NCT03844256: CRIMI

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

Recruiting now Phase 1/Phase 2 Last updated 11 August 2022

What this trial tests

Phase 1/Phase 2 trial testing nivolumab 480mg in Urinary Bladder Cancer in 50 participants. Currently enrolling.

Timeline

7 January 2019

Primary endpoint
1 July 2024

1 July 2026

Quick facts

Lead sponsor	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Phase	Phase 1/Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	factorial
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	7 January 2019
Primary completion	1 July 2024
Estimated completion	1 July 2026
Sites	3 locations across Netherlands

Drugs / interventions tested

• nivolumab 480mg
• nivolumab 3mg/kg, ipilimumab 1mg/kg
• nivolumab 1mg/kg, ipilimumab 3mg/kg

Conditions studied

• Urinary Bladder Cancer — all drugs for Urinary Bladder Cancer →
• Invasive Bladder Cancer — all drugs for Invasive Bladder Cancer →

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) — full company profile →

Who can join

18 and older, any sex, with Urinary Bladder Cancer or Invasive Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Toxicity scored with CTCAE v 4.03
  Time frame: 6 weeks after start of the combination therapy
  Toxicity scored with CTCAE v 4.03
• Incidence of dose limiting toxicity (DLT)
  Time frame: 6 weeks after start of combination therapy
• Disease free survival (DFS)
  Time frame: 5 years
• disease free survival-rate (DFS-rate)
  Time frame: 5 years

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Combined radiotherapy and immunotherapy in urothelial bladder cancer: harnessing the full potential of the anti-tumor immune response.
   Daro-Faye M, Kassouf W, Souhami L, Marcq G, et al · · 2021 · cited 45× · PMID 32915313 · DOI 10.1007/s00345-020-03440-4
2. Bladder-Sparing Chemoradiotherapy Combined with Immune Checkpoint Inhibition for Locally Advanced Urothelial Bladder Cancer-A Review.
   van Hattum JW, de Ruiter BM, Oddens JR, Hulshof MCCM, et al · · 2021 · cited 19× · PMID 35008202 · DOI 10.3390/cancers14010038
3. Role of immunotherapy in localized muscle invasive urothelial cancer.
   Kaur J, Choi W, Geynisman DM, Plimack ER, et al · · 2021 · cited 15× · PMID 34567274 · DOI 10.1177/17588359211045858
4. A Comprehensive Review of Current Approaches in Bladder Cancer Treatment.
   Kumbham S, Md Mahabubur Rahman K, Foster BA, You Y. · · 2025 · cited 10× · PMID 39974639 · DOI 10.1021/acsptsci.4c00663
5. Adverse Effects and Toxicity of Immune Checkpoint Inhibitors For Patients With Urothelial Carcinoma.
   Wang D, Sun K, Wang T, Zhang D, et al · · 2021 · cited 8× · PMID 34867321 · DOI 10.3389/fphar.2021.710943
6. Bladder preservation therapy in combination with atezolizumab and radiation therapy for invasive bladder cancer (BPT-ART) - A study protocol for an open-label, phase II, multicenter study.
   Sekino Y, Ishikawa H, Kimura T, Kojima T, et al · · 2021 · cited 6× · PMID 33615035 · DOI 10.1016/j.conctc.2021.100724
7. Immune Checkpoint Inhibitors in the Management of Urothelial Carcinoma.
   Patel A, Bisno DI, Patel HV, Ghodoussipour S, et al · · 2021 · cited 4× · PMID 34263255 · DOI 10.33696/cancerimmunol.3.047