Идёт набор NCT06319820

A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer

Фаза III С лечением Non-Muscle Invasive Bladder Neoplasms

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: TAR-210, Gemcitabine, MMC.
Кому может быть актуально: Состояния в реестре: Non-Muscle Invasive Bladder Neoplasms. 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, Аргентина, Австрия, Бельгия, Бразилия +15
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 3, Randomized Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Single Agent Intravesical Chemotherapy in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (IR-NMIBC) and Susceptible FGFR Alterations

Обзор

The main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC.

Вмешательства

Комбинированный продукт TAR-210
TAR-210 will be administered intravesically.
Препарат Gemcitabine
Gemcitabine will be administered intravesically.
Препарат MMC
MMC will be administered intravesically.

Первичные конечные точки

Disease Free Survival (DFS) [Срок оценки: From randomization to the date of the first documented recurrence, disease progression or death (approximately 4 years and 2 months)]

Вторичные конечные точки (10)

Time to next Treatment (TTNT) [Срок оценки: From randomization to the date of first documented subsequent treatment (local, systemic, surgical, or interventional) for bladder cancer (approximately 4 years and 2 months)]
High Grade Recurrence-free Survival (HG RFS) [Срок оценки: From randomization to the date of first documented evidence of HG NMIBC or death (approximately 4 years and 2 months)]
Progression Free Survival (PFS) [Срок оценки: From randomization to the date of first documented disease progression or death (approximately 4 years and 2 months)]
Number of Diagnostic and Therapeutic Invasive Urological Interventions after Study Treatment [Срок оценки: From study treatment completion up to trial discontinuation (approximately 4 years and 2 months)]
Number of Participants With Adverse Events (Including Physical Examination, Vital Signs and Laboratory Abnormalities) [Срок оценки: From first dose up to 30 days after last dose of study treatment (approximately 4 years and 2 months)]
Overall Survival (OS) [Срок оценки: From randomization to the date of death (approximately 4 years and 2 months)]
European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire Core-30 items (EORTC-QLQ-C30) Scores [Срок оценки: Baseline, Weeks 6, 12, 24, 36, and 48]
European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire for Non muscle Invasive Bladder Cancer (EORTC-QLQ-NMIBC24) Scores [Срок оценки: Baseline, Weeks 6, 12, 24, 36, and 48]
Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-C30 Scores [Срок оценки: Weeks 6, 12, 24, 36, and 48]
Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-NMIBC24 Scores [Срок оценки: Weeks 6, 12, 24, 36, and 48]

Критерии участия

Критерии включения

Main study only: Have a histologically confirmed diagnosis (within 90 days of randomization) of IR-NMIBC with at least one of the following criteria fulfilled: a. Ta low grade (LG)/ Grade 1 (G1): primary or recurrent, b. Ta LG/G2: primary or recurrent and c. Greater than or equal to (>=) 1 of the following risk factors: i. Multiple Ta LG tumors, ii. Solitary LG tumor >= 3 cm, iii. Early recurrence (less than \[<\] 1 year), iv. Frequent recurrence (greater than \[>\] 1 per year), v. Recurrence after prior adjuvant intravesical treatment (single perioperative dose of chemotherapy does not fulfill this risk factor)
Substudy only: Have a histologically confirmed new diagnosis (within 90 days of randomization) of IR-NMIBC for whom MMC is deemed the therapy of choice according to local standard of care with at least 1 of the following criteria fulfilled: a. Ta LG/G1, b. Ta LG/G2, and >=1 of the following risk factors: i) Multiple Ta LG tumors, ii) Solitary LG tumor >=3 cm
Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue), as determined by central or local testing
Participants must be willing to undergo all study procedures (e.g., multiple cystoscopies from Screening through the end of study and TURBT for assessment of recurrence/progression) and receive the assigned treatment, including intravesical chemotherapy if randomized into that arm.
Visible papillary disease must be fully resected prior to randomization and absence of disease must be documented at Screening cystoscopy
Can have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment
Have an Eastern Cooperative Oncology Group performance status of 0 to 2

Критерии исключения

Known allergies, hypersensitivity, or intolerance to any study component or its excipients, including: a. Erdafitinib excipients; b.TAR-210 drug delivery system constituent materials ; c. urinary placement catheter materials; d. MMC or chemically related drugs; e. Gemcitabine or chemically related drugs
Presence of any bladder or urethral anatomic feature (that is, urethral stricture) that, in the opinion of the investigator, may prevent the safe insertion, indwelling use, removal of TAR-210 or passage of a urethral catheter for intravesical chemotherapy
Polyuria with recorded 24-hour urine volumes > 4000 milliliters (mL)
Current indwelling urinary catheters, however, intermittent catheterization is acceptable
Had major surgery or had significant traumatic injury and/or not fully recovered within 4 weeks before first dose (TURBT is not considered major surgery)

Substudy:

\- Previous diagnosis of histologically confirmed urothelial bladder carcinoma at any time prior to current qualifying diagnosis

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 · 38 центров

Arkansas Urology — Little Rock
Genesis Research LLC — Los Alamitos
USC Norris Comprehensive Cancer Center — Los Angeles
University of California Irvine Medical Center — Orange
Om Research LLC — San Diego
Genesis Research LLC 1 — Sherman Oaks
University of Colorado Cancer Center Anschultz Cancer Pavilion — Aurora
Colorado Clinical Research — Lakewood
… и ещё 30 центров

Китай · 17 центров

Beijing Friendship Hospital Capital Medical University — Пекин
Peking University Third Hospital — Пекин
Hunan Cancer hospital — Чанша
The Third People's Hospital of Chengdu — Cheng Du Shi
West China School of Medicine/West China Hospital, Sichuan University — Cheng Du Shi
Chongqing Cancer Hospital — Чунцин
Fujian Medical University Union Hospital — Фучжоу
Sun Yat Sen University Cancer Center — Гуанчжоу
… и ещё 9 центров

Испания · 16 центров