Impact of anti-PD1 therapy on atypical nevi in melanoma patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the effects of anti-PD1 adjuvant immunotherapy on atypical and dysplastic nevi in patients with a history of melanoma. It aims to determine whether this therapy can prevent the development of melanoma by analyzing changes in the morphology, histopathology, and immune response of these nevi. The study will evaluate the immune responses, including CD8 T cell activity, and assess histopathologic changes in the nevi following treatment. By focusing on patients with specific melanoma stages and atypical nevi, the study seeks to provide insights into the potential preventive effects of anti-PD1 therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

1. 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.
2. Patients who have previously received anti-PD1 therapy
3. Patients with history of other active, non-melanoma cancers
4. Patients who are receiving other anti-neoplastic therapy.

Where it's running

• UPMC Hillman Cancer Center
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: John M Kirkwood, MD — UPMC Hillman Cancer Center
• Study coordinator: Danielle L Bednarz, RN
• Email: bednarzdl@upmc.edu
• Phone: (412) 623-1191

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.