NCT05119010

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Metastatic Renal Cell Carcinoma

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Continuous ketogenic diet	ARM A : continuous ketogenic diet
DIETARY_SUPPLEMENT	Discontinuous ketogenic diet	ARM B : discontinuous ketogenic diet
DIETARY_SUPPLEMENT	beta-hydroxybutyrate (BHB) supplementation	ARM C : BHB supplementation

Timeline

• Start date: 2023-03-24
• Primary completion: 2024-05-22
• Completion: 2024-05-22
• First posted: 2021-11-12
• Last updated: 2024-12-05

Locations

3 sites across 1 country: France