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BRIEF TITLE: Intravenous CAVATAK™ (Coxsackievirus A21, CVA21) Alone and in Combination With Pembrolizumab in Patients With Late Stage Solid Tumours (NSCLC, Castrate-resistant Prostate Cancer, Melanoma, Bladder Cancer).

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)


  • Org Study ID: VLA 009/ KEYNOTE-200
  • Secondary ID: 2012-005256-42
  • NCT ID: NCT02043665
  • NCT Alias:
  • Sponsor: Viralytics - Industry
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting Start Date: January 2014 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Response rate assessed according to immune-related RECIST 1.1 criteria

Primary Outcome 1 - Time Frame: Up to 6 months

Condition:

  • Non-small Cell Lung Cancer
  • Bladder Cancer

Eligibility

Criteria:
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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Hardev Pandha, MD

Role: Principal Investigator

Affiliation: Royal Surrey County Hospital

Overall Contact

Name: Lisa Guttman

Phone:

Email: Lisa.Guttman@viralytics.com

Link: Viralytics Limited

Locations

Facility Status Contact
John Wayne Cancer Institute
Santa Monica, California 90404
United States
Recruiting
University of Miami
Coral Gables, Florida 33146
United States
Recruiting
Oncology Specialists, SC
Niles, Illinois 60714
United States
Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Recruiting Sharon Amir

Providence Portland Medical Center
Portland, Oregon 97213
United States
Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United States
Recruiting
Huntsman Cancer Institute
Salt Lake City, Utah 84112
United States
Recruiting
Tasman Oncology Research
Southport, Queensland 4216
Australia
Recruiting
Monash Health
Clayton, Victoria 3168
Australia
Recruiting
St Vincent's Hospital, Melbourne
Fitzroy, Victoria 3065
Australia
Recruiting
Barwon Health
Geelong, Victoria 3220
Australia
Recruiting
Epworth HealthCare
Richmond, Victoria 3121
Australia
Recruiting
St John of God Healthcare
Subiaco, Western Australia 6008
Australia
Recruiting
Royal Marsden NHS Foundation Trust
Chelsea, SW3 6JJ
United Kingdom
Completed
Royal Surrey County Hospital
Guildford, GU2 7XX
United Kingdom
Recruiting
St. James University Hospital
Leeds, LS9 7TF
United Kingdom
Completed