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NCT Number: NCT07270666

ctDNA Testing to Inform Standard-of-Care Treatment Decisions in People With Endometrial Cancer

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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Basking Ridge (All Protocol Activites), Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ctDNA Testing

Genetic

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

Blood Draw

Other

at the 1-year timepoint

Surveys

Other

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

Other

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 outcomes

  1. will test the feasibility of ct-DNA

    Time frame: 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Paul Johannet, MD

CONTACT

646-888-5327

Ying Liu, MD, MPH

CONTACT

[email protected]

646-888-4946

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 8, 2025
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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