RecruitingNCT06599619

Effects of Anti-PD1 Adjuvant Checkpoint Blockade Immunotherapy on Atypical/Dysplastic Nevi

A Study of the Effects of Anti-PD1 Adjuvant Checkpoint Blockade Immunotherapy on Features of Atypical/Dysplastic Nevi in Patients With Stage IIB-IIIC Melanoma

Sponsor

John Kirkwood

Enrollment

30 participants

Start Date

Feb 20, 2025

Study Type

OBSERVATIONAL

Conditions

Melanoma

Summary

This study will examine the impact of anti-programmed cell death 1 (PD1) therapy given in the approved adjuvant therapeutic regimens upon the morphologic, histopathologic, molecular and immunologic as well as genomic features of atypical/dysplastic nevi (A/DN) in patients with a prior documented melanoma of Stages IIB, IIC, IIIA, IIIB, or IIIC and concurrent presence of two or more atypical nevi.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

Subjects must have at least two atypical nevi of ≥ 4 mm diameter.
Subjects must have a current documented history of melanoma.
Subject must be ≥ 18 years and if female of childbearing potential, must agree to practice effective contraception per institutional SOC if sexually active.
Subjects will have been deemed candidates for adjuvant therapy with single agent anti-PD1 therapy.
Subjects must give written informed consent to participate in this study with consent signed and dated prior to entry into trial.

Exclusion Criteria4

Patients with non-malignant diseases or indications that would preclude the administration of anti-PD1 therapy such as significant immune suppression or active autoimmune disease requiring disease modifying, immunosuppressive therapy, will be ineligible.
Patients who have previously received anti-PD1 therapy
Patients with history of other active, non-melanoma cancers
Patients who are receiving other anti-neoplastic therapy.

Interventions

DRUGSingle agent, adjuvant anti-PD1 therapy

One of the following Single-agent, adjuvant anti-PD1 therapies: Nivolumab is a type of targeted therapy drug called an immune checkpoint inhibitor (a type of immunotherapy). It is a monoclonal antibody that binds to the protein PD-1 on the surface of immune cells called T cells. It works by keeping cancer cells from suppressing the immune system. Dose = 240 mg IV every 2 weeks/480 mg every 4 weeks or, Pembrolizumab is a monoclonal antibody and a type of immune checkpoint inhibitor that's used in cancer immunotherapy. It works by attaching to the PD-1 protein on the surface of T cells, which are immune cells. This prevents cancer cells from suppressing the immune system, allowing the immune system to attack and kill the cancer cells. Dose = 200 mg IV every 3 weeks/ 400 mg every 6 weeks