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ACTIVE NOT RECRUITING
NCT06157099
PHASE2

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

Sponsor: OHSU Knight Cancer Institute

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2024-09-01

Completion Date

2029-09-01

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

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

Locations (1)

OHSU Knight Cancer Institute

Portland, Oregon, United States