Testing a blood test to predict response to cancer immunotherapy
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.
This study is testing a blood test to see if it can predict how well people with advanced cancer will respond to a specific type of immunotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oxford Biodynamics Inc. Industry-sponsored |
| Locations | 3 sites (Norwich, Connecticut and 2 other locations) |
| Trial ID | NCT06635954 on ClinicalTrials.gov |
What this trial studies
This research aims to evaluate the effectiveness of the Episwitch CiRT® test, which uses blood-based 3D genome conformation mapping to predict how patients with stage III and IV cancer will respond to PD-(L)-1 checkpoint inhibitors. Patients selected for this test will be monitored for their treatment responses over a six-month period, with data collected on various health outcomes and social determinants. The study will compare predicted responses to actual treatment outcomes, providing insights into the test's predictive capabilities.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with stage III or IV cancer who are clinically eligible for immune checkpoint inhibitor therapy.
Not a fit: Patients who are pregnant, breastfeeding, or have a history of bone marrow or organ transplant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify which cancer patients are most likely to benefit from immunotherapy, potentially improving treatment outcomes.
How similar studies have performed: Other studies have explored predictive tests for immunotherapy responses, but the specific approach of using blood-based 3D genome mapping is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Norwich, Connecticut and 2 other locations
- Eastern Connecticut Hematology and Oncology — Norwich, Connecticut, United States (Recruiting)
- Cancer Center of Middle Georgia — Dublin, Georgia, United States (Recruiting)
- Carolina Blood and Cancer Care Associates — Rock Hill, South Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Ryan Mathis, MD
- Email: ryan.mathis@myobdx.com
- Phone: 888-200-3361
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.