Lenvatinib and Pembrolizumab for Kidney Cancer with IVC Tumor Thrombus
This study is looking at how safe and effective a combination of two drugs, Lenvatinib and Pembrolizumab, is for people with advanced kidney cancer (renal cell carcinoma) that has spread into a major vein called the inferior vena cava (IVC). You would receive these drugs before surgery to remove the cancer. After surgery, you would continue to receive Pembrolizumab. The study aims to see how well the treatment controls the disease, if the cancer spreads, and if there are any complications after surgery. This study is currently recruiting about 30 participants who are at least 18 years old with this specific type of kidney cancer.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 30 participants.
- What's involved
- You would take Lenvatinib daily for 12 weeks and receive Pembrolizumab intravenously every 3 weeks for 4 doses before surgery. After surgery, you would receive Pembrolizumab intravenously every 3 weeks for up to 13 doses.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track disease control, progression, and post-operative complications for up to 13 weeks after surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Neoadjuvant Lenvatinib and Pembrolizumab for IVC Tumor Thrombus
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Vitaly Margulis, MD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Disease Control Rate12 weeks
Evaluation of changes in size of primary tumor and size and level of IVC tumor thrombus on imaging due to neoadjuvant therapy prior to surgery.
- Local and Metastatic Progression Rate12 weeks
Evaluation of local or metastatic progression on imaging prior to surgery following neoadjuvant therapy.
- 90 Day Post-Operative Complications13 weeks
Assessment of 90 day post-operative safety and morbidity of neoadjuvant therapy by evaluating the incidence of 90 day post-operative grade 3-5 adverse events.