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

NCT04808817 | Active Not Recruiting

• 2 other identifiers: APHP201166IDRCB 2020-A02262-37
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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.

Conditions

Metabolism Disorder; Cancer; Immune Checkpoint Inhibitors

Outcome Measures

Primary Outcomes (1)

• response rate according to metabolic status

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

  6 months from randomisation

Secondary Outcomes (4)

• 6 months progression free survival according to metabolic status

  6 months from randomisation

• 12 months overall survival according to metabolic status

  12months from randomisation

• correlations between metabolism/ cytokines dosage/ complement dosage and response to ICI

  12 months from randomisation

• incidence of irAEs according to metabolic profile

  6 months from randomisation

Study Arms (1)

patients

EXPERIMENTAL

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

Interventions

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

Also known as: biobanking (30ml)

patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• patients with history of auto immune disease
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Hôpital Cochin

Paris, Île-de-France Region, 75014, France

Location

AP-HP - Hôpital Européen Georges-Pompidou Paris

Paris, Île-de-France Region, 75015, France

Location

MeSH Terms

Conditions

Metabolic Diseases; Neoplasms

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

• SIMONAGGIO Audrey, MD

  Hopital europeen Georges-Pompidou

  PRINCIPAL INVESTIGATOR

• Charles Vauchier

  Hopital europeen Georges-Pompidou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 22, 2021
• Study Start: May 10, 2021
• Primary Completion: April 9, 2024
• Study Completion: October 9, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Two years after the last publication
• Access Criteria: 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).

Locations

FR (2)