Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-028/KEYNOTE-28)

Inclusion criteria:

- Histologically or cytologically documented locally-advanced and/or metastatic solid
malignancy that is incurable, and has failed prior standard therapy or for which
standard therapy is not appropriate

- Have biomarker-positive solid tumor

- Have measurable disease based on Response Criteria in Solid Tumors Version 1.1
(RECIST 1.1)

- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1

- Adequate organ function

- Female participants of childbearing potential must be willing to use 2 methods of
birth control or be surgically sterile, or abstain from heterosexual activity for the
course of the study through 120 days after the last dose of study medication

- Male participants 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 therapy

Exclusion Criteria:

- Is currently participating and receiving study therapy or has participated in a study
of an investigational agent and received study therapy or used an investigational
device within 4 weeks of the first dose of treatment

- Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form
of immunosuppressive therapy within 7 days prior to the first dose of trial treatment

- Prior anti-cancer therapy with a monoclonal antibody (mAb) within 4 weeks prior to
study Day 1 or not recovered from adverse events due to mAbs administered more than 4
weeks earlier

- Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2
weeks (12 weeks for measurable sites of CNS disease) prior to study Day 1 or not
recovered from adverse events due to a previously administered agent

- Known additional malignancy that is progressing or requires active treatment
excepting basal cell carcinoma of the skin, squamous cell carcinoma of the skin that
has undergone potentially curative therapy, or in situ cervical cancer

- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis

- Has an active autoimmune disease that has required systemic treatment in past 2 years
(i.e. with use of disease modifying agents, corticosteroids or immunosuppressive
drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid
replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a
form of systemic treatment

- Evidence of interstitial lung disease

- Active infection requiring systemic therapy

- Known psychiatric or substance abuse disorders that would interfere with cooperation
with the requirements of the trial

- Pregnant, breastfeeding, or expecting to conceive or father children within the
projected duration of the trial, starting with the pre-screening or screening visit
through 120 days after the last dose of trial treatment

- Has previously participated in any other pembrolizumab (MK-3475) trial, or received
prior therapy with an anti-PD-1, anti-PD-L1, and anti-PD-L2 (including ipilimumab or
any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint
pathways)

- Known history of human immunodeficiency virus (HIV)

- Known active Hepatitis B or Hepatitis C