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

Status:	Active, not recruiting
Conditions:	Lung Cancer, Lung Cancer, Prostate Cancer, Skin Cancer, Cancer, Cancer, Cancer, Cancer, Bladder Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	5/4/2018
Start Date:	January 2014
End Date:	August 2019

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)

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.

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

We found this trial at

sites

University of Miami

Coral Gables, Florida 33146

Principal Investigator: Jaime Merchan, MD

from

Coral Gables, FL