Immune Profiling for Cancer Immunotherapy Response

Dartmouth-Hitchcock Medical Center1,500 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,500

Conditions

Cancer Tumor, Solid Hematologic Malignancy Blood Cancer

Interventions

Methylation CytometryDIAGNOSTIC_TEST

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

RECRUITING

Outcomes

Primary Outcomes

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

Central Contacts

Brock C Christensen, PhD

CONTACT

603-650-1827 brock.c.christensen@dartmouth.edu

Hannah G Stolrow, BA

CONTACT

7205174950 hannah.stolrow@dartmouth.edu

Data from ClinicalTrials.gov

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