CAVATAK (CVA21) in Non-muscle Invasive Bladder Cancer (VLA-012 CANON)
CANON
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)
3 other identifiers
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2014
CompletedFirst Posted
Study publicly available on registry
December 12, 2014
CompletedStudy Start
First participant enrolled
January 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 14, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 14, 2016
CompletedResults Posted
Study results publicly available
June 17, 2019
CompletedJuly 27, 2022
July 1, 2022
1.2 years
December 7, 2014
November 2, 2017
July 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Dose-limiting Toxicities Treatment-related Adverse Events.
Number of Participants with Treatment-emergent adverse events. The events for each cohort of dose of CVA21 only are pooled for the analysis.
30 days from last dose
Study Arms (2)
CVA21
EXPERIMENTALCVA21 was administered by intravesical instillation at one of three (3) ascending dose levels or schedules.
CVA21/Mitomycin C
EXPERIMENTALMitomycin C (MMC) was administered at 10 mg by intravesical instillation on Day 1. Four hours after instillation of MMC, CVA21 was administered by intravesical instillation of one of 2 ascending dose levels or schedules. Subjects received a second instillation of CVA21 alone on Day 2 without pretreatment with MMC.
Interventions
CAVATAK is a purified preparation of CVA21
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of NMIBC based on cystoscopic appearance
- ECOG 0-2
- No intravesical therapy within 6 weeks of study entry
- No prior radiation to the pelvis
- ANC \>1500/mm³; Hb \>9.0 g/dL; Platelet \>100000/mm³
- Serum creatinine ≤ 1.5 mg/dL
- Bilirubin within normal limits; AST ≤ 2.5x upper limit of normal (ULN); ALT ≤ 2.5 x ULN; alkaline phosphatase ≤ 2.5x ULN unless bone metastasis is present in the absence of liver metastasis
- INR \< 1.2; aPPT = 0.8-1.2; PT = 0.9-1.8
- Candidate for TUR and planning to undergo TUR
- Negative pregnancy test within 7 days of treatment start
- Patients of child-bearing potential must agree to use an effective method of birth control
You may not qualify if:
- Prior local or systemic treatments for NMIBC
- Concurrent treatment with any chemotherapeutic agent
- Patients not deemed acceptable for general anaesthesia
- Women who are pregnant or lactating
- History of vesicoureteric reflux or an indwelling urinary stent
- Administration of an investigational agent within 3 months of study entry
- Active cardiac disease
- Known infection with HIV, hepatitis B or C
- Active uncontrolled infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Viralyticslead
Study Sites (1)
University of Surrey
Guildford, United Kingdom
Related Publications (1)
Annels NE, Mansfield D, Arif M, Ballesteros-Merino C, Simpson GR, Denyer M, Sandhu SS, Melcher AA, Harrington KJ, Davies B, Au G, Grose M, Bagwan I, Fox B, Vile R, Mostafid H, Shafren D, Pandha HS. Phase I Trial of an ICAM-1-Targeted Immunotherapeutic-Coxsackievirus A21 (CVA21) as an Oncolytic Agent Against Non Muscle-Invasive Bladder Cancer. Clin Cancer Res. 2019 Oct 1;25(19):5818-5831. doi: 10.1158/1078-0432.CCR-18-4022. Epub 2019 Jul 4.
PMID: 31273010RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Small number of subjects with limited follow-up; study not designed to give any indication of efficacy. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
Results Point of Contact
- Title
- Mark Grose
- Organization
- Viralytics
Study Officials
- PRINCIPAL INVESTIGATOR
Hardev Pandha
Royal Surrey County Hospital NHS Foundation Trust
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2014
First Posted
December 12, 2014
Study Start
January 16, 2015
Primary Completion
March 14, 2016
Study Completion
March 14, 2016
Last Updated
July 27, 2022
Results First Posted
June 17, 2019
Record last verified: 2022-07