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

Last updated: November 26, 2025
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pelvic Cancer

Endometrial Cancer

Vaginal Cancer

Treatment

ctDNA Testing

Blood draw

Clinical Study ID

NCT07270666
25-337
  • Ages > 18
  • Female

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients must have pathologically confirmed endometrial cancer

  • Patients with advanced endometrial cancer

  • Stage III with residual disease

  • 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

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: ctDNA Testing
Phase:
Study Start date:
November 25, 2025
Estimated Completion Date:
November 30, 2027

Connect with a study center

  • Memorial Sloan Kettering Basking Ridge (All Protocol Activites)

    Basking Ridge 5095409, New Jersey 5101760 07920
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Monmouth (All Protocol Activities)

    Middletown 5101170, New Jersey 5101760 07748
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Bergen (All Protocol Activities)

    Montvale 5101361, New Jersey 5101760 07645
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)

    Commack 5113412, New York 5128638 11725
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Westchester (All Protocol Activities)

    Harrison 5120095, New York 5128638 10604
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York 5128581, New York 5128638 10065
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Nassau (All Protocol Activities)

    Rockville Centre 5134203, New York 5128638 11570
    United States

    Active - Recruiting

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