Evaluating MK-3120 for advanced solid tumors
A Phase 1/2 Open-label Study to Evaluate the Safety and Efficacy of MK-3120 in Participants With Advanced Solid Tumors
PHASE1; PHASE2 · Merck Sharp & Dohme LLC · NCT06818643
This study is testing a new treatment called MK-3120 to see if it can help people with advanced solid tumors that can't be removed by surgery.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Merck Sharp & Dohme LLC (industry) |
| Locations | 45 sites (Birmingham, Alabama and 44 other locations) |
| Trial ID | NCT06818643 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and efficacy of MK-3120 in participants with advanced solid tumors that are unresectable or metastatic. The research focuses on individuals whose cancer has spread and cannot be surgically removed. Participants will undergo treatment with MK-3120, and the study will monitor their tolerance and any adverse effects. The goal is to gather data that could lead to new treatment options for these patients.
Who should consider this trial
Good fit: Ideal candidates include individuals with confirmed advanced solid tumors that are unresectable or metastatic and who meet specific health criteria.
Not a fit: Patients with solid tumors that are resectable or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors.
How similar studies have performed: Other studies have explored similar treatments for advanced solid tumors, but the specific approach with MK-3120 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Birmingham, Alabama and 44 other locations
- 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)
- Bradford Hill Centro de Investigaciones Clinicas ( Site 0030) — Santiago, Region M. de Santiago, Chile (RECRUITING)
- Peking University First Hospital ( Site 0180) — Beijing, Beijing Municipality, China (RECRUITING)
- Chongqing Cancer Hospital ( Site 0186) — Chongqing, Chongqing Municipality, China (RECRUITING)
- Hunan Cancer Hospital ( Site 0181) — Changsha, Hunan, China (RECRUITING)
- The First Hospital of Jilin University ( Site 0185) — Changchun, Jilin, China (RECRUITING)
- West China Hospital Sichuan University ( Site 0187) — Chengdu, Sichuan, China (RECRUITING)
- Institut Paoli Calmettes ( Site 0053) — Marseille, Bouches-du-Rhone, France (RECRUITING)
- Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer-Medical Oncology ( Site 0054) — Rennes, Ille-et-Vilaine, France (RECRUITING)
- Centre Oscar Lambret ( Site 0051) — Lille, Nord, France (RECRUITING)
- Gustave Roussy ( Site 0050) — Villejuif, Val-de-Marne, France (RECRUITING)
- Rambam Health Care Campus ( Site 0082) — Haifa, Israel (RECRUITING)
- Rabin Medical Center ( Site 0081) — Petah Tikva, Israel (RECRUITING)
- Sheba Medical Center ( Site 0080) — Ramat Gan, Israel (RECRUITING)
- National Cancer Center Hospital East ( Site 0190) — Kashiwa, Chiba, Japan (RECRUITING)
- Cancer Institute Hospital of JFCR ( Site 0192) — Koto, Tokyo, Japan (RECRUITING)
- Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 0191) — Osaka, Japan (RECRUITING)
- Radboudumc ( Site 0091) — Nijmegen, Gelderland, Netherlands (RECRUITING)
- Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0090) — Amsterdam, North Holland, Netherlands (RECRUITING)
- Amsterdam UMC, locatie VUmc ( Site 0093) — Amsterdam, North Holland, Netherlands (RECRUITING)
- Erasmus Medisch Centrum ( Site 0092) — Rotterdam, South Holland, Netherlands (RECRUITING)
- Seoul National University Hospital ( Site 0150) — Seoul, South Korea (RECRUITING)
- Severance Hospital Yonsei University Health System ( Site 0151) — Seoul, South Korea (RECRUITING)
- Asan Medical Center ( Site 0153) — Seoul, South Korea (RECRUITING)
- Samsung Medical Center ( Site 0152) — Seoul, South Korea (RECRUITING)
- Institut Català d'Oncologia - L'Hospitalet ( Site 0113) — L'Hospitalet de Llobregat, Barcelona, Spain (RECRUITING)
- HOSPITAL CLÍNIC DE BARCELONA ( Site 0112) — Barcelona, Catalonia, Spain (RECRUITING)
- Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 0111) — Madrid, Madrid, Comunidad de, Spain (RECRUITING)
- Hospital Universitario Virgen de la Victoria ( Site 0114) — Málaga, Spain (RECRUITING)
- Chi Mei Medical Center ( Site 0162) — Tainan, Tainan, Taiwan (RECRUITING)
- National Cheng Kung University Hospital ( Site 0161) — Tainan, Taiwan (RECRUITING)
- National Taiwan University Hospital ( Site 0160) — Taipei, Taiwan (RECRUITING)
- Ankara Bilkent Şehir Hastanesi. ( Site 0131) — Çankaya, Ankara, Turkey (Türkiye) (RECRUITING)
- Ankara University Health Practice and Research Hospitals ( Site 0134) — Ankara, Turkey (Türkiye) (RECRUITING)
- Hacettepe Universite Hastaneleri ( Site 0130) — Ankara, Turkey (Türkiye) (RECRUITING)
- Koc University, School of Medicine ( Site 0133) — Istanbul, Turkey (Türkiye) (RECRUITING)
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@msd.com
- Phone: 1-888-577-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Advanced Solid Tumors, Malignant Neoplasm