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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

ConditionsUrinary Bladder CancerInvasive Bladder Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Be willing and able to provide written informed consent for the trial.

Be ≥ 18 years of age on day of signing informed consent.

Wish to preserve their bladder function or be ineligible for cystectomy.

Must have undergone transurethral biopsy of the bladder tumor, within 35 days of planned treatment commencement. The patient should have a histologically-confirmed diagnosis of muscle-invasive T2-T4a, N0-1M0 urothelial cell carcinoma of the bladder.

Disqualifiers

Has DPD deficiency.

Has concurrent extra-vesical (i.e. urethra, ureter or renal pelvis) urothelial cell carcinoma of the urothelium. Patients who have involvement of the prostatic urethra with urothelial cell cancer may be included if the location can be safely incorporated in the radiation field.

Extensive or multifocal bladder carcinoma in situ (CIS) precluding curative chemoradiotherapy.

Evidence of distant metastatic disease on a CT or FDG PET/CT chest/abdomen/pelvis performed within 28 days prior to study entry. Up to 3 metastatic lymphnodes in the pelvis (below the common iliac arteries) are allowed, if these can be incorporated in the radiotherapy field.

Trial design

Design model

Factorial

Treatments tested in this trial

  • nivolumab 480mg

    Combination product

    Immuno-chemoradiotherapy

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

    Combination product

    Immuno-chemoradiotherapy

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

    Combination product

    Immuno-chemoradiotherapy

Treatment groups

50 Participants
are divided into 3 treatment groups
Group A: Regimen AExperimental treatment 1 intervention
Group B: Regimen BExperimental treatment 1 intervention
Group C: Regimen CExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Toxicity scored with CTCAE v 4.03

Toxicity scored with CTCAE v 4.03

Time frame
6 weeks after start of the combination therapy
2

Incidence of dose limiting toxicity (DLT)

Time frame
6 weeks after start of combination therapy
3

Disease free survival (DFS)

Time frame
5 years
4

disease free survival-rate (DFS-rate)

Time frame
5 years

Secondary outcomes

1

Overall survival

Time frame
5 years
2

Overall survival rate

Time frame
5 years
3

Response rate

Cystoscopy at week 12 and week 24 will be performed. From week 12 onward 3-montly CT scans will be done in the context of the current standard of care up to 5 years.

Time frame
up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Bristol-Myers Squibb

Collaborator

Source ClinicalTrials.gov
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