This is phase II clinical trial design randomizing patients who are cisplatin-ineligible or chemotherapy-refusing with MIBC (stages T2-T4, N0-N2, M0) to one of two treatment arms: Arm A - Nivolumab in combination with Urelumab or Arm B - Nivolumab monotherapy.~The study population will include male and female patients over the age of 18 with muscle invasive urothelial carcinoma of the bladder (MIBC) who are not suitable for cisplatin-based chemotherapy or refuse chemotherapy, but are fit to undergo surgical resection of their cancer by cystectomy. Patients with resectable clinical node positive disease within the true pelvis are eligible.
This study evaluates the post cystectomy CD8+ tumor response of patients receiving Nivolumab plus Urelumab versus Nivolumab alone. Half the patients will receive Nivolumab plus Urelumab, while the other half will receive Nivolumab alone.