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Neoadjuvant Lenvatinib and Pembrolizumab for IVC Tumor Thrombus

NCT05319015 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-08-22

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Vitaly Margulis, MD · University of Texas Southwestern Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-06
Primary Completion
2026-07-31
Completion
2026-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05319015 on ClinicalTrials.gov