Urinary Cancer MK-3475-361

April 11, 2017

Sponsor: Merck Sharp & Dohme Corp.

Number: MK-3475-361

The purpose of this study is to determine the efficacy and safety of Pembrolizumab (MK-3475) with or without chemotherapy versus chemotherapy alone. The study is for participants with advanced (infiltrating the musculature) or metastatic (the development of secondary malignant growths at a distance from a primary site of cancer) urothelial carcinoma/bladder cancer. The primary hypotheses are that Pembrolizumab plus chemotherapy is superior to chemotherapy alone with respect to Progression-free Survival (PFS) and Overall Survival (OS) in participants. These participants with programmed cell death ligand 1 (PD-L1), have positive tumors and/or PD-L1 negative tumors.

Who’s eligible:

• The patient must have a histologically (tissue microscopically examined) or cytologically (fluid cells microscopically examined) confirmed diagnosis of advanced/unresectable (inoperable) or metastatic urothelial carcinoma of the renal pelvis, ureter [upper urinary track], bladder, or urethra. Both transitional cell and mixed transitional/non- transitional cell histologies are allowed, but transitional cell carcinoma must be the predominant histology. There must be measurable disease based on RECIST 1.1 (Response Evaluation Criteria in Solid Tumors) as determined by the local site investigator/radiology assessment.
• The patient must have received no prior systemic chemotherapy for advanced or metastatic urothelial carcinoma, with the following exceptions:
  • Neoadjuvant (treatment given as a first step to shrink a tumor before the main treatment, which is usually surgery) platinum-based chemotherapy with recurrence >12 months from completion of therapy is permitted.
  • Adjuvant (treatment given after surgery, chemotherapy, and/or radiation therapy to lower the chance of the cancer coming back) platinum-based chemotherapy following radical cystectomy with recurrence >12 months from completion of therapy is permitted. 
• The patient has provided tissue for biomarker analysis from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
• This study is for patients age 18 and older.

Available at: Backus Hospital- Eastern Connecticut Hematology and Oncology.