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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 is a Phase 1 study that has completed, run by Viralytics. The registered enrollment target is 85 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02043665
The ClinicalTrials.gov registry entry for NCT02043665 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 85 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Viralytics, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CVA21/pembrolizumab is the first listed.
NCT02043665 reports 0 study locations.
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.
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