Full TitleE7080-G000-307: A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination with Everolimus or Pembrolizumab Versus Sunitinib Alone in First-Line Treatment of Subjects with Advanced Renal Cell Carcinoma
There are a variety of treatments for renal cell cancer (RCC), a type of kidney cancer, but the cancer often comes back or continues to grow. Doctors are therefore seeking more effective therapies. In this study, patients with advanced RCC will be randomly assigned to one of three different treatments that researchers are comparing:
- Lenvatinib plus everolimus (a therapy currently used for RCC)
- Lenvatinib plus pembrolizumab immunotherapy
- Sunitinib alone
Lenvatinib and sunitinib work by inhibiting the growth of the blood vessels that tumors need to grow and spread. Everolimus inhibits a molecule called mTOR, which helps cancer cells grow. Pembrolizumab blocks a molecule called PD-1 that shuts down the immune response. Blocking PD-1 can allow the immune system to detect and attack cancer cells.
Lenvatinib is already approved for treating thyroid cancer and RCC, and pembrolizumab is approved for treating several cancers. Their use together in this study is considered investigational. Sunitinib is used to treat RCC, gastrointestinal stromal tumors, and certain pancreatic tumors. Lenvatinib and sunitinib are taken orally (by mouth), while pembrolizumab is given intravenously (by vein).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have advanced RCC that has not yet been treated with chemotherapy or any systemic therapy.
- If patients had radiation therapy, at least 3 weeks must pass between the last treatment and entry into the study.
- This study is for patients age 18 and older.