A Study of Mitomycin-c/ Capecitabine ChemoRadiotherapy Combined With Nivolumab Monotherapy or Ipilumimab and Nivolumab, as Bladder Sparing Curative Treatment for Muscle Invasive Bladder Cancer: the CRIMI Study

A multicenter Phase 1b/2, two stage, open label study of MMC/Capecitabine ChRT combined with nivolumab monotherapy or nivolumab and ipilimumab combination therapy in adult (\>18 years) subjects with non-metastatic muscle invasive bladder cancer that qualify for ChRT with curative intent.

Trial Details

NCT ID
NCT03844256
Phase
PHASE1 / PHASE2
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Status
RECRUITING
Cancer Type
Non-Muscle-Invasive Bladder Cancer
Interventions
  • nivolumab 480mg
  • nivolumab 3mg/kg, ipilimumab 1mg/kg
  • nivolumab 1mg/kg, ipilimumab 3mg/kg
Locations (sample)
  • Amsterdam, North Holland, Netherlands|52.37403,4.88969
  • Amsterdam, North Holland, Netherlands|52.37403,4.88969
  • Leiden, South Holland, Netherlands|52.15833,4.49306

Key Eligibility Criteria

  • Be willing and able to provide written informed consent for the trial.
  • Be ≥ 18 years of age on day of signing informed consent.
  • Wish to preserve their bladder function or be ineligible for cystectomy.
  • Must have undergone transurethral biopsy of the bladder tumor, within 35 days of planned treatment commencement. The patient should have a histolog…

For full eligibility, visit ClinicalTrials.gov.

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