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Идёт набор NCT07480356

Efficacy and Safety of Intravesical TARA-002 Compared With Investigator's Choice of Intravesical Chemotherapy in Participants With BCG-naïve High-grade Non-muscle Invasive Bladder Cancer

Фаза III С лечением Bladder (Urothelial, Transitional Cell) Cancer Non-Muscle Invasive Bladder Carcinoma Non-muscle Invasive Bladder Cancer With Carcinoma in Situ

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: TARA-002, Investigator's Choice of Intravesical Chemotherapy.
Кому может быть актуально
Состояния в реестре: Bladder (Urothelial, Transitional Cell) Cancer, Non-Muscle Invasive Bladder Carcinoma, Non-muscle Invasive Bladder Cancer With Carcinoma in Situ. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США, Украина
Следующий шаг
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Официальное название

A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Intravesical TARA-002 Compared With Investigator's Choice of Intravesical Chemotherapy in Participants With BCG-naïve High-Grade Non-Muscle Invasive Bladder Cancer

Обзор

The goal of this clinical trial is to learn if TARA-002 can treat high-grade non-muscle invasive bladder cancer (NMIBC) in BCG-naïve adults 18 years of age or older. The main questions it aims to answer are: * Can the study drug help participants with this type of cancer? * Is the study drug safe? * What are the side effects of the study drug? Researchers will compare TARA-002 to chemotherapy to see if TARA-002 works to treat NMIBC.

Вмешательства

  • Препарат TARA-002
    Participants will receive 6 weekly instillations of TARA-002. Participants confirmed to have a CR at Week 12 will enter the maintenance treatment period and will receive 3 additional weekly instillations of TARA-002 every 3 months up to Month 19, and then 3 weekly doses at Month 25. Participants who are eligible for reinduction at Week 12 will receive 6 additional weekly instillations of TARA-002. Participants who undergo reinduction and are confirmed to have a CR at Week 24 will enter the maint
  • Препарат Investigator's Choice of Intravesical Chemotherapy
    Participants will receive 6 weekly instillations of Investigator's choice of intravesical chemotherapy. Participants confirmed to have a CR at Week 12 will enter the maintenance regimen treatment period and will receive one intravesical instillation of Investigator's choice of intravesical chemotherapy every 1 month up to Month 25.

Первичные конечные точки

  • Incidence of high-grade complete response [Срок оценки: Month 6]
Вторичные конечные точки (12)
  • Duration of high-grade complete response [Срок оценки: Up to Month 60]
  • Treatment emergent adverse events [Срок оценки: Up to Month 60]
  • Treatment emergent serious adverse events [Срок оценки: Up to Month 60]
  • High-grade complete response rate [Срок оценки: At Months 3, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42, 48, 54, and 60]
  • High-grade complete response rate (CIS only) [Срок оценки: Month 6]
  • Event-free survival [Срок оценки: Up to Month 60]
  • Recurrence-free survival [Срок оценки: Up to Month 60]
  • Progression-free survival [Срок оценки: Up to Month 60]
  • Disease-specific progression-free survival [Срок оценки: Up ro Month 60]
  • Overall survival [Срок оценки: Up to Month 60]
  • Disease-specific survival [Срок оценки: Up to Month 60]
  • Time to cystectomy [Срок оценки: Up to Month 60]

Критерии участия

Критерии включения

  • Male or female participants 18 years of age or older at the time of signing informed consent
  • Participants who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements prior to study entry
  • Central histologic confirmation of high-grade non-muscle invasive CIS (± Ta/T1) with active disease
  • Participants who are BCG naive, or participants who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis, or participants who received ≤2 doses of BCG within the 24 months prior to the most recent CIS diagnosis

Критерии исключения

  • Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory
  • Central confirmed variant histology
  • Concomitant prostatic or upper tract urothelial involvement per Investigator's assessment
  • Nodal and metastatic disease are excluded if they existed at any time (whether present or in the past)
  • Any history of ≥ T2 bladder cancer that existed at any point in time in the participant's history

For more information on eligibility criteria, please contact the Sponsor.

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

США · 5 центров
  • East Valley Urology Center of Arizona — Queen Creek
  • Arkansas Urology — Little Rock
  • Michael Oefelein Clinical Trials — Bakersfield
  • Renown Regional Medical Center — St Louis
  • START - Carolinas — Myrtle Beach
Украина · 1 центр
  • Arensia Kapitanivka - PPDS — Kapitanivka

Идентификаторы

NCT: NCT07480356 · TARA-002-301

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗