DETERMINANTS OF IMMUNOTHERAPY EFFICACY IN ENDOMETRIAL CANCER
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prospective exploratory cohort.
- Who it may be relevant to
- Registry conditions: Endometrial Cancer, Immune Checkpoint Inhibitors. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
INVESTIGATING DETERMINANTS OF IMMUNOTHERAPY EFFICACY IN ENDOMETRIAL CANCER: A MULTIDIMENSIONAL APPROACH IN A UNIQUE POPULATION (iDEA PROJECT)
Overview
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.
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.
Primary outcome measures
- Progression-Free Survival [Time frame: 2 years]
- Overall Survival [Time frame: 2 years]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Italy · 1 center
- European Institute of Oncology — Milan
Identifiers
NCT: NCT07690540 · UID 5328 · L2-593