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NCT Number: NCT06116032

Immune Profiling for Cancer Immunotherapy Response

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.

Recruiting

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Key information

Conditions

Cancer Blood Cancer Hematologic Diseases Hematologic Malignancy Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site Tumor, Solid

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location status: Recruiting

Location contact

Brock C Christensen, PhD

PRINCIPAL_INVESTIGATOR

Hannah G Stolrow, BA

CONTACT

[email protected]

7205174950

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Brock C Christensen, PhD

CONTACT

[email protected]

603-650-1827

Hannah G Stolrow, BA

CONTACT

[email protected]

7205174950

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2029
First posted
Nov 3, 2023
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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