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Investigational Treatments for Urothelial Carcinoma Resistant to PD-1/L1 Inhibitors

This study is for people with advanced urothelial carcinoma (a type of bladder cancer) that has not responded to previous treatments called PD-1/L1 inhibitors. It is testing new combinations of medicines, including zilovertamab vedotin, pembrolizumab, and MK-3120. The main goals are to see how safe these treatments are and if they can shrink the cancer. You would be eligible if you are 18 or older and have this specific type of cancer that has progressed despite prior PD-1/L1 inhibitor treatment. The study is currently unclear about its recruitment status and plans to enroll 48 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It is part of a larger study evaluating different investigational agents.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety for up to approximately 5 years. The effectiveness of the treatment will be measured for up to approximately 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05562830

A Substudy of Investigational Agents in Programmed Cell Death-1/Ligand 1 (PD-1/L1) Refractory Locally Advanced or Metastatic Urothelial Carcinoma (mUC) (MK-3475-04A)

Recruiting
PHASE1Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~48 participants
Updated 2026-05-27 on ClinicalTrials.gov
What's tested:Zilovertamab vedotinPembrolizumabMK-3120

At a glance

Recruiting sites
26 of 28 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants Who Experienced At Least One Adverse Event (AE)
Measured over Up to approximately 5 years
+3 more outcomes measured

Conditions

Urothelial Carcinoma

Explore related trials

Urothelial Carcinoma

Where it's being run

28 sites across 21 states
Israel3
South Korea3
California2
Region M. de Santiago2
London, City of2
Colorado1
Illinois1
Indiana1

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Histologically or cytologically confirmed diagnosis of locally advanced/unresectable or mUC of the renal pelvis, ureter (upper urinary tract), bladder, or urethra.
Arm A: PD-1/L1 refractory locally advanced or mUC as evidenced by: EITHER disease progression while on treatment or after treatment with an anti-PD-1/L1 monoclonal antibody (mAb) for locally advanced/unresectable or mUC administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies OR disease recurrence while on treatment or after treatment with an anti-PD-1/L1 mAb for muscle-invasive urothelial carcinoma (MIUC) administered as monotherapy.
Arm A: Participants must provide an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion demonstrating UC, not previously irradiated, and adequate for biomarker evaluation.
Arm B: PD-1/L1 refractory locally advanced or mUC as evidenced by: EITHER disease progression after treatment with an anti-PD-1/L1 mAb for locally advanced/unresectable or mUC administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies; OR disease recurrence after treatment with an anti-PD-1/L1 mAb for MIUC administered as monotherapy or in combination with other checkpoint therapies \>12 months after last dose of treatment with an anti-PD-1/L1 mAb.
Arm B: Participants must provide an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion from a metastatic site or from a primary tumor that has become locally advanced and not previously irradiated.

Exclusion

Known additional nonurothelial malignancy that is progressing or has required active treatment within 3 years prior to study randomization/allocation.
Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization/allocation.
Active infection requiring systemic therapy.
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
Known history of human immunodeficiency virus (HIV).
Known history of hepatitis B or known hepatitis C virus infection.

What this trial measures

  • Percentage of Participants Who Experienced At Least One Adverse Event (AE)Up to approximately 5 years

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.

  • Percentage of Participants Who Discontinued Study Treatment Due to an AEUp to approximately 5 years

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment

  • Arm A: Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR)Up to approximately 2 years

    ORR is defined as the percentage of participants who achieve a 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 Blinded Independent Central Review (BICR) will be presented.

  • Arm B: ORR as Assessed by InvestigatorUp to approximately 2 years

    ORR is defined as the percentage of participants who achieve a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by the investigator will be presented.