MK-8294 for people with advanced metastatic solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

MK-8294 is an investigational targeted therapy being given to adults with advanced or metastatic solid tumors who have progressed after standard treatments. This Phase 1 dose-escalation trial enrolls patients with a range of tumor types to define safety, tolerability, dose-limiting toxicities, and the maximum tolerated dose. The study will collect adverse event and pharmacokinetic data and record any preliminary signals of anti-tumor activity. The trial is sponsored by Merck and includes clinical sites in the United States and Israel.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

* Has histologically or cytologically confirmed advanced/metastatic solid tumor; including head and neck squamous cell carcinoma, cervical squamous cell carcinoma, esophageal squamous cell carcinoma, breast cancer (triple negative breast cancer, Estrogen Receptor \[ER\]/progesterone receptor +, human epidermal growth factor receptor 2 negative \[HER2-\]), endometrial, and bladder cancer by pathology report and have previously failed standard treatment, lack standard treatment options, or are intolerant to standard treatment
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Exclusion Criteria:

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

* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Has a history of New York Heart Association Class II or greater heart failure
* Has received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher immune-related Adverse Event (irAE) (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis
* Has ongoing radiation-related toxicities, requiring corticosteroids
* 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 (eg, thyroxine, insulin, or physiologic corticosteroid)
* Has active infection requiring systemic therapy
* Has history of stem cell/solid organ transplant
* Has not adequately recovered from major surgery or have ongoing surgical complications

Where it's running

• Northwestern University ( Site 0101)
  Chicago, Illinois, United States Recruiting
• John Theurer Cancer Center at Hackensack University Medical Center ( Site 0105)
  Hackensack, New Jersey, United States Recruiting
• Houston Methodist Hospital ( Site 0103)
  Houston, Texas, United States Recruiting
• MD Anderson Cancer Center ( Site 0104)
  Houston, Texas, United States Recruiting
• Rambam Health Care Campus ( Site 0201)
  Haifa, Israel Recruiting
• Sheba Medical Center ( Site 0200)
  Ramat Gan, Israel Recruiting

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.