Kidney Cancer, Lung Cancer
Conditions
Keywords
nivolumab, monoclonal antibody, Opdivo, antineoplastic agent, ELISA, pharmacokinetic
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
Interventions
OTHERPharmacokinetic 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.
Sponsors
University Hospital, Tours
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | Up to one year | Association between nivolumab concentration and progression free survival : time from start of nivolumab treatment to progression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | Up to one year | Association between nivolumab concentration and overall survival : time from start of nivolumab treatment to death |
| Target concentration | 14 days | Determination of nivolumab concentration associated with clinical benefit (complete response + partial response + stable disease) |
| 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). |
| 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). |
Countries
France
Outcome results
None listed