Metastatic CancerIMEPOCANCT05380336
Medico-economic Evaluation Comparing the Impact of the New Fixed-dose Nivolumab Regimen With the Old mg/kg Regimen in the Management of Patients With Metastatic Cancer
An observational study of Metastatic Cancer, run by Nantes University Hospital at 1 site in France.
Trial summary
Nivolumab is a selective monoclonal antibody that binds to the Programmed cell Death 1 (PD-1) receptor and causes reduced tumor growth. It is currently approved in France in many indications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer
- How many people
- 40,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2014to 31 Dec 2021
- Phase
- Observational
- 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
Study population: This study includes patients with metastatic cancers treated with nivolumab: lung cancer, melanoma and kidney cancer.
Who may be able to join
- Patients with metastatic melanoma, non-small cell lung cancer (NSCLC) and renal cell carcinoma treated with nivolumab monotherapy
- Patients whose nivolumab treatment was initiated between 2015 and 2020
- Patients with health insurance
Who cannot join
- Patients whose nivolumab treatment initiated in 2017 in mg/kg has progressed to a fixed dose in the 1st year of treatment
- Patients treated with nivolumab in the adjuvant setting for melanoma with lymph node involvement or metastatic disease and who have undergone complete resection (Approval in 2018 for this indication)
- Patients whose nivolumab treatment has been initiated in 2018
Trial locations and contacts
1 site in 1 country.
About this study
Nivolumab is a selective monoclonal antibody that binds to the Programmed cell Death 1 (PD-1) receptor and causes reduced tumor growth. It is currently approved in France in many indications. The firsts therapeutics indications validated by the French health authorities from 2015 - metastatic melanoma2, squamous and non-squamous NSCLC, Kidney cells carcinoma - were based on clinical trials demonstrating a clinical advantage over standard nivolumab treatment at a dose of 3mg/kg every two weeks.
By comparing the results predicted by simulation based on a pharmacokinetic model with those obtained in clinical trials, the manufacturer of nivolumab concluded that a fixed dose of 240 mg was equivalent to that calculated based on the weight of the patients, and the European and then French health authorities have validated this change in clinical practice The objective of the IMEPOCA study is to assess in real life the economic and clinical impact of the dose modification of nivolumab that occurred in December 2018 in France.
In order to assess the economic efficiency of the change in dose strategy at the national level, 2 cohorts of patients from the National Health Data System (SNDS), treated for metastatic cancer and followed up over 1 year will be compared: one having benefited from the weight-dependent dosage and the other having benefited from the fixed dosage
- Conditions
- Metastatic Cancer
- Keywords
- nivolumab, lung, kidney cancer, melanoma, cost-effectiveness
- Medical subject headings
- Neoplasm Metastasis, Kidney Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with the Nivolumab weight-dependent dosage | Patients treated for their metastatic cancer with Nivolumab, with a dosage calculated upon their weight (3mg/kg every two weeks). | |
| Patients with the Nivolumab fixed dosage | Patients treated for their metastatic cancer with Nivolumab, with a fixed-dose regimen of 240 mg every 2 weeks or 480 mg every 4 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-effectiveness analysis of the new nivolumab fixed-dose regimen of 240 mg every 2 weeks or 480 mg every 4 weeks compared to the old regimen of 3 mg/kg every 2 weeks in the management of patients with metastatic cancers.
Incremental cost effectiveness ratio (in cost per year of life alive) according to a collective perspective and a time horizon of one year, according to the type of cancer
Measured: 1 year
Secondary outcomes (8)
Comparison of the patients characteristics between the 2015-2017 "de novo" cohort in mg/kg dosage and the 2019-2020 de novo cohort in fixed dosage by type of cancer
Initial characteristics of patients treated with nivolumab (age, sex, average weight, medical history, previous treatments)
Measured: baseline
Comparison of nivolumab length of treatment between the 2015-2017 "de novo" cohort in mg/kg dosage and the 2019-2020 de novo cohort in fixed dosage by type of cancer
treatment time frame, including interruption or suspension periods
Measured: 1 year
Comparison of nivolumab treatment dosage between the 2015-2017 "de novo" cohort in mg/kg dosage and the 2019-2020 de novo cohort in fixed dosage by type of cancer
Average dosage of nivolumab per patient hospitalisation
Measured: 1 year
Comparison of number of hospitalisations for nivolumab treatment between the 2015-2017 "de novo" cohort in mg/kg dosage and the 2019-2020 de novo cohort in fixed dosage by type of cancer
Average number of hospitalisations for nivolumab treatment, per patient
Measured: 1 year
Comparison of complications related to nivolumab between the 2015-2017 "de novo" cohort in mg/kg dosage and the 2019-2020 de novo cohort in fixed dosage by type of cancer
number of complications related to nivolumab, identified through the health care consumptions
Measured: 1 year
Patient survival analysis
patients date of death, by cancer type
Measured: 6 years
Duration of treatment response
Duration of treatment
Measured: 6 years
Budget impact analysis of the nivolumab fixed-dose regimen of 240 mg every 2 weeks or 480 mg every 4 weeks compared to the old regimen of 3 mg/kg every 2 weeks
Comparison of the costs of nivolumab fixed-dose regimen of 240 mg every 2 weeks or 480 mg every 4 weeks compared to the old regimen of 3 mg/kg every 2 weeks
Measured: 7 years (2015-2022)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start1 Jan 2014
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 40,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas CORMIER, MD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380336
- Sponsor's protocol ID
- RC21_0371
- Acronym
- IMEPOCA
- Status last verified
- May 2022
- First submitted
- 5 May 2022
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medico-economic Evaluation Comparing the Impact of the New Fixed-dose Nivolumab Regimen With the Old mg/kg Regimen in the Management of Patients With Metastatic Cancer
- ClinicalTrials.gov ID
- NCT05380336
- Acronym / sponsor ID
- IMEPOCA / RC21_0371
- Conditions
- Metastatic Cancer
- Keywords
- nivolumab, lung, kidney cancer, melanoma, cost-effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40,000 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 18 May 2022 (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.
Nivolumab is a selective monoclonal antibody that binds to the Programmed cell Death 1 (PD-1) receptor and causes reduced tumor growth. It is currently approved in France in many indications. The firsts therapeutics indications validated by the French health authorities from 2015 - metastatic melanoma2, squamous and non-squamous NSCLC, Kidney cells carcinoma - were based on clinical trials demonstrating a clinical advantage over standard nivolumab treatment at a dose of 3mg/kg every two weeks.
By comparing the results predicted by simulation based on a pharmacokinetic model with those obtained in clinical trials, the manufacturer of nivolumab concluded that a fixed dose of 240 mg was equivalent to that calculated based on the weight of the patients, and the European and then French health authorities have validated this change in clinical practice The objective of the IMEPOCA study is to assess in real life the economic and clinical impact of the dose modification of nivolumab that occurred in December 2018 in France.
In order to assess the economic efficiency of the change in dose strategy at the national level, 2 cohorts of patients from the National Health Data System (SNDS), treated for metastatic cancer and followed up over 1 year will be compared: one having benefited from the weight-dependent dosage and the other having benefited from the fixed dosage
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with the Nivolumab weight-dependent dosage | – | –Patients treated for their metastatic cancer with Nivolumab, with a dosage calculated upon their weight (3mg/kg every two weeks). |
| Patients with the Nivolumab fixed dosage | – | –Patients treated for their metastatic cancer with Nivolumab, with a fixed-dose regimen of 240 mg every 2 weeks or 480 mg every 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study includes patients with metastatic cancers treated with nivolumab: lung cancer, melanoma and kidney cancer.
Key inclusion criteria (3 listed)
- Patients with metastatic melanoma, non-small cell lung cancer (NSCLC) and renal cell carcinoma treated with nivolumab monotherapy
- Patients whose nivolumab treatment was initiated between 2015 and 2020
- Patients with health insurance
Key exclusion criteria (3 listed)
- Patients whose nivolumab treatment initiated in 2017 in mg/kg has progressed to a fixed dose in the 1st year of treatment
- Patients treated with nivolumab in the adjuvant setting for melanoma with lymph node involvement or metastatic disease and who have undergone complete resection (Approval in 2018 for this indication)
- Patients whose nivolumab treatment has been initiated in 2018
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cost-effectiveness analysis of the new nivolumab fixed-dose regimen of 240 mg every 2 weeks or 480 mg every 4 weeks compared to the old regimen of 3 mg/kg every 2 weeks in the management of patients with metastatic cancers.
Time frame: 1 year
Incremental cost effectiveness ratio (in cost per year of life alive) according to a collective perspective and a time horizon of one year, according to the type of cancer
8 secondary outcomes
Comparison of the patients characteristics between the 2015-2017 "de novo" cohort in mg/kg dosage and the 2019-2020 de novo cohort in fixed dosage by type of cancer
Time frame: baseline
Comparison of nivolumab length of treatment between the 2015-2017 "de novo" cohort in mg/kg dosage and the 2019-2020 de novo cohort in fixed dosage by type of cancer
Time frame: 1 year
Comparison of nivolumab treatment dosage between the 2015-2017 "de novo" cohort in mg/kg dosage and the 2019-2020 de novo cohort in fixed dosage by type of cancer
Time frame: 1 year
Comparison of number of hospitalisations for nivolumab treatment between the 2015-2017 "de novo" cohort in mg/kg dosage and the 2019-2020 de novo cohort in fixed dosage by type of cancer
Time frame: 1 year
Comparison of complications related to nivolumab between the 2015-2017 "de novo" cohort in mg/kg dosage and the 2019-2020 de novo cohort in fixed dosage by type of cancer
Time frame: 1 year
Patient survival analysis
Time frame: 6 years
Duration of treatment response
Time frame: 6 years
Budget impact analysis of the nivolumab fixed-dose regimen of 240 mg every 2 weeks or 480 mg every 4 weeks compared to the old regimen of 3 mg/kg every 2 weeks
Time frame: 7 years (2015-2022)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
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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.
Nicolas CORMIER, MD principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Cancer, run by Nantes University Hospital at 1 site 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 3 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: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cost-effectiveness analysis of the new nivolumab fixed-dose regimen of 240 mg every 2 weeks or 480 mg every 4 weeks compared to the old regimen of 3 mg/kg every 2 weeks in the management of patients with metastatic cancers. (time frame: 1 year). 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 24 Jun 2026.