DV+BCG in HER2-Expressing, BCG-Naïve High-Risk NMIBC

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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
• Препарат 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

Первичные конечные точки

• Event free survival [Срок оценки: 55 months after first participant randomized]

Вторичные конечные точки (5)

• Overall Survival [Срок оценки: Randomization up to 60 months from last participant randomized]
• Complete response rate at 6m/12m in participants with CIS at randomization [Срок оценки: Randomization up to 12 months from last participant randomized]
• Disease-specific survival [Срок оценки: Randomization up to 60 months from last participant randomized]
• Health-related quality of life as measured by EORTC QLQ-C30 [Срок оценки: Randomization up to 60 months from last participant randomized]
• Health-related quality of life as measured by EORTC QLQ-NMIBC24 [Срок оценки: Randomization up to 60 months from last participant randomized]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fudan University Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT07207824 · RCVDUCIIR020-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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