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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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Viralytics
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Viralytics
ClinicalTrials.gov Identifier:
NCT02043665
First received: January 19, 2014
Last updated: September 13, 2016
Last verified: September 2016
  Purpose

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 will consist of 2 sequential parts: VLA-009 (Part A) conducted only in the UK employs CVA21 as a monotherapy in NSCLC, castrate-resistant prostate cancer, melanoma and bladder cancer. VLA-009 (Part B) conducted in the US 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.


Condition Intervention Phase
Non-small Cell Lung Cancer
Castrate-resistant Prostate Cancer
Melanoma
Bladder Cancer
Biological: CVA21
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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).

Resource links provided by NLM:


Further study details as provided by Viralytics:

Primary Outcome Measures:
  • Response rate assessed according to immune-related RECIST 1.1 criteria [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: January 2014
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VLA 009A (First stage), VLA 009B (Second stage) Biological: CVA21

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02043665

Contacts
Contact: Lisa Guttman Lisa.Guttman@viralytics.com

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Charles Rudin, MD         
Contact: Sharon Amir    6462272424    amirs@mskcc.org   
United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Brendan Curti, MD         
United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Sumati Gupta, MD         
United Kingdom
St James University Hospital Recruiting
Leeds, United Kingdom
Contact: Christy Ralph         
Institute of Cancer Research Recruiting
London, United Kingdom
Contact: Kevin Harrington         
University of Surrey Recruiting
Surrey, United Kingdom
Contact: Hardev Pandha         
Sponsors and Collaborators
Viralytics
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Hardev Pandha 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 
Study First Received: January 19, 2014
Last Updated: September 13, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Viralytics:
CAVATAK
KEYNOTE-200
pembrolizumab
lung cancer
bladder cancer

Additional relevant MeSH terms:
Lung Neoplasms
Prostatic Neoplasms
Carcinoma, Non-Small-Cell Lung
Melanoma
Urinary Bladder Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Urologic Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Pembrolizumab
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 26, 2016