Clinical trial NCT06635954: 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.
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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Oxford Biodynamics Inc.
Sponsor class: INDUSTRY
Collaborators: name: Community Clinical Oncology Research Network, LLC
First posted: 2024-10-10
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Eligibility 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.

Primary outcomes:
measure: Correlation between low probability of response prediction and actual response rate to Immune Checkpoint Inhibitor Therapy
timeFrame: From enrollment to the final Episwitch test at week 24
measure: Establish Health Economics Outcomes Research based on the potential cost savings from foregoing ICI therapy based on Episwitch CiRT prediction of response
timeFrame: From time of enrollment to the 24-week follow up test results
measure: Determine the existence of a correlation between Social Determinants of Health and test results and patient outcomes
timeFrame: From time of enrollment to the 24-week follow up test results
Secondary outcomes:
Other outcomes:
Locations:
city: Norwich
country: United States
facility: Eastern Connecticut Hematology and Oncology
state: Connecticut
city: Dublin
country: United States
facility: Cancer Center of Middle Georgia
state: Georgia
city: Rock Hill
country: United States
facility: Carolina Blood and Cancer Care Associates
state: South Carolina
Study officials:
affiliation: Oxford BioDynamics
name: Ryan Mathis, MD
role: STUDY_DIRECTOR
References: