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MK-4166

Phase 1

Solid Tumor | Monoclonal antibody | Oncology |Merck & Company, Inc.|Last Updated: Jan 28, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment116
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02132754Study of MK-4166 and MK-4166 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-4166-001)PHASE1 COMPLETED 116Jun 27, 2014Jul 31, 2019Jan 28, 2021 -
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Study Endpoints
Primary Endpoints
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Cycle 1 (up to 21 days)

DLT's were assessed during the first cycle (21 days) for each dose level and included the following if assessed by the Investigator to be possibly, probably or definitely related to MK-4166 or MK-4166 plus pembrolizumab combination: Grade 4 non-hematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia (Grade 4 thrombocytopenia of any duration or Grade 3 thrombocytopenia if associated with bleeding); Grade 3 non-hematologic toxicity lasting \>3 days despite optimal supportive care; Grade 3 nausea, vomiting or diarrhea if \>3 days despite optimal supportive care; any Grade 3 or Grade 4 non-hematologic laboratory abnormality if medical intervention is required or if leading to hospitalization or if persisting for \>1 week; febrile neutropenia Grade 3 or Grade 4; any drug-related AE which caused participant to discontinue treatment during Cycle 1; Grade 5 toxicity; any treatment-related toxicity which caused a \>2 week delay in initiation of Cycle 2.

Number of Participants Experiencing Adverse Events (AEs)
From first dose up to 90 days post last dose (up to 27 months)

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. Per protocol, the number of participants experiencing an AE was assessed and reported by arm (MK-4166 monotherapy and MK-4166 plus pembrolizumab combination therapy) as well as by dose cohort.

Number of Participants Discontinuing Study Treatment Due to AEs
Up to approximately 24 months

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. Per protocol, the number of participants discontinuing study treatment due to AEs was assessed and reported by arm (MK-4166 monotherapy and MK-4166 plus pembrolizumab combination therapy) as well as by dose cohort.

Secondary Endpoints
Maximum Concentration (Cmax) of MK-4166 Over Time
Cycles 1-4: Day 1 pre-dose, at end of MK-4166 infusion (up to 10 minutes), 2 hours; Days 2, 3, 5 (Cohorts 1-9 only), 8, 15. Each cycle was 21 days. (Up to ~3 months)
Time to Maximum Concentration (Tmax) of MK-4166 Over Time
Cycles 1-4: Day 1 pre-dose, at end of MK-4166 infusion (up to 10 minutes), 2 hours; Days 2, 3, 5 (Cohorts 1-9 only), 8, 15. Each cycle was 21 days. (Up to ~3 months)
Terminal Half-Life (t ½) of MK-4166 Over Time
Cycles 1-4: Day 1 pre-dose, at end of MK-4166 infusion (up to 10 minutes), 2 hours; Days 2, 3, 5 (Cohorts 1-9 only), 8, 15. Each cycle was 21 days. (Up to ~3 months)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MK-4166 0.0015 mgEXPERIMENTALParticipant received 0.0015 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166 0.0045 mgEXPERIMENTALParticipant received 0.0045 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166 0.014 mgEXPERIMENTALParticipant received 0.014 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166 0.04 mgEXPERIMENTALParticipant received 0.04 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166 0.12 mgEXPERIMENTALParticipant received 0.12 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166 0.37 mgEXPERIMENTALParticipant received 0.37 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166 1.1 mgEXPERIMENTALParticipant received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166 3.3 mgEXPERIMENTALParticipant received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166 10 mgEXPERIMENTALParticipant received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166 30 mgEXPERIMENTALParticipants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166 42 mgEXPERIMENTALParticipants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166 59 mgEXPERIMENTALParticipants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166 82 mgEXPERIMENTALParticipants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166 120 mgEXPERIMENTALParticipants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166 170 mgEXPERIMENTALParticipants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166 240 mgEXPERIMENTALParticipants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166 340 mgEXPERIMENTALParticipants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166 480 mgEXPERIMENTALParticipants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166 670 mgEXPERIMENTALParticipants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166 900 mgEXPERIMENTALParticipants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166 1.1 mg + PembroEXPERIMENTALParticipants received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
MK-4166 3.3 mg + PembroEXPERIMENTALParticipants received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
MK-4166 10 mg + PembroEXPERIMENTALParticipants received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
MK-4166 30 mg + PembroEXPERIMENTALParticipants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
MK-4166 42 mg + PembroEXPERIMENTALParticipants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
MK-4166 59 mg + PembroEXPERIMENTALParticipants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
MK-4166 82 mg + PembroEXPERIMENTALParticipants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
MK-4166 120 mg + PembroEXPERIMENTALParticipants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
MK-4166 170 mg + PembroEXPERIMENTALParticipants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
MK-4166 240 mg + PembroEXPERIMENTALParticipants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
MK-4166 340 mg + PembroEXPERIMENTALParticipants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
MK-4166 480 mg + PembroEXPERIMENTALParticipants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
MK-4166 670 mg + PembroEXPERIMENTALParticipants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
MK-4166 900 mg + PembroEXPERIMENTALParticipants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Interventions
NameTypeDescription
MK-4166BIOLOGICAL -
PembrolizumabBIOLOGICAL -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion criteria: * Has a histologically- or cytologically-confirmed metastatic solid tumor for which there is no available therapy which may convey clinical benefit. Part E: Has advanced malignant melanoma. * Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1...

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