Study on Lenvatinib and Pembrolizumab Before Surgery for Kidney Cancer with IVC Tumor Thrombus

Sponsor: University of Texas Southwestern Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05319015

This clinical trial is testing the safety and effectiveness of using the drugs lenvatinib and pembrolizumab before surgery in patients with advanced kidney cancer that has spread to the inferior vena cava (IVC).

Patient Parameters

Program Overview

The purpose of this study is to evaluate whether the combination of lenvatinib and pembrolizumab, given before surgery, is safe and effective in treating locally advanced kidney cancer that has spread to the inferior vena cava (IVC).

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older.
  • Diagnosed with advanced kidney cancer (stage III-IV) that has spread to the inferior vena cava (IVC).
  • Tumor and thrombus may be removable or not at the time of joining the study.
  • Men must agree to use approved birth control during treatment and for 90 days after the last dose, and not donate sperm during this time.
  • Women must not be pregnant or breastfeeding and must agree to use approved birth control during treatment and for 30 days after the last dose if they are of childbearing potential.
  • Must provide written consent to participate.
  • Have measurable disease based on specific medical criteria.
  • Must provide a tumor tissue sample for analysis.
  • Must be in good general health with a performance status score of 0 or 1.
  • Must have adequate organ function as shown by specific blood tests.
  • Must meet specific blood count and organ function criteria without recent blood transfusions or certain medications.

Exclusion Criteria

  • Women who are pregnant or have a positive pregnancy test.
  • Have received certain cancer treatments or vaccines recently.
  • Currently participating in another study or have used an investigational device recently.
  • Have a known immune deficiency or are on long-term steroid therapy.
  • Have another progressing cancer or have had active treatment for another cancer in the past year.
  • Have active brain metastases or certain other medical conditions.
  • Have severe allergies to the study drugs.
  • Have an active autoimmune disease requiring treatment in the past two years.
  • Have a history of lung inflammation requiring steroids.
  • Have an active infection needing treatment.
  • Have any condition that might interfere with the study.
  • Have psychiatric or substance abuse issues affecting study participation.
  • Have had an organ transplant.
  • Have certain heart conditions or abnormal heart rhythms.
  • Have uncontrolled high blood pressure.

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