Actively Recruiting
Neoadjuvant Pembrolizumab and Axitinib in Renal Cell Carcinoma With Inferior Vena Cava Tumor Thrombus
Led by University of Colorado, Denver · Updated on 2026-04-13
17
Participants Needed
3
Research Sites
308 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
C
Cancer League of Colorado
Collaborating Sponsor
AI-Summary
What this Trial 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. 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.
CONDITIONS
Official Title
Neoadjuvant Pembrolizumab and Axitinib in Renal Cell Carcinoma With Inferior Vena Cava Tumor Thrombus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated consent form.
- Willingness to comply with all study procedures and availability for the study duration.
- Age 18 years or older.
- Histologically confirmed clear cell component renal cell carcinoma.
- Candidate for definitive surgery as determined by treating urologist.
- Suitable and willing to undergo nephrectomy (cytoreductive or curative).
- Tumor stage cT3b, cT3c, or cT4.
- Nodal stage cN0 or cN1.
- Metastatic stage cM0 or cM1.
- ECOG performance status between 0 and 2.
- Urinalysis protein less than 2+; if 2+ or more, 24-hour urine protein must be less than 2g.
- Negative pregnancy test within 14 days before treatment for participants with reproductive potential.
- Women post-menopausal by defined criteria or surgically sterilized.
- Effective birth control recommended for males with reproductive potential during treatment.
You will not qualify if you...
- Participation in another investigational study or device use within 4 weeks prior to enrollment.
- Major surgery within 4 weeks or radiation therapy within 1 week before enrollment.
- Prior treatment with anti-PD-1, PD-L1, or similar immune checkpoint therapies.
- Prior systemic anti-cancer therapy targeting VEGF or VEGF receptors for RCC.
- History of severe allergic reaction to Axitinib.
- Immunodeficiency or systemic steroid use greater than prednisone 10 mg daily within 7 days before enrollment, except for CNS metastases.
- Active autoimmune disease requiring systemic treatment within past 2 years or severe autoimmune history, except stable conditions like vitiligo or hypothyroidism.
- Additional malignancy progressing or treated actively in last 3 years, except certain skin and localized cancers.
- Active CNS metastases or carcinomatous meningitis.
- History of pneumonitis needing steroids or current pneumonitis.
- Liver enzymes (ALT or AST) above 3 times normal limits.
- Live virus vaccine within 30 days before enrollment.
- Active gastrointestinal bleeding in past 3 months without resolution.
- Gastrointestinal conditions increasing risk of perforation.
- QTc interval 480 msec or higher.
- Major cardiovascular events or severe heart failure within past 12 months.
- Poorly controlled hypertension despite medication.
- Inadequate wound healing.
- Active bleeding disorder or significant bleeding episodes within 30 days.
- Use or anticipated need for strong CYP3A4/5 inhibitors or inducers within 7 days.
- Psychiatric or substance abuse disorders interfering with study compliance.
- Prior solid organ transplant.
- Pregnancy, breastfeeding, or planning conception during study and 120 days after last dose.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Hilands Ranch Hospital
Highlands Ranch, Colorado, United States, 80129
Actively Recruiting
3
Lone Tree Medical Center
Lone Tree, Colorado, United States, 80124
Actively Recruiting
Research Team
M
Matthew Lee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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