A Phase 1/2 interventional study of MK-3120 and EV in Bladder Cancer, sponsored by Merck Sharp & Dohme LLC. Recruiting at 17 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Merck Sharp & Dohme LLC · Phase 1/2, Interventional, and Treatment
Researchers are looking for new ways to treat people with urothelial cancer (UC) that is locally advanced or metastatic. The standard treatment for locally advanced or metastatic UC is enfortumab vedotin (EV) given with pembrolizumab.
The goals of this study are to learn about:
This is a substudy of the master protocol MK-3475-U04 (KEYMAKER-U04)
1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.
This study's planned enrollment of 55 is close to the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Participants will receive MK-3120 administered intravenously on Day 1 and Day 8 of each 3-week cycle and EV administered intravenously on Day 1 and Day 8 of each 3-week cycle until documented disease progression or any other discontinuation criterion is met and Pembrolizumab 200 mg administered intravenously on Day 1 of each 3-week cycle for up to 35 cycles (\~2 years).
Drug: MK-3120 · Drug: EV · Biological: Pembrolizumab · Drug: Rescue Medication
Administered via intravenous (IV) infusion on day 1 and day 8 of each 3-week cycle
Administered via IV infusion on day 1 and day 8 of each 3-week cycle
Also known as: AGS 22M6E, AGS-22CE
Administered via IV infusion on day 1 of each 3-week cycle
Also known as: MK-3475, KEYTRUDA®
Participants receive rescue medication at the investigator's discretion, per approved product label. Recommended rescue medication is Granulocyte Colony-Stimulating Factor (G-CSF).
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that experience AEs will be reported.
Time frame: Up to approximately 27 months
Number of Participants Who Experience a Dose Limiting Toxicity (DLT)
DLT will be defined as any drug-related AE observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next treatment. The number of participants who experience a DLT as Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 will be presented.
Time frame: Up to approximately 21 days
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that discontinue study intervention due to an AE will be reported.
Time frame: Up to approximately 24 months
Objective Response Rate (ORR) as Assessed by Investigator
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Investigator will be presented.
Time frame: Up to approximately 58 months
Duration of Response (DOR) as Assessed by Investigator
For participants who demonstrate a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. 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 at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by investigator will be presented.
Time frame: Up to approximately 58 months
Serum Maximum Concentration (Cmax) of MK-3120 Antibody-Drug Conjugate (ADC)
Cmax is defined as the peak concentration over the dosing interval. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Cmax of MK-3120 ADC.
Time frame: Predose and at designated time points post-dose (up to approximately 24 months)
Serum Trough Concentration (Ctrough) of MK-3120 ADC
Ctrough is defined as the trough concentration. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Ctrough of MK-3120 ADC.
Time frame: Predose and at designated time points post-dose (up to approximately 24 months)
Serum Cmax of MK-3120 Total Antibodies (TAb)
Cmax is defined as the peak concentration over the dosing interval. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Cmax of MK-3120 TAb.
Time frame: Predose and at designated time points post-dose (up to approximately 24 months)
Serum Ctrough of MK-3120 TAb
Ctrough is defined as the trough concentration. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Ctrough of MK-3120 TAb.
Time frame: Predose and at designated time points post-dose (up to approximately 24 months)
Plasma Cmax of MK-3120 Free Payload
Cmax is defined as the peak concentration over the dosing interval. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Cmax of MK-3120 Free Payload.
Time frame: Predose and at designated time points post-dose (up to approximately 24 months)
Plasma Ctrough of MK-3120 Free Payload
Ctrough is defined as the trough concentration. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Ctrough of MK-3120 Free Payload.
Time frame: Predose and at designated time points post-dose (up to approximately 24 months)
Serum Cmax of EV ADC
Cmax is defined as the peak concentration over the dosing interval. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Cmax of EV ADC.
Time frame: Predose and at designated time points post-dose (up to approximately 24 months)
Serum Ctrough of EV ADC
Ctrough is defined as the trough concentration. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Ctrough of EV ADC.
Time frame: Predose and at designated time points post-dose (up to approximately 24 months)
Serum Cmax of EV TAb
Cmax is defined as the peak concentration over the dosing interval. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Cmax of Enfortumab Vedotin (EV) TAb.
Time frame: Predose and at designated time points post-dose (up to approximately 24 months)
Serum Ctrough of EV TAb
Ctrough is defined as the trough concentration. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Ctrough of EV TAb.
Time frame: Predose and at designated time points post-dose (up to approximately 24 months)
Plasma Cmax of EV Free Payload
Cmax is defined as the peak concentration over the dosing interval. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Cmax of Enfortumab Vedotin (EV) Free Payload.
Time frame: Predose and at designated time points post-dose (up to approximately 24 months)
Plasma Ctrough of EV Free Payload
Ctrough is defined as the trough concentration. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Ctrough of EV Free Payload.
Time frame: Predose and at designated time points post-dose (up to approximately 24 months)
Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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