Clinical trial NCT06075524: Evaluation of Anti-PD-1 Therapy by Monitoring T Cell Responses in Melanoma, Lung and Other Cancer Types
Official title: Maximizing Anti-PD-1 Therapy by Monitoring T Cell Responses in Melanoma, Lung and Other Cancer Types
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-10-10
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Role of Bim for monitoring disease status during anti-PD-1 therapy
timeFrame: 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.
measure: Mechanisms of resistance to anti-PD-1 blockade
timeFrame: 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.
measure: Quantify and modulate levels of NKG7 mRNA in CD8+ T cells
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Svetomir N. Markovic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: