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

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.

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Key information

Conditions

Malignant Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ludwig Institute for Cancer Research; CHUV, Lausanne, Canton of Vaud, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CYT004-MelQbG10 + Montanide

Biological

CYT004-MelQbG10 + Montanide + Imiquimod

Biological

CYT004-MelQbG10 + Imiquimod

Biological

CYT004-MelQbG10 intra nodal injection

Biological

Sponsors and collaborators

Lead sponsor

Cytos Biotechnology AG

Industry

Registry information

Official study 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

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2010
First posted: Apr 3, 2008
Registry last updated: Nov 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed