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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
John Kirkwood
Study ID
NCT06599619
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Feb 20, 2025
Status verified
Jan 2026
Primary completion
May 31, 2029
Completion
May 31, 2029

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: 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)

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Hillman Cancer CenterPittsburghPennsylvania15232
Danielle L Bednarz, RN
[email protected]
(412) 623-1191
Amy Rose, RN
[email protected]
4126478587
John M Kirkwood, MD (PRINCIPAL_INVESTIGATOR)
Urvashi M Joshi, MD (SUB_INVESTIGATOR)

Find similar trials in Pittsburgh, PA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
UPMC Hillman Cancer Center· Pittsburgh, PA

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