Bladder CancerPhase 2NCT03982797
Treatment of High-risk Non-muscle Invasive Bladder Cancer With IMUNO BGC Moreau RJ as Prophylaxis
A Phase 2 study testing Instillation of IMUNO BCG Moreau RJ in people with Bladder Cancer, run by Biofabri, S.L at 15 sites in Spain.
Trial summary
Bladder cancer is the fourth reason of neoplasia in our environment, there are 25 new cases diagnosed per 100,000 inhabitants each year. To decrease the recurrence there are two standardized treatments: Mitomycin as chemotherapy drug and BCG *Bacile Calmette-Guérin" as immunotherapy drug. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Instillation of IMUNO BCG Moreau RJ
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 15 sitesSpain
- Study dates
- 17 May 2019to 3 Mar 2022
- Phase
- Phase 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signature of the informed consent before any activity related to the study, including the necessary evaluations for the selection.
- Age between 18 and 80 years at the time of signing the informed consent.
- Urothelial tumor.
- High risk non-muscle invasive bladder tumor (defined as Ta-T1 and GIIb or GIII) diagnosed de novo or relapsed with or without associated in situ carcinoma. or carcinoma in situ isolated without visible tumor.
- Patient with risk of recurrence or progression greater than or equal to 10 points, according to CUETO tables.
Who cannot join
- No muscle layer in pathological examination piece's.
- Non-urothelial tumor.
- Active cancer in any other location.
- Diagnosis of any other pathology that in the opinion of the researcher may increase the risk of the subject or reduce the chances of obtaining satisfactory data to achieve the objectives of the study, including the consumption of alcohol or any other drug.
- Administration of BCG in the last year before signing the informed consent. 6. BCG instillation contraindication during more than 15 days for any cause such as low bladder capacity, urinary infection, hematuria, etc.
- 7. Impossibility of performing a second transurethral resection (ReRTU) between 4 and 8 weeks after the first.
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- 8. Inability to start treatment within the first 4 weeks after the second transurethral resection (ReRTU).
- 9. Participation in another clinical study where they received a research drug in the 6 months prior to signing the informed consent.
- 10. Woman considered potentially fertile. Following the Clinical Trial Facilitation Group (CTFG) recommendations, a woman is considered childbearing potential (WOCBP), following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
- 11. Patients with difficulties to perform the follow-up visits established in the protocol.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Spain15 sites, 7 recruiting
- Not yet recruiting
Complexo Hospitalario Universitario A Coruña
A Coruña, 15006
Venancio Chantada Abal, MD, vchantada@hotmail.com
Venancio Chantada Abal, MD
- Active, not recruiting
Hospital Universitario Basurto
Bilbao, 48013
- Active, not recruiting
Complejo Hospitalario Puerta Del Mar
Cadiz, 11009
- Active, not recruiting
Complejo Hospitalario Regional Reina Sofía
Córdoba, 14004
- Recruiting
Hospital Universitario Virgen de Las Nieves
Granada, 18014
Ignacio Puche Sanz, MD, nacho.puchesanz@gmail.com
Ignacio Puche Sanz, MD
- Active, not recruiting
Complejo Hospitalario Médico Quirúrjico de Jaén
Jaén, 23007
- Active, not recruiting
Hospital de Especialidades de Jerez de La Frontera
Jerez de la Frontera, 11408
- Active, not recruiting
Hospital Fundacion Jimenez Diaz
Madrid, 28040
- Active, not recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
- Active, not recruiting
Complejo Universitario La Paz
Madrid, 28046
- Not yet recruiting
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, 28222
Joaquín Carballido Rodríguez, MD, carballidojoaquin@gmail.com
Joaquín Carballido Rodríguez, MD
- Not yet recruiting
Complejo Hospitalario Regional de Málaga
Málaga, 29010
Carlos Bautista Vidal, MD, yenyebaru@hotmail.com
Carlos Bautista Vidal, MD
- Not yet recruiting
Hospital Universitario Central de Asturias
Oviedo, 33011
Jesús Maria Fernández Gómez, MD, jmfergomez@gmail.com
Jesús Maria Fernández Gómez, MD
- Not yet recruiting
Clinica Universidad de Navarra
Pamplona, 31008
Felipe Villacampa Aubá, MD, fvauba@unav.es
Felipe Villacampa Aubá, MD
- Not yet recruiting
Hospital Clínico Universitario de Valladolid
Valladolid, 47003
Jose Ramón Cortiñas González, MD, jrcorti@gmail.com
Jose Ramón Cortiñas González, MD
About this study
Official title: Treatment of High-risk Non-muscle Invasive Bladder Cancer With IMUNO BGC Moreau RJ as Prophylaxis of Recurrence and Progression.
Bladder cancer is the fourth reason of neoplasia in our environment, there are 25 new cases diagnosed per 100,000 inhabitants each year. To decrease the recurrence there are two standardized treatments: Mitomycin as chemotherapy drug and BCG *Bacile Calmette-Guérin" as immunotherapy drug.
BCG Moreau strain is not authorized by AEMPS, it was developed in Brazil and this country has extensive experience in treatment of non-muscle invasive bladder cancer with BCG Moreau, also BCG Moreau Rio de Janeiro make same immunological reaction as TICE, but with less adverse events. Thus, BCG Moreau RJ treatment could be used more time than TICE with the same dose, keeping immunologic status and better prophylaxis of recurrence or progression results for the patient.
Each patient will be instillated via transurethral each time with 80 mg of IMUNO BCG Moreau RJ. There are 15 instillations during the clinical trial, 6 instillations on induction phase and 9 will be performed during maintaince phase.
- Conditions
- Bladder Cancer
- Being tested
- Instillation of IMUNO BCG Moreau RJ
- Keywords
- non-muscle invasive bladder tumors
- 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.
Instillation of IMUNO BCG Moreau RJBiological
Instillation in bladder will be done once per week during first six weeks after inclusion, and 3 instillations (one per week) on month three, another three on moth six and last three on month twelve .
| Study group | Role | What they receive |
|---|---|---|
| treated with IMUNO BCG Moreau RJ adjuvant. | Experimental | Not described Receives: Biological: Instillation of IMUNO BCG Moreau RJ |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
The primary objective is to assessment the progression-free survival of patients diagnosed with high-risk non-muscle invasive bladder tumors treated with IMUNO BCG Moreau RJ adjuvant.
Measured: 24 months
Secondary outcomes (4)
Disease-free survival.
The secondary objective is to assessment the disease-free survival.
Measured: 24 months
Assessment of the quality of life
Assessment will be measure with FACT-BL version4th
Measured: 24 months
Assessment of adverse reactions
Assessment will be measure in number and relation with IMP
Measured: 24 months
Assessment of the dropout rate due to toxicity
Assessment will be measure in number
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start17 May 2019
- Primary completion3 Apr 2021 (estimated)
- Study completion3 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biofabri, S.L
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fundación para la Investigación en Urología (FIU)
- Responsible party
- Sponsor
- Investigators
- Miguel Unda, MD, Principal investigator, Hospital Universitario Basurto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982797
- Sponsor's protocol ID
- ENCORE-01
- Other IDs
- 2017-002928-24, 2017
- Status last verified
- Jun 2019
- First submitted
- 7 Jun 2019
- Last updated
- 12 Jun 2019
- 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 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of High-risk Non-muscle Invasive Bladder Cancer With IMUNO BGC Moreau RJ as Prophylaxis of Recurrence and Progression.
- ClinicalTrials.gov ID
- NCT03982797
- Acronym / sponsor ID
- ENCORE-01
- Conditions
- Bladder Cancer
- Keywords
- non-muscle invasive bladder tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- Biofabri, S.LIndustry (pharma, biotech, devices)
- Collaborators
- Fundación para la Investigación en Urología (FIU)
- Study start
- 17 May 2019 (actual)
- Primary completion
- 3 Apr 2021 (estimated)
- Study completion
- 3 Mar 2022 (estimated)
- First posted
- 12 Jun 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.
Bladder cancer is the fourth reason of neoplasia in our environment, there are 25 new cases diagnosed per 100,000 inhabitants each year. To decrease the recurrence there are two standardized treatments: Mitomycin as chemotherapy drug and BCG *Bacile Calmette-Guérin" as immunotherapy drug.
BCG Moreau strain is not authorized by AEMPS, it was developed in Brazil and this country has extensive experience in treatment of non-muscle invasive bladder cancer with BCG Moreau, also BCG Moreau Rio de Janeiro make same immunological reaction as TICE, but with less adverse events. Thus, BCG Moreau RJ treatment could be used more time than TICE with the same dose, keeping immunologic status and better prophylaxis of recurrence or progression results for the patient.
Each patient will be instillated via transurethral each time with 80 mg of IMUNO BCG Moreau RJ. There are 15 instillations during the clinical trial, 6 instillations on induction phase and 9 will be performed during maintaince phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treated with IMUNO BCG Moreau RJ adjuvant. | Experimental | Biological: Instillation of IMUNO BCG Moreau RJ |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signature of the informed consent before any activity related to the study, including the necessary evaluations for the selection.
- Age between 18 and 80 years at the time of signing the informed consent.
- Urothelial tumor.
- High risk non-muscle invasive bladder tumor (defined as Ta-T1 and GIIb or GIII) diagnosed de novo or relapsed with or without associated in situ carcinoma. or carcinoma in situ isolated without visible tumor.
- Patient with risk of recurrence or progression greater than or equal to 10 points, according to CUETO tables.
Key exclusion criteria (10 listed)
- No muscle layer in pathological examination piece's.
- Non-urothelial tumor.
- Active cancer in any other location.
- Diagnosis of any other pathology that in the opinion of the researcher may increase the risk of the subject or reduce the chances of obtaining satisfactory data to achieve the objectives of the study, including the consumption of alcohol or any other drug.
- Administration of BCG in the last year before signing the informed consent. 6. BCG instillation contraindication during more than 15 days for any cause such as low bladder capacity, urinary infection, hematuria, etc.
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 |
|---|---|---|
| Instillation of IMUNO BCG Moreau RJInstillation in bladder will be done once per week during first six weeks after inclusion, and 3 instillations (one per week) on month three, another three on moth six and last three on month twelve . | Biological | treated with IMUNO BCG Moreau RJ adjuvant. |
Primary outcome
progression-free survival
Time frame: 24 months
The primary objective is to assessment the progression-free survival of patients diagnosed with high-risk non-muscle invasive bladder tumors treated with IMUNO BCG Moreau RJ adjuvant.
4 secondary outcomes
Disease-free survival.
Time frame: 24 months
Assessment of the quality of life
Time frame: 24 months
Assessment of adverse reactions
Time frame: 24 months
Assessment of the dropout rate due to toxicity
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
- 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.
Miguel Unda, MD principal investigator
Hospital Universitario Basurto
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Instillation of IMUNO BCG Moreau RJ in people with Bladder Cancer, run by Biofabri, S.L at 15 sites in Spain.
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 5 inclusion and 10 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 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Spain. 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 phase mean?
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 Ingrid Murillo, MSc. (0034986330400, ingrid.murillo@biofabri.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: 24 months). 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 Jun 2019.