Lenvatinib + Everolimus for Kidney Cancer
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive lenvatinib and everolimus for 8 weeks, followed by a 1-week washout period
Surgery
Participants undergo nephrectomy surgery after the washout period
Follow-up
Participants are monitored for surgical complications and disease status
Treatment Details
Interventions
- Everolimus
- Lenvatinib
- Partial or Radical Cytoreductive Nephrectomy
Everolimus is already approved in United States, European Union for the following indications:
- 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
- Subependymal giant cell astrocytoma
- Renal angiomyolipoma
- Tuberous sclerosis complex-associated partial-onset seizures
- Prevention of organ rejection in kidney transplant patients
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yousef Zakharia
Lead Sponsor
Eisai Inc.
Industry Sponsor
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