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 April 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: April 12, 2016
Last verified: April 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 experssion 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 Cytotoxic Chemotherapy 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
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 the selected cytotoxic therapy 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
  • VLA009B: no medical contraindications to planned cytotoxic therapy
  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, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States
Contact: Brendan Curti, MD       brendan.curti@providence.org   
United Kingdom
St James University Hospital Recruiting
Leeds, United Kingdom
Contact: Christy Ralph         
Contact: Jennifer Boards    +44 (0)113 206797    Jennifer.Boards@leedsth.nhs.uk   
Sub-Investigator: Christy Ralph         
Institute of Cancer Research Recruiting
London, United Kingdom
Contact: Kevin Harrington         
Contact: Rachel Starkings    +44 (0)207 8082516    Rachel.Starkings@rmh.nhs.uk   
Principal Investigator: Kevin Harrington         
University of Surrey Recruiting
Surrey, United Kingdom
Contact: Hardev Pandha         
Contact: Wendy Hobby    +44 (0)1483 688602    w.hobby@surrey.ac.uk   
Principal Investigator: 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: April 12, 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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Prostatic Neoplasms
Urinary Bladder Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Genital Diseases, Male
Genital Neoplasms, Male
Lung Diseases
Neoplasms
Neoplasms by Site
Prostatic Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Pembrolizumab
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 26, 2016