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

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm 1 Dose level 1 		Participants receive MK-3120 at dose level 1 as per the schedule specified in the arm.
  • Biological: MK-3120
    IV infusion
    Other names:
    • SKB410
Experimental
Arm 2 Dose level 2 		Participants receive MK-3120 at dose level 2 as per the schedule specified in the arm.
  • Biological: MK-3120
    IV infusion
    Other names:
    • SKB410

Recruiting Locations

The University of Alabama at Birmingham ( Site 1005)
Birmingham 4049979, Alabama 4829764 35249
Contact:
Study Coordinator
888-577-8839

University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1003)
Miami 4164138, Florida 4155751 33136
Contact:
Study Coordinator
305-243-5302

John Theurer Cancer Center at Hackensack University Medical Center ( Site 1009)
Hackensack 5098706, New Jersey 5101760 07601
Contact:
Study Coordinator
888-577-8839

Virginia Commonwealth University ( Site 1008)
Richmond 4781708, Virginia 6254928 23219
Contact:
Study Coordinator
888-577-8839

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com