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Relationship Between Immunity and Metabolism in Patients Receiving Immune Checkpoint Inhibitors for Advanced Cancer. ( RIMEC ) (RIMEC)

Primary Purpose

Metabolism Disorder, Cancer, Immune Checkpoint Inhibitors

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
calorimetry, impedance measurement at baseline and after 3 months of treatment
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metabolism Disorder

Eligibility Criteria

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

Inclusion Criteria:

  • patients ≥18 years
  • patients receiving immune checkpoint inhibitors, used alone or as a combination with chemotherapy or tyrosine kinase inhibitor or other immune checkpoint inhibitor, for advanced renal cell or lung carcinoma.
  • Patient Informed and signed the consent to participate in the research

Exclusion Criteria:

  • patients with history of auto immune disease
  • patients enrolled in an interventional study or be in the exclusion period following a previous research, if applicable
  • Patient not affiliated to the social security scheme or under AME
  • Patient under guardianship or curatorship or under legal protection
  • Patient unable or unwilling to give written consent
  • Pregnant patient

be in the exclusion period following a previous research, if applicable

Sites / Locations

  • Hôpital CochinRecruiting
  • AP-HP - Hôpital Européen Georges-Pompidou ParisRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients

Arm Description

Outcomes

Primary Outcome Measures

response rate according to metabolic status
response rate after 6 months of ICI treatment (iRECIST criteria)

Secondary Outcome Measures

6 months progression free survival according to metabolic status
6 months progression free survival according to metabolic status
12 months overall survival according to metabolic status
12 months overall survival according to metabolic status
correlations between metabolism/ cytokines dosage/ complement dosage and response to ICI
correlations between metabolism/ cytokines dosage/ complement dosage and
incidence of irAEs according to metabolic profile
incidence of irAEs according to metabolic profile

Full Information

First Posted
March 8, 2021
Last Updated
November 15, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04808817
Brief Title
Relationship Between Immunity and Metabolism in Patients Receiving Immune Checkpoint Inhibitors for Advanced Cancer. ( RIMEC )
Acronym
RIMEC
Official Title
Assessment of Metabolic and Immune Profiles in Patients Receiving Immune Checkpoint Inhibitors (ICI) for Advanced Renal Cell Carcinoma or Lung Carcinoma.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2021 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de 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
Recent EMA and FDA approvals have made immune checkpoint inhibitors (ICI) a standard of care in cancer treatment. ICI, used alone or as a combination are now the backbone of renal cell and lung carcinoma treatment. However, a significant proportion of patients does not respond to ICI. Thus the identification of predictive response factor is a major issue. While factors associated with the tumour and its micro environment have been widely studied, factors associated with the patient such as metabolism could also affect the response to ICI and remain poorly studied. The hypothesis of the investigators is that dysmetabolims, via the induction of a chronic inflammatory state could induce a defect of lymphocyte production and activation as well as a modification of the immunogenicity of tumor cells and immune cells infiltration. The consequences could be a decrease in ICI response rate as well as an increase in immune related adverse events (irAEs). To test this hypothesis, the investigators propose a prospective bi-centric exploratory study including 60 patients treated with ICI for advanced lung or renal cell carcinoma. The data collected will be : Clinical (calorimetry, impedancemetry, survey of eating habits, tumour characteristics, epidemiological data), Biologics (baseline and 3-months plasma bio banking for standard biology, inflammation markers TNF- α, IL1-6-8-11-17, TGF-ß, TWEAK, complement study C3, C4, C4d, CH50, C1q, CD46) Primary objective is to assess the response to ICI depending on metabolic status. Secondary objectives are to study the relationships between metabolism / cytokines profile/ complement profile and ICI response. The investigators seek to generate hypotheses and to obtain exploratory data before submission of a Hospital Clinical Research Program whose objective will be to evaluate the impact of dysmetabolism on overall survival and to characterize immune and anatomopathological profiles (using DNA microarrays and flow cytometry techinques) of patients treated with ICI for renal cell or lung carcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolism Disorder, Cancer, Immune Checkpoint Inhibitors

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
calorimetry, impedance measurement at baseline and after 3 months of treatment
Other Intervention Name(s)
biobanking (30ml)
Intervention Description
biobanking (30ml) for cytokines and complement dosages at baseline and after 3 months of treatment calorimetry and impedance measure will be collected at baseline and after 3 months of ICI treatment
Primary Outcome Measure Information:
Title
response rate according to metabolic status
Description
response rate after 6 months of ICI treatment (iRECIST criteria)
Time Frame
6 months from randomisation
Secondary Outcome Measure Information:
Title
6 months progression free survival according to metabolic status
Description
6 months progression free survival according to metabolic status
Time Frame
6 months from randomisation
Title
12 months overall survival according to metabolic status
Description
12 months overall survival according to metabolic status
Time Frame
12months from randomisation
Title
correlations between metabolism/ cytokines dosage/ complement dosage and response to ICI
Description
correlations between metabolism/ cytokines dosage/ complement dosage and
Time Frame
12 months from randomisation
Title
incidence of irAEs according to metabolic profile
Description
incidence of irAEs according to metabolic profile
Time Frame
6 months from randomisation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients ≥18 years patients receiving immune checkpoint inhibitors, used alone or as a combination with chemotherapy or tyrosine kinase inhibitor or other immune checkpoint inhibitor, for advanced renal cell or lung carcinoma. Patient Informed and signed the consent to participate in the research Exclusion Criteria: patients with history of auto immune disease patients enrolled in an interventional study or be in the exclusion period following a previous research, if applicable Patient not affiliated to the social security scheme or under AME Patient under guardianship or curatorship or under legal protection Patient unable or unwilling to give written consent Pregnant patient be in the exclusion period following a previous research, if applicable
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SIMONAGGIO Audrey, MD
Phone
+33 1 56 09 35 22
Email
audrey.simonaggio@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
LE MAO Laura, Msc
Phone
+33 1 56 09 54 97
Email
laura.le-mao@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SIMONAGGIO Audrey, MD
Organizational Affiliation
Hopital europeen Georges-Pompidou
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Cochin
City
Paris
State/Province
Île-de-France
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sixtine DE PERCIN
Phone
+33 1 58 41 19 27
Email
sixtine.depercin@aphp.fr
Facility Name
AP-HP - Hôpital Européen Georges-Pompidou Paris
City
Paris
State/Province
Île-de-France
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Audrey SIMONAGGIO, MD
Phone
+33 1 56 09 35 22
Email
audrey.simonaggio@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
IPD Sharing Time Frame
Two years after the last publication
IPD Sharing Access Criteria
Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. Data sharing must respect the agreements made with funders. Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractual agreement. Processing of shared data must comply with European General Data Protection Regulation (GDPR).

Learn more about this trial

Relationship Between Immunity and Metabolism in Patients Receiving Immune Checkpoint Inhibitors for Advanced Cancer. ( RIMEC )

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