Immune Profiling for Cancer Immunotherapy Response

Recruiting

• Conditions: Cancer; Tumor, Solid; Hematologic Malignancy; Blood Cancer
• Interventions: Diagnostic Test: Methylation Cytometry

• Registration Number: NCT06116032
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-03
• Study First Submitted: 2023-10-30
• Study First Submitted QC: 2023-10-30
• Study First Posted: 2023-11-03
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CAR T	Methylation Cytometry	Patients undergoing CAR T therapy
Standard of Care Checkpoint	Methylation Cytometry	Patients receiving standard of care FDA approved immunotherapy
Bone Marrow Transplant	Methylation Cytometry	Patients undergoing transplant for hematologic malignancy

Primary Outcome Measures

Name	Time	Method
Response to therapy	5 years	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.

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States