Lenvatinib + Everolimus for Kidney Cancer

Overseen By Yousef Zakharia, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Yousef Zakharia

Disqualifiers: Other cancers, CNS metastases, Hypertension, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 9 weeks

11 Participants Needed

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.

Research Team

Yousef Zakharia, MD

Principal Investigator

University of Iowa

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 ≥45%. Men and women must use contraception; women need a negative pregnancy test.

Inclusion Criteria

Your liver function test results (AST/ALT) are within the normal range.

I am not pregnant and agree to use two forms of birth control.

I am a man who can father a child and agree to use birth control.

Exclusion Criteria

Your cholesterol and triglyceride levels are very high when you haven't eaten for a while.

Subject that is pregnant or lactating

I have been cancer-free from another type for less than 3 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive lenvatinib and everolimus for 8 weeks, followed by a 1-week washout period

9 weeks

Weekly visits (in-person)

Surgery

Participants undergo nephrectomy surgery after the washout period

1 week

1 visit (in-person)

Follow-up

Participants are monitored for surgical complications and disease status

5 years

Monthly visits if metastatic disease, every three months if no evidence of disease

Treatment Details

Interventions

• Everolimus
• Lenvatinib
• Partial or Radical Cytoreductive Nephrectomy

Trial Overview 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.

Participant Groups

Group I: Lenvatinib and Everolimus prior to cytoreductive nephrectomy Experimental Treatment 3 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 for the following indications:

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

Approved in European Union as Votubia for:

• Subependymal giant cell astrocytoma
• Renal angiomyolipoma
• Tuberous sclerosis complex-associated partial-onset seizures

Approved in United States as Zortress for:

• Prevention of organ rejection in kidney transplant patients

Who Is Running the Clinical Trial?

Yousef Zakharia

Lead Sponsor

Trials

5

Recruited

160+

Eisai Inc.

Industry Sponsor

Trials

524

Recruited

161,000+

Founded

Eisai Inc. was established in 1995 as the U.S. subsidiary of Eisai Co., Ltd.

Headquarters

Woodcliff Lake, NJ, USA

Known For

Neurology and Oncology

Top Products

Aricept (donepezil), Lenvima (lenvatinib), Leqembi (lecanemab), Halaven (eribulin)

Lynn Kramer

Eisai Inc.

Chief Medical Officer since 2019

MD

Tatsuyuki Yasuno

Eisai Inc.

Chief Executive Officer since 2023

MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University