A Phase II Study of Sitravatinib plus Nivolumab Immunotherapy in Patients with Advanced or Metastatic Urothelial Cancer

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Full Title

A Phase 2 Study of Sitravatinib in Combination with Nivolumab in Patients with Advanced or Metastatic Urothelial Carcinoma

Purpose

The purpose of this study is to assess the safety and effectiveness of combining the investigational drug sitravatinib with nivolumab immunotherapy in patients with advanced or metastatic urothelial cancer, such as bladder cancer. Patients in this study will include those who have already received cisplatin and/or immunotherapy or no prior treatment.

Sitravatinib is a type of drug called a tyrosine kinase inhibitor. Sitravatinib blocks the proteins thought to trigger tumor growth and prevents the development of new blood vessels that help tumors grow and spread. Studies in patients have shown that sitravatinib may stimulate the immune system, boosting its ability to recognize and attack cancer cells.

Nivolumab also enhances the ability of the immune system to fight cancer cells, so using it in combination with sitravatinib may have an even greater effect. Sitravatinib is taken orally (by mouth) and nivolumab is 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 advanced or metastatic urothelial cancer (such as bladder, renal pelvis, ureter, or urethral cancer).
  • Patients should recover from the serious side effects of prior therapies before entering the study.
  • 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. Gopakumar Iyer at 646-888-4737.

Protocol

19-255

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators