Condition: Muscle Invasive Bladder Urothelial Carcinoma · Muscle Invasive Renal Pelvis Urothelial Carcinoma · Muscle Invasive Ureter Urothelial Carcinoma · Sponsor: National Cancer Institute (NCI)
This phase II/III trial examines whether patients who have undergone surgical removal of bladder, kidney, ureter or urethra, but require an additional treatment called immunotherapy to help prevent their urinary tract (urothelial) cancer from coming back, can be identified by a blood test. Many types of tumors tend to lose cells or release different types of cellular products including their DNA which is referred to as circulating tumor DNA (ctDNA) into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are at higher risk for disease progression or relapse. In this study, a blood test is used to measure ctDNA and see if there is still cancer somewhere in the body after surgery and if giving a treatment will help eliminate the cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and relatlimab, can help the body's immune system to attack the cancer, and can interfere with the ability of tumor cells to grow and spread. This trial may help doctors determine if ctDNA measurement in blood can better identify patients that need additional treatment, if treatment with nivolumab prolongs patients' life and whether the additional immunotherapy treatment with relatlimab extends time without disease progression or prolongs life of urothelial cancer patients who have undergone surgical removal of their bladder, kidney, ureter or urethra.
This description comes directly from the study's public registry record.
Contact details are listed per location below or on the registry record.
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| Cancer Center at Saint Joseph's | Phoenix, Arizona, United States | Recruiting |
| Mayo Clinic Hospital in Arizona | Phoenix, Arizona, United States | Recruiting |
| University of Arizona Cancer Center-Orange Grove Campus | Tucson, Arizona, United States | Suspended |
| Banner University Medical Center - Tucson | Tucson, Arizona, United States | Recruiting |
| University of Arizona Cancer Center-North Campus | Tucson, Arizona, United States | Recruiting |
| Highlands Oncology Group - Fayetteville | Fayetteville, Arkansas, United States | Recruiting |
| Highlands Oncology Group - Rogers | Rogers, Arkansas, United States | Recruiting |
| Highlands Oncology Group | Springdale, Arkansas, United States | Recruiting |
| Kaiser Permanente-Anaheim | Anaheim, California, United States | Recruiting |
| Kaiser Permanente-Baldwin Park | Baldwin Park, California, United States | Recruiting |
| Kaiser Permanente-Bellflower | Bellflower, California, United States | Recruiting |
| Kaiser Permanente Dublin | Dublin, California, United States | Recruiting |
+ 487 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05987241