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A Study Using ctDNA Testing to Inform Standard-of-Care Treatment Decisions in People With Endometrial Cancer
Trial Status: active
This clinical trial tests how well circulating tumor deoxyribonucleic acid (ctDNA) testing works in informing standard-of-care (SOC) treatment decisions to stop maintenance immune checkpoint inhibitor (ICI) treatment early in patients with mismatch repair deficient (MMR-D) or microsatellite instability high (MSI-H) endometrial cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has come back after a period of improvement (recurrent). Patients receive chemotherapy and ICI therapy as part of standard of care. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. ICIs, a type of immunotherapy, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Maintenance ICI is the continued use of ICI after finishing the initial part of treatment. The goal of maintenance ICI is to continue the treatment to keep the tumor under control and prevent it from coming back. However, most tumor recurrences happen within the first year of treatment, and long-term ICI therapy can cause lasting side effects and can be expensive. Many types of tumors tend to lose cells or release different types of cellular products including their DNA which is referred to as ctDNA into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are at higher risk for disease progression or relapse. Monitoring ctDNA testing results may help doctors and patients decide when to stop ICI treatment early and avoid unnecessary side effects and costs in patients with advanced or recurrent MMR-D or MSI-H endometrial cancer.
Inclusion Criteria
ON STUDY GUIDELINES: For patients with known HIV, hepatitis B virus (HBV), and/or hepatitis C virus (HCV) infection:
* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
ON STUDY GUIDELINES: The effects of immune checkpoint inhibitors and chemotherapy on the developing human fetus are unknown. For this reason, participants of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during study therapy and for 6 months following the completion of study therapy. Should a participant become pregnant or suspect pregnancy while participating in this study, they should inform their treating physician immediately
ON STUDY GUIDELINES: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
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 central nervous system (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 cycle 1 day 1 (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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07270666.
Locations matching your search criteria
United States
New Jersey
Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Active
Contact: Ying Liu
Phone: 646-888-4946
Middletown
Memorial Sloan Kettering Monmouth
Status: Active
Contact: Ying Liu
Phone: 646-888-4946
Montvale
Memorial Sloan Kettering Bergen
Status: Active
Contact: Ying Liu
Phone: 646-888-4946
New York
Commack
Memorial Sloan Kettering Commack
Status: Active
Contact: Ying Liu
Phone: 646-888-4946
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Ying Liu
Phone: 646-888-4946
Uniondale
Memorial Sloan Kettering Nassau
Status: Active
Contact: Ying Liu
Phone: 646-888-4946
West Harrison
Memorial Sloan Kettering Westchester
Status: Active
Contact: Ying Liu
Phone: 646-888-4946
PRIMARY OBJECTIVE:
I. To evaluate feasibility of ctDNA informed de-escalation of standard of care ICI maintenance therapy defined as willingness of patients/providers to stop ICI therapy after 1 year in those with negative ctDNA testing.
SECONDARY OBJECTIVES:
I. To determine progression-free survival using investigator-assessed recurrence/progression and time to next treatment.
II. To determine overall survival.
EXPLORATORY OBJECTIVES:
I. To characterize ctDNA kinetics during treatment.
II. To evaluate acceptability of de-escalation of ICI therapy in those with negative ctDNA at 1-year through patient and provider surveys.
OUTLINE:
Patients receive SOC chemotherapy and ICI per treating physician for up to 1 year in the absence of disease progression or unacceptable toxicity. After 1 year, patients without clinical disease progression and who are ctDNA positive continue SOC ICI maintenance for up to a total of at least 2 years. Patients who are ctDNA negative may stop ICI therapy per shared decision-making with their provider. Additionally, patients undergo blood sample collection throughout the study.
After completion treatment or at progression, patients are followed for up to 3 years from start of SOC treatment.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center
