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RECRUITING
NCT07690540
NA

DETERMINANTS OF IMMUNOTHERAPY EFFICACY IN ENDOMETRIAL CANCER

Sponsor: European Institute of Oncology

View on ClinicalTrials.gov

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.

Official title: INVESTIGATING DETERMINANTS OF IMMUNOTHERAPY EFFICACY IN ENDOMETRIAL CANCER: A MULTIDIMENSIONAL APPROACH IN A UNIQUE POPULATION (iDEA PROJECT)

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

510

Start Date

2026-04-14

Completion Date

2029-04

Last Updated

2026-07-08

Healthy Volunteers

No

Interventions

BIOLOGICAL

Prospective exploratory cohort

Fresh tumor samples, paired with FFPE tissue, will be collected prior to initiation of immunotherapy and will be used to generate patient-derived three-dimensional tumoroids on a microfluidic organ-on-chip platform.

Locations (1)

European Institute of Oncology

Milan, Italy, Italy