Clinical trial · Observational
Retrospective Study on the Safety of Nivolumab in Patients With mRCC and Renal Failure
Retrospective Observational Study on the Safety of Nivolumab in Patients With Metastatic Renal Carcinoma and Renal Failure
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Healted Prematurely
Summary
Brief summary (as posted)
This is an observational, retrospective, multicenter study aimed to compare the toxicity of Nivolumab in patients with metastatic renal cell carcinoma treated in line II and III stratified into 3 patient groups: * patients with normal or mildly reduced renal function (GFR\<90 and ≥60 ml/min/1.73 m\^2); * patients with moderate renal impairment (GFR \<60 e ≥30 ml/min/1.73 m\^2), * patients with severe renal impairment (GFR \<30 e ≥15 ml/min/1.73 m\^2) Patients must have been treated with Nivolumab, as per clinical practice. All patients who have received at least one drug administration between february 2017 to December 31, 2018 will be enrolled in the study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Patients with normal or mildly reduced renal function (GFR<90 and ≥60 ml/min/1.73 m^2)
- label
- Patients with moderate renal failure (GFR <60 e ≥30 ml/min/1.73 m^2)
- label
- Patients with severe renal failure (GFR <30 e ≥15 ml/min/1.73 m^2)
Primary outcomes (1)
- measure
- Incidence of Treatment-emergent Adverse Events
- timeFrame
- At study completion (up to 16 months)
- description
- To describe the safety of the treatment, the number of adverse events will be counted percentage, grade 1-2 and 3-4 and will compare for the 3 patient stratification groups.
Secondary outcomes (3)
- measure
- Effectiveness of the treatment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * signing informed consent, in case of patients still alive; * histologically confirmed diagnosis of metastatic renal cell carcinoma; * at least one administration of Nivolumab therapy, in the second-or third line of treatment february 2017 to December 31, 2018; * availability of inpatient and/or outpatient medical records for clinical data collection. Exclusion Criteria: * patients who have received immunotherapy under EAP (Expanded Access Programm) or other clinical trials; * dialysis patients.
References
Publications (11)
- BACKGROUNDMasini C, Vitale MG, Maruzzo M, Procopio G, de Giorgi U, Buti S, Rossetti S, Iacovelli R, Atzori F, Cosmai L, Vignani F, Prati G, Scagliarini S, Guida A, Berselli A, Pinto C. Safety and Efficacy of Pazopanib in First-Line Metastatic Renal-Cell Carcinoma With or Without Renal Failure: CORE-URO-01 Study. Clin Genitourin Cancer. 2019 Feb;17(1):e150-e155. doi: 10.1016/j.clgc.2018.10.001. Epub 2018 Oct 10. PMID 30396828
- BACKGROUNDGupta S, Parsa V, Heilbrun LK, Smith DW, Dickow B, Heath E, Vaishampayan U. Safety and efficacy of molecularly targeted agents in patients with metastatic kidney cancer with renal dysfunction. Anticancer Drugs. 2011 Sep;22(8):794-800. doi: 10.1097/CAD.0b013e328346af0d. PMID 21799472
- BACKGROUNDWanchoo R, Karam S, Uppal NN, Barta VS, Deray G, Devoe C, Launay-Vacher V, Jhaveri KD; Cancer and Kidney International Network Workgroup on Immune Checkpoint Inhibitors. Adverse Renal Effects of Immune Checkpoint Inhibitors: A Narrative Review. Am J Nephrol. 2017;45(2):160-169. doi: 10.1159/000455014. Epub 2017 Jan 12. PMID 28076863
- BACKGROUNDVitale MG, Scagliarini S, Galli L, Pignata S, Lo Re G, Berruti A, Defferrari C, Spada M, Masini C, Santini D, Ciuffreda L, Ruggeri EM, Bengala C, Livi L, Fagnani D, Bonetti A, Giustini L, Hamzaj A, Procopio G, Caserta C, Sabbatini R. Efficacy and safety data in elderly patients with metastatic renal cell carcinoma included in the nivolumab Expanded Access Program (EAP) in Italy. PLoS One. 2018 Jul 6;13(7):e0199642. doi: 10.1371/journal.pone.0199642. eCollection 2018. PMID 29979712
- BACKGROUNDCarlo MI, Feldman DR. Response to Nivolumab in a Patient With Metastatic Clear Cell Renal Cell Carcinoma and End-stage Renal Disease on Dialysis. Eur Urol. 2016 Dec;70(6):1082-1083. doi: 10.1016/j.eururo.2016.05.040. Epub 2016 Jun 13. No abstract available. PMID 27311362
- BACKGROUNDHerz S, Hofer T, Papapanagiotou M, Leyh JC, Meyenburg S, Schadendorf D, Ugurel S, Roesch A, Livingstone E, Schilling B, Franklin C. Checkpoint inhibitors in chronic kidney failure and an organ transplant recipient. Eur J Cancer. 2016 Nov;67:66-72. doi: 10.1016/j.ejca.2016.07.026. Epub 2016 Sep 8.