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mTOR inhibitor

Lenvatinib + Everolimus for Kidney Cancer

Phase 2

Waitlist Available

Research Sponsored by Eisai Inc.

Eligibility Criteria Checklist

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

Must have

Histological or cytological confirmation of predominant clear cell renal cell carcinoma (RCC) (original tissue diagnosis of RCC is acceptable)

Adequate renal function defined as calculated creatinine clearance >=30 milliliters per minute (mL/min)

Must not have

Females who are breastfeeding or pregnant at Screening or Baseline

Active infection (any infection requiring systemic treatment)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of randomization until the date of death from any cause, or up to date of data cut off for the primary analysis (up to 29 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at whether a lower dose of lenvatinib, in combination with everolimus, is just as effective as a higher dose of lenvatinib with everolimus, while also being safer.

Who is the study for?

Adults with advanced clear cell renal cell carcinoma who've had one prior VEGF-targeted treatment can join this trial. They must have a measurable lesion, good performance status, controlled blood pressure, and adequate organ function. Exclusions include more than one prior VEGF treatment, active malignancy in the last 24 months, recent cancer treatments or surgeries, CNS metastases without stable recovery, uncontrolled diabetes or heart issues.

What is being tested?

The study is testing two doses of lenvatinib (14 mg vs. 18 mg) combined with everolimus to see which dose has better efficacy and safety for kidney cancer patients. It's randomized and open-label; participants will be assigned by chance to receive either the lower or higher dose of lenvatinib.

What are the potential side effects?

Possible side effects include high blood pressure, fatigue, diarrhea, decreased appetite, weight loss and signs of liver dysfunction like jaundice. There may also be risks of abnormal bleeding or clotting disorders as well as potential gastrointestinal issues affecting drug absorption.

Eligibility Criteria

Inclusion Criteria

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

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My kidney cancer is mainly clear cell type, confirmed by tissue diagnosis.

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My kidneys work well enough, with a creatinine clearance rate of at least 30 mL/min.

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My kidney cancer is in an advanced stage.

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I am 18 years old or older.

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I am able to care for myself but may not be able to do active work.

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My blood tests show normal white blood cells, platelets, and hemoglobin levels.

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My liver tests are within the required limits.

Exclusion Criteria

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

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I am not pregnant or breastfeeding.

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I do not have any infections needing treatment through my bloodstream.

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

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I have a bleeding or clotting disorder, or I'm at high risk for severe bleeding.

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I haven't had major heart problems in the last 6 months.

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I have had more than one treatment targeting VEGF for my advanced kidney cancer.

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I have had cancer within the last 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of randomization until the date of death from any cause, or up to date of data cut off for the primary analysis (up to 29 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of randomization until the date of death from any cause, or up to date of data cut off for the primary analysis (up to 29 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of randomization until the date of death from any cause, or up to date of data cut off for the primary analysis (up to 29 months) 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 at Week 24 (ORR24W)

Percentage of Participants With Intolerable Grade 2 or Any Grade >=Grade 3 TEAEs Within 24 Weeks

Secondary study objectives

HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores

HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS)

Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores

+7 more

Side effects data

From 2024 Phase 3 trial • 794 Patients • NCT03713593

47%

Diarrhoea

45%

Hypertension

42%

Hypothyroidism

37%

Decreased appetite

34%

Palmar-plantar erythrodysaesthesia syndrome

33%

Proteinuria

32%

Fatigue

30%

Weight decreased

29%

Aspartate aminotransferase increased

26%

Blood bilirubin increased

25%

Platelet count decreased

23%

Alanine aminotransferase increased

23%

Nausea

22%

Arthralgia

21%

Dysphonia

18%

Abdominal pain

18%

Asthenia

17%

Pruritus

17%

Constipation

16%

Gamma-glutamyltransferase increased

16%

Rash

16%

Oedema peripheral

15%

Hypoalbuminaemia

14%

Lipase increased

14%

Back pain

13%

Cough

13%

Vomiting

12%

Headache

12%

Blood alkaline phosphatase increased

12%

Anaemia

11%

Abdominal pain upper

11%

Pyrexia

11%

Hyponatraemia

11%

Dyspnoea

10%

Amylase increased

10%

Blood creatinine increased

10%

Stomatitis

Hypokalaemia

Insomnia

Neutrophil count decreased

Urinary tract infection

Hyperthyroidism

Dyspepsia

Abdominal distension

White blood cell count decreased

Haematuria

Ascites

Hypertriglyceridaemia

Myalgia

Dizziness

Toothache

Mucosal inflammation

Hyperglycaemia

Hypomagnesaemia

Epistaxis

Hypophosphataemia

Pain in extremity

Dysgeusia

Oropharyngeal pain

Hepatic encephalopathy

Neutropenia

Dry mouth

Malaise

Hyperkalaemia

Pneumonia

General physical health deterioration

Hepatic pain

Pancreatitis

Pneumonia klebsiella

Septic shock

Hepatic failure

Tumour haemorrhage

Angina pectoris

Myocardial infarction

Gastric ulcer haemorrhage

Gastrointestinal haemorrhage

Hepatorenal syndrome

COVID-19

COVID-19 pneumonia

Atrial fibrillation

Immune thrombocytopenia

Acute myocardial infarction

Adrenal insufficiency

Hypophysitis

Colitis

Gastric haemorrhage

Haemorrhoidal haemorrhage

Death

Multiple organ dysfunction syndrome

Immune-mediated hepatitis

Sepsis

Dehydration

Diabetic ketoacidosis

Hypoglycaemia

Tumour lysis syndrome

Cerebrovascular accident

Depressed level of consciousness

Ischaemic stroke

Seizure

Acute kidney injury

Pemphigoid

100%

80%

60%

40%

20%

Study treatment Arm

Lenvatinib + Placebo

Lenvatinib + Pembrolizumab

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Lenvatinib 18 mg plus everolimus 5 mgExperimental Treatment2 Interventions

Participants will receive oral lenvatinib 18 mg QD plus oral everolimus 5 mg QD as the starting dose in Cycle 1 or later (cycle length =28 days) during randomization phase. After the data cutoff for the primary analysis, participants will receive study treatment as continuous 56-day cycles.

Group II: Lenvatinib 14 mg plus everolimus 5 mgExperimental Treatment2 Interventions

Participants will receive oral lenvatinib 14 mg once daily (QD) plus oral everolimus 5 mg QD as the starting dose for Cycle 1. If there are no intolerable Grade 2 or any \>= Grade 3 treatment-emergent adverse events (TEAEs) that require dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), the lenvatinib dose will be escalated to 18 mg QD (plus everolimus 5 mg) beginning in Cycle 2 or later (cycle length equal to \[=\] 28 days) during randomization phase. After the data cutoff for the primary analysis, participants will receive study treatment as continuous 56-day cycles.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

lenvatinib

2018

Completed Phase 3

~1950

everolimus

2005

Completed Phase 4

~1490