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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

NCT05380336 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40000

Last updated 2022-06-01

No results posted yet for this study

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

Conditions

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Nicolas CORMIER, MD · Nantes University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-01
Primary Completion
2021-12-31
Completion
2021-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05380336 on ClinicalTrials.gov