RecruitingPhase 2NCT05319015

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

Sponsor

University of Texas Southwestern Medical Center

Enrollment

30 participants

Start Date

Jan 6, 2023

Study Type

INTERVENTIONAL

Conditions

Renal Cell Carcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether giving lenvatinib and pembrolizumab (two targeted/immune therapy drugs) before surgery can shrink kidney cancer that has grown into the large vein (IVC) leading to the heart, potentially making surgery easier or more successful. **You may be eligible if...** - You have kidney cancer with a tumor thrombus (tumor growth) in the inferior vena cava (IVC) - You are medically fit for eventual surgery - You are 18 or older - Your organs are functioning adequately **You may NOT be eligible if...** - You have already had systemic therapy for this kidney cancer - You have active autoimmune disease - You are pregnant - Your cancer has spread to distant organs beyond what is expected Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNeoadjuvant Lenvatinib

20 mg PO daily for 12 weeks prior to surgery

DRUGNeoadjuvant Pembrolizumab

200 mg IV every 3 weeks for 4 doses prior to surgery

PROCEDURERadical nephrectomy, IVC thrombectomy, retroperitoneal lymph node dissection

Resection of locally advanced RCC with IVC tumor thrombus

DRUGAdjuvant Pembrolizumab

200 mg IV every 3 weeks for up to 13 doses after surgery

Locations(1)

University of Texas Southwestern Medical Center

Dallas, Texas, United States

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NCT05319015

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