Trial purpose
Cancer treatment
Tumor type
Genitourinary
Age
18+
Clinical summary
Summary
This study will enroll people with urothelial cancer (UC). UC can include cancer of the bladder, kidney, or the tubes that carry urine through the body (ureter, urethra).
This study will try to find out if the drugs disitamab vedotin with pembrolizumab works better than platinum-containing chemotherapy to treat people with UC.
This study will also test what side effects happen when participants take these drugs together. A side effect is anything a drug does to the body besides treating the disease.
Participants in this study will have cancer thas has spread through the body (metastatic) or spread near where it started (locally advanced). Their UC must be expressing HER2, with 1+ or greater on immunochemistry (IHC)
In this study, there are two different groups. Participants will be assigned to a group randomly (by chance).
- Participants in the disitamab vedotin arm will receive the study drug disitamab vedotin once every two weeks and pembrolizumab immunotherapy once every 6 weeks.
- Participants in the standard of care arm will receive chemotherapy that includes gemcitabine once a week for 2 weeks with either cisplatin or carboplatin once every 3 weeks.
Conditions
This trial is treating people with locally advanced or metastatic Urothelial Carcinoma that is previously untreated and expresses HER2
Eligibility
Inclusion
- Histopathological confirmation of locally advanced unresectable or metastatic urothelial carcinoma (LA/mUC), including UC originating from the renal pelvis, ureters, bladder, or urethra.
- Measurable disease by investigator assessment per RECIST v1.1.
- Participant must not have received prior systemic therapy for LA/mUC. Exception will be made for neoadjuvant or adjuvant therapy, if disease recurrence/progression occurred more than 12 months after the last dose of therapy.
- Eligible to receive cisplatin- or carboplatin-containing chemotherapy.
- Able to provide archived formalin-fixed paraffin-embedded tumor tissue blocks from a muscle-invasive or metastatic UC lesion or biopsy of metastatic UC prior to treatment initiation. If archival tissue is not available a newly obtained baseline biopsy of an accessible tumor lesion is required within 28 days of cycle 1 day 1.
- HER2 expression of 1+ or greater on immunohistochemistry (IHC).
- Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1, or 2 within 7 days prior to randomization.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:
- NCT05911295 *
- 2022-501105-12-00 *
- SGNDV-001; SGNDV-001_KN-D74
Trial sponsor
Seagen Inc.
Scientific 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)
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