DV+BCG in HER2-Expressing, BCG-Naïve High-Risk NMIBC
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University
About this trial
The purpose of this study is to learn about the safety and effects of the study medicine (Disitamab Vedotin) in people with non-muscle invasive bladder cancer. This study is seeking participants whose bladder cancer is still in early stages, has not spread outside of the bladder, has been removed with surgery, and is high risk. Each participant was assigned to one of two study treatment groups: One group is given Disitamab Vedotin and BCG.The second group is given BCG only and will not receive Disitamab Vedotin.
Eligibility criteria
Qualifiers
Age ≥ 18 years.
Histologically confirmed high-risk, non-muscle-invasive urothelial carcinoma of the bladder (UCC) (with >50% urothelial carcinoma as the predominant histological component), defined by the presence of any of the following: a. T1 tumor; b. High-grade Ta tumor; c. Carcinoma in situ (CIS).
Complete resection of all Ta/T1 papillary lesions (including patients with concomitant CIS). The most recent Transurethral Resection of Bladder Tumor (TURBT) must have been performed within 12 weeks prior to randomization. A second TURBT was required if indicated per current local applicable guidelines.
HER2 expression (IHC 1+/2+/3+) as confirmed by immunohistochemistry (IHC) testing at the local institution's pathology department.
Disqualifiers
Histologically confirmed evidence of muscle-invasive (T2 or higher), locally advanced, or metastatic urothelial carcinoma, or the presence of concurrent extravesical non-muscle-invasive urothelial carcinoma.
Histopathological findings of pure small cell carcinoma, pure adenocarcinoma, pure squamous cell carcinoma, or pure squamous CIS of the bladder.
History of upper tract urothelial carcinoma (except for cases with no recurrence within 2 years following radical treatment for UTUC).
Prior therapy with any other type of HER2-targeted inhibitor.
Trial design
Treatments tested in this trial
- Active Comparator: BCG induction and maintenance
- DV + BCG induction and maintenance
Treatment groups
182 Participants
are divided into 2 treatment groupsSponsors and collaborators
Fudan University
Lead sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Fujian Cancer Hospital
Collaborator
Tenth People's Hospital of Tongji Univeristy
Collaborator
Ningbo Medical Center Lihuili Hospital
Collaborator
Source ClinicalTrials.gov