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

Primary Purpose

Metastatic Renal Cell Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Continuous ketogenic diet
Discontinuous ketogenic diet
beta-hydroxybutyrate (BHB) supplementation
Sponsored by
Gustave Roussy, Cancer Campus, Grand Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Renal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adult men and women ≥ 18 years
  2. Patients with a histologically confirmed Renal Cell Carcinoma with a clear-cell component, sarcomatoid or rhabdoid
  3. Patients with metastatic (AJCC stage IV) Renal Cell Carcinoma, with at least one measurable lesion by CT Scan or MRI according to RECIST 1.1 or with clinically apparent disease that can be reliably monitored by the investigator
  4. Patients who have not received a prior systemic therapy. Prior cytokine therapies (e.g. interleukine-2, interferon-α), vaccine therapy are allowed.
  5. Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
  6. Intermediate or poor risk group patients measured by the IMDC model
  7. Patients with brain metastases will be eligible if they are: asymptomatic, without edema, not on corticosteroids more than 10 mg per day or already treated
  8. Patients treated with radiation therapy will be eligible if they are: palliative, on focal radiation therapy, on immunosuppressive doses of systemic corticosteroids less than 10 mg per day.
  9. Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed
  10. Patient should be able and willing to comply with study visits and procedures as per protocol
  11. Patients must be affiliated to a social security system or beneficiary of the same
  12. Women of childbearing potential must have a negative serum pregnancy test done within 24 hours prior to diet initiation. Potentially reproductive patients must agree to use an effective contraceptive method or practice adequate methods of birth control or practice complete abstinence while on treatment with Nivolumab and Ipilimumab
  13. Women who are breastfeeding should discontinue nursing prior to the first dose of study drug and until 6 months after the last dose

Exclusion Criteria:

  1. Weight loss > 5% in the last month
  2. Weight loss > 10% during last 6 months
  3. Albumin <30 g/l
  4. Known or underlying medical condition (e.g., a condition associated with diarrhea or acute diverticulitis) that, in the investigator's opinion, would make the administration of study drug hazardous to the patient or obscure the interpretation of toxicity determination or adverse events.
  5. Fatty acid oxidation disturbances
  6. Uncontrolled diabetes defined as a hemoglobin A1C level > 8%. Diabetes is not exclusionary provided the patient is not maintained with either oral medications or insulin.
  7. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements as determined by study team members.
  8. Failure to submit to study clinical and biological follow-up for medical, geographic or social reasons
  9. Pregnant or breastfeeding women
  10. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving his consent
  11. Known drug or alcohol abuse
  12. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of systemic immunosuppressive therapy within 7 days prior to the first dose of study treatment (except local/topical or aerosol steroids)
  13. Has a known history of active tuberculosis (Mycobacterium tuberculosis)
  14. Has had a prior monoclonal antibody within 4 weeks or 5 half-life time (whichever is shorter) prior to the first dose of study treatment or who has not recovered (i.e., ≥ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
  15. Has an active autoimmune / immune mediated inflammatory disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjörgen's syndrome will not be excluded from the study.
  16. Has evidence of interstitial lung disease or active, non-infectious pneumonitis
  17. Has an active infection requiring systemic therapy
  18. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
  19. Positive for Human Immunodeficiency Virus (HIV) antibody testing
  20. Active or chronic hepatitis C and/or B infection. Patients with past/resolved HBV infection (defined as the presence of anti-hepatitis B core antibody, IgG anti-HBs +) are eligible. Hepatitis B virus DNA should be obtained in these patients prior to the first dose of study treatment. Patients positive for hepatitis C virus antibody are eligible only if PCR is negative for HCV RNA
  21. Patients with altered hematopoietic or organ function, as indicated by the following criteria (assessed within 5 days prior registration):

    • White blood cell < 3000/μL
    • Polynuclear neutrophils < 1.5 x 109/L
    • Platelets < 100 x 109/L
    • Hemoglobin < 7.0 g/mL
    • Alanine aminotransferase/aspartate aminotransferase > 3.0 x ULN in the absence of liver metastases or > 5x upper limit of normal in the presence of liver metastases
    • Bilirubin > 1.5 x ULN (except Gilbert Syndrome: < 3.0 mg/dL)
    • Creatinine clearance ≤ 35 mL/min (measured or calculated by Cockcroft and Gault formula)

Sites / Locations

  • Hôpital Foch
  • Gustave Roussy
  • Hôpital Européen Georges PompidouRecruiting
  • Hôpitaux Cochin-Port-Royal

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

A

B

C

D

Arm Description

patients will be asked to follow in a continuous way a very low-carbohydrate, high-fat diets, which strictly limit carbohydrate consumption (less than 40g / day) and allow unlimited consumption of high-fat foods, such as pork belly, butter, coconuts oils, fat meat, eggs and cheese, etc… (cf appendix A). Patients will be provided with 2 meals (lunch and dinner), every meal with 2 dishes (first course and main course) and bread for every day for 3 months (ELIOR partnership).

patients will be asked to follow in a discontinuous way (15 days on, 15 days off) a very low-carbohydrate, high-fat diets, which strictly limit carbohydrate consumption (less than 40g / day) and allow unlimited consumption of high-fat foods, such as pork belly, butter, coconuts oils, fat meat, eggs and cheese…etc (cf appendix A). Patients will be provided with 2 meals (lunch and dinner), every meal with 2 dishes (first course and main course) and bread for every day for the ketogenic diet period for 3 months (ELIOR partnership).

patients will receive oral liquid ketone supplement BHB monoester, 2 tablespoons three times per day (depending on patient weight: at least 1g/kg weight body/day) 15 days-on 15 days off during 3 months. We would recommend taking it at least 30 to 60 min before meal times and they will receive standard diet (without any diet restrictions).

patients will receive standard diet (without any diet restrictions) and be followed up as in arms A, B, C.

Outcomes

Primary Outcome Measures

Objective response rate
Preliminary activity will be assessed by measuring objective response rate (ORR) (partial/complete response) of Nivolumab plus Ipilimumab concomitant to a special diet (KD continuous or discontinuous) or standard diet (SD) with or without (BHB) according to RECIST v1.1 at 8 weeks.

Secondary Outcome Measures

Safety of Nivolumab plus Ipilimumab concomitant to a special diet
the safety of Nivolumab plus Ipilimumab concomitant to a special diet (ketogenic diet, continuous or discontinuous) or standard diet (SD) with or without BHB will be measured by the rate of all and grade 3-4 adverse events (AEs) according to CTCAEv4, and compare the rate to historical datas.
Assessment of weight
Assessment of weight in kilograms by baseline test and follow up in order to evaluate the impact of the diet concomitant to immunotherapy on nutritional status, muscle mass, and sarcopenia.
Assessment of albuminemia
Assessment of albuminemia in g/L in order to evaluate the impact of the diet concomitant to immunotherapy on nutritional status, muscle mass, and sarcopenia.
Assessment of prealbuminemia
Assessment of prealbuminemia in g/L in order to evaluate the impact of the diet concomitant to immunotherapy on nutritional status, muscle mass, and sarcopenia.
Assessment of C reactive protein
Assessment of C reactive protein in mg/L in order to evaluate the impact of the diet concomitant to immunotherapy on nutritional status, muscle mass, and sarcopenia.
Assessment of sarcopenia
Sarcopenia will be assessed according to SliceOmatic software V5.0 and preestablished thresholds of skeletal muscle tissue (-29 to +150 Hounsfield units). Axial L3 sections will be used to measure the total muscle area (TMA) and calculate skeletal muscle index (SMI, cm²/m²). Sarcopenia is defined as SMI lower than a sex-based threshold (<55.4 in men and <38.9 in women).
Assessment of Quality of Life (QoL)
explore the evolution of Patient Reported Outcomes using EORTC QLQ 30 file in all treated patients.
progression-free survival assessment
PFS is specified as the time between the date of the starting of the diet and the first date of documented progression, based on assessments (as per RECIST v1.1 criteria), or death due to any cause.
Sarcopenic event-free survival (SFS)
SFS will be estimated from intervention starting.
Overall survival (OS)
OS is specified as the time between the date of the starting of the diet and the date of the death whatever the cause.

Full Information

First Posted
October 21, 2021
Last Updated
April 3, 2023
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
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1. Study Identification

Unique Protocol Identification Number
NCT05119010
Brief Title
A Pilot Study Evaluating a Ketogenic Diet Concomitant to Nivolumab and Ipilimumab in Patients With Metastatic Renal Cell Carcinoma
Acronym
KETOREIN
Official Title
A Pilot Study Evaluating a Ketogenic Diet Concomitant to Nivolumab and Ipilimumab in Patients With Metastatic Renal Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 24, 2023 (Actual)
Primary Completion Date
November 8, 2024 (Anticipated)
Study Completion Date
November 8, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Renal Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be included sequentially in each arm from arm A to arm D. When the first inclusion arm A will be full with 15 patients who passed the screening, then next patients will be enrolled in arm B, then it will be the same process with arm C and last patients will be included in arm D.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
patients will be asked to follow in a continuous way a very low-carbohydrate, high-fat diets, which strictly limit carbohydrate consumption (less than 40g / day) and allow unlimited consumption of high-fat foods, such as pork belly, butter, coconuts oils, fat meat, eggs and cheese, etc… (cf appendix A). Patients will be provided with 2 meals (lunch and dinner), every meal with 2 dishes (first course and main course) and bread for every day for 3 months (ELIOR partnership).
Arm Title
B
Arm Type
Experimental
Arm Description
patients will be asked to follow in a discontinuous way (15 days on, 15 days off) a very low-carbohydrate, high-fat diets, which strictly limit carbohydrate consumption (less than 40g / day) and allow unlimited consumption of high-fat foods, such as pork belly, butter, coconuts oils, fat meat, eggs and cheese…etc (cf appendix A). Patients will be provided with 2 meals (lunch and dinner), every meal with 2 dishes (first course and main course) and bread for every day for the ketogenic diet period for 3 months (ELIOR partnership).
Arm Title
C
Arm Type
Experimental
Arm Description
patients will receive oral liquid ketone supplement BHB monoester, 2 tablespoons three times per day (depending on patient weight: at least 1g/kg weight body/day) 15 days-on 15 days off during 3 months. We would recommend taking it at least 30 to 60 min before meal times and they will receive standard diet (without any diet restrictions).
Arm Title
D
Arm Type
No Intervention
Arm Description
patients will receive standard diet (without any diet restrictions) and be followed up as in arms A, B, C.
Intervention Type
Dietary Supplement
Intervention Name(s)
Continuous ketogenic diet
Intervention Description
ARM A : continuous ketogenic diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Discontinuous ketogenic diet
Intervention Description
ARM B : discontinuous ketogenic diet
Intervention Type
Dietary Supplement
Intervention Name(s)
beta-hydroxybutyrate (BHB) supplementation
Intervention Description
ARM C : BHB supplementation
Primary Outcome Measure Information:
Title
Objective response rate
Description
Preliminary activity will be assessed by measuring objective response rate (ORR) (partial/complete response) of Nivolumab plus Ipilimumab concomitant to a special diet (KD continuous or discontinuous) or standard diet (SD) with or without (BHB) according to RECIST v1.1 at 8 weeks.
Time Frame
at 8 weeks after diet initiation.
Secondary Outcome Measure Information:
Title
Safety of Nivolumab plus Ipilimumab concomitant to a special diet
Description
the safety of Nivolumab plus Ipilimumab concomitant to a special diet (ketogenic diet, continuous or discontinuous) or standard diet (SD) with or without BHB will be measured by the rate of all and grade 3-4 adverse events (AEs) according to CTCAEv4, and compare the rate to historical datas.
Time Frame
Events reported from the first day of diet and up to and including 100 days following the last day of diet could be included in estimating this incidence rate.
Title
Assessment of weight
Description
Assessment of weight in kilograms by baseline test and follow up in order to evaluate the impact of the diet concomitant to immunotherapy on nutritional status, muscle mass, and sarcopenia.
Time Frame
from the first day of diet and up to 2 years from diet initiation
Title
Assessment of albuminemia
Description
Assessment of albuminemia in g/L in order to evaluate the impact of the diet concomitant to immunotherapy on nutritional status, muscle mass, and sarcopenia.
Time Frame
from the first day of diet and up to 2 years from diet initiation
Title
Assessment of prealbuminemia
Description
Assessment of prealbuminemia in g/L in order to evaluate the impact of the diet concomitant to immunotherapy on nutritional status, muscle mass, and sarcopenia.
Time Frame
from the first day of diet and up to 2 years from diet initiation
Title
Assessment of C reactive protein
Description
Assessment of C reactive protein in mg/L in order to evaluate the impact of the diet concomitant to immunotherapy on nutritional status, muscle mass, and sarcopenia.
Time Frame
from the first day of diet and up to 2 years from diet initiation
Title
Assessment of sarcopenia
Description
Sarcopenia will be assessed according to SliceOmatic software V5.0 and preestablished thresholds of skeletal muscle tissue (-29 to +150 Hounsfield units). Axial L3 sections will be used to measure the total muscle area (TMA) and calculate skeletal muscle index (SMI, cm²/m²). Sarcopenia is defined as SMI lower than a sex-based threshold (<55.4 in men and <38.9 in women).
Time Frame
from the first day of diet and up to 2 years from diet initiation
Title
Assessment of Quality of Life (QoL)
Description
explore the evolution of Patient Reported Outcomes using EORTC QLQ 30 file in all treated patients.
Time Frame
At screening and 9 weeks after diet initiation
Title
progression-free survival assessment
Description
PFS is specified as the time between the date of the starting of the diet and the first date of documented progression, based on assessments (as per RECIST v1.1 criteria), or death due to any cause.
Time Frame
from the first day of diet and up to 2 years from diet initiation
Title
Sarcopenic event-free survival (SFS)
Description
SFS will be estimated from intervention starting.
Time Frame
from the first day of diet and up to 2 years from diet initiation
Title
Overall survival (OS)
Description
OS is specified as the time between the date of the starting of the diet and the date of the death whatever the cause.
Time Frame
from the first day of diet and up to 2 years from diet initiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult men and women ≥ 18 years Patients with a histologically confirmed Renal Cell Carcinoma with a clear-cell component, sarcomatoid or rhabdoid Patients with metastatic (AJCC stage IV) Renal Cell Carcinoma, with at least one measurable lesion by CT Scan or MRI according to RECIST 1.1 or with clinically apparent disease that can be reliably monitored by the investigator Patients who have not received a prior systemic therapy. Prior cytokine therapies (e.g. interleukine-2, interferon-α), vaccine therapy are allowed. Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤2. Intermediate or poor risk group patients measured by the IMDC model Patients with brain metastases will be eligible if they are: asymptomatic, without edema, not on corticosteroids more than 10 mg per day or already treated Patients treated with radiation therapy will be eligible if they are: palliative, on focal radiation therapy, on immunosuppressive doses of systemic corticosteroids less than 10 mg per day. Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed Patient should be able and willing to comply with study visits and procedures as per protocol Patients must be affiliated to a social security system or beneficiary of the same Women of childbearing potential must have a negative serum pregnancy test done within 24 hours prior to diet initiation. Potentially reproductive patients must agree to use an effective contraceptive method or practice adequate methods of birth control or practice complete abstinence while on treatment with Nivolumab and Ipilimumab Women who are breastfeeding should discontinue nursing prior to the first dose of study drug and until 6 months after the last dose Exclusion Criteria: Weight loss > 5% in the last month Weight loss > 10% during last 6 months Albumin <30 g/l Known or underlying medical condition (e.g., a condition associated with diarrhea or acute diverticulitis) that, in the investigator's opinion, would make the administration of study drug hazardous to the patient or obscure the interpretation of toxicity determination or adverse events. Fatty acid oxidation disturbances Uncontrolled diabetes defined as a hemoglobin A1C level > 8%. Diabetes is not exclusionary provided the patient is not maintained with either oral medications or insulin. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements as determined by study team members. Failure to submit to study clinical and biological follow-up for medical, geographic or social reasons Pregnant or breastfeeding women Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving his consent Known drug or alcohol abuse Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of systemic immunosuppressive therapy within 7 days prior to the first dose of study treatment (except local/topical or aerosol steroids) Has a known history of active tuberculosis (Mycobacterium tuberculosis) Has had a prior monoclonal antibody within 4 weeks or 5 half-life time (whichever is shorter) prior to the first dose of study treatment or who has not recovered (i.e., ≥ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. Has an active autoimmune / immune mediated inflammatory disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjörgen's syndrome will not be excluded from the study. Has evidence of interstitial lung disease or active, non-infectious pneumonitis Has an active infection requiring systemic therapy Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways) Positive for Human Immunodeficiency Virus (HIV) antibody testing Active or chronic hepatitis C and/or B infection. Patients with past/resolved HBV infection (defined as the presence of anti-hepatitis B core antibody, IgG anti-HBs +) are eligible. Hepatitis B virus DNA should be obtained in these patients prior to the first dose of study treatment. Patients positive for hepatitis C virus antibody are eligible only if PCR is negative for HCV RNA Patients with altered hematopoietic or organ function, as indicated by the following criteria (assessed within 5 days prior registration): White blood cell < 3000/μL Polynuclear neutrophils < 1.5 x 109/L Platelets < 100 x 109/L Hemoglobin < 7.0 g/mL Alanine aminotransferase/aspartate aminotransferase > 3.0 x ULN in the absence of liver metastases or > 5x upper limit of normal in the presence of liver metastases Bilirubin > 1.5 x ULN (except Gilbert Syndrome: < 3.0 mg/dL) Creatinine clearance ≤ 35 mL/min (measured or calculated by Cockcroft and Gault formula)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lynda MATI, MSc
Phone
+33 (0)1 42 11 42 11 (ext3730)
Email
lynda.mati@gustaveroussy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Thibaud MOTREFF, MSc
Phone
+33 (0)1 42 11 66 43
Email
thibaud.motreff@gustaveroussy.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emeline COLOMBA BLAMEBLE, MD
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Foch
City
Suresnes
State/Province
Hauts-de-Seine
ZIP/Postal Code
92150
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raffaele RATTA, MD
Email
r.ratta@hopital-foch.com
First Name & Middle Initial & Last Name & Degree
Lynda MATI
Phone
+33 (0)1 42 11 37 30
Email
lynda.mati@gustaveroussy.fr
Facility Name
Gustave Roussy
City
Villejuif
State/Province
Val-de-Marne
ZIP/Postal Code
94805
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emeline COLOMBA BLAMEBLE, MD
Phone
+33 (0)1 42 11 54 10
Email
Emeline.COLOMBA-BLAMEBLE@gustaveroussy.fr
First Name & Middle Initial & Last Name & Degree
Lynda MATI
Phone
+33 (0)1 42 11 37 30
Email
lynda.mati@gustaveroussy.fr
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire GERVAIS, MD
Email
claire.gervais@aphp.fr
First Name & Middle Initial & Last Name & Degree
Lynda MATI
Phone
+33 (0)1 42 11 37 30
Email
lynda.mati@gustaveroussy.fr
Facility Name
Hôpitaux Cochin-Port-Royal
City
Paris
ZIP/Postal Code
75679
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François GOLDWASSER, Prof
Email
francois.goldwasser@aphp.fr
First Name & Middle Initial & Last Name & Degree
Lynda MATI
Phone
+33 (0)1 42 11 37 30
Email
lynda.mati@gustaveroussy.fr

12. IPD Sharing Statement

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

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