This is a Phase 3 study in patients with melanoma that has spread to the lymph nodes (stage III), and who have had all of their cancer surgically removed. The purpose of this study is to evaluate the ability of the ‘CancerVax’ vaccine to prevent or slow the recurrence of melanoma.

Official Title

Phase III Randomized Double-Blind Pivotal Trial of Immunotherapy With BCG Plus a Polyvalent Melanoma Vaccine, ‘CancerVax’ Vaccine Versus BCG Plus a Placebo as a Post-Surgical Treatment for Stage III Melanoma

Conditions

Malignant Melanoma

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Study Start

Eligibility & Criteria

  • Ages Eligible for Study: 18 Years – 80 Years
  • Genders Eligible for Study: Both

Inclusion Criteria:

  • Must have Stage III melanoma
  • Must have had all clinically-detectable disease surgically removed
  • Cannot be taking any medications, or undergoing any therapies which compromise the functioning of your immune system (ie. Some corticosteroids, and certain types of radiation therapy)
  • Cannot have HIV or Hepatitis A, B, or C

Total Enrolment

Contact Details

  • NSW Breast Cancer Institute, Westmead, New South Wales, 2145, Australia
  • Royal Prince Alfred Hospital, Sydney, New South Wales, 2050, Australia
  • Princess Alexandra Hospital, Brisbane, Queensland, 4102, Australia
  • Royal Adelaide Hospital, Adelaide, South Australia, 5000, Australia
  • The Alfred Hospital, Melbourne, Victoria, 3181, Australia
  • Peter MacCallum Cancer Center, Melbourne, Victoria, 3002, Australia

CancerVax Corporation website