Not yet recruiting

Study of Disitamab Vedotin alone or with Pembrolizumab in patients with locally advanced or metastatic urothelial cancer that expresses HER2

Verified siteInvestigational

Clinical Trials Concierge

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

What is this trial about?

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

This study focuses on patients with urothelial carcinoma, a type of cancer that affects the lining of the urinary system, including the bladder, urethra, ureters, and renal pelvis. The study will test a medication called disitamab vedotin, which will be given either alone or in combination with another medication called pembrolizumab. The study specifically looks at cases where the cancer is either locally advanced (cannot be surgically removed) or has spread to other parts of the body (metastatic), and where the cancer cells show a specific protein marker called HER2.

The purpose of this research is to determine how well disitamab vedotin works in treating urothelial carcinoma, both when used alone and when combined with pembrolizumab. The medication will be given through an intravenous infusion, which means it is delivered directly into a vein. The maximum dose that may be given is 1.5 milligrams per kilogram of body weight, up to 150 milligrams total.

During the study, participants will receive regular medical examinations and scans to monitor their response to treatment. The study is designed for patients who have previously received treatment for their cancer, as well as those who have not yet received any treatment. Participants will be monitored for any side effects throughout their participation in the study.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Your doctor will confirm if you have urothelial carcinoma (cancer of the urinary system) that expresses a protein called HER2
A tissue sample from your tumor will be examined in a laboratory to check HER2 levels
Your overall health status will be evaluated to ensure you can participate safely
Step 2
Treatment assignment
You will receive either disitamab vedotin alone or in combination with another medication called pembrolizumab
The treatment choice depends on whether you have received previous cancer treatments
Step 3
Treatment administration
You will receive disitamab vedotin through an intravenous infusion (delivered directly into your vein)
The medication comes as a powder that will be mixed into a solution before administration
Regular visits to the medical center will be required for treatment administration
Step 4
Monitoring during treatment
Your cancer will be monitored using imaging scans to measure treatment response
Regular health checks will include blood tests and heart function monitoring
Side effects will be tracked throughout the treatment period
Step 5
Follow-up assessments
Regular check-ups will continue to monitor your health status
Imaging scans will be performed to assess how the cancer responds to treatment
The study will continue until June 2028

Who can join the trial?

10 criteria

Must have a life expectancy of at least 12 weeks
Must have urothelial cancer that has spread locally or to other parts of the body (advanced stage). The cancer can start in the kidney area, tubes that carry urine, bladder, or urethra
Must have received 1 or 2 previous treatments for advanced cancer, including one treatment containing platinum-based chemotherapy
Must show evidence that the cancer has grown or spread during or after the most recent treatment
Must have at least one tumor that can be measured on imaging scans
Must be willing to provide a tumor tissue sample (either previously collected or new biopsy) for laboratory testing
Must have a specific protein called HER2 present on tumor cells, which will be tested in a laboratory
Must be able to perform daily activities independently or with minimal assistance (ECOG performance status of 0 or 1)
Must be an adult (18 years or older)
Can be either male or female

Who cannot join the trial?

16 criteria

Prior treatment with any anti-HER2 therapy (a type of targeted cancer treatment)
Active brain metastases (cancer that has spread to the brain) or spinal cord compression
History of other cancer within 2 years before starting the study, except for successfully treated non-melanoma skin cancer or cervical cancer in situ
close
Severe heart conditions, including:
- Heart failure with symptoms
- Unstable heart rhythm problems
- Heart attack within the past 6 months
- close
  Active or chronic infections, including:
  - HIV
  - Hepatitis B
  - Hepatitis C
  - Severe liver problems or abnormal liver function tests
  - Severe kidney problems requiring dialysis
  - Any serious medical condition that could interfere with study participation
  - Pregnancy or breastfeeding
  - Unable to use effective birth control methods during the study period
  - Known allergies to study medications or their components
  - Participation in another clinical trial within 4 weeks before starting this study

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

Verified
Assistance Publique Hopitaux De Paris
Paris, France
Verified
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Verified
Centre Leon Berard
Lyon, France

Trial locations

Where you can join this trial

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

Not yet recruitingNot 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

Disitamab Vedotin
(RC48-ADC) is a targeted therapy medication that works specifically on cancer cells that express HER2 protein. It combines an antibody that targets HER2 with a drug that kills cancer cells. This medication is designed to treat urothelial carcinoma (bladder cancer) that has spread or cannot be removed by surgery.
Pembrolizumab
is an immunotherapy medication that helps the body's immune system detect and fight cancer cells. It works by blocking a protein called PD-1, which normally prevents T-cells (immune cells) from attacking cancer cells. By blocking this protein, pembrolizumab allows the immune system to work more effectively against cancer.

Disitamab Vedotin

What is already known about the treatment

Disitamab Vedotin
An antibody-drug conjugate administered through intravenous infusion, currently being investigated in clinical trials for treating locally advanced or metastatic urothelial carcinoma (bladder cancer) that expresses HER2 protein. This medication works by targeting cancer cells that have high levels of HER2 on their surface, delivering a toxic substance directly to these cells while minimizing damage to healthy tissue. It belongs to the class of targeted cancer therapies and is being studied both as a standalone treatment and in combination with pembrolizumab for patients who have not received prior treatment.
Pembrolizumab
A prescription medication given through intravenous infusion that belongs to a class of drugs called PD-1 inhibitors or checkpoint inhibitors. This immunotherapy medication works by helping the immune system detect and fight cancer cells by blocking the PD-1 pathway that cancer cells use to hide from immune cells. It is being studied in combination with disitamab vedotin for treating patients with HER2-expressing urothelial carcinoma who haven't received previous treatment.

Investigated diseases

Urothelial carcinoma – A type of cancer that begins in the cells that line the urinary system, most commonly affecting the bladder. It develops when cells in the urothelial lining start to grow abnormally and form tumors. The disease typically starts in the innermost layer of the bladder wall and can spread to deeper layers over time. Urothelial carcinoma can also occur in other parts of the urinary tract, including the renal pelvis, ureters, and urethra. The condition can progress from a localized form to more advanced stages where it spreads to nearby tissues or other parts of the body.