Study Name: A032103

Recruiting

Urothelial

A032103 (MODERN), AN INTEGRATED PHASE 2/3 AND PHASE 3 TRIAL OF MRD-BASED OPTIMIZATION OF ADJUVANT THERAPY IN UROTHELIAL CANCER

NCT#05987241

clinicaltrials.gov/show/NCT05987241

This phase II/III trial examines whether patients who have undergone surgical removal of bladder, but require an additional treatment called immunotherapy to help prevent their bladder 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 bladder cancer patients who have undergone surgical removal of their bladder.

Male and Female – 18 years and older

• Histologically confirmed urothelial cancer of the bladder
• Radical cystectomy ≥3 weeks, but ≤12 weeks prior to pre-registration
• No evidence of residual cancer or metastases after surgery
• No postoperative/adjuvant systemic therapy or radiation

• Active autoimmune disease or history of autoimmune disease that may recur
• Current or history of pneumonitis or myocarditis