Neoadjuvant Lenvatinib and Pembrolizumab for IVC Tumor Thrombus

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT05319015
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 6, 2023
Status verified
Aug 2025
Primary completion
Jul 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm
    Patients receive neoadjuvant lenvatinib (20 mg PO daily) for 12 weeks and pembrolizumab (200 mg IV every 3 weeks for four doses) prior to surgical resection of locally advanced RCC with IVC tumor thrombus. Following surgery, patients will receive adjuvant pembrolizumab (200 mg IV every 3 weeks for up to thirteen doses).

Primary Outcome Measure

Disease Control Rate [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical CenterDallasTexas75390
Vitaly Margulis
[email protected]
214-648-0567
MD

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