Urinary Bladder CancerPhase 1/2CRIMINCT03844256
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
A Phase 1/2 study testing nivolumab 480mg, nivolumab 3mg/kg, ipilimumab 1mg/kg and nivolumab 1mg/kg, ipilimumab 3mg/kg in people with Urinary Bladder Cancer and Invasive Bladder Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 3 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder Cancer, Invasive Bladder Cancer
- What is being tested?
- nivolumab 480mg, nivolumab 3mg/kg, ipilimumab 1mg/kg and nivolumab 1mg/kg, ipilimumab 3mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesNetherlands
- Study dates
- 7 Jan 2019to Jul 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
- Prior pelvic lymph-adenectomy
- Prior pelvic radiotherapy
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- 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.
- Unsuitable for concurrent MMC / capecitabine based ChRT based on pre-existing medical conditions.
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to the first dose of treatment.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy over 10mg daily prednisone (or equivalent) or any other form of immunosuppressive therapy within 14 days prior to registering the patient. Patients with adrenal insufficiency receiving replacement dose steroids are allowed on the trial.
- Has a known history of active TB (Bacillus Tuberculosis)
- Hypersensitivity to nivolumab and/or ipilimumab or any of its excipients.
- Prior or concurrent known additional malignancy of any site unless disease free for 5 years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer, Stage T1a well differentiated prostatic carcinoma in men (Gleason = 3+3, PSA <5)
- Has any history of active autoimmune disease, Stevens-Johnson syndrome or Guillain-Barre. Exceptions to this are:
- Patients with autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone
- Patients with controlled Type I diabetes mellitus on a stable dose of insulin regimen
- Has known history of, or any evidence of active, non-infectious pneumonitis.
- Has an active infection requiring systemic therapy.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
- Has an Human Immunodeficiency Virus (HIV) infection with a PCR detectable viral load.
- Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
- Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites, 3 recruiting
- Recruiting
Amsterdam UMC, VUmc
Amsterdam, North Holland, 1081 HV
Adriaan D. Bins, MD PhD
- Recruiting
Amsterdam UMC, AMC
Amsterdam, North Holland, 1105 AZ
Adriaan D. Bins, MD PhD
- Recruiting
LUMC
Leiden, South Holland
Tom van der Hulle, MD, PhD, +31 (0) 71-5298849, T.van_der_Hulle@lumc.nl
Tom van der Hulle, MD, PhD
About this study
Official title: 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
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.
Read the detailed description
Immunotherapy combined with chemoradiation for localized bladder cancer may exhibit improved efficacy with an acceptable toxicity profile.
The aim of this phase 1b/2, two stage, open label study of MMC/Capecitabine ChRT combined with nivolumab monotherapy or nivolumab and ipilimumab combination therapy stuy is: to assess the feasibility and safety, the disease free survival (DFS) and disease free survival rate (DFS-rate) of the addition of nivolumab and/or ipilimumab to MMC/capecitabine chemoradiation of the bladder.
- Conditions
- Urinary Bladder Cancer, Invasive Bladder Cancer
- Being tested
- nivolumab 480mg, nivolumab 3mg/kg, ipilimumab 1mg/kg, nivolumab 1mg/kg, ipilimumab 3mg/kg
- Keywords
- Immunotherapy, Chemoradiotherapy, Nivolumab, Ipilimumab, bladder sparing treatment
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nivolumab 480mgCombination product
Also called mitomycin-c 12mg/m2 IV, capecitabine 750mg/m2, radiotherapy 40Gy in 20 fractions of 2Gy
Immuno-chemoradiotherapy
nivolumab 3mg/kg, ipilimumab 1mg/kgCombination product
Also called mitomycin-c 12mg/m2 IV, capecitabine 750mg/m2, radiotherapy 40Gy in 20 fractions of 2Gy
Immuno-chemoradiotherapy
nivolumab 1mg/kg, ipilimumab 3mg/kgCombination product
Also called mitomycin-c 12mg/m2 IV, capecitabine 750mg/m2, radiotherapy 40Gy in 20 fractions of 2Gy
Immuno-chemoradiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Regimen A | Experimental | 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. Receives: Combination Product: nivolumab 480mg |
| Regimen B | Experimental | 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. Receives: Combination Product: nivolumab 3mg/kg, ipilimumab 1mg/kg |
| Regimen C | Experimental | 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. Receives: Combination Product: nivolumab 1mg/kg, ipilimumab 3mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity scored with CTCAE v 4.03
Toxicity scored with CTCAE v 4.03
Measured: 6 weeks after start of the combination therapy
Incidence of dose limiting toxicity (DLT)
Measured: 6 weeks after start of combination therapy
Disease free survival (DFS)
Measured: 5 years
disease free survival-rate (DFS-rate)
Measured: 5 years
Secondary outcomes (3)
Overall survival
Measured: 5 years
Overall survival rate
Measured: 5 years
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.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start7 Jan 2019
- Primary completionJul 2024 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder CancerStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- Patients will be treated with radiation therapy over 4 weeks and receive MMC IV on day1 of radiation therapy and capecitabine on each day of radiation therapy as radiosensitizers. Phase-1b: enrollment of maximum of 30 patients with a maximum of 10 patients per treatment regimen, in order to determine optimal regimen based on the occurrence of dose limiting toxicities (DLT). * Regimen-A: immunotherapy (w1-12) consists of nivolumab 480mg (fixed dose), on day(d)1, d29 and d57. * Regimen-B: immunotherapy (w1-12) consists of ipilimumab 1 mg/kg together with Nivolumab 3mg/kg on d1, d22, d43 and d65. * Regimen-C: immunotherapy (w1-12) consists of ipilimumab 3 mg/kg and nivolumab 1 mg/kg on d1, d22, d43 and d65. 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. Phase-2: enrollment of an additional 20 subjects at the regimen determined to be optimal in the phase-1b part.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Adriaan D. Bins, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Adriaan D. Bins, MD PhD, Principal investigator, Amsterdam UMC, AMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844256
- Sponsor's protocol ID
- CA2099TT
- Acronym
- CRIMI
- Status last verified
- Aug 2022
- First submitted
- 13 Feb 2019
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03844256
- Acronym / sponsor ID
- CRIMI / CA2099TT
- Conditions
- Urinary Bladder Cancer, Invasive Bladder Cancer
- Keywords
- Immunotherapy, Chemoradiotherapy, Nivolumab, Ipilimumab, bladder sparing treatment
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 18 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Immunotherapy combined with chemoradiation for localized bladder cancer may exhibit improved efficacy with an acceptable toxicity profile.
The aim of this phase 1b/2, two stage, open label study of MMC/Capecitabine ChRT combined with nivolumab monotherapy or nivolumab and ipilimumab combination therapy stuy is: to assess the feasibility and safety, the disease free survival (DFS) and disease free survival rate (DFS-rate) of the addition of nivolumab and/or ipilimumab to MMC/capecitabine chemoradiation of the bladder.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients will be treated with radiation therapy over 4 weeks and receive MMC IV on day1 of radiation therapy and capecitabine on each day of radiation therapy as radiosensitizers. Phase-1b: enrollment of maximum of 30 patients with a maximum of 10 patients per treatment regimen, in order to determine optimal regimen based on the occurrence of dose limiting toxicities (DLT). * Regimen-A: immunotherapy (w1-12) consists of nivolumab 480mg (fixed dose), on day(d)1, d29 and d57. * Regimen-B: immunotherapy (w1-12) consists of ipilimumab 1 mg/kg together with Nivolumab 3mg/kg on d1, d22, d43 and d65. * Regimen-C: immunotherapy (w1-12) consists of ipilimumab 3 mg/kg and nivolumab 1 mg/kg on d1, d22, d43 and d65. 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. Phase-2: enrollment of an additional 20 subjects at the regimen determined to be optimal in the phase-1b part.
| Arm | Type | Receives |
|---|---|---|
| Regimen A | Experimental | Combination Product: nivolumab 480mgNivolumab 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. |
| Regimen B | Experimental | Combination Product: nivolumab 3mg/kg, ipilimumab 1mg/kgNivolumab 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. |
| Regimen C | Experimental | Combination Product: nivolumab 1mg/kg, ipilimumab 3mg/kgNivolumab 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
- Prior pelvic lymph-adenectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nivolumab 480mgAlso: mitomycin-c 12mg/m2 IV, capecitabine 750mg/m2, radiotherapy 40Gy in 20 fractions of 2GyImmuno-chemoradiotherapy | Combination product | Regimen A |
| nivolumab 3mg/kg, ipilimumab 1mg/kgAlso: mitomycin-c 12mg/m2 IV, capecitabine 750mg/m2, radiotherapy 40Gy in 20 fractions of 2GyImmuno-chemoradiotherapy | Combination product | Regimen B |
| nivolumab 1mg/kg, ipilimumab 3mg/kgAlso: mitomycin-c 12mg/m2 IV, capecitabine 750mg/m2, radiotherapy 40Gy in 20 fractions of 2GyImmuno-chemoradiotherapy | Combination product | Regimen C |
Primary outcome
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
3 secondary outcomes
Overall survival
Time frame: 5 years
Overall survival rate
Time frame: 5 years
Response rate
Time frame: up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriaan D. Bins, MD PhD principal investigator
Amsterdam UMC, AMC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing nivolumab 480mg, nivolumab 3mg/kg, ipilimumab 1mg/kg and nivolumab 1mg/kg, ipilimumab 3mg/kg in people with Urinary Bladder Cancer and Invasive Bladder Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adriaan D. Bins, MD PhD (0205662339, a.d.bins@amc.uva.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity scored with CTCAE v 4.03 (time frame: 6 weeks after start of the combination therapy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2022.