Last updated on January 2019

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

Brief description of study

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 intravesical Bacillus Calmette-Guerin (BCG) therapy with induction course (weekly BCG for six weeks) and maintenance course (three courses of weekly BCG for three weeks at 3, 6 and 12 months after induction). After the last intravesical BCG administration (BCG15, end of Interventional Phase) 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.

Clinical Study Identifier: NCT03191578

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Recruitment Status: Open

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