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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-29

Study Completion Date

2018-12-21

Brief Summary

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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.

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Detailed Description

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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

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Kidney Cancer Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Pharmacokinetic of Nivolumab

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Opdivo

Eligibility Criteria

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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