Back to Trials
NCT07247110PHASE1Recruiting

A Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001)

Merck Sharp & Dohme LLC

Start Date

12/16/2025

Completion Date

12/1/2030

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

MK-4716

BIOLOGICAL

Pembrolizumab

BIOLOGICAL

Cetuximab

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Malignant Neoplasm

Locations

Rutgers Cancer Institute of New Jersey ( Site 0052)

New Brunswick, New Jersey 08903

United States

NEXT Oncology ( Site 0051)

Irving, Texas 75039

United States

NEXT Virginia ( Site 0054)

Fairfax, Virginia 22031

United States

Blacktown Hospital ( Site 0455)

Sydney, New South Wales 2148

Australia

Monash Health ( Site 0452)

Clayton, Victoria 3168

Australia

The Alfred Hospital ( Site 0453)

Melbourne, Victoria 3004

Australia

One Clinical Research ( Site 0454)

Nedlands, Western Australia 6009

Australia

Princess Margaret Cancer Centre ( Site 0001)

Toronto, Ontario M5G 2M9

Canada

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0002)

Québec, Quebec G1J 1Z4

Canada

Pontificia Universidad Catolica de Chile-CICUC ( Site 0103)

Santiago, Region M. de Santiago 8330073

Chile

Bradfordhill ( Site 0102)

Santiago, Region M. de Santiago 8420383

Chile

Rambam Health Care Campus ( Site 0252)

Haifa, 3109601

Israel

Rabin Medical Center ( Site 0253)

Petah Tikva, 4941492

Israel

Sheba Medical Center ( Site 0251)

Ramat Gan, 5265601

Israel

Seoul National University Hospital ( Site 0501)

Seoul, 03080

South Korea

Asan Medical Center ( Site 0502)

Seoul, 05505

South Korea

Hospital General Universitari Vall d Hebron ( Site 0360)

Barcelona, 08035

Spain

Hospital Clinic de Barcelona ( Site 0362)

Barcelona, 08036

Spain

Hospital Universitario Fundacion Jimenez Diaz ( Site 0361)

Madrid, 28040

Spain