A Study of MK-4700 Alone or With Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors (MK-4700-001)

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

A Phase 1 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-4700 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors

The goal of this study is to learn about the safety of different doses of MK-4700 and if people tolerate them. The study will also measure what happens in a person's body over time when MK-4700 is given alone or with pembrolizumab (MK-3475) in order to find a dose that is safe, tolerated, and may work to treat certain types of cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

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 Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Center ( Site 0101)
    • Quebec
      • Québec, Quebec, Canada, G1J 1Z4
        • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0102)
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus ( Site 0201)
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center ( Site 0202)
      • Ramat Gan, Israel, 5265601
        • Sheba Medical Center ( Site 0200)
  • United States
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0301)
    • Texas
      • San Antonio, Texas, United States, 78229
        • NEXT Oncology ( Site 0300)

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:

The key inclusion criteria include but are not limited to the following:

  • Has histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report who have experienced disease progression on or after prior anti-cancer treatments, or been intolerant to, or refused all treatment known to confer clinical benefit
  • Has head and neck squamous cell carcinoma (HNSCC), melanoma (cutaneous), non-small cell lung cancer (NSCLC), cervical cancer, triple negative breast cancer (TNBC), urothelial carcinoma (UC), or renal cell carcinoma (RCC; clear cell, papillary)
  • If human immunodeficiency virus (HIV) infected, must have well controlled HIV on antiretroviral therapy (ART)
  • Has normal cardiac function

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

  • If HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Has known additional malignancy that is progressing or has required active treatment within the past 2 years
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy
  • Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids
  • Has current pneumonitis/interstitial lung disease
  • Has active infection requiring systemic therapy
  • Has known history of Hepatitis B (defined as Hepatitis B surface antigen reactive) or known active Hepatitis C virus infection
  • Has had an allogeneic tissue/solid organ transplant in the last 5 years

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: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: MK-4700
Participants receive escalating doses every three weeks (Q3W) of MK-4700 for a maximum of 35 cycles (approximately 2 years; cycles are 21 days in length). Eligible participants enrolled in Arm 1 who experience progressive disease (PD) may cross over to Arm 2 to receive MK-4700 and pembrolizumab combination therapy.
Biological: MK-4700
Administered via subcutaneous (SC) injection
Experimental: Arm 2: MK-4700 + Pembrolizumab
Participants will receive MK-4700 and pembrolizumab Q3W for up to 35 cycles (approximately 2 years) or until PD, death, toxicity, or withdrawal of consent.
Biological: MK-4700
Administered via subcutaneous (SC) injection
Biological: Pembrolizumab
Administered via intravenous infusion
Other Names:
  • MK-3475
  • KEYTRUDA®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose-Limiting Toxicity (DLT)
Time Frame: Cycle 1 (up to 21 days)

The occurrence of any of the following toxicities during Cycle 1 will be considered a DLT, if assessed by the investigator related to study intervention administration:

  • Grade 4 nonhematologic toxicity
  • Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia
  • Any nonhematologic AE ≥Grade 3 in severity, with exceptions
  • Any Grade 3 or Grade 4 nonhematologic laboratory value, as with pre-specified exceptions
  • Any Grade 3 or Grade 4 laboratory abnormalities, with the exceptions
  • Febrile neutropenia Grade 3 or Grade 4
  • Prolonged delay (>2 weeks) in initiating Cycle 2 due to intervention-related toxicity
  • Any study drug toxicity that causes the participant to discontinue study drug during Cycle 1
  • Missing >25% of MK-4700 doses as a result of drug-related AEs during the first cycle
  • Grade 5 toxicity
Cycle 1 (up to 21 days)
Percentage of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to approximately 4.5 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.
Up to approximately 4.5 years
Percentage of Participants who Discontinue Study Treatment Due to an AE
Time Frame: Up to approximately 4.5 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.
Up to approximately 4.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Concentration-Time Curve of MK-4700
Time Frame: Predose and at prespecified time points during Cycles 1, 2, 3, 4, 5, 6, 7, and 10 up to approximately 7 months (Cycle length is 21 days)
AUC is defined as the area under the concentration versus time curve. Blood samples will be collected at pre-specified timepoints to determine AUC.
Predose and at prespecified time points during Cycles 1, 2, 3, 4, 5, 6, 7, and 10 up to approximately 7 months (Cycle length is 21 days)
Maximum Plasma Concentration (Cmax) of MK-4700
Time Frame: Predose and at prespecified time points during Cycles 1, 2, 3, 4, 5, 6, 7, and 10 up to approximately 7 months (Cycle length is 21 days)
Cmax is defined as the maximum concentration of MK-4700 observed in plasma after its administration and just prior to administration of the next dose. Blood samples will be collected at pre-specified timepoints to determine Cmax.
Predose and at prespecified time points during Cycles 1, 2, 3, 4, 5, 6, 7, and 10 up to approximately 7 months (Cycle length is 21 days)
Minimum Plasma Concentration (Cmin) of MK-4700
Time Frame: Predose and at prespecified time points during Cycles 1, 2, 3, 4, 5, 6, 7, and 10 up to approximately 7 months (Cycle length is 21 days)
Cmin is defined as the minimum concentration of MK-4700 observed in plasma after its administration and just prior to administration of the next dose. Blood samples will be collected at pre-specified timepoints to determine Cmin.
Predose and at prespecified time points during Cycles 1, 2, 3, 4, 5, 6, 7, and 10 up to approximately 7 months (Cycle length is 21 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)

April 23, 2025

Primary Completion (Actual)

December 8, 2025

Study Completion (Actual)

December 8, 2025

Study Registration Dates

First Submitted

March 3, 2025

First Submitted That Met QC Criteria

March 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4700-001
  • MK-4700-001 (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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