Every patient’s cancer is unique. At Moderna, we believe mRNA personalized vaccines may bring us much closer to the goal of helping cure more patients of their cancers — Tal Zaks, MD

Eligibility Criteria

Key Criteria List

Inclusion Criteria:

• Melanoma (skin cancer) that has spread to another area(s) (e.g. lymph node) and is at high risk of coming back
• Surgery to remove the skin cancer within 13 weeks before study enrollment
• Cancer free at study entry (after surgery)
• Willing to provide a sample of the skin cancer tumor to create the vaccine
• Normal organ and bone marrow function

Exclusion Criteria:

• Prior cancer, unless no evidence of that cancer for at least 5 years prior to study entry
• Prior medical treatment for your skin cancer (except surgery and interferon for thick primary melamonas. Radiotherapy after lymph node dissection is permitted)
• Active autoimmune disease (except diabetes and/or vitiligo)
• Immunodeficiency, systemic steroid therapy or any other immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab
• Solid organ or allogeneic bone marrow transplant
• Pneumonitis or a history of (noninfectious) pneumonitis that required steroids
• Prior interstitial lung disease
• Clinically significant heart failure
• Known history of HIV
• Known active hepatitis B or C
• Active infection requiring treatment

What to Expect

If you agree to participate in the study, you will have a screening visit at the study site. At this visit, the study doctor will review your medical history, conduct a physical examination, draw blood and collect a urine sample to confirm if you are eligible to participate. The study doctor will also use a sample of your tumor that was removed in your surgery to see if it can be utilized to make your personalized vaccine.

During participation, you will need to regularly travel to the study site for up to 3 years. You will have site visits every 3 weeks (21 days) for up to 1 year (approximately 18 visits) to receive study treatment and check your health. After you complete study treatment, you will be asked to complete safety follow-up visits. If your disease has not come back, you will be asked to come in for scans (every 3 to 6 months) for up to 2 years.

You will need to travel to one of the 32 sites taking part in this clinical trial. Sites are located in:

Why Participate

All patients in this study will receive pembrolizumab (also called Ketruda) and have regular health check-ups with the study doctor at no cost to you.

Pembrolizumab helps your immune system to fight cancer. Pembrolizumab is approved by the FDA for the treatment of patients with certain types of cancer including the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Some patients on this study will take just pembrolizumab, and some patients will take the combination of both pembrolizumab and mRNA-4157. Giving pembrolizumab and mRNA-4157 together may help the immune system to kill more cancer cells, but it is not known if the combination of pembrolizumab and mRNA-4157 will work any better.

It is possible that you may not personally benefit from your participation in this study. However, by taking part, you will provide new information that may benefit other patients in the future.

Frequently Asked Questions (FAQ)

What does mRNA do?

mRNA produces instructions to make proteins that may treat or prevent disease. mRNA medicines aren’t small molecules, like traditional pharmaceuticals. And they aren’t traditional biologics (recombinant proteins and monoclonal antibodies) – which were the genesis of the biotech industry. Instead, mRNA medicines are sets of instructions. And these instructions direct cells in the body to make proteins to prevent or fight disease.

It’s actually basic human biology.

DNA (deoxyribonucleic acid) is a double-stranded molecule that stores the genetic instructions your body’s cells need to make proteins. Proteins, on the other hand, are the ‘workhorses’ of the body. Nearly every function in the human body – both normal and disease-related – is carried out by one or many proteins.

mRNA is just as critical as DNA.

Without mRNA, your genetic code would never get used by your body. Proteins would never get made. And your body wouldn’t – actually couldn’t – perform its functions. Messenger ribonucleuc acid, or mRNA for short, plays a vital role in human biology, specifically in a process known as protein synthesis. mRNA is a single-stranded molecule that carries genetic code from DNA in a cell’s nucleus to ribosomes, the cell’s protein-making machinery.

How can I check to see if I'm eligible for this trial?

You can check if you are potentially eligible for this trial by completing a set of screening questions. You can find these on this web page by finding the ‘Get Started’ button.

What does a typical research study look like?

Clinical trials help determine the safety and effectiveness of new treatments. A research plan or protocol is created that outlines how trial participants may receive interventions which can include investigational medications, devices, or procedures. The trial may compare a new medical approach to a standard treatment option already available, to a placebo with no active investigational medication, or to no intervention at all. The trial team will share more details before you participate. For more information about this trial, please see the ‘What to Expect’ section of this website.

Can I stop the trial at any time?

You can leave the study at any time by telling your study doctor that you no longer want to take part. Your choice will not change the quality of care you receive outside of this study.

What personal information is collected about you for the study?

The study doctor and other study staff will collect your personal information. This may include:

• • Your name, address, telephone number, health insurance number where applicable.
• • Your age, gender, ethnic and racial background.
• • Lifestyle information; health and medical history.
• • Your study treatments and response to study treatments.
• • Data resulting from testing your biological samples and any images taken.

Who has access to your personal information?

All your personal information collected for this study will be stored in the study medical records at the study site. Sponsor staff, review boards and ethics committees (that approve and monitor studies), and others may check the study records. This is done to make sure that the study is being run properly. Regulatory agencies, such as the US Food and Drug Administration (FDA), European Medicine Agency (EMA) or others, review and approve new medicines. These agencies will be granted direct access to your information. This is so they can verify clinical trial procedures and/or data. If you share your personal data to contact a site, that data will be used by Informa to contact you about clinical trials and related information.