Are you or a loved one currently facing high-risk melanoma? Stand Up To Cancer (SU2C) is supporting a clinical trial that may benefit patients with high-risk stage III melanoma to potentially reduce the risk of recurrence and improve patient outcomes.
Melanoma is a type of cancer most often affecting the skin. Stage III melanoma indicates that the cancer has spread to the lymph nodes but not to distant organs and the chance of recurrence is high. Accumulating evidence suggests that combining a targeted therapy and immunotherapy may be a more effective way to treat advanced melanoma than the current standard of care.
The SU2C Catalyst study will test two different combinations of targeted therapies and immunotherapy to reduce melanoma recurrence risk and improve patient outcomes. This study will utilize neoadjuvant therapy, an approach used to shrink a tumor before surgery. This type of therapy approach is not yet common practice for stage III melanoma but is already routinely used for other types of stage III cancers.
Clinical trials are a critical step on the road to potential life-changing therapies; without them, new treatments for cancer cannot move forward. Your participation in this trial will help move research forward and allow us to test the benefits and effectiveness of a precision therapy approach based on a key genetic mutation and a combination of two active melanoma therapies. We believe this is the best path forward to improve outcomes for patients with high-risk stage III melanoma by downsizing the disease in the lymph nodes and potentially eradicating any microscopic metastatic disease elsewhere.
Key Insights for Participants
There is no guarantee patients will benefit from this research study. It is possible that your condition will improve, but it is also possible there will be no effect on your condition or that your condition may continue to progress.
Participants in this clinical trial will have their tumors screened for a mutation in a gene called BRAF, which promotes rapid tumor growth.
Based on the BRAF test result, participants will receive either a combination of atezolizumab, cobimetinib and vemurafenib, or atezolizumab and cobimetinib before surgery.
Following surgery all participants will receive atezolizumab immunotherapy.
We will study treatment response and time to recurrence for each patient, and investigate blood, tumor, and microbiome biomarkers associated with outcomes.
Results from this study are potentially practice-changing and will be used to inform a future phase 3 clinical trial.
Please note: travel assistance is available and research-related patient study costs are covered.
Patients with a diagnosis of high-risk stage III melanoma, defined as (any of the following): recurrent nodal metastasis, clinically detectable nodal metastasis, or metastatic involvement of more than one nodal basin.
There are additional criteria that must be met to participate, or that may prevent a patient from participating. Key criteria are summarized below and can be found in detail on ClinicalTrials.gov. Interested patients will need to review their medical histories with clinical trial patient coordinators before they can be accepted to participate in this trial.
Female or male
18 years and older
High-risk stage III melanoma
Eligible participants must have no prior therapy with an immune checkpoint inhibitor or targeted agent.
Participants must have no history of autoimmune disease requiring active immunosuppression within the last 5 years.
Eligible participants must have no immunodeficiency states or recent treatment with immunosuppressive drugs.
Participants will be required to either have a pre-study needle biopsy or have tissue available from a recent biopsy.
Participants will be treated with neoadjuvant therapy for three months followed by surgery and then adjuvant (postoperative) therapy with atezolizumab for 6 months.
Participants will be seen every two weeks during the neoadjuvant treatment period, and every three weeks during the adjuvant treatment period.
After completion of treatment participants will undergo surveillance (observation) every three months.
All required surgery, medical treatment and observation must take place at Mayo Clinic.
Here are the locations where you can participate in this clinical trial. If you, or a loved one, are interested in enrolling and learning more about this study, please contact the patient coordinator at your preferred site. The patient coordinator is there to help you understand every aspect of the clinical trial process and can answer any questions you may have.
Once you contact the patient coordinator, he or she, will start by reviewing your medical history with you to see whether you meet all the criteria to participate. The coordinator will then guide you through a review of the study and detailed “informed consent” documents that are required when you enroll in a clinical trial.
Jacksonville - Florida
Roxana Dronca, MD
Rochester - Minnesota
Matthew S. Block, MD, PhD
Minneapolis - Minnesota
University of Minnesota Health Masonic Cancer Clinic
Evidio Domingo-Musibay, MD
Here are some links to informational videos and organizations that provide more information about this study, and may provide information on patient support, treatment options, and current clinical trials.
Find out if there's a trial for you. Reach out today.
Even if you do not meet the requirements for this trial, there may be other trials for you. Get started with the SU2C Clinical Trial Finder, a free and confidential cancer clinical trial matching and referral service.
(Please fill out all fields and questions below to better assist you.)