ctDNA testing to guide maintenance immunotherapy decisions for advanced or recurrent endometrial cancer.
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
This project will test whether a blood ctDNA test can help people with MMR‑D/MSI‑H advanced or recurrent endometrial cancer and their doctors decide whether to continue immunotherapy after one year of standard chemotherapy plus an immune checkpoint inhibitor.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT07270666 on ClinicalTrials.gov |
What this trial studies
This interventional protocol uses serial blood draws to measure circulating tumor DNA (ctDNA) in people with MMR‑D or MSI‑H advanced or recurrent endometrial cancer. Participants receive standard-of-care chemotherapy combined with an immune checkpoint inhibitor for up to one year while ctDNA results are returned to treating clinicians. Clinicians and patients use the ctDNA information to decide whether to continue maintenance immunotherapy beyond one year, and investigators record how often ctDNA changes treatment decisions. The study also tracks clinical outcomes such as disease status and progression at study end and is conducted at Memorial Sloan Kettering sites in New Jersey with minimal additional procedures beyond routine blood draws.
Who should consider this trial
Good fit: Ideal candidates are adults with advanced endometrial cancer (stage III with residual disease or stage IV) or recurrent disease after adjuvant therapy only, whose tumors are MMR‑D or MSI‑H and who are eligible for standard chemotherapy plus an immune checkpoint inhibitor.
Not a fit: Patients without MMR‑D/MSI‑H tumors, those with early-stage disease, those who cannot tolerate immune checkpoint inhibitors, or those with rapidly progressing disease are unlikely to benefit from ctDNA-guided maintenance decisions.
Why it matters
Potential benefit: If successful, ctDNA-guided decisions could personalize maintenance immunotherapy, potentially sparing people unnecessary treatment or prompting earlier continuation of therapy when molecular signs suggest higher risk.
How similar studies have performed: ctDNA has been shown in other cancers to detect minimal residual disease and predict recurrence and early work in endometrial cancer is promising, but using ctDNA specifically to guide duration of maintenance ICI is a relatively new application.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering Basking Ridge (All Protocol Activites) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (All Protocol Activities) — Rockville Centre, New York, United States (Recruiting)
Study contacts
- Principal investigator: Ying Liu, MD, MPH — Memorial Sloan Kettering Cancer Center
- Study coordinator: Ying Liu, MD, MPH
- Email: liuy6@mskcc.org
- Phone: 646-888-4946
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.