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Tyrosine Kinase Inhibitor

Lenvatinib + Everolimus vs. Cabozantinib for Renal Cell Carcinoma

Phase 2
Waitlist Available
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
Must not have
Uncontrolled blood pressure
Patients receiving any concomitant systemic therapy for renal cell cancer are excluded
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
No Placebo-Only Group

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My blood pressure is not well-controlled.
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I am not on any other treatments for kidney cancer.
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I have previously been treated with lenvatinib, a c-MET inhibitor, or an mTOR inhibitor.
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My heart's pumping ability is below 40%.
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I am not currently on cancer treatment and haven't been for the last 2 weeks.
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I have a long-term liver condition like cirrhosis.
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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 have an active inflammatory bowel condition.

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-Free Survival (PFS)
Secondary study objectives
Disease Control Rate (DCR)
Health-Related Quality of Life (HRQoL)
Incidence of grade 3 or 4 adverse events
+2 more

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%
Hypoalbuminaemia
10%
Thrombocytopenia
10%
Oral pain
10%
Blood creatinine increased
10%
Electrocardiogram QT prolonged
10%
Upper respiratory tract infection
9%
Dehydration
9%
Neck pain
8%
Hypomagnesaemia
8%
Depression
8%
Influenza like illness
8%
Muscle spasms
8%
Lymphopenia
8%
Alanine aminotransferase increased
8%
Muscular weakness
7%
Malaise
7%
Haematuria
7%
Pruritus
7%
Ejection fraction decreased
7%
Hyponatraemia
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
6%
Flatulence
6%
Influenza
6%
Dysuria
6%
Anxiety
6%
Hyperglycaemia
6%
Leukopenia
5%
Non-cardiac chest pain
5%
Productive cough
5%
Paraesthesia
5%
Hypothyroidism
5%
Haemoptysis
5%
White blood cell count decreased
5%
Pneumonia
3%
General physical health deterioration
2%
Malignant pleural effusion
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%
Spinal cord compression
2%
Acute kidney injury
1%
Blood uric acid increased
1%
Acute respiratory failure
1%
Small intestinal obstruction
1%
Monoparesis
1%
Hepatic failure
1%
Acute coronary syndrome
1%
Appendicitis
1%
Hypercalcaemia
1%
Death
1%
Respiratory failure
1%
Osteoarthritis
1%
Intestinal obstruction
1%
Intracranial tumour haemorrhage
1%
Colitis
1%
Transient ischaemic attack
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%
Liver injury
1%
Diverticulitis
1%
Bacteraemia
1%
Gastroenteritis
1%
Perineal abscess
1%
Wound infection
1%
Malignant neoplasm progression
1%
Bone pain
1%
Cancer pain
1%
Syncope
1%
Vocal cord paralysis
1%
Nephrotic syndrome
100%
80%
60%
40%
20%
0%
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

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
Lenvatinib
2017
Completed Phase 4
~2070
Everolimus
2010
Completed Phase 4
~1510

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,501 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,490 Total Patients Enrolled
Nizar M TannirPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
52 Total Patients Enrolled
Paul M Corn, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Cabozantinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05012371 — Phase 2
Renal Cell Carcinoma Research Study Groups: Arm A (lenvatinib, everolimus), Arm B (cabozantinib)
Renal Cell Carcinoma Clinical Trial 2023: Cabozantinib Highlights & Side Effects. Trial Name: NCT05012371 — Phase 2
Cabozantinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05012371 — Phase 2
~20 spots leftby Oct 2025
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