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 | Completed

• 1 other identifier: RC21_0371
• Study Type: observational
• Target: 40,000
• Locations: 0 countries
• Sites: N/A

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

Keywords

nivolumab; lung; kidney cancer; melanoma; cost-effectiveness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

  baseline

• 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

  1 year

• 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

  1 year

• 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

  1 year

• 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

  1 year

Study Arms (2)

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).

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study includes patients with metastatic cancers treated with nivolumab: lung cancer, melanoma and kidney cancer.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

MeSH Terms

Conditions

Neoplasm Metastasis; Kidney Neoplasms; Melanoma

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Nicolas CORMIER, MD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 18, 2022
• Study Start: January 1, 2014
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 1, 2022

Record last verified: 2022-05