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Safety and Immunogenicity of a Melan-A VLP Vaccine in Advanced Stage Melanoma Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Safety and Immunogenicity of a Melan-A VLP Vaccine in Advanced Stage Melanoma Patients

A Phase IIa Study to Evaluate Safety, Tolerability, and Immunogenicity of a Melan-A VLP Vaccine in HLA-A2 Positive Patients With Stage III/IV Malignant Melanoma

NCT00306514•Cytos Biotechnology AG

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate whether vaccination with a Melan-A VLP vaccine leads to a specific cellular immune response in patients with malignant melanoma at advanced stage of the disease.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Able to provide written informed consent
•Able and willing to complete all protocol requirements
•Age: 18 years and older
•Histologically confirmed stage III or IV melanoma
•HLA-A\*0201 haplotype
•Expected survival of at least 6 months
•ECOG performance status of 0 or 1
•At least one and no more than 2 previous systemic therapies for metastatic melanoma
•Able to undergo computed tomography (CT) scan/ magnetic resonance imaging (MRI) scan for tumor assessment.
•Lack of response to or progression after most recent systemic therapy for metastatic melanoma.
+4 more criteria

Exclusion Criteria

•Pregnant or nursing
•Use of an investigational drug within 30 days before enrollment
•Known or suspected brain metastases
•Active malignancy in the 5 years prior to enrollment other than melanoma, basal cell carcinoma or cervical carcinoma in situ.
•Major surgery within 4 weeks prior to enrollment.
•Current use of an immunosuppressive drug or any concomitant medication that could potentially interfere with the study drug.
•Presence of significant cardiovascular, renal, pulmonary, endocrine, infectious, or neurological disorders.
•Serum tests positive for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV).
•Active autoimmune diseases or severe allergies.
•Known type 1 allergy.
+5 more criteria

Locations (1)

Dept. of Dermatology, Venerology and Allergy

Berlin, State of Berlin, Germany

Key Dates

Last Updated

September 20, 2007

Conditions

Melanoma

Interventions

CYT004-MelQbG10

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 20, 2007Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Immunogenicity of a Melan-A VLP Vaccine in Advanced Stage Melanoma Patients

Inclusion Criteria

Exclusion Criteria

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