IRB #

STUDY00016506

Title

A Phase III Randomized, Controlled Clinical Trial of Pembrolizumab with or without Platinum-Based Combination Chemotherapy versus Chemotherapy in Subjects with Advanced or Metastatic Urothelial Carcinoma

Principal Investigator

Jacqueline Vuky

Study Purpose

The purpose of this study is to determine the efficacy and safety of pembrolizumab with or without chemotherapy versus chemotherapy alone in participants with advanced or metastatic urothelial carcinoma

Medical Condition(s)

Metastatic Urothelial Carcinoma.

Eligibility Criteria

1. Male or female age 18 or older
2. Confirmed diagnosis of advanced/unresectable (inoperable) or metastatic urothelial carcinoma of the renal pelvis, ureter [upper urinary track], bladder, or urethra.

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

You will be in this study for up to about 3 years. Each treatment cycle is 3 weeks. After you finish study treatment your doctor will continue to watch you for side effects and follow your condition every 9 weeks for the first year then every 12 weeks through clinic visits or by telephone until the study ends.

Minors Included

No

Contact

Knight Clinical Trials Information Line
503-494-1080
knight@ohsu.edu

Sponsor

Merck Sharp & Dohme Corp., (a subsidiary of Merck & Co. Inc.)

Recruitment End

12/15/2030

Compensation Provided

No


Go Back