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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

Must not have

Has a history of (non-infectious) pneumonitis/interstitial lung disease that required maintenance steroids or current pneumonitis/interstitial lung disease

New York Heart Association congestive heart failure of grade II or above, unstable angina, myocardial infarction within the past 6 months, or serious cardiac arrhythmia associated with significant cardiovascular impairment within the past 6 months

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

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

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I have or had lung inflammation needing steroids, not caused by an infection.

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I have had serious heart issues, like a heart attack or unstable angina, in the last 6 months.

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I have had an organ or stem cell transplant from a donor.

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I haven't had major surgery in the last 4 weeks and don't plan any during the study.

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I am currently being treated for an infection.

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I am positive for HIV, Hepatitis B, or Hepatitis C.

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I have a serious wound, ulcer, or bone fracture that won't heal.

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I have not had a live vaccine in the last 30 days.

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My kidney cancer is mainly clear cell type.

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I have brain metastasis that is not being treated.

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I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.

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

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I have been treated for an autoimmune disease in the last 2 years.

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

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

Primary study objectives

Overall response rate (ORR)

Secondary study objectives

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%

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

Malignant pleural effusion

Sepsis

Cholecystitis

Pulmonary embolism

seizure

Acute myocardial infarction

Atrial fibrillation

Lower respiratory tract infection

Hypotension

Lung infection

Spinal cord compression

Acute kidney injury

Blood uric acid increased

Intracranial tumour haemorrhage

Monoparesis

Acute respiratory failure

Hypercalcaemia

Hepatic failure

Appendicitis

Death

Respiratory failure

Osteoarthritis

Intestinal obstruction

Small intestinal obstruction

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 + 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 3

~3150

Lenvatinib

2017

Completed Phase 4

~2070