Relationship Between Immunity and Metabolism in Patients Receiving Immune Checkpoint Inhibitors for Advanced Cancer. ( RIMEC ) (RIMEC)
Assessment of Metabolic and Immune Profiles in Patients Receiving Immune Checkpoint Inhibitors (ICI) for Advanced Renal Cell Carcinoma or Lung Carcinoma.
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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: SIMONAGGIO Audrey, MD
- Telefonnummer: +33 1 56 09 35 22
- E-post: audrey.simonaggio@aphp.fr
Studer Kontakt Backup
- Navn: LE MAO Laura, Msc
- Telefonnummer: +33 1 56 09 54 97
- E-post: laura.le-mao@aphp.fr
Studiesteder
-
-
Île-de-France
-
Paris, Île-de-France, Frankrike, 75014
- Rekruttering
- Hôpital Cochin
-
Ta kontakt med:
- Sixtine DE PERCIN
- Telefonnummer: +33 1 58 41 19 27
- E-post: sixtine.depercin@aphp.fr
-
Paris, Île-de-France, Frankrike, 75015
- Rekruttering
- AP-HP - Hôpital Européen Georges-Pompidou Paris
-
Ta kontakt med:
- Audrey SIMONAGGIO, MD
- Telefonnummer: +33 1 56 09 35 22
- E-post: audrey.simonaggio@aphp.fr
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: pasienter
|
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
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
response rate according to metabolic status
Tidsramme: 6 months from randomisation
|
response rate after 6 months of ICI treatment (iRECIST criteria)
|
6 months from randomisation
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
6 months progression free survival according to metabolic status
Tidsramme: 6 months from randomisation
|
6 months progression free survival according to metabolic status
|
6 months from randomisation
|
|
12 months overall survival according to metabolic status
Tidsramme: 12months from randomisation
|
12 months overall survival according to metabolic status
|
12months from randomisation
|
|
correlations between metabolism/ cytokines dosage/ complement dosage and response to ICI
Tidsramme: 12 months from randomisation
|
correlations between metabolism/ cytokines dosage/ complement dosage and
|
12 months from randomisation
|
|
incidence of irAEs according to metabolic profile
Tidsramme: 6 months from randomisation
|
incidence of irAEs according to metabolic profile
|
6 months from randomisation
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: SIMONAGGIO Audrey, MD, Hôpital Européen Georges-Pompidou
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- APHP201166
- IDRCB 2020-A02262-37 (Annen identifikator: ANSM)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
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).
IPD-deling Støtteinformasjonstype
- Studieprotokoll
- Informert samtykkeskjema (ICF)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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