Dose Evaluation of MK-1966 in Combination With SD-101 in Participants With Advanced Malignancies (MK-1966-001)

• Status: Terminated
• Trial end date: 2018-01-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

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