NCT06157099

Atorvastatin for Preventing Disease Metastasis in Patients With Resected High-Risk Stage IIA, IIB, or IIIA Melanoma

A Decentralized Phase II Randomized Controlled Trial of Atorvastatin in Resected High-Risk Melanoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial tests whether atorvastatin prevents metastasis of resected high-risk stage IIA, IIB or IIIA melanoma. The vast majority of melanomas are diagnosed at an early, localized stage. However, approximately 10-15% of these localized melanomas will eventually metastasize, despite appropriate local treatment. Once metastasis occurs, median survival is less than two years. Melanomas at high risk of metastasis can be identified by gene expression profiling. Statin drugs, like atorvastatin, have been used to treat high cholesterol for the prevention of major adverse cardiovascular events, but not for preventing melanoma metastasis. Statins could prevent melanoma metastasis through decreasing tumor cell migration, decreasing tumor cell adhesion, and increasing immune system response. Statins are also efficient inhibitors of new lymphatic vessels formation. Since tumor lymphatic vessels serve as highways to lymph nodes and may suppress immune system responses, statins may block a critical step towards melanoma metastasis. Using atorvastatin may have the potential to prevent metastasis and improve outcomes in patients with resected high-risk melanoma.

Detailed description

PRIMARY OBJECTIVE: I. To compare recurrence-free survival (RFS) of patients with high-risk melanoma treated with atorvastatin to placebo. SECONDARY OBJECTIVES: I. To compare distant metastasis-free survival (DMFS) between treatment arms. II. To compare overall survival (OS) between treatment arms. EXPLORATORY OBJECTIVE: I. To assess the clinical utility of gene expression profiling in melanoma. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive placebo orally (PO) once per day in the absence of disease progression or unacceptable toxicity for up to 5 years and undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) throughout the study. ARM II: Patients receive atorvastatin PO once per day in the absence of disease progression or unacceptable toxicity for up to 5 years and CT and/or MRI throughout the study. After completion of study treatment, patients are followed for 5 years.

Conditions

• Pathologic Stage IIIA Cutaneous Melanoma AJCC v8
• Pathologic Stage IIA Cutaneous Melanoma AJCC v8
• Pathologic Stage IIB Cutaneous Melanoma AJCC v8

Interventions

Type	Name	Description
DRUG	Atorvastatin	Given PO
DRUG	Placebo Administration	Given orally (PO)
PROCEDURE	Computed Tomography	Undergo CT
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
OTHER	Electronic Health Record Review	Ancillary studies

Timeline

• Start date: 2024-09-01
• Primary completion: 2028-03-01
• Completion: 2029-09-01
• First posted: 2023-12-05
• Last updated: 2026-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study