Immune Profiling for Cancer Immunotherapy Response
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDartmouth-Hitchcock Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Pregnant women/fetuses/neonates
Prisoners
Decision-impaired individuals
Trial population
Cancer patients who will receive or who are receiving immunotherapy under FDA- approved indication
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Methylation Cytometry
Diagnostic testAssessment 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.
Treatment groups
1,500 Participants
are divided into 3 treatment groupsGroup A: Standard of Care Checkpoint1 intervention
Group B: Bone Marrow Transplant1 intervention
Group C: CAR T1 intervention
Trial outcomes
Primary outcomes
1
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 yearsSponsors and contacts
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Source ClinicalTrials.gov