DV+BCG in HER2-Expressing, BCG-Naïve High-Risk NMIBC
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Active Comparator: BCG induction and maintenance
DrugDrug: Bacillus Calmette-Guerin Immunotherapy treatment approved by NMPA for patients with high-risk non-muscle invasive bladder cancer Other Names: BCG
DV + BCG induction and maintenance
DrugDrug: Disitamab vedotin(RC48) •An antibody-drug conjugates (ADCs) targeting HER2, has been approved in China for chemotherapy-refractory advanced UC with HER2-expression. Other Names: • RC48, DV Drug: Bacillus Calmette-Guerin Immunotherapy treatment approved by NMPA for patients with high-risk non-muscle invasive bladder cancer Other Names: BCG
Treatment groups
182 Participants
are divided into 2 treatment groupsGroup A: DV + BCGExperimental treatment 1 intervention
Group B: BCGActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Event free survival
Event free survival is defined as the time from randomization to date of EFS event.
Time frame
55 months after first participant randomizedSecondary outcomes
1
Overall Survival
Overall survival is defined as the time from the date of randomization to the date of death due to any cause.
Time frame
Randomization up to 60 months from last participant randomized2
Complete response rate at 6m/12m in participants with CIS at randomization
Complete response (CR) rate defined as the proportion of participants in the analysis population with CR.
Time frame
Randomization up to 12 months from last participant randomized3
Disease-specific survival
Disease specific survival (DSS) is defined as the time from randomization to death resulting from bladder cancer.
Time frame
Randomization up to 60 months from last participant randomized4
Health-related quality of life as measured by EORTC QLQ-C30
Health-related quality of life as measured by EORTC QLQ-C30
Time frame
Randomization up to 60 months from last participant randomizedSponsors and contacts
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Source ClinicalTrials.gov