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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03844256
Study type Interventional
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact Adriaan D. Bins, MD PhD
Phone 0205662339
Email a.d.bins@amc.uva.nl
Status Recruiting
Phase Phase 1/Phase 2
Start date January 7, 2019
Completion date July 2026

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