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

Who is this study for? Patients aged 18 or over with Non-Metastatic Muscle Invasive Bladder Cancer that qualify for Chemoradiotherapy with curative intent
What treatments are being studied? Nivolumab
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• Must have undergone maximal transurethral resection of the bladder tumour, to an extent that is judged as safe by the urologist performing the resection, within 35 days of planned treatment commencement.

• Subjects with tumors of mixed urothelial/non-urothelial cell histology are allowed, but urothelial cell carcinoma must be the predominant histology (\>50%). Subjects with predominant or exclusively non-urothelial cell histology are not allowed.

• Have planned for chemoradiotherapy as definitive treatment.

• Have a performance status of 0 or 1 on the ECOG Performance Scale

• Have a bladder function that is accessible for cystoscopical follow up.

• Demonstrate adequate organ function. All screening labs should be performed within 28 days of registering the patient on the trial.

• Female participants of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to registering the patient. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.

• Female participants of childbearing potential should be willing to one highly effective method of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 5 month after the last dose of study medication Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year.

• Male participants should agree to use condoms starting with the first dose of study therapy through 7 month after the last dose of study therapy.

• Willing to consent to the use of their collected tumor specimen, blood and urine as detailed in the protocol for future scientific research including but not limited to DNA, RNA and protein based biomarker detection.

Locations
Other Locations
Netherlands
Amsterdam UMC, AMC
RECRUITING
Amsterdam
Amsterdam UMC, VUmc
RECRUITING
Amsterdam
LUMC
RECRUITING
Leiden
Contact Information
Primary
Adriaan D. Bins, MD PhD
a.d.bins@amc.uva.nl
0205662339
Time Frame
Start Date: 2019-01-07
Estimated Completion Date: 2026-07
Participants
Target number of participants: 50
Treatments
Experimental: Regimen A
Nivolumab monotherapy at 480mg fixed dose administered intravenously (IV) over 60 minutes every 4 weeks for 3 doses.~All study participants can opt for an additional 10 administrations of nivolumab 480mg fixed dose at intervals of 4 weeks, from week 13 to week 52.
Experimental: Regimen B
Nivolumab at 3 mg/kg administered IV over 60 minutes combined with ipilimumab at 1 mg/kg administered IV over 90 minutes every 3 weeks for 4 doses.~All study participants can opt for an additional 10 administrations of nivolumab 480mg fixed dose at intervals of 4 weeks, from week 13 to week 52.
Experimental: Regimen C
Nivolumab at 1 mg/kg administered IV over 60 minutes combined with ipilimumab at 3 mg/kg administered IV over 90 minutes every 3 weeks for 4 doses.~All study participants can opt for an additional 10 administrations of nivolumab 480mg fixed dose at intervals of 4 weeks, from week 13 to week 52.
Sponsors
Collaborators: Bristol-Myers Squibb
Leads: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

This content was sourced from clinicaltrials.gov

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