Recruiting

Phase 1

Phase 2

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

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT06818643

Conditions

Advanced Solid Tumors

Malignant Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MK-3120

Study Details

Brief summary:

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.

Conditions

Advanced Solid Tumors

Malignant Neoplasm

Study ID

NCT06818643

Start date

Mar 25, 2025

Status verified date

Jul, 2026

Completion date

Mar 25, 2031

Anticipated

Primary completion date

Oct 25, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

270 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1 Dose level 1

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

experimental: Arm 2 Dose level 2

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

Interventions

MK-3120

IV infusion

Primary outcome measure

Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to approximately 43 months ]
Number of Participants Who Discontinue Study Treatment Due to an AE [ Time Frame: Up to approximately 42 months ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839 Trialsites@msd.com

Locations

The University of Alabama at Birmingham ( Site 1005)

Recruiting

Birmingham, Alabama, United States, 35249

Contacts

Study Coordinator

205-934-4199

University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1003)

Recruiting

Miami, Florida, United States, 33136

Contacts

Study Coordinator

305-243-5302

John Theurer Cancer Center at Hackensack University Medical Center ( Site 1009)

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Study Coordinator

551-996-5900

NEXT Oncology ( Site 1010)

Recruiting

Austin, Texas, United States, 78758

Contacts

Study Coordinator

737-610-5202

NEXT Oncology ( Site 1011)

Recruiting

Houston, Texas, United States, 77054

Contacts

Study Coordinator

832-384-7912

NEXT Oncology ( Site 1012)

Recruiting

Irving, Texas, United States, 75039

Contacts

Study Coordinator

972-893-8800

Virginia Commonwealth University ( Site 1008)

Recruiting

Richmond, Virginia, United States, 23219

Contacts

Study Coordinator

804-828-7999

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-07-27.