Study of the Concentration-effect Relationship of Nivolumab in Patients With Kidney or Lung Cancer
NIVEAL
3 other identifiers
observational
64
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2018
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2018
CompletedStudy Start
First participant enrolled
January 29, 2018
CompletedFirst Posted
Study publicly available on registry
February 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 21, 2018
CompletedNovember 12, 2019
November 1, 2019
11 months
January 24, 2018
November 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival
Association between nivolumab concentration and progression free survival : time from start of nivolumab treatment to progression
Up to one year
Secondary Outcomes (5)
Overall survival
Up to one year
Target concentration
14 days
Side effects
14 days
Nivolumab PK parameters : distribution volume
Baseline up to one year
Nivolumab PK parameters : clearance
Baseline up to one year
Study Arms (1)
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.
Interventions
Nivolumab residual concentration is measured 14 days after administration of nivolumab 3 mg/kg as an intravenous infusion just before the new administration.
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- Active brain metastasis not treated before by surgery or radiotherapy
- Autoimmune disease
- Patient having objected to the processing of his data
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Medical oncology department, University Hospital, Tours
Tours, 37044, France
Pneumology department, University Hospital, Tours
Tours, 37044, France
Biospecimen
Blood samples will be drawn to all patients to measure nivolumab concentration
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Claude Linassier
University Hospital, Tours
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2018
First Posted
February 14, 2018
Study Start
January 29, 2018
Primary Completion
December 21, 2018
Study Completion
December 21, 2018
Last Updated
November 12, 2019
Record last verified: 2019-11