Pembrolizumab + Axitinib for Kidney Cancer
(NEOPAX Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot use certain drugs that strongly affect liver enzymes (CYP3A4/5 inhibitors or inducers) within 7 days before joining the study.
What data supports the effectiveness of the drug combination of Pembrolizumab and Axitinib for kidney cancer?
Is the combination of Pembrolizumab and Axitinib safe for humans?
How is the drug combination of pembrolizumab and axitinib unique for kidney cancer?
The combination of pembrolizumab and axitinib is unique for treating advanced kidney cancer because it combines an immune checkpoint inhibitor (pembrolizumab) with a VEGF-R-TKI (axitinib), which has shown better outcomes in terms of tumor response and survival compared to the standard treatment with sunitinib.1291011
What is the purpose of this trial?
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.
Research Team
Elizabeth R. Kessler
Principal Investigator
University of Colorado, Denver
Eligibility Criteria
Adults with clear cell renal cell carcinoma and a tumor thrombus in the inferior vena cava who are candidates for surgery. They must have good performance status, controlled blood pressure, no major surgeries or radiation therapy within specific time frames before enrollment, and not be on certain medications that affect immune response or blood clotting.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive neoadjuvant therapy with Pembrolizumab and Axitinib for 12 weeks
Surgery
Participants undergo definitive surgery within 2 weeks after the end of treatment scan
Follow-up
Participants are monitored for safety and effectiveness after treatment, including surgical complications and adverse events
Long-term Follow-up
Participants are monitored for progression-free survival and overall survival up to 1 year
Treatment Details
Interventions
- Axitinib
- Pembrolizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
Cancer League of Colorado
Collaborator