Last updated 4 days ago
A Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001)
250 patients around the world
Available in Chile, United States
Merck Sharp & Dohme LLC
2Research sites
250Patients around the world
This study is for people with
Malignant neoplasm
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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 (e.g., 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.
Sites
Centro de Investigación Clínica Bradford Hill - Santiago, Región Metropolitana
Recruiting
Hospital Clínico Pontificia Universidad Católica de Chile - Santiago, Región Metropolitana
Recruiting
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
Malignant neoplasm
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07247110
