A clinical trial is a study conducted with actual patients, usually to evaluate a new treatment. Each study is designed to answer scientific questions and to find new and better ways to help patients.
Official Study Title: A Study of Intravesical Bacillus Calmette-Guerin (BCG) in Combination with ALT-803 in Patients with BCG-naïve Non-Muscle Invasive Bladder Cancer (NMIBC)
Objective of the study (lay terms): The purpose of this research study is to find out what are the side effects of the study drug, ALT-803, plus BCG in NMIBC. The study drug, ALT-803 is given through intravesical therapy, which means the drug is given directly into the bladder (through a catheter). In this study, we wish to find out how safe the study drug is and how well it is tolerated.
Design: This is a Phase Ib/II, open-label, dose-finding, multicenter study of intravesical BCG plus ALT-803 in BCG-naïve NMIBC. The study will be conducted in conformity with Good Clinical Practice (GCP).
Treatments: On an outpatient basis, all enrolled patients will receive via a urinary catheter in the bladder, BCG plus ALT-803 weekly for 6 consecutive weeks (induction therapy), modeled after induction BCG therapy
Investigator: Dr. Karim Chamie Sponsor: Altor Bioscience
Title of Study (Official): 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 Calmette-Guerin
Objective (Lay terms): A Study to compare two therapies: BCG or the Study Drug Vicinium, in the treatment of Bladder Cancer.
Investigator: Dr. Karim Chamie
Sponsor: Viventia Bio Inc.
For information on inclusion and exclusion criteria please call our Clinical Trials Office - 310-794-7700