Melanoma Stage IV MedDRA : 10025671
Conditions
Interventions
Product Name: M-Vax
Product Code: ME11
Pharmaceutical Form: Suspension for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intradermal use
Sponsors
AVAX Technologies Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Stage IV metastatic melanoma of cutaneous or mucosal origin or without known primary site - At least one metastatic mass that is surgically resectable, excluding metastases in brain, bowel, or bone - Successful preparation of a vaccine that meets quality control release criteria Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Failure to prepare a vaccine that meets all quality control release criteria - Uveal melanoma - Brain metastases, current or past (unless successfully treated at least one year prior to enrolment) - Known gentamicin allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the anti-tumor response rate induced by M Vax + Low Dose IL2 with that induced by Placebo Vaccine + Low Dose IL2;Secondary Objective: To compare the overall survival and progression-free survivals of patients treated with M Vax + Low Dose IL2 with patients treated with Placebo Vaccine + Low Dose IL2 To compare the safety of administration of M Vax + Low Dose IL2 with Placebo Vaccine + Low Dose IL2 ;Primary end point(s): - Best overall anti-tumor response rate (modified RECIST) - Overall survival (% survival at 2 years) | — |
Countries
Belgium
Outcome results
None listed