A Randomized Phase II Study of L-BLP25 in Combination With Standard Androgen Deprivation Therapy and Radiation Therapy for Newly Diagnosed, High Risk Prostate Cancer Patients
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Change from Baseline in the Enzyme-linked Immunosorbent Spot (ELISPOT) Level of Mucin-1 specific T cells at 2 Months After Radiation.
To determine impact of L-BLP25 vaccine in addition to standard treatment on the MUC1 specific systemic immune response in patients with newly diagnosed high risk prostate cancer L-BLP25 vaccine in combination with Androgen Deprivation Therapy (ADT) and radiation therapy.
Baseline (Day -16 to -1) to Week 27 (approximately 2 months after radiation)
Martin Falk, MD
Merck Serono S.A., Geneva
United States: Food and Drug Administration
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