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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02043665
Recruitment Status : Active, not recruiting
First Posted : January 23, 2014
Last Update Posted : March 1, 2018
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Bladder Cancer Biological: CVA21/pembrolizumab Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : January 2014
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: CVA21/pembrolizumab
Biological: CVA21/pembrolizumab

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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

United States, California
John Wayne Cancer Institute
Santa Monica, California, United States, 90404
United States, Florida
University of Miami
Coral Gables, Florida, United States, 33146
United States, Illinois
Oncology Specialists, SC
Niles, Illinois, United States, 60714
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Australia, Queensland
Tasman Oncology Research
Southport, Queensland, Australia, 4216
Australia, Victoria
Monash Health
Clayton, Victoria, Australia, 3168
St Vincent's Hospital, Melbourne
Fitzroy, Victoria, Australia, 3065
Barwon Health
Geelong, Victoria, Australia, 3220
Epworth HealthCare
Richmond, Victoria, Australia, 3121
Australia, Western Australia
St John of God Healthcare
Subiaco, Western Australia, Australia, 6008
United Kingdom
Royal Marsden NHS Foundation Trust
Chelsea, United Kingdom, SW3 6JJ
Royal Surrey County Hospital
Guildford, United Kingdom, GU2 7XX
St. James University Hospital
Leeds, United Kingdom, LS9 7TF
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Principal Investigator: Hardev Pandha, MD Royal Surrey County Hospital

Additional Information:
Responsible Party: Viralytics
ClinicalTrials.gov Identifier: NCT02043665     History of Changes
Other Study ID Numbers: VLA 009/ KEYNOTE-200
2012-005256-42 ( EudraCT Number )
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018

Keywords provided by Viralytics:
lung cancer
bladder cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Urinary Bladder Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Urologic Neoplasms
Urogenital Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Antineoplastic Agents