Nivolumab Plus Metformin in Metastatic Renal Cell Carcinoma (NCT06884683) | Clinical Trial Compass
TerminatedPhase 2
Nivolumab Plus Metformin in Metastatic Renal Cell Carcinoma
Stopped: slow enrollment
Italy12 participantsStarted 2020-09-17
Plain-language summary
Phase 2 single arm study that evaluated the addition of metformin to nivolumab in pre-treated metastatic renal cell carcinoma (mRCC) patients.
Primary aim: to investigate the efficacy of the combination of nivolumab+metformin in mRCC patients previously treated with VEGFR-TKI
Secondary aims:
* to assess the activity, safety and efficacy of the experimental combination
* to assess the quality of life of enrolled patients
Enrolled patients will received:
* nivolumab 240 mg e.v. every 14 day
* metformin 500 mg orally twice a day continuously Patients will be trated untill disease progression, or unexpected toxicity, whichever comes first
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
. Willing and able to provide written informed consent
. Male and female aged 18 years and above
. Histological confirmation of RCC with a clear cell component
. Advanced or metastatic RCC
. Measurable disease as defined by RECIST1.1criteria
. Must have received at least one prior systemic treatment regimen in the advanced or metastatic setting, and must have evidence of progression on or after the last treatment regimen received
. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
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.
What they're measuring
1
9-months PFS rate
Timeframe: 9 months after the last enrolled patient
. Adequate bone marrow and chemistry values defined as:
Exclusion criteria
. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection
. Any active known or suspected autoimmune disease
. Any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to the first dose of study drug. Inhaled steroids and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease
. Uncontrolled adrenal insufficiency
. Evidence of active pneumonitis during screening, except for pulmonary fibrosis induced by prior thoracic irradiation
. Dialitic patients
. Diabetes mellitus
. Any history of biguanide-based therapy within 1 year prior to enrollment