A Phase 3 Study Assessing Pembrolizumab Immunotherapy plus Belzutifan and Lenvatinib, or MK-1308A plus Lenvatinib, versus Pembrolizumab and Lenvatinib as Initial Treatment for Advanced Kidney Cancer

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Full Title

An Open-label, Randomized Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with MK-6482 and Lenvatinib (MK-7902), or MK-1308A in Combination with Lenvatinib, versus Pembrolizumab and Lenvatinib, as Firstline Treatment in Participants with Advanced Clear Cell Renal Cell Carcinoma (ccRCC) (WIRB)

Purpose

In this study, researchers are comparing the effectiveness of three different combination treatments for people with advanced clear cell renal cell carcinoma, a type of kidney cancer. Participants will be randomly assigned to receive one of these treatments:

  • Pembrolizumab immunotherapy plus belzutifan and lenvatinib
  • MK-1308A (pembrolizumab with MK-1308) plus lenvatinib
  • Pembrolizumab plus lenvatinib

Belzutifan and lenvatinib are taken orally (by mouth) and pembrolizumab and MK-1308A are given intravenously (by vein).

Eligibility

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

  • Participants must have inoperable or metastatic clear cell renal cell cancer.
  • Patients may not have received other systemic therapies, including immunotherapy for advanced kidney cancer, unless no metastatic disease was present at the time of such therapy and the treatment was completed at least 12 months ago.
  • At least 2 weeks must pass since the completion of prior radiation therapy and 4 weeks since major surgery and receipt of the study treatment.
  • Patients may not have any history of brain metastases.
  • 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 ask about eligibility for this study, please contact the office of Dr. Martin Voss at 646-888-4721.

Protocol

21-454

Phase

III

Investigator

Co-Investigators