A Phase II Study of Pembrolizumab in Patients with Inoperable or Metastatic Urothelial Cancers

Full Title

A Phase II Clinical Trial of Pembrolizumab (MK-3475) in Subjects with Advanced/Unresectable or Metastatic Urothelial Cancer

Purpose

Gemcitabine and cisplatin are standard drugs used to treat urothelial cancers (those affecting the bladder, ureters, urethra, or renal pelvis). However, not all patients can tolerate these drugs. In addition, more effective treatments are generally needed to treat these cancers when they have become advanced or cannot be surgically removed.

In this study, researchers are evaluating the safety and effectiveness of the drug pembrolizumab in patients with inoperable or metastatic urothelial cancers who are not eligible to receive gemcitabine and cisplatin. Pembrolizumab is already approved to treat melanoma and non-small cell lung cancer; its use in this study is considered investigational. It works by blocking a molecule called PD-1 that shuts down the immune response. Blocking PD-1 can allow the immune system to detect and attack cancer cells. Pembrolizumab 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 inoperable or metastatic urothelial transitional cell cancer and be unable to receive gemcitabine and cisplatin.
  • Patients may not have received prior therapy for inoperable or metastatic disease.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Dean Bajorin at 646-422-4333.

Protocol

15-248

Phase

II

Investigator

Co-Investigators

Locations