Retrospective Study on the Safety of Nivolumab in Patients With mRCC and Renal Failure (NCT07117409) | Clinical Trial Compass
TerminatedNot Applicable
Retrospective Study on the Safety of Nivolumab in Patients With mRCC and Renal Failure
Stopped: Healted Prematurely
Italy81 participantsStarted 2020-06-29
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.