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

Phase 2

Completed

• Conditions: Malignant Melanoma
• Interventions: Biological: CYT004-MelQbG10 + Montanide; Biological: CYT004-MelQbG10 + Montanide + Imiquimod; Biological: CYT004-MelQbG10 + Imiquimod; Biological: CYT004-MelQbG10 intra nodal injection

• Registration Number: NCT00651703
• Lead Sponsor: Cytos Biotechnology AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-01
• Study First Submitted QC: 2008-04-01
• Study First Posted: 2008-04-03
• Primary Completion: 2009-12
• Study Completion: 2010-07
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-11
• Last Update Posted: 2010-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	CYT004-MelQbG10 + Montanide	-
2	CYT004-MelQbG10 + Montanide + Imiquimod	-
3	CYT004-MelQbG10 + Imiquimod	-
4	CYT004-MelQbG10 intra nodal injection	-

Trial Locations

Locations (2)

Dermatologische Klinik, UniversitätsSpital Zürich; 🇨🇭 Zurich, Switzerland

Ludwig Institute for Cancer Research; CHUV; 🇨🇭 Lausanne, VD, Switzerland