RecruitingPHASE2INTERVENTIONAL

A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2

This study is investigating new ways to treat a specific type of cancer called urothelial cancer, which affects the bladder and related areas, especially for patients whose cancer has spread or is difficult to remove with surgery. The main goals are to find out if a drug called disitamab vedotin, given alone or together with another drug called pembrolizumab, can effectively treat this cancer in people whose cancer cells show a certain marker called HER2. Researchers also want to understand any side effects these treatments might cause. This study is an important step in finding better treatments for this condition by carefully observing how the drugs work and how people feel during the treatment.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Seagen, a wholly owned subsidiary of Pfizer

Enrolment target

372

Start

03 May 2022

Estimated completion

14 Apr 2029

Urothelial Carcinoma

What is this study about?

This study is looking into new treatments for a type of cancer called urothelial cancer. This cancer can start in the bladder, but also in other parts of the urinary system like the kidneys or the tubes that carry urine. For many people, if the cancer has spread in the body or can't be taken out with surgery, finding effective treatments is very important.

The main aim of this study is to test a new drug called disitamab vedotin. Sometimes, this drug might be given on its own, and other times it might be given together with another drug called pembrolizumab. Researchers want to see if these drugs can help shrink the cancer or stop it from growing, especially in people whose cancer cells have a specific marker called HER2. Finding out if a treatment works and how safe it is are key parts of any new drug study.

During the study, doctors will keep a close eye on anyone taking part. They will check to see how the treatment affects the cancer and also watch out for any side effects, which are any unwanted effects the drugs might have on the body. This careful monitoring helps ensure the safety of participants and provides important information for future medical treatments.

Key takeaways

This study explores new treatments for advanced urothelial cancer.
It tests new drugs, disitamab vedotin (alone or with pembrolizumab).
Focuses on cancer with a specific marker called HER2.
Researchers will check how well the drugs work and their side effects.
Participation involves regular clinic visits and monitoring.
You can stop participating at any time.

Who may be eligible?

To join this study, you would generally need to have urothelial cancer that has spread or is difficult to remove. A key requirement is that your cancer cells must show a certain marker called HER2.

Depending on which part of the study (called a 'cohort') you might join, there are different details. For some parts of the study, you would have already had one or two previous treatments for your cancer, including a type of chemotherapy. For other parts, you might not have received any previous treatment for your widespread cancer, or you might have had specific treatments if you are in Japan.

All participants will need to be well enough to take part in the study, which doctors will check with a general health assessment. You also need to have at least one part of your cancer that doctors can measure to see if the treatment is working.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have urothelial cancer that has spread or can't be removed by surgery?
Has my doctor tested my cancer for the HER2 marker, and does it show up?
Have I had one or two previous treatments for my widespread cancer (if applicable)?
Am I generally well enough to take part in a clinical study?
Are there parts of my cancer that doctors can measure on scans?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive either disitamab vedotin alone or disitamab vedotin with pembrolizumab. The doctors and nurses will explain exactly what this involves, including how and when you'll receive the medication. You will have regular visits to the clinic so the study team can check your health, see how the treatment is working, and look for any side effects. These visits will likely include blood tests, physical exams, and scans of your cancer. The total duration of your participation, including treatment and follow-up, will be clearly explained by the study team.

Potential risks and benefits

Taking part in this study could offer a new potential treatment for your cancer, which might not be available otherwise, and you would be closely monitored by a medical team. However, with any medication, there are potential risks of side effects, which can vary from mild to severe. The doctors and nurses will discuss all known potential side effects with you before you decide to join. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (223)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Banner Gateway Medical Center
Verified postcode
Gilbert, United States· Recruiting
Banner MD Anderson Cancer Center
Verified postcode
Gilbert, United States· Recruiting
Kaiser Permanente Anaheim Kraemer Medical Offices
Verified postcode
Anaheim, United States· Recruiting
Foothill Cardioology
Verified postcode
Arcadia, United States· Recruiting
Kaiser Permanente Baldwin Park Medical Center
Verified postcode
Baldwin Park, United States· Recruiting
Kaiser Permanente Bellflower Medical Offices
Verified postcode
Bellflower, United States· Recruiting
Beverly Hills Multi-Specialties Practice
Verified postcode
Beverly Hills, United States· Recruiting
Providence Saint Joseph Medical Center
Verified postcode
Burbank, United States· Recruiting
UCLA Burbank Cardiology
Verified postcode
Burbank, United States· Recruiting
UCLA Hematology/Oncology - Burbank
Verified postcode
Burbank, United States· Recruiting
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Verified postcode
Duarte, United States· Active not recruiting
UCLA Encino Specialty Care (Radiology)
Verified postcode
Encino, United States· Recruiting

Common questions

What is urothelial cancer?

Urothelial cancer is a type of cancer that starts in the cells lining the bladder, kidneys, or the tubes that carry urine.

What does 'HER2-expressing' mean?

HER2 is a specific protein that can be found on the surface of some cancer cells. If your cancer is 'HER2-expressing', it means these cells have this protein.

What are disitamab vedotin and pembrolizumab?

These are two different types of drugs being tested in this study. Disitamab vedotin is designed to target cancer cells with HER2, and pembrolizumab helps your body's immune system fight cancer.

What does Phase 2 study mean?

A Phase 2 study means that the treatment has been tested in a small number of people already, and now researchers want to see if it works well and what side effects it has in a larger group.

Will I know if I'm getting one or both drugs?

The study team will explain which treatment plan you would be on, depending on the specific part of the study you might be eligible for.

How to find out more

Pfizer CT.gov Call Center

clinicaltrials.gov_inquiries@pfizer.com 1-800-718-1021 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.