Single Arm Phase II Study of Bladder Preservation With Immunoradiotherapy After a Clinically Meaningful Response to Neoadjuvant Therapy in Patients With Muscle Invasive Bladder Cancer (BRIGHT)

• cT2-T4aN0M0 urothelial carcinoma of the bladder with biopsy done within 180 days rior to starting neoadjuvant tx
• Must have undergone TURBT with biopsy of areas of prior disease and systematic biopsies and radiologic staging showing clinically T0-T1 disease within 60 days after the last dose of neoadjuvant therapy. At least 4 out of 5 systemic biopsies must be performed.
  • TURBT must be within 90 days of registration
• Must be imaged and thought to be node and disease free outside of the tumor itself
• No small cell, neuroendocrine carcinoma, or plasmacytoid variants on any pathology
• Must be of the bladder (no upper tract unless CIS)
• May have had PD-1 or EV as part of neoadjuvant treatment but not for any other reason
• Muist have had at least 3 and no more than 6 doses of an approved neoadjuvant therapy
• ECOG PS 0-2
• No prior malignancies
• Controlled HBV/HCV/HIV allowed

• Primary
  • whether 3 year bladder intact event free survival (BI-EFS) is at least 70%
• Secondary
  • BI-EFS
  • Local muscle invasive RFS
  • Metastasis free survival
  • OS
  • Rates of salvage cystectomy
  • Toxicity
  • PRO