Trials / Recruiting
RecruitingNCT03844256
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
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2019-01-07
- Primary completion
- 2024-07-01
- Completion
- 2026-07-01
- First posted
- 2019-02-18
- Last updated
- 2022-08-12
Locations
3 sites across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT03844256. Inclusion in this directory is not an endorsement.