Endometrial Cancer
Conditions
Keywords
Stage III with residual disease, Stage IV, Recurrent endometrial cancer after adjuvant therapy only, ctDNA Testing, 25-337
Brief 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).
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
OTHERSurveys
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.
OTHERSemi-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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a pragmatic, pilot study of ctDNA informed, immune checkpoint inhibitor (ICI) de-escalation in advanced/recurrent mismatch repair deficient (MMR-D)/microsatellite instability high (MSI-H) endometrial cancer with a feasibility primary endpoint.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| will test the feasibility of ct-DNA | 1 year | 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. |
Countries
United States
Contacts
CONTACTYing Liu, MD, MPH
CONTACTPaul Johannet, MD
PRINCIPAL_INVESTIGATORYing Liu, MD, MPH
Memorial Sloan Kettering Cancer Center
Outcome results
None listed