Dose Evaluation of MK-1966 in Combination With SD-101 in Participants With Advanced Malignancies (MK-1966-001)
Condition: Neoplasms, Advanced
MeSH terms: Neoplasms
Intervention: MK-1966; SD-101
Intervention description: MK-1966 administered as an intravenous (IV) infusion; SD-101 administered as an intratumoral (IT) injection
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This was a non-randomized, open-label study of MK-1966 used in combination with SD-101 in the
      treatment of advanced malignancies. The study included an initial Dose Evaluation phase (Part
      A) to determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) by
      evaluating Dose Limiting Toxicities (DLTs) of four dose combinations of MK-1966 and SD-101.
      Following determination of the MTD/MAD, approximately 20 participants each were to be
      enrolled in two expansion cohorts (Parts B or C) to confirm/refine the MTD/MAD. The study was
      terminated by the Sponsor before enrollment into Part A concluded and before enrollment into
      Parts B and C began.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a histologically- or cytologically-confirmed advanced malignancy that has
             progressed after standard-of-care therapy/treatments and there is no available therapy
             likely to convey clinical benefit

          -  Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

          -  Has a life expectancy ≥ 6 months

          -  Female participants must not be pregnant (negative urine or serum human chorionic
             gonadotropin test at screening and again within 72 hours prior to receiving the first
             dose of study therapy)

          -  Female and male participants of reproductive potential must agree to use adequate
             contraception during the course of the study through 120 days after study the last
             dose of study therapy

          -  Has ability to submit archived or fresh tumor sample during the screening period

        Exclusion Criteria:

          -  Has had chemotherapy, radiation, or biological cancer therapy within 4 weeks prior to
             the first dose of study therapy, 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

          -  Has participated in a study of an investigational agent and received study therapy or
             used an investigational device within 28 days of study start

          -  Is expected to require any other form of antineoplastic therapy while on study

          -  Is on chronic systemic steroid therapy in excess of replacement doses, or on any other
             form of immunosuppressive medication

          -  Has a history of a malignancy, unless potentially curative treatment has been
             completed, with no evidence of malignancy for 5 years

          -  Has known active central nervous system (CNS) metastases and/or carcinomatous
             meningitis

          -  Has had a severe hypersensitivity reaction to treatment with another monoclonal
             antibody

          -  Has an active autoimmune disease that has required systemic treatment in past 2 years

          -  Has an active infection requiring therapy

          -  Has active, current pneumonitis, or a history of (non-infectious) pneumonitis that
             required steroids

          -  Has had a prior stem cell or bone marrow transplant

          -  Is positive for Human Immunodeficiency Virus (HIV) and/or Hepatitis B or C

          -  Has known psychiatric disorder that would interfere with fulfilling the requirements
             of the study

          -  Is a regular user of any illicit drugs or had a recent history of substance abuse

          -  Has symptomatic ascites or pleural effusion

          -  Is pregnant or breastfeeding or expecting to conceive or father children within the
             projected duration of the study

          -  Has clinically significant heart disease that affects normal activities

          -  Has had major surgery (requiring at least a 3 day hospital stay) in the past 28 days

          -  Has received a live vaccine within 30 days prior to first dose of study therapy