RECRUITINGOBSERVATIONAL
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
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form
Who Should NOT Join This Trial:
- Inability on the part of the patient to understand the willing to sign a consent form 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
PROCEDURE
Biospecimen Collection
Undergo blood and optional stool/tissue sample collection
OTHER
Electronic Health Record Review
Medical records are reviewed
Locations (1)
Mayo Clinic in Rochester
Rochester, Minnesota, United States