Nivolumab Plus Metformin in Metastatic Renal Cell Carcinoma

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

Timeline

Start

2020-09-17

Primary completion

2023-09-13

Completion

2023-09-13

Drugs

Indications