ctDNA testing to guide maintenance immunotherapy decisions for advanced or recurrent endometrial cancer.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients must have pathologically confirmed endometrial cancer
* Patients with advanced endometrial cancer
* Stage III with residual disease

  °Select patients with Stage III disease and no residual disease can be enrolled after discussion with PI
* 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 it's running

• 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.