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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02043665




Registration number
NCT02043665
Ethics application status
Date submitted
19/01/2014
Date registered
23/01/2014
Date last updated
6/05/2023

Titles & IDs
Public title
CVA21 and Pembrolizumab in NSCLC & Bladder Cancer (VLA-009 STORM/ KEYNOTE-200)
Scientific 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)
Secondary ID [1] 0 0
VLA 009/ KEYNOTE-200
Secondary ID [2] 0 0
3475-200
Universal Trial Number (UTN)
Trial acronym
STORM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer 0 0
Bladder Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bladder - transitional cell cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - CVA21/pembrolizumab

Experimental: CVA21/pembrolizumab - CVA21/pembrolizumab


Other interventions: CVA21/pembrolizumab
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Response rate assessed according to immune-related RECIST 1.1 criteria
Timepoint [1] 0 0
Up to 6 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/12/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/01/2020
Sample size
Target
Accrual to date
Final
85
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
Tasman Oncology Research - Southport
Recruitment hospital [2] 0 0
Monash Health - Clayton
Recruitment hospital [3] 0 0
St Vincent's Hospital, Melbourne - Fitzroy
Recruitment hospital [4] 0 0
Barwon Health - Geelong
Recruitment hospital [5] 0 0
Epworth HealthCare - Richmond
Recruitment hospital [6] 0 0
St John of God Healthcare - Subiaco
Recruitment postcode(s) [1] 0 0
4216 - Southport
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment postcode(s) [4] 0 0
3220 - Geelong
Recruitment postcode(s) [5] 0 0
3121 - Richmond
Recruitment postcode(s) [6] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Oregon
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Utah
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Chelsea
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Guildford
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Leeds

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Viralytics
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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 website
https://clinicaltrials.gov/ct2/show/NCT02043665
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Hardev Pandha, MD
Address 0 0
Royal Surrey County Hospital NHS Foundation Trust
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02043665