None listed
Conditions
Interventions
Treatment groups:
A) Pembrolizumab (MK-3475) 200 mg will be administered as a 30 minute IV infusion on Day 1 of each 3 week cycle
B) Investigator´s choice of:
- Paclitaxel 175 mg/m2 will be a
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
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
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
Countries
Austria, Belgium, Canada, Chile, Denmark, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Korea South, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Romania, Singapore, Spain, Sweden, Taiwan, Turkey, United States
Contacts
Public ContactNelva Garcia
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed