Clinical trial · Interventional
CAVATAK (CVA21) in Non-muscle Invasive Bladder Cancer (VLA-012 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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-muscle Invasive Bladder Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CVA21 | Biological | — | UNRESOLVED |
| Mitomycin C | Drug | Mitomycin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CVA21
- description
- CVA21 was administered by intravesical instillation at one of three (3) ascending dose levels or schedules.
- interventionNames
- Biological: CVA21
- type
- EXPERIMENTAL
- label
- CVA21/Mitomycin C
- description
- 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.
- interventionNames
- Biological: CVA21
- Drug: Mitomycin C
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (1)
- RESULTAnnels 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 31273010