- Title
- SWOG S427 Bladder bladder sparing BRIGHT trial
- Malignancy
- Bladder cancer, urothelial cancer
- Disease setting
- Neoadjuvant
- Line of therapy
- Neoadjuvant
- Investigational agent
- Radiotherapy + pembrolizumab
- Drug class
- Immontherapy/radiotherapy
- Principal investigator
- Dan Vaena, MD
- Sponsor
- SWOG
- Path
- Urothelial carcinoma
- Key eligibility criteria details
- 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
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