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

November 8, 2019 updated by: University Hospital, Tours

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Tours, France, 37044
        • Medical oncology department, University Hospital, Tours
      • Tours, France, 37044
        • Pneumology department, University Hospital, Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
Other Names:
  • Opdivo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: Up to one year
Association between nivolumab concentration and progression free survival : time from start of nivolumab treatment to progression
Up to one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Up to one year
Association between nivolumab concentration and overall survival : time from start of nivolumab treatment to death
Up to one year
Target concentration
Time Frame: 14 days
Determination of nivolumab concentration associated with clinical benefit (complete response + partial response + stable disease)
14 days
Side effects
Time Frame: 14 days
Association between nivolumab residual concentration and side effects
14 days
Nivolumab PK parameters : distribution volume
Time Frame: Baseline up to one year
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
Time Frame: Baseline up to one year
Nivolumab residual concentrations will be measured each 14 days until the end of the study (up to one year).
Baseline up to one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Investigators

  • Study Director: Claude Linassier, University Hospital, Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 29, 2018

Primary Completion (ACTUAL)

December 21, 2018

Study Completion (ACTUAL)

December 21, 2018

Study Registration Dates

First Submitted

January 24, 2018

First Submitted That Met QC Criteria

February 7, 2018

First Posted (ACTUAL)

February 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 12, 2019

Last Update Submitted That Met QC Criteria

November 8, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIPH3-RNI17/NIVEAL
  • 2017-A02788-45 (OTHER: IdRCB)
  • 2017.12.08 (OTHER: CPP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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