| Eligibility |
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.
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