RecruitingPhase 2NCT05969496

Neoadjuvant Pembrolizumab and Axitinib in Renal Cell Carcinoma With Inferior Vena Cava Tumor Thrombus

Neoadjuvant Pembrolizumab and Axitinib in Renal Cell Carcinoma With Associated Inferior Vena Cava Tumor Thrombus (NEOPAX)


Sponsor

University of Colorado, Denver

Enrollment

17 participants

Start Date

Dec 4, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The primary objective of this study is to evaluate whether the combination of Pembrolizumab and Axitinib given in the neoadjuvant setting can change the Inferior Vena Cava Tumor Thrombus burden. A decrease in the size of the tumor thrombus can potentially lead to decrease in surgical complications, improve patient related health outcomes, and improve long term outcomes such as progression free survival and overall survival.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving immunotherapy (pembrolizumab) and a targeted drug (axitinib) before surgery can improve outcomes for people with kidney cancer (renal cell carcinoma) that has grown into a major blood vessel called the inferior vena cava, forming a tumor thrombus (blood clot-like tumor). This kind of kidney cancer is typically very challenging to treat. The study aims to see if shrinking the tumor before surgery makes the operation safer and more effective. **You may be eligible if...** - You are 18 years or older with a confirmed diagnosis of clear cell kidney cancer - Imaging shows your cancer extends into the inferior vena cava (T3b, T3c, or T4 staging) - You are a candidate for surgery to remove the kidney (nephrectomy) as determined by your urologist - Your overall health and organ function are adequate for treatment - You have a negative pregnancy test if applicable **You may NOT be eligible if...** - You have significant autoimmune conditions requiring ongoing immunosuppressive treatment - You have severe cardiovascular problems or recent heart events - You have excessive protein in your urine (above study threshold) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAxitinib

Axitinib is a potent oral, vascular endothelial growth factor, c-kit and platelet derived growth factor inhibitor.

DRUGPembrolizumab

Pembrolizumab is a type of immunotherapy. It stimulates the body's immune system to fight cancer cells. Pembrolizumab targets and blocks a protein called PD-1 on the surface of certain immune cells called T-cells. Blocking PD-1 triggers the T-cells to find and kill cancer cells.


Locations(3)

University of Colorado Cancer Center

Aurora, Colorado, United States

Hilands Ranch Hospital

Highlands Ranch, Colorado, United States

Lone Tree Medical Center

Lone Tree, Colorado, United States

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NCT05969496


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