Evaluation of Anti-PD-1 Therapy by Monitoring T Cell Responses in Melanoma, Lung and Other Cancer Types

Mayo Clinic

Status

Enrolling

Conditions

Stage III Lung Cancer AJCC v8

Metastatic Malignant Solid Neoplasm

Clinical Stage IV Cutaneous Melanoma AJCC v8

Locally Advanced Melanoma

Metastatic Lung Carcinoma

Metastatic Melanoma

Locally Advanced Lung Carcinoma

Clinical Stage III Cutaneous Melanoma AJCC v8

Locally Advanced Malignant Solid Neoplasm

Stage IV Lung Cancer AJCC v8

Treatments

Other: Electronic Health Record Review

Procedure: Biospecimen Collection

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT06075524

NCI-2022-08127 (Registry Identifier)

F30CA250326 (U.S. NIH Grant/Contract)

R21CA197878 (U.S. NIH Grant/Contract)

15-000934 (Other Identifier)

MC200706 (Other Identifier)

Details and patient eligibility

About

This study explores the role of T cells in monitoring disease status and response during anti-PD-1/PD-L1 treatment in patients with melanoma, lung and other cancer types. Measuring levels of specific targets such as Bim and soluble PD-L1 during therapy may help track treatment resistance and clinical outcomes. This information may also help researchers determine why some people with melanoma, lung and other cancer types respond to PD-1/PD-L1 treatment and others do not.

Full description

PRIMARY OBJECTIVES:

I. Establish the role of Bim for monitoring disease status during anti-PD-1 therapy.

II. Identify the mechanisms of resistance to anti-PD-1 blockade. III. Quantify and modulate levels of NKG7 messenger ribonucleic acid (mRNA) in CD8+ T cells.

OUTLINE: This is an observational study.

Patients undergo blood sample collection throughout the study. Patients also undergo optional stool sample collection and have their medical records reviewed on study. In addition, patients provide previously-collected tissue sample, if available.

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Are 18 years of age or older
Have histologic evidence of locally or regionally advanced or stage IV malignancy
Are considered appropriate for starting therapy with anti-PD-1/anti-PD-L1 monoclonal antibody by their treating physician (prior therapy with immune checkpoint inhibitor (ICI) is allowed)
Have an understanding of the protocol and its requirements, risks, and discomforts
Are willing to undergo peripheral blood collection at the time points mentioned in the protocol
Are able and willing to sign an informed consent

Exclusion criteria

Inability on the part of the patient to understand the informed consent or be compliant with the protocol
Patients receiving any concurrent anti-cancer therapy or investigational agents (with the exception of an anti-PD-1/anti-PD-L1 agent as mentioned above)
Patients who are pregnant, nursing, or are of childbearing potential and are unwilling to employ adequate contraception