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

Launched by MERCK SHARP & DOHME LLC · Feb 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called MK-3120 for people with advanced solid tumors, which are cancers that have spread to other parts of the body and cannot be surgically removed. The main focus of this trial is to find out how safe MK-3120 is and how well patients can tolerate it. Researchers are currently looking for participants aged 65 and older who have a confirmed diagnosis of advanced solid tumors and meet specific health criteria, such as having measurable disease and good organ function.

If you join this trial, you can expect to undergo regular check-ups to monitor your health and how well you respond to the treatment. Participants will need to provide tissue samples from their tumors and should have recovered from any side effects of previous cancer treatments. This trial is a chance to explore a new potential therapy for advanced cancer, and all participants will be closely monitored throughout the study to ensure their safety.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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