SGNDV-001

About this trial

The SCNDV-001 study is testing whether a new drug combination, disitamab vedotin and pembrolizumab, is more effective than standard platinum-based chemotherapy for people with advanced or metastatic HER2-positive urothelial cancer. This cancer can begin in the bladder, ureters, kidneys (renal pelvis), or urethra. The study is open to adults who have not previously received chemotherapy for advanced disease. Eligible participants must have HER2-positive cancer confirmed by testing and be well enough to receive treatment. This is a Phase 3 clinical trial, meaning that it has been designed to measure the safety and effectiveness of this drug combination. It is a randomised and open-label study, meaning that participants will be randomly chosen to receive either the study drugs or standard chemotherapy, and will be informed of which treatment they have been assigned. The study drugs will be given as follws – disitamab vedotin every two weeks and pembrolizumab every six weeks. The comparison group (chemotherapy) will receive gemcitabine with either cisplatin or carboplatin every three weeks. The main aims are to measure progression-free survival (how long the cancer stays under control) and overall survival, along with monitoring side effects and quality of life.

Patient Profile

Locally advanced unresectable or metastatic urothelial carcinoma (LA/mUC), including UC originating from the renal pelvis, ureters, bladder, or urethra.

Where’s this trial being run?

Cork University Hospital and Tallaght University Hospital

Can I join this study / trial?

The first step we recommend is to talk to your doctor or the cancer trials team at your hospital. You can find contact details for cancer trials research units in Ireland here.

It’s also a good idea to print this page and bring it with you to your appointment. It can help guide the conversation and remind you of what to ask. You may also want to talk to your family or friends about your options, as they can offer support as you make decisions.

For more detailed information

Click Here

Questions?

Here’s a list of questions you may have for your doctor or local cancer research team.

Questions

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Summary Data

Name:	SGNDV-001
Number:	24-48
Full Title:	An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination With Pembrolizumab Versus Chemotherapy in Subjects With Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma That Expresses HER2 (IHC 1+ and Greater)

Principal Investigator:	Prof. Ray McDermott (TUH), Dr Richard Bambury (CUH)
Type:	Industry Sponsored
Sponsor:	Seagen (subsidiary of Pfizer)
Recruitment Started:	Global: June 2024 Ireland: April 2025

Global Recruitment Target:	400
Ireland Recruitment Target: