RecruitingPhase 1Phase 2NCT03844256

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 Phase 1b-2 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


Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Enrollment

50 participants

Start Date

Jan 7, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a chemoradiation treatment (combining radiation with two chemotherapy drugs — mitomycin-C and capecitabine) for people with muscle-invasive bladder cancer who want to keep their bladder, comparing this regimen to standard approaches to see if it is safer and more effective. **You may be eligible if...** - You are 18 or older and have been diagnosed with muscle-invasive bladder cancer (cancer that has grown into the muscle layer of the bladder), stage T2–T4a, with no distant spread - You want to preserve your bladder (rather than have it removed), OR you are not a candidate for bladder removal surgery - You have had as much of the bladder tumor removed as safely possible through a scope procedure (TURBT) within the past 35 days - You are in good health (ECOG performance status 0 or 1) - Your kidneys, liver, and blood counts are functioning adequately **You may NOT be eligible if...** - Your tumor is not primarily urothelial (bladder lining) cell type - You have not had a surgical attempt to remove the tumor before starting treatment - You have active infections or conditions that prevent treatment - You are unable to have regular follow-up cystoscopies (bladder camera checks) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

COMBINATION_PRODUCTnivolumab 480mg

Immuno-chemoradiotherapy

COMBINATION_PRODUCTnivolumab 3mg/kg, ipilimumab 1mg/kg

Immuno-chemoradiotherapy

COMBINATION_PRODUCTnivolumab 1mg/kg, ipilimumab 3mg/kg

Immuno-chemoradiotherapy


Locations(3)

Amsterdam UMC, VUmc

Amsterdam, North Holland, Netherlands

Amsterdam UMC, AMC

Amsterdam, North Holland, Netherlands

LUMC

Leiden, South Holland, Netherlands

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03844256


Related Trials