Immune Profiling for Cancer Immunotherapy Response
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Enrollment
- 1500
- Locations
- 1
- Primary Endpoint
- Response to therapy
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
In patients clinically treated with FDA-approved immunotherapy the investigators will assess the predictive value of pre- and on-treatment 1) immune-methylation profiling across cancer types, and 2) immune-methylation profiling and cytokine profiling within cancer types.
Investigators
Brock C. Christensen
Professor of Epidemiology, Molecular and Systems Biology, and of Community and Family Medicine
Dartmouth-Hitchcock Medical Center
Eligibility Criteria
Inclusion Criteria
- •Cancer patients receiving or will receive immunotherapy under FDA- approved indication (e.g. checkpoint inhibitor therapy with pembrolizumab, nivolumab, or ipilimumab, or cellular immunotherapy).
- •Participants are eligible regardless of the type of prior therapy (i.e. prior immunotherapy treated participants can be included).
Exclusion Criteria
- •Pregnant women/fetuses/neonates
- •Prisoners
- •Decision-impaired individuals
Outcomes
Primary Outcomes
Response to therapy
Time Frame: 5 years
The investigators will employ iRECIST, and outcome criteria will be clinically evaluated and include the primary endpoints of progression (non-responders) or response, with patients followed up every month for 6 months (or until death, loss to follow-up, or withdrawal of consent), judged according to the objective response rate (ORR) assessed using iRECIST.