CompletedNot Applicable

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

France40,000 participantsStarted 2014-01-01

Plain-language 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. 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Timeframe: 1 year

Trial details

NCT IDNCT05380336

SponsorNantes University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-12-31

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