Effects of Anti-PD1 Adjuvant Checkpoint Blockade Immunotherapy on Atypical/Dysplastic Nevi
ConditionMelanoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJohn Kirkwood
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Single agent, adjuvant anti-PD1 therapy
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
John Kirkwood
Lead sponsor
University of Pittsburgh
Sponsor institution
Melanoma Research Foundation
Collaborator
VeyTel Inc.
Collaborator
Source ClinicalTrials.gov