Trial Information
Vaccination of Melanoma Patients (Stage II-IV) With ImmuFact IMP321, Tumor Antigenic Peptides and Montanide
Inclusion Criteria:
- Histologically confirmed stage II, III or IV melanoma patients
- Tumor expression of Melan-A
- Human leukocyte antigen-A2 (HLA-A2) positive
Exclusion Criteria:
- Clinically significant heart disease
- Serious illness, eg serious infections requiring antibiotics, uncontrolled peptic
ulcer, or central nervous system disorders
- History of immunodeficiency disease or autoimmune disease
- Metastatic disease to the central nervous system, unless treated and stable
- Coagulation or bleeding disorders
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety of vaccination will be assessed according to NCI CTC scale
Outcome Time Frame:
Change from baseline at week 31
Safety Issue:
Yes
Principal Investigator
Olivier Michielin, MD PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Oncology Department, Centre Hospitalier Universitaire Vaudois, Lausanne
Authority:
Switzerland: Swissmedic
Study ID:
P009-2010DR1082
NCT ID:
NCT01308294
Start Date:
June 2010
Completion Date:
December 2014
Related Keywords:
- Melanoma
- Melanoma
- Stage II-IV
- Immunotherapy
- Vaccination
- HLA class I and II tumor-specific peptides
- IMP321
- Montanide ISA-51 VG
- Melanoma