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
Jan 25, 2023
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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
Immunotherapy combined with chemoradiation for localized bladder cancer may exhibit improved
efficacy with an acceptable toxicity profile.
The aim of this phase 1b/2, two stage, open label study of MMC/Capecitabine ChRT combined
with nivolumab monotherapy or nivolumab and ipilimumab combination therapy stuy is: to assess
the feasibility and safety, the disease free survival (DFS) and disease free survival rate
(DFS-rate) of the addition of nivolumab and/or ipilimumab to MMC/capecitabine chemoradiation
of the bladder.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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