#1 Clinical Trials Search in Europe

A study of SKB410, enfortumab vedotin, and pembrolizumab combination for patients with locally advanced or metastatic urothelial cancer

1 1 1 1

What is this study about?

This study is looking at urothelial carcinoma, which is a type of cancer that starts in the cells lining the urinary system, including the bladder and parts of the kidney and ureter. The study is testing new treatment combinations for people whose cancer has spread to other parts of the body or has grown locally in a way that cannot be removed by surgery. The treatments being studied include an experimental medicine called MK-3120, which will be given together with two other medicines: enfortumab vedotin and pembrolizumab. These medicines are given through a vein as an infusion.

The purpose of the study is to check how safe these medicine combinations are and whether they cause side effects that are too difficult for patients to tolerate. The study will also look at how well the combination works by measuring whether the tumors shrink or disappear after treatment. This type of study helps doctors understand if new treatment combinations might be helpful for patients with this type of cancer who have not yet received treatment for their advanced disease.

During the study, participants will receive the combination of medicines and will be monitored closely by the study doctors. The doctors will check for any unwanted effects and will measure the size of the tumors regularly to see if the treatment is working. Blood samples will be taken at different times to measure the levels of the medicines in the body and to understand how the body processes these treatments. The study will continue for several years to gather enough information about the safety and effectiveness of these treatment combinations.

1 Treatment period begins

Upon joining the study, treatment will commence with a combination of three medications administered through intravenous infusion, which means the medications will be delivered directly into a vein.

The three medications to be received are: MK-3120, enfortumab vedotin, and pembrolizumab. These medications work together to treat locally advanced or metastatic urothelial carcinoma, which is a type of cancer that affects the lining of the urinary system.

2 Tissue sample provision

A tissue sample from the tumor will need to be provided. This can be either a newly obtained sample or an archived sample from a previous biopsy.

The sample will be obtained through either a core biopsy, which involves removing a small cylinder of tissue with a needle, or an excisional biopsy, which involves surgically removing a piece of tissue.

3 Medication administration

MK-3120 will be administered as a solution for injection or infusion through intravenous use.

Enfortumab vedotin will be administered as an intravenous infusion.

Pembrolizumab (also known as Keytruda) will be administered as an intravenous infusion at a concentration of 25 milligrams per milliliter.

The specific dosage, frequency, and duration of each medication will be determined by the study protocol and medical team overseeing the treatment.

4 Safety and response monitoring

Throughout the study, safety and tolerability of the medication combination will be monitored. This includes tracking any adverse events, which are unwanted or harmful reactions that may occur during treatment.

The response to treatment will be assessed using RECIST 1.1 criteria, which is a standardized method for measuring changes in tumor size.

Blood samples will be collected at various times to measure the concentration of the medications in the bloodstream. This includes measuring the maximum concentration (the highest level reached) and trough concentration (the lowest level before the next dose) of each medication.

5 Response evaluation

The objective response rate will be evaluated, which measures the percentage of participants whose tumors shrink or disappear after treatment.

If a response to treatment occurs, the duration of response will be measured, which indicates how long the tumor remains smaller or absent.

6 Ongoing treatment and follow-up

Treatment will continue as prescribed by the study protocol until completion, disease progression, unacceptable side effects, or other reasons for discontinuation occur.

Regular assessments will be conducted to evaluate treatment effectiveness and monitor for any side effects or complications.

The study is estimated to continue until October 2030, though individual participation duration may vary based on treatment response and tolerability.

Who Can Join the Study?

  • You must have urothelial carcinoma, which is a type of cancer that starts in the cells lining the urinary system, including the bladder, and this cancer must be locally advanced, meaning it has grown into nearby tissues and cannot be removed by surgery, or metastatic, meaning it has spread to other parts of the body
  • You must provide a tissue sample from your tumor, either a newly collected sample or one that was previously stored, which can be obtained through a core biopsy, where a small piece of tissue is removed with a needle, or an excisional biopsy, where a larger piece of tissue is surgically removed
  • You must not have received any previous treatment with medications given throughout the body for your locally advanced or metastatic urothelial carcinoma
  • If you have Human Immunodeficiency Virus or HIV, which is a virus that affects the immune system, your infection must be well controlled with antiretroviral therapy, which are medications that keep the virus under control
  • If you test positive for hepatitis B surface antigen, which indicates an infection with hepatitis B virus or HBV that affects the liver, you must have been taking antiviral medication for at least 4 weeks and your blood tests must show that the virus is not detectable before joining the study
  • If you have had hepatitis C virus or HCV in the past, which is another virus that affects the liver, your blood tests must show that the virus is not detectable before joining the study

Who Cannot Join the Study?

  • The specific exclusion criteria (reasons why you cannot join this study) have not been provided in the available information for this clinical trial (a research study testing new treatments).
  • If you are interested in participating, you will need to discuss with the study team to learn about all conditions that would prevent you from joining.
  • Generally, clinical trials have rules about who can and cannot participate to ensure the safety of participants and the accuracy of results.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Clinico San Carlos Madrid Spain
Centre Hospitalier Universitaire De Bordeaux Bordeaux France

Other Sites

Site Name City Country Status
Netherlands Cancer Institute Amsterdam The Netherlands
Ejnbvhv Udtpdjvzgdvz Mvhroor Cvqoszo Rtfwdimkm (wyqvaci Mxi Rotterdam The Netherlands
Hhstwwxn Vamc detxrjnx Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
15.12.2025
Spain Spain
Recruiting
15.12.2025
The Netherlands The Netherlands
Recruiting
15.12.2025

Trial locations

Investigated drugs:

Enfortumab vedotin is a cancer treatment medication that works by targeting and delivering chemotherapy directly to cancer cells. It is designed to specifically attach to proteins found on the surface of certain cancer cells and then release its cancer-fighting medicine inside those cells.

Pembrolizumab is an immunotherapy medication that helps your own immune system fight cancer. It works by blocking a protein that prevents immune cells from attacking cancer cells, allowing your body’s natural defenses to recognize and destroy the cancer.

The trial also includes an investigational agent, which is an experimental medication that is being tested in combination with the other two treatments. This medication is still being studied to determine how well it works and how safe it is when used together with enfortumab vedotin and pembrolizumab.

Investigated diseases:

Urothelial Carcinoma – Urothelial carcinoma is a type of cancer that begins in the urothelial cells, which line the inside of the bladder, ureters, urethra, and part of the kidneys. These cells normally stretch when the bladder fills with urine and shrink when it empties. The cancer develops when these cells begin to grow abnormally and form a tumor. It most commonly occurs in the bladder, where it may start as a small growth on the inner lining. As the disease progresses, the cancer cells can grow deeper into the bladder wall and may spread to nearby tissues. In advanced stages, the cancer may spread to lymph nodes or other organs in the body.

Trial ID:
2025-522253-19-00
Protocol code:
MK-3475-04D
Trial Phase:
Human Pharmacology (Phase I) – Other

Other Trials to Consider

  • A Study of Zanidatamab for Patients with Previously Treated HER2-Expressing Solid Tumors

    Recruiting

    2 1 1
    Investigated drugs:
    Spain

  • A Study Testing BNT329 Safety and Effectiveness in Patients With Advanced Solid Tumors That Express the CA19-9 Tumor Marker

    Recruiting

    2 1 1
    Germany Spain