A clinical trial for refractory or relapsing solid tumours

This innovative clinical trial will test the combination of three classical metronomic chemotherapies with a PD-1 checkpoint inhibitor or Nivolumab®. 

Our immune system is capable of detecting the difference between “foreign” cells and “normal” cells. This capability enables the white blood cells to attack foreign cells while sparing the normal ones. In order to start an immune response, certain checkpoints located on the white blood cells must be activated but cancer cells, which are produced by our own body, are able to prevent the activation of those checkpoints. That’s why the white blood cells do not attack the cancer cells. 

Nivolumab® is able to block the inhibition of the checkpoint called PD-1. When the activation of that checkpoint is inhibited, the white blood cells can attack the cancer cells and cause their death.

Metronomic chemotherapy consists of giving low doses of anticancer agents on a continuous basis, which has been shown to target distinct features of the tumour biology.

The clinical trial supported by KickCancer will take place in six French hospitals [and one Belgian centre] for the benefit of patients affected by refractory or relapsing solid tumours, which do not respond to the standard treatment. It is structured in two phases and will include between 36 to 72 patients.

This project is also supported and was validated by the Anticancer Fund.

Latest developments: The project has been approved by the French ethics committee and will start recruiting patients in the French centres before the end of 2018. The trial in Belgium will open in the course of 2019. 

Next steps: The trial is structured in two phases; the first one will bring a first batch of results and will end in late 2019- early 2020. A first report will be drafted at the end of this first phase (December 2019 – January 2020) and afterwards, annually. The final results of the trial will be avail- able during the first quarter of 2024, or five years after the opening of the study, which allows for a two whole years of follow-up of the last patient included in the study. 

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