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 is taking place in six French hospitals and in three in Belgium (Ghent, Leuven and Brussels / Saint-Luc) for the benefit of patients affected by refractory or relapsing solid tumours, which do not respond to the standard treatment. The trial is split in two phases: a first one where the toxicity of the proposed combined drugs is analysed and a second one where the efficacy of each combination is compared.

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

Latest developments: In 2020, a total of 16 patients in 3 treatment arms were recruited for the first phase.

Next steps: Now, a total of 102 patients will have to be recruited for the second phase to complete the trial. As the pandemic caused some delay in the completion of the programme steps, the inclusion of all patients in the second phase is planned from March 2021 to January 2024.

A progress report will be produced annually. The final results of the trial will be available during the second quarter of 2025, or 6 years after the opening of the study, which allows for 1 year and 4 months of follow-up of the last patient included in the study.