Clinical trial · Observational
Effects of Anti-PD1 Adjuvant Checkpoint Blockade Immunotherapy on Atypical/Dysplastic Nevi
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Single agent, adjuvant anti-PD1 therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients Treated with single agent, adjuvant anti-PD1 therapy
- description
- Patients receiving single agent, adjuvant anti-PD1 therapy (given either as standard of care or as part of a separate investigational study)
- interventionNames
- Drug: Single agent, adjuvant anti-PD1 therapy
Primary outcomes (1)
- measure
- Change in the aggregate pigmentation
- timeFrame
- Pre-treatment, up to 12 months
- description
- 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.
Secondary outcomes (7)
- measure
- Change in predefined atypical nevi - size
- timeFrame
- Pre-treatment, up to 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available