Full TitleAtezolizumab in Combination with Gemcitabine and Cisplatin As First-Line Treatment in Metastatic Urothelial Cancer: A Multicenter Randomized Phase II Study of Two Alternative Dosing Schedules
Atezolizumab is designed to improve the immune system’s ability to recognize and destroy cancer cells by blocking PD-L1, a protein made by some cancers. It is used to treat metastatic bladder cancer and lung cancer. In this study, researchers are evaluating the safety and effectiveness of combining chemotherapy (gemcitabine and cisplatin) with atezolizumab immunotherapy in two different ways in patients with metastatic bladder cancer.
Patients will be randomly assigned to one of two groups:
- One group will have atezolizumab alone for two cycles, then atezolizumab plus chemotherapy for six cycles, followed by atezolizumab alone.
- The second group will have chemotherapy alone for two cycles, then atezolizumab plus chemotherapy for four cycles, followed by atezolizumab alone.
All of these medications are given intravenously (by vein).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have metastatic bladder cancer and may not have received chemotherapy or immunotherapy for metastatic disease.
- Patients may not have previously received a PD-1 or PD-L1 inhibitor.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- This study is for patients age 18 and older.
For more information about this study and to inquire about eligibility, please contact Dr. Jonathan Rosenberg at 646-422-4461.