A Clinical Study of MK-4716 in People With Certain Solid... | NCT07247110

ID	Type	Description
2025-522495-84	Registry Identifier	EU CT
U1111-1323-3663	Registry Identifier	UTN
MK-4701-001	Other Identifier	MSD

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MK-4716 Dose Escalation	Experimental	Participants receive MK-4716 at varying dose levels and schedules.	Drug: MK-4716
MK-4716 + Pembrolizumab	Experimental	Participants will receive MK-4716 + Pembrolizumab	Drug: MK-4716 Biological: Pembrolizumab
MK-4716 + Cetuximab	Experimental	Participants will receive MK-4716 + Cetuximab	Drug: MK-4716 Biological: Cetuximab

Name	Type	Description	Arm Group Labels	Other Names
MK-4716	Drug	Oral administration	MK-4716 + Cetuximab MK-4716 + Pembrolizumab MK-4716 Dose Escalation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLT)	A DLT is defined as the occurrence of protocol-specified toxicities, unless clearly related to disease progression or intercurrent illness.	Up to approximately 28 days
Number of Participants Who Experience an Adverse Event (AE)	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.	Up to approximately 4 years
Number of Participants Who Discontinue Study Intervention Due to an AE	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.	Up to approximately 4 years

Secondary Outcomes

Measure	Description	Time Frame
Area Under the Concentration-Time Curve (AUC) of MK-4716	Blood samples will be collected to determine the AUC of MK-4716.	At designated timepoints (up to approximately 58 days)
Maximum Plasma Concentration (Cmax) of MK-4716

Eligibility Module

Eligibility Criteria

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

Label	URL
Merck Clinical Trials Information	View source
Plain Language Summary	View source

ID	Term
C582435	pembrolizumab
D000068818	Cetuximab

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins