A Phase III Study of MK-6482 plus Lenvatinib versus Cabozantinib as Second-line or Third-line Treatment of Advanced Kidney Cancer Persisting after Immunotherapy

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Full Title

(MK6482-011) An Open-label, Randomized, Phase 3 Study of MK-6482 in Combination with Lenvatinib (MK-7902) vs Cabozantinib for Second-line Treatment in Participants with Advanced Renal Cell Carcinoma Who Have Progressed After 1 Prior Anti-PD-1/L1 Combination Regimen (WIRB)

Purpose

This study is comparing treatment with MK-6482 and lenvatinib together versus cabozantinib alone as the second or third regimen of treatment in patients with advanced clear cell renal cell carcinoma, a type of kidney cancer, that has continued to grow despite prior treatment with immunotherapy. MK-6482 inhibits a protein called HIF-2 alpha, which can accumulate and promote cancer growth in patients with a genetic disorder called von Hippel-Lindau (VHL) disease. Lenvatinib and cabozantinib are already each used to treat kidney cancer.

Patients will be randomly assigned to receive MK-6482 and lenvatinib together, or cabozantinib alone. The combination of MK-6482 and lenvatinib is considered investigational. All three medications are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic clear cell renal cell carcinoma that persists despite one or two prior regimens of treatment that included immunotherapy.
  • Patients should recover from the serious side effects of previous treatments before receiving the study therapy.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Robert Motzer at 646-888-4722.

Protocol

21-151

Phase

III

Investigator

Co-Investigators