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

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?

Research shows that the combination of Pembrolizumab and Axitinib is effective for advanced kidney cancer, with a 73% response rate in patients who have not been treated before. This combination also improves survival and delays cancer progression compared to another drug, sunitinib.12345

Is the combination of Pembrolizumab and Axitinib safe for humans?

The combination of Pembrolizumab and Axitinib has been studied for safety in patients with advanced kidney cancer. Some side effects include diarrhea, liver issues, fatigue, and heart-related problems, which require careful management by healthcare providers.14678

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 Kessler, MD | Profiles ...

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

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

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Combination Pembrolizumab and AxitinibExperimental Treatment2 Interventions
Neoadjuvant therapy with the combination of Pembrolizumab and Axitinib will be given for eligible RCC patients with an IVC TT for a total of 12 weeks. Patients will then undergo imaging with a contrast enhanced, diffusion weighted imaging MRI of the abdomen to evaluate the IVC TT response. A CT chest will also be done to ensure there is no progression of disease. Patients can undergo definitive surgery per treating Urologist within 2 weeks (+/- 7 days) after end of treatment scan.

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+

Findings from Research

The combination of axitinib and pembrolizumab shows a high response rate of 73% in patients with previously untreated advanced renal cell carcinoma, indicating strong efficacy for this treatment regimen.
This finding suggests that the dual approach of targeting both tumor growth and immune response may be effective in managing advanced kidney cancer.
Axitinib plus Pembrolizumab Is Effective in Renal Cell Carcinoma.[2019]
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 โ‰ฅ3 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]

References

Axitinib plus Pembrolizumab Is Effective in Renal Cell Carcinoma. [2019]
Real-World Therapy Management and Outcomes of First-Line Axitinib Plus Pembrolizumab in Patients With Advanced Renal Cell Carcinoma in the United States. [2022]
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. [2022]
Axitinib plus pembrolizumab in patients with advanced renal-cell carcinoma: Long-term efficacy and safety from a phase Ib trial. [2021]
Angiogenic and Immune-Related Biomarkers and Outcomes Following Axitinib/Pembrolizumab Treatment in Patients with Advanced Renal Cell Carcinoma. [2023]
Axitinib in combination with pembrolizumab in patients with advanced renal cell cancer: a non-randomised, open-label, dose-finding, and dose-expansion phase 1b trial. [2023]
Pembrolizumab plus axitinib versus sunitinib monotherapy as first-line treatment of advanced renal cell carcinoma (KEYNOTE-426): extended follow-up from a randomised, open-label, phase 3 trial. [2021]
Axitinib plus immune checkpoint inhibitor: evidence- and expert-based consensus recommendation for treatment optimisation and management of related adverse events. [2021]
Characterization and Management of Treatment-emergent Hepatic Toxicity in Patients with Advanced Renal Cell Carcinoma Receiving First-line Pembrolizumab plus Axitinib. Results from the KEYNOTE-426 Trial. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Pembrolizumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Outcomes With Combination Pembrolizumab and Axitinib in Second and Further Line Treatment of Metastatic Renal Cell Carcinoma. [2023]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceยทPrivacy PolicyยทCookiesยทSecurity