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

Phase 2RecruitingNCT06818643

Merck Sharp & Dohme LLC270 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

270

Conditions

Advanced Solid Tumors Malignant Neoplasm

Interventions

MK-3120BIOLOGICAL

IV infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (49)

Outcomes

Primary Outcomes

Number of Participants Who Experience an Adverse Event (AE)

An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE will be presented.

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

Secondary Outcomes

Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1) as Assessed by the Investigator

ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by the investigator per RECIST 1.1.

Time frame: Up to approximately 72 months

Duration Of Response (DOR) Per RECIST 1.1 as Assessed by the Investigator

For participants who demonstrate a confirmed CR (disappearance of all target lesions) or confirmed PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by the investigator per RECIST 1.1 will be presented.

Central Contacts

Toll Free Number

CONTACT

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

The University of Alabama at Birmingham ( Site 1005)

Birmingham, Alabama, United States

RECRUITING

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

Miami, Florida, United States

RECRUITING

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

Hackensack, New Jersey, United States

RECRUITING

NEXT Oncology ( Site 1010)

Austin, Texas, United States

RECRUITING

NEXT Oncology ( Site 1011)

Houston, Texas, United States

RECRUITING

NEXT Oncology ( Site 1012)

Irving, Texas, United States

RECRUITING

Virginia Commonwealth University ( Site 1008)

Richmond, Virginia, United States

RECRUITING

Centro de Estudios Clínicos SAGA ( Site 0033)

Santiago, Region M. de Santiago, Chile

RECRUITING

FALP ( Site 0031)

Santiago, Region M. de Santiago, Chile

RECRUITING

Pontificia Universidad Catolica de Chile ( Site 0032)

Santiago, Region M. de Santiago, Chile

RECRUITING

...and 39 more locations

Time frame: Up to approximately 72 months

Progression-free Survival (PFS) Per RECIST 1.1 as Assessed by the Investigator

PFS is defined as the time from the first dose of study treatment to the first documented PD or death due to any cause, whichever occurs first will be assessed by the investigator using RECIST 1.1. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by the investigator per RECIST 1.1 will be presented.

Time frame: Up to approximately 72 months

Overall Survival (OS) Per RECIST 1.1 as Assessed by the Investigator

OS is defined as the time from the first dose of study treatment to death due to any cause as assessed by the investigator per RECIST 1.1 will be presented.

Time frame: Up to approximately 72 months

Area Under the Concentration-Time Curve (AUC) of MK-3120 Antibody-Drug Conjugate (ADC)

Blood samples will be collected to determine the AUC of MK-3120 ADC.