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

NCT05119010 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2024-12-05

No results posted yet for this study

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.

Conditions

  • Metastatic Renal Cell Carcinoma

Interventions

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

Sponsors & Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris

    lead OTHER

Principal Investigators

  • Emeline COLOMBA BLAMEBLE, MD · Gustave Roussy, Cancer Campus, Grand Paris

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-24
Primary Completion
2024-05-22
Completion
2024-05-22

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05119010 on ClinicalTrials.gov