Metastatic Renal Cell CarcinomaRI-NIVONCT07117409
Retrospective Study on the Safety of Nivolumab in Patients With mRCC and Renal Failure
An observational study of Metastatic Renal Cell Carcinoma, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma
- How many people
- 81 participants
- Where
- 1 siteItaly
- Study dates
- 29 Jun 2020to 30 Jun 2025
- 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 affered to the structures involved treated with at least one administration of the drug Nivolumab line II or III for metastatic renal cell carcinoma.
Who may be able to join
- 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.
Who cannot join
- patients who have received immunotherapy under EAP (Expanded Access Programm) or other clinical trials;
- dialysis patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Observational Study on the Safety of Nivolumab in Patients With Metastatic Renal Carcinoma and Renal Failure
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.
Read the detailed description
The treatment of metastatic renal cancer has undergone several changes in recent years especially regarding second line treatment which has seen the development of new ones antiangiogenic drugs such as cabozantinib and immunotherapy with inhibitory checkpoints (nivolumab). Nivolumab is a human IgG4 monoclonal antibody that binds to the receptor 'programmed-death' 1 (PD-1) by blocking its interaction with its ligand (PD-L1). The PD-1 receptor has an action negative regulatory on T lymphocyte activity, the interaction between receptor and ligand (PD-L1) expressed by cancer cells involves inhibition of T cell proliferation and cytokine secretion. The metabolism of Nivolumab was not well characterized, although it is probably degraded into small peptides and amino acids through catabolic pathways similar way to endogenous IgG; all this is important as there is no involvement by normal excretory/emuntory organs such as liver and kidney. The patient affected by metastatic renal cell carcinoma presents more frequently than a subject of the same sex and age a picture of concomitant renal insufficiency (IR); this data could be linked to age median at diagnosis (65 years), high incidence of diabetes and arterial hypertension, and presence of a previous nephrectomy .Renal impairment (IR) is classified as: - mild (glomerular filtrate (GFR) <90 and ≥60 ml/min/1.73 m^2); - moderate (GFR <60 and ≥30 ml/min/1.73 m^2), or severe (GFR <30 and ≥15 ml/min/1.73 m^2) Some pharmacokinetic analyses have been conducted for patients with mild renal impairment or moderate who have not documented clinically detected differences in clearance of Nivolumab compared to patients with normal renal function; however this is a number very modest number of patients with moderate IR and an even more limited number of patients with severe IR such that these results cannot be considered conclusive; the studies in fact, registrars did not include patients with severe IR or on dialysis. Only some case reports of patients with severe renal insufficiency treated are described in the literature with inhibitory immunocheckpoints without this leading to aggravation of renal function baseline or changes efficacy or toxicity; however few of these reported cases involve patients with metastatic renal cell carcinoma. And' instead, a case of a patient with renal neoplasm in hemodialysis treatment with benefit in terms of objective response from nivolumab therapy. it is also known from the analysis conducted on patients treated with nivolumab within the EAP in Italy, that this drug has a benefit in terms of effectiveness and safety even for older patients, who represent only a small share of the population of pivotal studies; such patients may more frequently have both by age and by comorbidity a reduction in basic renal function. Aim of our retrospective study is to assess whether there are differences in the profile of toxicity in renal cell carcinoma patients treated with Nivolumab in line II or III based on renal function. Patients will be stratified in 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 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).
- Conditions
- Metastatic Renal Cell Carcinoma
- Keywords
- renal failure, carcinoma, nivolumab
- Medical subject headings
- Carcinoma, Renal Cell, Renal Insufficiency, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with normal or mildly reduced renal function (GFR<90 and ≥60 ml/min/1.73 m^2) | Not described | |
| Patients with moderate renal failure (GFR <60 e ≥30 ml/min/1.73 m^2) | Not described | |
| Patients with severe renal failure (GFR <30 e ≥15 ml/min/1.73 m^2) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At study completion (up to 16 months)
Secondary outcomes (3)
Effectiveness of the treatment
The effectiveness of treatment in the population in terms of objective responses will be described (ORR) defined as number of patients in complete response, partial response established by clinicians according to RECIST 1.1 criteria. Objective response rates will be compared between the three groups of patient stratification.
Measured: At study completion (up to 16 months)
Survival assessment
It will describe the possible correlation between the three patient stratification groups and the survival. The overall survival estimate is defined as the time from treatment start date to date of death from any cause. Survival time comes discontinued at the date of the last follow-up visit for patients alive or lost to follow-up.
Measured: At study completion (up to 16 months)
Evaluation of progression free time
The possible correlation between the three patient stratification groups and the progression free survival (PFS) will be described. The PFS estimate is defined as the time from the start date of treatment at the date of disease progression. Time to progression is interrupted at date of last follow-up visit for patients not progressed.
Measured: At study completion (up to 16 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start29 Jun 2020
- Primary completion30 May 2022
- Study completion30 Jun 2025
Why it stopped: Healted Prematurely
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117409
- Sponsor's protocol ID
- 622/2019/OSS/IRCCSRE
- Acronym
- RI-NIVO
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30396828Gupta 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.
PubMed 21799472Wanchoo 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.
PubMed 28076863Vitale 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.
PubMed 29979712Carlo 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.
PubMed 27311362Herz 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.
PubMed 27614165Motzer 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.
PubMed 29562145Motzer 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.
PubMed 26406148Choueiri 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.
PubMed 26406150Decastro 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.
PubMed 18992612Siegel 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.
PubMed 26742998
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Observational Study on the Safety of Nivolumab in Patients With Metastatic Renal Carcinoma and Renal Failure
- ClinicalTrials.gov ID
- NCT07117409
- Acronym / sponsor ID
- RI-NIVO / 622/2019/OSS/IRCCSRE
- Conditions
- Metastatic Renal Cell Carcinoma
- Keywords
- renal failure, carcinoma, nivolumab
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Healted Prematurely
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 12 Aug 2025 (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.
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.
Detailed description
The treatment of metastatic renal cancer has undergone several changes in recent years especially regarding second line treatment which has seen the development of new ones antiangiogenic drugs such as cabozantinib and immunotherapy with inhibitory checkpoints (nivolumab). Nivolumab is a human IgG4 monoclonal antibody that binds to the receptor 'programmed-death' 1 (PD-1) by blocking its interaction with its ligand (PD-L1). The PD-1 receptor has an action negative regulatory on T lymphocyte activity, the interaction between receptor and ligand (PD-L1) expressed by cancer cells involves inhibition of T cell proliferation and cytokine secretion. The metabolism of Nivolumab was not well characterized, although it is probably degraded into small peptides and amino acids through catabolic pathways similar way to endogenous IgG; all this is important as there is no involvement by normal excretory/emuntory organs such as liver and kidney. The patient affected by metastatic renal cell carcinoma presents more frequently than a subject of the same sex and age a picture of concomitant renal insufficiency (IR); this data could be linked to age median at diagnosis (65 years), high incidence of diabetes and arterial hypertension, and presence of a previous nephrectomy .Renal impairment (IR) is classified as: - mild (glomerular filtrate (GFR) <90 and ≥60 ml/min/1.73 m^2); - moderate (GFR <60 and ≥30 ml/min/1.73 m^2), or severe (GFR <30 and ≥15 ml/min/1.73 m^2) Some pharmacokinetic analyses have been conducted for patients with mild renal impairment or moderate who have not documented clinically detected differences in clearance of Nivolumab compared to patients with normal renal function; however this is a number very modest number of patients with moderate IR and an even more limited number of patients with severe IR such that these results cannot be considered conclusive; the studies in fact, registrars did not include patients with severe IR or on dialysis. Only some case reports of patients with severe renal insufficiency treated are described in the literature with inhibitory immunocheckpoints without this leading to aggravation of renal function baseline or changes efficacy or toxicity; however few of these reported cases involve patients with metastatic renal cell carcinoma. And' instead, a case of a patient with renal neoplasm in hemodialysis treatment with benefit in terms of objective response from nivolumab therapy. it is also known from the analysis conducted on patients treated with nivolumab within the EAP in Italy, that this drug has a benefit in terms of effectiveness and safety even for older patients, who represent only a small share of the population of pivotal studies; such patients may more frequently have both by age and by comorbidity a reduction in basic renal function. Aim of our retrospective study is to assess whether there are differences in the profile of toxicity in renal cell carcinoma patients treated with Nivolumab in line II or III based on renal function. Patients will be stratified in 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 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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- patients who have received immunotherapy under EAP (Expanded Access Programm) or other clinical trials;
- dialysis patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Treatment-emergent Adverse Events
Time frame: At study completion (up to 16 months)
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.
3 secondary outcomes
Effectiveness of the treatment
Time frame: At study completion (up to 16 months)
Survival assessment
Time frame: At study completion (up to 16 months)
Evaluation of progression free time
Time frame: At study completion (up to 16 months)
Results and safety
The study was stopped early (reason given: Healted Prematurely). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Background: PubMed 30396828Masini 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.
- Background: PubMed 21799472Gupta 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.
- Background: PubMed 28076863Wanchoo 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.
- Background: PubMed 29979712Vitale 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.
- Background: PubMed 27311362Carlo 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.
- Background: PubMed 27614165Herz 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.
- Background: PubMed 29562145Motzer 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.
- Background: PubMed 26406148Motzer 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.
- Background: PubMed 26406150Choueiri 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.
- Background: PubMed 18992612Decastro 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.
- Background: PubMed 26742998Siegel 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Renal Cell Carcinoma, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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 was stopped early (reason given: Healted Prematurely). Results are not available in the source record.
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?
Incidence of Treatment-emergent Adverse Events (time frame: At study completion (up to 16 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07117409, which also lists 11 linked publications.
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 11 Sep 2025.