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...
Date First Received: April 1, 2008
Last Updated: August 27, 2008
Verified by: Cytos Biotechnology AG, August 2008
Clinical Trial Phase: Phase 2 | Start Date: April 2008
Overall Status: Recruiting
Estimated Enrollment: 20
Brief Summary
Official Title: “Safety, Tolerability, and Immunogenicity of CYT004-MelQbG10 Vaccine With or Without Immunostimulating Adjuvant in HLA-A2 Positive Patients With Stage III/IV Malignant Melanoma”
Condition Keyword(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Study Primary Completion Date: December 2009
Intervention(s) in this Clinical Trial
- Biological: CYT004-MelQbG10 + Montanide
- Biological: CYT004-MelQbG10 + Montanide + Imiquimod
- Biological: CYT004-MelQbG10 + Imiquimod
- Biological: CYT004-MelQbG10 intra nodal injection
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Experimental: 2
- Experimental: 3
- Experimental: 4
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- 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 Criteria:
- 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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Cytos Biotechnology AG
Overall Clinical Trial Officials and Contacts
Overall Contact: Philipp Mueller ++41-44-733 info@cytos.com
Additional Information
Information obtained from ClinicalTrials.gov on November 20, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00651703
Study ID Number: CYT004-MelQbG10 04
ClinicalTrials.gov Identifier: NCT00651703
Health Authority: Switzerland: Swissmedic
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
