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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-15

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood and optional stool/tissue sample collection

Electronic Health Record Review

Intervention Type OTHER

Medical records are reviewed

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Biospecimen Collection

Undergo blood and optional stool/tissue sample collection

Intervention Type PROCEDURE

Electronic Health Record Review

Medical records are reviewed

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Biological Sample Collection Biospecimen Collected Specimen Collection

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Svetomir N. Markovic, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Clinical Trials Referral Office

Role: CONTACT

Phone: 855-776-0015

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Clinical Trials Referral Office

Role: primary