RecruitingNot Applicable

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

United States30 participantsStarted 2025-02-20

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Change in the aggregate pigmentation

Timeframe: Pre-treatment, up to 12 months

Trial details

NCT IDNCT06599619

SponsorJohn Kirkwood

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2029-05

Contact for this trial

Danielle L Bednarz, RN

(412) 623-1191 bednarzdl@upmc.edu

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