A Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001)
Recruiting now · Phase 1
Conditions studied: Malignant Neoplasm
In brief
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.
Key facts
- Study ID
- NCT07247110
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 250
- Starts
- 2025-12-16
- Expected to finish
- 2030-12-01
- Last updated by the study team
- 2026-06-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Rutgers Cancer Institute of New Jersey ( Site 0052) — New Brunswick, New Jersey, United States (enrolling)
- NEXT Oncology ( Site 0051) — Irving, Texas, United States (enrolling)
- NEXT Virginia ( Site 0054) — Fairfax, Virginia, United States (enrolling)
- Blacktown Hospital ( Site 0455) — Sydney, New South Wales, Australia (enrolling)
- Monash Health ( Site 0452) — Clayton, Victoria, Australia (enrolling)
- The Alfred Hospital ( Site 0453) — Melbourne, Victoria, Australia (enrolling)
- One Clinical Research ( Site 0454) — Nedlands, Western Australia, Australia (enrolling)
- Princess Margaret Cancer Centre ( Site 0001) — Toronto, Ontario, Canada (enrolling)
- Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0002) — Québec, Quebec, Canada (enrolling)
- Pontificia Universidad Catolica de Chile-CICUC ( Site 0103) — Santiago, Region M. de Santiago, Chile (enrolling)
- Bradfordhill ( Site 0102) — Santiago, Region M. de Santiago, Chile (enrolling)
- Rambam Health Care Campus ( Site 0252) — Haifa, Israel (enrolling)
- Rabin Medical Center ( Site 0253) — Petah Tikva, Israel (enrolling)
- Sheba Medical Center ( Site 0251) — Ramat Gan, Israel (enrolling)
- Seoul National University Hospital ( Site 0501) — Seoul, South Korea (enrolling)
- Asan Medical Center ( Site 0502) — Seoul, South Korea (enrolling)
- Hospital General Universitari Vall d Hebron ( Site 0360) — Barcelona, Spain (enrolling)
- Hospital Clinic de Barcelona ( Site 0362) — Barcelona, Spain (enrolling)
- Hospital Universitario Fundacion Jimenez Diaz ( Site 0361) — Madrid, Spain (enrolling)
Full record on ClinicalTrials.gov
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