Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-028/KEYNOTE-28)
Condition: Solid Tumor
MeSH terms: Neoplasms
Intervention: Pembrolizumab
Intervention description: IV infusion
Intervention MeSH terms: Pembrolizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 477.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Programmed Cell Death-1 (PD1, PD-1); Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1); Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)

Summary:

      This study will assess the efficacy and safety of pembrolizumab (MK-3475) administered to
      participants with incurable advanced biomarker-positive solid tumors that have not responded
      to current therapy or for which current therapy is not appropriate.

      The study hypothesis is that administration of pembrolizumab to participants with some types
      of solid tumors will result in a clinically meaningful response rate.
    

Eligibility criteria:

        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 an adequate
             method of contraception for the course of the study through 120 days after the last
             dose of study medication

          -  Male participants of childbearing potential must agree to use an adequate method of
             contraception starting with the first dose of study medication through 120 days after
             the last dose of study medication

        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 central nervous system [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 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

          -  Has evidence of interstitial lung disease or a history of (non-infectious) pneumonitis
             that required steroids or has current pneumonitis

          -  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

          -  Has received a live vaccine within 30 days of planned start of study medication.
             Examples of live vaccines include, but are not limited to, the following: measles,
             mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus
             Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection
             are generally killed virus vaccines and are allowed; however, intranasal influenza
             vaccines (e.g. FluMist®) are live attenuated vaccines and are not allowed.