Safety and Efficacy Study of Pembrolizumab (MK-3475) in Chinese Participants With Locally Advanced or Metastatic Melanoma (MK-3475-151/KEYNOTE-151)

Exclusion Criteria

• •Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti-PD-L1, anti-PD-L2 agents.
• •Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks of the first dose of study drug.
• •Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to the first dose of study drug or who has not recovered (i.e., ≤ Grade 1 or baseline) from AEs due to agents administered more than 4 weeks earlier.
• •Has had chemotherapy, targeted small molecule therapy, radiotherapy within 2 weeks prior to the first dose of study drug, or who has not recovered (i.e., ≤ Grade 1 or baseline) from AEs due to a previously administered agent.
• •Has a known history of another (including unknown primary) malignancy within 5 years prior to first dose of study drug. (Exceptions include adequately treated Stage 1 or Stage 2 basal/squamous cell carcinoma of the skin, superficial bladder cancer, or cancer in situ which has undergone potentially curative therapy.)
• •Is expected to require any other form of systemic or localized antineoplastic therapy while in study.
• •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• •Has active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
• •Is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 1 week prior to the first dose of study drug.
• •Has an active infection requiring intravenous systemic therapy.
• •Has received a live vaccine within 4 weeks prior to the first dose of study drug.
• •Has a known hypersensitivity to the components of the study drug or another mAb.
• •Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
• •Is known to be Human Immunodeficiency Virus (HIV) positive.
• •Has known active Hepatitis B or C.
• •Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
• •Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit (Visit 1) through 120 days after the last dose of study treatment.