A PHASE III RANDOMIZED CLINICAL TRIAL OF PEMBROLIZUMAB (MK-3475) VERSUS PACLITAXEL, DOCETAXEL OR VINFLUNINE IN SUBJECTS WITH RECURRENT OR PROGRESSIVE METASTATIC UROTHELIAL CANCER

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 2

Inclusion Criteria

Willing and able to provide written informed consent
≥18 years of age
Histologically or cytologically confirmed diagnosis of urothelial cancer of the renal pelvis, bladder, ureter or uretra
Progression or recurrence of urotheliar cancer following receipt of a first-line platinum containing regimen
Have received no more than 2 prior lines o systemic chemotherapy for urothelial cancer
Provided tissue for biomarker analysis
Measurable disease based on RECIST 1.1
Performance status of 0, 1 or 2 on the ECOG Performance Scale
Adequate organ function
Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication
Female subjects childbearing potential must be willing to use 2 methods of birth control or be surgicallly sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of pembrolizumab or 180 days after the last dose of paclitaxel, docetaxel or vinflunine
Male subjects must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study pembrolizumab (MK-3475) or 180 days after the last dose of paclitaxel, docetaxel or vinflunine.

Exclusion Criteria

Disease suitable for local therapy with curative intent
Participating in or has participated in a study of an investigational agent or device
Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy
Prior anti-cancer monoclonal antibody or not recovered from adverse events
Prior chemotherapy, targeted small molecule therapy, or radiation therapy or has not recovered from adverse events
Known additional malignancy that is progressing or requires active treatment
Known active central nervous system metastases and/or carcinomatous meningitis
Active autoimmune disease requiring systemic treatment or a documented history of clinically severe autoimmune disease
Active cardiac disease
Evidence of interstitial lung disease or active non-infectious pneumonitis
Active infection requiring systemic therapy
History of severe hypersensitivity reaction
Requires ongoing therapy with a medication that is a strong inhibitor of the CYP3A4 enzymes
Known psychiatric or substance abuse disorders
Is pregnant or breastfeeding, or expecting to conceive
Prior therapy with an anti-PD-1 or anti-PD-L1 agent, or with an agent directed to another co-inhibitory T-cell receptor
Prior chemotherapy for urothelial cancer with all available study therapies in the control arm. Known history of Human Immunodeficiency Virus. Known active Hepatitis B or C. Received a live virus vaccine within 30 days of planned start of trial treatment

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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