NCT03433534

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 64 (actual)
• Sponsor: University Hospital, Tours · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Kidney Cancer
• Lung Cancer

Interventions

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

Timeline

• Start date: 2018-01-29
• Primary completion: 2018-12-21
• Completion: 2018-12-21
• First posted: 2018-02-14
• Last updated: 2019-11-12

Locations

2 sites across 1 country: France