Actively Recruiting
ctDNA Testing to Inform Standard-of-Care Treatment Decisions in People With Endometrial Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-12-18
30
Participants Needed
7
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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).
CONDITIONS
Official Title
ctDNA Testing to Inform Standard-of-Care Treatment Decisions in People With Endometrial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 up to 10 patients 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 including pelvic radiation, extended field pelvic/para aortic radiation, 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 anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies or similar agents except for up to 10 patients allowed after C1D1 of standard care treatments
- Age 18 years or older
- Not pregnant and not nursing
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
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Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (All Protocol Activites)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (All Protocol Activities)
Rockville Centre, New York, United States, 11570
Actively Recruiting
Research Team
Y
Ying Liu, MD, MPH
CONTACT
P
Paul Johannet, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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