Clinical Trials | CA2440012: IZABRIGHT-Bladder01: A randomized, open-label, Phase 2/3 trial of izalontamab brengitecan versus platinum-based chemotherapy for metastatic urothelial cancer in participants with disease progression on or after an immunotherapy-based treatment
IZABRIGHT-Bladder01: A RANDOMIZED, OPEN-LABEL, PHASE 2/3 TRIAL OF IZALONTAMAB BRENGITECAN VERSUS PLATINUM-BASED CHEMOTHERAPY FOR METASTATIC UROTHELIAL CANCER IN PARTICIPANTS WITH DISEASE PROGRESSSION ON OR AFTER AN IMMUNOTHERAPY-BASED TREATMENT
The University of Virginia Comprehensive Cancer Center seeks participants ages 18 and over in people with urothelial cancer (cancer affecting the tissues that line the bladder, kidneys, and other parts of the urinary system, which has spread to other parts of the body) in patients whose cancer has gotten worse after receiving immunotherapy treatment for a research study. The purpose of the study is to learn whether the experimental study drug iza-bren works to treat metastatic urothelial cancer This study is: • A randomized study: You will get a drug assigned to you based on chance — like the flip of a coin. • An open-label study: Both you and your study doctor will know which drug you're getting. There are different groups or arms for each phase of the study. In Phase 1, you will be randomly assigned to one of the following 3 groups: • Iza-bren at one dose • Iza-bren at different dose • Platinum-based chemotherapy In Phase 2, you will be randomly assigned to one of the following 2 groups: • Iza-bren at the dose recommended based on Phase 1 • Platinum-based chemotherapy There are 3 separate phases of the study which includes screening, treatment and follow-up. From start to finish you can expect to be in this study for a maximum of approximately 5 years.