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ACTIVE NOT RECRUITING
NCT04640623
PHASE2

A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the overall complete response (CR) rate in participants treated with TAR-200 in combination with cetrelimab (Cohort 1), or TAR-200 alone (Cohort 2), or cetrelimab alone (Cohort 3) with Carcinoma in Situ (CIS), with or without concomitant high-grade Ta or T1 papillary disease; and disease-free survival (DFS) in participants treated with TAR-200 alone with papillary disease only (Cohort 4).

Official title: Phase 2b Clinical Study Evaluating Efficacy and Safety of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin (BCG) Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

220

Start Date

2020-12-18

Completion Date

2027-09-30

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

DRUG

TAR-200

TAR-200 will be administered transuretherally.

BIOLOGICAL

Cetrelimab

Cetrelimab will be administered.

Locations (144)

Del Sol Research Management, LLC

Tucson, Arizona, United States

University of Southern California

Los Angeles, California, United States

Genesis Healthcare Partners - Genesis Research Greater Los Angeles

Sherman Oaks, California, United States

The Urology Center of Colorado

Denver, Colorado, United States

Foothills Urology - Golden Off

Golden, Colorado, United States

DuPage Medical Group

Lisle, Illinois, United States

Urology of Indiana

Greenwood, Indiana, United States

Wichita Urology Group

Wichita, Kansas, United States

Michigan Institute of Urology

Troy, Michigan, United States

NYU Langone Health

New York, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

Associated Medical Professionals

Syracuse, New York, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

The Urology Group

Cincinnati, Ohio, United States

Urologic Consultants of Southeastern Pennsylvania

Bala-Cynwyd, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Urology Associates, PC

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Urology Austin

Austin, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Urology San Antonio Research

San Antonio, Texas, United States

Spokane Urology

Spokane, Washington, United States

Flinders Medical Centre

Bedford Park, Australia

Eastern Health Research

Box Hill, Australia

Macquarie University Hospital

Sydney, Australia

AZ Sint-Lucas Brugge

Assebroek, Belgium

AZ Sint-Jan Brugge

Bruges, Belgium

Hopital Erasme

Brussels, Belgium

Algemeen ziekenhuis Maria Middelares

Ghent, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

Algemeen Ziekenhuis Delta

Roeselare, Belgium

AZ Nikolaas

Sint-Niklaas, Belgium

Exdeo Clinical Research Inc

Abbotsford British Columbia, British Columbia, Canada

William Osler Health System

Brampton, Ontario, Canada

Princess Margaret Hospital- UHN

Toronto, Ontario, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Universite de Sherbrooke

Sherbrooke, Quebec, Canada

Hopital Pellegrin CHU Bordeaux

Bordeaux, France

Polyclinique Bordeaux Nord Acquitaine

Bordeaux, France

CHU Grenoble

Grenoble, France

Clinique Sainte Marguerite

Hyères, France

Polyclinique de Limoges - Francois Chenieux

Limoges, France

Hôpital Edouard Herriot

Lyon, France

Institut Paoli-Calmettes

Marseille, France

Centre de Cancerologie du Grand Montpellier

Montpellier, France

CHU Nimes

Nîmes, France

Hopital Saint Louis

Paris, France

Hôpital Universitaire Pitié-Salpêtrière

Paris, France

Hopital Europeen Georges-Pompidou

Paris, France

Groupe Hospitalier Diaconesses Croix Saint Simon

Paris, France

Hopital Bichat Claude Bernard

Paris, France

Clinical La Croix Du Sud - Ramsay Santé

Quint-Fonsegrives, France

Hopital Pontchaillou

Rennes, France

CHP Saint Gregoire

Saint-Grégoire, France

Institut de Cancerologie Strasbourg Europe ICANS

Strasbourg, France

Hopital Foch

Suresnes, France

Hopital Rangueil

Toulouse, France

Urologische Partnerschaft Koln UPK

Cologne, Germany

Urologicum Duisburg

Duisburg, Germany

Klinikum Herne - Urologie

Herne, Germany

Matthias Schulze - Germany

Markkleeberg, Germany

Urologie Neandertal Praxis Mettmann

Mettmann, Germany

Universitatsklinikum Munster

Münster, Germany

Schön Klinik Nürnberg Fürth

Nuremberg, Germany

Studienpraxis Urologie Nürtingen - Germany

Nürtingen, Germany

Urologische Praxis am Wasserturm - Germany

Würselen, Germany

Metropolitan General A E

Cholargós, Greece

Athens Medical Center

Marousi, Greece

Bioclinic - Thessaloniki

Thessaloniki, Greece

General Hospital of Thessaloniki G. Gennimatas

Thessaloniki, Greece

Euromedica General Clinic

Thessaloniki, Greece

Papageorgiou General Hospital Of Thessaloniki

Thessaloniki, Greece

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Bari, Italy

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Satellite 1

Bari, Italy

Azienda Ospedaliera Universitaria Careggi

Florence, Italy

Ospedale San Martino 1

Genova, Italy

Ospedale San Raffaele

Milan, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Azienda Ospedaliera Sant Andrea

Roma, Italy

Istituto Nazionale Tumori Regina Elena

Rome, Italy

Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino

Torino, Italy

Ospedale di Circolo e Fondazione Macchi

Varese, Italy

Ospedale San Bortolo

Vicenza, Italy

Aso Co.,Ltd Iizuka Hospital

Iizuka, Japan

St Marianna University Hospital

Kanagawa, Japan

Nara Medical University Hospital

Kashihara-shi, Japan

Kimitsu Chuo Hospital

Kisarazu-shi, Japan

Nagasaki University Hospital

Nagasaki, Japan

JOHAS Osaka Rosai Hospital

Osaka, Japan

Toranomon Hospital

Tokyo, Japan

Toyama University Hospital

Toyama, Japan

Fujita Health University Hospital

Toyoake, Japan

University of Tsukuba Hospital

Tsukuba, Japan

Yokohama City University Medical Center

Yokohama, Japan

Antoni van Leeuwenhoek

Amsterdam, Netherlands

Catharina Ziekenhuis

Eindhoven, Netherlands

Canisius-Wilhelmina Ziekenhuis

Nijmegen, Netherlands

The Julius Center - Utrecht Science Park - Stratenum

Utrecht, Netherlands

Hospital Garcia de Orta

Almada, Portugal

Uls Regiao Aveiro - Hosp. Infante D. Pedro

Aveiro, Portugal

Uls Alto Ave - Hosp. Sra. Da Oliveira Guimaraes

Guimarães, Portugal

Centro Hospitalar de Lisboa Central

Lisbon, Portugal

Fund. Champalimaud

Lisbon, Portugal

Uls Loures Odivelas - Hosp. Loures

Loures, Portugal

Instituto Portugues de Oncologia do Porto Francisco Gentil

Porto, Portugal

Centro Hospitalar de Vila Nova de Gaia Espinho E P E

Vila Nova de Gaia, Portugal

Centro Hospitalar de Trás os Montes e Alto-Douro

Vila Real, Portugal

Hertzen Oncology Research Institute

Moscow, Russia

Privolzhsky District Medical Centre

Nizhny Novgorod, Russia

Avicenna Medical Center

Novosibirsk, Russia

A. Tsyb Medical Radiological Research Center

Obninsk, Russia

BHI of Omsk region Clinical Oncology Dispensary

Omsk, Russia

Ultrasound Clinic 4D

Pyatigorsk, Russia

Saratov State Medical University

Saratov, Russia

Multifunctional clinical medical center 'Medical city'

Tyumen, Russia

Bashkir State Medical University

Ufa, Russia

Inje University Haeundae Paik Hospital

Busan, South Korea

Kyungpook National University Chilgok Hospital

Daegu, South Korea

Keimyung University Dongsan Hospital

Daegu, South Korea

National Cancer Center

Goyang-si, South Korea

Chonnam National University Hospital

Gwangju, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

Gangnam Severance Hospital

Seoul, South Korea

The Catholic University of Korea Seoul St Mary s Hospital

Seoul, South Korea

Pusan National University Yangsan Hospital

Yangsan, South Korea

Hosp Univ A Coruna

A Coruña, Spain

Hosp. Univ. Germans Trias I Pujol

Badalona, Spain

Fund. Puigvert

Barcelona, Spain

Hosp. Puerta Del Mar

Cadiz, Spain

Hosp. Univ. Virgen de Las Nieves

Granada, Spain

Hosp. de Jerez de La Frontera

Jerez de la Frontera, Spain

Hosp. Univ. Ramon Y Cajal

Madrid, Spain

Hosp. Univ. 12 de Octubre

Madrid, Spain

Hosp. Univ. La Paz

Madrid, Spain

Hosp. Univ. Hm Monteprincipe

Madrid, Spain

Hosp Virgen de La Victoria

Málaga, Spain

Corporacio Sanitari Parc Tauli

Sabadell, Spain

Instituto Valenciano de Oncologia

Valencia, Spain

Chernihivskyi oblasnyi onkolohichnyi dyspanser

Chernihiv, Ukraine

Asklepion LLC

Kiev, Ukraine

Sumy Regional Clinical Oncology Centre

Sumy, Ukraine

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom