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 range18 Years
SexALL
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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
✓. 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
What they're measuring
1
9-months PFS rate
Timeframe: 9 months after the last enrolled patient
. 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