DETERMINANTS OF IMMUNOTHERAPY EFFICACY IN ENDOMETRIAL CANCER

NCT07690540 — Not applicable, Recruiting, 510 participants, European Institute of Oncology

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

Registry	NCT07690540, acronym iDEA
Status	Recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, other
Enrollment	510 (Estimated)
Sponsor	European Institute of Oncology (Other); collaborators: Mario Negri Gynecologic Oncology group (MaNGO)
Conditions	Endometrial Cancer, Immune Checkpoint Inhibitors
Interventions	Prospective exploratory cohort (Biological)
Dates	start 2026-04-14, primary completion 2029-04-01 (estimated), completion 2029-04-01 (estimated), first posted 2026-07-08, last updated 2026-07-08
Locations	1 site in Italy

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Prospective Exploratory Cohort	Experimental	Biological: Prospective exploratory cohort	Genomic, epigenomic, transcriptomic, proteomic, and lipidomic analyses

Prospective exploratory cohort (Biological): 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.

+Outcome measures

Primary outcomes

Progression-Free Survival [2 years]: Time from enrollment to first disease progression or death from any cause, whichever occurs first
Overall Survival [2 years]: Time from enrollment to death from any cause

+Eligibility

Sex: Female, ages: 18 Years to any

Inclusion Criteria:

* 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

Exclusion Criteria:

* Refusal or inability to provide informed consent by the patient or legal representative
* Mesenchymal tumors or epithelial tumors of non-endometrial origin (e.g., ovarian cancer)
* Active treatment with immunomodulatory agents at the time of sample collection (e.g., immunotherapy for autoimmune disease)
* Known positivity for HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV)

+Locations (1)

Facility	City	Country	Status
European Institute of Oncology	Milan, Italy	Italy	Recruiting

+Investigators

Ilaria Betella, Principal investigator, European Institute of Oncology