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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 sequentially enrolled in a 1:1:1:1 ratio 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05119010
Study type Interventional
Source Gustave Roussy, Cancer Campus, Grand Paris
Contact Elodie LECERF, MSc
Phone +33142114211 (26 17)
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date November 8, 2021
Completion date November 8, 2024

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