DV with Pembrolizumab vs Chemotherapy in Untreated UC Expressing HER2
Research type
Research Study
Full title
An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination with PembrolizumabVersus Chemotherapy in Subjects with Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma that Expresses HER2 (IHC 1+ and Greater)
IRAS ID
1006741
Contact name
Marcel Koopman
Contact email
Sponsor organisation
Seagen Inc.
Eudract number
2022-501105-12
ISRCTN Number
ISRCTN11908197
Clinicaltrials.gov Identifier
Research summary
Patients with locally advanced unresectable or metastatic urothelial carcinoma (LA/mUC) represent a population with a significant unmet medical need, with an average life expectancy of under 2 years. The majority of patients progress during or after first-line therapy and long-term survival is very rare despite the availability of subsequent therapies. New, highly effective therapy, is therefore needed.
Disitamab vedotin has shown encouraging single agent activity in advanced urothelial carcinoma. Initial experience suggests that there is potential for clinically meaningful efficacy with a manageable safety profile when combined with other medications, such as Pembrolizumab. This study compares the efficacy of disitamab vedotin in combination with pembrolizumab (experimental arm, Arm A) versus platinum-containing chemotherapy (control arm, Arm B).
A total of approximately 700 subjects will be randomized in a 1:1 ratio to one of the study arms. Following screening participants in Arm A will receive disitamab vedotin once every 2 weeks and pembrolizumab IV infusions every 6 weeks. Participants in Arm B will receive gemcitabine once a week for 2 weeks with either cisplatin or carboplatin once every 3 weeks. Patients will be permitted to have maintenance therapy, sequenced after chemotherapy which is currently the standard of care in the UK.
This trial is for patients 18 years of age and older. Patients will be regularly examined by medical personnel, which include but are not limited to radiological tests (MRI or CT, with or without contrast, depending on tumour type), blood tests, and cardiogram, and may involve tumour biopsies, if not previously done. Results will be recorded and shared with the National Health Authorities (to decide if this drug should be used in other patients) but no patient’s personal information will be disclosed.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
24/SC/0161
Date of REC Opinion
21 Jun 2024
REC opinion
Further Information Favourable Opinion