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)

jRCT2031250198 (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: 270 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 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