A Phase IB/II Study of Immunotherapy and Targeted Combination Therapies in Patients with Kidney Cancer

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Full Title

A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants with RCC (KEYNOTE-U03)

Purpose

The purpose of this study is to assess the safety and effectiveness of different combinations of drugs to treat advanced clear cell renal cell carcinoma, a type of kidney cancer, in patients who have not received any prior treatment or who have recently developed worsening disease while receiving immunotherapy that targets the PD-1/PD-L1 proteins.

  • Patients who have not previously received treatment for their advanced cancer will be randomly assigned to receive pembrolizumab immunotherapy and lenvatinib alone or in combination with MK-1308 (quavonlimab, an anti-CTLA-4 immunotherapy), MK-4280 (favezelimab, an anti-LAG3 immunotherapy), or MK-6482 (belzutifan, an anti-HIF2).
  • Patients who were previously treated with immunotherapy will be randomly assigned to receive pembrolizumab with MK-1308, MK-4280, MK-4830, or MK-6482; lenvatinib with MK-6482; or pembrolizumab with lenvatinib.

The combination of these therapies may increase the immune system’s activity against cancer cells. Lenvatinib and MK-6482 are taken orally (by mouth) and the other medications are given intravenously (by vein).

Eligibility

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

  • Patients must have inoperable or metastatic clear cell renal cell carcinoma.
  • Patients may or may not have had prior treatment for advanced disease; their treatment history will determine which part of the study they participate in.
  • Patients should recover from the serious side effects of prior treatments before receiving the study treatment.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Chung-Han Lee at 646-888-5418.

Protocol

21-148

Phase

I/II

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators