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

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 1

Conditions: Malignant Neoplasm

Treatments: Drug: MK-4716; Biological: Cetuximab; Biological: Pembrolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT07247110

MK-4701-001 (Other Identifier)

2025-522495-84 (Registry Identifier)

4716-001

U1111-1323-3663 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• Arm MK-4716 + Cetuximab: Must be eligible for cetuximab
• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 3 patient groups

MK-4716 Dose Escalation

Experimental group

Description:

Participants receive MK-1084 at varying dose levels and schedules.

Treatment:

Drug: MK-4716

MK-4716 + Pembrolizumab

Experimental group

Description:

Participants will receive MK-4716 + Pembrolizumab

Treatment:

Biological: Pembrolizumab

Drug: MK-4716

MK-4716 + Cetuximab

Experimental group

Description:

Participants will receive MK-4716 + Cetuximab

Treatment:

Biological: Cetuximab

Drug: MK-4716