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

Introduction

• Org Study ID: 22-1669.cc
• NTC ID: NCT05969496
• Lead Sponsor Name: University of Colorado, Denver
• Status: RECRUITING

Conditions

• Clear Cell Renal Cell Carcinoma

Brief 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 Criteria

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 stage of any of the following: cN0 or cN1
* M stage of any of the following: cM0 or cM1
* ECOG performance status 0 - 2.
* Urinalysis