Study Comparing Lenvatinib with Everolimus to Cabozantinib for Second or Third-Line Treatment of Metastatic Kidney Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05012371

Provider View

This clinical trial is comparing two treatment options for patients with kidney cancer that has spread and worsened after previous treatments. The study aims to see if a combination of lenvatinib and everolimus is more effective than cabozantinib alone.

Patient Parameters

Program Overview

This phase II study is testing two different treatments for patients with metastatic renal cell cancer (RCC) that has spread to other parts of the body and has worsened after treatment with a PD-1/PD-L1 checkpoint inhibitor. The trial compares the effects of taking lenvatinib with everolimus against taking cabozantinib alone. These medications may help stop tumor growth by blocking certain enzymes needed for cancer cells to grow.

Description

The main goal of this study is to see if the combination of lenvatinib and everolimus works better than cabozantinib in patients with metastatic renal cell cancer (mRCC) who have already tried 1-2 other treatments, including a PD-1/PD-L1 checkpoint inhibitor.

Secondary goals include comparing how well the tumors respond to each treatment, the quality of life and safety for patients, and overall survival rates. Researchers will also explore if changes in certain genes are linked to how well the treatments work.

Participants will be randomly assigned to one of two groups:

  • Group A: Patients will take lenvatinib and everolimus by mouth once a day. Treatment cycles repeat every 30 days unless the disease progresses or side effects become unacceptable.
  • Group B: Patients will take cabozantinib by mouth once a day. Treatment cycles repeat every 30 days unless the disease progresses or side effects become unacceptable.

After finishing the study treatment, patients will have follow-up visits every 3 months.

Eligibility Criteria

Inclusion Criteria

  • Have metastatic or advanced clear cell renal cell cancer (RCC) or RCC with a clear cell component.
  • Have received 1 or 2 previous treatments for advanced or metastatic cancer, including a PD-1/PD-L1 checkpoint inhibitor.
  • Cancer must have worsened after previous treatment with a PD-1/PD-L1 regimen.
  • Have at least one measurable tumor that can be tracked using standard criteria.
  • Be in relatively good health with an ECOG performance status of 0, 1, or 2.
  • Be 18 years or older.
  • Have adequate organ and bone marrow function as shown by specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
  • Not be breastfeeding.
  • Be able to understand the study and agree to participate.
  • Patients with stable brain metastases that have been treated and have not recurred for at least 1 month are eligible.

Exclusion Criteria

  • Have previously received lenvatinib, cabozantinib, or everolimus.
  • Have had another cancer within the past 3 years, except for certain non-threatening cancers.
  • Are currently receiving or have recently received other cancer treatments.
  • Have had major surgery or a significant injury within the past 28 days.
  • Have active inflammatory bowel disease.
  • Have certain immune system conditions, such as HIV with low CD4+ T cell count.
  • Have any medical condition that could make the study treatment unsafe or affect the study results.
  • Are receiving other treatments for renal cell cancer.
  • Have severe heart, lung, or liver conditions.
  • Have uncontrolled high blood pressure.
  • Have a history of severe allergic reactions to lenvatinib or its ingredients.
  • Have a left ventricular ejection fraction below 40%.

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