Could a vaccine treat cancer? Texas Oncology testing mRNA Moderna shot for melanoma

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• In the U.S., for every 100,000 people 23 people are diagnosed with melanoma each year and two people die from it.
• Texas Oncology is hoping to enroll 10 to 15 patients in the melanoma vaccine trial.
• Vaccine uses patient's own tumor and immune system to fight recurrence of skin cancer.

When you think of Moderna mRNA vaccines, you probably think of COVID-19. But soon you could think of cancer.

Texas Oncology locations in Austin and Dallas are two of the 165 global sites testing a Moderna mRNA vaccine for the deadly melanoma skin cancer. Similar mRNA vaccines also are being tested on colon and pancreatic cancers. Merck is running this study, because it combines using Merck's standard Keytruda immunotherapy with this Moderna vaccine.

"It's exciting technology," said Dr. Jeff Yorio, Texas Oncology's Austin investigator for this clinical trial. Patients have been excited to enroll in the study, Yorio said, because "it's personalized immunotherapy. It's the ability to use your immune system to fight that person's melanoma."

How is the melanoma vaccine created?

To create each person's vaccine, Texas Oncology will send a sample of that patient's tumor to Moderna, much in the same way it sends tumors to be genetically sequenced to make better treatment decisions. Then Moderna will create a series of mRNA vaccines that will recognize that patient's specific tumor and trigger their immune system to fight that cancer, much in the same way Moderna trained its COVID-19 vaccines to recognize the COVID-19 virus and cause the immune system to fight it.

The participants will still receive the current treatment, which is surgery to remove the tumor and then a year of immunotherapy using Merck's Keytruda. After surgery, study patients will start on the immunotherapy and then once the vaccine is created, receive nine vaccines during a period of four to six months.

"The hope is that they remain cancer free and don't have a recurrence," Yorio said.

Just like in other mRNA vaccines, the vaccine does not use an active disease. "In no way would they be able to get melanoma from this," Yorio said.

Why is the melanoma vaccine important?

In the U.S., for every 100,000 people 23 people are diagnosed with melanoma each year and two people die from it, according to the Centers for Disease Control and Prevention.

"Melanoma is the bad guy of skin cancers because it's got a much higher risk to spread and metastasize," Yorio said. It also has no rules to where it will spread, he said. Sometimes it's the lungs or liver or brain, other times it's muscles and bones. Areas in the southern United States including Texas have higher rates of melanoma because of increased sun exposure, he said, which is why testing this vaccine in Austin is so exciting.

Who can enroll in the trial?

In Austin, Texas Oncology is hoping to enroll 10 to 15 patients in the trial. It's already enrolled its first two. Globally, Merck is hoping to enroll 1,089 participants. The patients will be randomized as to who receives the vaccine and who receives a placebo. Participants and investigators will not know what they are receiving.

The patients have to have either stage 2, 3 or 4 melanoma that has been surgically removed. The study is a phase 3 trial, usually the last phase, and is expected to last two years.

What results are expected?

The phase 2 results showed a 44% decrease of recurrence of death with the vaccine than with just the standard treatment.

If in this phase 3 trial, the vaccine shows better outcomes than just the standard therapy, it could be approved by the FDA after the study ends.

Once approved, the cost of this vaccine then will be determined and insurance can pay for it. Yorio expects it will be expensive because it is personalized. "Most of our cancer medicines carry a heavy price tag," he said.

How can you find melanoma and other skin cancers?

All adults of any age or skin tone should have an annual skin check with a dermatologist, but you should also do monthly skin checks at home. A good way to remember: "Birthday suit on your birthday." Every month, on the day of your birthday, check your skin.

Better yet, have a partner check for you, said Dr. Chad Hartmann, a dermatologist in Cedar Park. When partners check each other, they are 62% more likely to find something than when people try to check themselves using a mirror, he said.

During your skin check think ABCDE:

• Asymmetry: Is a mole looking unevenly shaped?
• Border: Is the border of the mole irregular?
• Color: Is the mole different colors, or does it have some darker parts?
• Diameter: Anything bigger than a pencil eraser should be checked out.
• Evolution: Has that mole changed in size, shape, color, border or any other way?

How can you prevent melanoma and other skin cancers?

• Wear a daily sunscreen, even in winter, that is SPF 15 or higher. You can use your moisturizer with an SPF of 15 as your skin protection, but foundation makeup usually isn't good enough because people don't get a heavy enough layer of it to adequately coat the skin.
• For days when you are going to have more skin exposure, switch to SPF 30 or above.
• Wear skin-protective clothing. Many manufacturers make shirts, pants, dresses and more with SPF built in.
• Wear a wide-brimmed hat that covers your forehead, neck and ears. A baseball cap doesn't do it.
• Avoid going outside when the sun is strongest, between 10 a.m. and 4 p.m., and if you are out during that time, seek shade.