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).

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

Non-Muscle Invasive Bladder Neoplasms

Non-Muscle Invasive Bladder Cancer

Genitourinary Cancer

Advanced Solid Tumors

Prostate Neoplasms

Cancer

Advanced Solid Malignancies

Advanced Solid Tumor

Solid Tumor, Adult

Neoplasms

Adenocarcinoma

Advanced Stage Solid Tumors

Gemcitabine

TAR-210

Mitomycin C

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)

DFS is measured as the time from randomization to the date of the first recurrence of
HR-NMIBC (high-grade Ta, any T1 or carcinoma in situ [CIS]), progression, or death due to
any cause, whichever occurs first.

RFS is measured as the time from randomization to the date of the first recurrence of
HR-NMIBC (high-grade Ta, any T1, or CIS), or death due to any cause, whichever occurs
first.

TTNI (i.e., transurethral resection of bladder tumor [TURBT], radical cystectomy [RC],
radiation therapy [RT], or chemotherapy) is measured as the time from randomization to
the date of next intervention (localized or systemic) for the treatment of urothelial
carcinoma (UC).

TTDW is measured as the time from randomization to the date of cystectomy, systemic
therapy, or radiation therapy, whichever occurs first.

TTP is measured as the time from randomization to the date of first documented evidence
of disease progression (i.e., progression to muscle-invasive bladder cancer [MIBC] [T
greater than or equal to {>=} 2], lymph node [N+], or distant disease [M+]), or death due
to disease progression, whichever occurs first.

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

Number of participants with AEs by severity grade as assessed by CTCAE version 5.0 will
be reported. Grade refers to the severity of AE as follows: Grade 1- Mild; Grade 2-
Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5- Death related to adverse
event.

Number of participants with change from baseline in laboratory abnormalities (hematology,
serum chemistry and urine analysis) will be reported.

Number of participants with change from baseline in vital signs (temperature, pulse/heart
rate, respiratory rate and blood pressure) will be reported.

EORTC QLQ-C30 is a 30-item questionnaire for evaluating the health-related quality of
life (HRQoL) of participants participating in cancer clinical studies. It includes 5
functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales
(fatigue, pain, and nausea or vomiting), a global health status or HRQoL scale and 6
single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial
difficulties). Ratings for each item range from 1 (not at all) to 4 (very much). Higher
scores indicate greater functioning, better global health status, or more severe
symptoms.

EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants
with NMIBC. The questionnaire is designed to supplement the QLQ-C30 and incorporates 6
multi-item scales (urinary symptoms, malaise, future worries, bloating and flatulence,
sexual function and male sexual problems) and 5 single items (intravesical treatment
issues, sexual intimacy, worries about risk of contaminating partner, sexual enjoyment,
and female sexual problems). Ratings for each item range from 1 (not at all) to 4 (very
much). Higher scores represent a high level of symptoms or problems, except for sexual
function and sexual enjoyment, where a higher score represents a higher level of
functioning.

EORTC Q168 is a single item from the EORTC item library used to measure the overall
impact of treatment side effects. Responses are rated on a 4-point Likert response scale
ranging from 1 "Not at all" to 4 "Very much." Higher score indicates greater impact.

Participants in Group A will have TAR-210 inserted in the bladder on Day 1. TAR-210 will
be inserted over a treatment duration of approximately 2 years.

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 maintenance
dosing once monthly for up to 1 year. An optional second year of additional maintenance
can be added at the investigator's discretion.

Hosp. Puerta Del Mar

Funabashi Municipal Medical Center

Sanatorio de la Mujer

CHU Pitie Salpetriere

The Jikei University Hospital

Instituto Alexander Fleming

The First Affiliated Hospital of Ningbo University

Ospedale San Raffaele

General Hospital of Athens G Gennimatas

CHP Saint Gregoire

Hosp. Gral. Univ. de Castellon

Urology Austin

Seoul National University Bundang Hospital

UroHealth Partners

Hosp. Arquitecto Marcide

Sheba Medical Center

Associated Medical Professionals

Canisius-Wilhelmina ZH

Hosp. Clinic de Barcelona

AZ Maria Middelares

Cliniche Humanitas Gavazzeni

Chungbuk National University Hospital

Lister Hospital

Rabin Medical Center

Greater Boston Urology

Fundacao Faculdade Regional De Medicina De Sao Jose Do Rio Preto

Laiko General Hospital of Athens

ASST Spedali Civili Brescia

Hosp Univ A Coruna

Juntendo University Hospital

New Jersey Urology LLC

Universitair Ziekenhuis Leuven

Hosp. de Jerez de La Frontera

University Of Pittsburgh Medical Center UPMC Hillman Cancer Center

TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology

Fondazione G Pascale Istituto Nazionale Tumori IRCCS

Severance Hospital Yonsei University Health System

Associated Urological Specialists

Georgia Urology

Comprehensive Urology

Liga Norte Riograndense Contra O Cancer

Gustave Roussy

Universitaetsklinikum Mannheim

General Hospital Of Thessaloniki Papageorgiou

Rambam Medical Center

Radboud Umcn

Samsung Medical Center

Hosp Virgen de La Victoria

St Bartholomews Hospital

Yokohama City University Medical Center

Hopital Saint Joseph

Universitaetsklinikum Koeln

Hospital Sirio Libanes

SPDC Villa Scassi

MidLantic Urology

The First Affiliated Hospital of Wenzhou Medical University

Meir Medical Center

Carolina Urologic Research Center

Investigaciones Clinico Moleculares (ICM)

Yokohama Municipal Citizen's Hospital

Urology of Indiana

Centro Urologico Profesor Bengio

West China Hospital Sichuan University

Real e Benemerita Associacao Portuguesa de Beneficencia

Nanjing Drum Tower Hospital

Studienpraxis Urologie Nurtingen

St Marianna University Hospital

Dayton Physicians Network Urology

The Urology Group

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Clinique de la Croix du Sud

Royal Marsden Hospital

The Second Hospital Of Tianjin Medical University

Hopital Saint Louis

Colorado Clinical Research

Oregon Urology Institute

Klinikum Leverkusen gGmbH

Caritas-Krankenhaus St. Josef

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

Seoul National University Hospital

Hosp.Univ.Parc Tauli

Institut Paoli Calmettes

Peking University First Hospital

Istituto Nazionale Tumori Regina Elena

Marien hospital Herne

Hopital Erasme

Sismanogleio General Hospital

Athens Medical Center S A Interbalkan Medical Center of Thessaloniki

Ziekenhuis Oost-Limburg

Hull University Teaching Hospitals NHS Trust

The Conrad Pearson Clinic

Hospital Regional do Cancer - Hospital de Esperança

Helios Clinical Research, LLC

Urology San Antonio PA dba USA Clinical Trials

Algemeen Ziekenhuis Delta

Carmel Medical Center

Toho University Sakura Medical Center

The Third People's Hospital of Chengdu

Tel Aviv Sourasky Medical Center

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

Trials at a glance

Trials at a glance

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

Outcome measures

Primary outcome measures

Secondary outcome measures