Metabolism DisorderRIMECNCT04808817
Relationship Between Immunity and Metabolism in Patients Receiving Immune Checkpoint Inhibitors for Advanced Cancer. ( RIMEC )
A study testing calorimetry, impedance measurement at baseline and after 3 months of treatment in people with Metabolism Disorder and Cancer, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolism Disorder, Cancer, Immune Checkpoint Inhibitors
- What is being tested?
- calorimetry, impedance measurement at baseline and after 3 months of treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesFrance
- Study dates
- 10 May 2021to 9 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Cochin
Paris, Île-de-France Region, 75014
AP-HP - Hôpital Européen Georges-Pompidou Paris
Paris, Île-de-France Region, 75015
About this study
Official title: 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.
Read more
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
- Being tested
- calorimetry, impedance measurement at baseline and after 3 months of treatment
- Medical subject headings
- Metabolic Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calorimetry, impedance measurement at baseline and after 3 months of treatmentDiagnostic test
Also called biobanking (30ml)
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
| Study group | Role | What they receive |
|---|---|---|
| patients | Experimental | Not described Receives: Diagnostic Test: calorimetry, impedance measurement at baseline and after 3 months of treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate according to metabolic status
response rate after 6 months of ICI treatment (iRECIST criteria)
Measured: 6 months from randomisation
Secondary outcomes (4)
6 months progression free survival according to metabolic status
6 months progression free survival according to metabolic status
Measured: 6 months from randomisation
12 months overall survival according to metabolic status
12 months overall survival according to metabolic status
Measured: 12months from randomisation
correlations between metabolism/ cytokines dosage/ complement dosage and response to ICI
correlations between metabolism/ cytokines dosage/ complement dosage and
Measured: 12 months from randomisation
incidence of irAEs according to metabolic profile
incidence of irAEs according to metabolic profile
Measured: 6 months from randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start10 May 2021
- Primary completion9 Apr 2024
- Study completion9 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolism DisorderStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SIMONAGGIO Audrey, MD, Principal investigator, Hopital europeen Georges-PompidouCharles Vauchier, Principal investigator, Hopital europeen Georges-Pompidou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808817
- Sponsor's protocol ID
- APHP201166
- Other IDs
- IDRCB 2020-A02262-37
- Acronym
- RIMEC
- Status last verified
- Jul 2024
- First submitted
- 8 Mar 2021
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Metabolic and Immune Profiles in Patients Receiving Immune Checkpoint Inhibitors (ICI) for Advanced Renal Cell Carcinoma or Lung Carcinoma.
- ClinicalTrials.gov ID
- NCT04808817
- Acronym / sponsor ID
- RIMEC / APHP201166
- Conditions
- Metabolism Disorder, Cancer, Immune Checkpoint Inhibitors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- 9 Apr 2024 (actual)
- Study completion
- 9 Oct 2024 (estimated)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | Experimental | Diagnostic Test: calorimetry, impedance measurement at baseline and after 3 months of treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| calorimetry, impedance measurement at baseline and after 3 months of treatmentAlso: biobanking (30ml)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 | Diagnostic test | patients |
Primary outcome
response rate according to metabolic status
Time frame: 6 months from randomisation
response rate after 6 months of ICI treatment (iRECIST criteria)
4 secondary outcomes
6 months progression free survival according to metabolic status
Time frame: 6 months from randomisation
12 months overall survival according to metabolic status
Time frame: 12months from randomisation
correlations between metabolism/ cytokines dosage/ complement dosage and response to ICI
Time frame: 12 months from randomisation
incidence of irAEs according to metabolic profile
Time frame: 6 months from randomisation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SIMONAGGIO Audrey, MD principal investigator
Hopital europeen Georges-Pompidou
Charles Vauchier principal investigator
Hopital europeen Georges-Pompidou
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing calorimetry, impedance measurement at baseline and after 3 months of treatment in people with Metabolism Disorder and Cancer, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate according to metabolic status (time frame: 6 months from randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.