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

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.

Conditions

Malignant Neoplasm
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Related Conditions:

Malignant Neoplasm

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Malignant Neoplasm
Intervention / Treatment

-

Contacts and Locations

Hackensack

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0301), Hackensack, New Jersey, United States, 07601

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Merck Sharp & Dohme LLC,

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

2029-10-02