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RecruitingLast updated: 6 July 2026

Testing a new drug (called MK-4716) when given alone, or in combination with other treatments, in people with advanced or metastatic solid tumoursA 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Clinical summary

Summary

Researchers are looking for new ways to treat certain advanced or metastatic solid tumours. The goal of this study is to learn about the safety of MK-4716 and how well people tolerate it when taken alone or with other treatments.

The study is for people who:

  • have a solid tumour
  • the cancer is advanced, has spread to other parts of the body (metastatic) or cannot be removed with surgery (unresectable)
  • the cancer has a gene change called a KRAS alteration
  • have had previous treatment for their cancer (for most parts of the study), or have not yet received treatment (for a specific lung cancer group)

Participants may receive:

  • MK-4716 on its own, or
  • MK-4716 combined with immunotherapy (pembrolizumab), or
  • MK-4716 combined with targeted therapy (cetuximab)

Some parts of the study are open to people with many different cancer types (as long as they have a KRAS alteration). One part is specifically for people with non-small cell lung cancer. 

Conditions

This trial is treating people with locally advanced or metastatic solid cancers, or non-small cell lung cancer

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are able to swallow medication by mouth.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

  • NCT07247110 *
  • 2025-522495-84 *
  • 4716-001; U1111-1323-3663; MK-4701-001

Trial sponsor

Merck Sharp & Dohme LLC

Scientific 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

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