Clinical trial · Observational
Study of the Concentration-effect Relationship of Nivolumab in Patients With Kidney or Lung Cancer
NCT03433534CI-TRIAL-00041568NIVEALcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pharmacokinetic of Nivolumab | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Other: Pharmacokinetic of Nivolumab
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- Up to one year
- description
- Association between nivolumab concentration and progression free survival : time from start of nivolumab treatment to progression
Secondary outcomes (5)
- measure
- Overall survival
- timeFrame
- Up to one year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.