NCT05969496

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients will receive the combination of Axitinib 5 mg orally twice daily (can be increased to 7 mg twice daily after 2 weeks, and further to 10 mg twice daily as tolerated) and Pembrolizumab 200 mg IV every 21 days. This combination will be given for a total of 12 weeks (4 cycles). A radiographic assessment will be done up to 12 weeks (4 cycles of therapy) to evaluate the primary endpoint of IVC TT response. Patients will undergo a definitive surgery per treating urologist within 2 weeks (+/- 7 days) after the end of treatment scan. During the course of the trial, patient-related health outcomes using Kidney Cancer validated questionnaires with FKSI-DRS and FKSI-19 will also be obtained. These are validated paper questionnaires that will be given to each patient on study visits while receiving neoadjuvant therapy.

Conditions

• Renal Cancer
• Kidney Cancer
• Renal Cell Carcinoma
• Inferior Vena Cava Thrombosis

Interventions

Type	Name	Description
DRUG	Axitinib	Axitinib is a potent oral, vascular endothelial growth factor, c-kit and platelet derived growth factor inhibitor.
DRUG	Pembrolizumab	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.

Timeline

• Start date: 2023-12-04
• Primary completion: 2026-11-01
• Completion: 2029-11-01
• First posted: 2023-08-01
• Last updated: 2026-04-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study