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

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

NCT ID: NCT06075524

Condition: 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

Conditions: Official terms:
Carcinoma
Lung Neoplasms
Neoplasms
Melanoma
Melanoma, Cutaneous Malignant
Skin Neoplasms

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Procedure
Intervention name: Biospecimen Collection
Description: Undergo blood and optional stool/tissue sample collection
Arm group label: Observational (Blood and stool sample collection)

Other name: Biological Sample Collection

Other name: Biospecimen Collected

Other name: Specimen Collection

Intervention type: Other
Intervention name: Electronic Health Record Review
Description: Medical records are reviewed
Arm group label: Observational (Blood and stool sample collection)

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.

Criteria for eligibility:

Study pop:
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.

Sampling method: Non-Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Mayo Clinic in Rochester

Address:
City: Rochester
Zip: 55905
Country: United States

Status: Recruiting

Contact:
Last name: Svetomir N. Markovic

Phone: 507-284-2511

Investigator:
Last name: Svetomir N. Markovic
Email: Principal Investigator

Start date: June 15, 2015

Completion date: December 31, 2025

Lead sponsor:
Agency: Mayo Clinic
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: Mayo Clinic

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06075524
https://www.mayo.edu/research/clinical-trials