A Phase I Study of CAVATAK™ in Patients with Bladder Cancer
Research type
Research Study
Full 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
IRAS ID
138175
Contact name
Darren Shafren
Contact email
Sponsor organisation
Viralytics Ltd
Eudract number
2014-003938-81
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
This dose finding study will assess the safety and tolerability of multi-dose CAVATAK™ (CVA21) in patients with non-muscle invasive bladder cancer (NMIBC), alone and in combination with cytotoxic therapy. The study will be conducted at 1 hospital site in the UK, involving about 50 people with NMIBC who are already scheduled to undergo surgery for the treatment of their disease. Research into the treatment of NMBIC has been minimal compared to other malignancies. No treatment in the last decade has resulted in significant improvements in patient survival. The investigational product, CVA21, is a live oncolytic (or cancer-killing) virus derived from Kuykendall strain of Coxsackievirus A21. The virus is not genetically modified in any way. The sponsor Viralytics Ltd. is currently evaluating the safety and efficacy of CVA21 in the treatment of melanoma skin cancer and advanced solid tumours. Previous laboratory and animal studies show CVA21 can destroy some types of cancer cells with little or no effect on normal cells. It is supposed that intravesical (meaning injected into the bladder) administration of CVA21 may be an option to treat certain types of bladder tumours. Current treatments are quite toxic and do not always work. This trial will explore the ability of CVA21 to target bladder tumours by intravesical administration.
Part A of this study will investigate increasing dose levels of CVA21 with the aim of identifying a tolerable dose and schedule for intravesical administered CVA2.
In Part B, the study will assess the safety and efficacy of intravesical CVA21 in combination with low doses of a type of chemotherapy (called mitomycin) which is normally used to treat this condition at some point.REC name
London - Surrey Borders Research Ethics Committee
REC reference
14/LO/1804
Date of REC Opinion
18 Nov 2014
REC opinion
Further Information Favourable Opinion