NCT05319015

Neoadjuvant Lenvatinib and Pembrolizumab for IVC Tumor Thrombus

A Phase II Study of the Safety and Efficacy of Neoadjuvant Lenvatinib and Pembrolizumab in Patients With Renal Cell Carcinoma and IVC Tumor Thrombus

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Neoadjuvant Lenvatinib	20 mg PO daily for 12 weeks prior to surgery
DRUG	Neoadjuvant Pembrolizumab	200 mg IV every 3 weeks for 4 doses prior to surgery
PROCEDURE	Radical nephrectomy, IVC thrombectomy, retroperitoneal lymph node dissection	Resection of locally advanced RCC with IVC tumor thrombus
DRUG	Adjuvant Pembrolizumab	200 mg IV every 3 weeks for up to 13 doses after surgery

Timeline

• Start date: 2023-01-06
• Primary completion: 2026-07-01
• Completion: 2026-08-01
• First posted: 2022-04-08
• Last updated: 2025-08-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study