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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

NCT03844256 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-08-12

No results posted yet for this study

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.

Conditions

  • Urinary Bladder Cancer
  • Invasive Bladder Cancer

Interventions

COMBINATION_PRODUCT

nivolumab 480mg

Immuno-chemoradiotherapy

COMBINATION_PRODUCT

nivolumab 3mg/kg, ipilimumab 1mg/kg

Immuno-chemoradiotherapy

COMBINATION_PRODUCT

nivolumab 1mg/kg, ipilimumab 3mg/kg

Immuno-chemoradiotherapy

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

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

    lead OTHER

Principal Investigators

  • Adriaan D. Bins, MD PhD · Amsterdam UMC, AMC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-07
Primary Completion
2024-07-31
Completion
2026-07-31

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03844256 on ClinicalTrials.gov