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M-Vax in stage III or IV melanoma
NCT00257465Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2005
- Primary completion
- Jun 2008
- Countries
- 1
- Sponsor
- AVAX Technologies, Inc.
- Drugs
- M-Vax
- Conditions
- melanoma
01
Overview
Phase 2, randomised, double-blind trial of M-Vax in melanoma (4 arms), sponsored by AVAX Technologies, Inc. Primary endpoint: Immune response to patients' own melanoma cells at 2 months. Started Jun 2005; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
5.0 million cells
High dose M-Vax
2.5 million cells
Medium dose M-Vax
0.5 million cells
Low dose M-Vax
0 cells
Placebo control
03
Who it enrols
Patients with stage III or IV melanoma with at least one tumor mass >= 2.5 cm and good performance status; excludes brain metastases and immunosuppressive drugs.
04
Endpoints
Primary
Immune response to patients' own melanoma cells
Secondary
Safety
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