PHASE III RANDOMIZED ADJUVANT STUDY OF MK-3475 (PEMBROLIZUMAB) IN MUSCLE INVASIVE AND LOCALLY ADVANCED UROTHELIAL CARCINOMA (AMBASSADOR) VERSUS OBSERVATION

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Muscle Invasive And Locally Advanced Urothelial Carcinoma
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1) Tissue available for Central PD-L1 Testing 2) Patient must fit into one of the following three categories: • Patients who received neoadjuvant chemotherapy and pathologic stage at surgical resection is = pT2 and/or N+ OR • Patients who are not cisplatin-eligible (according to = 1 of the following criteria: ECOG performance status of 2, creatinine clearance < 60 mL/min, grade = 2 hearing loss, grade = 2 neuropathy, or New York Heart Association Class III heart failure [38]) and pathologic stage at surgical resection is = pT3 or pN+) OR • Patients that decline adjuvant cisplatin-based or other systemic chemotherapy based on an informed discussion with the physician and pathologic stage at surgical resection is = pT3 or pN+

You may not be eligible for this study if the following are true:

  • 1) Medical condition such as uncontrolled infection, uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient. 2) Patients with a “currently active” second malignancy other than non-melanoma skin cancers or cervical carcinoma in situ or incidental organ-confined prostate cancer found on cystoprostatectomy 3) Has received systemic chemotherapy in the adjuvant setting following cystectomy/nephrectomy/ureterectomy


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