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

NCT06075524 | Recruiting DMC

• 5 other identifiers: MC200706NCI-2022-0812715-000934F30CA250326R21CA197878
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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; Clinical Stage III Cutaneous Melanoma AJCC v8

Outcome Measures

Primary Outcomes (3)

• Role of Bim for monitoring disease status during anti-PD-1 therapy

  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.

  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.

• Mechanisms of resistance to anti-PD-1 blockade

  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.

  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.

• Quantify and modulate levels of NKG7 mRNA in CD8+ T cells

  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.

  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.

Study Arms (1)

Observational (Blood and stool sample collection)

Patients undergo blood sample collection throughout the study. Patients also undergo optional stool sample collection and have their medical records reviewed on study. In addition, patients provide previously-collected tissue sample, if available.

Procedure: Biospecimen Collection; Other: Electronic Health Record Review

Interventions

Biospecimen Collection PROCEDURE

Undergo blood and optional stool/tissue sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Observational (Blood and stool sample collection)

Electronic Health Record Review OTHER

Medical records are reviewed

Observational (Blood and stool sample collection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with metastatic melanoma, lung or other cancer recruited from the clinical practice in the Department of Oncology at Mayo Clinic in Rochester, Minnesota who are considered appropriate for starting therapy with an open-label commercially available, FDA approved anti-PD-1 monoclonal antibody by their treating provider.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

DNA will be extracted from the blood and stool specimens

MeSH Terms

Conditions

Lung Neoplasms; Neoplasm Metastasis; Melanoma

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Svetomir N. Markovic, MD, PhD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 10, 2023
• Study Start: June 15, 2015
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

US (1)