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Observational Study of Anti-PD-1 Therapy in Melanoma, Lung, and Other Cancers

This observational study is looking at how anti-PD-1/PD-L1 (programmed cell death protein 1 / programmed death-ligand 1) therapy works in people with advanced melanoma, lung cancer, and other solid tumors. Researchers will collect blood and optional stool/tissue samples to understand how your body's immune cells, called T cells, respond to this treatment. They are particularly interested in measuring specific markers like Bim and soluble PD-L1 to see if they can predict how well the treatment is working or why some people might develop resistance. This information could help doctors better understand and monitor anti-PD-1/PD-L1 therapies. You may be eligible if you are 18 or older, have locally advanced or stage IV cancer, and your doctor believes anti-PD-1/PD-L1 therapy is appropriate for you. The study aims to enroll 500 participants.

Study design
This is an observational study involving 500 planned participants. It is not a treatment study, but rather observes patients receiving anti-PD-1/PD-L1 therapy.
What's involved
You would provide blood samples throughout the study, up to 10 times, at baseline, 6 weeks after starting therapy, and then at each tumor assessment. Optional stool and tissue samples may also be collected, and your medical records will be reviewed.
Compensation
Not stated in the trial record.
Follow-up
Samples will be collected up to 10 times, including at confirmed disease progression, to monitor disease status during anti-PD-1 therapy.

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NCT06075524

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

Recruiting
Not specifiedAges 18+Observational
Mayo Clinic
~500 participants
Updated 2026-06-18 on ClinicalTrials.gov
What's tested:Biospecimen CollectionElectronic Health Record Review

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Role of Bim for monitoring disease status during anti-PD-1 therapy
Measured over Up to 10 samples: at baseline; 6 weeks after initiation of therapy; subsequently at each radiographic tumor assessment (starting at approx. 9-12 weeks) including at confirmed disease progression.
+2 more outcomes measured

Conditions

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

Explore related trials

Lung CarcinomaMelanomaSolid Neoplasm

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Svetomir N. Markovic, MD, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Role of Bim for monitoring disease status during anti-PD-1 therapyUp to 10 samples: at baseline; 6 weeks after initiation of therapy; subsequently at each radiographic tumor assessment (starting at approx. 9-12 weeks) including at confirmed disease progression.

    Will be assessed by serial measurements of Bim levels in tumor-reactive CD8+ T cells from the peripheral blood of patients with advanced cancer undergoing therapy with an anti-PD-1 monoclonal antibody and correlate them with clinical outcome.

  • Mechanisms of resistance to anti-PD-1 blockadeUp to 10 samples: at baseline; 6 weeks after initiation of therapy; subsequently at each radiographic tumor assessment (starting at approx. 9-12 weeks) including at confirmed disease progression.

    Will be assessed by reviewing blood samples to determine whether high sPD-L1 levels are associated with higher Bim levels in CD11ahigh PD-1+CD8+ T cells and decreased response to single-agent anti-PD1 blocking antibody in patients with cancer.

  • Quantify and modulate levels of NKG7 mRNA in CD8+ T cellsUp to 10 samples: at baseline; 6 weeks after initiation of therapy; subsequently at each radiographic tumor assessment (starting at approx. 9-12 weeks) including at confirmed disease progression.

    CD8+ T cells will be isolated from the peripheral blood of patients with advanced cancer, and messenger ribonucleic acid (mRNA) will be isolated. Qualitative and quantitative reverse transcription polymerase chain reaction (RT-PCR) assays will be performed on these samples in order to determine the levels of six different mRNA splice variants of NKG7. Results will be compared to clinical outcome.