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

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

Recruiting
18 years and older
All
Phase 1

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Overview

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

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

Study details
    Malignant Neoplasm

NCT07247110

Merck Sharp & Dohme LLC

31 January 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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