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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Endometrial Cancer

Treatments: Other: Blood draw; Genetic: ctDNA Testing

Study type: Interventional

Funder types: Other

Identifiers

NCT07270666

25-337

Details and patient eligibility

About

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).

Enrollment: 30 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

ctDNA-negative group

Experimental group

Description:

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.

Treatment:

Other: Blood draw

Genetic: ctDNA Testing

ctDNA-positive group

Experimental group

Description:

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.

Treatment:

Other: Blood draw

Genetic: ctDNA Testing