CVA21 and Pembrolizumab in NSCLC & Bladder Cancer (VLA-009 STORM/ KEYNOTE-200)
- Conditions
- Bladder CancerNon-small Cell Lung Cancer
- Registration Number
- NCT02043665
- Lead Sponsor
- Viralytics
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 85
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Response rate assessed according to immune-related RECIST 1.1 criteria Up to 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
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
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