Pathologic Stage IIIA Cutaneous Melanoma AJCC v8Phase 2NCT06157099
Atorvastatin for Preventing Disease Metastasis in Patients With Resected High-Risk Stage IIA, IIB, or IIIA Melanoma
A Phase 2 study testing Atorvastatin, Computed Tomography and Magnetic Resonance Imaging in people with Pathologic Stage IIIA Cutaneous Melanoma AJCC v8 and Pathologic Stage IIA Cutaneous Melanoma AJCC v8, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pathologic Stage IIIA Cutaneous Melanoma AJCC v8, Pathologic Stage IIA Cutaneous Melanoma AJCC v8, Pathologic Stage IIB Cutaneous Melanoma AJCC v8
- What is being tested?
- Atorvastatin, Computed Tomography and Magnetic Resonance Imaging
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to 1 Sep 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years. Both men and women and members of all races and ethnic groups are eligible for inclusion
- Participants must have a diagnosis of American Joint Committee on Cancer (AJCC 8th) edition pathological stage IIA, IIB, or IIIA cutaneous melanoma that has been histologically confirmed and completely resected
- Participants must not have been previously treated for melanoma beyond complete surgical resection. Participants must not have been treated with radiation therapy for their melanoma before study entry
- No more than 10 weeks may elapse between final surgical resection and randomization. If there is a delay of 1 to 7 days exceeding 10 weeks due to unforeseen circumstances, the eligibility should be discussed with the principal investigator (at OHSU coordinating center) and the decision documented. A delay of 1 to 7 days for screening imaging requirements will be allowed if sponsor has allowed a 1-week extension between surgical resection and randomization
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 50%)
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- Liver function normal as defined by: Alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase ([SGPT]) =< 2.5 × laboratory defined upper limit of normal
- Creatine kinase (CK) =< 3 × laboratory defined upper limit of normal
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with an undetectable viral load within 6 months prior to consent are eligible for this trial
- Participant with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- A participant is eligible to participate if they are not pregnant or breastfeeding, AND at least one of the following is true: Is not a person of childbearing potential (WOCBP); OR Is a WOCBP and agrees to use adequate contraception (hormonal or barrier method of birth control; abstinence) before study entry, and for the duration of study participation
- The effects of atorvastatin on the developing human fetus are still under investigation. Animal data and retrospective human data suggest that statins may adversely affect pregnancy, thus WOCBP must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) before study entry, and for the duration of study participation. Should a participant become pregnant or suspect a pregnancy while participating in this study, the individual should inform their treating physician immediately
Who cannot join
- Participants who are receiving any other investigational agents
- 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
- Participants who are currently taking a statin or have taken a statin in the year before enrollment
- Patients currently taking cyclosporine, erythromycin, fibrates, niacin, or any other medication that is contraindicated with statin treatment in the view of the investigator
- Participant who in the opinion of the investigator, has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate
- Participant who has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: A Decentralized Phase II Randomized Controlled Trial of Atorvastatin in Resected High-Risk Melanoma
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To compare recurrence-free survival (RFS) of patients with high-risk melanoma treated with atorvastatin to placebo.
SECONDARY OBJECTIVES:
- To compare distant metastasis-free survival (DMFS) between treatment arms.
II. To compare overall survival (OS) between treatment arms.
EXPLORATORY OBJECTIVE:
- 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
- Being tested
- Atorvastatin, Placebo Administration, Computed Tomography, Magnetic Resonance Imaging, Electronic Health Record Review
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called (betaR,deltaR)-2-(4-Fluorophenyl)-beta, (betaR,deltaR)-2-(p-Fluorophenyl)-beta,delta-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-pyrrole-1-heptanoic Acid, 134523-00-5
Given PO
Placebo AdministrationDrug
Given orally (PO)
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography
Undergo CT
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging Scan, MR Imaging, MRI, NMR Imaging
Undergo MRI
Electronic Health Record ReviewOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Placebo) | Placebo comparator | Patients receive placebo PO daily (QD) in the absence of disease progression or unacceptable toxicity for up to 5 years and undergo CT and/or MRI throughout the study. Receives: Drug: Placebo Administration; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Other: Electronic Health Record Review |
| Arm II (Atorvastatin) | Experimental | Patients receive atorvastatin PO daily (QD) in the absence of disease progression or unacceptable toxicity for up to 5 years and undergo CT and/or undergo MRI throughout the study. Receives: Drug: Atorvastatin; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Other: Electronic Health Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival (RFS)
Will be assessed in patients with high-risk melanoma treated with atorvastatin compared to placebo. Hypothesis testing between two arms will be performed using the stratified log-rank test with a 2-sided 0.1 level of significance. The median RFS and the rate at fixed time points (e.g. 3 year-RFS or 5 year-RFS) will be derived from the Kaplan-Meier estimate along with their 95% confidence interval. The stratified hazard ratio between the two groups along with 95% confidence interval will be obtained by fitting a stratified Cox regression model with the group variables and adjusting potential confounders.
Measured: From randomization to any recurrence (local or regional [including invasive ipsilateral tumor and invasive loco-regional tumor], or distant) as ascertained by imaging and medical record review, or death due to any cause, assessed up to 5 years
Secondary outcomes (2)
Distant metastasis-free survival (DMFS)
Distant metastasis refers to cancer that has spread from the original (primary) tumor and beyond local or nearby tissues and lymph nodes to distant organs or distant lymph nodes. DMFS will be compared between treatment arms using a stratified log-rank test. The median and survival rates at various time points for each treatment arm will be derived from the Kaplan-Meier estimate along with their 95% confidence interval.
Measured: From randomization to appearance of distant metastasis as assessed by the investigator, assessed up to 5 years
Overall survival (OS)
OS will be compared between treatment arms using a stratified log-rank test. The median and survival rates at various time points for each treatment arm will be derived from the Kaplan-Meier estimate along with their 95% confidence interval.
Measured: From randomization to death due to any cause, assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start1 Sep 2024
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathologic Stage IIIA Cutaneous Melanoma AJCC v8Studies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University, Kuni Foundation
- Responsible party
- Principal investigator, Wesley Yu, M.D., OHSU Knight Cancer Institute
- Investigators
- Wesley Yu, M.D., Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157099
- Sponsor's protocol ID
- STUDY00025369
- Other IDs
- NCI-2023-03875
- Status last verified
- Mar 2026
- First submitted
- 3 Aug 2023
- Last updated
- 13 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Decentralized Phase II Randomized Controlled Trial of Atorvastatin in Resected High-Risk Melanoma
- ClinicalTrials.gov ID
- NCT06157099
- Acronym / sponsor ID
- STUDY00025369
- Conditions
- Pathologic Stage IIIA Cutaneous Melanoma AJCC v8, Pathologic Stage IIA Cutaneous Melanoma AJCC v8, Pathologic Stage IIB Cutaneous Melanoma AJCC v8
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Oregon Health and Science University, Kuni Foundation
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 5 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To compare recurrence-free survival (RFS) of patients with high-risk melanoma treated with atorvastatin to placebo.
SECONDARY OBJECTIVES:
- To compare distant metastasis-free survival (DMFS) between treatment arms.
II. To compare overall survival (OS) between treatment arms.
EXPLORATORY OBJECTIVE:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Placebo) | Placebo comparator | Drug: Placebo Administration, Procedure: Computed Tomography, Procedure: Magnetic Resonance Imaging, Other: Electronic Health Record ReviewPatients receive placebo PO daily (QD) in the absence of disease progression or unacceptable toxicity for up to 5 years and undergo CT and/or MRI throughout the study. |
| Arm II (Atorvastatin) | Experimental | Drug: Atorvastatin, Procedure: Computed Tomography, Procedure: Magnetic Resonance Imaging, Other: Electronic Health Record ReviewPatients receive atorvastatin PO daily (QD) in the absence of disease progression or unacceptable toxicity for up to 5 years and undergo CT and/or undergo MRI throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age >= 18 years. Both men and women and members of all races and ethnic groups are eligible for inclusion
- Participants must have a diagnosis of American Joint Committee on Cancer (AJCC 8th) edition pathological stage IIA, IIB, or IIIA cutaneous melanoma that has been histologically confirmed and completely resected
- Participants must not have been previously treated for melanoma beyond complete surgical resection. Participants must not have been treated with radiation therapy for their melanoma before study entry
- No more than 10 weeks may elapse between final surgical resection and randomization. If there is a delay of 1 to 7 days exceeding 10 weeks due to unforeseen circumstances, the eligibility should be discussed with the principal investigator (at OHSU coordinating center) and the decision documented. A delay of 1 to 7 days for screening imaging requirements will be allowed if sponsor has allowed a 1-week extension between surgical resection and randomization
- 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
Key exclusion criteria (6 listed)
- Participants who are receiving any other investigational agents
- 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
- Participants who are currently taking a statin or have taken a statin in the year before enrollment
- Patients currently taking cyclosporine, erythromycin, fibrates, niacin, or any other medication that is contraindicated with statin treatment in the view of the investigator
- Participant who in the opinion of the investigator, has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinAlso: (betaR,deltaR)-2-(4-Fluorophenyl)-beta, (betaR,deltaR)-2-(p-Fluorophenyl)-beta,delta-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-pyrrole-1-heptanoic Acid, 134523-00-5Given PO | Drug | Arm II (Atorvastatin) |
| Placebo AdministrationGiven orally (PO) | Drug | Arm I (Placebo) |
| Computed TomographyAlso: CAT, CAT Scan, Computerized Axial Tomography, Computerized TomographyUndergo CT | Procedure or surgery | Arm I (Placebo), Arm II (Atorvastatin) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging Scan, MR Imaging, MRI, NMR ImagingUndergo MRI | Procedure or surgery | Arm I (Placebo), Arm II (Atorvastatin) |
| Electronic Health Record ReviewAncillary studies | Other | Arm I (Placebo), Arm II (Atorvastatin) |
Primary outcome
Recurrence-free survival (RFS)
Time frame: From randomization to any recurrence (local or regional [including invasive ipsilateral tumor and invasive loco-regional tumor], or distant) as ascertained by imaging and medical record review, or death due to any cause, assessed up to 5 years
Will be assessed in patients with high-risk melanoma treated with atorvastatin compared to placebo. Hypothesis testing between two arms will be performed using the stratified log-rank test with a 2-sided 0.1 level of significance. The median RFS and the rate at fixed time points (e.g. 3 year-RFS or 5 year-RFS) will be derived from the Kaplan-Meier estimate along with their 95% confidence interval. The stratified hazard ratio between the two groups along with 95% confidence interval will be obtained by fitting a stratified Cox regression model with the group variables and adjusting potential confounders.
2 secondary outcomes
Distant metastasis-free survival (DMFS)
Time frame: From randomization to appearance of distant metastasis as assessed by the investigator, assessed up to 5 years
Overall survival (OS)
Time frame: From randomization to death due to any cause, assessed up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wesley Yu, M.D. principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atorvastatin, Computed Tomography and Magnetic Resonance Imaging in people with Pathologic Stage IIIA Cutaneous Melanoma AJCC v8 and Pathologic Stage IIA Cutaneous Melanoma AJCC v8, run by OHSU Knight Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival (RFS) (time frame: From randomization to any recurrence (local or regional [including invasive ipsilateral tumor and invasive loco-regional tumor], or distant) as ascertained by imaging and medical record review, or death due to any cause, assessed up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.