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

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Recruiting
CT.gov ID
NCT04808817
Collaborator
(none)
60
Enrollment
2
Locations
1
Arm
35.7
Anticipated Duration (Months)
30
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Diagnostic Test: calorimetry, impedance measurement at baseline and after 3 months of treatment
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Assessment of Metabolic and Immune Profiles in Patients Receiving Immune Checkpoint Inhibitors (ICI) for Advanced Renal Cell Carcinoma or Lung Carcinoma.
Actual Study Start Date :
May 10, 2021
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

ArmIntervention/Treatment
Experimental: patients

Diagnostic Test: calorimetry, impedance measurement at baseline and after 3 months of treatment
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
Other Names:
  • biobanking (30ml)
  • Outcome Measures

    Primary Outcome Measures

    1. response rate according to metabolic status [6 months from randomisation]

      response rate after 6 months of ICI treatment (iRECIST criteria)

    Secondary Outcome Measures

    1. 6 months progression free survival according to metabolic status [6 months from randomisation]

      6 months progression free survival according to metabolic status

    2. 12 months overall survival according to metabolic status [12months from randomisation]

      12 months overall survival according to metabolic status

    3. correlations between metabolism/ cytokines dosage/ complement dosage and response to ICI [12 months from randomisation]

      correlations between metabolism/ cytokines dosage/ complement dosage and

    4. incidence of irAEs according to metabolic profile [6 months from randomisation]

      incidence of irAEs according to metabolic profile

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Hôpital CochinParisÎle-de-FranceFrance75014
    2AP-HP - Hôpital Européen Georges-Pompidou ParisParisÎle-de-FranceFrance75015

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris

    Investigators

    • Principal Investigator: SIMONAGGIO Audrey, MD, Hopital europeen Georges-Pompidou

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT04808817
    Other Study ID Numbers:
    • APHP201166
    • IDRCB 2020-A02262-37
    First Posted:
    Mar 22, 2021
    Last Update Posted:
    Nov 19, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 19, 2021