Phase II Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer
Randomized, Open-label, Parallel-group, Multi-centre Phase II Clinical Trial of Active Cellular Immunotherapy With Preparation DCVAC/PCa in Patients With Castrate-resistant Prostate Cancer
Lead SponsorAccord Research
StatusCompleted No Results Posted
Indication/ConditionProstate Cancer ...
Intervention/Treatmentn-acetyl-s-(1,2-dichlorovinyl)-l-cysteine docetaxel ...
The purpose of this study is to determine whether DCVAC/PCa added onto Standard of Care therapy can improve survival times for patients with Metastatic Castration Resistant Prostate Cancer
DCVAC/PCa is the experimental therapy added on to Docetaxel
Docetaxel is Standard of Care First Line Chemotherapy
Combination therapy with Dendritic Cells DCVAC/PCa and Standard of Care
Docetaxel as an Active Comparator
Inclusion Criteria: Men aged ≥ 18 years Histologically confirmed prostate cancer Presence of skeletal metastasis (by CT or PET or MRI) Disease progression documented by increasing PSA or two new lesions Eastern Cooperative Oncology Group (ECOG) Performance status 0-2 Exclusion Criteria: Confirmed brain and/or leptomeningeal metastases Prior chemotherapy for prostate cancer Peripheral neuropathy of Common Toxicity Criteria (CTC) grade 2 or greater Other uncontrolled intercurrent illness Treatment with immunotherapy against PCa Clinically significant cardiovascular disease Active autoimmune disease requiring treatment