Immune Profiling for Cancer Immunotherapy Response

December 9, 2025 updated by: Brock C. Christensen, Dartmouth-Hitchcock Medical Center
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth-Hitchcock Medical Center
        • Contact:
        • Principal Investigator:
          • Brock C Christensen, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Standard of Care Checkpoint
Patients receiving standard of care FDA approved immunotherapy
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.
Bone Marrow Transplant
Patients undergoing transplant for hematologic malignancy
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.
CAR T
Patients undergoing CAR T therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response to therapy
Time Frame: 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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Investigators

  • Principal Investigator: Brock C Christensen, PhD, Dartmouth College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2022

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

October 30, 2023

First Submitted That Met QC Criteria

October 30, 2023

First Posted (Actual)

November 3, 2023

Study Record Updates

Last Update Posted (Actual)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Study02001227

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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