Safety and Immunogenicity of a Melan-A VLP Vaccine in Early 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 II Malignant Melanoma

NCT00306566•Cytos Biotechnology AG

View on ClinicalTrials.gov

Summary

The purpose of this study is to monitor a specific cellular immune response in melanoma patients at an early stage of the disease, that have been vaccinated with a Melan-A VLP vaccine.

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
•Histological confirmed stage II melanoma
•HLA-A\*0201 haplotype
•Expected survival of at least 6 months
•ECOG performance status of 0 or 1
•Full recovery from surgery
•Adequate organ and bone marrow functions
•Sexually active males should use adequate contraception throughout the study period and 3 months thereafter.
+1 more criteria

Exclusion Criteria

•Pregnant or nursing
•Use of an investigational drug within 30 days before enrolment
•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 (e.g. steroids, antihistamine drugs; topical or inhalational steroids are permitted).
•Presence of significant cardiovascular, renal, pulmonary, endocrine, infectious, or neurological disorders.
•Serum tests positive for HIV, HBV, HCV.
•Active autoimmune diseases or severe allergies.
•Current diagnosis or history of relevant and severe psychiatric disorder that compromises the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol or to complete the study.
•Blood donation or loss of \> 500mL within 8 weeks prior to inclusion.
+2 more criteria

Locations (1)

Centre Pluridisciplinaire d'Oncologie & LICR, CHUV

Lausanne, Vaude, Switzerland

Key Dates

Last Updated

September 20, 2007

Conditions

Malignant Melanoma

Interventions

CYT004-MelQbG10

BIOLOGICAL

An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors

NCT07371663

Solid CancersNSCLC (Advanced Non-small Cell Lung Cancer)+3 more

View study

RECRUITINGPHASE1/PHASE2

Modified Vaccine for High Risk or Low Residual Melanoma Patients

NCT01898039

Malignant Melanoma

View study

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 Early Stage Melanoma Patients

Inclusion Criteria

Exclusion Criteria

An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors

Modified Vaccine for High Risk or Low Residual Melanoma Patients

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