Randomized, Open Phase II Study of Immunization With the Recombinant MAGE-3 Protein Combined With Adjuvant AS02B or AS15 in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma
- Compare the objective response rate (complete and partial response) in patients with
unresectable stage III or stage IV M1a cutaneous melanoma immunized with vaccine
comprising D1/3-MAGE-3-His fusion protein and SB-AS02B adjuvant vs SB-AS15 adjuvant.
- Compare the activity of SB-AS02B adjuvant vs SB-AS15 adjuvant, in terms of maximizing
the antigenicity of MAGE-3, in patients treated with these regimens.
- Compare the rate of grade 3/4 vaccine-related toxicity in patients treated with these
- Compare progression-free survival in patients treated with these regimens.
OUTLINE: This is a randomized, open label, parallell-group, multicenter study. Patients are
stratified according to disease stage (III in transit vs other stage III vs IV), presence of
lesion ≥ 20 mm (yes vs no), and participating center. Patients are randomized to 1 of 2
- Induction therapy
- Arm I: Patients receive immunization comprising D1/3-MAGE-3-His fusion protein and
SB-AS02B adjuvant intramuscularly (IM) once weekly on weeks 1, 3, 5, 7, 9, and 11.
- Arm II: Patients receive immunization comprising D1/3-MAGE-3-His fusion protein
SB-AS15 adjuvant IM once weekly on weeks 1, 3, 5, 7, 9, and 11.
Patients achieving a clinical complete response (CR), partial response (PR), stable disease
(SD), or slow progressive disease (SPD) proceed to maintenance therapy.
- Maintenance therapy: Patients in both arms receive immunization (according to their
randomized arm) once weekly on weeks 15, 18, 21, 24, 27, 30, 34, 40, 46, and 52.
Patients maintaining a CR, PR, or SD proceed to long-term treatment.
- Long-term treatment: Beginning 3 months after completion of maintenance therapy,
patients in both arms receive immunization (according to their randomized arm) once
every 3 months for 4 courses and then once every 6 months for 4 courses.
Treatment continues in both arms in the absence of disease progression that does not
correspond to SPD status, unacceptable toxicity, or the diagnosis of an autoimmune disease.
Patients are followed every 12 weeks.
PROJECTED ACCRUAL: A total of 68 patients (34 patients per treatment arm) will be accrued
for this study.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Response rate (complete response and partial response) as assessed by RECIST criteria
Willem H. J. Kruit, MD, PhD
Daniel Den Hoed Cancer Center at Erasmus Medical Center
United States: Federal Government