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Modified Vaccine for High Risk or Low Residual Melanoma Patients

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary and study completion dates: Apr 2019 to Apr 2027
    • Study title shortened, about 1 word
    v3
  2. Primary completion date: Apr 2016 to Apr 2019
    • Study completion date: Apr 2019
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT01898039
Lead Sponsor Hadassah Medical Organization
Conditions
(from sponsor)		 Malignant Melanoma
Related terms Melanoma, Neoplasm, Residual
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov