A Phase 2/3 interventional study of Melanoma vaccine modified to express HLA A2/4-1BB ligand in High Risk HLA-A2+ Melanoma and Metastatic Disease, sponsored by Hadassah Medical Organization. Withdrawn. Per ClinicalTrials.gov, last updated 2025-10-02.
Sponsored by Hadassah Medical Organization · Phase 2/3, Interventional, and Treatment
This study is based on the hypothesis that stimulation of the immune response against the tumor can help destroy residual tumor in melanoma patients with very high risk for disease recurrence and in patients with relatively low tumor burden who already got first line treatment for their disease.
Ongoing clinical trials in the Hadassah Hospital have shown that vaccination of patients with a cell line of tumor cells from the patient himself, or with a combination of three cell lines that partially match the patient's cell characteristics, could improve the immune response against the tumor, was associated with improved disease-free and overall survival.
In this study, the investigators will evaluate the efficacy of a modified tumor cell vaccine, in terms of immune response,improved disease-free and overall survival. The vaccine consists of a cell line that has a high expression level of melanoma molecules, and has been genetically modified to induce a strong immune response.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
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Exclusion Criteria:
Biological: Melanoma vaccine modified to express HLA A2/4-1BB ligand
This study is designed for patients who had malignant melanoma and, following tumor removal, are now free of disease, or have only very minor residual disease, and are at a very high risk of disease recurrence. These patients will be treated with the A2/4-1BBL melanoma vaccine, a compatible melanoma cell line that has been engineered to express a molecule termed 4-1BBL, which enhances the chances of the cell line to be recognized by the patient's immune system, and to induce its stimulation. The hypothesis that drives the study states that the immune response against the cell line will also be effective against the residual tumor that may still be present in the body.
Number of adverse effects
Time frame: For 20 weeks from the start of treatment
Overall and disease free survival
Time frame: For at least five years
Emergence of anti-tumor T cell reactivity
Time frame: To be measured one month after the last vaccine was admininstered, on average 18-20 weeks after treatment start
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Hadassah Medical Organization