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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Pennsylvania
UPMC Hillman Cancer Center
RECRUITING
Pittsburgh
Contact Information
Primary
Danielle L Bednarz, RN
bednarzdl@upmc.edu
(412) 623-1191
Backup
Amy Rose, RN
kennaj@upmc.edu
4126478587
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 30
Treatments
Patients Treated with single agent, adjuvant anti-PD1 therapy
Patients receiving single agent, adjuvant anti-PD1 therapy (given either as standard of care or as part of a separate investigational study)
Related Therapeutic Areas
Sponsors
Collaborators: Melanoma Research Foundation, VeyTel Inc.
Leads: John Kirkwood

This content was sourced from clinicaltrials.gov