Clinicobiome, the microbiota clinic
- Four clinical trials involving microbiota intervention to significantly improve treatment efficacy
- A wide-ranging epidemiological study involving biological specimens to diagnose intestinal dysbiosis more efficiently and assess its impact on immunity and metabolism as well as its prognostic value
- Investigate various microbiota and their role in cancer treatment
- Define microbial metagenomic signatures to predict resistance to cancer therapies
- Investigate how certain micro-organisms affect the immune system and metabolism of patients
- Prove the concept that microbiota-based treatments can overcome resistance to immunotherapies
The 5 projects making up the Clinicobiome programme:
A prospective epidemiological study to assess intestinal dysbiosis in relation to cancer and primary resistance.
Aims: to validate microbial signatures capable of predicting treatment response and to create a biobank of data and rapid diagnostic kits for intestinal dysbiosis.
A phase II pilot study to assess the ketogenic diet in combination with nivolumab plus ipilimumab in the management of metastatic renal cell carcinoma.
Aim: to demonstrate that a ketogenic diet can improve the efficacy of prescribed immunotherapy in the management of advanced/metastatic renal cell cancer by 20%.
A non-randomised phase II trial to assess CAPOX-bevacizumab plus pembrolizumab as first-line therapy in the treatment of metastatic colon cancer.
Aim: to review the efficacy of CAPOX bevacizumab chemotherapy in the treatment of colon cancer with MSS (microsatellite stability) when administered concomitantly with pembrolizumab to a subpopulation of MSS patients with adjuvant ileal microbiota.
A randomised phase II study to assess faecal microbiota transplantation combined with cemiplimab versus the investigator's choice in patients with advanced lung, kidney and bladder cancer proving resistant to anti-PD-1/PD-L1 due to the use of antibiotics.
Aim: to demonstrate that faecal transplantation can restore an objective response in patients treated with antibiotics and proving resistant to immunotherapy.
A randomised phase II study combining Akkermansia pp2261 with pembrolizumab as first-line treatment in the management of non-small cell lung cancer.
Aim: to establish whether OncoBax - Akkermansia pp2261 - is capable of overcoming resistance to pembrolizumab as first-line therapy in cases where PDL-1 >50%.