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Tyrosine Kinase Inhibitor

Lenvatinib + Pembrolizumab for Kidney Cancer

Phase 2

Waitlist Available

Led By Joel Picus, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

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

Must have

Locally advanced or metastatic histologically confirmed nccRCC

Must have one of the following subtypes of nccRCC: papillary RCC, chromophobe RCC, TFE-3/B translocation RCC, SDHB-loss RCC, TSC1-loss RCC, sarcomatoid RCC without clear cell component, unclassified RCC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through completion of treatment (estimated to be 2 years)

Awards & highlights

Study Summary

This trial is testing a new combination therapy for people with kidney cancer that has spread and is not able to be removed by surgery.

Who is the study for?

Adults with advanced or metastatic non-clear cell renal carcinoma who haven't had chemotherapy for advanced disease. They must have specific subtypes of kidney cancer, normal blood pressure, adequate organ function, and no major surgery within the last month. Women must not be pregnant and agree to contraception; men also need to follow certain contraceptive guidelines.Check my eligibility

What is being tested?

The trial is testing a combination of two drugs: Lenvatinib (20 mg/day) and Pembrolizumab (200mg every three weeks), along with research blood collection in patients with certain types of kidney cancer that has spread and cannot be surgically removed.See study design

What are the potential side effects?

Possible side effects include high blood pressure, fatigue, loss of appetite, nausea, vomiting, weight loss, joint pain or muscle pain. There may also be risks related to immune system reactions such as inflammation in organs like lungs or intestines.

Eligibility Criteria

Inclusion Criteria

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

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My kidney cancer has spread and is confirmed by tests.

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My kidney cancer is a specific type, not the most common clear cell kind.

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My liver is working well.

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My bone marrow is working well.

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My kidney function is within the required range.

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I am 18 years old or older.

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I have only had initial cancer treatments before or after surgery.

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I have brain metastases that meet certain criteria.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through completion of treatment (estimated to be 2 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through completion of treatment (estimated to be 2 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of treatment (estimated to be 2 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall response rate (ORR)

Secondary outcome measures

Overall survival (OS)

Progression-free survival (PFS)

Safety and tolerability of regimen as measured by the number of adverse events

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

Skin fissures

Vitamin D deficiency

Ejection fraction decreased

Pneumonia

Hypomagnesaemia

Joint swelling

Bronchitis

Blood cholesterol increased

Dyspnoea exertional

Hyperhidrosis

Toothache

Hyperaesthesia

Sciatica

Gastrooesophageal reflux disease

Lung infection

Dermatitis acneiform

Hypothyroidism

Alanine aminotransferase increased

Dry skin

Flatulence

Productive cough

Non-cardiac chest pain

Abdominal distension

Gingival pain

Gastrointestinal infection

Pain

Lipase increased

Blood calcium increased

Electrocardiogram T wave inversion

Hypoalbuminaemia

Dementia

Varicose vein

Thermal burn

Blood creatinine increased

Electrocardiogram QT prolonged

Post procedural haemorrhage

Pathological fracture

Syncope

Cerebrovascular accident

Phlebitis infective

Haemorrhoids

Cholecystitis acute

Gastroenteritis

Delirium

General physical health deterioration

Dry mouth

Hyponatraemia

Dehydration

Coronary artery occlusion

Lymph gland infection

Metastatic pain

Transient ischaemic attack

Hydrocholecystis

Vasculitis

Hyperglycaemia

Neck pain

Thrombocytopenia

Malaise

100%

80%

60%

40%

20%

Study treatment Arm

OOL, Treatment Period: Lenvatinib 20 mg

Randomization Phase: Lenvatinib 24 mg

Randomization Phase: Placebo

OOL, Treatment Period: Lenvatinib 24 mg

Trial Design

1Treatment groups

Experimental Treatment

Group I: Lenvatinib + PembrolizumabExperimental Treatment3 Interventions

Lenvatinib 20 mg/day will be administered orally on a daily basis and pembrolizumab 200 mg will be infused once every 3 weeks. Subjects may be treated with pembrolizumab for a maximum of 35 cycles or approximately 2 years, but treatment with lenvatinib can continue beyond 2 years if the subject does not meet other treatment discontinuation criteria.

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

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,940 Previous Clinical Trials

2,303,384 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,896 Previous Clinical Trials

5,062,707 Total Patients Enrolled

Joel Picus, M.D.Principal InvestigatorWashington University School of Medicine

3 Previous Clinical Trials

56 Total Patients Enrolled

Media Library

Lenvatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04267120 — Phase 2

Kidney Cancer Research Study Groups: Lenvatinib + Pembrolizumab

Kidney Cancer Clinical Trial 2023: Lenvatinib Highlights & Side Effects. Trial Name: NCT04267120 — Phase 2

Lenvatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04267120 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What clinical indications is Lenvatinib used to address?

"Lenvatinib is a powerful medication used to fight malignant neoplasms, truculent melanoma unamenable to resection, microsatellite instability high conditions and progression of disease following chemotherapy."

Answered by AI

Has the United States Food and Drug Administration sanctioned Lenvatinib?

"The safety of Lenvatinib is rated at a 2 due to the limited clinical data available from Phase 2 trials. While there are some initial indications that it may be safe, efficacy has yet to be demonstrated."

Answered by AI

Are there any vacancies to participate in this research endeavor?

"Data accessible on clinicaltrials.gov reveals that this experiment, first announced on July 29th 2020, is actively seeking participants to join the study. The trial has been updated most recently in July 18th 2022."

Answered by AI

Are there any related studies which have utilized Lenvatinib?

"Lenvatinib is currently being studied in 1032 clinical trials, of which 134 are at the Phase 3 stage. While most research on Lenvatinib takes place near Sacramento, California, there are 37061 sites where studies for this treatment can be found."

Answered by AI

What is the current enrollment quota for this research trial?

"This clinical trial requires the enrolment of 34 participants that meet all the conditions listed in the inclusion criteria. Potential patients can join from either Stanford Cancer Center, located in Palo Alto, California or Washington University School of Medicine based out of Saint Louis, Missouri."

Answered by AI

How widely dispersed are the sites offering this clinical trial?

"4 active research centres are involved in this trial, namely Stanford Cancer Center (Palo Alto), Washington University School of Medicine (Saint Louis), Weill Cornell Medical College - New york Presbyterian Hospital (New York City) and 4 other locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Lenvatinib (LEN) in Combination With Pembrolizumab (KEYtruda) in Subjects With Locally Advanced or Metastatic Non-clear Cell Renal Cell Carcinoma (The LENKYN Trial)

2020. "Lenvatinib (LEN) in Combination With Pembrolizumab (KEYtruda) in Subjects With Locally Advanced or Metastatic Non-clear Cell Renal Cell Carcinoma (The LENKYN Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04267120.

All > Renal Cell Carcinoma