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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Blood Cancer
• Cancer
• Hematologic Malignancy
• Hematologic Neoplasms
• Tumor, Solid

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