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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

Must not have

Any other cancer from which the patient has been disease-free for less than 3 years

Symptomatic untreated metastases in the central nervous system

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

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

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

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I have been cancer-free from another type for less than 3 years.

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I have untreated brain metastases causing symptoms.

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I have HIV/AIDS.

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I have an active hepatitis B or C infection.

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My blood pressure is over 140/90 mm Hg, even with medication.

Timeline

Screening ~ 3 weeks3 visits

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.

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

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

Primary study objectives

Surgical complications as assessed by Clavien-Dindo classification system

Secondary study objectives

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%

Diarrhoea

69%

Hypertension

57%

Decreased appetite

54%

Weight decreased

49%

Nausea

44%

Fatigue

40%

Headache

38%

Proteinuria

38%

Vomiting

38%

Stomatitis

33%

Palmar-plantar erythrodysaesthesia syndrome

33%

Arthralgia

33%

Dysphonia

32%

Constipation

30%

Cough

26%

Asthenia

25%

Oedema peripheral

21%

Rash

20%

Back pain

20%

Myalgia

19%

Abdominal pain

18%

Dysgeusia

18%

Abdominal pain upper

18%

Pain in extremity

18%

Musculoskeletal pain

18%

Dry mouth

18%

Dyspnoea

17%

Dizziness

16%

Pyrexia

16%

Oropharyngeal pain

16%

Hypokalaemia

15%

Dyspepsia

15%

Hypocalcaemia

14%

Epistaxis

13%

Dysphagia

13%

Alopecia

12%

Anaemia

12%

Musculoskeletal chest pain

12%

Dry skin

11%

Urinary tract infection

11%

Nasopharyngitis

10%

Oral pain

10%

Thrombocytopenia

10%

Hypoalbuminaemia

10%

Blood creatinine increased

10%

Electrocardiogram QT prolonged

10%

Upper respiratory tract infection

Dehydration

Neck pain

Depression

Hypomagnesaemia

Influenza like illness

Muscle spasms

Lymphopenia

Alanine aminotransferase increased

Muscular weakness

Malaise

Haematuria

Ejection fraction decreased

Pruritus

Hyponatraemia

Blood thyroid stimulating hormone increased

Platelet count decreased

Aspartate aminotransferase increased

Toothache

Glossodynia

Blood alkaline phosphatase increased

Hyperkeratosis

Bronchitis

Flatulence

Influenza

Dysuria

Anxiety

Hyperglycaemia

Leukopenia

Non-cardiac chest pain

Productive cough

Paraesthesia

Hypothyroidism

Haemoptysis

White blood cell count decreased

Pneumonia

General physical health deterioration

Sepsis

Cholecystitis

Pulmonary embolism

Malignant pleural effusion

seizure

Acute myocardial infarction

Atrial fibrillation

Lower respiratory tract infection

Hypotension

Lung infection

Spinal cord compression

Acute kidney injury

Blood uric acid increased

Monoparesis

Acute respiratory failure

Hypercalcaemia

Hepatic failure

Appendicitis

Death

Respiratory failure

Osteoarthritis

Intestinal obstruction

Small intestinal obstruction

Intracranial tumour haemorrhage

Acute coronary syndrome

Colitis

Transient ischaemic attack

Pancreatitis

Atrial flutter

Cardio-respiratory arrest

Uterine prolapse

Coronary artery stenosis

Pneumatosis intestinalis

Cerebrovascular accident

Confusional state

Liver injury

Diverticulitis

Bacteraemia

Gastroenteritis

Perineal abscess

Wound infection

Malignant neoplasm progression

Bone pain

Cancer pain

Syncope

Vocal cord paralysis

Nephrotic syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Randomization Phase: Lenvatinib 24 mg

Randomization Phase: Placebo

OOL, Treatment Period: Lenvatinib 24 mg

OOL, Treatment Period: Lenvatinib 20 mg

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: 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

2017

Completed Phase 4

~2070