Actively Recruiting
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
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2022-08-12
50
Participants Needed
3
Research Sites
390 weeks
Total Duration
On this page
Sponsors
A
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent for the trial.
- At least 18 years of age at time of consent.
- Wish to preserve bladder function or be ineligible for cystectomy.
- Histologically confirmed muscle-invasive T2-T4a, N0-1M0 urothelial cell carcinoma of the bladder.
- Underwent transurethral biopsy of bladder tumor within 35 days before planned treatment.
- Underwent maximal transurethral resection of bladder tumor within 35 days before planned treatment.
- Tumors with mixed urothelial/non-urothelial histology allowed if urothelial carcinoma is predominant (>50%).
- Planned for chemoradiotherapy as definitive treatment.
- Performance status of 0 or 1 on ECOG scale.
- Bladder function accessible for cystoscopic follow-up.
- Adequate organ function with screening labs within 28 days before trial registration.
- Female participants of childbearing potential must have a negative pregnancy test within 72 hours before registration.
- Female participants of childbearing potential must use a highly effective birth control method, be surgically sterile, or abstain from heterosexual activity during the study and for 5 months after last dose.
- Male participants must agree to use condoms from first dose through 7 months after last dose.
- Willing to consent to use of tumor specimen, blood, and urine for future research.
You will not qualify if you...
- Has DPD deficiency.
- Has concurrent extra-vesical urothelial cell carcinoma outside bladder except safely irradiatable prostatic urethra involvement.
- Extensive or multifocal bladder carcinoma in situ precluding curative chemoradiotherapy.
- Evidence of distant metastatic disease on recent CT or PET/CT, except up to 3 pelvic lymph nodes within radiation field.
- Prior pelvic lymphadenectomy or pelvic radiotherapy.
- Prior intravenous chemotherapy, targeted therapy, or radiation for bladder cancer; prior intravesical BCG or MMC allowed.
- Unsuitable for concurrent MMC/capecitabine chemoradiotherapy due to medical conditions.
- Currently or recently participating in another investigational study within 4 weeks before treatment.
- Diagnosis of immunodeficiency or on systemic steroids >10 mg prednisone daily or immunosuppressive therapy within 14 days before registration.
- History of active tuberculosis.
- Hypersensitivity to nivolumab, ipilimumab, or their excipients.
- Prior or concurrent known additional malignancy unless disease-free for 5 years, with some exceptions.
- History of active autoimmune disease, Stevens-Johnson syndrome, or Guillain-Barre, except controlled hypothyroidism or Type I diabetes.
- Known history or evidence of active non-infectious pneumonitis.
- Active infection requiring systemic therapy.
- Any condition or abnormality interfering with trial participation or results.
- Psychiatric or substance abuse disorders interfering with trial cooperation.
- Pregnant, breastfeeding, or expecting to conceive/father children during the study and up to 120 days after last dose.
- Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents.
- HIV infection with detectable viral load.
- Known active Hepatitis B or C infection.
- Received live vaccine within 30 days before study start; inactivated seasonal influenza vaccines allowed.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Amsterdam UMC, VUmc
Amsterdam, North Holland, Netherlands, 1081 HV
Actively Recruiting
2
Amsterdam UMC, AMC
Amsterdam, North Holland, Netherlands, 1105 AZ
Actively Recruiting
3
LUMC
Leiden, South Holland, Netherlands
Actively Recruiting
Research Team
A
Adriaan D. Bins, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
3
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