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

NCT ID: NCT05380336

Last Updated: 2022-06-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-01
• Study Completion Date: 2021-12-31

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

Conditions

Metastatic Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

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).

No interventions assigned to this group

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

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas CORMIER, MD

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Other Identifiers

RC21_0371

Identifier Type: -

Identifier Source: org_study_id