A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer

Официальное название

A Phase 3, Randomized, Open-label, Multicenter Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Investigator's Choice of Intravesical Chemotherapy in Participants With High-risk Non-muscle-invasive Bladder Cancer With Susceptible FGFR Alterations Who Had Received Intravesical Bacillus Calmette-Guérin (BCG)

Обзор

The main purpose of this study is to compare the disease-free survival (the length of time after randomization that a participant survives without any signs or symptoms of the cancer returning, or progressing) between Bacillus Calmette-Guérin (BCG) treated participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of high-risk non-muscle-invasive bladder cancer (HR-NMIBC).

Вмешательства

• Препарат TAR-210
  TAR-210 will be administered intravesically.
• Препарат Mitomycin C
  MMC will be administered intravesically.
• Препарат Gemcitabine
  Gemcitabine will be administered intravesically.

Первичные конечные точки

• Disease-free Survival (DFS) [Срок оценки: Up to 5 years]

Вторичные конечные точки (12)

• Recurrence-Free Survival (RFS) [Срок оценки: Up to 5 years]
• Time to Next Intervention (TTNI) [Срок оценки: Up to 5 years]
• Time to Disease Worsening (TTDW) [Срок оценки: Up to 5 years]
• Time to Progression (TTP) [Срок оценки: Up to 5 years]
• Overall Survival (OS) [Срок оценки: Up to 5 years]
• Number of Participants with Adverse Events (AEs) According to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 [Срок оценки: Up to 5 years]
• Number of Participants With Change from Baseline in Laboratory Abnormalities [Срок оценки: Up to 5 years]
• Number of Participants With Change from Baseline in Vital Signs Abnormalities [Срок оценки: Up to 5 years]
• Change from Baseline in European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ)-C30 Scores [Срок оценки: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and 96]
• Change from Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores [Срок оценки: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and 96]
• Percentage of Participants With Meaningful Change From Baseline in EORTC-QLQ-C30 Scores [Срок оценки: Weeks 12, 24, 36, 48, 60, 72, 84 and 96]
• Percentage of Participants With Meaningful Change From Baseline in EORTC-QLQ-NMIBC24 Scores [Срок оценки: Weeks 12, 24, 36, 48, 60, 72, 84 and 96]

Критерии участия

Критерии включения

• Histologically confirmed diagnosis by local pathology of papillary-only HR-NMIBC (defined as high-grade Ta or any T1, no CIS). Mixed histology tumors are allowed if urothelial differentiation is predominant. However, neuroendocrine, and small cell variants will be excluded
• 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
• All visible tumor completely resected prior to randomization. Urine cytology must not be positive or suspicious for high grade UC before randomization. For participants with lamina propria invasion (T1) on the screening biopsy/TURBT, muscularis propria must be present to rule out MIBC
• Participants must have had either: a. Adequate Induction (5 of 6 doses) and either 2 of 3 doses of Maintenance or 2 of 6 doses of second Induction of BCG with high-grade T1 disease at first disease assessment after induction or high-grade Ta/any T1 disease within 6 months after last BCG (BCG-unresponsive population); b. had adequate induction (5 or 6 doses) with or without maintenance BCG with high-grade Ta/any T1 disease within 12 months after last BCG excluding BCG-unresponsive (BCG-experienced population); or c. been unable to complete an induction course of BCG with at least 5 doses due to grade >= 2 toxicity requiring BCG discontinuation (BCG intolerant population)
• Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2
• Must be ineligible for or refusing radical cystectomy (RC)

Критерии исключения

• Presence of CIS at any point from time of diagnosis of papillary-only HR-NMIBC recurrence to randomization. Additionally, presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is \[i.e.\], T2, T3, T4, N+, and/or M+)
• Active malignancies (i.e., progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. Allowed recent second or prior malignancies: a. Any malignancy that was not progressing nor requiring treatment change in the last 12 months; b. Malignancies treated within the last 12 months and considered at very low risk for recurrence for example (e.g.): non-melanoma skin cancers (treated with curative therapy or localized melanoma treated with curative surgical resection alone), non-invasive cervical cancer, breast cancer (adequately treated lobular CIS or ductal CIS, localized breast cancer and receiving antihormonal agents), localized prostate cancer (\[N0, M0\] with a Gleason score less than or equal to \[<=\] 7a, treated locally only \[radical prostatectomy/radiation therapy/focal treatment\]) and other malignancy that is considered at minimal risk of recurrence
• Presence of any bladder or urethral anatomic feature that, in the opinion of the investigator, may prevent the safe placement, indwelling use, or removal of TAR 210
• A history of clinically significant polyuria with recorded 24 hour urine volumes greater than (>) 4,000 milliliters (mL)
• Indwelling catheters are not permitted; however, intermittent catheterization is acceptable

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 · 25 центров

• Academic Urology and Urogynecology of Arizona — Sun City
• UCLA — Los Angeles
• Colorado Clinical Research — Lakewood
• Advanced Urology Institute — Largo
• Georgia Urology — Atlanta
• Associated Urological Specialists — Chicago Ridge
• Urology of Indiana — Carmel
• Southern Urology LLC — Lafayette
• … и ещё 17 центров

Китай · 9 центров

• Peking University First Hospital — Пекин
• The Third People's Hospital of Chengdu — Чэнду
• West China Hospital Sichuan University — Чэнду
• Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University — Гуанчжоу
• Nanjing Drum Tower Hospital — Нанкин
• The First Affiliated Hospital of Ningbo University — Ningbo
• The Second Hospital Of Tianjin Medical University — Тяньцзинь
• The First Affiliated Hospital of Wenzhou Medical University — Wenzhou
• … и ещё 1 центр

Испания · 9 центров

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Италия · 8 центров

• Cliniche Humanitas Gavazzeni — Bergamo
• ASST Spedali Civili Brescia — Brescia
• SPDC Villa Scassi — Genova
• Ospedale San Raffaele — Milan
• Fondazione G Pascale Istituto Nazionale Tumori IRCCS — Naples
• Istituto Nazionale Tumori Regina Elena — Roma
• Aou San Luigi Gonzaga — Sanatorio San Luigi
• … и ещё 1 центр

Япония · 8 центров

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Франция · 7 центров

• Institut Paoli Calmettes — Marseille
• Hopital Saint Louis — Paris
• CHU Pitie Salpetriere — Paris
• Hopital Saint Joseph — Paris
• Clinique de la Croix du Sud — Quint-Fonsegrives
• CHP Saint Gregoire — Saint-Grégoire
• Gustave Roussy — Villejuif

Германия · 6 центров

• Universitaetsklinikum Koeln — Cologne
• Marien hospital Herne — Herne
• Klinikum Leverkusen gGmbH — Leverkusen
• Universitaetsklinikum Mannheim — Mannheim
• Studienpraxis Urologie Nurtingen — Nürtingen
• Caritas-Krankenhaus St. Josef — Regensburg

Израиль · 6 центров

• Rambam Medical Center — Haifa
• Carmel Medical Center — Haifa
• Meir Medical Center — Kfar Saba
• Rabin Medical Center — Petah Tikva
• Sheba Medical Center — Ramat Gan
• Tel Aviv Sourasky Medical Center — Tel Aviv

Аргентина · 5 центров

• Hospital Sirio Libanes — Buenos Aires
• Instituto Alexander Fleming — Buenos Aires
• Investigaciones Clinico Moleculares (ICM) — Caba
• Centro Urologico Profesor Bengio — Córdoba
• Sanatorio de la Mujer — Rosario

Бельгия · 5 центров

• Hopital Erasme — Brussels
• Ziekenhuis Oost-Limburg — Genk
• AZ Maria Middelares — Ghent
• Universitair Ziekenhuis Leuven — Leuven
• Algemeen Ziekenhuis Delta — Roeselare

Бразилия · 5 центров

• Liga Norte Riograndense Contra O Cancer — Natal
• Hospital Regional do Cancer - Hospital de Esperanca — Presidente Prudente
• Fundacao Faculdade Regional De Medicina De Sao Jose Do Rio Preto — São José do Rio Preto
• Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo — São Paulo
• Real e Benemerita Associacao Portuguesa de Beneficencia — São Paulo

Греция · 5 центров

• General Hospital of Athens G Gennimatas — Athens
• Laiko General Hospital of Athens — Athens
• Sismanogleio General Hospital — Athens
• General Hospital Of Thessaloniki Papageorgiou — Thessaloniki
• Athens Medical Center S A Interbalkan Medical Center of Thessaloniki — Thessaloniki

South Korea · 5 центров

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Великобритания · 5 центров

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Нидерланды · 4 центра

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Идентификаторы

NCT: NCT06919965 · 42756493BLC3005 · 42756493BLC3005 · 2024-519493-39-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗