Clinical trial NCT02731742: Dose Evaluation of MK-1966 in Combination With SD-101 in Participants With Advanced Malignancies (MK-1966-001)
Official title: A Phase 1/1b Trial of MK-1966 in Combination With SD-101 in Subjects With Advanced Malignancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Neoplasms, Advanced
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2016-04-07
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Percentage of Participants With a Dose Limiting Toxicity (DLT)
timeFrame: From time of first dose of study drug to the end of Cycle 1. Each cycle was 21 days. (Up to 21 days)
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From first dose of study drug through 90 days after last dose of study drug (Up to approximately 22 weeks)
measure: Number of Participants Discontinuing Study Drug Due to AEs
timeFrame: From first dose of study drug up to last dose of study drug (Up to approximately 9 weeks)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: