Clinical trial • Phase III • Oncology

CETRELIMAB for High-risk non-muscle-invasive bladder cancer | Urothelial carcinoma (bladder)

Phase III trial of CETRELIMAB for High-risk non-muscle-invasive bladder cancer | Urothelial carcinoma (bladder).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
High-risk non-muscle-invasive bladder cancer | Urothelial carcinoma (bladder)
Trial Stage
Phase III
Drug Modality
Monoclonal antibody | Small molecule | Vaccine

Key dates

Initial CTIS Submission Date
29-02-2024
First CTIS Authorization Date
05-04-2024

Trial design

Randomised, open-label, three-arm randomised design: group a tar-200 + iv cetrelimab; group c tar-200 alone; group b intravesical bacillus calmette-guérin (bcg). doses and schedules are not specified in the provided ctis json.-controlled Phase III trial in Belgium, Czechia, France and others.

Randomised
Yes
Open Label
Yes
Comparator
Three-arm randomised design: Group A TAR-200 + IV cetrelimab; Group C TAR-200 alone; Group B intravesical Bacillus Calmette-Guérin (BCG). Doses and schedules are not specified in the provided CTIS JSON.
Target Sample Size
616

Eligibility

Recruits 616 Vulnerable population selected: True. The CTIS record indicates 'isVulnerablePopulationSelected': true and published subject information / informed consent forms include documents for pregnant partners and a 'Privacy Appendix Child Exposed to IP' (country-specific ICF documents listed). Participants must be ≥18 years, so assent for minors is not applicable; specific consent/assent handling text is not provided in the JSON..

Vulnerable Population
Vulnerable population selected: True. The CTIS record indicates 'isVulnerablePopulationSelected': true and published subject information / informed consent forms include documents for pregnant partners and a 'Privacy Appendix Child Exposed to IP' (country-specific ICF documents listed). Participants must be ≥18 years, so assent for minors is not applicable; specific consent/assent handling text is not provided in the JSON.

Inclusion criteria

  • {"criterion_text":"- Age 1. Age ≥18 years (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of informed consent.\n- Disease Characteristic 2. Criterion modified per Global Amendment 1 2.1 Criterion modified per Global Amendment 2 2.2 Histologically confirmed initial diagnosis by local pathology (within 90 days of the most recent signed informed consent) of HR-NMIBC (high-grade Ta,any T1 or CIS), [AJCC 2017], in participants who are BCG-naïve. 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. Participants may have had a history of HR-NMIBC (defined as high-gradeTa, any T1, or CIS) as long as it has been >3 years from current/novel diagnosis of HR-NMIBC (high-grade Ta, any T1 or CIS).\n- 3. BCG-naïve (participants who have not received prior intravesical BCG or who previously received but stopped BCG more than 3 years before date of randomization are eligible) (Kamat 2016).\n- 4. Participants must be willing to undergo all study procedures (eg, multiple cystoscopies from Screening through the end of study and TURBT/bladder biopsy for assessment of recurrence/progression).\n- 5. Criterion modified per Global Amendment 2 5.1 All visible papillary disease must be fully resected (absent) prior to date of randomization and documented at baseline cystoscopy. Local urine cytology at screening must be negative or atypical (for HGUC) for patients with papillary only disease (without CIS).\n- 6. All AEs associated with any prior surgery and/or intravesical therapy must have resolved to CTCAE version 5.0 Grade <2 prior to date of randomization.\n- Type of Participant 7. Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2.\n- 8. Thyroid function tests within normal range or stable per Investigator assessment. Investigators may consult an endocrinologist for participant eligibility assessment in the case of equivocal or marginal tests results."}

Exclusion criteria

  • {"criterion_text":"- Disease Characteristics 1.Criterion modified per Global Amendment 1 1.1 Presence or history of histologically confirmed, muscle invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (ie, ≥T2).\n- 2. Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder (ie, urethra, ureter, or renal pelvis). Ta/any 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.\n- 3. Criterion modified per Global Amendment 2 3.1 N+ and/or M+ per blinded independent central review (BICR) of computed tomography/magnetic resonance (CT/MR) Urography and chest CT. Any history of HR-NMIBC (high-grade Ta, any T1 or CIS) <3 years from current diagnosis.\n- Medical Conditions 4.1 Active malignancies (ie, progressing or requiring treatment change in the last 24 months prior to randomization) other than the disease being treated under study. Potential allowed exceptions include the following (others may be allowed with Sponsor approval). a. skin cancer (non-melanoma or melanoma) that is considered completely cured. b. non-invasive cervical cancer treated that is considered completely cured. c. adequately treated lobular carcinoma in situ (LCIS) and ductal CIS d. history of localized breast cancer and receiving antihormonal agents e. history of localized prostate cancer (N0M0) and receiving androgen deprivation therapy f. Locerion modified per Global Amendment 2alized prostate cancer (N0M0): i. with a Gleason score of 6, treated within the last 24 months or untreated and under surveillance, ii. with a Gleason score of 3+4 that has been treated more than 6 months prior to full study Screening and considered to have a very low risk of recurrence, iii. or history of localized prostate cancer and receiving androgen deprivation therapy and considered to have a very low risk of recurrence.\n- 5. Presence of any bladder or urethral anatomic feature (eg, urethral stricture) that, in the opinion of the Investigator, may prevent the safe insertion, indwelling use, removal of TAR-200, or administration of intravesical BCG. Participants with tumors involving the prostatic urethra in men will be excluded.\n- 6. A history of clinically significant polyuria with recorded 24-hour urine volumes greater than 4000 mL.\n- 7.1 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 (eg,COVID-19) by local health authorities are allowed.\n- 8.1. Participants should not have a history of acute ischemic heart disease within 42 days of randomization, or history of uncontrolled cardiovascular disease including any of the following in the 3 months prior to randomization: a. unstable angina, b. myocardial infarction, c. ventricular fibrillation, d. Torsades de Pointes, e. cardiac arrest, or known congestive New York Heart Association Class III-IV heart failure, f. cerebrovascular accident, g. transient ischemic attack, or h. pulmonary embolism or other venous thromboembolism in the 3 months prior to randomization."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- EFS will be measured as the time from randomization to either the time of the first recurrence of high-risk disease, progression, or death due to any cause, whichever occurs first. For participants with CIS, persistent disease at 6 months (Week 24) is also considered an EFS event. Progression is defined as: 1) an increase of stage from Ta to T1 or from CIS to T1, or 2) progression to MIBC (T≥2) or to lymph node (N+) or to distant disease (M+), whichever occurs first.","definition_or_measurement_approach":"Measured as time from randomization to first recurrence of high-risk disease, progression, or death (whichever occurs first). For CIS, persistent disease at Week 24 counts as an EFS event. Progression is defined as increase from Ta to T1 or CIS to T1, or progression to MIBC (T≥2), N+ or M+."}

Recruitment

Digital Remote Recruitment
True, recruitment materials include outreach banner ads and online outreach creatives and an investigator app/web platform (Teckro) for distribution of study documents.
Planned Sample Size
616
Recruitment Window Months
62
Consent Approach
Participants must be ≥18 years (or legal age of consent locally) and provide informed consent. Subject information and informed consent forms are available in multiple country/language-specific versions (examples in the documents list: English, French, Dutch, Spanish, Portuguese, Polish, Italian, Czech, German). There are specific ICF materials for pregnant partners and appendices for children exposed to IMP noted in country-specific documents.

Methods

  • Poster recruitment materials (country-specific PDFs listed in CTIS documents).
  • Recruitment brochures (country-specific).
  • Outreach banner ads / online outreach (documents reference 'Outreach Banner Ad' and 'Advocacy Outreach Banner Ad' for some countries).
  • ICF flipchart materials for site use.
  • Investigator platform (via app/web based) with study documents (Teckro listed in third parties as 'Investigator platform (via app/web based) with study documents.').
  • Country-specific recruitment arrangement documents (K1 placeholders) uploaded for BE, CZ, FR, IT, PT, SPA, DE, NL, PL, etc.

Geography

Total Number Of Sites
77
Total Number Of Participants
350

Belgium

Earliest CTIS Part Ii Submission Date
22-03-2024
Latest Decision Or Authorization Date
02-02-2026
Processing Time Days
682
Number Of Sites
8
Number Of Participants
46

Sites

Site Name
Ziekenhuis Aan De Stroom
Department Name
Urology
Contact Person Name
Filip Poelaert
Contact Person Email
filip.poelaert@zas.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Urology
Contact Person Name
Thomas Tailly
Contact Person Email
Thomas.Tailly@uzgent.be
Site Name
Az Maria Middelares Gent
Department Name
Urology
Contact Person Name
Karel Decaestecker
Site Name
Az St-Jan Brugge-Oostende A.V.
Department Name
Urology
Contact Person Name
Harm Arentsen
Contact Person Email
harm.arentsen@azsintjan.be
Site Name
Sint-Lucas General Hospital
Department Name
Urology
Contact Person Name
Frederic Baekelandt
Contact Person Email
Frederic.Baekelandt@stlucas.be
Site Name
Algemeen Ziekenhuis Delta
Department Name
Urology
Contact Person Name
Lieven Goeman
Contact Person Email
lieven.goeman@azdelta.be
Site Name
Vitaz
Department Name
Urology
Contact Person Name
Bart De Troyer
Contact Person Email
bart.detroyer@vitaz.be
Site Name
Hopital De Libramont
Department Name
Oncology
Contact Person Name
Frederic Forget
Contact Person Email
frederic.forget@vivalia.be

Czechia

Earliest CTIS Part Ii Submission Date
22-03-2024
Latest Decision Or Authorization Date
03-02-2026
Processing Time Days
683
Number Of Sites
8
Number Of Participants
27

Sites

Site Name
Fakultni Nemocnice U Sv Anny V Brne
Department Name
Oncology
Contact Person Name
Jana Katolicka
Contact Person Email
jana.katolicka@fnusa.cz
Site Name
Fakultni Thomayerova nemocnice
Department Name
Oncology
Contact Person Name
Michaela Matouskova
Contact Person Email
matouskova@urocentrum.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Oncology
Contact Person Name
Robert Grill
Contact Person Email
robert.grill@fnkv.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Oncology
Contact Person Name
Lukas Holub
Contact Person Email
lukas.holub@fnhk.cz
Site Name
Fakultni Nemocnice V Motole
Department Name
Oncology
Contact Person Name
Antonin Brisuda
Contact Person Email
abrisuda@seznam.cz
Site Name
Krajska nemocnice Liberec a.s.
Department Name
Oncology
Contact Person Name
Vladimir Samal
Contact Person Email
vladimir.samal@nemlib.cz
Site Name
University Hospital Olomouc
Department Name
Oncology
Contact Person Name
Bohuslav Melichar
Contact Person Email
Bohuslav.Melichar@fnol.cz
Site Name
Fakultni Nemocnice (additional site)
Department Name
Oncology

France

Earliest CTIS Part Ii Submission Date
22-03-2024
Latest Decision Or Authorization Date
03-02-2026
Processing Time Days
683
Number Of Sites
13
Number Of Participants
51

Sites

Site Name
Assistance Publique Hopitaux De Paris (20 Rue Leblanc)
Department Name
Department of Urology
Contact Person Name
Francois AUDENET
Contact Person Email
francois.audenet@aphp.fr
Site Name
Capio La Croix Du Sud
Department Name
Department of urology
Contact Person Name
Benjamin Pradere
Contact Person Email
benjaminpradere@gmail.com
Site Name
Assistance Publique Hopitaux De Paris (43 Boulevard De L Hopital)
Department Name
Cancerology and robotic and andrology
Contact Person Name
Morgan Roupret
Contact Person Email
morgan.roupret@aphp.fr
Site Name
Polyclinique De Limoges
Department Name
Department of Oncology
Contact Person Name
Sabrina Falkowski
Contact Person Email
sf@imagemed-87.com
Site Name
Hospital Edouard Herriot
Department Name
Urology and transplant surgery
Principal Investigator Name
Marc Colombel
Principal Investigator Email
marc.colombel@chu-lyon.fr
Contact Person Name
Francois AUDENET
Contact Person Email
marc.colombel@chu-lyon.fr
Site Name
Hospital Hotel Dieu
Department Name
Department of urology
Contact Person Name
Jerome Rigaud
Contact Person Email
jerome.rigaud@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
Urology and andrology and sexology Department
Contact Person Name
Stephane DROUPY
Contact Person Email
stephane.droupy@chu-nimes.fr
Site Name
Groupe Hospitalier Diaconesses Croix Saint Simon
Department Name
Urology depatment
Contact Person Name
Quentin ARNAUD
Contact Person Email
aquentin@hopital-dcss.org
Site Name
Centre Hospitalier Universitaire D Orleans
Department Name
Department of urological surgery
Contact Person Name
Nicolas Brichart
Site Name
Assistance Publique Hopitaux De Paris (46 Rue Henri Huchard)
Department Name
Department of urology
Contact Person Name
Evanguelos Xylinas
Contact Person Email
evanguelos.xylinas@aphp.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Urology and andrology and renal transplantation
Contact Person Name
Matthieu Thoulouzan
Contact Person Email
thoulouzan.m@chu-toulouse.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Department of Urology
Contact Person Name
Romain Mathieu
Contact Person Email
romain.MATHIEU@chu-rennes.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Department of urology and kidney transplant
Contact Person Name
Jean Luc Descotes
Contact Person Email
jldescotes@chu-grenoble.fr

Italy

Earliest CTIS Part Ii Submission Date
22-03-2024
Latest Decision Or Authorization Date
03-02-2026
Processing Time Days
683
Number Of Sites
4
Number Of Participants
30

Sites

Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Urologia Oncologica
Contact Person Name
Giuseppe Simone
Contact Person Email
giuseppe.simone@ifo.it
Site Name
Istituto Oncologico Veneto
Department Name
Urologia Oncologica
Contact Person Name
Antonio Amodeo
Contact Person Email
antonio.amodeo@iov.veneto.it
Site Name
AORN San Giuseppe Moscati Avellino
Department Name
Urologia
Contact Person Name
Vittorio Imperatore
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Urologia
Contact Person Name
Sisto Perdona
Contact Person Email
s.perdona@istitutotumori.na.it

Portugal

Earliest CTIS Part Ii Submission Date
22-03-2024
Latest Decision Or Authorization Date
04-02-2026
Processing Time Days
684
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Hospital De Santa Maria E.P.E.
Department Name
Urology
Contact Person Name
Jose Palma dos reis
Contact Person Email
jpalmareis@campus.ul.pt
Site Name
Centro Hospitalar De Vila Nova De Gaia/Espinho E.P.E.
Department Name
Oncology
Contact Person Name
Sandra Custodio
Site Name
Instituto Portugues De Oncologia De Coimbra Francisco Gentil E.P.E.
Department Name
Urology
Contact Person Name
Carlos Rabaça
Contact Person Email
carlosrabaca@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
22-03-2024
Latest Decision Or Authorization Date
06-02-2026
Processing Time Days
686
Number Of Sites
13
Number Of Participants
108

Sites

Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Urology
Contact Person Name
Sara Martinez Breijo
Contact Person Email
smarbre@hotmail.com
Site Name
Hospital Universitario Puerta Del Mar
Department Name
Urology
Contact Person Name
Jose Luis Alvarez-Ossorio
Contact Person Email
urossorio@gmail.com
Site Name
Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA
Department Name
Urology
Contact Person Name
Jose Maria Martinez Jabaloyas
Contact Person Email
marjabaloyas@gmail.com
Site Name
Bellvitge University Hospital
Department Name
Urology
Contact Person Name
Francesc Vigues Julia
Contact Person Email
fvigues@bellvitgehospital.cat
Site Name
Clinica Universidad De Navarra
Department Name
Urology
Contact Person Name
Felipe Villacampa
Contact Person Email
fvauba@unav.es
Site Name
Hospital Universitario Lucus Augusti
Department Name
Urology
Contact Person Name
Francisco Casas Nebra
Contact Person Email
javihouses@gmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Urology
Contact Person Name
Jose Maria Felix Guerrero
Contact Person Email
felixguerrero@gmail.com
Site Name
Hospital Universitario La Paz
Department Name
Urology
Contact Person Name
Mario Alvarez
Contact Person Email
malvarezmaestro@hotmail.com
Site Name
Hospital General Universitario De Castellon
Department Name
Urology
Contact Person Name
Miguel Rodrigo
Contact Person Email
m-rodrigo@hotmail.com
Site Name
Hospital Punta De Europa
Department Name
Urology
Contact Person Name
María Virués García
Contact Person Email
viruesmaria@gmail.com
Site Name
Fundacio Puigvert
Department Name
Urology
Contact Person Name
Oscar Rodriguez Faba
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Urology
Contact Person Name
Bernardo Herrera
Contact Person Email
ber.urologia@gmail.com
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Urology
Contact Person Name
Jose Luis Gutierrez
Contact Person Email
urogbj@humv.es

Netherlands

Earliest CTIS Part Ii Submission Date
22-03-2024
Latest Decision Or Authorization Date
02-02-2026
Processing Time Days
682
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Spaarne Gasthuis Stichting
Department Name
oncology
Contact Person Name
Aart Beeker
Contact Person Email
abeeker@spaarnegasthuis.nl
Site Name
Canisius Wilhelmina Hospital
Department Name
urology
Contact Person Name
Diederik Somford
Contact Person Email
r.somford@cwz.nl

Germany

Earliest CTIS Part Ii Submission Date
22-03-2024
Latest Decision Or Authorization Date
06-02-2026
Processing Time Days
686
Number Of Sites
11
Number Of Participants
44

Sites

Site Name
Urologische Partnerschaft Köln
Department Name
Urologische Partnerschaft Köln
Contact Person Name
Joerg Klier
Contact Person Email
info@drklier.de
Site Name
Universitaetsklinikum Frankfurt AöR
Department Name
Urology
Contact Person Name
Clara Julia Humke
Contact Person Email
Clara.humke@unimedizin-ffm.de
Site Name
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR
Department Name
Urology
Contact Person Name
Tilman Todenhoefer
Contact Person Email
todenhoefer@studienurologie.de
Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Department Name
Urology
Contact Person Name
Margitta Retz
Contact Person Email
margitta.retz@tum.de
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Urology
Contact Person Name
Peter Goebell
Contact Person Email
peter.goebell@uk-erlangen.de
Site Name
Klinikum Nuernberg
Department Name
Urology
Contact Person Name
Clemens Huettenbrink
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Klinik fuer Urologie
Contact Person Name
Marco Schnabel
Contact Person Email
marco.schnabel@ukr.de
Site Name
Urologie Neandertal - Praxis Mettmann
Department Name
Urology
Contact Person Name
Philipp Spiegelhalder
Contact Person Email
p_spiegelhalder@web.de
Site Name
Universitaetsklinikum Muenster AöR
Department Name
Urology
Contact Person Name
Martin Boegemann
Contact Person Email
martin.boegemann@ukmuenster.de
Site Name
Urologicum Duisburg
Department Name
Urology
Contact Person Name
Eva Hellmis
Contact Person Email
hellmis@urologicum-duisburg.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Urology
Contact Person Name
Steffen Rausch

Poland

Earliest CTIS Part Ii Submission Date
22-03-2024
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
759
Number Of Sites
8
Number Of Participants
76

Sites

Site Name
In Vivo Sp. z o.o.
Department Name
Oncology
Contact Person Name
Piotr Piasecki
Contact Person Email
sekretariat@in-vivo.pl
Site Name
Provita Centrum Medyczne Sp. z o.o.
Department Name
Oncology
Contact Person Name
Michal Maslowski
Contact Person Email
m.maslowski@provitacm.pl
Site Name
Clinical Research Center Sp. z o.o. Medic-R sp.k.
Department Name
Oncology
Contact Person Name
Michal Kretkowski
Contact Person Email
michal.kretkowski@cr-center.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Oncology
Contact Person Name
Pawel Wiechno
Contact Person Email
wiechno@gmail.com
Site Name
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.
Department Name
Oncology
Contact Person Name
Wojciech Rogowski
Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Oncology
Contact Person Name
Anna Kolodziej
Contact Person Email
ak-kolodziej@wp.pl
Site Name
Uniwersytecki Szpital Kliniczny W Bialymstoku
Department Name
Klinika Urologii i Urologii Onkologicznej
Contact Person Name
Jacek Kudelski
Contact Person Email
kl.urologii@uskwb.pl
Site Name
Provita Poliklinika Sp. z o.o.
Department Name
Oncology
Contact Person Name
Slawomir Poletajew
Contact Person Email
slawomir.poletajew@gmail.com

Sponsor

Primary sponsor

Full Name
Janssen - Cilag International
Organisation Type
Pharmaceutical company
Country Of Registered Address
Belgium

Contract research organisations

Name
Almac Clinical Technologies LLC
Responsibilities
Operational trial support (contact RTHelp@almacgroup.com; sponsor duty code 3).
Name
Bioclinica Inc.
Responsibilities
Imaging services and related activities.
Name
Labcorp Central Laboratory Services SARL
Responsibilities
Central laboratory services.
Name
Clinical Logistics Inc.
Responsibilities
Clinical logistics and supplies.

Third parties

  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"Sponsor duties code 3 (role code provided in CTIS); contact RTHelp@almacgroup.com","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Teckro Limited","duties_or_roles":"Investigator platform (via app/web based) with study documents.","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Propath","duties_or_roles":"Sponsor duties code 4; contact Kristina.weatherhead@propath.com","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Netherlands","full_name":"Ancillare Europe B.V.","duties_or_roles":"Ancillaries and sponsor duties code 4 (Ancillaries).","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Y-Prime UK Limited","duties_or_roles":"ePROs (electronic patient-reported outcomes).","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Image and other services (sponsor duties include 'Image' and code 4).","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Central laboratory services.","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Clinical Logistics Inc.","duties_or_roles":"Logistics services (sponsor duties code 4).","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Omnitrace Corp.","duties_or_roles":"Subject long term follow up.","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Qd Solutions Inc.","duties_or_roles":"IPE Material and sponsor duties code 2.","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Subject travel reimbursement.","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"ePROs.","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
JNJ-63723283
Active Substance
CETRELIMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous use
Route
Intravenous
Investigational Product Name
JNJ-17000139
Active Substance
GEMCITABINE HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
Intravesical use
Route
Intravesical
Investigational Product Name
BCG VACCINE
Modality
Vaccine
Routes Of Administration
Intravesical use
Route
Intravesical
Combination Treatment
Yes

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