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Other CancersOpen to EnrollmentPhase 2

BLADDER: NEOADJUVANT: BLADDER-SPARING: BRIGHT

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)

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Study snapshot

Title
SWOG S427 Bladder bladder sparing BRIGHT trial
Malignancy
Bladder cancer, urothelial cancer
Stage
Stage 2
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
Randomized
No
ClinicalTrials.gov ID
NCT07061964

Eligibility and objectives

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

Objective

  • 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

Treatment details