Plain-English translation of NCT05319015 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.
This clinical trial is testing a combination of two medications—lenvatinib and pembrolizumab—given before surgery to patients with advanced kidney cancer that has spread into the inferior vena cava (a major vein near the kidney). The goal is to see whether this medication combination can shrink the tumor and make surgery safer and more effective.
Advanced kidney cancer that has formed blood clots in major veins is very difficult to treat and surgery alone carries significant risks. Doctors are studying whether giving this medication before surgery might shrink the tumors first, making the operation easier and improving patient outcomes.
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You would take a daily oral medication at home for 12 weeks while receiving intravenous infusions of the second medication every 3 weeks (four doses total). After this 12-week preparation period, you would have surgery to remove the tumor. Following surgery, you would receive additional intravenous infusions of one medication every 3 weeks for up to 13 more weeks. Throughout this time, you would have regular blood tests, scans, and clinic visits to monitor your progress and check for side effects.
AI-generated summary from trial data · Jun 24, 2026 · Not medical advice
United States
Phase
Testing effectiveness
Sponsor
University of Texas Southwestern Medical Center
Enrollment target
~30 participants
Started
January 2023
Primary completion
July 2026
This trial's estimated completion date has passed — the record may not be fully up to date.
Age range
18 Years and older
Last updated on clinicaltrials.gov in August 2025.
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Central contact
Donna Mitchell
University of Texas Southwestern Medical Center
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