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Phase 1/2 Evaluation of Zilovertamab Vedotin in PD-1/L1 Refractory Locally Advanced or Metastatic Urothelial Carcinoma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called urothelial carcinoma, which affects the bladder and other parts of the urinary system. The study is specifically looking at cases where the cancer is either locally advanced or has spread to other parts of the body, known as metastatic urothelial carcinoma. The trial is testing a new treatment called Zilovertamab vedotin, which is given as a solution through an intravenous infusion. This treatment is being tested on patients whose cancer has not responded to previous treatments that target proteins called PD-1 or PD-L1.

The purpose of the study is to understand how safe and tolerable the new treatment is for patients, as well as to see how well it works in reducing the size of the cancer. Participants in the study will receive the investigational treatment, and their response to the treatment will be monitored over time. The study will also look at how long any positive effects of the treatment last.

Throughout the study, researchers will keep track of any side effects experienced by participants and whether these side effects lead to stopping the treatment. The study aims to gather important information that could help in developing new treatment options for people with this type of cancer. The trial is expected to continue until early 2028.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study enrollment confirmed

    After the decision to join the study, the enrollment is recorded and the participant receives a schedule for the first study visits.

  2. Step 2

    Baseline assessments

    Initial medical examinations, laboratory tests, and imaging scans are performed to document the current condition of the cancer.

    The results are used to compare later measurements and to ensure safety before any study medication is given.

  3. Step 3

    First intravenous infusion

    The participant receives an intravenous infusion of the study medication.

    The medication may be pembrolizumab alone or together with an investigational agent such as mk-3120 or zilovertamab vedotin.

    The exact dose, frequency, and total number of infusions are defined by the study protocol and are not specified in this summary.

  4. Step 4

    Subsequent infusions

    Additional intravenous infusions are given at regular intervals as described in the protocol.

    Each infusion follows the same procedure as the first infusion and includes the same medication(s).

  5. Step 5

    Regular safety monitoring

    At each visit, the participant undergoes safety checks that include physical examinations, blood tests, and assessment of any side effects.

    Any adverse event is recorded and evaluated by the study team.

  6. Step 6

    Tumor response evaluation

    Imaging studies are performed periodically to determine whether the tumor is responding to the treatment.

    The results are reviewed by independent experts according to standardized criteria.

  7. Step 7

    Possible treatment discontinuation

    Treatment may be stopped early if the participant experiences significant side effects, if the disease progresses, or if the study protocol requires discontinuation.

  8. Step 8

    End of treatment phase

    When the planned number of infusions has been completed or treatment is otherwise ended, the participant enters the end‑of‑treatment visit.

    Final safety assessments and imaging are performed at this visit.

  9. Step 9

    Post‑treatment follow‑up

    After treatment stops, the participant continues to be monitored for a defined follow‑up period.

    Follow‑up visits include safety checks and imaging to observe any long‑term effects or disease changes.

Who can join the trial?

7 criteria

  • Must have a confirmed diagnosis (checked by a lab test of tissue) of locally advanced or metastatic urothelial carcinoma (cancer of the lining of the kidney pelvis, ureter, bladder, or urethra).
  • Must be either male or female.
  • Must be an adult (generally 18 years of age or older).
  • For Arm A: The cancer must have continued to grow or returned while receiving or after receiving a PD-1/L1 therapy (a type of treatment that blocks a protein called PD‑1 or PD‑L1). This can be shown by disease progression during treatment or after treatment with a monoclonal antibody that targets PD‑1/L1, either alone or together with other checkpoint‑inhibitor medicines.
  • For Arm B: The cancer must have continued to grow after a PD-1/L1 therapy, or it must have come back more than 12 months after the last dose of a PD‑1/L1 monoclonal antibody, whether the drug was given alone or with other checkpoint‑inhibitor medicines.
  • For Arm A: You must be able to provide either an old (archival) tumor tissue sample or a new small tissue sample (called a core or excisional biopsy) from a tumor that has not been treated with radiation and is suitable for testing a biomarker (a biological marker used to study the cancer).
  • For Arm B: You must be able to provide either an old (archival) tumor tissue sample or a new small tissue sample from a metastatic site (a place where the cancer has spread) or from the primary tumor that has become locally advanced, and that has not been treated with radiation.

Who cannot join the trial?

6 criteria

  • Known additional non‑urinary tract cancer (cancer that is not in the bladder or urinary system) that is getting worse or has needed active treatment within the past 3 years.
  • Received any systemic anticancer therapy (cancer medicines that travel through the whole body) including experimental drugs within 4 weeks before joining the study.
  • Has an active infection that requires medication taken by mouth or injection.
  • Received a live or live‑attenuated vaccine (a vaccine that contains a weakened form of the germ) within 30 days before the first study dose; killed vaccines are allowed.
  • Has a known history of human immunodeficiency virus (HIV).
  • Has a known history of hepatitis B or hepatitis C virus infection (viruses that affect the liver).
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Investigated drugs

  • Pembrolizumab

    is a medicine that helps the immune system recognize and attack cancer cells. It works by blocking a protein called PD‑1, which normally tells the immune system to slow down. By stopping this “brake,” pembrolizumab may allow the body’s defenses to target the bladder cancer that has not responded to other PD‑1/PD‑L1 treatments. In this study, pembrolizumab is given through an IV infusion and is used either alone or together with other experimental drugs to see how well it works and how safe it is.

  • MK‑3120

    (also known by the code name SKB410) is an experimental medication being tested for the first time in people with advanced bladder cancer. It is given as an IV infusion. The exact way it works is still being studied, but researchers hope it may help the immune system fight the cancer or work together with pembrolizumab to improve results. The trial is looking at how safe MK‑3120 is and whether it can shrink tumors.

  • Zilovertamab vedotin

    is a newer type of cancer drug called an antibody‑drug conjugate. It combines a special antibody that finds a protein on cancer cells with a chemotherapy‑like payload that kills those cells once attached. Like the other drugs, it is given by IV infusion. In this study, researchers are testing whether zilovertamab vedotin can reduce tumor size and how well patients tolerate it, either on its own or together with pembrolizumab.

What is already known about the treatment

  • Pembrolizumab

    Pembrolizumab is given as an intravenous infusion and is an approved medicine used to treat several cancers, including advanced urothelial carcinoma. It works by blocking the PD‑1 protein on immune cells, helping the body’s immune system recognize and attack tumor cells. This drug belongs to the class of immune checkpoint inhibitors and is well documented in medical literature. It is widely used in clinical practice for patients whose disease has progressed after other treatments.

  • SKB410

    SKB410 is administered by intravenous infusion and is currently an investigational agent being studied in clinical trials for locally advanced or metastatic urothelial carcinoma. It is intended to modify the immune response against cancer, although its exact molecular target is still under research. The drug is classified as an experimental immunotherapy and has not yet received regulatory approval. Its safety and effectiveness are being evaluated in the present study.

  • Zilovertamab vedotin

    Zilovertamab vedotin is delivered as an intravenous infusion and is an experimental antibody‑drug conjugate aimed at treating advanced urothelial cancer. The antibody part binds to the ROR1 protein on cancer cells, and the attached toxin (MMAE) is released inside the cell to kill it. It falls under the pharmacological class of antibody‑drug conjugates and is still in the research phase, with its benefits and risks being assessed in clinical trials.

Investigated diseases

Locally advanced or metastatic urothelial carcinoma - Locally advanced or metastatic urothelial carcinoma is a cancer that begins in the lining of the urinary tract, such as the bladder, ureters, or renal pelvis. In the locally advanced stage, the tumor grows beyond the inner lining and may involve nearby tissues or lymph nodes. When it becomes metastatic, cancer cells travel through the blood or lymph system to distant parts of the body, such as the bones, liver, or lungs. The disease typically progresses from a confined growth to wider spread, with tumors increasing in size and number over time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-506384-34-00Protocol codeMK-3475-04AEstimated enrolment46 patientsSponsorMerck Sharp & Dohme LLC

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).