CVA21 and Pembrolizumab in NSCLC & Bladder Cancer (VLA-009 STORM/ KEYNOTE-200)

Non-small Cell Lung Cancer Clinical Trial

— STORM  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02043665
• Other study ID #: 3475-200
• Secondary ID: VLA 009/ KEYNOTE
• Status: Completed
• Phase: Phase 1
• Start date: December 18, 2013
• Est. completion date: January 10, 2020

Study information

• Verified date: May 2023
• Source: Viralytics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Bladder Cancer
• Non-small Cell Lung Cancer
• Urinary Bladder Neoplasms

Intervention

Biological:
• CVA21/pembrolizumab

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Viralytics	Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Australia,  United Kingdom, 

References & 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-esc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate assessed according to immune-related RECIST 1.1 criteria		Up to 6 months