RECRUITING

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

Conditions

Advanced Solid Tumors Malignant Neoplasm

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1/2 Open-label Study to Evaluate the Safety and Efficacy of MK-3120 in Participants With Advanced Solid Tumors

Quick Facts

Study Start:2025-03-25

Study Completion:2028-01-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06818643

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Has a confirmed advanced (unresectable and/or metastatic) solid tumor * Has measurable disease by RECIST 1.1 as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions * Has archival tumor tissue sample or newly obtained biopsy of a tumor lesion not previously irradiated has been provided * Who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART) * Hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization. * Who has history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening * Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 3 days before intervention allocation/randomization * Has adequate organ function	* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea) * Has uncontrolled significant cardiovascular disease or cerebrovascular disease * Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing * Has pleural effusion, ascites, and/or pericardial effusion that are symptomatic or require repeated drainage * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the start of study intervention * Has received prior radiotherapy within 2 weeks of start of study intervention * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Has active infection requiring systemic therapy * Has concurrent active Hepatitis B (defined as hepatitis B surface antigen (HBsAg) positive and/or detectable HBV deoxyribonucleic acid (DNA) and Hepatitis C virus (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA) infection

Inclusion Criteria

Exclusion Criteria

* Has a confirmed advanced (unresectable and/or metastatic) solid tumor
* Has measurable disease by RECIST 1.1 as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions
* Has archival tumor tissue sample or newly obtained biopsy of a tumor lesion not previously irradiated has been provided
* Who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
* Hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.
* Who has history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 3 days before intervention allocation/randomization
* Has adequate organ function

* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
* Has uncontrolled significant cardiovascular disease or cerebrovascular disease
* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing
* Has pleural effusion, ascites, and/or pericardial effusion that are symptomatic or require repeated drainage
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the start of study intervention
* Has received prior radiotherapy within 2 weeks of start of study intervention
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has active infection requiring systemic therapy
* Has concurrent active Hepatitis B (defined as hepatitis B surface antigen (HBsAg) positive and/or detectable HBV deoxyribonucleic acid (DNA) and Hepatitis C virus (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA) infection

Contacts and Locations

Study Contact

Toll Free Number

CONTACT

1-888-577-8839

Trialsites@msd.com

Principal Investigator

Medical Director

STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Study Locations (Sites)

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

Hackensack, New Jersey, 07601

United States

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-25

Study Completion Date2028-01-28

Study Record Updates

Study Start Date2025-03-25

Study Completion Date2028-01-28

Terms related to this study

Additional Relevant MeSH Terms

Advanced Solid Tumors
Malignant Neoplasm