A double-blind, randomized, 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.

Study Sponsor: GlaxoSmithKline Biologicals

TRIAL OVERVIEW

• Patients with AJCC Stage IIIb or IIIc melanoma who have been rendered disease free by surgery may qualify to participate in this clinical trial.
• After pre-study tests by trial staff to confirm eligibility, patients are randomised to receive either the recMAGE-A3 + AS15 ASCI vaccine or placebo in a 2 : 1 ratio.
• The primary objective is to evaluate the efficacy of the recMAGE-A3 + AS15 ASCI compared to placebo in terms of relapse free survival.
• MAGE-A3 is a protein expressed in about two thirds of melanomas
• This trial is open to patients throughout New Zealand. North Shore Hospital commences recruitment early February 2009. Recruitment at Wellington and Christchurch Hospitals TBA. 
• Globally it is intended that 1300 participants will be recruited
• Other centres are in Australia, UK and Europe.
• IM injections of vaccine/placebo are given at 13 visits over 2.5years.
• Follow up visits are then 6monthly to 5years after first study treatment

KEY INCLUSION CRITERIA

• Fully resected AJCC Stage IIIb or IIIc melanoma (clinically detectable lymph node metastases)
• Tumour expression of MAGE-A3 antigen

• First study treatment within 8weeks of melanoma surgery.
• ≥ 18 years 

KEY EXCLUSION CRITERIA

• In-transit metastases
• Mucosal or Ocular melanoma
• Other malignancy within last 5years
• Immunosuppressive drug use
• Adjuvant treatment (including radiotherapy) after regional relapse
• Autoimmune diseases
• Family Hx congenital or hereditary immunodeficiency

This trial has been approved by the Multi Region Ethics Committee MEC08/10/133


 FOR REFERRALS OR FURTHER INFORMATION PLEASE CONTACT:

Mob:   021 606 529                               mikemc@adhb.govt.nz

Mob:  021 671 777                                richard.martin@waitematadhb.govt.nz

Mr Richard Harman                          Surgical Oncologist

Mob:  021 934 570                                richard.harman@waitematadhb.govt.nz

Mob: 021718249                               mike.hulmemoir@waitematadhb.govt.nz 

Anna Brown                                     Research Nurse

Mob:   021 954 147                               anna.brown@waitematadhb.govt.nz