OncoMatch/Clinical Trials/NCT03844256
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
Is NCT03844256 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including nivolumab 480mg and nivolumab 3mg/kg, ipilimumab 1mg/kg for urinary bladder cancer.
Treatment: nivolumab 480mg · nivolumab 3mg/kg, ipilimumab 1mg/kg · nivolumab 1mg/kg, ipilimumab 3mg/kg — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage T2-T4A, N0-1
muscle-invasive T2-T4a, N0-1M0 urothelial cell carcinoma of the bladder
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: intravenous chemotherapy
Exception: Prior intravesical use of BCG and MMC is permissible.
Has had prior intravenous chemotherapy, targeted small molecule therapy, or radiation therapy for treatment of bladder cancer. Prior intravesical use of BCG and MMC is permissible.
Cannot have received: targeted small molecule therapy
Exception: Prior intravesical use of BCG and MMC is permissible.
Has had prior intravenous chemotherapy, targeted small molecule therapy, or radiation therapy for treatment of bladder cancer. Prior intravesical use of BCG and MMC is permissible.
Cannot have received: radiation therapy
Exception: Prior intravesical use of BCG and MMC is permissible.
Has had prior intravenous chemotherapy, targeted small molecule therapy, or radiation therapy for treatment of bladder cancer. Prior intravesical use of BCG and MMC is permissible.
Cannot have received: anti-PD-1 therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
Cannot have received: anti-PD-L1 therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
Cannot have received: anti-PD-L2 therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
Cannot have received: pelvic radiotherapy
Prior pelvic radiotherapy
Lab requirements
Blood counts
Demonstrate adequate organ function. All screening labs should be performed within 28 days of registering the patient on the trial.
Kidney function
Demonstrate adequate organ function. All screening labs should be performed within 28 days of registering the patient on the trial.
Liver function
Demonstrate adequate organ function. All screening labs should be performed within 28 days of registering the patient on the trial.
Demonstrate adequate organ function. All screening labs should be performed within 28 days of registering the patient on the trial.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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