Study to Evaluate Efficacy and Safety of Sunitinib in Renal Cell Carcinoma Progressed to 1L Immunotherapy Treatment.

Inclusion criteria

• 1. Eighteen years or older on the day of consent
• 2. Documented histological or cytological diagnosis of renal cell cancer with a clear-cell component.
• 3. Patient must have progressed to at least one immune check point inhibitor-based therapy (antiPD1, anti-PDL1 o antiCTLA4) for the first line
• 4. Measurable disease per RECIST 1.1 as determined by the investigator
• 5. The subjects should not present disease that may be subsidiary of surgical treatment, radiotherapy or combined treatment with curative intent.
• 6. Recovery of toxicities related to any prior treatments to ≤ Grade 1 CTCAE v.4.03, unless adverse event(s) are clinically nonsignificant and/or stable on supportive therapy.
• 7. Eastern Cooperative Oncology Group Performance Status (PS) 0-2
• 8. Adequately controlled blood pressure (BP) with or without antihypertensive medication to maintain a BP <150/90 mmHg before the start of study treatment.
• 9. Adequate marrow function

• Absolute neutrophil count (ANC) ≥ 1500/mm3 (≥ 1.5 GI/L).
• Platelets ≥ 100,000/mm3 (≥ 100 GI/L).
• Hemoglobin ≥ 9 g/dL (≥ 5,6 mmol/L).
• 10. Adequate liver function

• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 × ULN.
• Total bilirubin ≤ 1.5 × upper limit of normal (ULN).
• 11. Adequate kidney function: calculated creatinine clearance ≥ 30 mL/min (≥ 0.5 mL/sec) using the Cockroft-Gault equation
• 12. Proteinuria <2+ on urine test strip
• 13. Prothrombin Time (PT) or International Standard Ratio (INR) ≤ 1.2 x ULN.
• 14. Life expectancy >3 months.
• 15. Patient able to ingest study drug and meet study follow-up requirements.
• 16. Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception
• 17. Female subjects of childbearing potential must not be pregnant at screening.

Exclusion criteria

• 1. Previous treatments with sunitinib are not permitted for the advanced or localized disease.
• 2. Major surgery within 3 weeks of patient inclusion
• 3. Radiation therapy or embolization within 2 weeks of first dose of sunitinib
• 4. Previous treatment with immunosuppressive drugs such as cyclosporine, tacrolimus, azathioprine, or long-term oral glucocorticoids taken prior to (3 months) patient inclusion
• 5. Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.
• 6. Current treatment on another clinical trial.
• 7. Treatment with known potent CYP3A4 inhibitors or inducers or that prolong the QT interval, within 7 days prior to the inclusion.
• 8. Prior radiation therapy to >25% of the bone marrow.
• 9. Uncontrolled brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.
• 10. Any gastrointestinal malabsorption disorder or any other condition that, in the opinion of the investigator, may affect the absorption of sunitinib or increase the risk of bleeding or perforation.
• 11. Presence of an unhealed wound or active ulcer.
• 12. Diarrhea grade III/IV in the screening period.
• 13. Diagnosis of any second malignancy within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
• 14. Clinically significant cardio-cerebrovascular disease within 6 months prior to initiation of treatment.
• 15. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2, atrial fibrillation of any grade that require treatment.
• 16. Corrected QT interval (QTc) interval >500 msec.
• 17. Active hemoptysis within 6 weeks prior to initiation of study treatment.
• 18. Evidence of active bleeding or hemorrhagic diathesis.
• 19. Presence of endobronchial lesions and / or lesions that infiltrate large vessels.
• 20. Current treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
• 21. Other clinically significant alterations:

• Known human immunodeficiency virus (HIV) infection.
• Presence of an uncontrolled active infection.
• Presence of uncontrolled or symptomatic hypothyroidism.
• Moderate-severe liver disease (Child Pugh B-C).
• Requirement for hemodialysis or peritoneal dialysis.
• History of solid organ transplantation.
• 22. Pregnancy or breastfeeding.
• 23. Any disease that, in the opinion of the investigator, interferes with the patient's ability to participate in the clinical trial.