Trial status: Open

Treatment type: Immunotherapy

Stage of disease: Stage III

A Phase III study to test the benefit of a new kind of anti-cancer treatment in appropriate melanoma patients, after removal of their tumour.

(A double-blind, randomised, placebo-controlled Phase III study to assess the efficacy of recMAGE-A3 + AS15 ASCI as adjuvant therapy in patients with MAGE-A3 positive resected stage III melanoma with macroscopic lymph node involvement).

The trial sponsor is GlaxoSmithKline (GSK)

Primary objective

The purpose of this clinical trial is to evaluate the benefit of the immunotherapeutic product in preventing disease relapse when given to melanoma patients, after surgical removal of involved lymph node(s).

Screening phase

A screening procedure needs to be performed to determine if a patients melanoma produces a particular protein called MAGE-A3.  About half of patients with melanoma, which has spread to the lymph nodes, are found to have tumours that produce the MAGE-A3 protein.  Other things will need to be checked at a later stage of the assessment process but only for patients whose tumours produce the MAGE-A3 protein.

Main phase

This new anti-cancer treatment is based upon immunisation, which means that it teaches your immune system to fight the cancer in the same way that it fights an infection caused by germs. Because cancer is produced by your own body, your immune system does not easily recognise cancer cells as being harmful and therefore does not fight them as it would fight foreign germs. Your immune system needs to be “trained” to do this. This is done by injecting a protein that is found only in your tumour, i.e., the MAGE-A3 protein, and thus training your body to recognise this protein and to destroy cells on which this protein is found. It is hoped that in this way recurrence of cancer may be slowed down or even prevented.

The study treatment is administered over a period of a little more than 2 years (27 months) and consists of a maximum of 13 injections of the study medication. These injections will be given into the muscles of the thighs or the upper arm.

The treatment given to the participants will be decided by a randomisation procedure, which means that the treatment type for each is chosen by chance, similar to drawing a number out of a hat. Two out of 3 participants will receive the anti-cancer treatment and one out of 3 participants will receive the placebo. Neither the Doctor, the personnel at the hospital, GSK personnel,  nor the patient will know to which treatment group the patient  belongs.

Contacts

Professor John Thompson – Principal Investigator

Maria Cronin – Trial Coordinator - Tel: +61 2 9911 7302