A Pilot Study Evaluating a Ketogenic Diet Concomitant to Nivolumab and Ipilimumab in Patients With Metastatic Renal Cell Carcinoma — KETOREIN  

Metastatic Renal Cell Carcinoma Clinical Trial

Official title: A Pilot Study Evaluating a Ketogenic Diet Concomitant to Nivolumab and Ipilimumab in Patients With Metastatic Renal Cell Carcinoma

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

After being informed about the study and potential risks, all patients giving informed consent will undergo a 10 days screening period to determine eligibility for study entry. At week1day1, patients who meet the eligibility requirements will be enrolled in to :

• Arm A : continuous ketogenic diet for 3 months

• Arm B : discontinuous ketogenic diet (15 days on, 15 days off) for 3 months

• Arm C : oral liquid ketone supplement BHB monoester, 15 days-on 15 days off during 3 months.

• Arm D : standard diet (without any diet restrictions). and follow up as in arms A, B, C.

All patients will receive Nivolumab plus Ipilimumab according to practical routine. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Metastatic Renal Cell Carcinoma

• NCT number: NCT05119010
• Study type: Interventional
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: Lynda MATI, MSc
• Phone: +33 (0)1 42 11 42 11 (ext3730)
• Email: lynda.mati@gustaveroussy.fr
• Status: Recruiting
• Phase: N/A
• Start date: March 24, 2023
• Completion date: November 8, 2024