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

Completed

• Conditions: Lung Cancer; Kidney Cancer
• Interventions: Other: Pharmacokinetic of Nivolumab

• Registration Number: NCT03433534
• Lead Sponsor: University Hospital, Tours

Brief 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

Study Timeline

• Study First Submitted: 2018-01-24
• Study Start: 2018-01-29
• Study First Submitted QC: 2018-02-07
• Study First Posted: 2018-02-14
• Primary Completion: 2018-12-21
• Study Completion: 2018-12-21
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-08
• Last Update Posted: 2019-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pharmacokinetic of Nivolumab	Pharmacokinetic of Nivolumab	Patients under nivolumab (Opdivo 10 MG/ML) for the treatment of non small cell lung carcinoma or renal cell carcinoma. Measure of nivolumab residual concentration 14 days after administration of nivolumab and just before the new perfusion.

Primary Outcome Measures

Name	Time	Method
Progression free survival	Up to one year	Association between nivolumab concentration and progression free survival : time from start of nivolumab treatment to progression

Secondary Outcome Measures

Name	Time	Method
Overall survival	Up to one year	Association between nivolumab concentration and overall survival : time from start of nivolumab treatment to death
Side effects	14 days	Association between nivolumab residual concentration and side effects
Nivolumab PK parameters : distribution volume	Baseline up to one year	Nivolumab residual concentrations will be measured each 14 days until the end of the study (up to one year).
Target concentration	14 days	Determination of nivolumab concentration associated with clinical benefit (complete response + partial response + stable disease)
Nivolumab PK parameters : clearance	Baseline up to one year	Nivolumab residual concentrations will be measured each 14 days until the end of the study (up to one year).

Trial Locations

Locations (2)

Medical oncology department, University Hospital, Tours; 🇫🇷 Tours, France

Pneumology department, University Hospital, Tours; 🇫🇷 Tours, France