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A Study to Evaluate the Safety and Efficacy of MK-3120 in Participants With Advanced Solid Tumors (MK-3120-002)

RECRUITINGPhase 1/2Sponsored by Merck Sharp & Dohme LLC
Actively Recruiting
PhasePhase 1/2
SponsorMerck Sharp & Dohme LLC
Started2025-03-25
Est. completion2028-10-25
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations4 sites

Summary

Researchers are looking for new ways to treat people with certain advanced solid tumors. Advanced means the cancer has spread to other parts of the body and cannot be removed with surgery. Solid tumors are cancers mostly in body organs and tissues, not in the blood or other body liquids. The main goal of this study is to learn about the safety of MK-3120 and if people tolerate it.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Has a confirmed advanced (unresectable and/or metastatic) solid tumor and has received or been intolerant to all available treatments
* If human immunodeficiency virus (HIV) positive, has well controlled HIV on antiretroviral therapy (ART)
* If hepatitis B surface antigen (HBsAg) positive, must have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load
* If hepatitis C virus (HCV) infected, must have undetectable HCV viral load

Exclusion Criteria:

* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
* Has uncontrolled significant cardiovascular disease or cerebrovascular disease
* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
* Has pleural effusion, ascites, and/or pericardial effusion that are symptomatic or require repeated drainage
* Is HIV-positive and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Known additional malignancy that is progressing or has required active treatment within the past 2 years
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Active infection requiring systemic therapy, with exceptions
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has HBV or HCV infection

Conditions3

Advanced Solid TumorsCancerMalignant Neoplasm

Locations4 sites

Alabama

1 site
The University of Alabama at Birmingham ( Site 1005)
Birmingham, Alabama, 35249
Study Coordinator205-934-4199

Florida

1 site
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1003)
Miami, Florida, 33136
Study Coordinator305-243-5302

New Jersey

1 site
John Theurer Cancer Center at Hackensack University Medical Center ( Site 1009)
Hackensack, New Jersey, 07601
Study Coordinator551-996-5900

Virginia

1 site
Virginia Commonwealth University ( Site 1008)
Richmond, Virginia, 23219
Study Coordinator804-828-7999

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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