Neoadjuvant Pembrolizumab and Axitinib in Renal Cell Carcinoma With Associated Inferior Vena Cava Tumor Thrombus (NEOPAX)
University of Colorado, Denver
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.
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 outc…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Provision to sign and date the consent form. * Stated willingness to comply with all study procedures and be available for the duration of the study. * Participant self-identified gender ages \>/= 18 years old is acceptable and appropriate if they meet other inclusion criteria. * Histologically proven clear cell component RCC. * An upfront candidate for definitive surgery per treating Urologist. * Suitable for and willing to undergo nephrectomy (either cytoreductive or with curative intent) per treating urologist. * T Stage of any of the following: cT3b, cT3c, cT4 * N st…
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 CenterAurora, Colorado
- Hilands Ranch HospitalHighlands Ranch, Colorado
- Lone Tree Medical CenterLone Tree, Colorado