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HMG-CoA Reductase Inhibitor

Atorvastatin for Melanoma

Phase 2

Recruiting

Led By Wesley Yu, M.D.

Research Sponsored by OHSU Knight Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

DecisionDx Melanoma test result completed and resulted as class 2B

Participant must have no evidence of metastatic disease on imaging as determined by investigator assessment. All suspicious lesions amenable to biopsy should be confirmed negative for malignancy

Must not have

Participants who are currently taking a statin or have taken a statin in the year before enrollment

Participant who has a history of severe hypersensitivity (>= grade 3) attributed to compounds of similar chemical or biologic composition to atorvastatin or other agents used in the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to death due to any cause, assessed up to 5 years

Summary

This trial tests if atorvastatin can prevent metastasis of high-risk stage IIA melanoma, which can spread & reduce survival time. Statins may block a critical step towards melanoma metastasis & improve outcomes.

Who is the study for?

This trial is for adults over 18 with a specific type of skin cancer called high-risk stage IIA cutaneous melanoma that's been surgically removed. They must not have had other melanoma treatments or certain medications, and should be generally healthy with no evidence of cancer spread. Women who can get pregnant must agree to use birth control.

What is being tested?

The study tests if atorvastatin, commonly used for cholesterol, can prevent the spread (metastasis) of resected high-risk melanoma by affecting tumor cell behavior and immune response. Participants will either receive atorvastatin or a placebo while being monitored through scans and health records.

What are the potential side effects?

Atorvastatin may cause muscle pain, liver changes, digestive issues, and in rare cases severe allergic reactions. It might also affect pregnancy; hence women capable of childbearing need to use contraception during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My melanoma test result is class 2B.

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My scans show no signs of cancer spread, and any suspicious areas have been tested and are not cancerous.

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I can take care of myself but might not be able to do heavy physical work.

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My liver tests, specifically ALT, are within normal limits.

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I have only had surgery for my melanoma, with no prior radiation therapy.

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My skin cancer was confirmed and fully removed; it was stage IIA.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on a statin or was on one in the past year.

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I have had a severe allergic reaction to atorvastatin or similar medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to death due to any cause, assessed up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to death due to any cause, assessed up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to death due to any cause, assessed up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Recurrence-free survival (RFS)

Secondary study objectives

Distant metastasis-free survival (DMFS)

Overall survival (OS)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm II (Atorvastatin)Experimental Treatment4 Interventions

Patients receive atorvastatin PO once per day in the absence of disease progression or unacceptable toxicity for up to 5 years and undergo CT and/or MRI throughout the study.

Group II: Arm I (Placebo)Placebo Group4 Interventions

Patients receive placebo PO once per day in the absence of disease progression or unacceptable toxicity for up to 5 years and undergo CT and/or MRI throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atorvastatin

1998

Completed Phase 4

~10900

Computed Tomography

2017

Completed Phase 2

~2740