A Phase IIa Study to Evaluate Safety, Tolerability, and Immunogenicity of a Melan-A-VLP Vaccine in HLA-A2 Positive Patients with stage III/IV Malignant Melanoma

• Conditions: Patients with Stage III/IV Malignant Melanoma

• Registration Number: EUCTR2005-000727-42-DE
• Lead Sponsor: Cytos Biotechnology AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Able to provide written informed consent
- Able to complete all protocol requirements
- Age: 18 years and older
- Histologically confirmed stage III or IV melanoma (per American Joint Committee on
- HLA-A*0201 haplotype (serological and genomic typing)
- Expected survival of at least 6 months
- ECOG performance status of 0 or 1
- At least one and no more than two previous systemic therapies for metastatic melanoma.
- Adequate organ and bone marrow functions
- All AEs from prior anticancer therapy have resolved to >= Grade 1

-Sexually active males should use adequate contraception throughout the study and 3 months therafter

- Females of child bearing potential should use adequate contraception that can be oral contraception or a double-barrier local contraception (intra-uterine device plus condom or spermicidal gel plus condom) and have a negative serum pregnancy test within 4 weeks prior to the first dose of the vaccine

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Pregnant or nursing
- Use of an investigational drug within 30 days before enrolment
- Known or suspected brain metastases
- Current use of an immunosuppressive drug or any concomitant medication that could potentially interfere with the study drug
- Presence of significant cardiovascular, renal, pulmonary, endocrine, infectious, or neurological disorders
- Serum tests positive for HIV, HBV, HCV
- Active autoimmune diseases or severe allergies
- Current diagnosis or history of relevant and severe psychiatric disorder
- Blood donation or loss of >400mL within 8 weeks prior to inclusion
- Abuse of alcohol or other recreational drugs.- Smokers consuming >20 cigarettes per day
- Previous participation in a clinical trial with a Qb based vaccine (DerQb, NicQb, TNFQb, AngQb, GhrQb, QbG10, AllQbG10)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified