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.
Lay Title: A new study to treat your bladder cancer
Technical Title: A Study of Intravesical Bacillus Calmette-Guerin (BCG) in Combination with ALT-803 in Patients with Non-Muscle Invasive Bladder Cancer (NMIBC)
Disease Type: High-grade Non-Muscle Invasive Bladder Cancer (NMIBC) in patients who have not received treatment with BCG.
Basic information: The purpose of this research study is to look at the effectiveness of a combination treatment using ALT-803 (study drug) and BCG, compared to treatment with BCG alone. This study is for patients with non-muscle invasive bladder cancer (NMIBC) who have not received prior treatment with BCG. BCG is the standard treatment given to patients with NMIBC. In this study, patients will be assigned to a disease cohort, either A or B, based on the type of tumor(s) you have (carcinoma in situ or high-grade papillary disease). Regardless of your cohort, you will be randomized to receive either BCG alone, or BCG in combination with ALT-803.
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Read more about this study (NCT02138734) on ClinicalTrials.gov.
Lay Title: A Study for the Treatment of High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)
Technical Study Title: A Phase 3 Trial of BCG with or without Pembrolizumab for High Risk Non-Muscle-Invasive Bladder Cancer (KEYNOTE-676)
Disease Type: Patients who have been treated with BCG and have recurrent or persistent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC)
Basic information: The purpose of this research study is to test the safety of pembrolizumab in combination with Bacillus Calmette-Guerin (BCG) and to see how well this combination treatment works compared to BCG alone. Pembrolizumab (MK-3475) has been approved for patients with certain types of bladder cancer; however, it has not been approved for your type of bladder cancer. BCG has been approved for patients with your type of bladder cancer.
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Read more about this study (NCT03711032) on ClinicalTrials.gov.
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. One cohort of patients (Cohort C) will receive ALT-803 alone, without BCG. Both BCG and ALT-803 are given through intravesical therapy, which means the drug is given directly into the bladder through a catheter.
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Sponsor: Altor Bioscience
Read more about this study (NCT03022825) on ClinicalTrials.gov.
For information on inclusion and exclusion criteria please call our Clinical Trials Office - 310-794-7700
