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NCT00651703 Clinical Trial

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

Malignant Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00651703
Other study ID # CYT004-MelQbG10 04
Secondary ID
Status Completed
Phase Phase 2
First received April 1, 2008
Last updated November 11, 2010
Start date April 2008
Est. completion date July 2010

Study information
Verified date November 2010
Source Cytos Biotechnology AG
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 21
Est. completion date July 2010
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• CYT004-MelQbG10 + Montanide

• CYT004-MelQbG10 + Montanide + Imiquimod

• CYT004-MelQbG10 + Imiquimod

• CYT004-MelQbG10 intra nodal injection

Locations
Country Name City State
Switzerland Ludwig Institute for Cancer Research; CHUV Lausanne VD
Switzerland Dermatologische Klinik, UniversitätsSpital Zürich Zurich

Sponsors (1)
Lead Sponsor Collaborator
Cytos Biotechnology AG

Country where clinical trial is conducted

Switzerland, 

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