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Purpose

Researchers are looking for new ways to treat certain advanced or metastatic solid tumors. The goal of this study is to learn about the safety of MK-4716 and if people tolerate it when taken alone or with other treatments.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Subset of arm MK-4716 Dose Escalation and subset of arm MK-4716 + Cetuximab: Has a confirmed diagnosis of locally advanced unresectable or metastatic solid tumor - 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 - Has measurable disease - Has the ability to swallow and retain oral medication

Exclusion Criteria

  • Arm MK-4716 + Pembrolizumab: Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention - 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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
MK-4716 Dose Escalation 		Participants receive MK-4716 at varying dose levels and schedules.
  • Drug: MK-4716
    Oral administration
Experimental
MK-4716 + Pembrolizumab 		Participants will receive MK-4716 + Pembrolizumab
  • Drug: MK-4716
    Oral administration
  • Biological: Pembrolizumab
    Intravenous administration
    Other names:
    • Keytruda
    • MK-3475
Experimental
MK-4716 + Cetuximab 		Participants will receive MK-4716 + Cetuximab
  • Drug: MK-4716
    Oral administration
  • Biological: Cetuximab
    Intravenous administration

Recruiting Locations

Rutgers Cancer Institute of New Jersey ( Site 0052)
New Brunswick, New Jersey 08903
Contact:
Study Coordinator
732-253-3939

NEXT Oncology ( Site 0051)
Irving, Texas 75039
Contact:
Study Coordinator
972-893-8800

NEXT Virginia ( Site 0054)
Fairfax, Virginia 22031
Contact:
Study Coordinator
703-783-4510

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.