CancerNCT06116032
Immune Profiling for Cancer Immunotherapy Response
An observational study of Cancer and Tumor, Solid, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Tumor, Solid, Hematologic Malignancy
- What is being tested?
- Methylation Cytometry
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2022to 1 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer patients who will receive or who are receiving immunotherapy under FDA- approved indication
Who may be able to join
- 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).
Who cannot join
- Pregnant women/fetuses/neonates
- Prisoners
- Decision-impaired individuals
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Hannah G Stolrow, BA, 7205174950, hannah.stolrow@dartmouth.edu
Brock C Christensen, PhD
About this study
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
- Being tested
- Methylation Cytometry
- Keywords
- Immunotherapy
- Medical subject headings
- Neoplasms, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylation CytometryDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Checkpoint | Patients receiving standard of care FDA approved immunotherapy Receives: Diagnostic Test: Methylation Cytometry | |
| Bone Marrow Transplant | Patients undergoing transplant for hematologic malignancy Receives: Diagnostic Test: Methylation Cytometry | |
| CAR T | Patients undergoing CAR T therapy Receives: Diagnostic Test: Methylation Cytometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start3 Oct 2022
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brock C. Christensen, Dartmouth-Hitchcock Medical Center
- Investigators
- Brock C Christensen, PhD, Principal investigator, Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116032
- Sponsor's protocol ID
- Study02001227
- Status last verified
- Dec 2025
- First submitted
- 30 Oct 2023
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Profiling for Cancer Immunotherapy Response
- ClinicalTrials.gov ID
- NCT06116032
- Acronym / sponsor ID
- Study02001227
- Conditions
- Cancer, Tumor, Solid, Hematologic Malignancy, Blood Cancer
- Keywords
- Immunotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Checkpoint | – | Diagnostic Test: Methylation CytometryPatients receiving standard of care FDA approved immunotherapy |
| Bone Marrow Transplant | – | Diagnostic Test: Methylation CytometryPatients undergoing transplant for hematologic malignancy |
| CAR T | – | Diagnostic Test: Methylation CytometryPatients undergoing CAR T therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients who will receive or who are receiving immunotherapy under FDA- approved indication
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (3 listed)
- Pregnant women/fetuses/neonates
- Prisoners
- Decision-impaired individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylation CytometryAssessment 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. | Diagnostic test | Bone Marrow Transplant, CAR T, Standard of Care Checkpoint |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brock C Christensen, PhD principal investigator
Dartmouth College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Tumor, Solid, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brock C Christensen, PhD (603-650-1827, brock.c.christensen@dartmouth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to therapy (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.