CVA21 and Pembrolizumab in NSCLC & Bladder Cancer (VLA-009 STORM/ KEYNOTE-200) (STORM)
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|ClinicalTrials.gov Identifier: NCT02043665|
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : September 18, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer Bladder Cancer||Biological: CVA21/pembrolizumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Dose-finding and Signal-seeking Study of the Safety & Efficacy of Intravenous CAVATAK® Alone and in Combination With Pembrolizumab in Patients With Late Stage Solid Tumours (VLA-009 STORM / KEYNOTE-200)|
|Actual Study Start Date :||December 18, 2013|
|Actual Primary Completion Date :||January 10, 2020|
|Actual Study Completion Date :||January 10, 2020|
- Response rate assessed according to immune-related RECIST 1.1 criteria [ Time Frame: Up to 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02043665
|Principal Investigator:||Hardev Pandha, MD||Royal Surrey County Hospital NHS Foundation Trust|