Nivolumab Plus Metformin in Metastatic Renal Cell Carcinoma
Status:
TERMINATED
Trial end date:
2023-09-13
Target enrollment:
Participant gender:
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