Evaluation of Anti-PD-1 Therapy by Monitoring T Cell Responses in Melanoma, Lung and Other Cancer Types
Recruiting · NCT06075524 · Observational (researchers observe without assigning treatment) · Lead sponsor: Mayo Clinic
View the official record on ClinicalTrials.gov →Interventions studied
Biospecimen CollectionElectronic Health Record Review
What this trial is 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed across 1 US state.
- Mayo Clinic in Rochester - Rochester, Minnesota, United States