Intravesical Recombinant BCG Followed by Perioperative Chemo-immunotherapy for Patients With MIBC

Inclusion Criteria: * Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures * Histologically proven urothelial cell carcinoma of the bladder (cT2, cT3 or cT4a and ≤ cN1 (defined as a solitary lymph node ≤ 2 cm in the greatest dimension) and cM0) and be considered suitable for curative multimodality treatment including radical cystectomy by a multidisciplinary tumor board * All histological subtypes eligible with the exception of small cell component * Age ≥ 18 years * WHO performance status 0-1 * Hematological function: hemoglobin ≥ 90 g/L, neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L * Hepatic function: total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert's disease ≤ 3.0 x ULN), AST ≤ 2.5 x ULN and ALT ≤ 2.5 x ULN, AP ≤ 2.5 x ULN * Renal function: estimated glomerular filtration rate (eGFR) \> 50 mL/min/1.73m², according to CKD-EPI formula * Women of childbearing potential must use effective contraception, are not pregnant or lactating and agree not to become pregnant during trial treatment and until 5 months after the last dose of investigational drug * Men agree not to donate sperm or to father a child during trial treatment and until 5 months after the last dose of investigational drug (www.swissmedicinfo.ch). Exclusion Criteria: * Any pathological evidence of small-cell carcinoma component * Presence of any distant metastasis * History of hematologic or primary solid tumor malignancy, un…