Trial Summary
What is the purpose of this trial?The purpose of this research study is to see what effect the combination of lenvatinib plus everolimus has in local and metastatic renal cell carcinoma to potentially make surgically unresectable tumors resectable.
Eligibility Criteria
Adults with advanced or metastatic renal cell carcinoma, clear cell type, who may undergo surgery. They must have normal kidney function or mild impairment, acceptable blood counts and liver enzymes, an ECOG performance status of 0-2 (meaning they can care for themselves), a life expectancy over 12 weeks, measurable disease by medical imaging, and a heart ejection fraction โฅ45%. Men and women must use contraception; women need a negative pregnancy test.Inclusion Criteria
My kidney function is normal or nearly normal.
I can take care of myself and am up and about more than half of my waking hours.
I am 18 years old or older.
My kidney cancer is advanced but may be treated with surgery.
Exclusion Criteria
I have been cancer-free from another type for less than 3 years.
I have untreated brain metastases causing symptoms.
I have HIV/AIDS.
I have an active hepatitis B or C infection.
My blood pressure is over 140/90 mm Hg, even with medication.
Treatment Details
The trial is testing the combination of two drugs: lenvatinib plus everolimus in patients with local and metastatic renal cell carcinoma. The goal is to see if this drug combo can shrink tumors enough to make them operable when they previously weren't considered so.
1Treatment groups
Experimental Treatment
Group I: Lenvatinib and Everolimus prior to cytoreductive nephrectomyExperimental Treatment3 Interventions
Eligible patients will start treatment with lenvatinib 18 mg PO daily (administered as one 10 mg capsule and two 4 mg capsules) and everolimus 5 mg PO daily for 4 weeks constituting one cycle. Two cycles of treatment will be administered and after 2 weeks wash out period, the patients will go for nephrectomy.
Everolimus is already approved in United States, European Union, United States for the following indications:
๐บ๐ธ Approved in United States as Afinitor for:
- Advanced renal cell carcinoma
- Subependymal giant cell astrocytoma
- Progressive neuroendocrine tumors of pancreatic origin
- Advanced hormone receptor-positive, HER2-negative breast cancer
- Tuberous sclerosis complex-associated partial-onset seizures
๐ช๐บ Approved in European Union as Votubia for:
- Subependymal giant cell astrocytoma
- Renal angiomyolipoma
- Tuberous sclerosis complex-associated partial-onset seizures
๐บ๐ธ Approved in United States as Zortress for:
- Prevention of organ rejection in kidney transplant patients
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of Iowa Hospitals and ClinicsIowa City, IA
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Who is running the clinical trial?
Yousef ZakhariaLead Sponsor
Eisai Inc.Industry Sponsor