Clinical trial NCT05380336: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Cancer
Keywords: nivolumab
lung
kidney cancer
melanoma
cost-effectiveness
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 40000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study includes patients with metastatic cancers treated with nivolumab: lung cancer, melanoma and kidney cancer.

Brief 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


Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: 1 year
Secondary outcomes:
measure: 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
timeFrame: baseline
measure: 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
timeFrame: 1 year
measure: 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
timeFrame: 1 year
measure: 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
timeFrame: 1 year
measure: 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
timeFrame: 1 year
measure: Patient survival analysis
timeFrame: 6 years
measure: Duration of treatment response
timeFrame: 6 years
measure: 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
timeFrame: 7 years (2015-2022)
Other outcomes:
Locations:
Study officials:
affiliation: Nantes University Hospital
name: Nicolas CORMIER, MD
role: PRINCIPAL_INVESTIGATOR
References: