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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
European Institute of Oncology
RECRUITING
Milan
Contact Information
Primary
Ilaria Betella, MD
ilaria.betella@ieo.it
+390257489431
Time Frame
Start Date: 2026-04-14
Estimated Completion Date: 2029-04
Participants
Target number of participants: 510
Treatments
Experimental: Prospective Exploratory Cohort
Genomic, epigenomic, transcriptomic, proteomic, and lipidomic analyses
Related Therapeutic Areas
Sponsors
Leads: European Institute of Oncology
Collaborators: Mario Negri Gynecologic Oncology group (MaNGO)

This content was sourced from clinicaltrials.gov

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