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

NCT04640623 | Active Not Recruiting Phase 2 DMC FDA Drug

• 4 other identifiers: CR10892117000139BLC20012020-002646-162023-506146-23-00
• Study Type: interventional
• Target: 220
• Locations: 16 countries
• Sites: 144

Brief 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).

Conditions

Urinary Bladder Neoplasms

Outcome Measures

Primary Outcomes (2)

• Cohort 1, 2, and 3: Overall Complete Response (CR) Rate

  Overall CR rate is defined as the percentage of participants achieving a CR at any time post-treatment. It will be measured by determining the percentage of participants without presence of high-grade disease using results from cystoscopy and centrally read urine cytology at any time point.

  Up to 5 years

• Cohort 4: Disease-free Survival (DFS)

  DFS will be measured as the time from the date of first dose of study treatment to either the time of the first recurrence of high-risk disease, progression, or death due to any cause, whichever occurs first.

  Up to 5 years

Secondary Outcomes (8)

• Cohort 1, 2, and 3: Duration of Response (DOR)

  Up to 5 years

• Overall Survival (OS)

  Up to 5 years

• Cohort 1, 2, and 4: Concentrations of Gemcitabine and 2',2' difluorodeoxyuridine (dFdU) in Urine and Plasma

  Up to Week 21

• Cohort 1 and 3: Serum Concentration of Anti-cetrelimab Antibodies

  Predose, up to 3 years

• Number of Participants with Anti-cetrelimab Antibodies

  Predose, up to 3 years

Study Arms (4)

Cohort 1: TAR-200 and Cetrelimab

EXPERIMENTAL

TAR-200 is placed into the bladder through a urinary placement catheter in participants with carcinoma in situ (CIS), with or without papillary disease, on Day 0 and will be dosed every 3 weeks (Q3W) for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2). In addition, Cetrelimab will be dosed Q3W through Week 78 (18 months).

Drug: TAR-200; Biological: Cetrelimab

Cohort 2: TAR-200

EXPERIMENTAL

TAR-200 is placed into the bladder through a urinary placement catheter in participants with CIS, with or without papillary disease, on Day 0 and will be dosed Q3W for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2).

Drug: TAR-200

Cohort 3: Cetrelimab

EXPERIMENTAL

Participants with CIS, with or without papillary disease, will receive Cetrelimab which will be dosed Q3W through Week 78 (18 months).

Biological: Cetrelimab

Cohort 4: TAR-200 (Participants with Papillary Disease only)

EXPERIMENTAL

TAR-200 is placed into the bladder through a urinary placement catheter in participants with papillary disease only, on Day 0 and will be dosed Q3W for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2).

Drug: TAR-200

Interventions

TAR-200 DRUG

TAR-200 will be administered transuretherally.

Also known as: JNJ-17000139, Gemcitabine-Releasing Intravesical System

Cohort 1: TAR-200 and Cetrelimab; Cohort 2: TAR-200; Cohort 4: TAR-200 (Participants with Papillary Disease only)

Cetrelimab BIOLOGICAL

Cetrelimab will be administered.

Also known as: JNJ-63723283

Cohort 1: TAR-200 and Cetrelimab; Cohort 3: Cetrelimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (144)

Del Sol Research Management, LLC

Tucson, Arizona, 85715, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Genesis Healthcare Partners - Genesis Research Greater Los Angeles

Sherman Oaks, California, 91411, United States

Location

The Urology Center of Colorado

Denver, Colorado, 80211, United States

Location

Foothills Urology - Golden Off

Golden, Colorado, 80401, United States

Location

DuPage Medical Group

Lisle, Illinois, 60532, United States

Location

Urology of Indiana

Greenwood, Indiana, 46143, United States

Location

Wichita Urology Group

Wichita, Kansas, 67226, United States

Location

Michigan Institute of Urology

Troy, Michigan, 48084, United States

Location

NYU Langone Health

New York, New York, 10017, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210-2375, United States

Location

Associated Medical Professionals

Syracuse, New York, 13210, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

The Urology Group

Cincinnati, Ohio, 45212, United States

Location

Urologic Consultants of Southeastern Pennsylvania

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Urology Associates, PC

Nashville, Tennessee, 37209, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Urology Austin

Austin, Texas, 78745, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Urology San Antonio Research

San Antonio, Texas, 78229, United States

Location

Spokane Urology

Spokane, Washington, 99202, United States

Location

Flinders Medical Centre

Bedford Park, 5042, Australia

Location

Eastern Health Research

Box Hill, 3128, Australia

Location

Macquarie University Hospital

Sydney, 2109, Australia

Location

AZ Sint-Lucas Brugge

Assebroek, 8310, Belgium

Location

AZ Sint-Jan Brugge

Bruges, 8000, Belgium

Location

Hopital Erasme

Brussels, 1070, Belgium

Location

Algemeen ziekenhuis Maria Middelares

Ghent, 9000, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Algemeen Ziekenhuis Delta

Roeselare, 8800, Belgium

Location

AZ Nikolaas

Sint-Niklaas, 9100, Belgium

Location

Exdeo Clinical Research Inc

Abbotsford British Columbia, British Columbia, V2S 3N5, Canada

Location

William Osler Health System

Brampton, Ontario, L6R 3J7, Canada

Location

Princess Margaret Hospital- UHN

Toronto, Ontario, M5G 2M9, Canada

Location

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

Universite de Sherbrooke

Sherbrooke, Quebec, J1H 5H3, Canada

Location

Hopital Pellegrin CHU Bordeaux

Bordeaux, 33076, France

Location

Polyclinique Bordeaux Nord Acquitaine

Bordeaux, 33300, France

Location

CHU Grenoble

Grenoble, 38043, France

Location

Clinique Sainte Marguerite

Hyères, 83400, France

Location

Polyclinique de Limoges - Francois Chenieux

Limoges, 87000, France

Location

Hôpital Edouard Herriot

Lyon, 69437, France

Location

Institut Paoli-Calmettes

Marseille, 13273, France

Location

Centre de Cancerologie du Grand Montpellier

Montpellier, 34070, France

Location

CHU Nimes

Nîmes, 30029, France

Location

Hopital Saint Louis

Paris, 75010, France

Location

Hôpital Universitaire Pitié-Salpêtrière

Paris, 75013, France

Location

Hopital Europeen Georges-Pompidou

Paris, 75015, France

Location

Groupe Hospitalier Diaconesses Croix Saint Simon

Paris, 75020, France

Location

Hopital Bichat Claude Bernard

Paris, 75877, France

Location

Clinical La Croix Du Sud - Ramsay Santé

Quint-Fonsegrives, 31130, France

Location

Hopital Pontchaillou

Rennes, 35033, France

Location

CHP Saint Gregoire

Saint-Grégoire, 35760, France

Location

Institut de Cancerologie Strasbourg Europe ICANS

Strasbourg, 67200, France

Location

Hopital Foch

Suresnes, 92151, France

Location

Hopital Rangueil

Toulouse, 31059, France

Location

Urologische Partnerschaft Koln UPK

Cologne, 50968, Germany

Location

Urologicum Duisburg

Duisburg, 47179, Germany

Location

Klinikum Herne - Urologie

Herne, 44625, Germany

Location

Matthias Schulze - Germany

Markkleeberg, 04416, Germany

Location

Urologie Neandertal Praxis Mettmann

Mettmann, 40822, Germany

Location

Universitatsklinikum Munster

Münster, 48149, Germany

Location

Schön Klinik Nürnberg Fürth

Nuremberg, 90491, Germany

Location

Studienpraxis Urologie Nürtingen - Germany

Nürtingen, 72622, Germany

Location

Urologische Praxis am Wasserturm - Germany

Würselen, 52146, Germany

Location

Metropolitan General A E

Cholargós, 155 62, Greece

Location

Athens Medical Center

Marousi, 151 25, Greece

Location

Bioclinic - Thessaloniki

Thessaloniki, 546 22, Greece

Location

General Hospital of Thessaloniki G. Gennimatas

Thessaloniki, 54635, Greece

Location

Euromedica General Clinic

Thessaloniki, 54645, Greece

Location

Papageorgiou General Hospital Of Thessaloniki

Thessaloniki, TK 56403, Greece

Location

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Bari, 70120, Italy

Location

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Satellite 1

Bari, 70124, Italy

Location

Azienda Ospedaliera Universitaria Careggi

Florence, 50135, Italy

Location

Ospedale San Martino 1

Genova, 16132, Italy

Location

Ospedale San Raffaele

Milan, 20132, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, 56126, Italy

Location

Azienda Ospedaliera Sant Andrea

Roma, 00189, Italy

Location

Istituto Nazionale Tumori Regina Elena

Rome, 00144, Italy

Location

Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino

Torino, 10126, Italy

Location

Ospedale di Circolo e Fondazione Macchi

Varese, 21100, Italy

Location

Ospedale San Bortolo

Vicenza, 36100, Italy

Location

Aso Co.,Ltd Iizuka Hospital

Iizuka, 820-8501, Japan

Location

St Marianna University Hospital

Kanagawa, 216 8511, Japan

Location

Nara Medical University Hospital

Kashihara-shi, 634-8522, Japan

Location

Kimitsu Chuo Hospital

Kisarazu-shi, 292-8535, Japan

Location

Nagasaki University Hospital

Nagasaki, 852-8501, Japan

Location

JOHAS Osaka Rosai Hospital

Osaka, 591-8025, Japan

Location

Toranomon Hospital

Tokyo, 105-8470, Japan

Location

Toyama University Hospital

Toyama, 930-0194, Japan

Location

Fujita Health University Hospital

Toyoake, 470-1192, Japan

Location

University of Tsukuba Hospital

Tsukuba, 305-8520, Japan

Location

Yokohama City University Medical Center

Yokohama, 232 0024, Japan

Location

Antoni van Leeuwenhoek

Amsterdam, 1066 CX, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, 5623EJ, Netherlands

Location

Canisius-Wilhelmina Ziekenhuis

Nijmegen, 6532SZ, Netherlands

Location

The Julius Center - Utrecht Science Park - Stratenum

Utrecht, 3508 GA, Netherlands

Location

Hospital Garcia de Orta

Almada, 2805-267, Portugal

Location

Uls Regiao Aveiro - Hosp. Infante D. Pedro

Aveiro, 3810-193, Portugal

Location

Uls Alto Ave - Hosp. Sra. Da Oliveira Guimaraes

Guimarães, 4835-044, Portugal

Location

Centro Hospitalar de Lisboa Central

Lisbon, 1150-199, Portugal

Location

Fund. Champalimaud

Lisbon, 1400-038, Portugal

Location

Uls Loures Odivelas - Hosp. Loures

Loures, 2674 514, Portugal

Location

Instituto Portugues de Oncologia do Porto Francisco Gentil

Porto, 4200-072, Portugal

Location

Centro Hospitalar de Vila Nova de Gaia Espinho E P E

Vila Nova de Gaia, 4434 502, Portugal

Location

Centro Hospitalar de Trás os Montes e Alto-Douro

Vila Real, 5000508, Portugal

Location

Hertzen Oncology Research Institute

Moscow, 125284, Russia

Location

Privolzhsky District Medical Centre

Nizhny Novgorod, 603074, Russia

Location

Avicenna Medical Center

Novosibirsk, 630099, Russia

Location

A. Tsyb Medical Radiological Research Center

Obninsk, 249031, Russia

Location

BHI of Omsk region Clinical Oncology Dispensary

Omsk, 644013, Russia

Location

Ultrasound Clinic 4D

Pyatigorsk, 357502, Russia

Location

Saratov State Medical University

Saratov, 410054, Russia

Location

Multifunctional clinical medical center 'Medical city'

Tyumen, 625041, Russia

Location

Bashkir State Medical University

Ufa, 450008, Russia

Location

Inje University Haeundae Paik Hospital

Busan, 612-896, South Korea

Location

Kyungpook National University Chilgok Hospital

Daegu, 41404, South Korea

Location

Keimyung University Dongsan Hospital

Daegu, 42601, South Korea

Location

National Cancer Center

Goyang-si, 10408, South Korea

Location

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital

Seoul, 03722, South Korea

Location

Gangnam Severance Hospital

Seoul, 06273, South Korea

Location

The Catholic University of Korea Seoul St Mary s Hospital

Seoul, 06591, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, 50612, South Korea

Location

Hosp Univ A Coruna

A Coruña, 15006, Spain

Location

Hosp. Univ. Germans Trias I Pujol

Badalona, 08916, Spain

Location

Fund. Puigvert

Barcelona, 08025, Spain

Location

Hosp. Puerta Del Mar

Cadiz, 11009, Spain

Location

Hosp. Univ. Virgen de Las Nieves

Granada, 18014, Spain

Location

Hosp. de Jerez de La Frontera

Jerez de la Frontera, 11407, Spain

Location

Hosp. Univ. Ramon Y Cajal

Madrid, 28034, Spain

Location

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

Location

Hosp. Univ. La Paz

Madrid, 28046, Spain

Location

Hosp Univ Hm Sanchinarro

Madrid, 28050, Spain

Location

Hosp Virgen de La Victoria

Málaga, 29010, Spain

Location

Corporacio Sanitari Parc Tauli

Sabadell, 08208, Spain

Location

Instituto Valenciano de Oncologia

Valencia, 46009, Spain

Location

Chernihivskyi oblasnyi onkolohichnyi dyspanser

Chernihiv, 14029, Ukraine

Location

Asklepion LLC

Kiev, 08173, Ukraine

Location

Sumy Regional Clinical Oncology Centre

Sumy, 40022, Ukraine

Location

NHS Greater Glasgow and Clyde

Glasgow, G12 0YN, United Kingdom

Location

Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

Location

Related Publications (1)

• Daneshmand S, Van der Heijden MS, Jacob JM, Guerrero-Ramos F, Bogemann M, Simone G, Pieczonka CM, Casco NC, Zainfeld D, Spiegelhalder P, Xylinas E, Cahn D, Lotan Y, Murray KS, Kawahara T, Stromberg K, Martin J, Shukla A, Cutie CJ, Bertzos K, Hampras S, Sweiti H, Necchi A; SunRISe-1 Study. TAR-200 for Bacillus Calmette-Guerin-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer: Results From the Phase IIb SunRISe-1 Study. J Clin Oncol. 2025 Nov 20;43(33):3578-3588. doi: 10.1200/JCO-25-01651. Epub 2025 Jul 30.

  PMID: 40737582 DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: November 23, 2020
• Study Start: December 18, 2020
• Primary Completion: July 3, 2025
• Study Completion (Estimated): September 30, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

AU (3); DE (9); GR (6); RU (9); JP (11); UA (3); GB (2); KR (10); FR (20); NL (4); IT (11); CA (5); BE (7); PT (9); ES (13); US (22)