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

May 2, 2023 updated by: Viralytics

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Southport, Queensland, Australia, 4216
        • Tasman Oncology Research
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Health
      • Fitzroy, Victoria, Australia, 3065
        • St Vincent's Hospital, Melbourne
      • Geelong, Victoria, Australia, 3220
        • Barwon Health
      • Richmond, Victoria, Australia, 3121
        • Epworth Healthcare
    • Western Australia
      • Subiaco, Western Australia, Australia, 6008
        • St John of God Healthcare
  • United Kingdom
      • Chelsea, United Kingdom, SW3 6JJ
        • Royal Marsden NHS Foundation Trust
      • Guildford, United Kingdom, GU2 7XX
        • Royal Surrey County Hospital
      • Leeds, United Kingdom, LS9 7TF
        • St. James University Hospital
  • United States
    • California
      • Santa Monica, California, United States, 90404
        • John Wayne Cancer Institute
    • Florida
      • Coral Gables, Florida, United States, 33146
        • University of Miami
    • Illinois
      • Niles, Illinois, United States, 60714
        • Advocate Health
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CVA21/pembrolizumab
Biological: CVA21/pembrolizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate assessed according to immune-related RECIST 1.1 criteria
Time Frame: Up to 6 months
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Viralytics

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Hardev Pandha, MD, Royal Surrey County Hospital NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2013

Primary Completion (Actual)

January 10, 2020

Study Completion (Actual)

January 10, 2020

Study Registration Dates

First Submitted

January 19, 2014

First Submitted That Met QC Criteria

January 21, 2014

First Posted (Estimate)

January 23, 2014

Study Record Updates

Last Update Posted (Estimate)

May 4, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3475-200
  • 2012-005256-42 (EudraCT Number)
  • VLA 009/ KEYNOTE-200 (Other Identifier: Viralytics Study ID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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