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

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Malignant Neoplasm; Advanced Solid Tumors

Treatments: Biological: MK-3120

Study type: Interventional

Funder types: Industry

Identifiers

NCT06818643

3120-002

2024-516817-19-00 (Registry Identifier)

U1111-1311-1904 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Arm 1 Dose level 1

Experimental group

Description:

Participants receive MK-3120 at dose level 1 as per the schedule specified in the arm.

Treatment:

Biological: MK-3120

Arm 2 Dose level 2

Experimental group

Description:

Participants receive MK-3120 at dose level 2 as per the schedule specified in the arm.

Treatment:

Biological: MK-3120