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Fachinformation

JOURNAL ONKOLOGIE – STUDIE

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-Guerin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

Rekrutierend

NCT-Nummer:
NCT04640623

Studienbeginn:
Dezember 2020

Letztes Update:
19.01.2021

Wirkstoff:
TAR-200, Cetrelimab

Indikation (Clinical Trials):
Urinary Bladder Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Janssen Research & Development, LLC

Collaborator:
-

Studienleiter

Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC

Kontakt

Studienlocations (3 von 151)

Urologicum Duisburg
47179 Duisburg
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Klinikum Herne - Urologie
44625 Herne
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Lungenkrebszentrum Uniklinik Köln / Solingen
Kerpener Straße 62
50937 Köln
DeutschlandNoch nicht rekrutierend» Google-Maps
Urologische Partnerschaft Köln UPK
50968 Köln
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Matthias Schulze - Germany
04416 Markkleeberg
(Sachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Urologie Neandertal Praxis Mettmann
40822 Mettmann
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Kinderonkologisches Zentrum am Universitätsklinikum Münster
Albert-Schweitzer-Campus 1
48149 Münster
DeutschlandNoch nicht rekrutierend» Google-Maps
Schön Klinik Nürnberg Fürth
90491 Nürnberg
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Studienpraxis Urologie Nürtingen - Germany
72622 Nürtingen
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Kliniken Nordoberpfalz AG/Klinikum Weiden
92637 Weiden
(Bayern)
GermanyZurückgezogen» Google-Maps
Urologische Praxis am Wasserturm - Germany
52146 Würselen
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Bladder Cancer Genitourinary Oncology
85032 Phoenix
United StatesZurückgezogen» Google-Maps
Urological Associates of Southern Arizona, P.C.
85715 Tucson
United StatesNoch nicht rekrutierend» Google-Maps
University of Southern California
90033 Los Angeles
United StatesNoch nicht rekrutierend» Google-Maps
The Urology Center of Colorado
80211 Denver
United StatesNoch nicht rekrutierend» Google-Maps
Foothills Urology - Golden Off
80401 Golden
United StatesNoch nicht rekrutierend» Google-Maps
DuPage Medical Group
60532 Lisle
United StatesNoch nicht rekrutierend» Google-Maps
Indiana University
46202-5116 Indianapolis
United StatesZurückgezogen» Google-Maps
Johns Hopkins Medical Institutions
21287 Baltimore
United StatesNoch nicht rekrutierend» Google-Maps
Wayne State University
48202 Detroit
United StatesNoch nicht rekrutierend» Google-Maps
NYU Langone Health
10017 New York
United StatesNoch nicht rekrutierend» Google-Maps
University of Rochester
14627 Rochester
United StatesNoch nicht rekrutierend» Google-Maps
SUNY Upstate Medical University
13210-2375 Syracuse
United StatesNoch nicht rekrutierend» Google-Maps
Associated Medical Professionals
13210 Syracuse
United StatesNoch nicht rekrutierend» Google-Maps
Levine Cancer Institute
28204 Charlotte
United StatesNoch nicht rekrutierend» Google-Maps
Oregon Urology Institute
97477 Springfield
United StatesZurückgezogen» Google-Maps
Urologic Consultants of Southeastern Pennsylvania
19004 Bala-Cynwyd
United StatesRekrutierend» Google-Maps
Thomas Jefferson University
19107 Philadelphia
United StatesNoch nicht rekrutierend» Google-Maps
Urology Associates, PC
37209 Nashville
United StatesNoch nicht rekrutierend» Google-Maps
Vanderbilt University Medical Center
37232 Nashville
United StatesNoch nicht rekrutierend» Google-Maps
University of Texas Southwestern Medical Center
75390 Dallas
United StatesNoch nicht rekrutierend» Google-Maps
Urology San Antonio Research
78229 San Antonio
United StatesNoch nicht rekrutierend» Google-Maps
Spokane Urology
99202 Spokane
United StatesNoch nicht rekrutierend» Google-Maps
Flinders Medical Centre
5042 Bedford Park
AustraliaNoch nicht rekrutierend» Google-Maps
Eastern Health Research
3128 Box Hill
AustraliaNoch nicht rekrutierend» Google-Maps
Prince Of Wales Hospital
2031 Randwick
AustraliaNoch nicht rekrutierend» Google-Maps
Royal North Shore Hospital
2065 St Leonards
AustraliaNoch nicht rekrutierend» Google-Maps
Macquarie University Hospital
2109 Sydney
AustraliaNoch nicht rekrutierend» Google-Maps
Princess Alexandra Hospital
4102 Woolloongabba
AustraliaNoch nicht rekrutierend» Google-Maps
AZ St.-Jan Brugge-Oostende AV
8000 Brugge
BelgiumNoch nicht rekrutierend» Google-Maps
Universitair Ziekenhuis Gent
9000 Gent
BelgiumNoch nicht rekrutierend» Google-Maps
Algemeen Ziekenhuis Delta
8800 Roeselare
BelgiumNoch nicht rekrutierend» Google-Maps
Exdeo Clinical Research Inc
V2S 3N5 Abbotsford
CanadaNoch nicht rekrutierend» Google-Maps
The Male/Female Health and Research Centre
L4M 7G1 Barrie
CanadaNoch nicht rekrutierend» Google-Maps
Princess Margaret Hospital- UHN
M5G 2M9 Toronto
CanadaNoch nicht rekrutierend» Google-Maps
McGill University Health Centre
H4A 3J1 Montreal
CanadaNoch nicht rekrutierend» Google-Maps
Universite de Sherbrooke
J1H 5H3 Sherbrooke
CanadaNoch nicht rekrutierend» Google-Maps
Polyclinique Bordeaux Nord Acquitaine
33300 Bordeaux
FranceNoch nicht rekrutierend» Google-Maps
Clinique Sainte Marguerite
83400 Hyeres
FranceNoch nicht rekrutierend» Google-Maps
Polyclinique de Limoges - Francois Chenieux
87000 Limoges
FranceNoch nicht rekrutierend» Google-Maps
Hôpital Edouard Herriot
69437 Lyon Cedex 03
FranceNoch nicht rekrutierend» Google-Maps
Institut Paoli-Calmettes
13273 Marseille
FranceNoch nicht rekrutierend» Google-Maps
Hôpital Universitaire Pitié-Salpêtrière
75013 Paris Cedex 13
FranceNoch nicht rekrutierend» Google-Maps
Hopital Europeen Georges-Pompidou
75015 Paris
FranceNoch nicht rekrutierend» Google-Maps
Groupe Hospitalier Diaconesses Croix Saint Simon
75020 Paris
FranceNoch nicht rekrutierend» Google-Maps
Hopital Bichat Claude Bernard
75877 Paris
FranceNoch nicht rekrutierend» Google-Maps
Hopital Pontchaillou
35033 Rennes cedex 9
FranceNoch nicht rekrutierend» Google-Maps
CHP Saint Gregoire
35760 Saint Gregoire
FranceNoch nicht rekrutierend» Google-Maps
Institut de Cancérologie Strasbourg Europe (ICANS)
67200 Strasbourg
FranceNoch nicht rekrutierend» Google-Maps
Attikon University General Hospital of Attica
12462 Athens
GreeceZurückgezogen» Google-Maps
Metropolitan General A.E.
155 62 Holargos
GreeceNoch nicht rekrutierend» Google-Maps
Athens Medical Center
151 25 Maroussi
GreeceNoch nicht rekrutierend» Google-Maps
Bioclinic - Thessaloniki
546 22 Thessaloniki
GreeceNoch nicht rekrutierend» Google-Maps
General Hospital of Thessaloniki G. Gennimatas
54635 Thessaloniki
GreeceNoch nicht rekrutierend» Google-Maps
Euromedica General Clinic
54645 Thessaloniki
GreeceNoch nicht rekrutierend» Google-Maps
'Papageorgiou' General Hospital of Thessaloniki
TK 56403 Thessaloniki
GreeceNoch nicht rekrutierend» Google-Maps
Azienda Ospedaliero Universitaria Pisana
56126 Pisa
ItalyNoch nicht rekrutierend» Google-Maps
Istituto Nazionale Tumori Regina Elena
00144 Rome
ItalyNoch nicht rekrutierend» Google-Maps
Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino
10126 Torino
ItalyNoch nicht rekrutierend» Google-Maps
Ospedale San Bortolo
36100 Vicenza
ItalyNoch nicht rekrutierend» Google-Maps
St.Marianna University School of Medicine
216-8511 Kanagawa
JapanNoch nicht rekrutierend» Google-Maps
Kimitsu Chuo Hospital
292-8535 Kisarazu
JapanNoch nicht rekrutierend» Google-Maps
Nagasaki University Hospital
852-8501 Nagasaki
JapanNoch nicht rekrutierend» Google-Maps
JOHAS Osaka Rosai Hospital
591-8025 Osaka
JapanNoch nicht rekrutierend» Google-Maps
Toranomon Hospital
105-8470 Tokyo
JapanNoch nicht rekrutierend» Google-Maps
Toyama University Hospital
930-0194 Toyama-shi
JapanNoch nicht rekrutierend» Google-Maps
Fujita Health University Hospital
470-1192 Toyoake
JapanNoch nicht rekrutierend» Google-Maps
University of Tsukuba Hospital
305-8520 Tsukuba-Shi
JapanNoch nicht rekrutierend» Google-Maps
Yamaguchi University Hospital
755-8505 Ube
JapanNoch nicht rekrutierend» Google-Maps
Yokohama City University Medical Center
232-0024 Yokohama
JapanNoch nicht rekrutierend» Google-Maps
Inje University Haeundae Paik Hospital
612-896 Busan
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Kyungpook National University Chilgok Hospital
41404 Daegu
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Keimyung University Dongsan Hospital
42601 Daegu
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
National Cancer Center
10408 Goyang-si
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Chonnam National University Hospital
61469 Gwangju
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Seoul National University Hospital
03080 Seoul
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Severance Hospital
03722 Seoul
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Gangnam Severance Hospital
06273 Seoul
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
The Catholic University of Korea, Seoul St. Mary's Hospital
06591 Seoul
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Pusan National University Yangsan Hospital
50612 Yangsan-si
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Hospital Garcia de Orta
2805-267 Almada
PortugalNoch nicht rekrutierend» Google-Maps
Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE
3000-075 Coimbra
PortugalNoch nicht rekrutierend» Google-Maps
Hospital da Senhora da Oliveira
4835-044 Guimarães
PortugalNoch nicht rekrutierend» Google-Maps
Centro Hospitalar de Lisboa Central
1150-199 Lisboa
PortugalNoch nicht rekrutierend» Google-Maps
Fundação Champalimaud
1400-038 Lisbon
PortugalNoch nicht rekrutierend» Google-Maps
Hospital Beatriz Angelo
2674-514 Loures
PortugalNoch nicht rekrutierend» Google-Maps
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
4434-502 Vila Nova de Gaia
PortugalNoch nicht rekrutierend» Google-Maps
Centro Hospitalar de Trás os Montes e Alto-Douro
5000508 Vila Real
PortugalNoch nicht rekrutierend» Google-Maps
N. N. Blokhin Russian Academy of Medical Sciences
115478 Moscow
Russian FederationNoch nicht rekrutierend» Google-Maps
Hertzen Oncology Research Institute
125284 Moscow
Russian FederationNoch nicht rekrutierend» Google-Maps
City Clinical Hospital #1
603109 Nizhny Novgorod
Russian FederationNoch nicht rekrutierend» Google-Maps
Avicenna Medical Center
630099 Novosibirsk
Russian FederationNoch nicht rekrutierend» Google-Maps
A. Tsyb Medical Radiological Research Center
249031 Obninsk
Russian FederationNoch nicht rekrutierend» Google-Maps
BHI of Omsk region Clinical Oncology Dispensary
644013 Omsk
Russian FederationNoch nicht rekrutierend» Google-Maps
Ultrasound Clinic 4D
357502 Pyatigorsk
Russian FederationNoch nicht rekrutierend» Google-Maps
Hospital for War Veterans
344037 Rostov-on-Don
Russian FederationNoch nicht rekrutierend» Google-Maps
City Multiple-Discipline Hospital # 2
192174 Saint Petersburg
Russian FederationNoch nicht rekrutierend» Google-Maps
FSBHI RSCRST n.a. Ac. Granov A.M. of MoH
197758 Saint Petersburg
Russian FederationNoch nicht rekrutierend» Google-Maps
Saratov State Medical University
410054 Saratov
Russian FederationNoch nicht rekrutierend» Google-Maps
Multifunctional clinical medical center 'Medical city'
625041 Tyumen
Russian FederationNoch nicht rekrutierend» Google-Maps
Bashkir State Medical University
450008 Ufa
Russian FederationNoch nicht rekrutierend» Google-Maps
Hosp. Univ. A Coruña
15006 A Coruña
SpainNoch nicht rekrutierend» Google-Maps
Hosp. Univ. Germans Trias I Pujol
08916 Badalona
SpainNoch nicht rekrutierend» Google-Maps
Fundacion Puigvert
08025 Barcelona
SpainNoch nicht rekrutierend» Google-Maps
Hosp. Clinic I Provincial de Barcelona
08036 Barcelona
SpainNoch nicht rekrutierend» Google-Maps
Hosp. Univ. Virgen de Las Nieves
18014 Granada
SpainNoch nicht rekrutierend» Google-Maps
Hosp. de Jerez de La Frontera
11407 Jerez De La Frontera
SpainNoch nicht rekrutierend» Google-Maps
Hosp. Univ. Ramon Y Cajal
28034 Madrid
SpainNoch nicht rekrutierend» Google-Maps
Hosp. Univ. 12 de Octubre
28041 Madrid
SpainNoch nicht rekrutierend» Google-Maps
Hosp. Univ. Hm Monteprincipe
28660 Madrid
SpainNoch nicht rekrutierend» Google-Maps
Hosp. Virgen de La Victoria
29010 Málaga
SpainNoch nicht rekrutierend» Google-Maps
Corporacio Sanitari Parc Tauli
08208 Sabadell
SpainNoch nicht rekrutierend» Google-Maps
Instituto Valenciano de Oncologia
46009 Valencia
SpainNoch nicht rekrutierend» Google-Maps
Yildirim Beyazit University Medical Faculty Ankara Atatürk Research and Training Hospital
06050 Ankara
TurkeyNoch nicht rekrutierend» Google-Maps
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
06590 Ankara
TurkeyNoch nicht rekrutierend» Google-Maps
Trakya University Medical Faculty
22130 Edirne
TurkeyNoch nicht rekrutierend» Google-Maps
Istanbul Medeniyet University Goztepe Training and Research Hospital
34732 Istanbul
TurkeyNoch nicht rekrutierend» Google-Maps
Office Of Ahmet Cag Cal, MD
35110 Izmir
TurkeyNoch nicht rekrutierend» Google-Maps
Izmir Medical Park Hospital
35530 Izmir
TurkeyNoch nicht rekrutierend» Google-Maps
Inonu University Medical Faculty
44000 Malatya
TurkeyNoch nicht rekrutierend» Google-Maps
Cherkassy Regional Oncology Dispensary, Department of Hematology
18009 Cherkasy
UkraineNoch nicht rekrutierend» Google-Maps
Chernihivskyi oblasnyi onkolohichnyi dyspanser
14029 Chernihiv
UkraineNoch nicht rekrutierend» Google-Maps
Chernivtsi Regional Clinical Hospital
58000 Chernivtsi
UkraineSchwebend» Google-Maps
SE Dnipropetrovsk Medical Academy
49005 Dnipro
UkraineNoch nicht rekrutierend» Google-Maps
Main Military Clinical Hospital of MDU
01133 Kiev
UkraineNoch nicht rekrutierend» Google-Maps
Kyiv City Clinical Hospital #3
02660 Kyiv
UkraineNoch nicht rekrutierend» Google-Maps
State Institution Academy Of Medical Sciences Of Ukraine
04053 Kyiv
UkraineNoch nicht rekrutierend» Google-Maps
Lviv Regional Clinical Hospital
79000 Lviv
UkraineNoch nicht rekrutierend» Google-Maps
Odes'ka mis'ka klinichna likarnya №10
65000 Odessa
UkraineNoch nicht rekrutierend» Google-Maps
Sumy Regional Clinical Oncology Centre
40022 Sumy
UkraineNoch nicht rekrutierend» Google-Maps
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Studien-Informationen

Detailed Description:

Bladder cancer is the tenth most common malignancy worldwide. The natural history of

high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) is unpredictable; rates of recurrence

vary from 15 percent (%) to 78%, and rates of progression to muscle invasion and metastasis

vary from less than (<) 1 to 45%. The TAR-200/gemcitabine (JNJ-17000139-AAC) product

(hereafter, TAR-200) is an intravesical drug delivery system regulated as an investigational

drug. The drug constituent consists of gemcitabine minitablets, and osmotic minitablets

containing urea as the osmotic agent. Cetrelimab (JNJ-63723283) is a fully human

immunoglobulin G4 (IgG4) kappa monoclonal antibody (mAb) that binds PD-1. This study consists

3 periods: screening phase (up to 30 days); treatment phase (up to 2 years); follow up phase

(up to 5 years). Total duration of study is up to 5 years. Efficacy, safety, pharmacokinetics

(PK), and biomarkers will be assessed at specified time points during this study.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Histologically confirmed diagnosis of high-risk, non-muscle invasive urothelial

carcinoma in situ (CIS; Tis), with or without papillary disease (T1, high-grade Ta)

within 12 months of completion of adequate Bacillus Calmette-Guerin (BCG) therapy.

Mixed histology tumours are allowed if urothelial differentiation (transitional cell

histology) is predominant (example, less than (<) 20 percent (%) variant histologic

subtype). 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)

- Visible papillary disease must be fully resected (absent) prior to randomization

(residual CIS acceptable) and documented at screening cystoscopy

- 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 doses of an induction course (adequate induction) plus 2 of 3

doses of a maintenance course, or 2 of 6 doses of a second induction course

- Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2

Exclusion Criteria:

- Histologically confirmed, muscle-invasive, locally advanced, nonresectable, or

metastatic urothelial carcinoma (that is, T2, T3, T4, and/or Stage IV

- Concurrent extra-vesical (that is, urethra, ureter, or renal pelvis) non-muscle

invasive transitional cell carcinoma of the urothelium

- Participants with an active, known or suspected autoimmune disease. Participants with

autoimmune disorders not requiring systemic treatment (example, skin conditions such

as vitiligo, psoriasis, alopecia) or conditions requiring hormonal replacement

therapies such as type 1 diabetes mellitus or hypothyroidism are permitted to enroll

- Known active hepatitis B or C infection (for example, participants with history of

hepatitis C infection but normal hepatitis C virus polymerase chain reaction test and

participants with hepatitis B with positive hepatitis B surface antigen (HBsAg)

antibody 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

Studien-Rationale

Primary outcome:

1. Overall Clinical Response (CR) Rate (Time Frame - Up to 5 years):
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.



Secondary outcome:

1. Durability of Response (DOR) (Time Frame - Up to 5 years):
DOR is defined from the time of first CR achieved to first evidence of recurrence or progression or death (whichever is earlier) for participants who achieve a CR.

2. Overall Survival (OS) (Time Frame - Up to 5 years):
OS, defined as the time from first dose of study treatment to death; if a participant has not died at the time of analysis, the participant will be censored at the date last known alive.

3. Cohort 1 and 2: Concentrations of Gemcitabine and 2',2' difluorodeoxyuridine (dFdU) in Urine and Plasma (Time Frame - Up to Week 21):
Concentrations of gemcitabine and its metabolite dFdU in urine and plasma will be assessed.

4. Cohort 1 and 3: Serum Concentration of Anti-cetrelimab Antibodies (Time Frame - Predose, up to 3 years):
Serum concentration of anti-cetrelimab antibodies will be assessed using a validated immunoassay for anti-drug antibody (ADA) analysis.

5. Number of Participants with Anti-cetrelimab Antibodies (Time Frame - Predose, up to 3 years):
Number of participants with anti-cetrelimab antibodies will be reported.

6. Change from Baseline in European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ) -C30 Scores (Time Frame - Baseline, up to 3 years and 4 months):
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).

7. Change from Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores (Time Frame - Baseline, up to 3 years and 4 months):
EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with superficial (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).

8. Number of Participants with Adverse Events (AEs) by Severity Grades (Time Frame - Up to 5 years):
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity grades ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.

9. Number of Product Quality Complaints (PQC) (Time Frame - Up to 3 years and 1 month):
A PQC is defined as any suspicion of a product defect related to manufacturing, labeling, or packaging, that is, any dissatisfaction relative to the identity, quality, durability, reliability, or performance of a distributed product, including its labeling, drug delivery system, or package integrity.

Studien-Arme

  • Experimental: Cohort 1: TAR-200 and Cetrelimab
    TAR-200 is placed into the bladder through an inserter on Day 0 and will be dosed every 21 days for up to the first 24 weeks (6 months), then every 12 weeks through Week 96 (Study Year 2). In addition, Cetrelimab will be administered.
  • Experimental: Cohort 2: TAR-200
    TAR-200 is placed into the bladder through an inserter on Day 0 and will be dosed every 21 days for up to the first 24 weeks (6 months), then every 12 weeks through Week 96 (Study Year 2).
  • Experimental: Cohort 3: Cetrelimab
    Participants will receive Cetrelimab.

Geprüfte Regime

  • TAR-200 (JNJ-17000139 / Gemcitabine-Releasing Intravesical System / ):
    TAR-200 will be administered transuretherally.
  • Cetrelimab (JNJ-63723283):
    Cetrelimab will be administered.

Quelle: ClinicalTrials.gov


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