Patients with advanced renal cell carcinoma pre-treated with VEGFR inhibitors. MedDRA version: 21.0 Level: PT Classification code 10073251 Term: Clear cell renal cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Opdivo
Product Name: Nivolumab
Product Code: [Nivolumab]
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: NIVOLUMAB
CAS Number: 946414-94-4
Current Sponsor c
Sponsors
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide written informed consent 2. Male aged 18 years and above 3. Histological confirmation of RCC with a clear cell component 4. Advanced or metastatic RCC 5. Measurable disease as defined by RECIST1.1criteria 6. 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 7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 8. Adequate bone marrow and chemistry values defined as: a. Hemoglobin = 9.0 g/dL independent of transfusion b. Platelet count =100.000/µL c. Serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: 1. 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 2. Any active known or suspected autoimmune disease 3. 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 4. Uncontrolled adrenal insufficiency 5. Evidence of active pneumonitis during screening, except for pulmonary fibrosis induced by prior thoracic irradiation 6. Dialitic patients 7. Diabetes mellitus 8. Any history of biguanide-based therapy within 1 year prior to enrollment 9. Current severe, uncontrolled systemic disease 10. Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of < 50% at baseline 11. Other malignancy with a previous diagnosis within 5 years (with the exclusions of NMIBC, CIN). 12. Prior treatment with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate if the addiction of metformin increases the activiti of nivolumab in metastatic kidney cancer.;Secondary Objective: To investigate the safety, activity and quality of life of patients who received the combination of metformin and nivolumab for metastatic kidney cancer.;Primary end point(s): To evaluate the Progression-Free Survival (PFS) rate at 9 months of the combination of nivolumab plus metformin in mRCC patients previously treated with at least one anti-angiogenic therapy.;Timepoint(s) of evaluation of this end point: 9 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Objective response rate; Median progression free surival; Overall survival; Safety of the combination; Quality of life;Timepoint(s) of evaluation of this end point: 9 months; 9 months; 9 months; 9 months; 9 months | — |
Countries
Italy
Contacts
Public ContactDirezione Scientifica Fondazione Po
Direzione scientifica Fondazione Policlinico A.Gemelli IRCCS
Outcome results
None listed