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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Drug: metformin tablet 500 mg, 1 tablet twice a day (total dose 1000 mg daily), administered orally continuously \+ Biological: Nivolumab 240 mg via IV infusion every 14 days Other Names: Opdivo®
Giampaolo Tortora
Roma, Italy
Francesca Primi
Viterbo, Italy
9-months PFS rate
The percentage of patients without disease progression after 9 months from the start of therapy
Time frame: 9 months after the last enrolled patient
ORR
objective response rate (percentage of patients with complete or partial response
Time frame: the ORR analysis will be performed after 12 months from the last patient enrolled
median PFS
median time of survival without disease progression
Time frame: the PFS analysis will be performed after 12 months from the last patient enrolled
median OS
median time of overall survival
Time frame: the OS analysis will be performed after 12 months from the last patient enrolled
Adverse Events
description and rate of treatment-related adverse events
Time frame: AEs will be collected until 3 months from the discontinuation of the experimental therapy by the last patient enrolled
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