17 Participants Needed

Pembrolizumab + Axitinib for Kidney Cancer

(NEOPAX Trial)

Recruiting at 2 trial locations
ML
Overseen ByMatthew Lee
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human 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.12345

Why 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 Kessler, MD | Profiles ...

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

Stated willingness to comply with all study procedures and be available for the duration of the study
My urologist considers me a good candidate for immediate surgery.
I am a candidate for and agree to have kidney surgery as advised by my urologist.
See 9 more

Exclusion Criteria

I haven't had major surgery or radiation therapy in the last month.
I have had heart problems in the last year.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study by subject self-report
See 21 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive neoadjuvant therapy with Pembrolizumab and Axitinib for 12 weeks

12 weeks
4 cycles of therapy with visits every 21 days

Surgery

Participants undergo definitive surgery within 2 weeks after the end of treatment scan

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including surgical complications and adverse events

4 weeks
Post-operative monitoring up to 30 days

Long-term Follow-up

Participants are monitored for progression-free survival and overall survival up to 1 year

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Axitinib
  • Pembrolizumab
Trial Overview The trial is testing if Pembrolizumab combined with Axitinib can reduce the size of kidney cancer-related blood clots in the vein before surgery. The goal is to see if this pre-surgery treatment leads to fewer surgical complications and better long-term health outcomes like survival without cancer progression.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Combination Pembrolizumab and AxitinibExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

Cancer League of Colorado

Collaborator

Trials
13
Recruited
450+

Published Research Related to This Trial

Axitinib combined with immune checkpoint inhibitors (ICI) like pembrolizumab or avelumab is now approved for treating advanced renal cell carcinoma, but distinguishing between adverse events (AEs) caused by each treatment is crucial for optimizing therapy.
Experts identified specific AEs such as diarrhea, hepatic toxicity, fatigue, and cardiovascular issues that require unique management strategies when using axitinib-ICI combinations, emphasizing the need for careful clinical monitoring and tailored treatment approaches.
Axitinib plus immune checkpoint inhibitor: evidence- and expert-based consensus recommendation for treatment optimisation and management of related adverse events.Grünwald, V., Voss, MH., Rini, BI., et al.[2021]
In a real-world study of 355 patients with advanced clear cell renal cell carcinoma, the combination of axitinib and pembrolizumab showed a best overall response rate of 47.9% and a one-year overall survival rate of 73.5%.
Treatment-related toxicity was the primary reason for dose adjustments, but over 80% of patients who experienced treatment management events were able to continue their therapy, suggesting that dose holds can be an effective strategy to manage side effects.
Real-World Therapy Management and Outcomes of First-Line Axitinib Plus Pembrolizumab in Patients With Advanced Renal Cell Carcinoma in the United States.Zakharia, Y., Thomaidou, D., Li, B., et al.[2022]
In a subgroup analysis of 94 Japanese patients with metastatic renal cell carcinoma, the combination of pembrolizumab and axitinib showed improved overall survival and progression-free survival compared to sunitinib, consistent with results from the larger global study.
The safety profile was also favorable, with fewer grade ≥3 treatment-related adverse events in the pembrolizumab-axitinib group (70%) compared to sunitinib (78%), and no deaths from treatment-related adverse events were reported.
Pembrolizumab plus axitinib versus sunitinib in metastatic renal cell carcinoma: outcomes of Japanese patients enrolled in the randomized, phase III, open-label KEYNOTE-426 study.Tamada, S., Kondoh, C., Matsubara, N., et al.[2022]

Citations

Pembrolizumab plus Axitinib versus Sunitinib for Advanced ...Treatment with pembrolizumab plus axitinib resulted in significantly longer overall survival and progression-free survival, as well as a higher objective ...
Results from a clinical trial of KEYTRUDA + axitinibKEYTRUDA with axitinib reduced the risk of cancer spreading, growing, or getting worse by 31% compared to sunitinib. Half of the patients receiving KEYTRUDA ...
KEYTRUDA® (pembrolizumab) in Combination with Inlyta ...KEYTRUDA (pembrolizumab) in combination with Inlyta (axitinib) reduced risk of death by nearly half compared to Sunitinib as first-line treatment for advanced ...
Pembrolizumab and axitinib induced pathological ...However, pembrolizumab plus axitinib combination is safe and improves long-term survival. Herein, we report a case of a pathological complete ...
INLYTA® (axitinib) with pembrolizumab Clinical Trial ResultsINLYTA with pembrolizumab decreased the overall risk of death by 47% compared to sunitinib (Overall survival). More time without advanced RCC growing or ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36681606/
Outcomes With Combination Pembrolizumab and Axitinib ...Combination pembrolizumab/axitinib among previously treated mRCC patients has activity, with AE rates comparable to those reported in the first line.
Real-world treatment outcomes in patients with advanced ...Axitinib with Pembrolizumab (AP) is one of the combinations which demonstrated improved outcomes in the KEYNOTE 426 study. We report real-world ...
8.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39405768/
Data From the Prospective ProPAXI StudyDisease control rate was achieved in 84.6% of patients: 4.3% reached a complete response, 52% had a partial response and 28.8% a stable disease. Primary ...
NCT02853331 | Study to Evaluate the Efficacy and Safety ...The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) in combination with axitinib versus sunitinib monotherapy as a ...
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