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Urothelial Carcinoma Treatment Study

Clinical Trial 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.
Clinical Trial Protocol ID: 
16060702
Clinical Trial Investigator Name: 
Nicklas Pfanzelter, MD
Clinical Trial Protocol Description: 

The purpose of this study is to test the safety and tolerability of the research study drug pembrolizumab (MK-3475) with or without platinum-based combination chemotherapy versus chemotherapy in subjects with urothelial carcinoma and to collect data.

Mk-3475 Keytruda® (pembrolizumab) has been approved for use in certain types of adult melanoma and lung cancer, and head and neck cancer, however, it has not been approved for urothelial carcinoma.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Have a histologically or cytologically 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/nontransitional cell histologies are allowed, but transitional cell carcinoma must be the predominant histology.
  • Have measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
  • Agree to participate by providing written informed consent/assent for the trial. You may also provide consent for Future Biomedical Research. However, you may participate in the main trial without participating in Future Biomedical Research.
  • Are at least 18 years of age on the day of signing informed consent.

You will be excluded from the study if any of the following criteria apply to you:

  • Have disease that is suitable for local therapy administered with curative intent. An example of local therapy with curative intent is treatment with chemotherapy and radiation for stage 3 disease. You will also be excluded if you have non-urothelial carcinoma of the urinary tract.
  • Are currently participating and receiving study therapy or have participated in a study of an investigational agent and received study therapy or have used an investigation device within 4 weeks of the first dose of treatment.
  • Have a diagnosis of immunodeficiency or are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to randomization.
  • Have had a prior anti-cancer mAb for direct anti-neoplastic treatment within 4 weeks prior to the first dose of trial treatment (6 weeks for nitrosoureas or mitomycin C) or have not recovered (ie, ≤ Grade 1 or at baseline) from AEs due to mAbs administered more than 4 weeks earlier. Subjects previously treated with a mAb will be eligible to participate after a 28-day washout period.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Genitourinary Cancers
Contact Phone: 
(312) 942-5526
Contact Name: 
Pam Sroka, BS, MT(ASCP), BSN, RN, CCRC