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

Cancer Clinical Trial

— RIMEC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04808817
• Other study ID #: APHP201166
• Secondary ID: IDRCB 2020-A0226
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2021
• Est. completion date: May 2024

Study information

• Verified date: November 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: SIMONAGGIO Audrey, MD
• Phone: +33 1 56 09 35 22
• Email: audrey.simonaggio[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2024
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Immune Checkpoint Inhibitors
• Metabolic Diseases
• Metabolism Disorder

Intervention

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

Locations

Country	Name	City	State
France	AP-HP - Hôpital Européen Georges-Pompidou Paris	Paris	Île-de-France
France	Hôpital Cochin	Paris	Île-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate according to metabolic status	response rate after 6 months of ICI treatment (iRECIST criteria)	6 months from randomisation
Secondary	6 months progression free survival according to metabolic status	6 months progression free survival according to metabolic status	6 months from randomisation
Secondary	12 months overall survival according to metabolic status	12 months overall survival according to metabolic status	12months from randomisation
Secondary	correlations between metabolism/ cytokines dosage/ complement dosage and response to ICI	correlations between metabolism/ cytokines dosage/ complement dosage and	12 months from randomisation
Secondary	incidence of irAEs according to metabolic profile	incidence of irAEs according to metabolic profile	6 months from randomisation