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

NCT ID: NCT00651703

Last Updated: 2010-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-07-31

Brief Summary

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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

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Conditions

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Malignant Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

CYT004-MelQbG10 + Montanide

Intervention Type BIOLOGICAL

2

Group Type EXPERIMENTAL

CYT004-MelQbG10 + Montanide + Imiquimod

Intervention Type BIOLOGICAL

3

Group Type EXPERIMENTAL

CYT004-MelQbG10 + Imiquimod

Intervention Type BIOLOGICAL

4

Group Type EXPERIMENTAL

CYT004-MelQbG10 intra nodal injection

Intervention Type BIOLOGICAL

Interventions

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CYT004-MelQbG10 + Montanide

Intervention Type BIOLOGICAL

CYT004-MelQbG10 + Montanide + Imiquimod

Intervention Type BIOLOGICAL

CYT004-MelQbG10 + Imiquimod

Intervention Type BIOLOGICAL

CYT004-MelQbG10 intra nodal injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cytos Biotechnology AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Cytos Biotechnology AG

Locations

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Ludwig Institute for Cancer Research; CHUV

Lausanne, Canton of Vaud, Switzerland

Site Status

Dermatologische Klinik, UniversitätsSpital Zürich

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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CYT004-MelQbG10 04

Identifier Type: -

Identifier Source: org_study_id