Clinical Trial: NCT02043665 - My Cancer Genome

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:

Completed

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT02043665

Trial Eligibility

Document

Title

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

Clinical Trial IDs

ORG STUDY ID: 3475-200
SECONDARY ID: 2012-005256-42
SECONDARY ID: VLA 009/ KEYNOTE-200
NCT ID: NCT02043665

Conditions

Non-small Cell Lung Cancer
Bladder Cancer

Interventions

Drug	Synonyms	Arms
CVA21/pembrolizumab		CVA21/pembrolizumab

Purpose

Trial Arms

Name	Type	Description	Interventions
CVA21/pembrolizumab	Experimental	CVA21/pembrolizumab	CVA21/pembrolizumab

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:	Completed
Lead Sponsor:	Viralytics

Trial Keywords

CAVATAK
KEYNOTE-200
pembrolizumab
lung cancer
bladder cancer

Last Updated

September 18, 2020

Clinical Trials /

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