07690540 · Data updated 2026-11-12
This study tests molecular and epigenetic features to see if they can predict which endometrial cancer patients will respond to immune checkpoint inhibitors.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 510 (estimated) |
| Sponsor | European Institute of Oncology Academic / other |
| Drugs / interventions | immunotherapy, chemotherapy |
| Locations | 1 site (Milan, Italy) |
| Status | Recruiting |
| Started | April 14, 2026 |
| Main results expected | April 2029 |
| Study ends | April 2029 |
| Registry record updated | July 8, 2026 |
| Trial ID | NCT07690540 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with advanced or recurrent endometrial carcinoma or carcinosarcoma who have not previously received immune checkpoint inhibitors and can provide paired tumor samples.
✕Probably not a fit
Patients whose tumors lack the studied biomarkers or whose disease biology does not correlate with response may not benefit from these findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective exploratory, translational study focused on identifying biomarkers that predict or prognosticate response to immunotherapy in endometrial cancer. Researchers will analyze paired fresh-frozen and FFPE tumor samples to integrate molecular and epigenetic data. The goal is to improve patient selection by uncovering factors beyond MMR status that influence treatment outcomes. The study is conducted at the European Institute of Oncology in Milan, in collaboration with MaNGO, and does not involve a standard randomized intervention beyond collecting and analyzing samples. Participants must be adults with advanced or recurrent disease who have not previously received immune checkpoint inhibitors.
Why it matters
Potential benefit: If successful, the findings could help tailor immunotherapy to patients most likely to benefit and reduce unnecessary exposure for non-responders.
How similar studies have gone: Prior work has shown that limited biomarkers beyond MMR status may help predict response; this study extends translational efforts with broader molecular and epigenetic profiling.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
-
European Institute of Oncology
Milan, Italy, Italy Recruiting
Study contacts
- Principal investigator: Ilaria Betella — European Institute of Oncology
- Study coordinator: Ilaria Betella, MD
- Email: ilaria.betella@ieo.it
- Phone: +390257489431
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.