CVA21 and Pembrolizumab in NSCLC & Bladder Cancer (VLA-009 STORM/ KEYNOTE-200)
STORM
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)
3 other identifiers
interventional
85
3 countries
18
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 nonsmall-cell-lung-cancer
Started Dec 2013
Longer than P75 for phase_1 nonsmall-cell-lung-cancer
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 18, 2013
CompletedFirst Submitted
Initial submission to the registry
January 19, 2014
CompletedFirst Posted
Study publicly available on registry
January 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2020
CompletedMay 6, 2023
May 1, 2023
6.1 years
January 19, 2014
May 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response rate assessed according to immune-related RECIST 1.1 criteria
Up to 6 months
Study Arms (1)
CVA21/pembrolizumab
EXPERIMENTALCVA21/pembrolizumab
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Viralyticslead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (18)
John Wayne Cancer Institute
Santa Monica, California, 90404, United States
University of Miami
Coral Gables, Florida, 33146, United States
Advocate Health
Niles, Illinois, 60714, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
UT Southwestern
Dallas, Texas, 75390, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Tasman Oncology Research
Southport, Queensland, 4216, Australia
Monash Health
Clayton, Victoria, 3168, Australia
St Vincent's Hospital, Melbourne
Fitzroy, Victoria, 3065, Australia
Barwon Health
Geelong, Victoria, 3220, Australia
Epworth HealthCare
Richmond, Victoria, 3121, Australia
St John of God Healthcare
Subiaco, Western Australia, 6008, Australia
Royal Marsden NHS Foundation Trust
Chelsea, SW3 6JJ, United Kingdom
Royal Surrey County Hospital
Guildford, GU2 7XX, United Kingdom
St. James University Hospital
Leeds, LS9 7TF, United Kingdom
Related Publications (1)
Rudin CM, Pandha HS, Zibelman M, Akerley WL, Harrington KJ, Day D, Hill AG, O'Day SJ, Clay TD, Wright GM, Jennens RR, Gerber DE, Rosenberg JE, Ralph C, Campbell DC, Curti BD, Merchan JR, Ren Y, Schmidt EV, Guttman L, Gupta S. Phase 1, open-label, dose-escalation study on the safety, pharmacokinetics, and preliminary efficacy of intravenous Coxsackievirus A21 (V937), with or without pembrolizumab, in patients with advanced solid tumors. J Immunother Cancer. 2023 Jan;11(1):e005007. doi: 10.1136/jitc-2022-005007.
PMID: 36669791RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hardev Pandha, MD
Royal Surrey County Hospital NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2014
First Posted
January 23, 2014
Study Start
December 18, 2013
Primary Completion
January 10, 2020
Study Completion
January 10, 2020
Last Updated
May 6, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will share
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf