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

Recruiting Phase 1 Phase 2 Interventional Study
Urinary Bladder Cancer Invasive Bladder Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Other
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About This Trial

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 Locations
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Eligibility Criteria
Inclusion 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 …
Contacts

Adriaan D. Bins, MD PhD

0205662339

a.d.bins@amc.uva.nl

CONTACT