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Contact Information:

Pfizer CT.gov Call Center 1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com


Study Location:

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Be Part of Research - Trial Details - A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2

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

Recruiting

Open to: ALL

Age: 18.0 - N/A

Medical Conditions

Carcinoma
Carcinoma, Transitional Cell


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This study is being done to see if a drug called disitamab vedotin, alone or with pembrolizumab, works to treat HER2 expressing urothelial cancer. It will also test how safe the drug is for participants.

Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic).

It will also study what side effects happen when participants get the drug. A side effect is anything a drug does to your body besides treating the disease.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

May 2022 Dec 2026

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Given into the vein (IV; intravenous) every 2 weeks.

Intervention Arm Group : Cohort A - DV monotherapy for HER2-positive tumor types;Cohort B - DV monotherapy for HER2-low tumor types;Cohort C - Non-randomized combination therapy;Cohort C - Randomized combination therapy;Cohort C - Randomized monotherapy;Cohort D - DV monotherapy (Japan only);Cohort E - DV combination therapy (Japan only);Cohort G - DV monotherapy;

Intervention Type : DRUG
Intervention Description : Given by IV on Day 1 of each 6-week cycle.

Intervention Arm Group : Cohort C - Non-randomized combination therapy;Cohort C - Randomized combination therapy;Cohort E - DV combination therapy (Japan only);



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Imperial College Healthcare NHS Trust
    London
    W2 1NY
  • Cambridge University Hospitals NHS Foundation Trust
    Cambridge
    Other
    CB2 0QQ
  • The Clatterbridge Cancer Centre NHS Foundation Trust
    Bebington
    Other
    CH63 4JY
  • NHS Greater Glasgow and Clyde (NHSGGC) - The Beatson West of Scotland Cancer Centre
    Glasgow
    Other
    G12 0Yn
  • Barts Health NHS Trust Saint Bartholomews Hospital
    London
    Other
    EC1A 7BE
  • The Christie NHS Foundation Trust
    Manchester
    Other
    M20 4GJ
  • Guys and St Thomas Hospital
    London
    SE1 7EH


The study is sponsored by Seagen, a wholly owned subsidiary of Pfizer and is in collaboration with Merck Sharp & Dohme LLC.




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Read full details for Trial ID: NCT04879329
Last updated 17 March 2025

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