Lenvatinib + Everolimus vs. Cabozantinib for Renal Cell Carcinoma

Recruiting in Palo Alto (17 mi)

+2 other locations

Paul G. Corn | MD Anderson Cancer Center

Overseen byNizar Tannir

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase II trial compares the effects of lenvatinib given in combination with everolimus to the effects of cabozantinib given alone in treating patients with renal cell cancer (RCC) that has spread to other parts of the body (metastatic) and that got worse on a previous PD-1/PD-L1 checkpoint inhibitor. Lenvatinib, everolimus, and cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Eligibility Criteria

Adults with advanced renal cell cancer that has spread and worsened after PD-1/PD-L1 checkpoint inhibitor treatment. They must have good organ function, no major psychiatric illness, and at least one measurable disease site. Excluded are those with uncontrolled blood pressure, recent surgery or injury, other medical conditions affecting study participation, severe allergies to trial drugs, certain heart problems, prior use of similar drugs, other cancers within 3 years (with exceptions), inflammatory bowel or serious liver disease.

Inclusion Criteria

Your blood clotting levels need to be within a certain range before you can join the study.

My organs and bone marrow are working well.

My cancer progressed after treatment with a PD-1/PD-L1 drug, or I had a severe reaction to it.

+9 more

Exclusion Criteria

Patients with severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study

My blood pressure is not well-controlled.

You have high levels of protein in your urine, unless a specific urine test shows that the ratio of protein to creatinine is within a certain range.

+14 more

Participant Groups

This phase II trial is testing the effectiveness of lenvatinib combined with everolimus versus cabozantinib alone in patients whose metastatic renal cell cancer has progressed despite previous treatments. The goal is to see which regimen better halts tumor growth by blocking enzymes needed for cell proliferation.

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A (lenvatinib, everolimus)Experimental Treatment3 Interventions

Patients receive lenvatinib PO QD and everolimus PO QD. Cycles repeat every 30 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm B (cabozantinib)Active Control2 Interventions

Patients receive cabozantinib PO QD. Cycles repeat every 30 days in the absence of disease progression or unacceptable toxicity.

Cabozantinib is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Cabometyx for: