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NCT Number: NCT07690540

DETERMINANTS OF IMMUNOTHERAPY EFFICACY IN ENDOMETRIAL CANCER

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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Key information

Conditions

Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Immune Checkpoint Inhibitors Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

European Institute of Oncology

Milan, Italy, 20141

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Progression-Free Survival

    Time frame: 2 years

    Time from enrollment to first disease progression or death from any cause, whichever occurs first

  2. Overall Survival

    Time frame: 2 years

    Time from enrollment to death from any cause

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Collaborators

  • Mario Negri Gynecologic Oncology group (MaNGO)

Registry information

Official study title

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

Acronym: iDEA

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 8, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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