Study of MK-4166 and MK-4166 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-4166-001)
Condition: Solid Tumor
Intervention: MK-4166; Pembrolizumab
Intervention MeSH terms: Pembrolizumab; MK-4166
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 116.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is planned to be a 5-part dose-escalation study to determine the safety and tolerability
      of MK-4166 monotherapy and MK-4166 plus pembrolizumab combination therapy, and to establish
      the maximum tolerated dose (MTD) or maximum administered dose (MAD) of MK-4166 and MK-4166
      plus pembrolizumab by defining dose-limiting toxicities (DLTs) in participants with advanced
      solid tumors.
    

Eligibility criteria:

        Inclusion criteria:

          -  Has a histologically- or cytologically-confirmed metastatic solid tumor for which
             there is no available therapy which may convey clinical benefit. Part E: Has advanced
             malignant melanoma.

          -  Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version
             1.1

          -  Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
             Performance Scale

          -  Adequate organ function

          -  Female participants of childbearing potential must have a negative urine or serum
             pregnancy test and must be surgically sterile or willing to use 2 methods of birth
             control or abstain from heterosexual activity for the course of the study through 120
             days after last dose of study drug

          -  Male participants must agree to use an adequate method of contraception during sexual
             contact with females of childbearing potential starting with the first dose of study
             drug through 180 days after the last dose of study drug

          -  Submit an evaluable tumor sample for analysis.

        Exclusion criteria:

          -  Chemotherapy, radiation, or biological cancer therapy within 4 weeks prior to the
             first dose of study drug, or who has not recovered to Common Terminology Criteria for
             Adverse Events (CTCAE) Grade 1 or better from the adverse events due to cancer
             therapeutics administered more than 4 weeks earlier

          -  Currently participating or has participated in a study of an investigational agent or
             using an investigational device within 28 days of administration of MK-4166

          -  Expected to require any other form of antineoplastic therapy while on study

          -  On chronic systemic steroid therapy in excess of replacement doses, or on any other
             form of immunosuppressive medication

          -  History of a malignancy for which potentially curative treatment has been completed,
             with no evidence of malignancy for 5 years excepting successful definitive resection
             of basal cell carcinoma of the skin, superficial bladder cancer, or in situ cervical
             cancer

          -  Known active central nervous system (CNS) metastases and/or carcinomatous meningitis

          -  Severe hypersensitivity reaction to treatment with another monoclonal antibody

          -  Active autoimmune disease or a documented history of autoimmune disease, except
             vitiligo or resolved childhood asthma/atopy

          -  Active infection requiring therapy

          -  Current pneumonitis, or a history of (non-infectious) pneumonitis that required
             steroids

          -  Prior stem cell or bone marrow transplant

          -  Positive for human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C

          -  Known psychiatric or substance abuse disorders that would interfere with cooperation
             with the requirements of the trial

          -  Regular user (including "recreational use") of any illicit drugs or recent history
             (within the last year) of substance abuse (including alcohol)

          -  Symptomatic ascites or pleural effusion

          -  Pregnant, breastfeeding, or expecting to conceive or father children within the
             projected duration of the study

          -  Clinically significant heart disease

          -  Major surgery in the past 16 weeks

          -  Received a live vaccine within 30 days prior to first dose of study drug