Safety, Tolerability, and Immunogenicity of CYT004-MelQbG10 Vaccine With or Without Immunostimulating Adjuvant in HLA-A2 Positive Patients With Stage III/IV Malignant Melanoma

Cytos Biotechnology AG2 sites in 1 country21 target enrollmentApril 2008

ConditionsMalignant Melanoma

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Malignant Melanoma
Sponsor: Cytos Biotechnology AG
Enrollment: 21
Locations: 2
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2008

End Date

July 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cytos Biotechnology AG

Eligibility Criteria

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.