Clinical trial NCT04808817: Relationship Between Immunity and Metabolism in Patients Receiving Immune Checkpoint Inhibitors for Advanced Cancer. ( 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Metabolism Disorder
Cancer
Immune Checkpoint Inhibitors
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: response rate according to metabolic status
timeFrame: 6 months from randomisation
Secondary outcomes:
measure: 6 months progression free survival according to metabolic status
timeFrame: 6 months from randomisation
measure: 12 months overall survival according to metabolic status
timeFrame: 12months from randomisation
measure: correlations between metabolism/ cytokines dosage/ complement dosage and response to ICI
timeFrame: 12 months from randomisation
measure: incidence of irAEs according to metabolic profile
timeFrame: 6 months from randomisation
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Cochin
state: Île-de-France
city: Paris
country: France
facility: AP-HP - Hôpital Européen Georges-Pompidou Paris
state: Île-de-France
Study officials:
affiliation: Hopital europeen Georges-Pompidou
name: SIMONAGGIO Audrey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital europeen Georges-Pompidou
name: Charles Vauchier
role: PRINCIPAL_INVESTIGATOR
References: