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

Официальное название

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

Обзор

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).

Вмешательства

• Генная терапия ctDNA Testing
  Patients will undergo ctDNA sampling at the 1-year timepoint using the commercially available Natera SignateraTM test.
• Другое Blood draw
  at the 1-year timepoint
• Другое Surveys
  Patients and providers will also complete surveys at various timepoints to evaluate distress, shared decision-making, acceptability and other factors contributing to the decision-making process.
• Другое Semi-structured interviews
  Will be performed within 6 months of receiving the 1-year clinical ctDNA result. Discussion via telephone or during a standard of care clinical visit (in person or telemedicine) with treating physician or team member within 28 days of clinical 1-year ctDNA result to discuss results with the patient and decide on de-escalation if applicable.

Первичные конечные точки

• will test the feasibility of ct-DNA [Срок оценки: 1 year]

Критерии участия

Критерии включения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 7 центров

• Memorial Sloan Kettering Basking Ridge (All Protocol Activites) — Basking Ridge
• Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown
• Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale
• Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities) — Commack
• Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison
• Memorial Sloan Kettering Cancer Center — New York
• Memorial Sloan Kettering Nassau (All Protocol Activities) — Rockville Centre

Идентификаторы

NCT: NCT07270666 · 25-337

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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