Pembrolizumab + Axitinib for Kidney Cancer
(NEOPAX Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if combining Pembrolizumab (an immunotherapy drug) and Axitinib (a targeted therapy) can shrink tumor clots in the main vein (Inferior Vena Cava) near the kidney in individuals with kidney cancer. By reducing these clots, the trial seeks to make surgeries safer and improve long-term health outcomes for participants. It is recruiting individuals with clear cell kidney cancer who are planning to undergo surgery. Those advised to have surgery for their kidney cancer might be suitable candidates for this trial. As a Phase 2 trial, it focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important research.
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.
Is there any evidence suggesting that the combination of Pembrolizumab and Axitinib is likely to be safe for humans?
Research has shown that the combination of pembrolizumab and axitinib is generally well-tolerated by patients. Earlier studies found that side effects were similar to those seen when each drug is used alone, indicating no significant increase in side effects when used together.
Using pembrolizumab and axitinib together has improved outcomes in kidney cancer. In a large study, this combination lowered the risk of death compared to another treatment. Additionally, about 85% of patients experienced some control over their disease, with many showing a reduction in tumor size.
While side effects occur, they are expected and often manageable. Previous studies have provided researchers with a good understanding of its safety. For those considering joining a trial, this information suggests that the treatment is safe enough to continue testing.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Pembrolizumab and Axitinib for treating kidney cancer because it offers a new approach that targets cancer more aggressively. Pembrolizumab is an immunotherapy drug that boosts the body’s immune response to attack cancer cells, while Axitinib inhibits blood vessel growth that tumors need to grow. By combining these two, there's potential for a more comprehensive attack on the cancer than standard treatments, which often focus on just one of these pathways. This dual-action approach could lead to better outcomes and offer hope for patients with advanced kidney cancer.
What evidence suggests that the combination of Pembrolizumab and Axitinib could be effective for kidney cancer?
Research has shown that using pembrolizumab and axitinib together yields promising results for treating kidney cancer. In this trial, participants will receive the combination as neoadjuvant therapy. One study found that this combination helped patients live longer and slowed cancer growth more effectively than sunitinib. Specifically, it reduced the chance of cancer worsening by 31% and nearly halved the risk of death for patients with advanced kidney cancer. In some cases, patients even saw their cancer completely disappear. These findings suggest that using pembrolizumab and axitinib together might be a good option for shrinking tumors and potentially improving long-term health outcomes.26789
Who Is on the Research Team?
Elizabeth R. Kessler
Principal Investigator
University of Colorado, Denver
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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