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.

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

Non-Muscle Invasive Bladder Cancer

Non-Muscle Invasive Bladder Neoplasms

Genitourinary Cancer

Prostate Neoplasms

Advanced Solid Tumors

Cancer

Advanced Solid Malignancies

Advanced Solid Tumor

Solid Tumor, Adult

Neoplasms

Adenocarcinoma

Advanced Stage Solid Tumors

Gemcitabine

TAR-210

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

DFS is measured as the time from randomization to the date of the first documented
recurrence of non-muscle invasive bladder cancer (NMIBC) of any grade, disease
progression, or death due to any cause, whichever occurs first.

TTNT is measured as the time from randomization to the date of first documented
subsequent treatment (local, systemic, surgical, or interventional) for bladder cancer.

HG RFS is measured as the time from randomization to the date of first documented
evidence of HG NMIBC or death, whichever occurs first

PFS is measured as the time from randomization to the date of first documented evidence
of disease progression or death, whichever occurs first.

Rate of diagnostic and therapeutic invasive urological interventions after study
treatment, that is, endoscopic procedures (e.g., cystoscopies, transurethral resection of
bladder tumors (TURBTs), ureteroscopies, urethral interventions, urethral
stricture/bladder neck incision), catheterization (intravesical, suprapubic),
intravesical treatments, major surgeries (e.g., radical cystectomy, simple cystectomy,
urethroplasty) will be reported.

An AE is any untoward medical occurrence in a participant participating in a clinical
study participant administered a pharmaceutical (investigational or non-investigational)
product, that does not necessarily have a causal relationship with the treatment. AEs
will be evaluated according to National Cancer Institute Common Terminology Criteria for
Adverse Events (NCI-CTCAE) Version 5.0. Severity of AEs has 5 grades based on CTCAE
criteria: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening
and Grade 5: Death. Number of participants with adverse events (including physical
examination, vital signs and laboratory abnormalities) will be reported.

OS is defined as the time from randomization to the date of death from any cause.

EORTC QLQ-C30 is a core 30-item questionnaire for evaluating the health-related quality
of life (HRQoL) of participants participating in cancer clinical studies. It incorporates
5 functional scales (physical, role, cognitive, emotional, and social functioning), 3
symptom scales (fatigue, pain, and nausea or vomiting), and a global health status or
HRQoL scale. Ratings for each item range from 1 (not at all) to 4 (very much). Higher
scores indicated greater severity.

EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants
with non-muscle-invasive bladder cancer. The questionnaire is designed to supplement the
QLQ C30 and incorporates 6 multi-item scales and 5 single items. Ratings for each item
range from 1 (not at all) to 4 (very much). Higher scores indicated greater severity.

EORTC QLQ-C30 is a core 30-item questionnaire for evaluating the HRQoL of participants
participating in cancer clinical studies. It incorporates 5 functional scales (physical,
role, cognitive, emotional, and social functioning), 3 symptom scales (fatigue, pain, and
nausea or vomiting), and a global health status or HRQoL scale. Ratings for each item
range from 1 (not at all) to 4 (very much). Higher scores indicated greater severity.

Participants in Group A will have TAR-210 inserted in the bladder on Day 1 and removed
after 12 weeks. One TAR-210 will be inserted every 12 weeks over a treatment period of
approximately 1 year.

Participants in Group B will receive intravesical mitomycin C (MMC) or gemcitabine
(investigator's choice) once weekly for 4 to 6 induction doses followed by a maintenance
phase for a minimum of 6 months and up to 1 year.

Arkansas Urology

Genesis Research LLC

USC Norris Comprehensive Cancer Center

University of California Irvine Medical Center

Genesis Research

University of Colorado Cancer Center Anschultz Cancer Pavilion

Colorado Clinical Research

Moffitt Cancer Center

Northwestern University

First Urology

Wichita Urology Group

Ochsner Health System

Chesapeake Urology Research Associates

Brigham And Women's Hospital

Karmanos Cancer Institute

Comprehensive Urology

Mercy Research

Specialty Clinical Research of St Louis

The Urology Center, PC

Cancer Institute Of New Jersey

Integrated Medical Professionals

Memorial Sloan Kettering Cancer Center

Associated Medical Professionals of Ny

SUNY Upstate Med Univ

Levine Cancer Institute

Associated Urologists of North Carolina

MidLantic Urology

Keystone Urology Specialists

Carolina Urologic Research Center

The Conrad Pearson Clinic

University of Tennessee Medical Center

Urology Associates

Urology Austin

Urology Clinics of North Texas

UT Southwestern

Houston Metro Urology

Spokane Urology

Hospital Sirio Libanes

Investigaciones Clinico Moleculares (ICM)

Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

Centro Urologico Profesor Bengio

Hospital Privado de la Comunidad

Sanatorio de la Mujer

Medizinische Universitaet Graz

Medizinische Universitat Innsbruck

Ordensklinikum Linz GmbH Elisabethinen

Universitaetsklinikum Salzburg Landeskrankenhaus

Medical University Vienna MUV

Onze -Lieve-Vrouwziekenhuis

AZ Sint-Jan

UZ Antwerpen

AZ Maria Middelares

Universitair Ziekenhuis Gasthuisberg

Vitaz

CHU UCL Namur - Site Godinne

Fundacao Pio XII

Universidade Estadual De Campinas

Liga Norte Riograndense Contra O Cancer

Associacao Hospitalar Moinhos de Vento

Irmandade da Santa Casa de Misericordia de Porto Alegre

HBA SA Assitencia Medica e Hospitalar

Fundacao do ABC Centro Universitario FMABC

Irmandade Da Santa Casa De Misericordia De Sao Paulo

Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo

Real e Benemérita Associação Portuguesa de Beneficência

Fundacao Antonio Prudente A C Camargo Cancer Center

Beijing Friendship Hospital Capital Medical University

Peking University Third Hospital

Hunan Cancer hospital

The Third People's Hospital of Chengdu

West China School of Medicine/West China Hospital, Sichuan University

Chongqing Cancer Hospital

Fujian Medical University Union Hospital

Sun Yat Sen University Cancer Center

Nanjing Drum Tower Hospital

Zhongda Hospital Southeast University

Huadong Hospital Affiliated to Fudan University

The Second Hospital Of Tianjin Medical University

Cancer Hospital of Xinjiang Medical University

The First Affiliated Hospital of Wenzhou Medical University

Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology

The First Affiliated Hospital of Xian Jiaotong University

The Affiliated Hospital of Xuzhou Medical University

Fakultni nemocnice Hradec Kralove

Fakultni nemocnice Olomouc

Vseobecna fakultni nemocnice v Praze

Fakultni Thomayerova nemocnice

Fakultni nemocnice v Motole

Aarhus University Hospital

Rigshospitalet

Herlev Hospital

Odense Universitetshospital

Zealand University Hospital

Hospital Center University De Lille

Polyclinique de Limoges - Francois Chenieux

Hôpital Edouard Herriot

Institut Paoli Calmettes

Hopital Saint Louis

CHU Pitie Salpetriere

Klinikum St. Elisabeth Straubing GmbH

4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu

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

Trials at a glance

Trials at a glance

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

Outcome measures

Primary outcome measures

Secondary outcome measures