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

Plain Language Summary

Simplified for easier understanding

This study is investigating whether anti-PD1 immunotherapy — a type of cancer treatment that helps the immune system fight cancer — affects abnormal or unusual moles (called atypical or dysplastic nevi) in people with melanoma who are already receiving this treatment. **You may be eligible if...** - You are 18 or older - You have been diagnosed with melanoma - You have at least two atypical (unusual-looking) moles that are at least 4mm wide - You have been recommended for anti-PD1 immunotherapy as part of your melanoma treatment - Women of childbearing age must agree to use effective contraception **You may NOT be eligible if...** - You have conditions that would prevent you from receiving anti-PD1 therapy, such as active autoimmune disease requiring immunosuppressive treatment - You have previously received anti-PD1 therapy - You have another active cancer other than melanoma - You are receiving other cancer treatments at the same time Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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