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.
Technical Study Title: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination with ALT-803 in Patients with BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer
Objective of the study (lay terms): The purpose of this research study is to test the safety, tolerability, and effectiveness of the study drug (called ALT-803) in combination with BCG in patients with non-muscle invasive bladder cancer (NMIBC) that did not respond to prior treatment with BCG. Both BCG and ALT-803 are given through intravesical therapy, which means the drug is given directly into the bladder through a catheter.
Investigator: Dr. Karim Chamie
Sponsor: Altor Bioscience
Read more about this study on ClinicalTrials.gov.
Technical Study Title: An Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Multi-Centre, Multi-arm Phase 1b Study in patients with Muscle Invasive Bladder Cancer (MIBC) who have progressed on prior treatment (BISCAY) D2615C00001
Objective of the study (lay terms): This research is testing two new study drugs (MEDI4736 and AZD4547) to find out if they can treat metastatic MIBC effectively. The study will also look for side effects caused by the study drugs and examine how long the drugs remain in blood. To participate in this study, you will need to provide a sample of your tumor tissue to determine what genetic type of bladder cancer you have. You will only be offered treatment on this study if your tumor sample shows certain types of genetic mutations. The treatment you receive will match the genetics of your tumor sample. This means that different patients are offered different treatments on this study. This study will test the theory that these matched treatments may give a better treatment response.
Investigator: Dr. Karim Chamie
Sponsor: Astra Zeneca
Read more about this study on ClinicalTrials.gov
Lay Title: A new study to treat your bladder cancer that has spread into the muscle tissue
Technical Title: Randomized Phase II Study of Neoadjuvant Nivolumab with and without Urelumab in Patients with Cisplatin-Ineligible Muscle-Invasive Urothelial Carcinoma of the Bladder
Disease Type: Muscle-invasive urothelial carcinoma of the bladder. This study is for patients who are planning to undergo cystectomy (surgical removal of some or all of the bladder) and are not eligible to be treated with standard cisplatin-based chemotherapy.
Basic information: The purpose of this research study is to study the effects, safety, and tolerability of the study drugs nivolumab and urelumab when given to people who have advanced bladder cancer that has spread into the muscle issue. Patients on this study will be randomized to be treated with a combination of nivolumab and urelumab, or with nivolumab alone. Patients will receive treatment for approximately 2 months before their planned cystectomy (removal of bladder).
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For information on inclusion and exclusion criteria please call our Clinical Trials Office - 310-794-7700