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Tyrosine Kinase Inhibitor
Lenvatinib + Everolimus vs. Cabozantinib for Renal Cell Carcinoma
Phase 2
Recruiting
Led By Nizar M Tannir
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have adequate organ and marrow function
Female patients of childbearing potential must have a negative pregnancy test
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from start of study drug until disease progression defined by response evaluation criteria in solid tumors (recist) 1.1, assessed up to 2 years
Awards & highlights
Study Summary
This trial is comparing two different drugs to see which is more effective in treating metastatic renal cell cancer.
Who is the study for?
Adults with advanced renal cell cancer that has spread and worsened after PD-1/PD-L1 checkpoint inhibitor treatment. They must have good organ function, no major psychiatric illness, and at least one measurable disease site. Excluded are those with uncontrolled blood pressure, recent surgery or injury, other medical conditions affecting study participation, severe allergies to trial drugs, certain heart problems, prior use of similar drugs, other cancers within 3 years (with exceptions), inflammatory bowel or serious liver disease.Check my eligibility
What is being tested?
This phase II trial is testing the effectiveness of lenvatinib combined with everolimus versus cabozantinib alone in patients whose metastatic renal cell cancer has progressed despite previous treatments. The goal is to see which regimen better halts tumor growth by blocking enzymes needed for cell proliferation.See study design
What are the potential side effects?
Potential side effects include high blood pressure; fatigue; diarrhea; mouth sores; hand-foot syndrome (redness and pain on palms and soles); protein in urine indicating kidney issues; bleeding or clotting disorders; allergic reactions to drug components. Each patient's experience may vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My organs and bone marrow are working well.
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I am a woman who can have children and my pregnancy test is negative.
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I have advanced kidney cancer treated with up to 2 therapies, including a PD-1/PD-L1 inhibitor.
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I am 18 years old or older.
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I have at least one tumor that can be measured.
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I can take care of myself but might not be able to do heavy physical work.
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I am 18 years old or older.
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My cancer progressed after my last PD-1/PD-L1 treatment within the past 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from start of study drug until disease progression defined by response evaluation criteria in solid tumors (recist) 1.1, assessed up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from start of study drug until disease progression defined by response evaluation criteria in solid tumors (recist) 1.1, assessed up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-Free Survival (PFS)
Secondary outcome measures
Disease Control Rate (DCR)
Health-Related Quality of Life (HRQoL)
Incidence of grade 3 or 4 adverse events
+2 moreSide 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%
Oral pain
10%
Thrombocytopenia
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%
Productive cough
5%
Non-cardiac chest pain
5%
Paraesthesia
5%
Hypothyroidism
5%
Haemoptysis
5%
White blood cell count decreased
5%
Pneumonia
3%
General physical health deterioration
2%
Cholecystitis
2%
Sepsis
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%
Hypercalcaemia
1%
Intestinal obstruction
1%
Monoparesis
1%
Death
1%
Small 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
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (lenvatinib, everolimus)Experimental Treatment3 Interventions
Patients receive lenvatinib PO QD and everolimus PO QD. Cycles repeat every 30 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm B (cabozantinib)Active Control2 Interventions
Patients receive cabozantinib PO QD. Cycles repeat every 30 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Everolimus
2010
Completed Phase 4
~1510
Lenvatinib
2005
Completed Phase 4
~2690
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,306 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,667 Previous Clinical Trials
40,926,042 Total Patients Enrolled
Nizar M TannirPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
52 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood clotting levels need to be within a certain range before you can join the study.My blood pressure is not well-controlled.My organs and bone marrow are working well.You have high levels of protein in your urine, unless a specific urine test shows that the ratio of protein to creatinine is within a certain range.My cancer progressed after treatment with a PD-1/PD-L1 drug, or I had a severe reaction to it.I haven't had any other cancer types in the last 3 years.I am a woman who can have children and my pregnancy test is negative.I have previously been treated with lenvatinib, a c-MET inhibitor, or an mTOR inhibitor.My heart's pumping ability is below 40%.I have advanced kidney cancer treated with up to 2 therapies, including a PD-1/PD-L1 inhibitor.I am not on any other treatments for kidney cancer.I don't have any health conditions that would make it unsafe for me to take lenvatinib, everolimus, or cabozantinib.I am not currently on cancer treatment and haven't been for the last 2 weeks.I am 18 years old or older.I have at least one tumor that can be measured.I can take care of myself but might not be able to do heavy physical work.I understand the study's risks and its investigational nature despite my psychiatric history.My brain metastases have been treated and are stable for at least 1 month.I am 18 years old or older.You have a strong allergic reaction to lenvatinib or any of its ingredients.I have a long-term liver condition like cirrhosis.I have not had major surgery or significant injury within the last 28 days.You have a weakened immune system.I have a bleeding or clotting disorder, or I'm at high risk for severe bleeding.I have an active inflammatory bowel condition.My cancer progressed after my last PD-1/PD-L1 treatment within the past 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (lenvatinib, everolimus)
- Group 2: Arm B (cabozantinib)
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.
Lenvatinib has been linked with certain side effects, could you please enumerate them?
"Lenvatinib's safety was estimated to be a 2 because, at the time of this Phase 2 trial, there was no data supporting efficacy."
Answered by AI
Are researchers still looking for study participants?
"Yes, this study is still recruiting patients according to the latest update on clinicaltrials.gov from October 11th, 2022. The study was originally posted February 16th of the same year."
Answered by AI
What does Lenvatinib usually treat?
"Lenvatinib is not only helpful in treating waldenstrom macroglobulinemia, but also other diseases such as lung cancer, advanced carcinoid tumor, and renal cell carcinoma."
Answered by AI
What are the previous clinical trials that have used Lenvatinib?
"Currently, there are 351 ongoing clinical trials for Lenvatinib. Of these, 59 are in Phase 3. Most of the studies for Lenvatinib are being conducted in Nanning, Guangxi; however, there are 15656 total locations running trials for Lenvatinib."
Answered by AI
How many people are receiving care through this program?
"That is correct. The clinical trial, which was posted on February 16th, 2022, is currently looking for 90 individuals from 1 site according to the data available on clinicaltrials.gov."
Answered by AI
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