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IMMUNOBCG: Systemic Immunological Response of Bladder Cancer Patients Under BCG
NCT04806178Phase 3
Key facts
- Status
- Completed
- Start
- Sep 2021
- Primary completion
- May 2024
- Countries
- 1
- Sponsor
- Universidade Estadual de Campinas
- Modality
- Vaccines & Immunotherapeutics
- Drugs
- bcg vaccine
- Conditions
- bladder cancer
01
Overview
Phase 3, randomised, double-blind trial in bladder cancer comparing BCG intradermal vaccine with Placebo (2 arms). Primary endpoint: Flow Cytometry (Immunological Signatures) at Day 180. Started Sep 2021; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
BCG intradermal vaccine
Intradermal BCG priming followed by intravesical BCG.
Placebo
Intradermal Placebo priming followed by intravesical BCG.
03
Who it enrols
Patients with NMIBC indicated for intravesical BCG treatment, excluding those with previous BCG treatment or muscle invasive tumors.
04
Endpoints
Primary
Flow Cytometry (Immunological Signatures)
Secondary
Adverse Effects
Change from Baseline Voiding Symptoms
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