An Open-Label, Multicenter, Phase 3 Study to Evaluate the Efficacy and Tolerability of Intravesical Vicinium™ in Subjects with Non Muscle-Invasive Carcinoma in Situ (CIS) and/or High-Grade Papillary Disease of the Bladder Previously Treated with Bacillus
An Open-Label, Multicenter, Phase 3 Study to Evaluate the Efficacy and Tolerability of Intravesical Vicinium™ in Subjects with Non Muscle-Invasive Carcinoma in Situ (CIS) and/or High-Grade Papillary Disease of the Bladder Previously Treated with Bac
This study is designed to obtain information on the safety and the effectiveness of an experimental drug called Vicinium when it is given to human subject(s)/participant(s) with bladder cancer that has not spread to the muscle of the bladder. Vicinium is part of an antibody connected to a protein that can kill cells. The protein is a modified “pseudomonas exotoxin A”. Vicinium is designed to attach to cells that have a different protein called EpCAM on the outside of the cell. After attaching to a cell, the modified pseudomonas exotoxin A can be released in the cell causing the cell to die. It is thought that almost all bladder cancer cells has EpCAM on the outside. About 70 medical centers in North America (United States and Canada) are expected to participate in this study. About 134 subject(s)/participant(s) will participate in the study. Male and non-pregnant/non-lactating females age 18 years or older that meet all study requirements will be able to participate in this study. The expected treatment length of this study is up to 24 months.
Are you Eligible? (Inclusion Criteria)
1. Histologically-confirmed high-grade non muscle-invasive bladder cancer - CIS, Ta or T1 papillary disease or some combination thereof (i.e., CIS plus papillary disease) following adequate BCG treatment. Adequate BCG treatment is defined as at least 7 instillations of BCG over two cycles (1 induction course of at least 5 doses over six weeks+ 1 maintenance cycle of at least 2 doses over six weeks, or up to 2 induction courses. This diagnosis must be confirmed by the protocol-specified, independent central pathology reviewer prior to subject enrollment in the trial and the start of study treatment. A subject treatment number may not be assigned until the confirmed diagnosis is received.
2. The CIS, Ta or T1 disease is documented as unresponsive to (i.e., not intolerant) adequate BCG therapy (with or without interferon). Unresponsive subjects may be either refractory (i.e., evaluable disease remains after adequate BCG treatment) or relapsing (a subject who had undergone a complete response after adequate BCG treatment but has an emergence of disease within 6 months of completion of last BCG treatment.
1) Evidence of urethral or upper tract transitional cell carcinoma (TCC) by biopsy or upper tract
radiological imaging (e.g., intravenous pyelogram,