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

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What is this trial about?

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

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

6 criteria

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 trial?

3 criteria

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.

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Verified sites

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

Verified
Centre Hospitalier Universitaire De Bordeaux
Bordeaux, France
Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands
Verified
Hospital Clinico San Carlos
Madrid, Spain

Trial locations

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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.

What is already known about the treatment

Enfortumab Vedotin
This medication is given through an intravenous infusion directly into a vein and is currently approved and used in medical practice for treating certain types of bladder cancer. It is primarily indicated for patients with urothelial carcinoma, which is a cancer that starts in the cells lining the urinary tract, including the bladder. Enfortumab vedotin works by attaching to a specific protein called Nectin-4 found on cancer cells, delivering a toxic substance directly into these cells to destroy them, while the medication is classified as an antibody-drug conjugate that combines targeted therapy with chemotherapy.
Pembrolizumab
This medication is administered as an intravenous infusion into a vein and is an established cancer treatment widely recognized in medical practice for various types of cancers. It is used to treat urothelial carcinoma and other cancers by helping the body's immune system recognize and attack cancer cells more effectively. Pembrolizumab works by blocking a protein called PD-1 on immune cells, which prevents cancer cells from hiding from the immune system, and it belongs to a class of medications known as immune checkpoint inhibitors that enhance the body's natural defense against cancer.

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.