Clinical Trials /

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

NCT02043665

Description:

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.

Related Conditions:
  • Bladder Carcinoma
  • Melanoma
  • Non-Small Cell Lung Carcinoma
  • Prostate Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: VLA 009/ KEYNOTE-200
  • SECONDARY ID: 2012-005256-42
  • NCT ID: NCT02043665

Conditions

  • Non-small Cell Lung Cancer
  • Bladder Cancer

Interventions

DrugSynonymsArms
CVA21VLA 009A (Part A now complete), VLA 009B (Part B enrolling)

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.

Trial Arms

NameTypeDescriptionInterventions
VLA 009A (Part A now complete), VLA 009B (Part B enrolling)Experimental

    Eligibility 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
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

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

    Details

    Phase:Phase 1
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Viralytics

    Trial Keywords

    • CAVATAK
    • KEYNOTE-200
    • pembrolizumab
    • lung cancer
    • bladder cancer

    Last Updated

    September 4, 2017