CVA21 and Pembrolizumab in NSCLC & Bladder Cancer (VLA-009 STORM/ KEYNOTE-200)
NCT ID: NCT02043665
Last Updated: 2023-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
85 participants
INTERVENTIONAL
2013-12-18
2020-01-10
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CVA21/pembrolizumab
CVA21/pembrolizumab
CVA21/pembrolizumab
Interventions
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CVA21/pembrolizumab
Eligibility Criteria
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Inclusion Criteria
* 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
* Concurrent immunosuppressive therapy and no known immunosuppressive disease other than primary tumour
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Viralytics
INDUSTRY
Responsible Party
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Principal Investigators
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Hardev Pandha, MD
Role: PRINCIPAL_INVESTIGATOR
Royal Surrey County Hospital NHS Foundation Trust
Locations
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John Wayne Cancer Institute
Santa Monica, California, United States
University of Miami
Coral Gables, Florida, United States
Advocate Health
Niles, Illinois, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Providence Portland Medical Center
Portland, Oregon, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
UT Southwestern
Dallas, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Tasman Oncology Research
Southport, Queensland, Australia
Monash Health
Clayton, Victoria, Australia
St Vincent's Hospital, Melbourne
Fitzroy, Victoria, Australia
Barwon Health
Geelong, Victoria, Australia
Epworth HealthCare
Richmond, Victoria, Australia
St John of God Healthcare
Subiaco, Western Australia, Australia
Royal Marsden NHS Foundation Trust
Chelsea, , United Kingdom
Royal Surrey County Hospital
Guildford, , United Kingdom
St. James University Hospital
Leeds, , United Kingdom
Countries
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References
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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.
Other Identifiers
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VLA 009/ KEYNOTE-200
Identifier Type: OTHER
Identifier Source: secondary_id
2012-005256-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3475-200
Identifier Type: -
Identifier Source: org_study_id
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