High-Risk Non-Muscle-Invasive Bladder CancerPhase 1RUTIVAC-1NCT03191578
Immunological Response to Intravesical BCG Therapy of Superficial Bladder Cancer by Prior Administration of RUTI®
A Phase 1 study testing RUTI® in people with High-Risk Non-Muscle-Invasive Bladder Cancer, run by Archivel Farma S.L. at 1 site in Spain.
Trial summary
The RUTIVAC-1 study is a Phase I Clinical Trial designed to evaluate the systemic and mucosal immunological response and provide safety information after the use of RUTI® administration to individuals with NMIBC. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- High-Risk Non-Muscle-Invasive Bladder Cancer
- What is being tested?
- RUTI®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- 16 Jun 2017to 22 Dec 2022
- Phase
- Phase 1
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written ICF for participation in the study.
- Age ≥18 years.
- General health status according to WHO ≤ 2.
- Have primary histologically confirmed T1 and/or high grade tumors and/or CIS.
- All visible papillary tumors must be completely resected.
- Early postoperative (within 24 hours of TURBT) single dose chemotherapy is allowed.
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- BCG therapy indication.
- Never treated with BCG immunotherapy
- Willing to comply with study visits and procedures as per protocol
- Use of reliable contraception (see section 8.6) from the screening visit to 30 days after the last RUTI® or placebo injection.
Who cannot join
- Life expectancy <5 years.
- Have a severe concomitant disease that might limit compliance or completion of the protocol.
- Have any other malignancy that might impact 3-year survival or might be potentially confused with NMIBC.
- Have other neoplasms.
- Have congenital or acquired immune deficiencies or under immunomodulatory treatment.
- Be receiving cytotoxic drugs or systemic corticosteroids within 8 weeks of receiving the first administration of BCG.
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- Have received radiation therapy for their bladder cancer within 4 months prior to study entry.
- Have active infections (including urinary tract infections) defined as viral, bacterial, or fungal infections requiring therapy, HIV-positive status, concurrent febrile illness, gross hematuria or other factor that could influence tolerability to intravesical BCG therapy.
- Have biopsy, TURBT, or traumatic catheterization within 14 days of start of intravesical BCG treatment.
- Have active tuberculosis at screening visit.
- Active pregnancy or breastfeeding.
- Soy allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase I Trial to Evaluate the Immunomodulatory Effect of RUTI® in Individuals With High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) Treated With Intravesical Bacillus Calmette-Guerin (BCG)
The RUTIVAC-1 study is a Phase I Clinical Trial designed to evaluate the systemic and mucosal immunological response and provide safety information after the use of RUTI® administration to individuals with NMIBC.
The study will enroll individuals treated with Transurethral resection of bladder tumor (TURBT), diagnosed to have high-risk Non-muscle invasive bladder cancer (NMIBC) and suitable candidates for BCG therapy and who meet all eligibility criteria.
Read more
Forty individuals will be recruited and randomized 1:1 to receive two subcutaneous shots of 25 μg RUTI® or placebo. After vaccination, individuals will receive the standard induction course, of intravesical Bacillus Calmette-Guerin (BCG)therapy (weekly BCG for six weeks).
4 to 8 weeks after the last intravesical BCG administration (BCG6) a visit will be performed (Visit 1, end of the interventional phase). Once all participants have performed VISIT 1 immunological assays will be performed and data will be analyzed.
At the end of the Interventional Phase the blind will be opened, except for the study physicians who will remain blind during all the follow-up. All the individuals will be followed up for three years since TURBT.
- Being tested
- RUTI®, Placebo
- Keywords
- NMIBC, Immunotherapy, RUTI, Non-muscle invasive bladder cancer
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RUTI®Drug
Administration of RUTI®
PlaceboDrug
Administration of placebo
| Study group | Role | What they receive |
|---|---|---|
| RUTI® injection | Experimental | Not described Receives: Drug: RUTI® |
| Sodium Chloride 0.9% injection | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the systemic Th1 immune response.
IFN-γ production assessed by intracellular staining after ex vivo stimulation of PBMCs with PPD
Measured: Baseline, Day 10, weeks 2, 7 and 16
Changes in the local immune response in peritumoral tissue (Th1/Th2 ratio)
Th1/Th2 ratio in cells in the peritumoral tissue
Measured: Baseline and week 16 visit
Changes in the local immune response in urine
Urine levels of cytokines by multiplex analysis
Measured: Baseline, Day 10, weeks 2, 7 and 16
Secondary outcomes (5)
Recurrence date
Recurrence date
Measured: Until 3 years since TURBT
Disease worsening
Disease worsening: events that included diagnosis of T2 or greater
Measured: Until 3 years since TURBT
Death
Measured: Until 3 years since TURBT
Proportion of patients who develop a Grade 3 or 4 local reactions
From Baseline to BCG administration number 6
Measured: through study completion an average of 1,5 year
Proportion of patients who develop a Grade 3 or 4 systemic reactions
Proportion of patients who develop a Grade 3 or 4 systemic reactions (adverse events related to RUTI/placebo).
Measured: through study completion an average of 1,5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start16 Jun 2017
- Primary completion14 Jan 2020
- Study completion22 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-Risk Non-Muscle-Invasive 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Archivel Farma S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fundació Institut Germans Trias i Pujol
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191578
- Sponsor's protocol ID
- RUTIVAC-1
- Acronym
- RUTIVAC-1
- Status last verified
- Jul 2023
- First submitted
- 9 Jun 2017
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase I Trial to Evaluate the Immunomodulatory Effect of RUTI® in Individuals With High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) Treated With Intravesical Bacillus Calmette-Guerin (BCG)
- ClinicalTrials.gov ID
- NCT03191578
- Acronym / sponsor ID
- RUTIVAC-1 / RUTIVAC-1
- Keywords
- NMIBC, Immunotherapy, RUTI, Non-muscle invasive bladder cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Archivel Farma S.L.Industry (pharma, biotech, devices)
- Collaborators
- Fundació Institut Germans Trias i Pujol
- Study start
- 16 Jun 2017 (actual)
- Primary completion
- 14 Jan 2020 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 19 Jun 2017 (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.
The RUTIVAC-1 study is a Phase I Clinical Trial designed to evaluate the systemic and mucosal immunological response and provide safety information after the use of RUTI® administration to individuals with NMIBC.
The study will enroll individuals treated with Transurethral resection of bladder tumor (TURBT), diagnosed to have high-risk Non-muscle invasive bladder cancer (NMIBC) and suitable candidates for BCG therapy and who meet all eligibility criteria.
Forty individuals will be recruited and randomized 1:1 to receive two subcutaneous shots of 25 μg RUTI® or placebo. After vaccination, individuals will receive the standard induction course, of intravesical Bacillus Calmette-Guerin (BCG)therapy (weekly BCG for six weeks).
4 to 8 weeks after the last intravesical BCG administration (BCG6) a visit will be performed (Visit 1, end of the interventional phase). Once all participants have performed VISIT 1 immunological assays will be performed and data will be analyzed.
At the end of the Interventional Phase the blind will be opened, except for the study physicians who will remain blind during all the follow-up. All the individuals will be followed up for three years since TURBT.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RUTI® injection | Experimental | Drug: RUTI® |
| Sodium Chloride 0.9% injection | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Written ICF for participation in the study.
- Age ≥18 years.
- General health status according to WHO ≤ 2.
- Have primary histologically confirmed T1 and/or high grade tumors and/or CIS.
- All visible papillary tumors must be completely resected.
Key exclusion criteria (12 listed)
- Life expectancy <5 years.
- Have a severe concomitant disease that might limit compliance or completion of the protocol.
- Have any other malignancy that might impact 3-year survival or might be potentially confused with NMIBC.
- Have other neoplasms.
- Have congenital or acquired immune deficiencies or under immunomodulatory treatment.
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 |
|---|---|---|
| RUTI®Administration of RUTI® | Drug | RUTI® injection |
| PlaceboAdministration of placebo | Drug | Sodium Chloride 0.9% injection |
Primary outcome
Changes in the systemic Th1 immune response.
Time frame: Baseline, Day 10, weeks 2, 7 and 16
IFN-γ production assessed by intracellular staining after ex vivo stimulation of PBMCs with PPD
Changes in the local immune response in peritumoral tissue (Th1/Th2 ratio)
Time frame: Baseline and week 16 visit
Th1/Th2 ratio in cells in the peritumoral tissue
Changes in the local immune response in urine
Time frame: Baseline, Day 10, weeks 2, 7 and 16
Urine levels of cytokines by multiplex analysis
5 secondary outcomes
Recurrence date
Time frame: Until 3 years since TURBT
Disease worsening
Time frame: Until 3 years since TURBT
Death
Time frame: Until 3 years since TURBT
Proportion of patients who develop a Grade 3 or 4 local reactions
Time frame: through study completion an average of 1,5 year
Proportion of patients who develop a Grade 3 or 4 systemic reactions
Time frame: through study completion an average of 1,5 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RUTI® in people with High-Risk Non-Muscle-Invasive Bladder Cancer, run by Archivel Farma S.L. at 1 site 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 10 inclusion and 12 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: finished, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the systemic Th1 immune response. (time frame: Baseline, Day 10, weeks 2, 7 and 16). The study lists 3 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 14 Jul 2023; AzTrials last refreshed its copy on 8 Nov 2026.