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

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ClinicalTrials.gov Identifier: NCT02043665
Recruitment Status : Recruiting
First Posted : January 23, 2014
Last Update Posted : September 6, 2017
Information provided by (Responsible Party):

Study Description
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 Phase 1

Study Design

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 and Efficacy of Intravenous CAVATAK® (Coxsackievirus A21, CVA21) Alone and in Combination With Pembrolizumab in Patients With Late Stage Solid Tumours (NSCLC, Castrate-resistant Prostate Cancer, Melanoma, Bladder Cancer).
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

Arms and Interventions

Arm Intervention/treatment
Experimental: VLA 009A (Part A now complete), VLA 009B (Part B enrolling) Biological: CVA21

Outcome Measures

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

Eligibility Criteria

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
Contacts and Locations

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

Contact: Lisa Guttman Lisa.Guttman@viralytics.com

United States, California
John Wayne Cancer Institute Recruiting
Santa Monica, California, United States, 90404
Contact: Steven O'Day, MD         
United States, Florida
University of Miami Recruiting
Coral Gables, Florida, United States, 33146
Contact: Jaime Merchan, MD         
United States, Illinois
Oncology Specialists, SC Recruiting
Niles, Illinois, United States, 60714
Contact: Arthur Hooberman, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Charles Rudin, MD         
Contact: Sharon Amir         
United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Brendan Curti, MD         
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Matthew Zibelman, MD         
United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Sumati Gupta, MD         
Australia, Queensland
Tasman Oncology Research Recruiting
Southport, Queensland, Australia, 4216
Contact: Andrew Hill, MBBS, FRACP         
Australia, Victoria
Monash Health Recruiting
Clayton, Victoria, Australia, 3168
Contact: Vinod Ganju, MBBS, FRACP         
St Vincent's Hospital, Melbourne Recruiting
Fitzroy, Victoria, Australia, 3065
Contact: Gavin Wright         
Barwon Health Recruiting
Geelong, Victoria, Australia, 3220
Contact: David Campbell         
Epworth HealthCare Recruiting
Richmond, Victoria, Australia, 3121
Contact: Ross Jennens         
Australia, Western Australia
St John of God Healthcare Recruiting
Subiaco, Western Australia, Australia, 6008
Contact: Timothy Clay         
United Kingdom
Royal Marsden NHS Foundation Trust Completed
Chelsea, United Kingdom, SW3 6JJ
Royal Surrey County Hospital Completed
Guildford, United Kingdom, GU2 7XX
St. James University Hospital Completed
Leeds, United Kingdom, LS9 7TF
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Principal Investigator: Hardev Pandha, FRCP, FRACP, PhD, FSB Royal Surrey County Hospital
More 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: September 6, 2017
Last Verified: September 2017

Keywords provided by Viralytics:
lung cancer
bladder cancer

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