A Phase I/II Study of a Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumours

This phase I/II clinical study will evaluate the ability of a new type of vaccine in combination with another drug, pembrolizumab (also called Keytruda), to provide a beneficial effect as a treatment for certain types of colorectal cancer (CRC).  

Nous-209 is a genetic vaccine that has been developed to treat tumours that have a genetic mutation known as deficient Mismatch Repair (dMMR) or Microsatellite Instability High (MSI-H). The vaccine acts to train and arm your immune system to specifically target cancer cells in your tumour.

Pembrolizumab is an approved drug and standard of care treatment for unresectable or metastatic colorectal cancer that is dMMR or MSI-H.

Nous-209, when given with pembrolizumab, has the potential of making the tumour more sensitive to pembrolizumab. The goal of this study is to find out if this approach is better or worse than the standard of care, which is pembrolizumab alone. In this study, participants will be randomly assigned to be treated either with Nous-209 vaccine in combination with standard of care pembrolizumab or pembrolizumab alone.  

In Canada, this study will take place in two participating hospitals in Ontario: 

 

Toronto, Ontario 

Princess Margaret Cancer Centre 

Principal Investigator: Dr. Eric Chen 

Actively recruiting 

Contact: D.Amakye@nouscom.com 

 

Toronto, Ontario 

Mount Sinai Hospital 

Principal Investigator: Dr. Ronald Burkes 

Soon to be recruiting 

For more information on this trial:
https://clinicaltrials.gov/study/NCT04041310?spons=Nouscom&rank=2#study-overview