A Clinical Study of MK-1084 in People With Advanced Solid Tumors (MK-1084-014)
NCT ID: NCT07209111
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
150 participants
INTERVENTIONAL
2025-12-04
2032-04-09
Brief Summary
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The goals of this study are to learn:
* How many people have the cancer respond (get smaller or go away) to MK-1084 alone or with cetuximab and how these responses compare
* About the safety of MK-1084 alone or with cetuximab and if people tolerate the treatments.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MK-1084
Participants will receive MK-1084 orally. Per protocol treatment of MK-1084 has no maximum number of cycles. Participants will be treated until any of the criteria for discontinuation of study intervention are met.
MK-1084
Oral administration
MK-1084 + Cetuximab
Participants will receive MK-1084 orally. Participants will receive Cetuximab 500 mg/m\^2 via intravenous (IV) infusion once every 2 weeks (Q2W). Per protocol treatment of MK-1084 and Cetuximab has no maximum number of cycles. Participants will be treated until any of the criteria for discontinuation of study intervention are met.
MK-1084
Oral administration
Cetuximab
Intravenous administration
Interventions
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MK-1084
Oral administration
Cetuximab
Intravenous administration
Eligibility Criteria
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Inclusion Criteria
* Has a tumor that demonstrates the presence of Kirsten rat sarcoma (KRAS) G12C mutation
Exclusion Criteria
* Has known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has known active central nervous system metastases and/or carcinomatous meningitis and/or primary brain tumors
* Has active infection, other than those permitted per protocol, requiring systemic therapy
* Has not adequately recovered from major surgery or has ongoing surgical complications
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
Locations
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Greater Baltimore Medical Center ( Site 1104)
Baltimore, Maryland, United States
START Midwest ( Site 1103)
Grand Rapids, Michigan, United States
START Mountain Region ( Site 1106)
West Valley City, Utah, United States
Odense Universitetshospital ( Site 1401)
Odense, Region Syddanmark, Denmark
Haukeland universitetssykehus ( Site 2102)
Bergen, Hordaland, Norway
Oslo universitetssykehus, Radiumhospitalet ( Site 2101)
Oslo, , Norway
Seoul National University Hospital ( Site 2301)
Seoul, , South Korea
Asan Medical Center ( Site 2302)
Seoul, , South Korea
Samsung Medical Center ( Site 2300)
Seoul, , South Korea
Hospital Virgen de la Victoria ( Site 2403)
Málaga, Malaga, Spain
Hospital Clinic de Barcelona ( Site 2402)
Barcelona, , Spain
Karolinska Universitetssjukhuset Solna ( Site 2501)
Stockholm, Stockholm County, Sweden
Countries
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Central Contacts
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Facility Contacts
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Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-1084-014
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1320-8626
Identifier Type: REGISTRY
Identifier Source: secondary_id
2025-521737-91-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
1084-014
Identifier Type: -
Identifier Source: org_study_id