A031501 Phase III Randomized Adjuvant Study of MK-3475 (Pembrolizumab) in Muscle Invasive and Locally Advanced Urothelial Carcinoma (AMBASSADOR) versus Observation
Johns Hopkins Kimmel Cancer Center in Baltimore
Sibley Memorial Hospital
The purpose of this study is to compare any good and bad effects of using a drug called MK-3475 (pembrolizumab) after the removal of your muscle invasive bladder cancer. MK-3475 is a drug that uses a person’s own immune system to treat cancer.
You may be eligible if you have had surgery to remove bladder cancer which is in the deep muscle of the bladder wall (called muscle-invasive bladder cancer).
This study has two study groups. If you are in Group 1 you will receive treatment with MK-3475. The MK-3475 will be given through your vein over 30 minutes once every 3 weeks. If you are in Group 2 you will be followed with scans without treatment. You will not receive any treatment but you will be contacted every 3 weeks with a phone call from your doctor’s office to see how you are feeling. You will also be asked to come back to the clinic every 6 weeks for a check-up for one year.A computer will by chance assign you to one of the 2 groups in this study. This is called randomization. This is done by chance because no one knows if one study group is better or worse than the others. You will have an equal chance of being placed in either group.Prior to randomization, a sample of your tumor tissue will be sent to a laboratory to determine if it contains a protein called PD-L1. This test is required because they will help the investigators determine who will be most likely to respond to this treatment in the future. In addition, it will ensure that the 2 groups are equal. The results of the PD-L1 will not be shared with you or your physician.If you are in Group 1 you will receive MK-3475 once every 3 weeks for one year. After you finish one year of treatment, your doctor will continue to watch you for side effects and follow your condition for a total of five years after you were registered to this study. Once you stop therapy you will need to be seen every 3 months for the first 2 years following the start of treatment and then yearly the next 3 years.If you are in Group 2 you will not receive treatment and your doctor’s office will call you every 3 weeks to check on you. You will also be asked to come into the clinic every 6 weeks for a check-up for the first year after you are put onto the study. After that first year you will be seen every 3 months for the second year after you are registered to the trial and then yearly for the next 3 years.
02/18/2020 05:03 AM