A Phase II Study of Pembrolizumab, Lenvatinib, and Belzutifan in People with Pancreatic Cancer or Biliary Cancer

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Full Title

An Open-label, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Pembrolizumab Plus Lenvatinib in Combination With Belzutifan in Multiple Solid Tumors

Purpose

The purpose of this study is to assess the safety and effectiveness of adding the drug belzutifan to pembrolizumab immunotherapy and lenvatinib in people with pancreatic or biliary cancer that has continued to grow or came back despite treatment. Belzutifan is an investigational drug that blocks a protein (called HIF-2alpha) that is involved in tumor growth. By blocking this protein, the drug may cause cancer to shrink or stop growing.

Pembrolizumab boosts the power of the immune system to find and destroy cancer cells. Lenvatinib works against cancer by inhibiting the development of the blood vessels that tumors need to grow and spread. Belzutifan and lenvatinib 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 pancreatic or bile duct cancer that has continued to grow or came back despite treatment.
  • At least 4 weeks must pass since the completion of prior therapy and receipt of the study treatment.
  • 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.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Anna Varghese at 646-888-4308.

Protocol

22-169

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators