Purpose of this Study
The purpose of this study is to determine whether an experimental blood test (Signatera®) can help us make better decisions about who should get immunotherapy after surgery to remove the bladder for bladder cancer and which immunotherapy treatment will be the best choice.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Have histologically confirmed urothelial cancer of the bladder
- Have had a radical cystectomy at least 3 weeks, but not more than 12 weeks, before joining the study
- Have no evidence of residual cancer or metastases after surgery
- Have never received previous treatment with any PD-1 or PD-L1 axis inhibitors
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will get a blood draw and have the study test run. Based on the results of the study test, you will then get a group assignment.
- Group A: You will be in this group if you have a "positive" first study test. People in this group will get a random assignment (by chance) to get either a single immunotherapy drug, called nivolumab, or a combination of two immunotherapy drugs, called nivolumab plus relatlimab. You will get the drug(s) through a vein in the arm once every 28 days. 28 days is called 1 cycle. You will receive up to 12 total cycles of immunotherapy treatment.
- Group B: You will be in this group if you have a "negative" first study test. People in this group will get a random assignment to get an immunotherapy drug called nivolumab or be on close monitoring without receiving initial immunotherapy. If you are assigned to receive immediate treatment with nivolumab, you will get this drug \through a vein in the arm once every 28 days. 28 days is called 1 cycle. You will receive up to 12 cycles. If you are assigned to close monitoring without immediate immunotherapy, you will be told if your Signatera test changes from negative to positive and then offered treatment with nivolumab at that time for up to 12 cycles if you have a later positive result.
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
A032201: Short TeRm Intensified Pembrolizumab (KEytruda) and Tivozanib for High-risk renal cell carcinoma ? STRIKE
Principal Investigator
Hannah
McManus
Protocol Number
PRO00118061
NCT ID
NCT06661720
Phase
III
Enrollment Status
Pending Open to Enrollment