Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster display

3698 - Intravenous coxsackievirus A21 in combination with pembrolizumab in advanced cancer patients: phase Ib KEYNOTE 200 study


09 Oct 2016


Poster display


Hardev Pandha


Annals of Oncology (2016) 27 (6): 359-378. 10.1093/annonc/mdw378


H.S. Pandha1, K. Harrington2, C. Ralph3, A. Melcher4, E. Schmidt5, D.R. Kaufman6, M. Grose7, R. Karpathy7, D. Shafren7

Author affiliations

  • 1 Oncology, University of Surrey, GU2 7WG - Surrey/GB
  • 2 Division Of Radiotherapy And Imaging, The Institute of Cancer Research and Royal Marsden Hospital, SW7 6JB - London/GB
  • 3 St. James's Institute Of Oncology, University of Leeds, Leeds/GB
  • 4 Oncology And Clinical Research, Leeds Institute of Cancer and Pathology, Leeds/GB
  • 5 Clinical, Merck Co, Kenilworth/US
  • 6 Oncology Clinical Research, Merck & Co., Inc., Kenilworth/US
  • 7 Viralytics, Viralytics Limited, Sydney/AU


Abstract 3698


CAVATAKTM is a novel, bio-selected ICAM-1-targeted immunotherapeutic Coxsackievirus A21 (CVA21). Infection of the tumour micro-environment by CVA21 can increase levels of immune-checkpoint molecules, immune-cell infiltration and enhancement of systemic antitumour immune response. Pembrolizumab is a human programmed death receptor-1 (PD-1) blocking antibody that has induced responses in a number of tumour types via reversal of tumour-induced T-cell suppression. Preclinical studies in immune-competent mouse models of NSCLC and melanoma suggest combinations of IV CVA21 + anti-PD-1 mAbs mediate greater antitumour activity compared to single agent use. As such, we propose that the combination of CVA21 + pembrolizumab may translate to similar benefits in the clinic. The KEYNOTE 200 Phase Ib study (NCT02043665) assesses tolerance and efficacy of IV-delivered CVA21 ± pembrolizumab in advanced cancer pts.

Trial design

Primary objectives are to assess dose-limiting toxicities (DLT) of CVA21 ± pembrolizumab. Secondary objectives include ORR by irRECIST criteria, PFS, and OS. Treatment: Part A: Pts are infused with CVA21 in Cohort 1 (n = 3), at a dose of 1 x 108 TCID50, in Cohort 2 (n = 3) at a dose of 3 x 108 TCID50 and in Cohort 3 (n = 12-18) at a dose of 1 x 109 TCID50 on study days 1,3,5,22 and Q3W for 6 additional infusions. Part A enrollment is almost complete. Part B: Pts are infused with CVA21 + pembrolizumab. In Cohort 1 (n = 3), CVA21 is administered at a dose of 1 x 108 TCID50, in Cohort 2 (n = 3) at a dose of 3 x 108 TCID50 and in Cohort 3 (n = ∼80) at a dose of 1 x 109 TCID50 on study days 1,3,5,8,29,and Q3W for 6 additional infusions. All subjects receive pembrolizumab at 200 mg IV Q3W from Day 8 for up to 2 years. Treatment with IV CVA21 ± pembrolizumab will continue until confirmed CR or PD (whichever comes first) per irRECIST or DLT. Key eligibility: Pts with advanced disease, lesion(s) accessible for core biopsy, ECOG PS 0-1, no active cerebral metastases, no autoimmunity/immunosuppression.

Clinical trial identification


Legal entity responsible for the study

Viralytics Limited


Viralytics Limited


H.S. Pandha: Research Funding - Viralytics Limited Travel, Accommodations, Expenses – Viralytics. K. Harrington: Honoraria - Amgen; Celgene; Merck Sharp & Dohme; Oncos Therapeutics Consulting - Amgen; Merck Sharp & Dohme; Viralytics (Inst). Research Funding - AstraZeneca; Genelux Oncolytics Biotech, Viralytics Travel - Boehringer Ingelheim, Viralytics. C. Ralph: Travel, Accommodations, Expenses – Viralytics. A. Melcher: Research Funding - Oncolytics Biotech, Viralytics Limited Travel, Accommodations, Expenses – Viralytics. E. Schmidt, D.R. Kaufman: Employment: Merck & Co. M. Grose, R. Karpathy, D. Shafren: Viralytics stock and employment.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings