Recruiting

ctDNA Testing

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07270666

Conditions

Endometrial Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ctDNA Testing

Blood draw

Surveys

Semi-structured interviews

Study Details

Brief 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. 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

Study ID

NCT07270666

Start date

Nov 25, 2025

Status verified date

Jul, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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
  • 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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ctDNA-negative group

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.

experimental: ctDNA-positive group

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.

Interventions

ctDNA Testing

Patients will undergo ctDNA sampling at the 1-year timepoint using the commercially available Natera SignateraTM test.

Blood draw

at the 1-year timepoint

Surveys

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 interviews

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.

Primary outcome measure

  • will test the feasibility of ct-DNA [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Ying Liu, MD, MPH

646-888-4946liuy6@mskcc.org

Paul Johannet, MD

646-888-5327

Locations

Memorial Sloan Kettering Basking Ridge (All Protocol Activites)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Ying Liu, MD

646-888-4946

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Ying Liu, MD

646-888-4946

Memorial Sloan Kettering Bergen (All Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Ying Liu, MD

646-888-4946

Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Ying Liu, MD

646-888-4946

Memorial Sloan Kettering Westchester (All Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Ying Lui, MD

646-888-4946

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Ying Liu, MD, MPH.

646-888-4946

Roisin O'Cearbhaill, MD

646-888-4227

Memorial Sloan Kettering Nassau (All Protocol Activities)

Recruiting

Rockville Centre, New York, United States, 11570

Contacts

Ying Liu, MD

646-888-4946

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

  • Stage III with residual disease
  • Stage IV
  • Recurrent endometrial cancer after adjuvant therapy only
  • ctDNA Testing
  • 25-337

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-07-13.