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NCT Number: NCT04808817

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AP-HP - Hôpital Européen Georges-Pompidou Paris, Paris, Île-de-France Region, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

calorimetry, impedance measurement at baseline and after 3 months of treatment

Diagnostic Test

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)

Primary outcomes

  1. response rate according to metabolic status

    Time frame: 6 months from randomisation

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

Secondary outcomes

  1. 6 months progression free survival according to metabolic status

    Time frame: 6 months from randomisation

    6 months progression free survival according to metabolic status

  2. 12 months overall survival according to metabolic status

    Time frame: 12months from randomisation

    12 months overall survival according to metabolic status

  3. correlations between metabolism/ cytokines dosage/ complement dosage and response to ICI

    Time frame: 12 months from randomisation

    correlations between metabolism/ cytokines dosage/ complement dosage and

  4. incidence of irAEs according to metabolic profile

    Time frame: 6 months from randomisation

    incidence of irAEs according to metabolic profile

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Assessment of Metabolic and Immune Profiles in Patients Receiving Immune Checkpoint Inhibitors (ICI) for Advanced Renal Cell Carcinoma or Lung Carcinoma.

Acronym: RIMEC

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 22, 2021
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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