A Phase 1 interventional study of CVA21 and Mitomycin C in Non-muscle Invasive Bladder Cancer, sponsored by Viralytics. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-27.
Sponsored by Viralytics · Phase 1, Interventional, and Treatment
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.
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.
Exclusion Criteria:
CVA21 was administered by intravesical instillation at one of three (3) ascending dose levels or schedules.
Biological: CVA21
Mitomycin 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.
Biological: CVA21 · Drug: Mitomycin C
CAVATAK is a purified preparation of CVA21
Also known as: CAVATAK, Coxsackievirus A21
Chemotherapy
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.
Time frame: 30 days from last dose
9 patients were enrolled into VLA012A and 6 patients into VLA012B and data presented for these 15 patients. One patient was enrolled, but not treated due to difficulties in placing the urinary catheter.
| Milestone | A1 - CVA21 1x10^8 TCID50 | CVA21/Mitomycin C | A2 - CVA21 3x10^8 TCID50. | A3 - CVA21 3x10^8 TCID50 x2 |
|---|---|---|---|---|
| Started | 4 | 6 | 3 | 3 |
| Completed | 3 | 6 | 3 | 3 |
| Not completed | 1 | 0 | 0 | 0 |
| Withdrew: Difficulties with urinary catheter | 1 | 0 | 0 | 0 |
Number of Participants with Treatment-emergent adverse events. The events for each cohort of dose of CVA21 only are pooled for the analysis.
| Participants | CVA21 | CVA21/Mitomycin C |
|---|---|---|
| Incidence of Dose-limiting Toxicities Treatment-related Adverse Events. | 9 | 6 |
Collected over 30 days. 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CVA21 | 0/9 (0%) | 1/9 (11.1%) | 9/9 (100%) |
| CVA21/Mitomycin C | 0/6 (0%) | 0/6 (0%) | 6/6 (100%) |
| Event | CVA21 | CVA21/Mitomycin C |
|---|---|---|
| E. Coli urinary tract infectionInfections and infestations | 1/9 | 0/6 |
| Event | CVA21 | CVA21/Mitomycin C |
|---|---|---|
| HematuriaRenal and urinary disorders | 5/9 | 4/6 |
| DysuriaRenal and urinary disorders | 5/9 | 1/6 |
| PollakiuriaRenal and urinary disorders | 3/9 | 1/6 |
| HyperglycaemiaMetabolism and nutrition disorders | 3/9 | 1/6 |
| Urinary tract infection enterococcalInfections and infestations | 2/9 | 1/6 |
| Escherichia urinary tract infectionInfections and infestations | 2/9 | 0/6 |
| Blood urea increasedInvestigations | 2/9 | 0/6 |
| Blood uric acid increasedInvestigations | 2/9 | 0/6 |
| FatigueGeneral disorders | 2/9 | 0/6 |
| Decreased appetiteMetabolism and nutrition disorders | 2/9 | 0/6 |
Received at least one dose of treatment.
| Age, Continuous(years) | CVA21 | CVA21/MitomycinC | Total |
|---|---|---|---|
| Mean | 67 ± 11.6 | 62.7 ± 8.3 | 65 ± 9.4 |
| Sex: Female, Male(Participants) | CVA21 | CVA21/MitomycinC | Total |
|---|---|---|---|
| Female | 2 | 1 | 3 |
| Male | 7 | 5 | 12 |
| Ethnicity (NIH/OMB)(Participants) | CVA21 | CVA21/MitomycinC | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 9 | 6 | 15 |
| Unknown or Not Reported | 0 | 0 | 0 |
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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