RecruitingObservational

Immune Profiling for Cancer Immunotherapy Response

NCT ID: NCT06116032Sponsor: Dartmouth-Hitchcock Medical CenterLast updated: 2025-12-16

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.

Arms & interventions

Diagnostic TestMethylation Cytometry
Assessment of the ability of Methylation Cytometry in pre-treatment peripheral blood and in repeated measures over the duration of treatment to predict treatment response or occurrence of adverse events.

Outcome measures

Primary

Response to therapy
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.
Time frame: 5 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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

Study locations (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756

Recruiting

Hannah G Stolrow, BA · Contact

7205174950 hannah.stolrow@dartmouth.edu

Brock C Christensen, PhD · Principal Investigator