The purpose of this study is to compare disease free survival (DFS) in participants with
recurrence of papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC)
within 1 year of last dose of Bacillus Calmette-Guérin (BCG) therapy and who refused or
are unfit for Radical Cystectomy (RC), receiving TAR-200 versus investigator's choice of
single agent intravesical chemotherapy.

A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)

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

TAR-200

Gemcitabine

Mitomycin C

A Phase 3, Randomized, Open-label, Multi-center Study Evaluating the Efficacy and Safety of TAR-200 Versus Investigator's Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High-risk Non-muscle-invasive Bladder Cancer (HR-NMIBC) and Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

DFS will be measured as the time from randomization to the time of the first recurrence
of high-risk non-muscle-invasive bladder cancer (HR-NMIBC) [high grade (HG) Ta, any T1 or
carcinoma in situ (CIS)], progression, or death due to any cause, whichever occurs first.

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

TTNI will be measured as the time from randomization to the time of next intervention
(localized or systemic) for the treatment of bladder cancer.

TTDW is measured as the time from randomization to cystectomy, systemic therapy, or
radiation therapy (treatments of disease worsening).

TTP will be measured as the time from randomization to the time of first documented
evidence of disease progression (that is, progression to muscle-invasive bladder cancer
[MIBC] [T greater than or equal to {>=} 2], lymph node disease [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.

DFS rate that is percentage of participants with DFS at 12 and 24 months will be
reported.

Number of participants with AEs by severity grade as assessed by CTCAE version 5 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 (including
hematology, clinical chemistry and routine urinalysis) will be reported.

Number of participants with change from baseline in vital signs including temperature,
pulse/heart rate, respiratory rate, and blood pressure (systolic and diastolic) (supine)
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), and a global health status or HRQoL scale.
Ratings for each item range from 1 (not at all) to 4 (very much).

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).

Proportion of participants with meaningful change in EORTC QLQ-C30 and EORTC QLQ-NMIBC24
scores will be reported.

Participants will receive intravesical TAR-200 every 3 weeks during an induction phase
and every 12 weeks during a maintenance phase.

Participants will receive either single agent intravesical MMC or gemcitabine every week
during an induction phase and every 4 weeks during a maintenance phase.

Arkansas Urology

Genesis Research LLC

USC Norris Comprehensive Cancer Center

University of California Irvine Medical Center

University of California San Francisco

Colorado Clinical Research

Florida Urology Partners

Northwestern University

UroPartners

Urology of Indiana

First Urology, PSC

Wichita Urology Group

Comprehensive Urology

Specialty Clinical Research of St Louis

Associated Medical Professionals

The Urology Group

Central Ohio Urology Group

Centers for Advanced Urology LLC d b a MidLantic Urology

Ralph H. Johnson Veterans Affairs Medical Center

Carolina Urologic Research Center

Low Country Urology Clinics

Urology Associates

Vanderbilt University Medical Center

Urology Austin

Urology Clinics of North Texas

University of Texas Southwestern Medical Center

Houston Metro Urology

Spokane Urology

Clinica Santa Isabel

Investigaciones Clinico Moleculares (ICM)

Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

Centro Urologico Profesor Bengio

Hospital Privado de la Comunidad

AZ Sint-Jan

Cliniques Universitaires Saint Luc

Ziekenhuis Oost-Limburg

Algemeen ziekenhuis Maria Middelares

Algemeen Ziekenhuis Delta

Fundacao Pio XII

NAIC Nair Antunes Instituto do Cancer

Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP

Liga Paranaense de Combate ao Cancer

Irmandade Santa Casa de Misericordia de Porto Alegre

Hospital da Bahia

Sociedade Beneficente de Senhoras Hospital Sirio Libanes

Real e Benemérita Associação Portuguesa de Beneficência

Fundacao Antonio Prudente A C Camargo Cancer Center

Peking University First Hospital

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

Chongqing Cancer Hospital

Sun Yat Sen University Cancer Center

Shengjing Hospital Of China Medical University

Tianjin Medical University Cancer Institute and Hospital

The Second Hospital Of Tianjin Medical University

The First Affiliated Hospital of Wenzhou Medical University

Tongji Medical College of Huazhong University Science Technology of Medicine Health Management

Xi an Jiaotong University Hospital

Hopital Claude Huriez

Polyclinique de Limoges - Francois Chenieux

Institut Paoli Calmettes

APHP - Hopital Bichat - Claude Bernard

Clinique de la Croix du Sud

Chu Rennes Hopital Pontchaillou

Hopital Foch

Universitaetsklinikum Koeln

Universitaetsklinikum Halle Saale

Klinikum Leverkusen gGmbH

Universitatsklinikum Schleswig Holstein Campus Lubeck

Urologie Neandertal Praxis Mettmann

Klinikum der Universitaet Muenchen

Ospedale San Donato

Ospedale Provinciale di Macerata

San Raffaele Hospital

Istituto Dei Tumori Di Milano

Ospedale S. Maria Delle Croci

Universita Campus Bio-Medico di Roma

Istituto Nazionale Tumori Regina Elena

Istituto Clinico Humanitas

PO Molinette Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino

Funabashi Municipal Medical Center

Hakodate Goryoukaku Hospital

Hyogo Prefectural Amagasaki General Medical Center

Niigata Cancer Center Hospital

National Hospital Organization Okayama Medical Center

Toho University Sakura Medical Center

Toranomon Hospital

Yokohama City University Medical Center

Uniwersytecki Szpital Kliniczny w Bialymstoku

IN VIVO Sp. z o.o

Szpital Uniwersytecki w Krakowie

Uniwersytecki Szpital Kliniczny nr 4

Wojewodzki Szpital im Sw Ojca Pio w Przemyslu

Szpital Wojewodzki im Sw Lukasza SP ZOZ

MICS Centrum Medyczne Torun

Mazowiecki Szpital Onkologiczny

Dolnoslaskie Centrum Onkologii

Centrul Medical Unirea SRL

Ponderas Academic Hospital

Institutul Oncologic Ion Chiricuta

TTP will be measured as the time from randomization to the time of first documented
evidence of disease progression (that is, 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.

A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)

Trials at a glance

Trials at a glance

A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)

Outcome measures

Primary outcome measures

Secondary outcome measures