DV+BCG in HER2-Expressing, BCG-Naïve High-Risk NMIBC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active Comparator: BCG induction and maintenance, DV + BCG induction and maintenance.
- Who it may be relevant to
- Registry conditions: Bladder (Urothelial, Transitional Cell) Cancer, NMIBC. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase III Randomized Controlled Trial of Disitamab Vedotin (DV) Combined With Bacillus Calmette-Guérin (BCG) in BCG-Naïve Patients With HER2-Expressing, High-Risk Non-Muscle-Invasive Bladder Cancer
Overview
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.
Detailed description
HERO: A Phase III Randomized Controlled Trial of Disitamab Vedotin (DV) Combined with Bacillus Calmette-Guérin (BCG) in BCG-Naïve Patients with HER2-Expressing, High-Risk Non-Muscle-Invasive Bladder Cancer
This Phase 3, open-label, randomized, controlled clinical trial will enroll approximately 182 patients, who will be assigned in a 1:1 ratio to one of two treatment groups:
Group A: Disitamab Vedotin plus BCG (induction and maintenance therapy)
Group B: BCG alone (induction and maintenance therapy)
The study is designed to demonstrate the superiority of Disitamab Vedotin combined with BCG (during both induction and maintenance phases) over BCG alone in prolonging event-free survival (EFS) among BCG-naïve participants with high-risk, HER2-expressing non-muscle invasive bladder cancer.
Interventions
- Drug Active Comparator: BCG induction and maintenance
Drug: Bacillus Calmette-Guerin Immunotherapy treatment approved by NMPA for patients with high-risk non-muscle invasive bladder cancer Other Names: BCG - Drug DV + BCG induction and maintenance
Drug: 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
Primary outcome measures
- Event free survival [Time frame: 55 months after first participant randomized]
Secondary outcome measures (5)
- Overall Survival [Time frame: Randomization up to 60 months from last participant randomized]
- Complete response rate at 6m/12m in participants with CIS at randomization [Time frame: Randomization up to 12 months from last participant randomized]
- Disease-specific survival [Time frame: Randomization up to 60 months from last participant randomized]
- Health-related quality of life as measured by EORTC QLQ-C30 [Time frame: Randomization up to 60 months from last participant randomized]
- Health-related quality of life as measured by EORTC QLQ-NMIBC24 [Time frame: Randomization up to 60 months from last participant randomized]
Eligibility criteria
Inclusion criteria
- 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.
- Unwillingness or ineligibility to undergo radical cystectomy.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 2.
- Signed informed consent form (ICF).
Exclusion criteria
- 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.
- Major surgery within 2 weeks prior to randomization.
- Any other condition that, in the investigator's judgment, would make the patient unsuitable for participation in this study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fudan University Shanghai Cancer Center — Shanghai
Identifiers
NCT: NCT07207824 · RCVDUCIIR020-2