9947 A Randomized Phase 2 Trial of Cisplatin/Gemcitabine with or without M6620 (VX-970) in Metastatic Urothelial Carcinoma
Johns Hopkins Kimmel Cancer Center in Baltimore
The purpose of this study is to compare any good and bad effects of using VX-970 along with the usual chemotherapy compared to usual chemotherapy alone.
Generally healthy adults with advanced metastatic bladder cancer may be eligible.
This study has two study groups. Group 1 will receive the study drug VX-970 in combination with chemotherapy (cisplatin and gemcitabine) and Group 2 will receive chemotherapy alone (cisplatin and gemcitabine. A computer will by chance assign you to treatment groups in the study. This is called randomization. This is done by chance because no one knows if one study group is better or worse than the other. You have a 50% chance of being assigned to Group 1 and a 50% chance of being assigned to Group 2.VX-970 is given by vein over an approximately 1 hour infusion. We have previously referred to a 21 day cycle in which cisplatin is given on the first day and gemcitabine is given on the first and eighth days. On this 21 day cycle, VX-970 is given on the second and ninth days.You will receive in total, six 3-week cycles of cisplatin with gemcitabine which is typically given, amounting to 18 weeks or roughly 4 ½ months. After you finish chemotherapy alone (cisplatin and gemcitabine) or chemotherapy with VX-970, your doctor will continue to watch you for side effects and follow your condition for 3 years.
03/05/2019 05:03 AM