Safety and Immunogenicity of CYT004-MelQbG10 Vaccine With and Without Adjuvant in Advanced Stage Melanoma Patients
Phase 2
Completed
- Conditions
- Malignant Melanoma
- Registration Number
- NCT00651703
- Lead Sponsor
- Cytos Biotechnology AG
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie CYT004-MelQbG10's immunogenicity in HLA-A2 positive melanoma patients?
How does CYT004-MelQbG10 compare to standard-of-care vaccines for stage III/IV malignant melanoma?
Which biomarkers correlate with response to CYT004-MelQbG10 vaccine with or without adjuvants in melanoma?
What are the adverse event profiles of CYT004-MelQbG10 combinations in melanoma phase 2 trials?
How do Montanide and Imiquimod adjuvants enhance CYT004-MelQbG10's efficacy in melanoma immunotherapy?
Trial Locations
- Locations (2)
Ludwig Institute for Cancer Research; CHUV
🇨🇭Lausanne, VD, Switzerland
Dermatologische Klinik, UniversitätsSpital Zürich
🇨🇭Zurich, Switzerland
Ludwig Institute for Cancer Research; CHUV🇨🇭Lausanne, VD, Switzerland