Immune Profiling for Cancer Immunotherapy Response

Sponsor

Dartmouth-Hitchcock Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT06116032

Collaborator

(none)

1,500

Enrollment

Location

Anticipated Duration (Months)

38.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Tumor, Solid Hematologic Malignancy Blood Cancer	Diagnostic Test: Methylation Cytometry

Study Design

Study Type:

Observational

Anticipated Enrollment :

1500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Immune Profiling for Cancer Immunotherapy Response

Actual Study Start Date :

Oct 3, 2022

Anticipated Primary Completion Date :

Jan 1, 2026

Anticipated Study Completion Date :

Jan 1, 2026

Arms and Interventions

Arm	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.

Arm

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

CAR T

Patients undergoing CAR T therapy

Diagnostic Test: Methylation Cytometry

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756

Sponsors and Collaborators

Dartmouth-Hitchcock Medical Center

Investigators

Principal Investigator: Brock C Christensen, PhD, Dartmouth College

Study Documents (Full-Text)

None provided.

More Information

Publications

Salas LA, Zhang Z, Koestler DC, Butler RA, Hansen HM, Molinaro AM, Wiencke JK, Kelsey KT, Christensen BC. Enhanced cell deconvolution of peripheral blood using DNA methylation for high-resolution immune profiling. Nat Commun. 2022 Feb 9;13(1):761. doi: 10.1038/s41467-021-27864-7.

Responsible Party:

Brock C. Christensen, Associate Professor of Epidemiology, Molecular and Systems Biology, and of Community and Family Medicine, Dartmouth-Hitchcock Medical Center

ClinicalTrials.gov Identifier:

NCT06116032

Other Study ID Numbers:

Study02001227

First Posted:

Nov 3, 2023

Last Update Posted:

Nov 8, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Brock C. Christensen, Associate Professor of Epidemiology, Molecular and Systems Biology, and of Community and Family Medicine, Dartmouth-Hitchcock Medical Center

Immunotherapy

Additional relevant MeSH terms:

Hematologic Neoplasms

Study Results

No Results Posted as of Nov 8, 2023