University of Texas Southwestern Medical Center
This study will be evaluating safety and efficacy of the combination of lenvatinib and pembolizumab neoaadjuvant therapy prior to surgical resection of locally advanced renal cell carcinoma with IVC tumor thrombus.
Inclusion Criteria: 1. Male/female participants who are at least 18 years of age on the day of signing informed consent 2. Have histologically confirmed cT3-4,N0-1,M0-1 (clinical stage III-IV) diagnosis of renal cell carcinoma (any subtype) with level II-IV inferior vena cava tumor thrombus as per the Mayo classification of macroscopic venous invasion in renal cell carcinoma: 1. Level 1 tumor thrombus is either at the entry of renal vein or within the IVC \< 2 cm from the confluence of renal vein and IVC 2. Level II tumor thrombus extends within the IVC \> 2 cm above the confluence of…
20 mg PO daily for 12 weeks prior to surgery
200 mg IV every 3 weeks for 4 doses prior to surgery
Resection of locally advanced RCC with IVC tumor thrombus
200 mg IV every 3 weeks for up to 13 doses after surgery
Arctuva estimate
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