drugset / Trial / NCT01898039

Modified Vaccine for High Risk or Low Residual Melanoma Patients

NCT01898039 ↗

Phase 1/2 Recruiting 50 enrolled Hadassah Medical Organization
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2013-05
Primary completion
2027-04
Completion
2027-04

Drugs

EvaluationDrugModalityDoseRoute
Subject A2/4-1BBL melanoma vaccine Vaccine — Other
Background Cyclophosphamide Other / unclassified 300 mg/m2 Intravenous

Indications