A Phase III Study of Belzutifan and Pembrolizumab Immunotherapy versus Pembrolizumab Alone After Kidney Cancer Surgery in People with Clear Cell Renal Cell Cancer

Share

Full Title

A Multicenter, Double-blind, Randomized Phase 3 Study to Compare the Efficacy and Safety of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab, in the Adjuvant Treatment of Clear Cell Renal Cell Carcinoma (ccRCC) Post Nephrectomy (MK-6482-022)

Purpose

The purpose of this study is to compare the effectiveness of belzutifan (MK-6482) and pembrolizumab immunotherapy given together versus pembrolizumab with a placebo (inactive drug) in people with clear cell renal cell carcinoma (a type of kidney cancer) who have had kidney cancer surgery. Patients in this study will have cancer that has a greater risk of coming back or spreading or has already spread.

Belzutifan works by blocking a protein involved in cancer cell growth. Pembrolizumab boosts the power of the immune system to detect and destroy cancer cells. Researchers believe it may be more effective to use pembrolizumab with belzutifan than pembrolizumab alone for people with clear cell renal cell carcinoma. Participants in this study will be randomly assigned to receive pembrolizumab with belzutifan or with a placebo. Belzutifan and the placebo are taken orally (by mouth) and pembrolizumab is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have intermediate-risk, high-risk, or metastatic clear cell renal cell carcinoma that was surgically removed within 12 weeks of entering the study.
  • Patients may not have previously received anticancer medication or radiation therapy for their kidney cancer.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

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

Protocol

22-122

Phase

III

Disease Status

Newly Diagnosed

Investigator

Co-Investigators