NCT03982797

Treatment of High-risk Non-muscle Invasive Bladder Cancer With IMUNO BGC Moreau RJ as Prophylaxis

Treatment of High-risk Non-muscle Invasive Bladder Cancer With IMUNO BGC Moreau RJ as Prophylaxis of Recurrence and Progression.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 306 (estimated)
• Sponsor: Biofabri, S.L · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Bladder cancer is the fourth reason of neoplasia in our environment, there are 25 new cases diagnosed per 100,000 inhabitants each year. To decrease the recurrence there are two standardized treatments: Mitomycin as chemotherapy drug and BCG \*Bacile Calmette-Guérin" as immunotherapy drug. BCG Moreau strain is not authorized by AEMPS, it was developed in Brazil and this country has extensive experience in treatment of non-muscle invasive bladder cancer with BCG Moreau, also BCG Moreau Rio de Janeiro make same immunological reaction as TICE, but with less adverse events. Thus, BCG Moreau RJ treatment could be used more time than TICE with the same dose, keeping immunologic status and better prophylaxis of recurrence or progression results for the patient. Each patient will be instillated via transurethral each time with 80 mg of IMUNO BCG Moreau RJ. There are 15 instillations during the clinical trial, 6 instillations on induction phase and 9 will be performed during maintaince phase.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Instillation of IMUNO BCG Moreau RJ	Instillation in bladder will be done once per week during first six weeks after inclusion, and 3 instillations (one per week) on month three, another three on moth six and last three on month twelve .

Timeline

• Start date: 2019-05-17
• Primary completion: 2021-04-03
• Completion: 2022-03-03
• First posted: 2019-06-12
• Last updated: 2019-06-12

Locations

15 sites across 1 country: Spain