Recruiting

Episwitch CiRT®

Sponsor:

Oxford Biodynamics Inc.

Code:

NCT06635954

Conditions

Cancer

Immunotherapy

PD-1

PD-L1

Immune Checkpoint Therapy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT06635954

Start date

May 14, 2024

Status verified date

Oct, 2024

Completion date

May 14, 2027

Anticipated

Primary completion date

May 14, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Correlation between low probability of response prediction and actual response rate to Immune Checkpoint Inhibitor Therapy [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: From time of enrollment to the 24-week follow up test results ]

Central Contacts and Locations

Central contacts

Ryan Mathis, MD

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

Joseph DeSimone, BA

803-329-7772joseph@ccorn.net

Locations

Eastern Connecticut Hematology and Oncology

Recruiting

Norwich, Connecticut, United States, 06360

Contacts

Susan Johnson, MD

(860) 886-8362sjohnson@echoct.com

Stephanie Pacheco

860-886-8362SPacheco@echoct.com

Principal Investigator:

Dennis Slater, MD

Cancer Center of Middle Georgia

Recruiting

Dublin, Georgia, United States, 31021

Contacts

Harsha Vyas, MD

(478) 272-8266hvyas@ccmgeorgia.com

Audrey Bryan, BS

(478) 272-8266abryan@ccmgeorgia.com

Principal Investigator:

Harsha Vyas, MD

Carolina Blood and Cancer Care Associates

Recruiting

Rock Hill, South Carolina, United States, 29732

Contacts

Sashi Naidu, MD

803-329-7772snaidu@cbcca.net

Joseph DeSimone, BA

803-329-7772jdesimone@cbcca.net

Principal Investigator:

Sashi Naidu, MD

More Information

Sponsor

Oxford Biodynamics Inc.

Last update posted

Mar 17, 2025

Last verified

Oct, 2024

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oxford Biodynamics Inc. on 2025-03-17.