A Phase 1, Dose-Finding and Signal-Seeking Study of the Safety and Efficacy of Intravenous CAVATAK (Coxsackievirus A21, CVA21) Alone and in Combination with Pembrolizumab in Patients with Late Stage Solid Tumors (NSCLC, Castrate-resistant Prostate cancer, Melanoma and Bladder cancer)

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 experssion of ICAM-1 and/ or DAF receptor occurs.

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.
* locally advanced and/or metastatic disease and judged to be a candidate for the selected cytotoxic therapy 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
Phase I
Cancer, All Other
Multiple Tumor Types
Brendan Curti, M.D.
Viralytics Ltd
Brenda Fisher
  • Oncology and Hematology Care Eastside