Autologous dendritic cell vaccination (DCVAC/PCa) added to docetaxel chemotherapy in a double-blind, randomized phase III trial (VIABLE) in men with advanced (mCRPC) prostate cancer.
ABSTRACT
Background: Prostate cancer (PCa) is the second most common cancer, and the fifth leading cause of cancer related death among men worldwide. Immunotherapy designed to induce tumor cell specific immune responses capable of destroying tumor cells has emerged as a promising treatment modality in solid malignant tumors. Clinical and preclinical trials have shown that docetaxel chemotherapy can be combined with vaccine without impairing the immune response.
Methods: VIABLE is a randomized, double-blind, placebo-controlled, parallel-group, international phase III study to evaluate the efficacy and safety of DCVAC/PCa (active cellular immunotherapy based on dendritic cells) versus placebo in patients with mCRPC eligible for first-line docetaxel chemotherapy. The study was initiated in May 2014 and plans to enroll almost 1200 patients at approximately 300 sites globally. Eligible patients are required to present with metastatic castrate-resistant PCa defined by both presence and progression of the disease, maintenance of a castrate state with serum testosterone level less than 50 ng/dl, ECOG score 0-2, and adequate hematologic, hepatic and renal functions. All patients will receive standard of care docetaxel plus prednisone, and will be randomized 2:1 to DCVAC/PCa or placebo. Patients will be stratified by region (US vs other), previous therapy (enzalutamide and/or abiraterone) and ECOG score (0, 1 vs 2). The primary endpoint is overall survival (OS). Secondary objectives include assessments of safety, radiographic progression free survival, time to PSA progression, time to the first occurrence of skeletal related events (SRE), and quality of life (QoL) assessments based on the FACT-P questionnaire. Clinical trial information: Registration number NCT02111577, EudraCT number 2012-002814-38. Clinical trial information: NCT02111577