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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

2026-11-03

Healthy Volunteers

Conditions

Urinary Bladder Neoplasms

Interventions

DRUG

TAR-200

TAR-200 will be administered transuretherally.

BIOLOGICAL

Cetrelimab

Cetrelimab will be administered.

Inclusion Criteria: * Histologically confirmed diagnosis of persistent or recurrent high-risk non-muscle invasive bladder cancer (HR-NMIBC), (carcinoma in situ \[CIS\] or tumor in situ \[Tis\]), with or without papillary disease (T1, high-grade Ta) or papillary disease only (high-grade Ta or any T1 and absence of CIS), within 12 months of completion of the last dose of Bacillus Calmette-Guerin (BCG) therapy, in participants who have received adequate BCG. Mixed histology tumors are allowed if urothelial differentiation (transitional cell histology) is predominant. However, the presence of neuroendocrine, micropapillary, signet ring cell, plasmacytoid, or sarcomatoid features will make a participant ineligible. For participants with lamina propria invasion (T1) on the screening biopsy/ transurethral resection of bladder tumor (TURBT), muscularis propria must be present in order to rule out Muscle Invasive Bladder Cancer (MIBC) * All visible papillary disease must be fully resected (absent) prior to randomization (residual CIS is acceptable for participants eligible for Cohorts 1, 2, and 3 only) and documented in the electronic case report form (eCRF) at screening cystoscopy. For participants with papillary disease only (Cohort 4), local urine cytology at screening must be negative or atypical (for High-Grade Urothelial Carcinoma \[HGUC\]) * Participants must be ineligible for or have elected not to undergo radical cystectomy * BCG-unresponsive high-risk NMIBC after treatment with adequate BCG therapy defined as a minimum of 5 of 6 full doses of an induction course (adequate induction) plus 2 of 3 doses of a maintenance course, or at least 2 of 6 doses of a second induction course * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2 Exclusion Criteria: * Presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, T2, T3, T4, and/or Stage IV) * Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder. Ta/T1/CIS of the upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephroureterectomy more than 24 months prior to randomization * Received a live virus vaccine within 30 days prior to the initiation of study treatment. Inactivated (non-live or non-replicating) vaccines approved or authorized for emergency use (for example, COVID-19) by local health authorities are allowed * Active hepatitis B or C infection (for example, participants with history of hepatitis C infection but undetectable hepatitis C virus polymerase chain reaction (PCR) test and participants with history of hepatitis B infection with positive hepatitis B surface antigen (HBsAg) antibody and undetectable PCR are allowed) * Prior therapy with an anti-programmed-cell death 1 (PD-1), anti-PD-ligand 2 (L2) agent, or with an agent directed to another co-inhibitory T-cell receptor

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

And 44 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (144)