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Completed

NCT Number: NCT06894771

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

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.

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Key information

Conditions

Malignant Neoplasm Adenocarcinoma Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Carcinoma, Squamous Cell Carcinoma, Transitional Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Head and Neck Neoplasms Kidney Diseases Kidney Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Squamous Cell Carcinoma of Head and Neck Thoracic Neoplasms Triple Negative Breast Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Princess Margaret Cancer Center ( Site 0101), Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

MK-4700

Biological

Administered via subcutaneous (SC) injection

Pembrolizumab

Biological

Administered via intravenous infusion

Other names: MK-3475, KEYTRUDA®

Primary outcomes

  1. 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

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 25, 2025
Registry last updated
Mar 16, 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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