MedPath

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

Phase 3
Recruiting
Conditions
Non-Muscle Invasive Bladder Cancer
Interventions
Combination Product: TAR-210
Registration Number
NCT06319820
Lead Sponsor
Janssen Research & Development, LLC
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
540
Inclusion Criteria
  • 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)
  • 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
Exclusion Criteria
  • 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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group A: TAR-210TAR-210Participants 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.
Group B: MMC or GemcitabineGemcitabineParticipants 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.
Group B: MMC or GemcitabineMMCParticipants 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.
Primary Outcome Measures
NameTimeMethod
Disease Free Survival (DFS)From randomization to the date of the first documented recurrence, disease progression or death (approximately 4 years and 2 months)

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.

Secondary Outcome Measures
NameTimeMethod
Time to next Treatment (TTNT)From randomization to the date of first documented subsequent treatment (local, systemic, surgical, or interventional) for bladder cancer (approximately 4 years and 2 months)

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

High Grade Recurrence-free Survival (HG RFS)From randomization to the date of first documented evidence of HG NMIBC or death (approximately 4 years and 2 months)

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

Progression Free Survival (PFS)From randomization to the date of first documented disease progression or death (approximately 4 years and 2 months)

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 TreatmentFrom study treatment completion up to trial discontinuation (approximately 4 years and 2 months)

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.

Number of Participants With Adverse Events (Including Physical Examination, Vital Signs and Laboratory Abnormalities)From first dose up to 30 days after last dose of study treatment (approximately 4 years and 2 months)

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.

Overall Survival (OS)From randomization to the date of death (approximately 4 years and 2 months)

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

European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire Core-30 items (EORTC-QLQ-C30) ScoresBaseline, Weeks 6, 12, 24, 36, and 48

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.

European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire for Non muscle Invasive Bladder Cancer (EORTC-QLQ-NMIBC24) ScoresBaseline, Weeks 6, 12, 24, 36, and 48

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.

Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-C30 ScoresWeeks 6, 12, 24, 36, and 48

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.

Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-NMIBC24 ScoresWeeks 6, 12, 24, 36, and 48

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.

Trial Locations

Locations (190)

Adelaide and Meath Hospital

🇮🇪

Dublin, Ireland

National Cancer Center

🇰🇷

Gyeonggi-do, Korea, Republic of

Chonnam National University Hwasun Hospital

🇰🇷

Jeollanam-do, Korea, Republic of

Samsung Medical Center

🇰🇷

Seoul, Korea, Republic of

The Catholic University of Korea Seoul St Marys Hospital

🇰🇷

Seoul, Korea, Republic of

Seoul National University Hospital

🇰🇷

Seoul, Korea, Republic of

Uniwersytecki Szpital Kliniczny w Bialymstoku

🇵🇱

Bialystok, Poland

IN VIVO Sp. z o.o

🇵🇱

Bydgoszcz, Poland

Centrum Onkologii im Prof F Lukaszczyka w Bydgoszczy

🇵🇱

Bydgoszcz, Poland

Uniwersytecki Szpital Kliniczny nr 4

🇵🇱

Lublin, Poland

Wojewodzki Szpital im Sw Ojca Pio w Przemyslu

🇵🇱

Przemysl, Poland

Charing Cross Hospital

🇬🇧

London, United Kingdom

Southampton General Hospital

🇬🇧

Southampton, United Kingdom

Royal Marsden Hospital

🇬🇧

Sutton, United Kingdom

Colorado Clinical Research

🇺🇸

Lakewood, Colorado, United States

Mater Private Hospital

🇮🇪

Dublin, Ireland

Arkansas Urology

🇺🇸

Little Rock, Arkansas, United States

Genesis Research LLC

🇺🇸

Sherman Oaks, California, United States

USC Norris Comprehensive Cancer Center

🇺🇸

Los Angeles, California, United States

University of California Irvine Medical Center

🇺🇸

Orange, California, United States

Genesis Research

🇺🇸

San Diego, California, United States

University of Colorado Cancer Center Anschultz Cancer Pavilion

🇺🇸

Aurora, Colorado, United States

Moffitt Cancer Center

🇺🇸

Tampa, Florida, United States

Northwestern University

🇺🇸

Chicago, Illinois, United States

First Urology

🇺🇸

Jeffersonville, Indiana, United States

Wichita Urology Group

🇺🇸

Wichita, Kansas, United States

Ochsner Health System

🇺🇸

New Orleans, Louisiana, United States

Chesapeake Urology Research Associates

🇺🇸

Hanover, Maryland, United States

Karmanos Cancer Institute

🇺🇸

Detroit, Michigan, United States

Comprehensive Urology

🇺🇸

Royal Oak, Michigan, United States

Mercy Research

🇺🇸

Saint Louis, Missouri, United States

Specialty Clinical Research of St Louis

🇺🇸

Saint Louis, Missouri, United States

The Urology Center, PC

🇺🇸

Omaha, Nebraska, United States

Cancer Institute Of New Jersey

🇺🇸

New Brunswick, New Jersey, United States

Integrated Medical Professionals

🇺🇸

New York, New York, United States

Associated Medical Professionals of Ny

🇺🇸

Syracuse, New York, United States

SUNY Upstate Med Univ

🇺🇸

Syracuse, New York, United States

Levine Cancer Institute

🇺🇸

Charlotte, North Carolina, United States

Associated Urologists of North Carolina

🇺🇸

Raleigh, North Carolina, United States

MidLantic Urology

🇺🇸

Bala-Cynwyd, Pennsylvania, United States

Keystone Urology Specialists

🇺🇸

Lancaster, Pennsylvania, United States

Carolina Urologic Research Center

🇺🇸

Myrtle Beach, South Carolina, United States

The Conrad Pearson Clinic

🇺🇸

Germantown, Tennessee, United States

University of Tennessee Medical Center

🇺🇸

Knoxville, Tennessee, United States

Urology Associates

🇺🇸

Nashville, Tennessee, United States

Urology Austin

🇺🇸

Austin, Texas, United States

Urology Clinics of North Texas

🇺🇸

Dallas, Texas, United States

UT Southwestern

🇺🇸

Dallas, Texas, United States

Houston Metro Urology

🇺🇸

Houston, Texas, United States

Spokane Urology

🇺🇸

Spokane, Washington, United States

Investigaciones Clinico Moleculares (ICM)

🇦🇷

Caba, Argentina

Hospital Sirio Libanes

🇦🇷

Ciudad Autonoma de Buenos Aires, Argentina

Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

🇦🇷

Cordoba, Argentina

Centro Urologico Profesor Bengio

🇦🇷

Cordoba, Argentina

Hospital Privado de la Comunidad

🇦🇷

Mar del Plata, Argentina

Sanatorio de la Mujer

🇦🇷

Rosario, Argentina

Medizinische Universitaet Graz

🇦🇹

Graz, Austria

Medizinische Universitat Innsbruck

🇦🇹

Innsbruck, Austria

Ordensklinikum Linz GmbH Elisabethinen

🇦🇹

Linz, Austria

Universitaetsklinikum Salzburg Landeskrankenhaus

🇦🇹

Salzburg, Austria

Medical University Vienna MUV

🇦🇹

Wien, Austria

Onze -Lieve-Vrouwziekenhuis

🇧🇪

Aalst, Belgium

AZ Sint-Jan

🇧🇪

Brugge, Belgium

UZ Antwerpen

🇧🇪

Edegem, Belgium

AZ Maria Middelares

🇧🇪

Gent, Belgium

Universitair Ziekenhuis Gasthuisberg

🇧🇪

Leuven, Belgium

Vitaz

🇧🇪

Sint Niklaas, Belgium

CHU UCL Namur - Site Godinne

🇧🇪

Yvoir, Belgium

Fundacao Pio XII

🇧🇷

Barretos, Brazil

Universidade Estadual De Campinas

🇧🇷

Campinas, Brazil

Liga Norte Riograndense Contra O Cancer

🇧🇷

Natal, Brazil

Associacao Hospitalar Moinhos de Vento

🇧🇷

Porto Alegre, Brazil

Irmandade da Santa Casa de Misericordia de Porto Alegre

🇧🇷

Porto Alegre, Brazil

HBA SA Assitencia Medica e Hospitalar

🇧🇷

Salvador, Brazil

Fundacao do ABC Centro Universitario FMABC

🇧🇷

Santo Andre, Brazil

Herlev Hospital

🇩🇰

Herlev, Denmark

Irmandade Da Santa Casa De Misericordia De Sao Paulo

🇧🇷

Sao Paulo, Brazil

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

🇧🇷

Sao Paulo, Brazil

Real e Benemérita Associação Portuguesa de Beneficência

🇧🇷

Sao Paulo, Brazil

Fundacao Antonio Prudente A C Camargo Cancer Center

🇧🇷

Sao Paulo, Brazil

Beijing Friendship Hospital Capital Medical University

🇨🇳

Beijing, China

Peking University Third Hospital

🇨🇳

Beijing, China

Hunan Cancer hospital

🇨🇳

Changsha, China

The Third People's Hospital of Chengdu

🇨🇳

Cheng Du Shi, China

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

🇨🇳

Cheng Du Shi, China

Chongqing Cancer Hospital

🇨🇳

Chong Qing, China

Fujian Medical University Union Hospital

🇨🇳

Fu Zhou Shi, China

Sun Yat Sen University Cancer Center

🇨🇳

Guang Zhou Shi, China

Nanjing Drum Tower Hospital

🇨🇳

Nan Jing Shi, China

Zhongda Hospital Southeast University

🇨🇳

Nan Jing Shi, China

Huadong Hospital Affiliated to Fudan University

🇨🇳

Shanghai, China

The Second Hospital Of Tianjin Medical University

🇨🇳

Tianjin, China

Cancer Hospital of Xinjiang Medical University

🇨🇳

Urumqi, China

The First Affiliated Hospital of Wenzhou Medical University

🇨🇳

Wenzhou, China

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

🇨🇳

Wu Han Shi, China

The First Affiliated Hospital of Xian Jiaotong University

🇨🇳

XI An Shi, China

The Affiliated Hospital of Xuzhou Medical University

🇨🇳

Xuzhou, China

Fakultni nemocnice Hradec Kralove

🇨🇿

Hradec Kralove, Czechia

Fakultni nemocnice Olomouc

🇨🇿

Olomouc, Czechia

Vseobecna fakultni nemocnice v Praze

🇨🇿

Praha 2, Czechia

Fakultni Thomayerova nemocnice

🇨🇿

Praha 4, Czechia

Fakultni nemocnice v Motole

🇨🇿

Praha, Czechia

Aarhus University Hospital

🇩🇰

Aarhus, Denmark

Rigshospitalet

🇩🇰

Kobenhavn, Denmark

Odense Universitetshospital

🇩🇰

Odense, Denmark

Zealand University Hospital

🇩🇰

Roskilde, Denmark

Hospital Center University De Lille

🇫🇷

Lille, France

Polyclinique de Limoges - Francois Chenieux

🇫🇷

Limoges, France

Hôpital Edouard Herriot

🇫🇷

Lyon, France

Institut Paoli Calmettes

🇫🇷

Marseille, France

Hopital Saint Louis

🇫🇷

Paris, France

CHU Pitie Salpetriere

🇫🇷

Paris, France

APHP - Hopital Bichat - Claude Bernard

🇫🇷

Paris, France

Clinique de la Croix du Sud

🇫🇷

Quint-Fonsegrives, France

Chu Rennes Hopital Pontchaillou

🇫🇷

Rennes, France

CHU Rangueil

🇫🇷

Toulouse, France

Institut Gustave Roussy

🇫🇷

Villejuif, France

Charite - Universitaetsmedizin Berlin (CCM)

🇩🇪

Berlin, Germany

Stadtisches Klinikum Braunschweig gGmbH-Klinik fur Urologie und Uroonkologie

🇩🇪

Braunschweig, Germany

Urologische Gemeinschaftspraxis

🇩🇪

Dresden, Germany

Universitaetsklinikum Frankfurt

🇩🇪

Frankfurt am Main, Germany

Urologikum Hamburg MVZ - Germany

🇩🇪

Hamburg, Germany

Marien hospital Herne

🇩🇪

Herne, Germany

Universitatsklinikum Jena

🇩🇪

Jena, Germany

Studienzentrum Bayenthal

🇩🇪

Koeln, Germany

Klinikum rechts der Isar an der Technischen Universitat Munchen

🇩🇪

Munchen, Germany

Klinikum St. Elisabeth Straubing GmbH

🇩🇪

Straubing, Germany

Katharinenhospital Innere Medizin

🇩🇪

Stuttgart, Germany

Prince Of Wales Hospital

🇭🇰

Hong Kong, Hong Kong

Queen Mary Hospital

🇭🇰

Hong Kong, Hong Kong

Cork University Hospital

🇮🇪

Cork, Ireland

Mater Misericordiae University Hospital

🇮🇪

Dublin, Ireland

Rambam Health Care Campus

🇮🇱

Haifa, Israel

Hadassah University Hospita Ein Kerem

🇮🇱

Jerusalem, Israel

Sheba Medical Center

🇮🇱

Ramat Gan, Israel

Ziv Medical Center

🇮🇱

Safed, Israel

Sourasky Medical Center

🇮🇱

Tel-Aviv, Israel

Ospedale S. Donato Arezzo, USL 8 - U.O. Oncologia Medica

🇮🇹

Arezzo, Italy

Cliniche Humanitas Gavazzeni

🇮🇹

Bergamo, Italy

ASST Spedali Civili Brescia

🇮🇹

Brescia, Italy

Ospedale San Raffaele

🇮🇹

Milano, Italy

Istituto Dei Tumori Di Milano

🇮🇹

Milano, Italy

Universita Campus Bio-Medico di Roma

🇮🇹

Roma, Italy

Istituto Nazionale Tumori Regina Elena

🇮🇹

Roma, Italy

Istituto Clinico Humanitas

🇮🇹

Rozzano, Italy

A.O.Citta della Salute e della Scienza di Torino

🇮🇹

Torino, Italy

Hyogo Prefectural Amagasaki General Medical Center

🇯🇵

Amagasaki shi, Japan

St Marianna University Hospital

🇯🇵

Kawasaki Shi, Japan

Kobe City Medical Center General Hospital

🇯🇵

Kobe City, Japan

National Hospital Organization Kumamoto Medical Center

🇯🇵

Kumamoto City, Japan

Osaka International Cancer Institute

🇯🇵

Osaka, Japan

Gunma Prefectural Cancer Center

🇯🇵

Ota, Japan

Saitama Medical Center

🇯🇵

Saitama, Japan

JRC Wakayama Medical Center

🇯🇵

Wakayama, Japan

Yokohama Municipal Citizen's Hospital

🇯🇵

Yokohama, Japan

Yokohama City University Medical Center

🇯🇵

Yokohama, Japan

Yokosuka Kyosai Hospital

🇯🇵

Yokosuka, Japan

Chungbuk National University Hospital

🇰🇷

Chungcheongbuk Do, Korea, Republic of

Szpital Wojewodzki Im Sw Lukasza Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Tarnowie

🇵🇱

Tarnow, Poland

Medicover Integrated Clinical Services Sp z o o

🇵🇱

Torun, Poland

Mazowiecki Szpital Onkologiczny Sp z o o

🇵🇱

Wieliszew, Poland

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

🇵🇱

Wroclaw, Poland

Dolnoslaskie Centrum Onkologii Pulmonologii i Hematologii

🇵🇱

Wroclaw, Poland

Hosp Univ A Coruna

🇪🇸

A Coruna, Spain

Hosp. Univ. de La Ribera

🇪🇸

Alzira, Spain

Fund. Puigvert

🇪🇸

Barcelona, Spain

Hosp Univ Vall D Hebron

🇪🇸

Barcelona, Spain

Hosp Clinic de Barcelona

🇪🇸

Barcelona, Spain

Hosp. Puerta Del Mar

🇪🇸

Cadiz, Spain

Hosp. Gral. Univ. de Castellon

🇪🇸

Castellon, Spain

Hosp. de Jerez de La Frontera

🇪🇸

Jerez De La Frontera, Spain

Hosp. Gral. Univ. Gregorio Maranon

🇪🇸

Madrid, Spain

Clinica Univ. de Navarra

🇪🇸

Madrid, Spain

Hosp. Univ. 12 de Octubre

🇪🇸

Madrid, Spain

Hosp Virgen de La Victoria

🇪🇸

Malaga, Spain

Hosp. Univ. Central de Asturias

🇪🇸

Oviedo, Spain

Hosp.Univ.Parc Tauli

🇪🇸

Sabadell, Spain

Hosp. Virgen Del Rocio

🇪🇸

Sevilla, Spain

Hosp. Clinico Univ. de Valencia

🇪🇸

Valencia, Spain

Adana Baskent Practice and Research Hospital

🇹🇷

Adana, Turkey

Ankara University Medical Faculty

🇹🇷

Ankara, Turkey

Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital

🇹🇷

Ankara, Turkey

Istanbul University Cerrahpasa Medical Faculty

🇹🇷

Istanbul, Turkey

T C Saglik Bakanlıgi Goztepe Prof Dr Suleyman Yalcın Sehir Hastanesi

🇹🇷

Istanbul, Turkey

Kartal Dr Lutfi Kirdar sehir Hastanesi

🇹🇷

Istanbul, Turkey

Dokuz Eylul University Medical Faculty

🇹🇷

Izmir, Turkey

St Bartholomews Hospital

🇬🇧

London, United Kingdom

Newcastle Freeman Hospital

🇬🇧

Newcastle Upon Tyne, United Kingdom

Southmead Hospital

🇬🇧

Bristol, United Kingdom

Sheffield Teaching Hospitals NHS Foundation Trust

🇬🇧

Sheffield, United Kingdom

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