NCT05969496 · University of Colorado, Denver
Neoadjuvant Pembrolizumab and Axitinib in Renal Cell Carcinoma With Inferior Vena Cava Tumor Thrombus
(NEOPAX)
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
Evaluate Change in IVC Tumor Thrombus Extent Based on the Mayo Classification
Time frame: baseline and 12 weeks
* Patients will get baseline imaging with an MRI of the abdomen to evaluate the level of the IVC TT based on the Mayo Classification. Patients will get an end of treatment MRI at 12 weeks to evaluate the efficacy of neoadjuvant therapy with Pembrolizumab and Axitinib. The Mayo classification is described as below: * Level 0: thrombus limited to the renal vein * Level 1: into IVC \<2cm from renal vein ostium level * Level 2: IVC extension \>2cm from renal vein ostium and below hepatic vein * Level 3: thrombus at the level of or above the hepatic veins but below the diaphragm * Level 4: thrombus extending above the diaphragm
Evaluate a change in IVC TT Size from Baseline
Time frame: baseline and 12 weeks
o Evaluation of IVC TT anteroposterior and transverse diameter will also be measured at baseline and the end of treatment at 12 weeks. The baseline largest diameter will be subtracted to the largest diameter as the end of treatment divided by the baseline largest diameter will be computed to evaluate the percentage change in the IVC TT size.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 \<2+ protein. If dipstick is ≥2+ then a 24-hour urine collection should be performed, and the patient may enter the trial if urinary protein is \<2g per 24 hours.
- All participants who have reproductive potential must have a negative serum or urine pregnancy test wit
Where
- Aurora, Colorado
- Highlands Ranch, Colorado
- Lone Tree, Colorado
Collaborators
Cancer League of Colorado
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations