Effects of Anti-PD1 Adjuvant Checkpoint Blockade Immunotherapy on Atypical/Dysplastic Nevi

ConditionMelanoma

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorJohn Kirkwood

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Patients with a prior documented melanoma of Stages IIB, IIC, IIIA, IIIB, or IIIC and concurrent presence of two or more atypical nevi who have received anti-programmed cell death 1 (PD1) therapy given in the approved adjuvant therapeutic regimens.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Single agent, adjuvant anti-PD1 therapy
Drug
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

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: Patients Treated with single agent, adjuvant anti-PD1 therapy1 intervention

Trial outcomes

Primary outcomes

Change in the aggregate pigmentation

Percentage change in the total aggregate pigmentation including A/DN and benign melanocytic nevi. Percent change will be quantified from posterior trunk digital photographic images utilizing DermViz automated image comparison software.

Time frame