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JOURNAL ONKOLOGIE – STUDIE
CREST

Study of Sasanlimab (PF-06801591) in Combination With Bacillus Calmette-Guerin (BCG) in Participants With High-Risk Non-Muscle Invasive Bladder Cancer

Rekrutierend

NCT-Nummer:
NCT04165317

Studienbeginn:
Dezember 2019

Letztes Update:
30.07.2021

Wirkstoff:
PF-06801591, Bacillus Calmette-Guerin

Indikation (Clinical Trials):
Urinary Bladder Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Pfizer

Collaborator:
-

Studienleiter

Pfizer CT.gov Call Center
Study Director
Pfizer

Kontakt

Pfizer CT.gov Call Center
Kontakt:
Phone: 1-800-718-1021
E-Mail: ClinicalTrials.gov_Inquiries@pfizer.com
» Kontaktdaten anzeigen

Studienlocations
(3 von 205)

Urologicum Duisburg
47179 Duisburg
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Klinikum der Goethe-Universitaet Frankfurt
60590 Frankfurt
(Hessen)
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Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
55131 Mainz
(Rheinland-Pfalz)
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Universitaetsklinikum Muenster, Urologie
48149 Muenster
(Nordrhein-Westfalen)
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Studienpraxis Urologie
72622 Nuertingen
(Baden-Württemberg)
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Universitaetsklinikum Tuebingen
72076 Tuebingen
(Baden-Württemberg)
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Urological Associates of Southern Arizona, P.C .
85715 Tucson
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Urological Associates of Southern Arizona P.C.
85741 Tucson
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Centerview Surgery Center
72211 Little Rock
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Koman Family Outpatient Pavilion
92037 La Jolla
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Sulpizio Cardiovascular Center at UC San Diego Health
92037 La Jolla
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UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
92037 La Jolla
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UC San Diego Moores Cancer Center
92093 La Jolla
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University of California Irvine Medical Center
92868 Orange
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UC San Diego Medical Center - Hillcrest
92103 San Diego
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The Urology Center of Colorado
80211 Denver
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Urological Research Network Corp
33016 Hialeah
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UF Health Jacksonville
32209 Jacksonville
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Florida Urology Partners, LLP
33578 Riverview
United StatesNoch nicht rekrutierend» Google-Maps
Florida Urology Partners, LLP
33606 Tampa
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John H. Stroger, Jr. Hospital of Cook County/IND Pharmacy
60612 Chicago
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John H. Stroger, Jr. Hospital of Cook County
60612 Chicago
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DuPage Medical Group Ambulatory Surgery Center
60148 Lombard
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Regional Urology Oncology & Radiation Center
71106 Shreveport
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Regional Urology, LLC
71106 Shreveport
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Chesapeake Urology Research Associates
21076 Hanover
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Michigan Institute of Urology, PC
48084 Troy
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Pharmacy Address: University of Minnesota Medical Center, Fairview IDS Pharmacy
55455 Minneapolis
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University of Minnesota Health: Clinics and Surgery Center
55455 Minneapolis
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University of Minnesota Medical Center, Fairview
55455 Minneapolis
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University of Missouri - Ellis Fischel Cancer Center
65212 Columbia
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Montefiore Medical Center - Montefiore Medical Park
10461 Bronx
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Montefiore Medical Center - Oncology Investigational Services
10461 Bronx
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Premier Medical Group of the Hudson Valley PC
12553 New Windsor
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Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
10016 New York
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NYU Langone Medical Center (Tisch Hospital)
10016 New York
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NYU Langone Health Urology Associates
10017 New York
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Icahn School of Medicine at Mount Sinai
10029 New York
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Dutchess Ambulatory Surgery Center
12601 Poughkeepsie
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Premier Medical Group of the Hudson Valley PC
12603 Poughkeepsie
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Associated Medical Professionals of New York, PLLC
13210 Syracuse
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Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
44195 Cleveland
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Cleveland Clinic
44195 Cleveland
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VA Portland Healthcare System
97239 Portland
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UPMC Urology
15232 Pittsburgh
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Carolina Urologic Research Center
29572 Myrtle Beach
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Parkway Surgery Center
29572 Myrtle Beach
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Urology Clinics of North Texas
75231 Dallas
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75246 Dallas
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Houston Methodist Hospital
77030 Houston
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Urology San Antonio PA
78229 San Antonio
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Sentara Norfolk General Hospital
23507 Norfolk
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Urology of Virginia, PLLC
23462 Virginia Beach
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Southern Highlands Cancer Centre
2756 Bowral
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Campbelltown Private Hospital
2560 Campbelltown
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Box Hill Hospital
3128 Box Hill
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Eastern Clinical Research Unit
3128 Box Hill
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Yarra Ranges Health
3140 Lilydale
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Hamilton Regional Laboratory Medicine Program
L8N 4A6 Hamilton
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McMaster Institute of Urology/St Joseph's Healthcare Hamilton
L8N 4A6 Hamilton
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Kingston Health Sciences Centre - Kingston General Hospital
K7L 2V7 Kingston
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Centre for Applied Urological Research
K7L 3J7 Kingston
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Kingston Health Sciences Centre -- Hotel Dieu Hospital
K7L 5G2 Kingston
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University Health Network - Princess Margaret Cancer Centre
M5G 2M9 Toronto
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University Health Network - Toronto General Hospital
M5G2C4 Toronto
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Centre intégré universitaire de santé et de services sociaux du Saguenay-Lac-Saint-Jean
G7H 5H6 Chicoutimi
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Jewish General Hospital
H3T 1E2 Montreal
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McGill University Health Centre
H4A 3J1 Montreal
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Hotel-Dieu de Quebec - CHU de Quebec - Universite Laval
G1R 2J6 Quebec
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Centre de recherche clinique et evaluative en oncologie (CRCEO)
G1R 3S1 Quebec
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The First Affiliated Hospital of Anhui Medical University
230022 Hefei
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Peking University First Hospital
100034 Beijing
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Peking University Third Hospital
100191 Beijing
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Peking Union Medical College Hospital
100730 Beijing
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Fujian Medical University Affiliated First Hospital
350005 Fuzhou
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
430022 Wuhan
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Second Affiliated Hospital of Suzhou University
215004 Suzhou
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The First Affiliated Hospital of Nanchang University
330006 Nanchang
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First Affiliated Hospital of Xi 'an Jiaotong University
710061 Xi'an
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Yantai Yu Huang Ding Hospital
264000 Yantai
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West China Hospital of Sichuan University
610041 Chengdu
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Zhejiang Provincial People's Hospital
310014 Hangzhou
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The First Affiliated Hospital of Wenzhou Medical University
325000 Wenzhou
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The First Affiliated Hospital of Wenzhou Medical University
325035 Wenzhou
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Chongqing University Cancer Hospital
400030 Chongqing
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Fudan University Cancer Hospital
200032 Shanghai
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The Second Hospital of Tianjin Medical University
300211 Tianjin
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Hôpital privé Antony (Pharmacy)
92160 Antony
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Clinique Saint-Augustin
33074 BORDEAUX Cedex
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CHU de Bordeaux Hôpital Pellegrin
33000 Bordeaux
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Groupe Vivalto Sante - Clinique Pasteur-Lanroze- CFRO
29229 Brest Cedex 2
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Pôle Santé République
63100 Clermont-Ferrand
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Centre d'oncologie Bourgogne
59000 Lille
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Polyclinique de Limoges Site Emailleurs-Colombier
87038 Limoges Cedex 1
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Polyclinique de Limoges Site Chenieux
87000 Limoges
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Hôpital Bichat - Claude-Bernard
75877 Paris
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Humanitas Istituto Clinico Catanese S.p.A - U.O. Oncologia Medica
95045 Misterobianco (CT)
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UO Oncologia, ASST di Cremona - Istituti Ospitalieri - Ospedale di Cremona
26100 Cremona
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IRCSS Istituto Clinico Humanitas - U.O. Oncologia Medica
20089 Rozzano
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AO Azienda Ospedaliera Ordine Mauriziano Di Torino
10128 Torino
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Ospedale Area Aretina Nord - UOC Oncologia Medica
52100 Arezzo
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UO Oncologia Medica IRCCS Istituto Tumori "Giovanni Paolo II"
70124 Bari
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IRCCS Azienda Ospedaliera Universitaria Policlinico San Martino Urologia
16132 Genova
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Ospedale Generale Provinciale di Macerata - UOC Oncologia
62100 Macerata
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Medical Oncology Unit, AO Papardo
98158 Messina
ItalyNoch nicht rekrutierend» Google-Maps
IRCCS Ospedale San Raffaele, URI (Urological Research Institute)
20132 Milan
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AUSL/IRCCS di Reggio Emilia
42123 Reggio Emilia
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ASST Sette Laghi Ospedale di Circolo Fondazione Macchi
21100 Varese
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National Hospital Organization Shikoku Cancer Center
791-0280 Matsuyama
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National Hospital Organization Kyushu Cancer Center
811-1395 Fukuoka-shi
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Gunma Prefectural Cancer Center
373-8550 Ota
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National Hospital Organization Hokkaido Cancer Center
003-0804 Sapporo
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Niigata University Medical & Dental Hospital
951-8520 Niigata-shi
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Osaka International Cancer Institute
541-8567 Osaka-shi
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Kindai University Hospital
589-8511 Osakasayama
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Hamamatsu University Hospital
431-3192 Hamamatsu
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Keio University Hospital
160-8582 Shinjuku-ku
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Kagoshima University Hospital
890-8520 Kagoshima
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National Hospital Organization Kumamoto Medical Center
860-0008 Kumamoto
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Yamagata University Hospital
990-9585 Yamagata
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National Cancer Center
10408 Goyang-si
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Seoul National University Bundang Hospital
13620 Seongnam-si
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Kyungpook National University Chilgok Hospital
41404 Daegu
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Korea University Anam Hospital
02841 Seoul
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Seoul National University Hospital
03080 Seoul
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Severance Hospital, Yonsei University Health System
03722 Seoul
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Samsung Medical Center
06351 Seoul
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Regionalny Szpital Specjalistyczny im. Dr. Wladyslawa Bieganskiego
86-300 Grudziadz
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Niepubliczny Zaklad Opieki Zdrowotnej Centrum Urologiczne Sp. z o.o.
41-400 Mysłowice
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Provita Profamilia
97-300 Piotrkow Trybunalski
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Clinical Research Center Spolka z ograniczona odpowiedzialnoscia MEDIC-R Spolka Komandytowa
60-848 Poznan
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Niepubliczny Zakład Opieki Zdrowotnej Nr 1
84-230 Rumia
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Medical Concierge Centrum Medyczne
02-798 Warszawa
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A.Tsyb Medical Research Radiological Center of the Ministry of Health of the Russian Federation
249036 Obninsk
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State Budgetary Institution of Healthcare of the Republic of Mordovia
430032 Saransk
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Private Medical Institution "Euromedservice"
196603 Pushkin
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Klinika UZI 4D, LLC
357502 Pyatigorsk
Russian FederationRekrutierend» Google-Maps
State Budgetary Healthcare Institution "Leningrad Regional Clinical Oncology Dispensary"
188663 Kuzmolovsky Settlement
Russian FederationRekrutierend» Google-Maps
Regional Budgetary Healthcare Institution "Ivanovo Regional Oncology Dispensary"
153040 Ivanovo
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Ars Medika Center, LLC
236006 Kaliningrad
Russian FederationRekrutierend» Google-Maps
Kaluga Regional Clinical Oncology Center
248007 Kaluga
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P.A. Hertsen Moscow Oncology Research Center- branch of the National Medical Research
125284 Moscow
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Federal Budgetary Institution of Healthcare "Privolzhsky District Medical Center of the Federal
603074 Nizhny Novgorod
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BHI of Omsk region "Clinical Oncological Dispensary"
644013 Omsk
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State Budgetary Institution of Ryazan Region "Regional Clinical Oncology Center"
390011 Ryazan
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Joint-Stock Company "North-Western Centre of Evidence-Based Medicine" ("NWCoEBM" JSC)
194355 Saint Petersburg
Russian FederationRekrutierend» Google-Maps
Federal State Budgetary Healthcare Institution Saint - Petersburg
194017 Saint-Petersburg
Russian FederationRekrutierend» Google-Maps
Hospital OrKli LLC
199178 Saint-Petersburg
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Republican Clinical Oncology Dispensary of the Ministry of Health of Bashkortostan Republic
450054 Ufa
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Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"
160022 Vologda
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SBHI YaR Regional clinical oncology hospital
150054 Yaroslavl
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Hospital Universitari Germans Trias i Pujol
08916 Badalona
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Hospital General de Granollers
08402 Granollers
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Hospital Universitari de Bellvitge
08907 L'Hospitalet de Llobregat
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Hospital Duran i Reynals- ICO L'Hospitalet
08908 L'Hospitalet de Llobregat
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Hospital Universitario Puerta de Hierro Majadahonda
28222 Majadahonda
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Complejo Hospitalario de Navarra
31008 Pamplona
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Hospital Universitari Sant Joan de Reus
43204 Reus
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Complejo Hospitalario Universitario A Coruna
15006 A Coruna
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Hospital de la Santa Creu i Sant Pau
08041 Barcelona
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Hospital San Pedro de Alcantara
10003 Caceres
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Hospital Universitari de Girona Doctor Josep Trueta
17007 Girona
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Hospital Universitario Lucus Augusti
27003 Lugo
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Hospital Universitario de La Princesa
28006 Madrid
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Hospital Universitario La Princesa
28006 Madrid
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Hospital Universitario 12 de Octubre
28041 Madrid
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Fundacion Instituto Valenciano de Oncologia
46009 Valencia
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Barts Health NHS Trust, St Bartholomew's Hospital
EC1A 7BE London
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Charing Cross Hospital
W6 8RF London
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Alle anzeigen

Studien-Informationen

Brief Summary:

CREST: Combination of sasanlimab and alternative BCG Regimens to Evaluate outcomes with

Subcutaneous anti-PD-1 Treatment

Phase 3 Design with 3 study Arms (A, B and C). Arms A and B consists of two study drugs,

PF-06801591 plus BCG. Arm C consists of one study drug, BCG.

The study is designed to demonstrate that PF-06801591 plus Bacillus Calmette Guerin (BCG)

(induction and maintenance periods) is superior to BCG alone (induction and maintenance

periods) in prolonging event free survival (EFS) in participants with high-risk naïve

non-muscle invasive bladder cancer (NMIBC) and to demonstrate that PF-06801591 plus BCG

(induction period only) is superior to BCG alone (induction and maintenance periods) in

prolonging EFS in participants with high-risk NMIBC.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Histological confirmed diagnosis of high risk non-muscle invasive transitional cell

carcinoma (TCC) of the urothelium of the urinary bladder (tumors of mixed

transitional/non-transitional cell histology are allowed, but TCC must be the

predominant histology)

- Complete resection of all Ta/T1 papillary disease (including participants with

concurrent CIS), with most recent TURBT occurring within 12 weeks prior to

randomization. A second TURBT must have been performed if indicated according to the

current locally applicable guidelines, ie, American Urological Association, European

Association of Urology

Exclusion Criteria:

- Evidence of muscle-invasive, locally advanced or metastatic urothelial cancer or

concurrent extravesical, non-muscle invasive TCC of the urothelium

- Intravesical BCG therapy within 2 years prior to randomization. Prior intravesical

chemotherapy for NMIBC is allowed

- Prior immunotherapy with anti PD-1, anti PD-L1, anti PD-L2, or anti cytotoxic

T-lymphocyte-associated antigen-4 (CTLA-4) antibody

- Prior treatment with immunostimulatory agents including interleukin (IL)-2, IL-15,

interferon (INF)

- Prior radiation therapy to the bladder

Studien-Rationale

Primary outcome:

1. Event free survival (Arm A compared to Arm C) (Time Frame - Randomization up to 55 months):
Event free survival is defined as the time from randomization to date of EFS event.

2. Event free survival (Arm B compared to Arm C) (Time Frame - Randomization up to 55 months):
Event free survival is defined as the time from randomization to date of EFS event.

Secondary outcome:

1. Overall Survival (Arm A compared to Arm C) (Time Frame - Randomization up to 60 months from last participant randomized):
Overall survival is defined as the time from the date of randomization to the date of death due to any cause.

2. Overall Survival (Arm B compared to Arm C) (Time Frame - Randomization up to 60 months from last participant randomized):
Overall survival is defined as the time from the date of randomization to the date of death due to any cause.

3. Complete response in participants with CIS at randomization (Time Frame - Randomization up to 60 months from last participant randomized):
Number of CIS participants with complete response.

4. Disease-specific survival (Time Frame - Randomization up to 60 months from last participant randomized):
Disease specific survival (DSS) is defined as the time from randomization to death resulting from bladder cancer.

5. Health-related quality of life as measured by EORTC QLQ-C30 (European Organization for Treatment of Cancer Quality of Life Questionnaire for cancer patients) (Time Frame - Randomization up to 60 months from last participant randomized):
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties).

6. ctrough of PF-06801591 when in combination with BCG (induction and maintenance or induction). Arms A and B only. (Time Frame - Randomization up to 24 months):
Ctrough will be summarized in Arms A and B only.

7. Incidence of ADA/Nab of PF-06801591 when in combination with BCG (induction and maintenance or induction). Arms A and B only. (Time Frame - Randomization up to 24 months):
Immunogenicity will be evaluated for Arms A and B only.

8. Tumor sample biomarker status based on PD-L1 expression (high or low) (Time Frame - Baseline):
Evaluate PD-L1 expression.

9. Duration of CR for participants with CIS at randomization (Time Frame - Randomization up to 60 months from last participant randomized):
Duration of CR is defined as time from first CR to first recurrence or death due to any cause, whichever occurs first.

10. Time to recurrence of low grade disease (Time Frame - Randomization up to 60 months from last participant randomized):
Time to recurrence defined as time from randomization to the date of first documentation of recurrence of low grade disease or death due to any cause, whichever occurs first.

11. Time to cystectomy (Time Frame - Randomization to date of cystectomy (up to 5 years after last participant is randomized)):
Time to cystectomy is defined as time from randomization to cystectomy in participants with NMIBC

12. Health-related quality of life as measured by PTAB (Patient Treatment Administration Burden Questionnaire) (Time Frame - Randomization up to 24 months):
PTAB is a 2-item PRO designed to assess, from the patient perspective, any pain associated with the treatment administration and the burden of the amount of time required to complete the treatment administration procedures (1 item each).

13. Percentage of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs (Time Frame - Baseline up to 60 months from the last participant randomized):
An adverse event (AE) is any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. Causality assessment is made by the investigator. Grading is per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) version 3.0.

14. Percentage of Participants With Laboratory Abnormalities (Time Frame - Baseline up to 60 months from last participant randomized):
Percentage of participants with laboratory test abnormalities without regard to baseline abnormality. Grading is per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) version 3.0.

15. Health-related quality of life as measured by EORTC QLQ-NMIBC24 (European Organization for Treatment of Cancer in patients with non-muscle invasion bladder cancer) (Time Frame - Randomization up to 60 months from the last participant randomized):
EORTC-QLQ-NMIBC24 has 24 items which can be grouped into 6 subscales: urinary symptoms (7 items), malaise (2 items), future worries (4 items), bloating/flatulence (2 items), sexual functioning (2 items), and male sexual issues (2 items). The NMIBC24 also assesses intravesical treatment, female sexual issues, sexual intimacy, risk of contaminating a partner, and sexual enjoyment (1 item each).

Studien-Arme

  • Experimental: PF-06801591 + BCG induction and maintenance
    PF-06801591 in combination with Bacillus Calmette Guerin(induction+maintenance).
  • Experimental: PF-06801591 + BCG induction only
    PF-06801591 in combination with Bacillus Calmette Guerin (induction only).
  • Active Comparator: BCG induction and maintenance
    Bacillus Calmette Guerin (induction and maintenance).

Geprüfte Regime

  • PF-06801591 (Sasanlimab):
    A monoclonal antibody (mAb) that blocks the interaction between PD-1 and PD-L1/PD-L2.
  • Bacillus Calmette-Guerin (BCG):
    Immunotherapy treatment approved by FDA for patients with high-risk non-muscle invasive bladder cancer

Quelle: ClinicalTrials.gov


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