Clinical trials ‘push the envelope’ to test new therapies for melanoma

By Carol McPhail
cmcphail@health.southalabama.edu

Treatment for melanoma, the most serious form of skin cancer, continues to evolve and improve thanks to clinical research trials at cancer centers across the United States, including the USA Health Mitchell Cancer Institute.

One recent clinical trial available at the MCI found patients with advanced-stage melanoma treated with immunotherapy before (neoadjuvant) and after surgery fared better than those who received the standard of care — surgery followed by immunotherapy. The findings from the phase II trial known as SWOG 1801 were published in the March 2 issue of the New England Journal of Medicine.

“This has been a practice-changing trial for folks with advanced but resectable melanoma,” said J. Harrison Howard, M.D., a surgical oncologist at the MCI and associate professor of surgery at the Frederick P. Whiddon College of Medicine. “Usually, these patients have recurrence rates in the 40% to 60% range. Now we’re seeing a 20% to 30% recurrence for patients treated with neoadjuvant immunotherapy.”

Currently, the MCI is enrolling newly diagnosed melanoma patients in another clinical trial, MelMarT-II, an international study being coordinated in Australia. This trial aims to determine whether reducing the amount of skin removed during surgery can reduce the risk of long-term pain and improve the quality of life for patients without increasing the risk of the melanoma returning. “This also has the opportunity to change the way we treat patients diagnosed with melanoma,” Howard said.

While melanoma makes up only 1% of all skin cancers, it is dangerous because it is more likely to spread to other parts of the body if it is not diagnosed and treated early.

Several patients at the MCI enrolled in the SWOG 1801 trial, which was open to those with advanced melanoma whose cancer could be removed with surgery. The MCI was the only healthcare provider in the area to offer and enroll patients in this trial. “Clinical trials are the way we push the envelope,” Howard said. “In our immediate region, these trials offer novel treatments for our patients.”

A clinical trial is a research study that tests a new therapy in people to determine whether it is more effective than existing therapies. New treatments typically are tested in four phases. Phase I trials examine whether a new treatment is safe, while phase II trials explore how safe a treatment is and how well it works. Phase III clinical trials, which are larger and take longer to complete, help determine how a treatment works in different people. Phase IV trials study a treatment in different doses or in combination with other therapies.

Howard, who treats melanoma and sarcoma, said he advises his patients to consider enrolling in a clinical trial if they are eligible. One benefit is that patients are followed extremely closely throughout a study.

“Clinical trials are set up to be highly regulated,” he said. “At a minimum, patients get the standard of care, and in some cases, they get more. I tell people that enrolling in a trial may not help you, but it will definitely help someone in the future.”

Howard praised the MCI’s multidisciplinary clinic that focuses on melanoma. Each Wednesday, surgical oncologists, medical oncologists, radiation oncologists, pathologists and other providers discuss the way forward on melanoma cases, including whether clinical trials are an option.

“When I recognize a patient may be a candidate for a trial or multidisciplinary care, I am working side by side with other providers in real time at the Mitchell Cancer Institute to improve the efficiency of cancer care,” he said. “Our patients are really grateful to have all those disciplines in one clinic.”