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NCT Number: NCT03191578

Immunological Response to Intravesical BCG Therapy of Superficial Bladder Cancer by Prior Administration of RUTI®

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.

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Key information

Conditions

High-Risk Non-Muscle-Invasive Bladder Cancer Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-Muscle Invasive Bladder Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Germans Trias i Pujol Hospital

Badalona, Barcelona, 08916, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RUTI®

Drug

Administration of RUTI®

Placebo

Drug

Administration of placebo

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Recurrence date

    Time frame: Until 3 years since TURBT

    Recurrence date

  2. Disease worsening

    Time frame: Until 3 years since TURBT

    Disease worsening: events that included diagnosis of T2 or greater

  3. Death

    Time frame: Until 3 years since TURBT

  4. 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

  5. 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).

Sponsors and collaborators

Lead sponsor

Archivel Farma S.L.

Industry

Collaborators

  • Fundació Institut Germans Trias i Pujol

Registry information

Official study 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)

Acronym: RUTIVAC-1

Important dates

Study start
2017
Primary completion
2020
Study completion
2022
First posted
Jun 19, 2017
Registry last updated
Jul 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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