Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

A study of loxo-435, enfortumab vedotin, and pembrolizumab in adults with advanced or metastatic bladder cancer

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Featured sites

Sites that work closely with us on this trial

What is this trial about?

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

This study focuses on individuals with Urothelial Carcinoma, a type of cancer that starts in the lining of the urinary tract, which may include Urinary Bladder Neoplasms. The research specifically targets cases that are locally advanced or have experienced Neoplasm Metastasis, meaning the cancer has spread to other parts of the body. The study is also focused on patients whose cancer has an FGFR3 genetic alteration, which is a specific change in the DNA of the cancer cells.

The purpose of this study is to test the effectiveness and safety of a new drug called vepugratinib compared to a placebo. Participants in the study will receive a combination of treatments. This includes vepugratinib or a placebo taken as an oral tablet, along with enfortumab vedotin and pembrolizumab, which are administered through intravenous use, meaning they are delivered directly into a vein. The study is designed so that neither the participants nor the researchers know which specific treatment is being administered during the process.

During the study, participants will undergo regular medical monitoring to track the progress of the treatment. The involvement in this clinical trial may last for up to approximately 6 years.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study entry and treatment assignment

    After joining the study, assignment to a specific treatment group occurs. this assignment is randomized, meaning it is decided by chance, and double-blind, meaning neither the patient nor the doctors know which specific medicine is being received.

    One group receives vepugratinib (the test medicine) as a tablet taken by mouth at a dose of 400 mg. the other group receives a placebo, which is an inactive substance that looks like the medicine, also taken by mouth.

  2. Step 2

    Combination therapy administration

    Regardless of the group assignment, enfortumab vedotin is administered through intravenous use, which means it is delivered into a vein. the dose is 1.25 mg per kilogram of body weight.

    pembrolizumab is also administered through intravenous use at a dose of 200 mg.

  3. Step 3

    Monitoring and duration

    The study involves monitoring for safety and efficacy, which refers to how well the medicine works to control the cancer.

    The total time for participating in the study may last up to approximately 6 years.

Who can join the trial?

7 criteria

  • You have urothelial cancer, which is a type of cancer that starts in the cells lining the urinary tract, and this cancer has spread to other parts of your body and cannot be treated with surgery.
  • Your cancer cells show a specific genetic change in a gene called FGFR3, which is a piece of your DNA that can be identified through a tumor or blood sample.
  • Your tumors must be large enough to be measured by a doctor using a standard method called RECIST v1.1, which is a specific set of rules used to track how much a tumor grows or shrinks.
  • You have a moderate to good level of physical ability, meaning you are able to take care of yourself and perform daily activities.
  • Your laboratory test results, which are the findings from your blood and other medical tests, must be within a healthy or acceptable range.
  • You are either male or female.
  • You fall within the required age range specified for this study.

Who cannot join the trial?

5 criteria

  • You have already received treatment for metastasis, which means cancer that has traveled from its original location to other parts of your body.
  • You are still experiencing side effects from a previous cancer treatment that are more than mild, meaning they are moderate or severe.
  • You have nerve damage, which is a problem with your nervous system that changes how you feel sensations or how you move your body.
  • You have cancer in your brain that is either not being treated or is not currently under control.
  • You have eye problems, such as corneal keratopathy (a condition affecting the clear front surface of the eye) or retinal disorder (a problem with the light-sensitive layer at the back of the eye), that are causing symptoms or have not been treated.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

RecruitingNot yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • LOXO-435

    is the code name for the test medication (also known as vepugratinib) being studied. It is an oral tablet taken by mouth that is being tested to see if it can help treat patients with specific types of advanced bladder cancer.

  • Pembrolizumab

    is a medication given through an intravenous infusion (into a vein) that works as a type of immunotherapy to help the body's immune system fight cancer cells.

  • Enfortumab vedotin

    is a medication given through an intravenous infusion (into a vein) that is designed to target and kill cancer cells directly.

What is already known about the treatment

  • Pembrolizumab

    This medication is an immunotherapy drug administered through an intravenous infusion into the bloodstream. It is currently widely used in medicine to treat various types of cancer by helping the body's immune system recognize and attack cancer cells. It works by blocking a specific protein on immune cells that normally prevents them from attacking tumors. This drug belongs to a class of medications known as immune checkpoint inhibitors.

  • Loxo-435

    Also known as vepugratinib, this medication is taken orally in the form of a tablet. It is an investigational drug currently being studied for its ability to treat cancers with specific genetic changes, such as certain types of bladder cancer. The drug works by targeting and blocking a specific protein called FGFR that helps cancer cells grow and divide. It is classified as a targeted therapy.

  • Enfortumab Vedotin

    This medication is an anticancer treatment administered through an intravenous infusion. It is already established in medical practice for treating specific types of advanced bladder cancer. The drug works by attaching to a specific protein found on the surface of cancer cells and then releasing a powerful medicine directly inside those cells to destroy them. It is classified as an antibody-drug conjugate.

Investigated diseases

Transitional Cell Carcinoma - This is a type of cancer that starts in the cells lining the urinary tract. These cells are known as transitional cells because they have the ability to stretch and change shape. The disease often begins in the bladder but can involve other parts of the urinary system. Over time, the abnormal cells can grow into a mass and spread to nearby tissues. Urinary Bladder Neoplasms - These are abnormal growths of cells located within the urinary bladder. These growths can be either non-cancerous or cancerous. When the growths are cancerous, they can develop within the bladder lining. As the disease progresses, the cells may multiply uncontrollably and invade the bladder wall. Neoplasm Metastasis - This refers to the process where cancer cells spread from their original location to other parts of the body. The cells break away from the primary tumor and travel through the blood or the lymph system. Once they reach a new organ or tissue, they begin to grow new tumors. This process represents an advanced stage of the original disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522855-25-00Protocol codeJ4G-MC-JZVDEstimated enrolment503 patientsSponsorEli Lilly & Co.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.