Status:
RECRUITING
Effects of Anti-PD1 Adjuvant Checkpoint Blockade Immunotherapy on Atypical/Dysplastic Nevi
Lead Sponsor:
John Kirkwood
Collaborating Sponsors:
Melanoma Research Foundation
VeyTel Inc.
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Brief 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...
Detailed Description
Given the established efficacy of anti-PD1 therapy as an adjuvant treatment in both advanced nodal and earlier stage deep primary node negative melanoma, this study hypothesizes that anti-PD1 therapy ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06599619
Start Date
November 1 2024
End Date
December 1 2025
Last Update
March 28 2025
Active Locations (1)
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1
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232