Impact of anti-PD1 therapy on atypical nevi in melanoma patients
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
This study is testing whether anti-PD1 therapy can help prevent melanoma by looking at changes in unusual moles in patients who have had melanoma before.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT06599619 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effects of anti-PD1 adjuvant immunotherapy on atypical and dysplastic nevi in patients with a history of melanoma. It aims to determine whether this therapy can prevent the development of melanoma by analyzing changes in the morphology, histopathology, and immune response of these nevi. The study will evaluate the immune responses, including CD8 T cell activity, and assess histopathologic changes in the nevi following treatment. By focusing on patients with specific melanoma stages and atypical nevi, the study seeks to provide insights into the potential preventive effects of anti-PD1 therapy.
Who should consider this trial
Good fit: Ideal candidates are adults with a documented history of melanoma and at least two atypical nevi of 4 mm or larger.
Not a fit: Patients with significant immune suppression, active autoimmune diseases, or those who have previously received anti-PD1 therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new preventive strategies against melanoma in high-risk patients.
How similar studies have performed: While the use of anti-PD1 therapy has shown success in treating melanoma, this specific approach focusing on atypical nevi is novel and not extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subjects must have at least two atypical nevi of ≥ 4 mm diameter. 2. Subjects must have a current documented history of melanoma. 3. Subject must be ≥ 18 years and if female of childbearing potential, must agree to practice effective contraception per institutional SOC if sexually active. 4. Subjects will have been deemed candidates for adjuvant therapy with single agent anti-PD1 therapy. 5. Subjects must give written informed consent to participate in this study with consent signed and dated prior to entry into trial. Exclusion Criteria: 1. 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. 2. Patients who have previously received anti-PD1 therapy 3. Patients with history of other active, non-melanoma cancers 4. Patients who are receiving other anti-neoplastic therapy.
Where this trial is running
Pittsburgh, Pennsylvania
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: John M Kirkwood, MD — UPMC Hillman Cancer Center
- Study coordinator: Danielle L Bednarz, RN
- Email: bednarzdl@upmc.edu
- Phone: (412) 623-1191
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.