NCT07374809Not yet recruiting
IMMUNOTHERAPY EFFICACY TARGETING ENDOMETRIAL CANCER
DISSECTING THE EPIGENOME AND MICROENVIRONMENT TO UNDERSTAND IMMUNOTHERAPY EFFICACY TARGETING ENDOMETRIAL CANCER (DEMETER PROJECT)
Source: ClinicalTrials.gov · Last updated 29 Jan 2026
Brief summary (registry, in English)
Endometrial carcinoma (EC) represents the most common gynecological malignancy in developed countries. Despite therapeutic advances, patients with advanced or recurrent disease still have a poor prognosis, with high recurrence rates and a 5-year survival of less than 20%. Recently, four phase III studies (RUBY, NRG-GY018, AtTEnd, and DUO-E) have demonstrated that the addition of anti-PD-1/PD-L1 immunotherapy to first-line chemotherapy significantly improves progression-free survival, particularly in tumors with altered DNA repair mechanisms known as mismatch repair (MMR) (so-called mismatch repair-deficient or dMMR tumors), but with benefits also observed in a subset of tumors with normal MMR function (so-called MMR-proficient or pMMR tumors). However, despite the clinical approval of these therapies, reliable biomarkers capable of predicting response to immunotherapy are still lacking. This project aims to comprehensively characterize the genomic, epigenetic, and lipid properties of the tumor and the tumor microenvironment (TME) in order to identify predictive markers of response to immunotherapy, thereby laying the foundation for a personalized therapeutic approach in endometrial carcinoma.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 21 Jan 2026
- Start date
- 21 Jan 2026
- Primary completion date
- 30 Nov 2027
- Lead sponsor
- European Institute of Oncology
- Diseases
- Endometrial cancer
- NCT number
- NCT07374809
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 21 Jan 2026 to the primary completion date, 30 Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior systemic treatment with immune checkpoint inhibitors for other malignancies.
Other illness
- Active or uncontrolled infection with HIV, HBV, or HCV.
- Any condition that, in the investigator's judgment, would compromise patient safety or study integrity.
Other
- Mesenchymal tumors or epithelial tumors of non-endometrial origin (e.g., ovarian, cervical).
- Insufficient or poor-quality tumor tissue available for molecular analyses.
Who the study is looking for
- Female patients ≥ 18 years old.
- Histologically confirmed epithelial endometrial carcinoma (endometrioid, serous, clear cell, mixed, or carcinosarcoma).
- Advanced (stage III-IV) or recurrent disease, eligible for surgery or biopsy as part of the therapeutic plan.
- Availability of fresh-frozen or OCT-embedded tumor tissue obtained at surgery/biopsy and stored in the IEO Biobank.
- Mismatch-repair-deficient (dMMR) or -proficient (pMMR) molecular subtype (when available).
- Written informed consent for participation and use of biological material for translational research purposes.
Age in the registry: 18 years to 120 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Istituto Europeo di Oncologa Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.