Effects of Anti-PD1 Adjuvant Checkpoint Blockade Immunotherapy on Atypical/Dysplastic Nevi
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Single agent, adjuvant anti-PD1 therapy.
- Who it may be relevant to
- Registry conditions: Melanoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
Given the established efficacy of anti-PD1 therapy as an adjuvant treatment in both advanced nodal and earlier stage deep primary node negative melanoma, this study hypothesizes that anti-PD1 therapy may provide a basis for effective therapeutic prevention. To study if anti-PD1 therapy can help prevent the development of melanoma, this study will examine its effects upon atypical/dysplastic nevi, which are well established as non-obligate pre-cursor lesions that are markers of increased risk of melanoma. This single agent, adjuvant study will evaluate the impact of adjuvant anti-PD1 therapy on morphology, histopathology, immunologic/molecular features, and gene expression of atypical/dysplastic nevi present in patients with stage IIB-III melanoma. This study aims to determine if anti-PD1 therapy will increase CD8 T cell responses to melanoma antigens, resulting in immune surveillance and anti-tumor immune responses within A/DN. It postulates that in response to anti-PD1 therapy, the aggregate pigmentation of total nevi including atypical/dysplastic nevi and benign melanocytic nevi will decrease with a measurable morphologic response. This study also asserts that there will be histopathologic changes within A/DN including increased density of immune infiltrate and increased presence of regression features. Increased anti-tumor immune response measured by increased CD8, IFN-y, and PD-1 expression within nevi is anticipated, along with a decrease in genes involved in pathways of melanomagenesis, pigmentation, and inflammation.
Interventions
- Drug 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
Primary outcome measures
- Change in the aggregate pigmentation [Time frame: Pre-treatment, up to 12 months]
Secondary outcome measures (7)
- Change in predefined atypical nevi - size [Time frame: Pre-treatment, up to 12 months]
- Change in predefined atypical nevi - margin [Time frame: Pre-treatment, up to 12 months]
- Change in predefined atypical nevi - pigmentation [Time frame: Pre-treatment, up to 12 months]
- Change in histopathologic features of A/DN - cellular infiltrate [Time frame: Pre-treatment, up to 12 months]
- Change in histopathologic features of A/DN - regression features [Time frame: Pre-treatment, up to 12 months]
- Change in histopathologic features of A/DN - cytologic features [Time frame: Pre-treatment, up to 12 months]
- Change in histopathologic features of A/DN - dysplastic features [Time frame: Pre-treatment, up to 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- UPMC Hillman Cancer Center — Pittsburgh
Identifiers
NCT: NCT06599619 · HCC 23-167