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

ConditionsAdvanced Solid Tumors Malignant Neoplasm

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorMerck Sharp & Dohme LLC

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

MK-3120

Treatment groups

270 Participants

are divided into 2 treatment groups

Locations

Chile

Bradford Hill Centro de Investigaciones Clinicas ( Site 0030)8420383, SantiagoRegion M. de Santiago, Chile

Centro de Estudios Clínicos SAGA ( Site 0033)7500653, SantiagoRegion M. de Santiago, Chile

FALP ( Site 0031)7500921, SantiagoRegion M. de Santiago, Chile

Pontificia Universidad Catolica de Chile ( Site 0032)8330032, SantiagoRegion M. de Santiago, Chile

Sponsors and collaborators

Merck Sharp & Dohme LLC

Lead sponsor

Source ClinicalTrials.gov