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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A02788-45 | Other Identifier | IdRCB | |
| 2017.12.08 | Other Identifier | CPP |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated with nivolumab at CHRU of Tours for squamous or non squamous non small cell lung cancer stage IV or renal cell carcinoma stage IV
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| Name | Affiliation | Role |
|---|---|---|
| Claude Linassier | University Hospital, Tours | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical oncology department, University Hospital, Tours | Tours | 37044 | France | |||
| Pneumology department, University Hospital, Tours |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Blood samples will be drawn to all patients to measure nivolumab concentration
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| 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 |
| Tours |
| 37044 |
| France |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |