Immune Profiling for Cancer Immunotherapy Response

NCT06116032 | Recruiting FDA Drug

• 1 other identifier: Study02001227
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Tumor, Solid; Hematologic Malignancy; Blood Cancer

Keywords

Immunotherapy

Outcome Measures

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.

  5 years

Study Arms (3)

Standard of Care Checkpoint

Patients receiving standard of care FDA approved immunotherapy

Diagnostic Test: Methylation Cytometry

Bone Marrow Transplant

Patients undergoing transplant for hematologic malignancy

Diagnostic Test: Methylation Cytometry

CAR T

Patients undergoing CAR T therapy

Diagnostic Test: Methylation Cytometry

Interventions

Methylation Cytometry DIAGNOSTIC_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.

Bone Marrow Transplant; CAR T; Standard of Care Checkpoint

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cancer patients who will receive or who are receiving immunotherapy under FDA- approved indication

You may qualify if:

• 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).

You may not qualify if:

• Pregnant women/fetuses/neonates
• Prisoners
• Decision-impaired individuals

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood and FFPE tumor tissue

MeSH Terms

Conditions

Neoplasms; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Brock C Christensen, PhD

  Dartmouth College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brock C Christensen, PhD

CONTACT

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

Hannah G Stolrow, BA

CONTACT

7205174950; hannah.stolrow@dartmouth.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Epidemiology, Molecular and Systems Biology, and of Community and Family Medicine

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 3, 2023
• Study Start: October 3, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2029
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

US (1)