Spots Global Cancer Trial Database for CAVATAK (CVA21) in Non-muscle Invasive Bladder Cancer (VLA-012 CANON)

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Trial Identification

Brief Title: CAVATAK (CVA21) in Non-muscle Invasive Bladder Cancer (VLA-012 CANON)

Official Title: A Phase 1 Study to Evaluate the Safety and Clinical Activity of Intravesicular CAVATAK (Coxsackievirus A21, CVA21) Alone and in Sequential Combination With Low Dose Mitomycin C in Patients With Non-Muscle Invasive Bladder Cancer (VLA-012 CANON)

Study ID: NCT02316171

Conditions

Non-muscle Invasive Bladder Cancer

Interventions

CVA21

Mitomycin C

Study Description

Brief Summary: The study consisted of 2 sequential parts. Part A assessed the safety and tolerability of CAVATAK administered via intravesical instillation in patients with non-muscle invasive bladder cancer scheduled to undergo TUR. Part B assessed the safety and tolerability of CAVATAK administered in sequential combination with low dose Mitomycin C in the same patient population.

Detailed Description: This was a Phase I, two-part, open-label, dose-escalation study designed to evaluate CVA21 alone and in sequential combination with low-dose mitomycin C in patients with non-muscle invasive bladder cancer (NMIBC) who were candidates for and were planning to undergo TUR for treatment of their disease. This gave a relatively homogeneous study population and facilitated collection of resected tumour tissue for histological, pharmacodynamics (PD) and pharmacokinetic (PK) analyses.