New drug combo aims to boost bladder cancer remission before surgery

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Main Inclusion Criteria: * Signed and dated informed consent, and able to comply with the study procedures and any locally required authorization. * Male or female aged ≥ 18 years. * Histopathologically confirmed urothelial carcinoma. * Clinical Stage T2-T4aN0M0 MIBC. * Ineligible for cisplatin therapy per modified Galsky criteria or refuses cisplatin-based chemotherapy. * Eligible for radical cystectomy. * Pretreatment tumor material from transurethral resection of the bladder tumor (TURBT) must be available. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Adequate organ function (bone marrow, hepatic, renal function and coagulation). Main Exclusion Criteria: * Pregnant or breastfeeding. * Received prior radiotherapy on the bladder tumor. * Received a partial cystectomy. * Any prior systemic anti-cancer therapy including investigational agents and immunotherapy. * Following cardio-vascular risk factors: 1. Myocardial infarction in the past 6 months before planned treatment start. 2. Uncontrolled heart failure. 3. Uncontrolled ventricular arrhythmia. 4. A peri/myocarditis in the past 3 months before planned treatment start. Note: Stable atrial fibrillation is permissive with or without anticoagulation if there was no decompensation in the past 3 months before planned treatment start. * Left ventricular ejection fraction (LVEF) \< 50% measured by echocardiogram or MUGA. * QTcF ≥ 470 ms regardless of sex. * Any active autoimmune disease requiring systemic immunosuppressive treatments. * Any history of non-infectious pneumonitis \< 6 months prior to Screening. * Any active inflammatory bowel disease such as Crohn's disease or ulcerative colitis which are generally excluded or active autoimmune thyroiditis present \< 6 months prior to Screening. * History of CNS disease such as stroke, seizure, encephalitis, or multiple sclerosis (\< 6 months prior to Screening).