IMMUNOTHERAPY EFFICACY TARGETING ENDOMETRIAL CANCER

Starting soon · Not applicable

Conditions studied: Endometrial Carcinoma (EC), pMMR, DMMR Cancer

In brief

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.

Key facts

Study ID

NCT07374809

Run by

European Institute of Oncology

People needed

50

Starts

2026-01-21

Expected to finish

2027-11-30

Last updated by the study team

2026-01-29

Who can join

Age: 18 and older, up to 120. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Mesenchymal tumors or epithelial tumors of non-endometrial origin (e.g., ovarian, cervical).
• Prior systemic treatment with immune checkpoint inhibitors for other malignancies.
• Insufficient or poor-quality tumor tissue available for molecular analyses.
• Active or uncontrolled infection with HIV, HBV, or HCV.
• Any condition that, in the investigator's judgment, would compromise patient safety or study integrity.

Where it is running

• Istituto Europeo di Oncologa — Milan, Lombardy, Italy

Full record on ClinicalTrials.gov

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