RECRUITING

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

Conditions

Malignant Neoplasm Head and Neck Squamous Cell Carcinoma Melanoma Non-small Cell Lung Cancer Cervical Cancer Triple Negative Breast Cancer Urothelial Carcinoma Renal Cell Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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

Quick Facts

Study Start:2025-04-23

Study Completion:2029-10-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06894771

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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	* 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

Inclusion Criteria

Exclusion Criteria

* 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

* 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

Contacts and Locations

Study Contact

Toll Free Number

CONTACT

1-888-577-8839

Trialsites@msd.com

Principal Investigator

Medical Director

STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Study Locations (Sites)

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0301)

Hackensack, New Jersey, 07601

United States

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

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 Registration Dates

Study Start Date2025-04-23

Study Completion Date2029-10-02

Study Record Updates

Study Start Date2025-04-23

Study Completion Date2029-10-02

Terms related to this study

Keywords Provided by Researchers

Head and Neck Squamous Cell Carcinoma
Melanoma
Non-small Cell Lung Cancer
Cervical Cancer
Triple Negative Breast Cancer
Urothelial Carcinoma
Renal Cell Carcinoma

Additional Relevant MeSH Terms

Malignant Neoplasm