A Study to Evaluate the Safety and Efficacy of MK-3120 in Participants With Advanced Solid Tumors (MK-3120-002)
180 patients around the world
Available in Chile
Merck Sharp & Dohme LLC
4Research sites
180Patients around the world
This study is for people with
Advanced tumors
Solid tumors
Requirements for the patient
From 18 Years
All Gender
Medical requirements
Has a confirmed advanced (unresectable and/or metastatic) solid tumor.
Has measurable disease by RECIST 1.1 as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.
Has archival tumor tissue sample or newly obtained biopsy of a tumor lesion not previously irradiated has been provided.
Who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible.
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART).
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 prior to randomization.
Who has history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 3 days before intervention allocation/randomization.
Has adequate organ function.
Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).
Has uncontrolled significant cardiovascular disease or cerebrovascular disease.
Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
Has pleural effusion, ascites, and/or pericardial effusion that are symptomatic or require repeated drainage.
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the start of study intervention.
Has received prior radiotherapy within 2 weeks of start of study intervention.
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Has active infection requiring systemic therapy.
Has concurrent active Hepatitis B (defined as hepatitis B surface antigen (HBsAg) positive and/or detectable HBV deoxyribonucleic acid (DNA) and Hepatitis C virus (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA) infection.
Sites
Centro de Investigación Clínica Bradford Hill - Santiago, Región Metropolitana
Recruiting
Manzano 343, Recoleta, Región Metropolitana, Santiago
Hospital Clínico Pontificia Universidad Católica de Chile - Santiago, Región Metropolitana
Recruiting
Portugal 61, Santiago
Centro de Estudios Clínicos SAGA - CECSAGA
Recruiting
Antonio Varas 517, 7500653 Providencia, Región Metropolitana
Instituto Oncológico FALP (Fundación Arturo Lopez Perez)
Recruiting
José Manuel Infante 805, Providencia, Región Metropolitana, Santiago