Safety and Immunogenicity of CYT004-MelQbG10 Vaccine With and Without Adjuvant in Advanced Stage Melanoma Patients

This study has been completed.
Sponsor:
Information provided by:
Cytos Biotechnology AG
ClinicalTrials.gov Identifier:
NCT00651703
First received: April 1, 2008
Last updated: November 11, 2010
Last verified: November 2010

April 1, 2008
November 11, 2010
April 2008
December 2009   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00651703 on ClinicalTrials.gov Archive Site
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Safety and Immunogenicity of CYT004-MelQbG10 Vaccine With and Without Adjuvant in Advanced Stage Melanoma Patients
Safety, Tolerability, and Immunogenicity of CYT004-MelQbG10 Vaccine With or Without Immunostimulating Adjuvant in HLA-A2 Positive Patients With Stage III/IV Malignant Melanoma

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Malignant Melanoma
  • Biological: CYT004-MelQbG10 + Montanide
  • Biological: CYT004-MelQbG10 + Montanide + Imiquimod
  • Biological: CYT004-MelQbG10 + Imiquimod
  • Biological: CYT004-MelQbG10 intra nodal injection
  • Experimental: 1
    Intervention: Biological: CYT004-MelQbG10 + Montanide
  • Experimental: 2
    Intervention: Biological: CYT004-MelQbG10 + Montanide + Imiquimod
  • Experimental: 3
    Intervention: Biological: CYT004-MelQbG10 + Imiquimod
  • Experimental: 4
    Intervention: Biological: CYT004-MelQbG10 intra nodal injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
July 2010
December 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00651703
CYT004-MelQbG10 04
No
Head Clinical Development, Cytos Biotechnology AG
Cytos Biotechnology AG
Not Provided
Not Provided
Cytos Biotechnology AG
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP