- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03191578
Immunological Response to Intravesical BCG Therapy of Superficial Bladder Cancer by Prior Administration of RUTI® (RUTIVAC-1)
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Barcelona
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Badalona, Barcelona, Spain, 08916
- Germans Trias I Pujol Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RUTI® injection
|
Administration of RUTI®
|
Placebo Comparator: Sodium Chloride 0.9% injection
|
Administration of placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline, Day 10, weeks 2, 7 and 16
|
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
|
Baseline and week 16 visit
|
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
|
Baseline, Day 10, weeks 2, 7 and 16
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrence date
Time Frame: Until 3 years since TURBT
|
Recurrence date
|
Until 3 years since TURBT
|
Disease worsening
Time Frame: Until 3 years since TURBT
|
Disease worsening: events that included diagnosis of T2 or greater
|
Until 3 years since TURBT
|
Death
Time Frame: Until 3 years since TURBT
|
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
|
From Baseline to BCG administration number 6
|
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
|
Proportion of patients who develop a Grade 3 or 4 systemic reactions (adverse events related to RUTI/placebo).
|
through study completion an average of 1,5 year
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Urologic Diseases
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Urinary Bladder Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Urinary Bladder Neoplasms
- Non-Muscle Invasive Bladder Neoplasms
Other Study ID Numbers
- RUTIVAC-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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