NCT06075524

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. Establish the role of Bim for monitoring disease status during anti-PD-1 therapy. II. Identify the mechanisms of resistance to anti-PD-1 blockade. III. Quantify and modulate levels of NKG7 messenger ribonucleic acid (mRNA) in CD8+ T cells. OUTLINE: This is an observational study. 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.

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

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood and optional stool/tissue sample collection
OTHER	Electronic Health Record Review	Medical records are reviewed

Timeline

• Start date: 2015-06-15
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2023-10-10
• Last updated: 2025-12-26

Locations

1 site across 1 country: United States