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

Purpose

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).

Condition

  • Endometrial Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

Criteria

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
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.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ctDNA-negative group 		Participants in this group will have negative ctDNA test results at 1 year after they start standard treatment. (Negative results indicate that no cancer DNA is detected in their blood.) Participants in this group will decide with their doctor if they want to stop standard maintenance ICI treatment.
  • Genetic: ctDNA Testing
    Patients will undergo ctDNA sampling at the 1-year timepoint using the commercially available Natera SignateraTM test.
  • Other: Blood draw
    at the 1-year timepoint
  • Other: 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.
  • Other: 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.
Experimental
ctDNA-positive group 		Participants in this group will have positive ctDNA test results at 1 year after they start standard treatment. (Positive results indicate that cancer DNA is detected in their blood.) Participants in this group will continue receiving standard treatment with their doctor.
  • Genetic: ctDNA Testing
    Patients will undergo ctDNA sampling at the 1-year timepoint using the commercially available Natera SignateraTM test.
  • Other: Blood draw
    at the 1-year timepoint
  • Other: 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.
  • Other: 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.

Recruiting Locations

Memorial Sloan Kettering Basking Ridge (All Protocol Activites)
Basking Ridge, New Jersey 07920
Contact:
Ying Liu, MD
646-888-4946

Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey 07748
Contact:
Ying Liu, MD
646-888-4946

Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey 07645
Contact:
Ying Liu, MD
646-888-4946

Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
Commack, New York 11725
Contact:
Ying Liu, MD
646-888-4946

Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York 10604
Contact:
Ying Lui, MD
646-888-4946

Memorial Sloan Kettering Cancer Center
New York, New York 10065
Contact:
Ying Liu, MD, MPH.
646-888-4946

Memorial Sloan Kettering Nassau (All Protocol Activities)
Rockville Centre, New York 11570
Contact:
Ying Liu, MD
646-888-4946

More Details

Status
Recruiting
Sponsor
Memorial Sloan Kettering Cancer Center

Study Contact

Ying Liu, MD, MPH
646-888-4946
liuy6@mskcc.org