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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm 1 Dose level 1 |
Participants receive MK-3120 at dose level 1 as per the schedule specified in the arm. |
|
|
Experimental Arm 2 Dose level 2 |
Participants receive MK-3120 at dose level 2 as per the schedule specified in the arm. |
|
Recruiting Locations
The University of Alabama at Birmingham ( Site 1005)
Birmingham, Alabama 35249
Birmingham, Alabama 35249
Contact:
Study Coordinator
205-934-4199
Study Coordinator
205-934-4199
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1003)
Miami, Florida 33136
Miami, Florida 33136
Contact:
Study Coordinator
305-243-5302
Study Coordinator
305-243-5302
John Theurer Cancer Center at Hackensack University Medical Center ( Site 1009)
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
Contact:
Study Coordinator
551-996-5900
Study Coordinator
551-996-5900
NEXT Oncology ( Site 1010)
Austin, Texas 78758
Austin, Texas 78758
Contact:
Study Coordinator
737-610-5202
Study Coordinator
737-610-5202
NEXT Oncology ( Site 1011)
Houston, Texas 77054
Houston, Texas 77054
Contact:
Study Coordinator
832-384-7912
Study Coordinator
832-384-7912
NEXT Oncology ( Site 1012)
Irving, Texas 75039
Irving, Texas 75039
Contact:
Study Coordinator
972-893-8800
Study Coordinator
972-893-8800
Virginia Commonwealth University ( Site 1008)
Richmond, Virginia 23219
Richmond, Virginia 23219
Contact:
Study Coordinator
804-828-7999
Study Coordinator
804-828-7999
More Details
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC