CancerPROWESNCT06635954
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.
An observational study of Cancer and Immunotherapy, run by Oxford Biodynamics Inc. at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Immunotherapy, PD-1
- How many people
- 2,000 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 May 2024to 14 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 18 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
Who cannot join
- Pregnant or breastfeeding
- History of bone marrow or organ transplant
- Contra indication for receiving Immune Check Point inhibitor.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Cancer Center of Middle Georgia
Dublin, Georgia, 31021
Harsha Vyas, MD, (478) 272-8266, hvyas@ccmgeorgia.com
Audrey Bryan, BS, (478) 272-8266, abryan@ccmgeorgia.com
- Recruiting
Eastern Connecticut Hematology and Oncology
Norwich, Connecticut, 06360
Susan Johnson, MD, (860) 886-8362, sjohnson@echoct.com
Stephanie Pacheco, 860-886-8362 ext. 253, SPacheco@echoct.com
- Recruiting
Carolina Blood and Cancer Care Associates
Rock Hill, South Carolina, 29732
Sashi Naidu, MD, 803-329-7772, snaidu@cbcca.net
Joseph DeSimone, BA, 803-329-7772, jdesimone@cbcca.net
About this study
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.
Read the 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
- 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
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From time of enrollment to the 24-week follow up test results
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start14 May 2024
- Primary completion14 May 2026 (estimated)
- Study completion14 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oxford Biodynamics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Community Clinical Oncology Research Network, LLC
- Responsible party
- Sponsor
- Investigators
- Ryan Mathis, MD, Study director, Oxford BioDynamics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635954
- Sponsor's protocol ID
- OB202401
- Acronym
- PROWES
- Status last verified
- Oct 2024
- First submitted
- 5 Sep 2024
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This topic has not been discussed in depth between us and the sponsor. The priority now is to recruit and collect data to show the efficacy of this test. Please reach out to Joseph DeSimone or Ryan Mathis if more information is desired.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06635954
- Acronym / sponsor ID
- PROWES / OB202401
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Oxford Biodynamics Inc.Industry (pharma, biotech, devices)
- Collaborators
- Community Clinical Oncology Research Network, LLC
- Study start
- 14 May 2024 (actual)
- Primary completion
- 14 May 2026 (estimated)
- Study completion
- 14 May 2027 (estimated)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 18 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
Key exclusion criteria (3 listed)
- Pregnant or breastfeeding
- History of bone marrow or organ transplant
- Contra indication for receiving Immune Check Point inhibitor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- What is CiRT?Link provided by the sponsor.
- Oxford BiodynamicsLink provided by the sponsor.
- Community Clinical Oncology Research Network (CCORN)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. This topic has not been discussed in depth between us and the sponsor. The priority now is to recruit and collect data to show the efficacy of this test. Please reach out to Joseph DeSimone or Ryan Mathis if more information is desired.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ryan Mathis, MD study director
Oxford BioDynamics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Immunotherapy, run by Oxford Biodynamics Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ryan Mathis, MD (888-200-3361, ryan.mathis@myobdx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.