A Prospective Real World Evidence Study (PROWES) for Concordance Rate of Blood-based 3D Genome Conformation Mapping (Episwitch CiRT®) to Identify Likelihood of Response and Actual Response Rates to PD-(L)-1 Checkpoint Inhibitors Across Multiple Oncological Indications.

NCT06635954 | Recruiting

• 1 other identifier: OB202401
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 3

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.

Conditions

Cancer; Immunotherapy; PD-1; PD-L1; Immune Checkpoint Therapy

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

Outcome Measures

Primary Outcomes (3)

• Correlation between low probability of response prediction and actual response rate to Immune Checkpoint Inhibitor Therapy

  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.

  From enrollment to the final Episwitch test at week 24

• Establish Health Economics Outcomes Research based on the potential cost savings from foregoing ICI therapy based on Episwitch CiRT prediction of response

  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.

  From time of enrollment to the 24-week follow up test results

• Determine the existence of a correlation between Social Determinants of Health and test results and patient outcomes

  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.

  From time of enrollment to the 24-week follow up test results

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a stage III or IV cancer diagnosis that have been identified and indicated by their healthcare provider to receive immune check point inhibitors as a therapy now or in the near future.

You may qualify if:

• years of age or older
• Stage III or IV cancer
• 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.
• ECOG performance status ≤ 2
• Clinically eligible for ICI therapy
• Able to read, understand and provide written informed consent.
• Willing and able to comply with the study requirements

You may not qualify if:

• Pregnant or breastfeeding
• History of bone marrow or organ transplant
• Contra indication for receiving Immune Check Point inhibitor.

Sponsors & Collaborators

• Oxford Biodynamics Inc.: lead
• Community Clinical Oncology Research Network, LLC: collaborator

Study Sites (3)

Eastern Connecticut Hematology and Oncology

Norwich, Connecticut, 06360, United States

RECRUITING

Cancer Center of Middle Georgia

Dublin, Georgia, 31021, United States

RECRUITING

Carolina Blood and Cancer Care Associates

Rock Hill, South Carolina, 29732, United States

RECRUITING

Related Links

• What is CiRT?
• Oxford Biodynamics
• Community Clinical Oncology Research Network (CCORN)

MeSH Terms

Conditions

Neoplasms

Study Officials

• Ryan Mathis, MD

  Oxford BioDynamics

  STUDY DIRECTOR

Central Study Contacts

Ryan Mathis, MD

CONTACT

888-200-3361; ryan.mathis@myobdx.com

Joseph DeSimone, BA

CONTACT

803-329-7772; joseph@ccorn.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: October 10, 2024
• Study Start: May 14, 2024
• Primary Completion (Estimated): May 14, 2026
• Study Completion (Estimated): May 14, 2027
• Last Updated: March 17, 2025

Record last verified: 2024-10

Locations

US (3)