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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 belowSelect...
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.
Select...
My liver is working well.
Select...
My bone marrow is working well.
Select...
My kidney function is within the required range.
Select...
I am 18 years old or older.
Select...
I have only had initial cancer treatments before or after surgery.
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I have brain metastases that meet certain criteria.
Select...
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)
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 • NCT0132155470%
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%
Pain in extremity
18%
Abdominal pain upper
18%
Musculoskeletal pain
18%
Dry mouth
18%
Dyspnoea
18%
Dysgeusia
17%
Dizziness
16%
Pyrexia
16%
Oropharyngeal pain
16%
Hypokalaemia
15%
Hypocalcaemia
15%
Dyspepsia
14%
Epistaxis
13%
Dysphagia
13%
Alopecia
12%
Anaemia
12%
Musculoskeletal chest pain
12%
Dry skin
11%
Urinary tract infection
11%
Nasopharyngitis
10%
Thrombocytopenia
10%
Oral pain
10%
Blood creatinine increased
10%
Electrocardiogram QT prolonged
10%
Hypoalbuminaemia
10%
Upper respiratory tract infection
9%
Dehydration
9%
Neck pain
8%
Hypomagnesaemia
8%
Influenza like illness
8%
Muscle spasms
8%
Depression
8%
Lymphopenia
8%
Alanine aminotransferase increased
8%
Muscular weakness
7%
Hyponatraemia
7%
Ejection fraction decreased
7%
Haematuria
7%
Malaise
7%
Blood thyroid stimulating hormone increased
7%
Platelet count decreased
7%
Aspartate aminotransferase increased
7%
Toothache
7%
Glossodynia
7%
Blood alkaline phosphatase increased
7%
Hyperkeratosis
7%
Bronchitis
7%
Pruritus
6%
Influenza
6%
Anxiety
6%
Flatulence
6%
Hyperglycaemia
6%
Leukopenia
6%
Dysuria
5%
Paraesthesia
5%
Non-cardiac chest pain
5%
Productive cough
5%
Hypothyroidism
5%
Haemoptysis
5%
White blood cell count decreased
5%
Pneumonia
3%
General physical health deterioration
2%
Sepsis
2%
Cholecystitis
2%
Pulmonary embolism
2%
seizure
2%
Acute myocardial infarction
2%
Atrial fibrillation
2%
Lower respiratory tract infection
2%
Hypotension
2%
Lung infection
2%
Malignant pleural effusion
2%
Spinal cord compression
2%
Acute kidney injury
1%
Acute coronary syndrome
1%
Blood uric acid increased
1%
Death
1%
Monoparesis
1%
Small intestinal obstruction
1%
Hypercalcaemia
1%
Intestinal obstruction
1%
Osteoarthritis
1%
Colitis
1%
Transient ischaemic attack
1%
Acute respiratory failure
1%
Pancreatitis
1%
Atrial flutter
1%
Cardio-respiratory arrest
1%
Uterine prolapse
1%
Coronary artery stenosis
1%
Pneumatosis intestinalis
1%
Cerebrovascular accident
1%
Confusional state
1%
Hepatic failure
1%
Liver injury
1%
Diverticulitis
1%
Appendicitis
1%
Bacteraemia
1%
Gastroenteritis
1%
Perineal abscess
1%
Wound infection
1%
Intracranial tumour haemorrhage
1%
Malignant neoplasm progression
1%
Bone pain
1%
Cancer pain
1%
Syncope
1%
Vocal cord paralysis
1%
Respiratory failure
1%
Nephrotic syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Randomization Phase: Lenvatinib 24 mg
Randomization Phase: Placebo
OOL, Treatment Period: Lenvatinib 20 mg
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
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,698 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,560 Total Patients Enrolled
Joel Picus, M.D.Principal InvestigatorWashington University School of Medicine
3 Previous Clinical Trials
56 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have or had lung inflammation needing steroids, not caused by an infection.I have had serious heart issues, like a heart attack or unstable angina, in the last 6 months.I am using birth control as a man with a partner who can have children.I have had an organ or stem cell transplant from a donor.I haven't taken any immune system modifying drugs in the last 4 weeks.I can provide a recent tumor sample for testing.Your heart takes longer than it should to recharge between beats.My blood pressure is 150/90 or lower, and my medication hasn't changed recently.My kidney cancer has spread and is confirmed by tests.I haven't had major surgery in the last 4 weeks and don't plan any during the study.My kidney cancer is a specific type, not the most common clear cell kind.I am currently being treated for an infection.My liver is working well.Your blood clotting function is good, as shown by an INR level of 1.5 or lower.My bone marrow is working well.My kidney function is within the required range.I am positive for HIV, Hepatitis B, or Hepatitis C.I have a serious wound, ulcer, or bone fracture that won't heal.I am 18 years old or older.I have not had any other cancer besides the one I'm enrolling for in the last 3 years.I have not coughed up blood in the last 3 weeks.I have only had initial cancer treatments before or after surgery.I have not had a live vaccine in the last 30 days.I have brain metastases that meet certain criteria.My kidney cancer is mainly clear cell type.I am able to care for myself but may not be able to do active work.I have brain metastasis that is not being treated.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.You have high levels of protein in your urine.I have a condition that affects how my body absorbs medication.I have been treated for an autoimmune disease in the last 2 years.Your disease can be seen on a scan and meets certain size requirements.
Research Study Groups:
This trial has the following groups:- Group 1: Lenvatinib + Pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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