Metastatic melanoma study reports positive results

A metastatic melanoma clinical trial has reported promising results according to an article in the New England Journal of Medicine published on August 19, 2010. Metastatic melanoma occurs when a person’s melanoma spreads to other parts of their body. It’s also know as stage 4 melanoma.

The trial, which was testing an experimental drug called ipilimumab, was a so-called Phase 3 trial. A Phase 3 trial represents the last stage of testing that a drug must undergo before it can be submitted to the FDA for marketing approval.

To participate in the study, participants either had to have stage 3 or stage 4 melanoma. And they had to have undergone unsuccessful treatment using another cancer drug.

In the study, 676 people were randomly assigned into one of three groups. Group 1 received ipilimumab and a placebo of gp100, a cancer vaccine. Group 2 received ipilimumab plus active gp100. Meanwhile, Group 3 were given
gp100 and a ipilimumab placebo.

As the study was double blinded, neither the study participants nor the research team knew who was receiving what.

In terms of results, those study participants who were given ipilimumab, both by itself and with gp100, lived a median of about 10 months. Conversely, people who were only given gp100 lived about 6.4 months.

Two years after their participation in the study, 23 percent of those who received ipilimumab were still alive. Meanwhile, only 14 percent of those who did not get the study drug survived.

Some of the 540 people who received the study drug had a negative reaction. Between 10% and 15% suffered attacks on their immune systems known as autoimmune reactions. However, most adverse events were able to be treated.

Metastatic melanoma has become more common over the past 30 years. In 2009, 68,000 new cases were diagnosed. In the same year, 8,700 deaths were caused by the disease.