Endometrial CancerNCT07270666
ctDNA Testing to Inform Standard-of-Care Treatment Decisions in People With Endometrial Cancer
A study testing ctDNA Testing, Blood draw and Surveys in people with Endometrial Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The researchers are doing this study to evaluate the use of circulating tumor DNA (ctDNA) testing in making treatment decisions for advanced/recurrent endometrial cancer that has a change (mutation) in the mismatch repair deficient (MMR-D) gene or microsatellite instability high (MSI-H) gene. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- ctDNA Testing, Blood draw and Surveys
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesUnited States
- Study dates
- 25 Nov 2025to Nov 2027
- Phase
- Interventional
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
- Patients must have pathologically confirmed endometrial cancer
- Patients with advanced endometrial cancer
- Stage III with residual disease
- °Select patients with Stage III disease and no residual disease can be enrolled after discussion with PI
- Stage IV
- Recurrent endometrial cancer after adjuvant therapy only
Show all 17Show fewer
- Patients can have primary or planned interval surgery
- MMR-D on immunohistochemistry OR MSI-H using any commercially available test
- Patients with treated brain metastases are eligible if follow up brain imaging after CNS directed therapy shows no evidence of progression.
- Eligible for standard of care chemotherapy with immune checkpoint inhibitor per treating investigator with no clinical contraindications
- For the up to 10 patients who are allowed to enroll after C1D1 of standard of care treatments, they need to be on treatment with no clinical evidence of disease progression.
- Patients may have received prior radiation therapy for treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para aortic radiation therapy, intravaginal brachytherapy, and/or palliative radiation therapy.
- Patients may have received prior hormonal therapy for treatment of endometrial cancer.
- Patients may not have received prior therapy with an anti-PD-1, anti-PD-L1 or anti-CTLA-4 therapeutic antibody or other similar agents.
- Except for the up to 10 patients who are allowed to enroll after C1D1 of standard of care treatments (chemotherapy and/or immune checkpoint inhibitors) per protocol.
- Age ≥ 18
- Not Pregnant and Not Nursing
Who cannot join
None listed.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Paul Johannet, MD contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (All Protocol Activites)
Basking Ridge, New Jersey, 07920
Ying Liu, MD, 646-888-4946
- Recruiting
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
Commack, New York, 11725
Ying Liu, MD, 646-888-4946
- Recruiting
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
Ying Lui, MD, 646-888-4946
- Recruiting
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
Ying Liu, MD, 646-888-4946
- Recruiting
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645
Ying Liu, MD, 646-888-4946
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Ying Liu, MD, MPH., 646-888-4946
Roisin O'Cearbhaill, MD, 646-888-4227
- Recruiting
Memorial Sloan Kettering Nassau (All Protocol Activities)
Rockville Centre, New York, 11570
Ying Liu, MD, 646-888-4946
About this study
Official title: Pragmatic Pilot Study of ctDNA Informed Immune Checkpoint Inhibitor De-escalation in Advanced/Recurrent Mismatch Repair Deficient (MMR-D)/Microsatellite Instability High (MSI-H) Endometrial Cancer Using Standard of Care Treatments
The researchers are doing this study to evaluate the use of circulating tumor DNA (ctDNA) testing in making treatment decisions for advanced/recurrent endometrial cancer that has a change (mutation) in the mismatch repair deficient (MMR-D) gene or microsatellite instability high (MSI-H) gene. The researchers will see how doctors and their patients use the results of ctDNA testing after 1 year of standard chemotherapy and immune checkpoint inhibitor (ICI) treatment to decide whether to continue maintenance ICI treatment past 1 year. The researchers will also look at the health outcomes of people in this study (for example, whether they are cancer free at the end of their participation in the study).
- Conditions
- Endometrial Cancer
- Being tested
- ctDNA Testing, Blood draw, Surveys, Semi-structured interviews
- Keywords
- Stage III with residual disease, Stage IV, Recurrent endometrial cancer after adjuvant therapy only, ctDNA Testing, 25-337
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ctDNA TestingGenetic
Patients will undergo ctDNA sampling at the 1-year timepoint using the commercially available Natera SignateraTM test.
Blood drawOther
at the 1-year timepoint
SurveysOther
Patients and providers will also complete surveys at various timepoints to evaluate distress, shared decision-making, acceptability and other factors contributing to the decision-making process.
Semi-structured interviewsOther
Will be performed within 6 months of receiving the 1-year clinical ctDNA result. Discussion via telephone or during a standard of care clinical visit (in person or telemedicine) with treating physician or team member within 28 days of clinical 1-year ctDNA result to discuss results with the patient and decide on de-escalation if applicable.
| Study group | Role | What they receive |
|---|---|---|
| ctDNA-negative group | Experimental | Participants in this group will have negative ctDNA test results at 1 year after they start standard treatment. (Negative results indicate that no cancer DNA is detected in their blood.) Participants in this group will decide with their doctor if they want to stop standard maintenance ICI treatment. Receives: Genetic: ctDNA Testing; Other: Blood draw; Other: Surveys; Other: Semi-structured interviews |
| ctDNA-positive group | Experimental | Participants in this group will have positive ctDNA test results at 1 year after they start standard treatment. (Positive results indicate that cancer DNA is detected in their blood.) Participants in this group will continue receiving standard treatment with their doctor. Receives: Genetic: ctDNA Testing; Other: Blood draw; Other: Surveys; Other: Semi-structured interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
will test the feasibility of ct-DNA
informed de-escalation of standard of care ICI maintenance therapy defined as willingness of patients/providers to stop ICI therapy after 1 year in those with negative ctDNA testing.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start25 Nov 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (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.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a pragmatic, pilot study of ctDNA informed, immune checkpoint inhibitor (ICI) de-escalation in advanced/recurrent mismatch repair deficient (MMR-D)/microsatellite instability high (MSI-H) endometrial cancer with a feasibility primary endpoint.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying Liu, MD, MPH, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270666
- Sponsor's protocol ID
- 25-337
- Status last verified
- Sep 2026
- First submitted
- 26 Nov 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.