A Phase II Study of Ibrutinib plus Pembrolizumab Immunotherapy in People with Advanced Urothelial Cancer

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Full Title

A Phase 1b/2 Study of Ibrutinib Combination Therapy in Selected Advanced Gastrointestinal And Genitourinary Tumors

Purpose

The purpose of this study is to assess the safety and effectiveness of adding ibrutinib to pembrolizumab immunotherapy in patients with advanced urothelial cancers, such as bladder cancer. Ibrutinib works by blocking a protein inside cancer cells called Bruton’s tyrosine kinase (BTK), which helps cancer cells to live and grow, and is also known to affect the body’s immune system. Its use for urothelial cancer is investigational.

Pembrolizumab takes the brakes off the immune response by targeting a protein called PD-1, enabling the immune system to detect and destroy cancer cells. It is already used to treat urothelial cancer; its use in combination with ibrutinib is investigational. Pembrolizumab is given intravenously (by vein) and ibrutinib is 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 inoperable or metastatic bladder cancer or other urothelial cancer, such as cancers of the ureter, renal pelvis, or urethra.
  • Patients may not have previously received checkpoint inhibitors (the class of drugs to which pembrolizumab belongs).
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Min Yuen Teo at 646-888-4867.

Protocol

20-072

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators