Study of MK-1248 With and Without Pembrolizumab (MK-3475) for Participants With Advanced Solid Tumors (MK-1248-001)
Condition: Advanced Solid Tumor
MeSH terms: Neoplasms
Intervention: MK-1248; pembrolizumab
Intervention description: IV infusion; IV infusion
Intervention MeSH terms: Pembrolizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Solid tumor; PD1; PD-L1; PDL1

Summary:

      In this study, participants with advanced solid tumors were assigned to receive escalating
      doses of either MK-1248 alone or MK-1248 in combination with pembrolizumab (MK-3475). This
      study used the number of dose-limiting toxicities (DLTs) at each dose level to find and
      confirm the maximum tolerated dose (or maximum administered dose) for MK-1248 alone and in
      combination with pembrolizumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically- or cytologically-confirmed metastatic solid tumor for which there is
             no available therapy that may convey clinical benefit

          -  Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
             criteria

          -  Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
             Performance Scale

          -  Adequate organ function

          -  Female participants of childbearing potential should be willing to use adequate
             contraception for the course of the study through 120 days after the last dose of
             study medication

          -  Male participants should agree to use adequate contraception starting with the first
             dose of study therapy through 180 days after the last dose of study medication

          -  Can submit a baseline tumor sample

        Exclusion Criteria:

          -  Has had chemotherapy, radiation, or biological cancer therapy within 4 weeks prior to
             the first dose of study medication, or not recovered from adverse events due to cancer
             therapeutics administered more than 4 weeks earlier

          -  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 study medication

          -  Previous treatment with another agent targeting the glucocorticoid-induced tumor
             necrosis factor receptor-related protein (GITR) receptor

          -  Previous treatment with an immunomodulatory therapy and was discontinued from that
             therapy due to an immune-related adverse event

          -  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 previous, additional malignancy, unless potentially curative treatment
             has been completed, with no evidence of malignancy for 5 years with the exception of
             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 with the
             exception of vitiligo or resolved childhood asthma/atopy, or endocrine deficiency
             following treatment with an immunomodulatory agent

          -  Active infection requiring therapy

          -  Active or a history of non-infectious pneumonitis

          -  Prior stem cell or bone marrow transplant

          -  Known history of human immunodeficiency virus (HIV), active chronic or acute hepatitis
             B or C

          -  Known psychiatric or substance abuse disorders that would interfere with cooperation
             with the requirements of the study

          -  Regular user (including "recreational use") of any illicit drugs or had a recent
             history (within the last year) of substance abuse (including alcohol), at the time of
             signing informed consent

          -  Symptomatic ascites or pleural effusion

          -  Pregnant, breastfeeding, or expecting to conceive or father children within the
             projected duration of the study through 180 days after the last dose of study
             medication

          -  Major surgery within 16 weeks prior to screening

          -  Live vaccine within 30 days prior to first dose of study medication