RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-11-01

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06599619

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Danielle L Bednarz, RN

CONTACT

(412) 623-1191

bednarzdl@upmc.edu

Amy Rose, RN

CONTACT

4126478587

kennaj@upmc.edu

Principal Investigator

John M Kirkwood, MD

PRINCIPAL_INVESTIGATOR

UPMC Hillman Cancer Center

Study Locations (Sites)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

United States

Collaborators and Investigators

Sponsor: John Kirkwood

John M Kirkwood, MD, PRINCIPAL_INVESTIGATOR, UPMC Hillman Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-01

Study Completion Date2025-12

Study Record Updates

Study Start Date2024-11-01

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Melanoma