Recruiting

Anti-PD1 Immunotherapy

Sponsor:

John Kirkwood

Code:

NCT06599619

Conditions

Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Single agent, adjuvant anti-PD1 therapy

Study Details

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.

Conditions

Melanoma

Study ID

NCT06599619

Start date

Feb 20, 2025

Status verified date

Jan, 2026

Completion date

May, 2029

Anticipated

Primary completion date

May, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

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)

Interventions

Single agent, adjuvant anti-PD1 therapy

One of the following Single-agent, adjuvant anti-PD1 therapies:

Nivolumab is a type of targeted therapy drug called an immune checkpoint inhibitor (a type of immunotherapy). It is a monoclonal antibody that binds to the protein PD-1 on the surface of immune cells called T cells. It works by keeping cancer cells from suppressing the immune system.

Dose = 240 mg IV every 2 weeks/480 mg every 4 weeks or, Pembrolizumab is a monoclonal antibody and a type of immune checkpoint inhibitor that's used in cancer immunotherapy. It works by attaching to the PD-1 protein on the surface of T cells, which are immune cells. This prevents cancer cells from suppressing the immune system, allowing the immune system to attack and kill the cancer cells.

Dose = 200 mg IV every 3 weeks/ 400 mg every 6 weeks

Primary outcome measure

  • Change in the aggregate pigmentation [ Time Frame: Pre-treatment, up to 12 months ]

Central Contacts and Locations

Central contacts

Locations

UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Principal Investigator:

John M Kirkwood, MD

More Information

Sponsor

John Kirkwood

Last update posted

Jan 26, 2026

Last verified

Jan, 2026

Keywords

  • anti-PD1 therapy
  • immune checkpoint blockade
  • dysplastic nevi
  • BRAF and NRAS mutations

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by John Kirkwood on 2026-01-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.