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mTOR Inhibitor

Lenvatinib + Everolimus for Kidney Cancer

Phase 1
Waitlist Available
Led By Yousef Zakharia, MD
Research Sponsored by Yousef Zakharia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Renal function within normal institutional limit or creatinine clearance >30 mL/min/1.73 m2
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening (within 14 days of day 1) and pre-surgery (week 9-10). 1) if metastatic disease followup monthly or 2) if no evidence of disease followup every three months until five years or death.
Awards & highlights

Study Summary

This trial is testing a combination of drugs to see if it can make previously inoperable tumors resectable in patients with kidney cancer.

Who is the study for?
Adults with advanced or metastatic renal cell carcinoma, clear cell type, who may undergo surgery. They must have normal kidney function or mild impairment, acceptable blood counts and liver enzymes, an ECOG performance status of 0-2 (meaning they can care for themselves), a life expectancy over 12 weeks, measurable disease by medical imaging, and a heart ejection fraction ≥45%. Men and women must use contraception; women need a negative pregnancy test.Check my eligibility
What is being tested?
The trial is testing the combination of two drugs: lenvatinib plus everolimus in patients with local and metastatic renal cell carcinoma. The goal is to see if this drug combo can shrink tumors enough to make them operable when they previously weren't considered so.See study design
What are the potential side effects?
Possible side effects include high blood pressure that's hard to control even with medication; increased levels of cholesterol and triglycerides; proteinuria which means excess protein in urine indicating kidney issues; cardiovascular problems like heart failure or unstable angina.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function is normal or nearly normal.
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I can take care of myself and am up and about more than half of my waking hours.
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I am 18 years old or older.
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My kidney cancer is advanced but may be treated with surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening (within 14 days of day 1) and pre-surgery (week 9-10). 1) if metastatic disease followup monthly or 2) if no evidence of disease followup every three months until five years or death.
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening (within 14 days of day 1) and pre-surgery (week 9-10). 1) if metastatic disease followup monthly or 2) if no evidence of disease followup every three months until five years or death. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Surgical complications as assessed by Clavien-Dindo classification system
Secondary outcome measures
Changes in overall response rate as assessed by RECIST 1.1
Comparison of surgical outcomes to historical controls
Treatment related adverse events as assessed by CTCAE criteria, version 4.03

Side effects data

From 2019 Phase 3 trial • 392 Patients • NCT01321554
70%
Hypertension
70%
Diarrhoea
60%
Weight decreased
43%
Fatigue
43%
Stomatitis
40%
Arthralgia
40%
Proteinuria
40%
Nausea
37%
Decreased appetite
33%
Headache
33%
Asthenia
33%
Dysphonia
30%
Myalgia
30%
Palmar-plantar erythrodysaesthesia syndrome
30%
Abdominal pain upper
30%
Vomiting
27%
Cough
27%
Abdominal pain
27%
Dizziness
23%
Pain in extremity
20%
Alopecia
20%
Back pain
20%
Rash
20%
Dysgeusia
20%
Nasopharyngitis
17%
Constipation
17%
Muscle spasms
17%
Dyspnoea
17%
Epistaxis
17%
Platelet count decreased
17%
Pyrexia
13%
Hypotension
13%
Oropharyngeal pain
13%
Musculoskeletal pain
10%
Anaemia
10%
Paraesthesia
10%
Flank pain
10%
Dyspepsia
10%
Dysphagia
10%
Sinusitis
10%
Oedema peripheral
10%
Pelvic pain
10%
Urinary tract infection
10%
Hypocalcaemia
10%
Musculoskeletal chest pain
10%
Haemoptysis
10%
Depression
10%
Upper respiratory tract infection
10%
Insomnia
7%
Vitamin D deficiency
7%
Ejection fraction decreased
7%
Hypomagnesaemia
7%
Pneumonia
7%
Skin fissures
7%
Joint swelling
7%
Bronchitis
7%
Blood cholesterol increased
7%
Dyspnoea exertional
7%
Hyperhidrosis
7%
Toothache
7%
Hyperaesthesia
7%
Sciatica
7%
Gastrooesophageal reflux disease
7%
Lung infection
7%
Dermatitis acneiform
7%
Hypothyroidism
7%
Alanine aminotransferase increased
7%
Dry skin
7%
Flatulence
7%
Productive cough
7%
Non-cardiac chest pain
7%
Abdominal distension
7%
Gingival pain
7%
Gastrointestinal infection
7%
Pain
7%
Lipase increased
3%
Electrocardiogram T wave inversion
3%
Thermal burn
3%
Dementia
3%
Blood calcium increased
3%
Electrocardiogram QT prolonged
3%
Varicose vein
3%
Blood creatinine increased
3%
Hypoalbuminaemia
3%
Post procedural haemorrhage
3%
Pathological fracture
3%
Syncope
3%
Cerebrovascular accident
3%
Phlebitis infective
3%
Haemorrhoids
3%
Cholecystitis acute
3%
Gastroenteritis
3%
Delirium
3%
General physical health deterioration
3%
Dry mouth
3%
Hyponatraemia
3%
Dehydration
3%
Coronary artery occlusion
3%
Lymph gland infection
3%
Metastatic pain
3%
Transient ischaemic attack
3%
Hydrocholecystis
3%
Vasculitis
3%
Hyperglycaemia
3%
Neck pain
3%
Thrombocytopenia
3%
Malaise
100%
80%
60%
40%
20%
0%
Study treatment Arm
OOL, Treatment Period: Lenvatinib 20 mg
OOL, Treatment Period: Lenvatinib 24 mg
Randomization Phase: Placebo
Randomization Phase: Lenvatinib 24 mg

Trial Design

1Treatment groups
Experimental Treatment
Group I: Lenvatinib and Everolimus prior to cytoreductive nephrectomyExperimental Treatment3 Interventions
Eligible patients will start treatment with lenvatinib 18 mg PO daily (administered as one 10 mg capsule and two 4 mg capsules) and everolimus 5 mg PO daily for 4 weeks constituting one cycle. Two cycles of treatment will be administered and after 2 weeks wash out period, the patients will go for nephrectomy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Everolimus
2010
Completed Phase 4
~1510
Lenvatinib
2005
Completed Phase 4
~2690

Find a Location

Who is running the clinical trial?

Yousef ZakhariaLead Sponsor
4 Previous Clinical Trials
184 Total Patients Enrolled
Eisai Inc.Industry Sponsor
516 Previous Clinical Trials
158,948 Total Patients Enrolled
Yousef Zakharia, MDPrincipal Investigator - University of Iowa
University of Iowa Chemical Dependency Center, University of Iowa Hospitals & Clinics
4 Previous Clinical Trials
184 Total Patients Enrolled

Media Library

Everolimus (mTOR Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03324373 — Phase 1
Kidney Cancer Research Study Groups: Lenvatinib and Everolimus prior to cytoreductive nephrectomy
Kidney Cancer Clinical Trial 2023: Everolimus Highlights & Side Effects. Trial Name: NCT03324373 — Phase 1
Everolimus (mTOR Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03324373 — Phase 1
~2 spots leftby Jun 2025