Recruiting

Phase 1

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

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07247110

Conditions

Malignant Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MK-4716

Pembrolizumab

Cetuximab

Study Details

Brief 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.

Conditions

Malignant Neoplasm

Study ID

NCT07247110

Start date

Dec 16, 2025

Status verified date

Sep, 2026

Completion date

Dec 1, 2030

Anticipated

Primary completion date

Dec 1, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

250 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MK-4716 Dose Escalation

Participants receive MK-4716 at varying dose levels and schedules.

experimental: MK-4716 + Pembrolizumab

Participants will receive MK-4716 + Pembrolizumab

experimental: MK-4716 + Cetuximab

Participants will receive MK-4716 + Cetuximab

Interventions

MK-4716

Oral administration

Pembrolizumab

Intravenous administration

Cetuximab

Intravenous administration

Primary outcome measure

Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLT) [ Time Frame: Up to approximately 28 days ]
Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to approximately 4 years ]
Number of Participants Who Discontinue Study Intervention Due to an AE [ Time Frame: Up to approximately 4 years ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839 Trialsites@msd.com

Locations

Rutgers Cancer Institute of New Jersey ( Site 0052)

Recruiting

New Brunswick, New Jersey, United States, 08903

Contacts

Study Coordinator

732-253-3939

NEXT Oncology ( Site 0051)

Recruiting

Irving, Texas, United States, 75039

Contacts

Study Coordinator

972-893-8800

NEXT Virginia ( Site 0054)

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Study Coordinator

703-783-4510

Princess Margaret Cancer Centre ( Site 0001)

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Study Coordinator

4165865371

Centre Hospitalier de l'Université de Montréal ( Site 0003)

Recruiting

Montreal, Quebec, Canada, H2X 0A9

Contacts

Study Coordinator

5148908000

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

Recruiting

Québec, Quebec, Canada, G1J 1Z4

Contacts

Study Coordinator

418-525-4444

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-09-03.