Study of MK-3475 (Pembrolizumab) in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma After Treatment With Platinum-based and Cetuximab Therapy (MK-3475-055/KEYNOTE-055)
Condition: Head and Neck Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: pembrolizumab
Intervention MeSH terms: Pembrolizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 172.0
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)

Summary:

      This is a study of single-agent pembrolizumab (MK-3475) in participants with recurrent and/or
      metastatic head and neck squamous cell carcinoma (HNSCC) who have progressed on
      platinum-based and cetuximab therapy. The primary study hypothesis is that pembrolizumab will
      provide a clinically meaningful objective response rate (ORR).

      With protocol amendment 05 (02-Jan-2018), once study participants have achieved the study
      objective or the study has ended, participants will be discontinued from this study and
      enrolled in an extension study to continue protocol-defined assessments and treatment.
    

Eligibility criteria:

        Inclusion criteria:

          -  Histologically- or cytologically-confirmed recurrent or metastatic HNSCC of the oral
             cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local
             therapies

          -  Tumor progression or recurrence within 6 months of the last dose of any number of
             platinum-based and cetuximab therapy lines in the adjuvant, primary, recurrent, or
             metastatic setting; must be resistant (not responding) to both platinum and cetuximab

          -  Available tissue for biomarker analysis

          -  Measurable disease based on RECIST 1.1 as determined by central review

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Adequate organ function

          -  Female participants of childbearing potential must have a negative urine or serum
             pregnancy test and must be willing to use 2 adequate methods of contraception starting
             with the screening visit through 120 days after the last dose of pembrolizumab

          -  Male participants with a female partner(s) of childbearing potential must be willing
             to use 2 adequate methods of contraception from screening through 120 days after the
             last dose of pembrolizumab

        Exclusion criteria:

          -  Disease that is suitable for local therapy administered with curative intent

          -  Currently receiving treatment in a study of an investigational agent or using an
             investigational device <= 4 weeks prior to the first dose of trial medication

          -  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 medication

          -  Not recovered from AEs due to a previously administered therapy

          -  Known additional malignancy that is progressing or requires active treatment excluding
             basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has
             undergone potentially curative therapy or in situ 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

          -  Active, non-infectious pneumonitis

          -  Active infection requiring systemic therapy

          -  Pregnant, breastfeeding, or expecting to conceive or father children within the
             projected duration of the trial, starting with the screening visit through 120 days
             after the last dose of trial medication

          -  Human immunodeficiency virus (HIV)

          -  Hepatitis B or C

          -  Received live vaccine within 30 days of planned start of study therapy