Neoadjuvant Therapy for Patients with High-Risk Stage III Melanoma

Matthew S. Block, MD, PhD, is an immunologist and medical oncologist with an interest in understanding the mechanisms leading to pathologic inflammation in cancer and developing novel immune-based cancer therapies.

His translational research efforts have focused on identifying genes and proteins that play key roles in inflammatory and immunosuppressive responses during tumorigenesis and progression of ovarian cancer and melanoma.

Dr. Block’s goal is to use this understanding to develop and test novel immune-modulatory strategies, including vaccines and therapies that target pathologic inflammation, in order to enhance clinical outcomes for ovarian cancer and melanoma patients.

Tina Hieken, MD

Mayo ClinicView Bio

Tina J. Hieken, MD, is a surgical oncologist with a specialty interest in melanoma and breast cancer. She has a passionate interest in advancing the care of melanoma patients and the care of patients at high risk for future breast cancer as well as those diagnosed with breast cancer. Her practice philosophy focuses on patient-centered care to provide the best possible oncologic outcomes with excellent aesthetics, while respecting patient needs and preferences.

In addition to her clinical activities, Dr. Hieken leads research efforts to understand the microbiome in relation to cancer risk, treatment response and the immune system. She is active nationally and internationally in specialty societies and is a member of the Mayo Clinic Cancer Center.

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Meet the Team

Matthew S. Block, MD, PhD, Mayo Clinic
Tina J. Hieken, MD, Mayo Clinic
Vera Suman, PhD, Mayo Clinic
Thomas Flotte, MD, Mayo Clinic
Evidio Domingo-Musibay, MD, University of Minnesota

Patient Advocate: Cynthia Chauhan, Heidi Turner, Simone Veum

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About This SU2C Catalyst Clinical Trial

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.

We Need You

Why Your Participation Matters

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.

Eligibility

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.

Gender:

Female or male

Age Range:

18 years and older

Diagnosis:

High-risk stage III melanoma

Requirements

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.

Participate

You play a vital role.

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

Mayo Clinic
Roxana Dronca, MD
P: 855-776-0015

Rochester - Minnesota

Mayo Clinic
Matthew S. Block, MD, PhD
P: 855-776-0015

Minneapolis - Minnesota

University of Minnesota Health Masonic Cancer Clinic
Evidio Domingo-Musibay, MD
P: 612-624-5373

Resources

Support for this study comes from Genentech.

Genentech +

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.

Mayo Clinic +
For additional resources, please visit StandUpToCancer.org +

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