Lenvatinib + Everolimus vs. Cabozantinib for Renal Cell Carcinoma

Recruiting at 2 trial locations

Overseen By Paul Corn, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

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

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years

90 Participants Needed

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.

Research Team

Andrew W Hahn, MD

Principal Investigator

M.D. Anderson Cancer Center

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive lenvatinib and everolimus or cabozantinib orally once daily. Cycles repeat every 30 days in the absence of disease progression or unacceptable toxicity.

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Every 3 months

Treatment Details

Interventions

• Cabozantinib
• Everolimus
• Lenvatinib

Trial Overview 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.

Participant Groups

Group I: Arm A (lenvatinib, everolimus) Experimental Treatment 3 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 Control 2 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:

• Renal cell carcinoma
• Hepatocellular carcinoma

Approved in United States as Cabometyx for:

• Renal cell carcinoma
• Hepatocellular carcinoma

Approved in Canada as Cabometyx for:

• Renal cell carcinoma
• Hepatocellular carcinoma

Approved in Japan as Cabometyx for:

• Renal cell carcinoma

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+