About this trial
This study looks at how blood tests can help find patients who might need extra treatment after surgery for urothelial cancer. The goal is to see if measuring tumor DNA in the blood can show if there is still cancer and if giving immunotherapy can help. Immunotherapy uses medicines to help the body fight cancer. The trial will help doctors understand if these blood tests can better identify patients who need treatment and if certain medicines can help them live longer without the cancer returning.
This is a Phase 2/3 trial, meaning it is looking at how well the treatment works and how safe it is. The trial is FDA-regulated and aims to include about 992 participants.
Who can join
This trial is open to adults aged 18 and older, including both men and women. Patients must have a specific type of bladder or urinary tract cancer and have had surgery to remove it. There are some criteria that must be met, such as the type of cancer and how recent the surgery was. The trial team will confirm who is eligible to join.
Conditions
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma, Muscle Invasive Ureter Urothelial Carcinoma, Muscle Invasive Urethral Urothelial Carcinoma, Stage II Bladder Urothelial Carcinoma AJCC v6 and v7, Stage III Bladder Urothelial Carcinoma AJCC v6 and v7, Stage IV Bladder Urothelial Carcinoma AJCC v7
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
Participants will be randomly placed into different groups. Some will receive nivolumab, while others will receive both nivolumab and relatlimab. Both treatments are given through an IV every 28 days for up to 12 cycles. Patients will also have blood tests and imaging scans to monitor their health during the trial.
Where
This trial is running at 491 locations in the United States. 447 of them are currently recruiting.
Abbott-Northwestern Hospital
Minneapolis, Minnesota
Addison Gilbert Hospital
Gloucester, Massachusetts
AdventHealth Orlando
Orlando, Florida
Advocate Christ Medical Center
Oak Lawn, Illinois
Advocate Good Samaritan Hospital
Downers Grove, Illinois
Advocate Good Shepherd Hospital
Barrington, Illinois
Advocate Illinois Masonic Medical Center
Chicago, Illinois
Advocate Lutheran General Hospital
Park Ridge, Illinois
The first 8 of 491 sites are listed here. The registry record has the full list.