A Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001)
NCT ID: NCT07247110
Last Updated: 2025-12-30
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
PHASE1
250 participants
INTERVENTIONAL
2025-12-16
2030-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MK-4716 Dose Escalation
Participants receive MK-1084 at varying dose levels and schedules.
MK-4716
Oral administration
MK-4716 + Pembrolizumab
Participants will receive MK-4716 + Pembrolizumab
MK-4716
Oral administration
Pembrolizumab
Intravenous administration
MK-4716 + Cetuximab
Participants will receive MK-4716 + Cetuximab
MK-4716
Oral administration
Cetuximab
Intravenous administration
Interventions
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MK-4716
Oral administration
Pembrolizumab
Intravenous administration
Cetuximab
Intravenous administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subset of arm MK-4716 Dose Escalation and subset of arm MK-4716 + Cetuximab: Must demonstrate presence of Kirsten rat sarcoma viral oncogene homolog (KRAS) alteration
* Subset of arm MK-4716 Dose Escalation and subset of arm MK-4716 + Cetuximab: Has received at least 1 prior line of systemic therapy for locally advanced unresectable or metastatic disease
* Arm MK-4716 + Pembrolizumab: Has a confirmed diagnosis of metastatic non-small cell lung cancer
* Arm MK-4716 + Pembrolizumab: Must demonstrate presence of KRAS alteration
* Arm MK-4716 + Pembrolizumab: Must be untreated
* Arm MK-4716 + Cetuximab: Must be eligible for cetuximab
* Has measurable disease
* Has the ability to swallow and retain oral medication
Exclusion Criteria
* Arm MK-4716 + Pembrolizumab: Has received any prior immunotherapy and was discontinued from that treatment
* Arm MK-4716 + Pembrolizumab: Has active autoimmune disease that has required systemic treatment in the past 2 years. Hormonal supplementation (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
* History of human immunodeficiency virus infection
* Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
* Has a known active central nervous system metastases and/or carcinomatous meningitis
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has active infection requiring systemic therapy
* Has Hepatitis B or Hepatitis C virus infection
* History of stem cell/solid organ transplant
* 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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NEXT Oncology ( Site 0051)
Irving, Texas, United States
NEXT Virginia ( Site 0054)
Fairfax, Virginia, United States
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
Related Links
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Merck Clinical Trials Information
Other Identifiers
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2025-522495-84
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1323-3663
Identifier Type: REGISTRY
Identifier Source: secondary_id
MK-4701-001
Identifier Type: OTHER
Identifier Source: secondary_id
4716-001
Identifier Type: -
Identifier Source: org_study_id