Ketogenesis to enhance immunotherapy in advanced renal cell cancer

KETOREIN is a project developed within ClinicObiome at Gustave Roussy, centered on metastatic renal cell cancer (RCC) with dismal prognosis features (intermediate or poor IMDC) amenable to first line combination of immune checkpoint inhibitors (Ipilimumab+Nivolumab). It is a prospective, 4 single-arm, open-label, multicentric phase II study enrolling a total of 60 metastatic Renal Cell Carcinoma patients. The purpose of this study is to assess objective response rate (partial and complete response) of Nivolumab and Ipilimumab concomitant to a special diet (ketogenic diet, continuous or discontinuous) or standard diet with or without BHB according to RECIST v1.1 at 8 weeks. The expected response rate is <40% at 3 months with side effects in all-comers (i.e., unselected). Given the published data (Ferrere et al JCI Insight 2021, supported by Seerave), it is anticipated that preconditioning with ketogenic diet (KD) or the main resulting systemic ketone body beta hydroxybutyrate (BHB) will increase objective responses rates and decreases side effects in human cancer patients undergoing immunotherapy.

For more information on the study, visit NCT05119010 at clinicaltrials.gov