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

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What is this study about?

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.

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

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

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

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

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 Study?

  • 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 Study?

  • 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
  • Severe heart conditions, including:
    • Heart failure with symptoms
    • Unstable heart rhythm problems
    • Heart attack within the past 6 months
  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Institut Gustave Roussy Villejuif France

Other Sites

Site Name City Country Status
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Azienda Ospedaliera S Maria Di Terni Terni Italy
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
MD Anderson Cancer Center Madrid Spain
Centre Antoine Lacassagne Nice France
Virgen del Rocío University Hospital Sevilla Spain
Ospedale San Raffaele S.r.l. Milan Italy
Az Maria Middelares Gent Gent Belgium
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Hfntfzgo Ummditwdphggx Mlnadwd Do Vnfhdubttl Santander Spain
Plrz Tzszb Hzqaswvj Uuysekvgadih Sabadell Spain
Aqsqahujpm Pclpgduq Hvywdmrf Dh Pbrsi Paris France
Hdwicwiu Dc Lg Sbieb Cngy I Srhl Pvy Barcelona Spain
Ceuzqc Lnbr Bmcjia Lyon France
Iqkeqccj Ciewvu Dkdgvlqxzsouqjlue L'hospitalet De Llobregat Spain
Hwgrawzk Vegx dwauzpms Barcelona Spain

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
28.05.2024
France France
Not yet recruiting
28.05.2024
Italy Italy
Not recruiting
28.05.2024
Spain Spain
Not recruiting
28.05.2024

Trial locations

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.

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.

Trial ID:
2022-500030-28-01
Protocol code:
RC48G001
NCT ID:
NCT04879329
Trial Phase:
Therapeutic exploratory (Phase II)

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