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

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Lung Cancer; Kidney Cancer

Treatments: Other: Pharmacokinetic of Nivolumab

Study type: Observational

Funder types: Other

Identifiers

NCT03433534

2017-A02788-45 (Other Identifier)

RIPH3-RNI17/NIVEAL

2017.12.08 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

64 participants in 1 patient group

Pharmacokinetic of Nivolumab

Description:

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.

Treatment:

Other: Pharmacokinetic of Nivolumab