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NCT02043665 · ClinicalTrials.gov registry record · Phase 1
CVA21 and Pembrolizumab in NSCLC & Bladder Cancer (VLA-009 STORM/ KEYNOTE-200)
A Phase 1 study, sponsored by Viralytics.
- Completed
- Registry status
- Phase 1
- Development phase
- 85
- Enrollment target
NCT02043665: Completed Phase 1 study, sponsored by Viralytics.
NCT02043665 is a Phase 1 study that has completed, run by Viralytics. The registered enrollment target is 85 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02043665, a Phase 1 study, has completed, sponsored by Viralytics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 85 participants
- Enrollment target
Study Summary
The purpose of this trial is to assess the ability of CVA21, either alone (Part A) or in combination with pembrolizumab (Part B), to reach and to replicate in existing tumors (while sparing normal cells) and to establish a safe multi-dose schedule of the virus for the treatment of solid tumors where enhanced expression of ICAM-1 and/ or DAF receptor occurs. This trial consists of 2 sequential parts: VLA-009 (Part A) conducted only in the UK and employed CVA21 as a monotherapy in NSCLC, castrate-resistant prostate cancer, melanoma and bladder cancer. VLA-009 (Part B) conducted in the US, AUS and UK employs CVA21 with pembrolizumab in NSCLC and bladder cancer. Both VLA-009A and VLA-009B are open-label, multi-center, ascending dose escalation (3+3 design) dose-finding and signal-seeking studies. Part A of the study is now complete and closed to enrolment. Part B is currently enrolling.
Interventions
- BIOLOGICAL CVA21/pembrolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2013-12-18 |
| Est. Completion | 2020-01-10 |
| Phase | Phase 1 |
What the finished NCT02043665 record still lists
NCT02043665 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% higher).
The record links to 0 conditions, and to 1 intervention - of which CVA21/pembrolizumab is the first listed.
NCT02043665 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02043665 about?
NCT02043665 is a clinical study titled "CVA21 and Pembrolizumab in NSCLC & Bladder Cancer (VLA-009 STORM/ KEYNOTE-200)". The purpose of this trial is to assess the ability of CVA21, either alone (Part A) or in combination with pembrolizumab (Part B), to reach and to replicate in existing tumors (while sparing normal cells) and to establish a safe multi-dose schedule of the virus for the treatment of solid tumors where...
What is the current status of trial NCT02043665?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 85 participants. The study started on 2013-12-18. Estimated completion is 2020-01-10.
What interventions are being tested in trial NCT02043665?
The interventions under investigation include: CVA21/pembrolizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02043665?
This trial is sponsored by Viralytics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02043665's enrollment target sits among peer trials
85 656th of 2000 higher than 1,342 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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