Non-small Cell Lung Cancer Clinical Trial
— STORMOfficial 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)
Verified date | May 2023 |
Source | Viralytics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 85 |
Est. completion date | January 10, 2020 |
Est. primary completion date | January 10, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Monash Health | Clayton | Victoria |
Australia | St Vincent's Hospital, Melbourne | Fitzroy | Victoria |
Australia | Barwon Health | Geelong | Victoria |
Australia | Epworth HealthCare | Richmond | Victoria |
Australia | Tasman Oncology Research | Southport | Queensland |
Australia | St John of God Healthcare | Subiaco | Western Australia |
United Kingdom | Royal Marsden NHS Foundation Trust | Chelsea | |
United Kingdom | Royal Surrey County Hospital | Guildford | |
United Kingdom | St. James University Hospital | Leeds | |
United States | University of Miami | Coral Gables | Florida |
United States | UT Southwestern | Dallas | Texas |
United States | Karmanos Cancer Institute | Detroit | Michigan |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | Advocate Health | Niles | Illinois |
United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
United States | Providence Portland Medical Center | Portland | Oregon |
United States | Huntsman Cancer Institute | Salt Lake City | Utah |
United States | John Wayne Cancer Institute | Santa Monica | California |
Lead Sponsor | Collaborator |
---|---|
Viralytics | Merck Sharp & Dohme LLC |
United States, Australia, United Kingdom,
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-esc — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response rate assessed according to immune-related RECIST 1.1 criteria | Up to 6 months |
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