Suspended
A Phase 1/1b Trial of MK-1966 in Combination With SD-101 in Subjects With Advanced Malignancies
What is being tested
MK-1966
+ SD-101
BiologicalDrug
Who is being recruted
Neoplasms
Over 18 Years
+25 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Study Start: June 2016
Summary
Principal SponsorMerck Sharp & Dohme LLC
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: June 22, 2016
Actual date on which the first participant was enrolled.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.
Official TitleA Phase 1/1b Trial of MK-1966 in Combination With SD-101 in Subjects With Advanced Malignancies
Principal SponsorMerck Sharp & Dohme LLC
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
14 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Neoplasms
Criteria
6 inclusion criteria required to participate
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)
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19 exclusion criteria prevent from participating
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
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
6 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalParticipants received a combination of MK-1966 (Days 1 and 21) and SD-101 (Days 1, 8, 15 and Day 22) in Part A of the study (approximately 21 days). Participants were to continue in one of two expansion cohorts (Part B or C) and receive up to 8 cycles of treatment (approximately 24 weeks). Each cycle was 21 days.
Group II
ExperimentalParticipants received a combination of MK-1966 (Days 1 and 21) and SD-101 (Days 1, 8, 15 and Day 22) in Part A of the study (approximately 21 days). Participants were to continue in one of two expansion cohorts (Part B or C) and receive up to 8 cycles of treatment (approximately 24 weeks). Each cycle was 21 days.
Group III
ExperimentalParticipants received a combination of MK-1966 (Days 1 and 21) and SD-101 (Days 1, 8, 15 and Day 22) in Part A of the study (approximately 21 days). Participants were to continue in one of two expansion cohorts (Part B or C) and receive up to 8 cycles of treatment (approximately 24 weeks). Each cycle was 21 days.
Group IV
ExperimentalParticipants received a combination of MK-1966 (Days 1 and 21) and SD-101 (Days 1, 8, 15 and Day 22) in Part A of the study (approximately 21 days). Participants were to continue in one of two expansion cohorts (Part B or C) and receive up to 8 cycles of treatment (approximately 24 weeks). Each cycle was 21 days.
Group 5
ExperimentalParticipants were to receive the MTD/MAD of MK-1966 and SD-101 established in Part A for up to 7 additional treatment cycles with MK-1966 and up to 6 additional treatment cycles with SD-101. Each cycle was to be 21 days.
Group 6
ExperimentalParticipants were to receive the MTD/MAD of MK-1966 and SD-101 established in Part A for up to 7 additional treatment cycles with MK-1966 and 6 additional treatment cycles with SD-101. Each cycle was to be 21 days.
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has no location dataSave this study to your profile to know when the location data is available.
SuspendedNo study centers