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Pembrolizumab + Axitinib for Kidney Cancer (NEOPAX Trial)
Phase 2
Recruiting
Led By Elizabeth E Kessler, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Suitable for and willing to undergo nephrectomy (either cytoreductive or with curative intent) per treating urologist
M stage of any of the following: cM0 or cM1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months, 9 months, 12 months from study enrollment
Awards & highlights
NEOPAX Trial Summary
This trial aims to shrink tumor thrombus to reduce surgical complications and improve patient health outcomes, with the hope of providing better long-term results.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include high blood pressure, fatigue, liver enzyme changes, thyroid dysfunction, diarrhea, loss of appetite, hand-foot syndrome (redness and pain on palms or soles), immune-related reactions such as inflammation in organs like lungs (pneumonitis) or intestines.
NEOPAX Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a candidate for and agree to have kidney surgery as advised by my urologist.
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My cancer may or may not have spread to distant parts of my body.
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My kidney cancer is confirmed to be clear cell type.
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My cancer has not spread to more than 1 nearby lymph node.
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My cancer is at an advanced local stage.
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I can take care of myself and perform daily activities.
NEOPAX Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months, 6 months, 9 months, 12 months from study enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months, 9 months, 12 months from study enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate Change in IVC Tumor Thrombus Extent Based on the Mayo Classification
Evaluate a change in IVC TT Size from Baseline
Secondary outcome measures
1 year Overall Survival
1 year Progression Free Survival
Evaluate Surgical Complications after the Neoadjuvant Combination of Pembrolizumab and Axitinib Among Patients with RCC with IVC TT
+1 moreNEOPAX Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Axitinib
2020
Completed Phase 2
~3050
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Cancer League of ColoradoOTHER
8 Previous Clinical Trials
214 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,509 Total Patients Enrolled
Elizabeth E Kessler, MDPrincipal InvestigatorUniversity of Colorado, Denver
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.I haven't had major surgery or radiation therapy in the last month.I have had heart problems in the last year.My cancer may or may not have spread to distant parts of my body.My kidney cancer is confirmed to be clear cell type.I am currently using or might need strong CYP3A4/5 inhibitors.I have been treated with drugs targeting the immune system for cancer.I have not received a live virus vaccine in the last 30 days.My cancer has not spread to more than 1 nearby lymph node.My cancer is at an advanced local stage.I can take care of myself and perform daily activities.I have had active bleeding in my digestive tract in the last 3 months without proof of it stopping.You have had a serious allergic reaction to Axitinib in the past.You have had an organ transplant in the past.Your heart's QT interval, when adjusted for your heart rate, is greater than or equal to 480 milliseconds.I am 18 years or older.I am not using, nor do I plan to use, certain strong medications or supplements recently.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.My blood pressure is high despite taking three or more medications for it.My doctor says my wounds don't heal properly.I haven't had significant bleeding or a bleeding disorder in the last 30 days.I have had treatment targeting blood vessel growth in my kidney cancer.I have another cancer that has worsened or needed treatment in the past 3 years.I have active brain metastases or cancer in the lining of my brain.I have had pneumonitis treated with steroids or have it now.My urine protein levels are low enough to qualify.You have a serious autoimmune disease that needs ongoing treatment, or you have had a very severe autoimmune disease in the past.Your liver enzymes (ALT or AST) are more than three times the normal level.I am a man who can father a child and will use birth control during my treatment.I have a GI condition that could lead to bleeding or a tear in my stomach or intestines.
Research Study Groups:
This trial has the following groups:- Group 1: Combination Pembrolizumab and Axitinib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How efficacious is the concurrent use of pembrolizumab and axitinib for human patients?
"Our team at Power has ranked the safety of Combination Pembrolizumab and Axitinib a 2 due to this being an early stage Phase 2 trial, which indicates that there is some data confirming its safety but none attesting to its efficacy."
Answered by AI
Are volunteers still being recruited for this clinical exploration?
"The information on clinicaltrials.gov reveals that this particular trial has temporarily suspended recruitment efforts, with the last update occurring on July 24th 2023. However, there are currently 2821 other studies actively searching for participants."
Answered by AI
What aims are scientists aiming to achieve with this research?
"This clinical trial's primary outcome, which will be monitored for a span of two years, is to assess the decrease in Intravenous Chemodectoma Tumor Size from Baseline. Secondary goals include assessing safety with neoadjuvant therapy among patients presenting RCCs and IVC TT via Adverse Events; determining Progression-free Survival (PFS); and measuring Overall Survival at one year."
Answered by AI
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