DETERMINANTS OF IMMUNOTHERAPY EFFICACY IN ENDOMETRIAL CANCER
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorEuropean Institute of Oncology
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Prospective exploratory cohort
Biological/VaccineFresh 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.
Treatment groups
510 Participants
are divided into 1 treatment groupGroup A: Prospective Exploratory CohortExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Progression-Free Survival
Time from enrollment to first disease progression or death from any cause, whichever occurs first
Time frame
2 years2
Overall Survival
Time from enrollment to death from any cause
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
European Institute of Oncology
Lead sponsor
Mario Negri Gynecologic Oncology group (MaNGO)
Collaborator
Source ClinicalTrials.gov