DERMA: Adjuvant immunotherapy with MAGE-A3 in melanoma

• Research type

  Research Study

• Full title

  A double-blind, randomized, placebo-controlled Phase III study to assess the efficacy of MAGE-A3 + AS15 ASCI as adjuvant therapy in patients with MAGE-A3 positive resected stage III melanoma.

• IRAS ID

  23472

• Contact name

  Charles Kelly

• Sponsor organisation

  GlaxoSmithKline Biologicals

• Eudract number

  2008-002447-16

• Clinicaltrials.gov Identifier

  NCT00796445

• Research summary

  Surgery of stage III melanoma is not always curative and approximately 60% of patients will die of metastatic disease. There is a need for adjuvant therapy to prevent disease relapse. The DERMA study will test a potential new treatment for melanoma. The purpose of the study is to see if this new treatment is safe and if it can delay or prevent melanoma returning. Study treatment will be given after surgical removal of the melanoma and other involved tissues (lymph nodes). DERMA treatment doesn’t work for all types of melanoma. For it to work, the melanoma must produce a protein called MAGE-A3. So participants must first be screened for MAGE-A3, by testing a sample of their melanoma. The DERMA treatment has been well tolerated in clinical trials to date. It is called an ASCI meaning Antigen-Specific Cancer-Immunotherapeutic. It targets a defined antigen (antigen-specific) that's found on cancer cells, and uses the immune system to fight cancer (cancer-immunotherapeutic). In other words, this treatment works by immunisation- much like a prophylactic vaccine. The ASCI is given as an injection into the muscle. The ASCI contains a recombinant protein or “antigen” (man-made, synthetic protein), along with another component, that boosts the body's immune response to the protein. This immune response will then attack the cancer cells that produce MAGE-A3. This is a double-blind placebo controlled study, meaning neither the doctor nor the participant knows which treatment is given. For every two participants who receive the study drug, one will receive the inactive placebo. Participants will attend regular study visits for five years. During the study, CT scans and blood tests will be taken. This trial is being conducted at about 150 sites worldwide. Approximately 1300 people will enter the trial by June 2011.This study is sponsored by GlaxoSmithKline Biologicals.

• REC name

  North East - York Research Ethics Committee

• REC reference

  10/H0903/39

• Date of REC Opinion

  3 Sep 2010

• REC opinion

  Further Information Favourable Opinion