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NCT06818643PHASE1, PHASE2Recruiting

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

Merck Sharp & Dohme LLC

Start Date

3/25/2025

Completion Date

3/25/2031

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

BIOLOGICAL

MK-3120

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Conditions

Advanced Solid TumorsMalignant Neoplasm

Locations

The University of Alabama at Birmingham ( Site 1005)

Birmingham, Alabama 35249

United States

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

Miami, Florida 33136

United States

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

Hackensack, New Jersey 07601

United States

NEXT Oncology ( Site 1010)

Austin, Texas 78758

United States

NEXT Oncology ( Site 1011)

Houston, Texas 77054

United States

NEXT Oncology ( Site 1012)

Irving, Texas 75039

United States

Virginia Commonwealth University ( Site 1008)

Richmond, Virginia 23219

United States

Centro de Estudios Clínicos SAGA ( Site 0033)

Santiago, Region M. de Santiago 7500653

Chile

FALP ( Site 0031)

Santiago, Region M. de Santiago 7500921

Chile

Pontificia Universidad Catolica de Chile ( Site 0032)

Santiago, Region M. de Santiago 8330032

Chile

Bradford Hill Centro de Investigaciones Clinicas ( Site 0030)

Santiago, Region M. de Santiago 8420383

Chile

Peking University First Hospital ( Site 0180)

Beijing, Beijing Municipality 100034

China

Chongqing Cancer Hospital ( Site 0186)

Chongqing, Chongqing Municipality 400030

China

Hunan Cancer Hospital ( Site 0181)

Changsha, Hunan 410013

China

The First Hospital of Jilin University ( Site 0185)

Changchun, Jilin 130021

China

West China Hospital Sichuan University ( Site 0187)

Chengdu, Sichuan 610041

China

Institut Paoli Calmettes ( Site 0053)

Marseille, Bouches-du-Rhone 13273

France

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

Rennes, Ille-et-Vilaine 35000

France

Centre Oscar Lambret ( Site 0051)

Lille, Nord 59000

France

Gustave Roussy ( Site 0050)

Villejuif, Val-de-Marne 94800

France

Rambam Health Care Campus ( Site 0082)

Haifa, 3109601

Israel

Rabin Medical Center ( Site 0081)

Petah Tikva, 4941492

Israel

Sheba Medical Center ( Site 0080)

Ramat Gan, 5265601

Israel

National Cancer Center Hospital East ( Site 0190)

Kashiwa, Chiba 277-8577

Japan

Cancer Institute Hospital of JFCR ( Site 0192)

Koto, Tokyo 135-8550

Japan

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

Osaka, 541-8567

Japan

Radboudumc ( Site 0091)

Nijmegen, Gelderland 6525 GA

Netherlands

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

Amsterdam, North Holland 1066 CX

Netherlands

Amsterdam UMC, locatie VUmc ( Site 0093)

Amsterdam, North Holland 1081HV

Netherlands

Erasmus Medisch Centrum ( Site 0092)

Rotterdam, South Holland 3015 GD

Netherlands

Pratia Poznan ( Site 0105)

Poznan, Greater Poland Voivodeship 60-192

Poland

Pratia MCM Krakow ( Site 0106)

Krakow, Lesser Poland Voivodeship 30-727

Poland

Narodowy Instytut Onkologii ( Site 0100)

Warsaw, Masovian Voivodeship 02-781

Poland

Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie ( Site 0104)

Koszalin, West Pomeranian Voivodeship 75-581

Poland

Seoul National University Hospital ( Site 0150)

Seoul, 03080

South Korea

Severance Hospital Yonsei University Health System ( Site 0151)

Seoul, 03722

South Korea

Asan Medical Center ( Site 0153)

Seoul, 05505

South Korea

Samsung Medical Center ( Site 0152)

Seoul, 06351

South Korea

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

L'Hospitalet de Llobregat, Barcelona 08908

Spain

HOSPITAL CLÍNIC DE BARCELONA ( Site 0112)

Barcelona, Catalonia 08036

Spain

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

Madrid, Madrid, Comunidad de 28040

Spain

Hospital Universitario Virgen de la Victoria ( Site 0114)

Málaga, 29016

Spain

Chi Mei Medical Center ( Site 0162)

Tainan, Tainan 71004

Taiwan

National Cheng Kung University Hospital ( Site 0161)

Tainan, 704

Taiwan

National Taiwan University Hospital ( Site 0160)

Taipei, 10002

Taiwan

Ankara Bilkent Şehir Hastanesi. ( Site 0131)

Çankaya, Ankara 06800

Turkey (Türkiye)

Ankara University Health Practice and Research Hospitals ( Site 0134)

Ankara, 06620

Turkey (Türkiye)

Hacettepe Universite Hastaneleri ( Site 0130)

Ankara, 6230

Turkey (Türkiye)

Koc University, School of Medicine ( Site 0133)

Istanbul, 34010

Turkey (Türkiye)