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Trial record 1 of 2 for:    NCT02043665
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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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2017 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: May 10, 2017
Last verified: May 2017
  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 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 Intervention Phase
Non-small Cell Lung Cancer
Bladder Cancer
Biological: CVA21
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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 ]

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 (Part A now complete), VLA 009B (Part B enrolling) Biological: CVA21

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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, 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         
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
Viralytics
Merck Sharp & Dohme Corp.
Investigators
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 )
Study First Received: January 19, 2014
Last Updated: May 10, 2017

Keywords provided by Viralytics:
CAVATAK
KEYNOTE-200
pembrolizumab
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
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Pembrolizumab
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 25, 2017