A Study to Evaluate the Safety and Efficacy of MK-3120 in Participants With Advanced Solid Tumors (MK-3120-002)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
MK-3120
Biological/VaccineIV infusion
Treatment groups
270 Participants
are divided into 2 treatment groupsGroup A: Arm 1 Dose level 1Experimental treatment 1 intervention
Group B: Arm 2 Dose level 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants Who Experience an Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE will be presented.
Time frame
Up to approximately 43 months2
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be presented.
Time frame
Up to approximately 42 monthsSecondary outcomes
1
Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1) as Assessed by the Investigator
ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by the investigator per RECIST 1.1.
Time frame
Up to approximately 72 months2
Duration Of Response (DOR) Per RECIST 1.1 as Assessed by the Investigator
For participants who demonstrate a confirmed CR (disappearance of all target lesions) or confirmed PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by the investigator per RECIST 1.1 will be presented.
Time frame
Up to approximately 72 months3
Progression-free Survival (PFS) Per RECIST 1.1 as Assessed by the Investigator
PFS is defined as the time from the first dose of study treatment to the first documented PD or death due to any cause, whichever occurs first will be assessed by the investigator using RECIST 1.1. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by the investigator per RECIST 1.1 will be presented.
Time frame
Up to approximately 72 months4
Overall Survival (OS) Per RECIST 1.1 as Assessed by the Investigator
OS is defined as the time from the first dose of study treatment to death due to any cause as assessed by the investigator per RECIST 1.1 will be presented.
Time frame
Up to approximately 72 monthsSponsors and contacts
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Source ClinicalTrials.gov