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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

Must not have

Has current use (within 7 days of enrollment) or anticipated need for treatment with drugs or foods that are known to be strong cytochrome P450 (CYP3A4/5) inhibitors

Has had prior treatment with any anti-programmed cell death (anti-PD-1) or programmed cell death ligand 1 (PD-L1), or an antibody targeting any other immune-regulatory receptors or mechanisms

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months, 6 months, 9 months, 12 months from study enrollment

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently using or might need strong CYP3A4/5 inhibitors.

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I have been treated with drugs targeting the immune system for cancer.

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I have had active bleeding in my digestive tract in the last 3 months without proof of it stopping.

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I am not using, nor do I plan to use, certain strong medications or supplements recently.

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My blood pressure is high despite taking three or more medications for it.

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I have had treatment targeting blood vessel growth in my kidney cancer.

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I have active brain metastases or cancer in the lining of my brain.

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I have had pneumonitis treated with steroids or have it now.

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I have a GI condition that could lead to bleeding or a tear in my stomach or intestines.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months, 9 months, 12 months from study enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Evaluate Change in IVC Tumor Thrombus Extent Based on the Mayo Classification

Evaluate a change in IVC TT Size from Baseline

Secondary study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 3

~3150