NCT06599619 Effects of Anti-PD1 Adjuvant Checkpoint Blockade Immunotherapy on Atypical/Dysplastic Nevi
| NCT ID | NCT06599619 |
| Status | Recruiting |
| Phase | — |
| Sponsor | John Kirkwood |
| Condition | Melanoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-02-20 |
| Primary Completion | 2029-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2025-02-20 with a primary completion date of 2029-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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.
Contact & Investigator
John M Kirkwood, MD
PRINCIPAL INVESTIGATOR
UPMC Hillman Cancer Center
Frequently Asked Questions
Who can join the NCT06599619 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06599619 currently recruiting?
Yes, NCT06599619 is actively recruiting participants. Contact the research team at bednarzdl@upmc.edu for enrollment information.
Where is the NCT06599619 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT06599619 clinical trial?
NCT06599619 is sponsored by John Kirkwood. The principal investigator is John M Kirkwood, MD at UPMC Hillman Cancer Center. The trial plans to enroll 30 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.