Retrospective Study on the Safety of Nivolumab in Patients With mRCC and Renal Failure

NCT07117409 | Terminated

• 1 other identifier: 622/2019/OSS/IRCCSRE
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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

Metastatic Renal Cell Carcinoma

Keywords

renal failure; carcinoma; nivolumab

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-emergent Adverse Events

  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.

  At study completion (up to 16 months)

Secondary Outcomes (3)

• Effectiveness of the treatment

  At study completion (up to 16 months)

• Survival assessment

  At study completion (up to 16 months)

• Evaluation of progression free time

  At study completion (up to 16 months)

Study Arms (3)

Patients with normal or mildly reduced renal function (GFR<90 and ≥60 ml/min/1.73 m^2)

Patients with moderate renal failure (GFR <60 e ≥30 ml/min/1.73 m^2)

Patients with severe renal failure (GFR <30 e ≥15 ml/min/1.73 m^2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affered to the structures involved treated with at least one administration of the drug Nivolumab line II or III for metastatic renal cell carcinoma.

You may qualify if:

• 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.

You may not qualify if:

• patients who have received immunotherapy under EAP (Expanded Access Programm) or other clinical trials;
• dialysis patients.

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (1)

Azienda USL IRCCS di Reggio Emilia

Reggio Emilia, Italy

Location

Related Publications (11)

• Masini 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 BACKGROUND

• Gupta 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 BACKGROUND

• Wanchoo 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 BACKGROUND

• Vitale 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 BACKGROUND

• Carlo 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 BACKGROUND

• Herz 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.

  PMID: 27614165 BACKGROUND

• Motzer RJ, Tannir NM, McDermott DF, Aren Frontera O, Melichar B, Choueiri TK, Plimack ER, Barthelemy P, Porta C, George S, Powles T, Donskov F, Neiman V, Kollmannsberger CK, Salman P, Gurney H, Hawkins R, Ravaud A, Grimm MO, Bracarda S, Barrios CH, Tomita Y, Castellano D, Rini BI, Chen AC, Mekan S, McHenry MB, Wind-Rotolo M, Doan J, Sharma P, Hammers HJ, Escudier B; CheckMate 214 Investigators. Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma. N Engl J Med. 2018 Apr 5;378(14):1277-1290. doi: 10.1056/NEJMoa1712126. Epub 2018 Mar 21.

  PMID: 29562145 BACKGROUND

• Motzer RJ, Escudier B, McDermott DF, George S, Hammers HJ, Srinivas S, Tykodi SS, Sosman JA, Procopio G, Plimack ER, Castellano D, Choueiri TK, Gurney H, Donskov F, Bono P, Wagstaff J, Gauler TC, Ueda T, Tomita Y, Schutz FA, Kollmannsberger C, Larkin J, Ravaud A, Simon JS, Xu LA, Waxman IM, Sharma P; CheckMate 025 Investigators. Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma. N Engl J Med. 2015 Nov 5;373(19):1803-13. doi: 10.1056/NEJMoa1510665. Epub 2015 Sep 25.

  PMID: 26406148 BACKGROUND

• Choueiri TK, Escudier B, Powles T, Mainwaring PN, Rini BI, Donskov F, Hammers H, Hutson TE, Lee JL, Peltola K, Roth BJ, Bjarnason GA, Geczi L, Keam B, Maroto P, Heng DY, Schmidinger M, Kantoff PW, Borgman-Hagey A, Hessel C, Scheffold C, Schwab GM, Tannir NM, Motzer RJ; METEOR Investigators. Cabozantinib versus Everolimus in Advanced Renal-Cell Carcinoma. N Engl J Med. 2015 Nov 5;373(19):1814-23. doi: 10.1056/NEJMoa1510016. Epub 2015 Sep 25.

  PMID: 26406150 BACKGROUND

• Decastro GJ, McKiernan JM. Epidemiology, clinical staging, and presentation of renal cell carcinoma. Urol Clin North Am. 2008 Nov;35(4):581-92; vi. doi: 10.1016/j.ucl.2008.07.005.

  PMID: 18992612 BACKGROUND

• Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016 Jan-Feb;66(1):7-30. doi: 10.3322/caac.21332. Epub 2016 Jan 7.

  PMID: 26742998 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Renal Cell; Renal Insufficiency; Carcinoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: June 29, 2020
• Primary Completion: May 30, 2022
• Study Completion: June 30, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-08

Locations

IT (1)