Endometrial CanceriDEANCT07690540
DETERMINANTS OF IMMUNOTHERAPY EFFICACY IN ENDOMETRIAL CANCER
A study testing Prospective exploratory cohort in people with Endometrial Cancer and Immune Checkpoint Inhibitors, run by European Institute of Oncology at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer, Immune Checkpoint Inhibitors
- What is being tested?
- Prospective exploratory cohort
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 510 participants
- Where
- 1 siteItaly
- Study dates
- 14 Apr 2026to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
European Institute of Oncology
Milan, Italy, 20141
Giovanna Maria Spano, Phd, +39 025748951, giovanna.spano@ieo.it
Sara Cerri, Bs, 0257489951, sara.cerri@ieo.it
About this study
Official title: INVESTIGATING DETERMINANTS OF IMMUNOTHERAPY EFFICACY IN ENDOMETRIAL CANCER: A MULTIDIMENSIONAL APPROACH IN A UNIQUE POPULATION (iDEA PROJECT)
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.
- Conditions
- Endometrial Cancer, Immune Checkpoint Inhibitors
- Being tested
- Prospective exploratory cohort
- Keywords
- endometrial cancer, immune checkpoint inhibitors, biomarkers, target therapy, translational research
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective exploratory cohortBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Exploratory Cohort | Experimental | Genomic, epigenomic, transcriptomic, proteomic, and lipidomic analyses Receives: Biological: Prospective exploratory cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
Time from enrollment to first disease progression or death from any cause, whichever occurs first
Measured: 2 years
Overall Survival
Time from enrollment to death from any cause
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start14 Apr 2026
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 510 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Mario Negri Gynecologic Oncology group (MaNGO)
- Responsible party
- Sponsor
- Investigators
- Ilaria Betella, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690540
- Sponsor's protocol ID
- UID 5328
- Other IDs
- L2-593
- Acronym
- iDEA
- Status last verified
- Jun 2026
- First submitted
- 2 Jul 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INVESTIGATING DETERMINANTS OF IMMUNOTHERAPY EFFICACY IN ENDOMETRIAL CANCER: A MULTIDIMENSIONAL APPROACH IN A UNIQUE POPULATION (iDEA PROJECT)
- ClinicalTrials.gov ID
- NCT07690540
- Acronym / sponsor ID
- iDEA / UID 5328
- Conditions
- Endometrial Cancer, Immune Checkpoint Inhibitors
- Keywords
- endometrial cancer, immune checkpoint inhibitors, biomarkers, target therapy, translational research
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 510 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Collaborators
- Mario Negri Gynecologic Oncology group (MaNGO)
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective Exploratory Cohort | Experimental | Biological: Prospective exploratory cohortGenomic, epigenomic, transcriptomic, proteomic, and lipidomic analyses |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prospective exploratory cohortFresh 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. | Biological | Prospective Exploratory Cohort |
Primary outcome
Progression-Free Survival
Time frame: 2 years
Time from enrollment to first disease progression or death from any cause, whichever occurs first
Overall Survival
Time frame: 2 years
Time from enrollment to death from any cause
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ilaria Betella principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prospective exploratory cohort in people with Endometrial Cancer and Immune Checkpoint Inhibitors, run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ilaria Betella, MD (+390257489431, ilaria.betella@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.