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

Launched by MERCK SHARP & DOHME LLC · Mar 19, 2025

Keywords

ClinConnect Summary

This clinical trial, called MK-4700-001, is studying a new medication called MK-4700, both on its own and in combination with another drug called pembrolizumab, in patients with advanced or metastatic solid tumors, which are types of cancer that have spread beyond their original site. The main goal is to understand how safe different doses of MK-4700 are and how well patients tolerate them. Researchers will also look at how the body responds to these treatments over time to find the best and safest dose that might help treat certain cancers.

To participate in this trial, individuals should be between the ages of 65 and 74 and have a confirmed diagnosis of specific types of advanced cancer, such as melanoma, lung cancer, or triple-negative breast cancer. They should have either not responded to previous treatments or cannot receive them. Participants can expect regular check-ups and monitoring to ensure their safety while receiving the study treatments. It's important to note that certain health conditions, like active infections or recent cancer treatments, may make someone ineligible for the trial. This study is currently recruiting participants, and people interested should discuss it with their healthcare provider to see if they qualify.

Gender

ALL

Eligibility criteria

• 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 and have received, 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