Melanoma clinical trials: the DERMA study
DERMA is a large, international clinical study evaluating a potential new melanoma treatment called ASCI*. ASCI* can work by educating our own immune system to fight cancer. You can find out more about ASCI* and melanoma on GSK’s Immunotherapy for Cancer site.
An ASCI* (Antigen-Specific Cancer Immunotherapeutics) is being developed as a potential new treatment for melanoma. This ASCI* specifically targets the MAGE-A3 antigen, which is a substance found on melanoma cells. Encouraging results observed in a group of melanoma patients have led to the setting up of a large Phase III clinical study in melanoma treatment, called DERMA (aDjuvant immunothERapy with MAGE-A3 in melanomA).
What is the objective of DERMA?
The purpose of DERMA is to measure how well the MAGE-A3 ASCI* works in preventing cancer from coming back when given to patients with stage 3B or 3C melanoma which has spread macroscopically to the lymph node, after the removal of their tumor by surgery. It will also evaluate the potential side effects of the MAGE-A3 ASCI*.
Patients’ progress will be measured by periodic examinations (including CT scans and photography, blood tests and physical examinations) at the hospital where they receive the treatment.
What will the treatment consist of?
Over a period of 27 months, 13 injections will be given in the muscle of your upper arm. The first 5 injections will be given every 3 weeks, then the next 8 every 3 months.
In the study, 2 patients out of 3 will receive the MAGE-A3 ASCI*, while 1 patient out of 3 will receive a placebo control (a substance that has no treatment value). This is so doctors can see whether patients who receive ASCI* do better than patients who do not receive it. Neither doctors nor patients will know who is getting ASCI* and who is getting placebo. This information is only revealed after the study is finished, so that the results can be analyzed.
How long will the study last?
After the treatment, you will receive regular check-ups every 6 months up until 5 years after your first treatment, in order to continue checking that cancer has not returned. After that, your progress will be checked annually by phone contact up until 10 years from the start of treatment.
Where will the study take place?
Approximately 225 hospitals all over the world – in Europe, Australia and America – will be involved in this study. You will receive your treatment and check-ups at the participating hospital you choose. To find the study hospital nearest to you, click here.
Next: Melanoma clinical trials: who can participate in DERMA?
