Monitoring T Cell Responses in Cancer Patients Receiving Anti-PD-1 Therapy
Official title: Maximizing Anti-PD-1 Therapy by Monitoring T Cell Responses in Melanoma, Lung and Other Cancer Types
Run by Mayo Clinic · NCT06075524 · Data updated 2026-11-12
This study is trying to see how T cells in the blood can help doctors understand how well anti-PD-1 therapy works for people with melanoma, lung cancer, and other cancers.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Status | Recruiting |
| Started | June 15, 2015 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | June 18, 2026 |
| Trial ID | NCT06075524 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with advanced melanoma or lung cancer who are starting anti-PD-1 therapy.
✕Probably not a fit
Patients who are currently receiving other concurrent anti-cancer therapies or investigational agents may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the role of T cells in tracking disease status and response to anti-PD-1/PD-L1 treatment in patients with melanoma, lung cancer, and other malignancies. It aims to measure specific biomarkers such as Bim and soluble PD-L1 to understand treatment resistance and clinical outcomes. Patients will provide blood samples, optional stool samples, and previously collected tissue samples, while their medical records will be reviewed to gather comprehensive data on their treatment responses.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of treatment responses and resistance mechanisms in cancer patients, leading to more personalized and effective therapies.
How similar studies have gone: Other studies have shown promise in using T cell monitoring to assess treatment responses, indicating that this approach may be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
-
Mayo Clinic in Rochester
Rochester, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Svetomir N. Markovic, MD, PhD — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.