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

May 13, 2026 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2148
        • Recruiting
        • Blacktown Hospital ( Site 0455)
        • Contact:
          • Study Coordinator
          • Phone Number: 98818000
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Monash Health ( Site 0452)
        • Contact:
          • Study Coordinator
          • Phone Number: +61474769510
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • The Alfred Hospital ( Site 0453)
        • Contact:
          • Study Coordinator
          • Phone Number: +61 3 9076 3129
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • One Clinical Research ( Site 0454)
        • Contact:
          • Study Coordinator
          • Phone Number: +61862799466
  • Chile
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 8330073
        • Recruiting
        • Pontificia Universidad Catolica de Chile-CICUC ( Site 0103)
        • Contact:
          • Study Coordinator
          • Phone Number: +56934331806
      • Santiago, Region M. de Santiago, Chile, 8420383
        • Recruiting
        • Bradfordhill ( Site 0102)
        • Contact:
          • Study Coordinator
          • Phone Number: +56229490970
  • Israel
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus ( Site 0252)
        • Contact:
          • Study Coordinator
          • Phone Number: +97247772688
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center ( Site 0253)
        • Contact:
          • Study Coordinator
          • Phone Number: +97239377377
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Sheba Medical Center ( Site 0251)
        • Contact:
          • Study Coordinator
          • Phone Number: +97235303030
  • South Korea
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital ( Site 0501)
        • Contact:
          • Study Coordinator
          • Phone Number: 82-2-2072-0242
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center ( Site 0502)
        • Contact:
          • Study Coordinator
          • Phone Number: 82-2-3010-1727
  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic de Barcelona ( Site 0362)
        • Contact:
          • Study Coordinator
          • Phone Number: +34932274208
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital General Universitari Vall d Hebron ( Site 0360)
        • Contact:
          • Study Coordinator
          • Phone Number: +34932746000
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Universitario Fundacion Jimenez Diaz ( Site 0361)
        • Contact:
          • Study Coordinator
          • Phone Number: +34915504800x2805
  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Recruiting
        • Rutgers Cancer Institute of New Jersey ( Site 0052)
        • Contact:
          • Study Coordinator
          • Phone Number: 732-253-3939
    • Texas
      • Irving, Texas, United States, 75039
        • Recruiting
        • NEXT Oncology ( Site 0051)
        • Contact:
          • Study Coordinator
          • Phone Number: 972-893-8800
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • NEXT Virginia ( Site 0054)
        • Contact:
          • Study Coordinator
          • Phone Number: 703-783-4510

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MK-4716 + Pembrolizumab
Participants will receive MK-4716 + Pembrolizumab
Drug: MK-4716
Oral administration
Biological: Pembrolizumab
Intravenous administration
Other Names:
  • Keytruda
  • MK-3475
Experimental: MK-4716 + Cetuximab
Participants will receive MK-4716 + Cetuximab
Biological: Cetuximab
Intravenous administration
Drug: MK-4716
Oral administration
Experimental: MK-4716 Dose Escalation
Participants receive MK-4716 at varying dose levels and schedules.
Drug: MK-4716
Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to approximately 28 days
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to approximately 5 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.
Up to approximately 5 years
Number of Participants Who Discontinue Study Intervention Due to an AE
Time Frame: Up to approximately 5 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.
Up to approximately 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At designated timepoints (up to approximately 58 days)
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.
At designated timepoints (up to approximately 58 days)
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.
At designated timepoints (up to approximately 19 months)
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.
At designated timepoints (up to approximately 58 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2025

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Actual)

November 25, 2025

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4716-001
  • 2025-522495-84 (Registry Identifier: EU CT)
  • U1111-1323-3663 (Registry Identifier: UTN)
  • MK-4701-001 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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