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

Metastatic Cancer Clinical Trial

— IMEPOCA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05380336
• Other study ID #: RC21_0371
• Status: Completed
• Start date: January 1, 2014
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2022
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40000
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Second Primary

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year
Secondary	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)	baseline
Secondary	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	1 year
Secondary	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	1 year
Secondary	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	1 year
Secondary	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	1 year
Secondary	Patient survival analysis	patients date of death, by cancer type	6 years
Secondary	Duration of treatment response	Duration of treatment	6 years
Secondary	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	7 years (2015-2022)