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

Lung Cancer Clinical Trial

— NIVEAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03433534
• Other study ID #: RIPH3-RNI17/NIVEAL
• Secondary ID: 2017-A02788-4520
• Status: Completed
• Start date: January 29, 2018
• Est. completion date: December 21, 2018

Study information

• Verified date: November 2019
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 21, 2018
• Est. primary completion date: December 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Cancer
• Kidney Neoplasms
• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	Medical oncology department, University Hospital, Tours	Tours
France	Pneumology department, University Hospital, Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	Association between nivolumab concentration and progression free survival : time from start of nivolumab treatment to progression	Up to one year
Secondary	Overall survival	Association between nivolumab concentration and overall survival : time from start of nivolumab treatment to death	Up to one year
Secondary	Target concentration	Determination of nivolumab concentration associated with clinical benefit (complete response + partial response + stable disease)	14 days
Secondary	Side effects	Association between nivolumab residual concentration and side effects	14 days
Secondary	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
Secondary	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