Actively Recruiting
Maximizing Anti-PD-1 Therapy by Monitoring T Cell Responses in Melanoma, Lung and Other Cancer Types
Led by Mayo Clinic · Updated on 2025-12-26
500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the role of T cells in monitoring disease status and treatment response in patients with melanoma, lung cancer, and other advanced cancer types receiving anti-PD-1/PD-L1 therapy. The study aims to understand why some patients respond to these treatments while others do not by measuring specific targets like Bim and soluble PD-L1 during therapy. It also seeks to identify mechanisms of resistance and evaluate the levels of NKG7 mRNA in CD8+ T cells. This observational study involves collecting blood samples throughout the treatment period to track these markers at baseline, six weeks after starting therapy, and at regular tumor assessments approximately every 9 to 12 weeks, including times of disease progression. Optional stool samples and previously collected tissue samples may also be provided. Medical records are reviewed as part of the evaluation. Participants provide blood samples and possibly stool and tissue samples while researchers review their medical history. The study measures changes in biomarkers related to disease status and resistance to treatment. The monitoring occurs alongside regular tumor imaging and clinical assessments. The study is led by Mayo Clinic and participation continues as long as patients are receiving anti-PD-1/PD-L1 therapy.
CONDITIONS
Brief Title
Evaluation of Anti-PD-1 Therapy by Monitoring T Cell Responses in Melanoma, Lung and Other Cancer Types
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 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
You will not qualify if you...
- Inability to understand the informed consent or comply with the protocol
- Receiving any concurrent anti-cancer therapy or investigational agents other than anti-PD-1/anti-PD-L1 therapy
- Pregnant, nursing, or of childbearing potential and unwilling to use adequate contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 2 years
Participants undergo blood sample collection throughout the study. They may also provide optional stool samples and previously collected tissue samples. Medical records are reviewed to monitor disease status during anti-PD-1 therapy.
Up to 10 blood sample collections at baseline, 6 weeks after therapy starts, and at each radiographic tumor assessment approximately every 9-12 weeks including at disease progression
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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