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

Cytos Biotechnology

Status and phase

Completed

Phase 2

Conditions

Malignant Melanoma

Treatments

Biological: CYT004-MelQbG10 + Imiquimod

Biological: CYT004-MelQbG10 + Montanide + Imiquimod

Biological: CYT004-MelQbG10 intra nodal injection

Biological: CYT004-MelQbG10 + Montanide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00651703

CYT004-MelQbG10 04

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.