Study of MK-4166 and MK-4166 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-4166-001)
Status and phase
Completed
Phase 1
Conditions
Solid Tumor
Treatments
Biological: Pembrolizumab
Biological: MK-4166
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
This is planned to be a 5-part dose-escalation study to determine the safety and tolerability of MK-4166 monotherapy and MK-4166 plus pembrolizumab combination therapy, and to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD) of MK-4166 and MK-4166 plus pembrolizumab by defining dose-limiting toxicities (DLTs) in participants with advanced solid tumors.
Full description
In Part A, MK-4166 doses will be escalated quickly in successive cohorts and based on safety events may progress to Part B, in which the preliminary MTD will be identified. Based on safety events the study may progress to Part C in which the MTD will be confirmed. In Part D, participants will receive escalating doses of MK-4166 plus a fixed dose of pembrolizumab (MK-3475) 200 mg to determine the MTD for MK-4166 in combination with pembrolizumab. Based on safety events in Part D, the study may progress to Part E in which the MTD for MK-4166 in combination with pembrolizumab will be confirmed.
With Amendments 05/06, the dose confirmation Part C will be removed and the dose confirmation Part E (combination of MK-4166 and pembrolizumab) will be limited to participants with advanced malignant melanoma.
Enrollment
116 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
- Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
- Adequate organ function
- Female participants of childbearing potential must have a negative urine or serum pregnancy test and must be surgically sterile or willing to use 2 methods of birth control or abstain from heterosexual activity for the course of the study through 120 days after last dose of study drug
- Male participants must agree to use an adequate method of contraception during sexual contact with females of childbearing potential starting with the first dose of study drug through 180 days after the last dose of study drug
- Submit an evaluable tumor sample for analysis.
Exclusion criteria
- Chemotherapy, radiation, or biological cancer therapy within 4 weeks prior to the first dose of study drug, 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
- Currently participating or has participated in a study of an investigational agent or using an investigational device within 28 days of administration of MK-4166
- Expected to require any other form of antineoplastic therapy while on study
- On chronic systemic steroid therapy in excess of replacement doses, or on any other form of immunosuppressive medication
- History of a malignancy for which potentially curative treatment has been completed, with no evidence of malignancy for 5 years excepting successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, or in situ cervical cancer
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Severe hypersensitivity reaction to treatment with another monoclonal antibody
- Active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy
- Active infection requiring therapy
- Current pneumonitis, or a history of (non-infectious) pneumonitis that required steroids
- Prior stem cell or bone marrow transplant
- Positive for human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
- Regular user (including "recreational use") of any illicit drugs or recent history (within the last year) of substance abuse (including alcohol)
- Symptomatic ascites or pleural effusion
- Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study
- Clinically significant heart disease
- Major surgery in the past 16 weeks
- Received a live vaccine within 30 days prior to first dose of study drug
Trial design
Primary purpose
Treatment
Allocation
Non-Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
116 participants in 34 patient groups
MK-4166 0.0015 mg
Experimental group
Description:
Participant received 0.0015 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Treatment:
Biological: MK-4166
MK-4166 0.0045 mg
Experimental group
Description:
Participant received 0.0045 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Treatment:
Biological: MK-4166
MK-4166 0.014 mg
Experimental group
Description:
Participant received 0.014 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Treatment:
Biological: MK-4166
MK-4166 0.04 mg
Experimental group
Description:
Participant received 0.04 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Treatment:
Biological: MK-4166
MK-4166 0.12 mg
Experimental group
Description:
Participant received 0.12 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Treatment:
Biological: MK-4166
MK-4166 0.37 mg
Experimental group
Description:
Participant received 0.37 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Treatment:
Biological: MK-4166
MK-4166 1.1 mg
Experimental group
Description:
Participant received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Treatment:
Biological: MK-4166
MK-4166 3.3 mg
Experimental group
Description:
Participant received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Treatment:
Biological: MK-4166
MK-4166 10 mg
Experimental group
Description:
Participant received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Treatment:
Biological: MK-4166
MK-4166 30 mg
Experimental group
Description:
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Treatment:
Biological: MK-4166
MK-4166 42 mg
Experimental group
Description:
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Treatment:
Biological: MK-4166
MK-4166 59 mg
Experimental group
Description:
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Treatment:
Biological: MK-4166
MK-4166 82 mg
Experimental group
Description:
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Treatment:
Biological: MK-4166
MK-4166 120 mg
Experimental group
Description:
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Treatment:
Biological: MK-4166
MK-4166 170 mg
Experimental group
Description:
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Treatment:
Biological: MK-4166
MK-4166 240 mg
Experimental group
Description:
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Treatment:
Biological: MK-4166
MK-4166 340 mg
Experimental group
Description:
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Treatment:
Biological: MK-4166
MK-4166 480 mg
Experimental group
Description:
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Treatment:
Biological: MK-4166
MK-4166 670 mg
Experimental group
Description:
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Treatment:
Biological: MK-4166
MK-4166 900 mg
Experimental group
Description:
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Treatment:
Biological: MK-4166
MK-4166 1.1 mg + Pembro
Experimental group
Description:
Participants 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.
Treatment:
Biological: Pembrolizumab
Biological: MK-4166
MK-4166 3.3 mg + Pembro
Experimental group
Description:
Participants 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.
Treatment:
Biological: Pembrolizumab
Biological: MK-4166
MK-4166 10 mg + Pembro
Experimental group
Description:
Participants 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.
Treatment:
Biological: Pembrolizumab
Biological: MK-4166
MK-4166 30 mg + Pembro
Experimental group
Description:
Participants 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.
Treatment:
Biological: Pembrolizumab
Biological: MK-4166
MK-4166 42 mg + Pembro
Experimental group
Description:
Participants 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.
Treatment:
Biological: Pembrolizumab
Biological: MK-4166
MK-4166 59 mg + Pembro
Experimental group
Description:
Participants 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.
Treatment:
Biological: Pembrolizumab
Biological: MK-4166
MK-4166 82 mg + Pembro
Experimental group
Description:
Participants 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.
Treatment:
Biological: Pembrolizumab
Biological: MK-4166
MK-4166 120 mg + Pembro
Experimental group
Description:
Participants 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.
Treatment:
Biological: Pembrolizumab
Biological: MK-4166
MK-4166 170 mg + Pembro
Experimental group
Description:
Participants 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.
Treatment:
Biological: Pembrolizumab
Biological: MK-4166
MK-4166 240 mg + Pembro
Experimental group
Description:
Participants 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.
Treatment:
Biological: Pembrolizumab
Biological: MK-4166
MK-4166 340 mg + Pembro
Experimental group
Description:
Participants 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.
Treatment:
Biological: Pembrolizumab
Biological: MK-4166
MK-4166 480 mg + Pembro
Experimental group
Description:
Participants 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.
Treatment:
Biological: Pembrolizumab
Biological: MK-4166
MK-4166 670 mg + Pembro
Experimental group
Description:
Participants 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.
Treatment:
Biological: Pembrolizumab
Biological: MK-4166
MK-4166 900 mg + Pembro
Experimental group
Description:
Participants 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.
Treatment:
Biological: Pembrolizumab
Biological: MK-4166
Trial contacts and locations
0
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal
© Copyright 2026 Veeva Systems