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

Study Overview
=================
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

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

Conditions
-----------------
Kidney Cancer, Lung Cancer

Intervention / Treatment
-----------------
* Other: Pharmacokinetic of Nivolumab


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pharmacokinetic of Nivolumab<br>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. | Other: Pharmacokinetic of Nivolumab<br>* Nivolumab residual concentration is measured 14 days after administration of nivolumab 3 mg/kg as an intravenous infusion just before the new administration.<br>* Other names: Opdivo;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | Association between nivolumab concentration and progression free survival : time from start of nivolumab treatment to progression | Up to one year | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nivolumab, monoclonal antibody, Opdivo, antineoplastic agent, ELISA, pharmacokinetic