RecruitingNCT06075524

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

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

Sponsor

Mayo Clinic

Enrollment

500 participants

Start Date

Jun 15, 2015

Study Type

OBSERVATIONAL

Conditions

Clinical Stage III Cutaneous Melanoma AJCC v8 Clinical Stage IV Cutaneous Melanoma AJCC v8 Locally Advanced Malignant Solid Neoplasm Locally Advanced Melanoma Metastatic Malignant Solid Neoplasm Metastatic Melanoma Stage III Lung Cancer AJCC v8 Stage IV Lung Cancer AJCC v8 Metastatic Lung Carcinoma Locally Advanced Lung Carcinoma

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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 Criteria3

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