Ovarian Neoplasms Clinical Trial
In this study, patients will be randomized to one of three dose regimen groups. Each dose of
OvaRex MAb-B43.13 is 2 mg by slow intravenous administration.
Group 1 will receive two doses, one month apart.
Group 2 will receive three consecutive monthly doses, then at 12-week intervals through 2
years or until disease relapse up to a total of 9 doses.
Group 3 will receive six consecutive monthly doses, then at 12-week intervals through 2
years or until disease relapse up to a total of 11 doses.
The study will compare the time to disease relapse of patients who demonstrate an immune
response to OvaRex MAb-B43.13 with time to disease relapse of those who do not demonstrate
an immune response to OvaRex MAb-B43.13. Differences in the percentage of patients
demonstrating an immune response in each dose regimen group will also be assessed.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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