Clinical Trial: Systemic Treatment Of Resistant Metastatic Disease Employing CVA21 and Pembrolizumab in Non-small Cell Lung Cancer and Bladder Cancer (STORM/ KEYNOTE-200)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 1, Dose-finding and Signal-seeking Study of the Safety and Efficacy of Intravenous CAVATAK™ (Coxsackievirus A21, CVA21) Alone and in Combination With Pembrol

Brief 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.

Detailed Summary:
Sponsor: Viralytics

Current Primary Outcome: Response rate assessed according to immune-related RECIST 1.1 criteria [ Time Frame: Up to 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Viralytics

Dates:
Date Received: January 19, 2014
Date Started: January 2014
Date Completion: August 2019
Last Updated: May 10, 2017
Last Verified: May 2017