Effects of Anti-PD1 Adjuvant Checkpoint Blockade Immunotherapy on Atypical/Dysplastic Nevi
Recruiting · NCT06599619 · Observational (researchers observe without assigning treatment) · Lead sponsor: John Kirkwood
View the official record on ClinicalTrials.gov →Interventions studied
Single agent, adjuvant anti-PD1 therapy
What this trial is about
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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
1 location listed across 1 US state.
- UPMC Hillman Cancer Center - Pittsburgh, Pennsylvania, United States