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

NCT ID: NCT06818643

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-25

Study Completion Date

2031-03-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Advanced Solid Tumors Malignant Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1 Dose level 1

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

Group Type EXPERIMENTAL

MK-3120

Intervention Type BIOLOGICAL

IV infusion

Arm 2 Dose level 2

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

Group Type EXPERIMENTAL

MK-3120

Intervention Type BIOLOGICAL

IV infusion

Interventions

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MK-3120

IV infusion

Intervention Type BIOLOGICAL

Other Intervention Names

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SKB410

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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The University of Alabama at Birmingham ( Site 1005)

Birmingham, Alabama, United States

Site Status RECRUITING

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

Miami, Florida, United States

Site Status RECRUITING

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

Hackensack, New Jersey, United States

Site Status RECRUITING

Virginia Commonwealth University ( Site 1008)

Richmond, Virginia, United States

Site Status RECRUITING

Centro de Estudios Clínicos SAGA ( Site 0033)

Santiago, Region M. de Santiago, Chile

Site Status RECRUITING

FALP ( Site 0031)

Santiago, Region M. de Santiago, Chile

Site Status RECRUITING

Pontificia Universidad Catolica de Chile ( Site 0032)

Santiago, Region M. de Santiago, Chile

Site Status RECRUITING

Bradford Hill Centro de Investigaciones Clinicas ( Site 0030)

Santiago, Region M. de Santiago, Chile

Site Status RECRUITING

Peking University First Hospital ( Site 0180)

Beijing, Beijing Municipality, China

Site Status RECRUITING

Chongqing Cancer Hospital ( Site 0186)

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Hunan Cancer Hospital ( Site 0181)

Changsha, Hunan, China

Site Status RECRUITING

The First Hospital of Jilin University ( Site 0185)

Changchun, Jilin, China

Site Status RECRUITING

West China Hospital Sichuan University ( Site 0187)

Chengdu, Sichuan, China

Site Status RECRUITING

Institut Paoli Calmettes ( Site 0053)

Marseille, Bouches-du-Rhone, France

Site Status RECRUITING

Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer-Medical Oncology ( Site 0054)

Rennes, Ille-et-Vilaine, France

Site Status RECRUITING

Centre Oscar Lambret ( Site 0051)

Lille, Nord, France

Site Status RECRUITING

Gustave Roussy ( Site 0050)

Villejuif, Val-de-Marne, France

Site Status RECRUITING

Rambam Health Care Campus ( Site 0082)

Haifa, , Israel

Site Status RECRUITING

Rabin Medical Center ( Site 0081)

Petah Tikva, , Israel

Site Status RECRUITING

Sheba Medical Center ( Site 0080)

Ramat Gan, , Israel

Site Status RECRUITING

National Cancer Center Hospital East ( Site 0190)

Kashiwa, Chiba, Japan

Site Status RECRUITING

Cancer Institute Hospital of JFCR ( Site 0192)

Koto, Tokyo, Japan

Site Status RECRUITING

Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 0191)

Osaka, , Japan

Site Status RECRUITING

Radboudumc ( Site 0091)

Nijmegen, Gelderland, Netherlands

Site Status RECRUITING

Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0090)

Amsterdam, North Holland, Netherlands

Site Status RECRUITING

Amsterdam UMC, locatie VUmc ( Site 0093)

Amsterdam, North Holland, Netherlands

Site Status RECRUITING

Erasmus Medisch Centrum ( Site 0092)

Rotterdam, South Holland, Netherlands

Site Status RECRUITING

Seoul National University Hospital ( Site 0150)

Seoul, , South Korea

Site Status RECRUITING

Severance Hospital Yonsei University Health System ( Site 0151)

Seoul, , South Korea

Site Status RECRUITING

Asan Medical Center ( Site 0153)

Seoul, , South Korea

Site Status RECRUITING

Samsung Medical Center ( Site 0152)

Seoul, , South Korea

Site Status RECRUITING

Institut Català d'Oncologia - L'Hospitalet ( Site 0113)

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status RECRUITING

HOSPITAL CLÍNIC DE BARCELONA ( Site 0112)

Barcelona, Catalonia, Spain

Site Status RECRUITING

Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 0111)

Madrid, Madrid, Comunidad de, Spain

Site Status RECRUITING

Hospital Universitario Virgen de la Victoria ( Site 0114)

Málaga, , Spain

Site Status RECRUITING

Chi Mei Medical Center ( Site 0162)

Tainan, Tainan, Taiwan

Site Status RECRUITING

National Cheng Kung University Hospital ( Site 0161)

Tainan, , Taiwan

Site Status RECRUITING

National Taiwan University Hospital ( Site 0160)

Taipei, , Taiwan

Site Status RECRUITING

Ankara Bilkent Şehir Hastanesi. ( Site 0131)

Çankaya, Ankara, Turkey (Türkiye)

Site Status RECRUITING

Ankara University Health Practice and Research Hospitals ( Site 0134)

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Hacettepe Universite Hastaneleri ( Site 0130)

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Koc University, School of Medicine ( Site 0133)

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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United States Chile China France Israel Japan Netherlands South Korea Spain Taiwan Turkey (Türkiye)

Central Contacts

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Toll Free Number

Role: CONTACT

[email protected]
1-888-577-8839

Facility Contacts

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Study Coordinator

Role: primary

888-577-8839

Study Coordinator

Role: primary

305-243-5302

Study Coordinator

Role: primary

888-577-8839

Study Coordinator

Role: primary

888-577-8839

Study Coordinator

Role: primary

+56991612199

Study Coordinator

Role: primary

+56224205098

Study Coordinator

Role: primary

+56934331806

Study Coordinator

Role: primary

+56229490970

Study Coordinator

Role: primary

010-83572211

Study Coordinator

Role: primary

023-65079277

Study Coordinator

Role: primary

073188651900

Study Coordinator

Role: primary

0431-88783330

Study Coordinator

Role: primary

028-85421141

Study Coordinator

Role: primary

+33491223789

Study Coordinator

Role: primary

+33299253196

Study Coordinator

Role: primary

+33320295959

Study Coordinator

Role: primary

+33 (0)1 42 11 42 11

Study Coordinator

Role: primary

97247776234

Study Coordinator

Role: primary

+97239378110

Study Coordinator

Role: primary

9725304498

Study Coordinator

Role: primary

+81-4-7133-1111

Study Coordinator

Role: primary

+81-3-3520-0111

Study Coordinator

Role: primary

+81-6-6945-1181

Study Coordinator

Role: primary

+31 24 361 0353

Study Coordinator

Role: primary

+31 20 512 2446

Study Coordinator

Role: primary

+31 20 444 4875

Study Coordinator

Role: primary

+31 10 704 0252

Study Coordinator

Role: primary

+82220720795

Study Coordinator

Role: primary

82-2-393-3652

Study Coordinator

Role: primary

02-3010-3266

Study Coordinator

Role: primary

+82234103438

Study Coordinator

Role: primary

+34932603261

Study Coordinator

Role: primary

+34932274208

Study Coordinator

Role: primary

+34915504800x2805

Study Coordinator

Role: primary

+34951032508

Study Coordinator

Role: primary

+88662812811x53571

Study Coordinator

Role: primary

88662353535

Study Coordinator

Role: primary

886223123456

Study Coordinator

Role: primary

+905555306271

Study Coordinator

Role: primary

+90 312 595 71 39

Study Coordinator

Role: primary

+90 312 305 43 30

Study Coordinator

Role: primary

0212 467 87 00.

Related Links

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https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

Other Identifiers

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2024-516817-19-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1311-1904

Identifier Type: REGISTRY

Identifier Source: secondary_id

jRCT2031250198

Identifier Type: REGISTRY

Identifier Source: secondary_id

3120-002

Identifier Type: -

Identifier Source: org_study_id

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