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
Memorial Sloan Kettering Cancer Center
Summary
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).
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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 treatin…
Interventions
- GeneticctDNA Testing
Patients will undergo ctDNA sampling at the 1-year timepoint using the commercially available Natera SignateraTM test.
- OtherBlood draw
at the 1-year timepoint
Locations (7)
- Memorial Sloan Kettering Basking Ridge (All Protocol Activites)Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (All Protocol Activities)Middletown, New Jersey
- Memorial Sloan Kettering Bergen (All Protocol Activities)Montvale, New Jersey
- Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)Commack, New York
- Memorial Sloan Kettering Westchester (All Protocol Activities)Harrison, New York
- Memorial Sloan Kettering Cancer CenterNew York, New York