Kidney CancerNIVEALNCT03433534
Study of the Concentration-effect Relationship of Nivolumab in Patients With Kidney or Lung Cancer
An observational study of Kidney Cancer and Lung Cancer, run by University Hospital, Tours at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer, Lung Cancer
- What is being tested?
- Pharmacokinetic of Nivolumab
- Type of treatment
- Injection or infusion
- How many people
- 64 participants
- Where
- 2 sitesFrance
- Study dates
- 29 Jan 2018to 21 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Active brain metastasis not treated before by surgery or radiotherapy
- Autoimmune disease
- Patient having objected to the processing of his data
Trial locations and contacts
2 sites in 1 country.
France2 sites
Medical oncology department, University Hospital, Tours
Tours, 37044
Pneumology department, University Hospital, Tours
Tours, 37044
About this study
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.
Read the 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
- Conditions
- Kidney Cancer, Lung Cancer
- Being tested
- Pharmacokinetic of Nivolumab
- Keywords
- nivolumab, monoclonal antibody, Opdivo, antineoplastic agent, ELISA, pharmacokinetic
- Medical subject headings
- Kidney Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacokinetic of NivolumabOther
Also called Opdivo
Nivolumab residual concentration is measured 14 days after administration of nivolumab 3 mg/kg as an intravenous infusion just before the new administration.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Pharmacokinetic of Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Association between nivolumab concentration and progression free survival : time from start of nivolumab treatment to progression
Measured: Up to one year
Secondary outcomes (5)
Overall survival
Association between nivolumab concentration and overall survival : time from start of nivolumab treatment to death
Measured: Up to one year
Target concentration
Determination of nivolumab concentration associated with clinical benefit (complete response + partial response + stable disease)
Measured: 14 days
Side effects
Association between nivolumab residual concentration and side effects
Measured: 14 days
Nivolumab PK parameters : distribution volume
Nivolumab residual concentrations will be measured each 14 days until the end of the study (up to one year).
Measured: Baseline up to one year
Nivolumab PK parameters : clearance
Nivolumab residual concentrations will be measured each 14 days until the end of the study (up to one year).
Measured: Baseline up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start29 Jan 2018
- Primary completion21 Dec 2018
- Study completion21 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claude Linassier, Study director, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433534
- Sponsor's protocol ID
- RIPH3-RNI17/NIVEAL
- Other IDs
- 2017-A02788-45, 2017.12.08
- Acronym
- NIVEAL
- Status last verified
- Nov 2019
- First submitted
- 24 Jan 2018
- Last updated
- 12 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Concentration-effect Relationship of Nivolumab in Patients With Kidney or Lung Cancer
- ClinicalTrials.gov ID
- NCT03433534
- Acronym / sponsor ID
- NIVEAL / RIPH3-RNI17/NIVEAL
- Conditions
- Kidney Cancer, Lung Cancer
- Keywords
- nivolumab, monoclonal antibody, Opdivo, antineoplastic agent, ELISA, pharmacokinetic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 14 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmacokinetic of Nivolumab | – | Other: Pharmacokinetic of NivolumabPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Active brain metastasis not treated before by surgery or radiotherapy
- Autoimmune disease
- Patient having objected to the processing of his data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacokinetic of NivolumabAlso: OpdivoNivolumab residual concentration is measured 14 days after administration of nivolumab 3 mg/kg as an intravenous infusion just before the new administration. | Other | Pharmacokinetic of Nivolumab |
Primary outcome
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
5 secondary outcomes
Overall survival
Time frame: Up to one year
Target concentration
Time frame: 14 days
Side effects
Time frame: 14 days
Nivolumab PK parameters : distribution volume
Time frame: Baseline up to one year
Nivolumab PK parameters : clearance
Time frame: Baseline up to one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claude Linassier study director
University Hospital, Tours
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Cancer and Lung Cancer, run by University Hospital, Tours at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: Up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2019.