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NCT06116032 Clinical Trial

Immune Profiling for Cancer Immunotherapy Response

Cancer Clinical Trial

Official title:
Immune Profiling for Cancer Immunotherapy Response

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06116032
Other study ID # Study02001227
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 3, 2022
Est. completion date January 1, 2026

Study information
Verified date November 2023
Source Dartmouth-Hitchcock Medical Center
Contact Brock C Christensen, PhD
Phone 603-650-1827
Email brock.c.christensen@dartmouth.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1500
Est. completion date January 1, 2026
Est. primary completion date January 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Methylation 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.

Locations
Country Name City State
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire

Sponsors (1)
Lead Sponsor Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Salas LA, Zhang Z, Koestler DC, Butler RA, Hansen HM, Molinaro AM, Wiencke JK, Kelsey KT, Christensen BC. Enhanced cell deconvolution of peripheral blood using DNA methylation for high-resolution immune profiling. Nat Commun. 2022 Feb 9;13(1):761. doi: 10.1038/s41467-021-27864-7. — View Citation

Outcome
Type Measure Description Time frame Safety issue
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. 5 years
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