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NCT Number: NCT07247110

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

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.

Recruiting

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Key information

Conditions

Malignant Neoplasm Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Blacktown Hospital ( Site 0455), Sydney, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK-4716

Drug

Oral administration

Pembrolizumab

Biological

Intravenous administration

Other names: Keytruda, MK-3475

Cetuximab

Biological

Intravenous administration

Primary outcomes

  1. Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLT)

    Time frame: Up to approximately 28 days

    A DLT is defined as the occurrence of protocol-specified toxicities, unless clearly related to disease progression or intercurrent illness.

  2. Number of Participants Who Experience an Adverse Event (AE)

    Time frame: Up to approximately 4 years

    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.

  3. Number of Participants Who Discontinue Study Intervention Due to an AE

    Time frame: Up to approximately 4 years

    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.

Secondary outcomes

  1. Area Under the Concentration-Time Curve (AUC) of MK-4716

    Time frame: At designated timepoints (up to approximately 58 days)

    Blood samples will be collected to determine the AUC of MK-4716.

  2. Maximum Plasma Concentration (Cmax) of MK-4716

    Time frame: At designated timepoints (up to approximately 58 days)

    Blood samples will be collected to estimate Cmax of MK-4716.

  3. Trough Plasma Concentration (Ctrough) of MK-4716

    Time frame: At designated timepoints (up to approximately 19 months)

    Blood samples will be collected to determine the Ctrough of MK-4716.

  4. Half-Life (t1/2) of MK-4716

    Time frame: At designated timepoints (up to approximately 58 days)

    Blood samples will be collected to determine the t1/2 of MK-4716.

Study contacts

Contact information is provided by the study sponsor or research team.

Toll Free Number

CONTACT

[email protected]

1-888-577-8839

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase 1, Open-Label, Multicenter Study to Assess Safety, Tolerability, Pharmacokinetics, and Efficacy of MK-4716 as Monotherapy and as Part of Combination Therapy in Participants With KRAS-Altered Advanced or Metastatic Solid Tumors

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Nov 25, 2025
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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