Cancer, Immune Checkpoint Therapy, Immunotherapy, PD-1, PD-L1
Conditions
Keywords
immunotherapy, immune checkpoint inhibitor, ICI therapy, ICI, Immune Checkpoint Inhibitor therapy, Episwitch, Episwitch CiRT, Immune Related Adverse Event, IRAE, cancer, PD-1, PD-L1
Brief summary
The purpose of this research is to test whether a blood-based 3D genome conformation mapping test called the Episwitch CiRT® can help to identify likelihood of response to PD-(L)-1 checkpoint inhibitors (a class of cancer drugs) across multiple oncological indications by comparing the results to actual treatment responses for cancer patients.
Detailed description
The Episwitch CiRT® (Checkpoint inhibitor Response Test) predicts how a patient will respond to immune checkpoint inhibitor (ICI) therapies by delivering a binary response likelihood profile (High Probability vs. Low Probability). Patients who have been diagnosed with stage III and IV cancer and who are candidates and/or planned to receive immune check point inhibitors as a therapy now or in near future will be offered the Episwitch CiRT™ before starting treatment or if on active treatment. Those patients with high probability of response to ICI will undergo repeat testing every three months. Patients will be followed for up to six months. Treatment administered, disease-free survival, overall survival, stable disease, progressive disease, complete response, time to recurrence, physician questionnaires and patient-reported outcomes will be recorded for six months. Comprehensive data of Social Determinants of Health (SDoH) will be collected to identify any correlation to unmet Health Related Social Needs (HrSN) and likelihood to response and/or resistance
Interventions
None listed
Sponsors
Community Clinical Oncology Research Network, LLC
Oxford Biodynamics Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age or older 2. Stage III or IV cancer 3. Selected by their healthcare provider to receive the Episwitch CiRT® test according to the current evidence-based schedule (per protocol) as part of their standard of practice. 4. ECOG performance status ≤ 2 5. Clinically eligible for ICI therapy 6. Able to read, understand and provide written informed consent. 7. Willing and able to comply with the study requirements
Exclusion criteria
1. Pregnant or breastfeeding 2. History of bone marrow or organ transplant 3. Contra indication for receiving Immune Check Point inhibitor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between low probability of response prediction and actual response rate to Immune Checkpoint Inhibitor Therapy | From enrollment to the final Episwitch test at week 24 | At the time of enrollment, case report forms will be completed that capture the patient's current and previous treatments, stage of disease, and prognosis. After receiving results from Episwitch CiRT, a follow up case report form will be completed that captures the response prediction from the test as well as the patient's response to their current treatment, and whether or not that treatment is an ICI therapy. The patients on ICI that receive results that indicate low probability of response will be compared to their actual response to treatment. |
| Establish Health Economics Outcomes Research based on the potential cost savings from foregoing ICI therapy based on Episwitch CiRT prediction of response | From time of enrollment to the 24-week follow up test results | Patients that are predicted to have a low probability of response to ICI therapy and are receiving ICI therapy will be identified throughout the study via case report forms. We will estimate drug cost savings based on the amount of ICI therapy received by the patient. We will also capture any immune related adverse events from the ICI therapy and account for any costs related to these reactions. This will all be used as a rough model and predictor of the potential cost savings of using the Episwitch CiRT in treatment decisions. |
| Determine the existence of a correlation between Social Determinants of Health and test results and patient outcomes | From time of enrollment to the 24-week follow up test results | Upon enrollment, patients will complete a Social Determinants of Health Questionnaire that captures the following information: ethnicity, race, quality of housing, housing insecurity, highest education, employment status, insurance, income, how frequently patients talk to those they care about, transportation needs, refugee status, and lack of access to the following resources food, utilities, phone, clothing, childcare, and medicine/health care. The responses will be used to identify patients that have no, low, or high needs and compare these groups' testing results and outcomes to each other. Further or more in-depth analysis may be needed to understand correlations between SDOH and ICI therapy outcome. |
Countries
United States
Contacts
Primary ContactRyan Mathis, MD
Backup ContactJoseph DeSimone, BA
Outcome results
None listed