CVA21 and Pembrolizumab in NSCLC & Bladder Cancer (VLA-009 STORM/ KEYNOTE-200)

Completed · Phase 1

Conditions studied: Non-small Cell Lung Cancer, Bladder Cancer

In brief

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.

Key facts

Study ID

NCT02043665

Run by

Viralytics

People needed

85

Starts

2013-12-18

Expected to finish

2020-01-10

Last updated by the study team

2023-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically-confirmed (1) NSCLC, (2) bladder cancer, (3) castrate-resistant prostate cancer which are metastatic, or (4) stage 3C or stage 4 melanoma.
• VLA009A: Locally advanced and/or metastatic disease for which curative surgery and/or radiation therapy is not possible and judged not to be a candidate for the current standard of care treatment. VLA009B: locally advanced and/or metastatic disease and judged to be a candidate for pembrolizumab to be used in combination with CVA21.
• All subjects in Cohort 3 or Phase 2 dose (P2D) must have a lesion accessible for FNA or core or open biopsy on day 8 of the first treatment cycle.
• No CVA21 neutralising antibody (≤ 1:16)
• Measurable or evaluable disease

You may not qualify if…

• Second primary malignancy within the past 2 years (except non-melanoma skin cancer, in situ carcinoma of the cervix, breast cancer)
• Concurrent immunosuppressive therapy and no known immunosuppressive disease other than primary tumour

Where it is running

• John Wayne Cancer Institute — Santa Monica, California, United States
• University of Miami — Coral Gables, Florida, United States
• Advocate Health — Niles, Illinois, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Providence Portland Medical Center — Portland, Oregon, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• UT Southwestern — Dallas, Texas, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States
• Tasman Oncology Research — Southport, Queensland, Australia
• Monash Health — Clayton, Victoria, Australia
• St Vincent's Hospital, Melbourne — Fitzroy, Victoria, Australia
• Barwon Health — Geelong, Victoria, Australia
• Epworth HealthCare — Richmond, Victoria, Australia
• St John of God Healthcare — Subiaco, Western Australia, Australia
• Royal Marsden NHS Foundation Trust — Chelsea, United Kingdom
• Royal Surrey County Hospital — Guildford, United Kingdom
• St. James University Hospital — Leeds, United Kingdom

Full record on ClinicalTrials.gov

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