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NOT YET RECRUITING
NCT07374809
NA

IMMUNOTHERAPY EFFICACY TARGETING ENDOMETRIAL CANCER

Sponsor: European Institute of Oncology

View on ClinicalTrials.gov

Summary

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.

Official title: DISSECTING THE EPIGENOME AND MICROENVIRONMENT TO UNDERSTAND IMMUNOTHERAPY EFFICACY TARGETING ENDOMETRIAL CANCER (DEMETER PROJECT)

Key Details

Gender

FEMALE

Age Range

18 Years - 120 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-01-21

Completion Date

2027-11-30

Last Updated

2026-01-29

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

DNA methylation profiles

MAP mutations, DNA methylation profiles, transcriptome, TME composition, and lipid abundance of tumor samples from EC patients that underwent immunotherapy;

Locations (1)

Istituto Europeo di Oncologa

Milan, Lombardy, Italy