NCT06884683

Nivolumab Plus Metformin in Metastatic Renal Cell Carcinoma

A Phase II Study of Nivolumab Combined With Metformin in Pretreated Metastatic Renal Cell Carcinoma (mRCC) Patients. NivoMet TWINS-GU002 Study

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Metastatic Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Metformin	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®

Timeline

• Start date: 2020-09-17
• Primary completion: 2023-09-13
• Completion: 2023-09-13
• First posted: 2025-03-19
• Last updated: 2025-03-19

Locations

2 sites across 1 country: Italy