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Tyrosine Kinase Inhibitor

Lenvatinib + Pembrolizumab for Locally Advanced Kidney Cancer

Phase 2

Recruiting

Led By Mehmet A Bilen, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with a renal mass consistent with a clinical stage >= T3Nx or TanyN+ or deemed unresectable by surgeon

Hepatic: Total bilirubin=≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN AST (SGOT) and ALT (SGPT)=≤2.5 × ULN (≤5 × ULN for participants with liver metastases)

Must not have

Has a known history of active Hepatitis B (e.g., hepatitis B surface antigen [HBsAg]) or hepatitis C (e.g., HCV RNA qualitative is detected)

Has uncontrolled HIV defined by a CD4+ count < 350 cells/uL, an AIDS-defining opportunistic infection within the last 12 months prior to study enrollment or documented multidrug resistance that prevents effective HIV therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years after study start

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing lenvatinib and pembrolizumab as a possible treatment for kidney cancer that has spread to nearby tissues or lymph nodes.

Who is the study for?

This trial is for adults with advanced kidney cancer that hasn't spread beyond nearby tissues or lymph nodes. Participants must have a certain level of physical fitness (ECOG <=1), adequate organ function, and no recent other cancer treatments. They should not be pregnant or breastfeeding and must agree to use effective contraception.

What is being tested?

The study tests the combination of Lenvatinib, an enzyme inhibitor, with Pembrolizumab, an immunotherapy drug, before surgery in patients with non-metastatic clear cell renal carcinoma. The goal is to see if this pre-surgery treatment can better eliminate tumor cells.

What are the potential side effects?

Potential side effects include high blood pressure, fatigue, nausea, decreased appetite, inflammation-related symptoms from Pembrolizumab such as joint pain or skin rash and possible liver enzyme changes due to Lenvatinib.

Eligibility Criteria

Inclusion Criteria

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

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My kidney tumor is large or has spread to lymph nodes and cannot be surgically removed.

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My liver function tests are within the required limits.

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My kidney function is within the required range.

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I can carry out all my usual activities without help.

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My kidney cancer biopsy shows clear cell features.

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I haven't had a blood transfusion or taken erythropoietin in the last 2 weeks.

Exclusion Criteria

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

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I have an active Hepatitis B or C infection.

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My HIV is not under control, with a low CD4+ count or recent serious infection.

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I am currently being treated for an infection.

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My high blood pressure is not controlled even with medication.

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I have not received any live vaccines in the last 30 days.

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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

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I have a condition that affects how my body absorbs medication.

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I have previously been treated with lenvatinib or drugs targeting immune checkpoints.

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I have received treatments like chemotherapy for kidney cancer.

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I have or had lung inflammation that needed steroids.

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My urine protein is less than 1 g/24-hour.

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My heart's electrical activity (QTc interval) is not longer than 480 msec.

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I have not had significant bleeding or coughed up more than half a teaspoon of blood in the last 3 weeks.

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I have a serious wound or broken bone that is not healing.

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I have had a transplant of tissue or an organ from another person.

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I have had serious heart issues, like a heart attack or unstable angina, in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years after study start

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years after study start

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years after study start for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Objective response rate (complete and partial responses)

Secondary study objectives

Disease free survival (DFS)

Incidence of adverse events (AEs)

Overall survival (OS)

Other study objectives

Biomarker analysis

Degree of sarcopenia

Fried Frailty Score

+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: Treatment (lenvatinib, pembrolizumab)Experimental Treatment5 Interventions

Patients receive lenvatinib PO QD on days 1-21 and pembrolizumab IV over 30 minutes on day 1. Treatments repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

Lenvatinib

2017

Completed Phase 4

~2070