Dose Evaluation of MK-1966 in Combination With SD-101 in Participants With Advanced Malignancies (MK-1966-001)
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/11/2017 |
Start Date: | June 22, 2016 |
End Date: | December 28, 2018 |
Contact: | Toll Free Number |
Phone: | 1-888-577-8839 |
A Phase 1/1b Trial of MK-1966 in Combination With SD-101 in Subjects With Advanced Malignancies
This is a non-randomized, open-label study of MK-1966 used in combination with SD-101 in the
treatment of advanced malignancies. The study will include an initial Dose Evaluation phase
to determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) by evaluating
Dose Limiting Toxicities (DLTs) on four dose combinations of MK-1966 and SD-101. Following
determination of the MTD/MAD, approximately 20 participants each will be enrolled in two
expansion cohorts to confirm/refine the MTD/MAD.
treatment of advanced malignancies. The study will include an initial Dose Evaluation phase
to determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) by evaluating
Dose Limiting Toxicities (DLTs) on four dose combinations of MK-1966 and SD-101. Following
determination of the MTD/MAD, approximately 20 participants each will be enrolled in two
expansion cohorts to confirm/refine the MTD/MAD.
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
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