Status:
COMPLETED
Safety and Immunogenicity of CYT004-MelQbG10 Vaccine With and Without Adjuvant in Advanced Stage Melanoma Patients
Lead Sponsor:
Cytos Biotechnology AG
Conditions:
Malignant Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate a specific cellular immune response in melanoma patients that have been vaccinated with a Melan-A VLP vaccine alone or in combination with different adjuvants.
Eligibility Criteria
Inclusion
- Histological confirmed Stage III or IV malignant melanoma
- HLA-A\*0201 haplotype
- Expected survival of at least 9 months
- Willing and able to comply with all trial requirements (e.g. diaries, CTs)
- Given written informed consent
- Females only if non-reproductive or if they agree to consistently practice an effective and accepted method of contraception
Exclusion
- Any contraindication to any study related test or assessment
- Current or planned use of contraindicated concomitant medication
- Presence or history of relevant cardiovascular, renal, pulmonary, endocrine, autoimmune, neurological and psychiatric disease
- Infection with HIV, HBV or HCV
- Pregnancy or lactation or females planning to become pregnant during the study
- Abuse of alcohol or other drugs
- Use of investigational drug within 30 days before enrolment
- Previous participation in a clinical trial with a Qb-based Cytos vaccine.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00651703
Start Date
April 1 2008
End Date
July 1 2010
Last Update
November 15 2010
Active Locations (2)
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1
Ludwig Institute for Cancer Research; CHUV
Lausanne, Canton of Vaud, Switzerland, CH-1005
2
Dermatologische Klinik, UniversitätsSpital Zürich
Zurich, Canton of Zurich, Switzerland, CH-8091