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OpenTrials
Completed

NCT Number: NCT03433534

Study of the Concentration-effect Relationship of Nivolumab in Patients With Kidney or Lung Cancer

To assess the relationship between progression free survival of patients treated with nivolumab for metastatic non small cell lung carcinoma or a metastatic renal cell carcinoma and nivolumab blood concentration.

Collection of standard data prospectively.

Completed

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Key information

Conditions

Kidney Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical oncology department, University Hospital, Tours, Tours, France

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About this study

Nivolumab is a monoclonal antibody used for the treatment of non small cell lung carcinoma and renal cell carcinoma. Huge variability exists between patients treated by nivolumab in terms of efficacy and side effects. Like others monoclonal antibodies, a relation between concentration and effects of nivolumab may exist.

The aim of this study is to assess the relationship between blood concentration of nivolumab and progression free survival, overall survival and side effects on the one hand, and on the other to describe pharmacokinetic of nivolumab

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with squamous or non squamous non small cell lung cancer stage IV or patient with renal cell carcinoma stage IV
  • Patient receiving nivolumab or who will receive nivolumab
  • Age ⩾ 18 years old
  • OMS stage ≤ 2
  • Evaluable disease

Exclusion criteria

  • Active brain metastasis not treated before by surgery or radiotherapy
  • Autoimmune disease
  • Patient having objected to the processing of his data

Treatment and study plan

Pharmacokinetic of Nivolumab

Other

Nivolumab residual concentration is measured 14 days after administration of nivolumab 3 mg/kg as an intravenous infusion just before the new administration.

Other names: Opdivo

Primary outcomes

  1. Progression free survival

    Time frame: Up to one year

    Association between nivolumab concentration and progression free survival : time from start of nivolumab treatment to progression

Secondary outcomes

  1. Overall survival

    Time frame: Up to one year

    Association between nivolumab concentration and overall survival : time from start of nivolumab treatment to death

  2. Target concentration

    Time frame: 14 days

    Determination of nivolumab concentration associated with clinical benefit (complete response + partial response + stable disease)

  3. Side effects

    Time frame: 14 days

    Association between nivolumab residual concentration and side effects

  4. Nivolumab PK parameters : distribution volume

    Time frame: Baseline up to one year

    Nivolumab residual concentrations will be measured each 14 days until the end of the study (up to one year).

  5. Nivolumab PK parameters : clearance

    Time frame: Baseline up to one year

    Nivolumab residual concentrations will be measured each 14 days until the end of the study (up to one year).

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: NIVEAL

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 14, 2018
Registry last updated
Nov 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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