Study of Pembrolizumab (MK-3475) in Participants With Advanced Melanoma (MK-3475-041/KEYNOTE-041)
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Pembrolizumab
Intervention description: IV infusion
Intervention MeSH terms: Pembrolizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: PD1; PD-1; PDL1; PD-L1

Summary:

      This study will assess the safety, tolerability, and efficacy of every-3-week dosing (Q3W) of
      pembrolizumab (MK-3475) in participants with advanced melanoma; participants may receive
      pembrolizumab for up to 2 years if deriving clinical benefit. The primary study hypothesis is
      that treatment with single agent pembrolizumab will result in a clinically meaningful overall
      response rate.
    

Eligibility criteria:

        Inclusion criteria:

          -  Histologically confirmed diagnosis of locally advanced (unresectable Stage III) or
             metastatic (Stage IV) melanoma not amenable to local therapy

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  At least one measurable lesion

          -  Adequate organ function

        Exclusion criteria:

          -  Prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-PD ligand-1
             (PD-L1), anti-PD-L2, anti-CD137 antibody, or anti-cytotoxic T-lymphocyte-associated
             antigen-4 (CTLA-4) agent

          -  Is currently participating or has participated in a study with an investigational
             compound or device within 30 days, or 5X half-life of the investigational compound,
             whichever is longer, of initial dosing on this study

          -  Chemotherapy, targeted small molecule therapy, radiotherapy, or biological cancer
             therapy (including monoclonal antibodies) within 4 weeks prior to the first dose of
             trial treatment, or not recovered (<= Grade 1 or baseline) from adverse events due to
             a previously administered agent

          -  Expected to require any other form of systemic or localized antineoplastic therapy
             while in study

          -  Known active central nervous system (CNS) metastases and/or carcinomatous meningitis

          -  Documented history of clinically severe autoimmune disease, or a syndrome that
             requires systemic steroids or immunosuppressive agents

          -  Receiving systemic steroid therapy or any other form of immunosuppressive therapy
             within 1 week prior to the first dose of study treatment

          -  Received a live vaccine within 4 weeks prior to the first dose of trial treatment

          -  Has a known hypersensitivity to the components of the study drug or another monoclonal
             antibody

          -  History or evidence of active pneumonitis

          -  Human immunodeficiency virus (HIV)-positive

          -  Has known history of active Hepatitis B or C

          -  Pregnant, breastfeeding, or expecting to conceive or father children within the
             projected duration of the trial treatment through 120 days after the last dose of
             study medication