Study of MK-4166 and MK-4166 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-4166-001)
NCT ID: NCT02132754
Last Updated: 2021-01-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
116 participants
INTERVENTIONAL
2014-06-27
2019-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MK-4166 0.0015 mg
Participant received 0.0015 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166
MK-4166 0.0045 mg
Participant received 0.0045 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166
MK-4166 0.014 mg
Participant received 0.014 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166
MK-4166 0.04 mg
Participant received 0.04 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166
MK-4166 0.12 mg
Participant received 0.12 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166
MK-4166 0.37 mg
Participant received 0.37 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166
MK-4166 1.1 mg
Participant received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166
MK-4166 3.3 mg
Participant received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166
MK-4166 10 mg
Participant received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166
MK-4166 30 mg
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166
MK-4166 42 mg
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166
MK-4166 59 mg
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166
MK-4166 82 mg
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166
MK-4166 120 mg
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166
MK-4166 170 mg
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166
MK-4166 240 mg
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166
MK-4166 340 mg
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166
MK-4166 480 mg
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166
MK-4166 670 mg
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166
MK-4166 900 mg
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
MK-4166
MK-4166 1.1 mg + Pembro
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.
MK-4166
Pembrolizumab
MK-4166 3.3 mg + Pembro
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.
MK-4166
Pembrolizumab
MK-4166 10 mg + Pembro
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.
MK-4166
Pembrolizumab
MK-4166 30 mg + Pembro
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.
MK-4166
Pembrolizumab
MK-4166 42 mg + Pembro
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.
MK-4166
Pembrolizumab
MK-4166 59 mg + Pembro
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.
MK-4166
Pembrolizumab
MK-4166 82 mg + Pembro
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.
MK-4166
Pembrolizumab
MK-4166 120 mg + Pembro
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.
MK-4166
Pembrolizumab
MK-4166 170 mg + Pembro
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.
MK-4166
Pembrolizumab
MK-4166 240 mg + Pembro
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.
MK-4166
Pembrolizumab
MK-4166 340 mg + Pembro
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.
MK-4166
Pembrolizumab
MK-4166 480 mg + Pembro
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.
MK-4166
Pembrolizumab
MK-4166 670 mg + Pembro
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.
MK-4166
Pembrolizumab
MK-4166 900 mg + Pembro
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.
MK-4166
Pembrolizumab
Interventions
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MK-4166
Pembrolizumab
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Papadopoulos KP, Autio K, Golan T, Dobrenkov K, Chartash E, Chen Q, Wnek R, Long GV. Phase I Study of MK-4166, an Anti-human Glucocorticoid-Induced TNF Receptor Antibody, Alone or with Pembrolizumab in Advanced Solid Tumors. Clin Cancer Res. 2021 Apr 1;27(7):1904-1911. doi: 10.1158/1078-0432.CCR-20-2886. Epub 2020 Dec 21.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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MK-4166-001
Identifier Type: OTHER
Identifier Source: secondary_id
4166-001
Identifier Type: -
Identifier Source: org_study_id
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