ctDNA Testing to Inform Standard-of-Care Treatment Decisions in People With Endometrial Cancer
NCT ID: NCT07270666
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2025-11-25
2027-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Ying Liu, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Basking Ridge (All Protocol Activites)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
Commack, New York, United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Nassau (All Protocol Activities)
Rockville Centre, New York, United States
Countries
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Central Contacts
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Paul Johannet, MD
Role: CONTACT
Phone: 646-888-5327
Facility Contacts
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Ying Liu, MD
Role: primary
Ying Liu, MD
Role: primary
Ying Liu, MD
Role: primary
Ying Liu, MD
Role: primary
Ying Lui, MD
Role: primary
Ying Liu, MD, MPH.
Role: primary
Roisin O'Cearbhaill, MD
Role: backup
Ying Liu, MD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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25-337
Identifier Type: -
Identifier Source: org_study_id