A Randomized, Double‑Blind Study of RUTI as Adjunct to Bacillus Calmette‑Guérin in High‑Risk Non‑Muscle‑Invasive Bladder Cancer: Safety and Immunologic Effects

Primary objective: • Assess the safety profile of RUTI when administered in combination with standard intravesical BCG in patients with high-risk non-muscle invasive bladder cancer. • Evaluate immunologic modulation, including changes in systemic and local immune markers, associated with the combination therapy.

The trial enrolled patients diagnosed with high‑risk non‑muscle invasive bladder cancer (NMIBC). Both male and female individuals were eligible, encompassing adult age groups corresponding to codes 3 and 4, which represent a broad adult to senior population. The sponsor did not provide the total number of participants. Selection was based on a confirmed diagnosis of the condition; no specific diet, physical‑activity, or habit requirements were reported. Key inclusion criteria required a confirmed diagnosis of the disease, while exclusion criteria were not detailed in the provided information.

The study is a Phase 1, randomized, double‑blind, controlled trial evaluating the safety of adding RUTI® to standard intravesical BCG therapy in patients with high‑risk non‑muscle invasive bladder cancer. Eligible participants undergo a screening visit to confirm eligibility, followed by baseline assessments and randomization to receive either RUTI® or a matching placebo in addition to BCG. Follow‑up visits are scheduled at weeks 2, 4, 8, 12, and 24 to monitor adverse events, conduct laboratory safety tests, and assess immunologic endpoints; an end‑of‑study visit at week 52 concludes the protocol. Participant involvement therefore extends for approximately one year from the first dose. Early termination may occur due to a serious adverse event related to the investigational product, withdrawal of consent, or non‑compliance with the study schedule.

No specific investigational medication, formulation, dosage, route of administration, or frequency is described in the provided source. Likewise, details regarding standard‑of‑care therapy, placebo, or comparator treatments are not supplied, and therefore information on dosing schedules, administration procedures, or participant compliance monitoring cannot be presented.