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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years after study start
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My kidney tumor is large or has spread to lymph nodes and cannot be surgically removed.
Select...
My liver function tests are within the required limits.
Select...
My kidney function is within the required range.
Select...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (complete and partial responses)
Secondary outcome measures
Disease free survival (DFS)
Incidence of adverse events (AEs)
Overall survival (OS)
Other outcome measures
Biomarker analysis
Degree of sarcopenia
Fried Frailty Score
+1 moreTrial 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 2
~2010
Lenvatinib
2005
Completed Phase 4
~2690
Lenvatinib Mesylate
2016
Completed Phase 2
~90
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,638 Previous Clinical Trials
2,560,510 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,926,051 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,055,035 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an active Hepatitis B or C infection.My HIV is not under control, with a low CD4+ count or recent serious infection.My liver function tests are within the required limits.Your kidney function is measured using the Cockcroft and Gault formula.Your kidney function needs to be checked based on the hospital's method for measuring it.My kidney function is within the required range.My kidney tumor is large or has spread to lymph nodes and cannot be surgically removed.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I am currently being treated for an infection.My blood clotting time is normal or managed with medication.I have no active cancer other than the one I'm enrolling for, except for certain skin, prostate, bladder, or cervical cancers.My high blood pressure is not controlled even with medication.I have not received any live vaccines in the last 30 days.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.My blood clotting tests are within normal limits, or if I'm on blood thinners, they're in the therapeutic range.I have a condition that affects how my body absorbs medication.I have previously been treated with lenvatinib or drugs targeting immune checkpoints.I or my partner will use effective birth control during and after the study.I have received treatments like chemotherapy for kidney cancer.Your hemoglobin level must be at least 9.0 g/dL or 5.6 mmol/L within 72 hours before starting the study treatment.I have or had lung inflammation that needed steroids.I can carry out all my usual activities without help.My kidney cancer biopsy shows clear cell features.My blood clotting time is normal or managed if I'm on blood thinners.My liver function tests are within the required range.My urine protein is less than 1 g/24-hour.I do not have any major uncontrolled illnesses.My heart's electrical activity (QTc interval) is not longer than 480 msec.Your imaging shows that the cancer has spread to other parts of the body.I have not had significant bleeding or coughed up more than half a teaspoon of blood in the last 3 weeks.I have recovered from any major surgery complications before starting treatment.I have a serious wound or broken bone that is not healing.I haven't taken immune system boosters in the last 4 weeks, but I'm on stable erythropoietin therapy.I have had a transplant of tissue or an organ from another person.I have had serious heart issues, like a heart attack or unstable angina, in the last 6 months.You must have a certain level of a type of white blood cell called neutrophils in your blood before starting the study treatment.I haven't had a blood transfusion or taken erythropoietin in the last 2 weeks.Your platelet count is at least 100,000 per microliter of blood within 72 hours before starting the study treatment.Your bilirubin levels must be within a certain range, and the blood test must be done within 72 hours before starting the study treatment.We will measure the levels of ALT, AST, and GFR in your blood to make sure they are within a normal range.My kidney function is within the required range for the study.I do not have any heart conditions.
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.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (lenvatinib, pembrolizumab)
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what degree is Pembrolizumab risky for participants?
"While there is some proof of Pembrolizumab's safety, the lack of data demonstrating efficacy has led to a score of 2 being assigned."
Answered by AI
What medical conditions does Pembrolizumab usually address?
"Pembrolizumab has been shown to be effective for treating malignant neoplasms, unresectable melanoma, and microsatellite instability high."
Answered by AI
What other clinical experimentation has been conducted using Pembrolizumab?
"Currently, 1033 clinical trials are researching the effects and efficacy of Pembrolizumab. Of these studies 134 have reached Phase 3 while Sacramento is home to many of the sites conducting this research; 37103 locations across the globe are taking part in studying Pembrolizumab."
Answered by AI
What is the upper limit of subjects taking part in this investigation?
"That's correct. As evidenced on clinicaltrials.gov, this medical trial is currently enrolling participants and the initial posting was made June 22nd 2020 with a final edit taking place November 28th 2022. A total of 22 individuals are being sought out from one research centre."
Answered by AI
Are there any vacancies left in this clinical investigation?
"Affirmative. Clinicaltrials.gov data indicates that this research endeavor is still welcoming participants, having initially been posted on June 22nd 2020 and most recently updated on November 28th 2022. The study requires the enrollment of 22 individuals from a single medical facility."
Answered by AI
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