Status:
TERMINATED
Dose Evaluation of MK-1966 in Combination With SD-101 in Participants With Advanced Malignancies (MK-1966-001)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Neoplasms, Advanced
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 determ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 22 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2018
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT02731742
Start Date
June 22 2016
End Date
January 8 2018
Last Update
February 4 2019
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