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:
13.01.2021
Wirkstoff:
PF-06801591, Bacillus Calmette-Guerin
Indikation (Clinical Trials):
Urinary Bladder Neoplasms
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
Phase 3
Sponsor:
Pfizer
Collaborator:
-
Studienleiter
Study Director
Pfizer
Kontakt
Kontakt:
Phone: 1-800-718-1021
E-Mail: ClinicalTrials.gov_Inquiries@pfizer.com» Kontaktdaten anzeigen
Studienlocations (3 von 130)
Klinikum der Goethe-Universitaet Frankfurt
60590 Frankfurt
(Hessen)
GermanyNoch nicht rekrutierend» Google-MapsUniversitaetsklinikum Tuebingen
72076 Tuebingen
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-MapsUrological Associates of Southern Arizona, P.C .
85715 Tucson
United StatesNoch nicht rekrutierend» Google-Maps
60590 Frankfurt
(Hessen)
GermanyNoch nicht rekrutierend» Google-MapsUniversitaetsklinikum Tuebingen
72076 Tuebingen
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-MapsUrological Associates of Southern Arizona, P.C .
85715 Tucson
United StatesNoch nicht rekrutierend» Google-Maps
Urological Associates of Southern Arizona P.C.
85741 Tucson
United StatesNoch nicht rekrutierend» Google-MapsUniversity of California Irvine Medical Center
92868 Orange
United StatesRekrutierend» Google-MapsUrological Research Network Corp
33016 Hialeah
United StatesRekrutierend» Google-MapsUF Health Jacksonville
32209 Jacksonville
United StatesRekrutierend» Google-MapsUF Health North
32218 Jacksonville
United StatesRekrutierend» Google-MapsJohn H. Stroger, Jr. Hospital of Cook County/IND Pharmacy
60612 Chicago
United StatesRekrutierend» Google-MapsJohn H. Stroger, Jr. Hospital of Cook County
60612 Chicago
United StatesRekrutierend» Google-MapsDuPage Medical Group
60532 Lisle
United StatesRekrutierend» Google-MapsDuPage Medical Group Ambulatory Surgery Center
60148 Lombard
United StatesRekrutierend» Google-MapsEdward Hospital
60540 Naperville
United StatesRekrutierend» Google-MapsRegional Urology Oncology & Radiation Center
71106 Shreveport
United StatesRekrutierend» Google-MapsRegional Urology, LLC
71106 Shreveport
United StatesRekrutierend» Google-MapsChesapeake Urology Research Associates
21076 Hanover
United StatesNoch nicht rekrutierend» Google-MapsMichigan Institute of Urology, PC
48084 Troy
United StatesRekrutierend» Google-MapsMontefiore Medical Center - Montefiore Medical Park
10461 Bronx
United StatesNoch nicht rekrutierend» Google-MapsMontefiore Medical Center - Oncology Investigational Services
10461 Bronx
United StatesNoch nicht rekrutierend» Google-MapsBellevue Hospital
10016 New York
United StatesNoch nicht rekrutierend» Google-MapsLaura & Isaac Perlmutter Cancer Center at NYU Langone Health
10016 New York
United StatesNoch nicht rekrutierend» Google-MapsNYU Langone Medical Center (Tisch Hospital)
10016 New York
United StatesNoch nicht rekrutierend» Google-MapsNYU Langone Health Urology Associates
10017 New York
United StatesNoch nicht rekrutierend» Google-MapsIcahn School of Medicine at Mount Sinai
10029 New York
United StatesNoch nicht rekrutierend» Google-MapsMount Sinai Hospital
10029 New York
United StatesNoch nicht rekrutierend» Google-MapsDutchess Ambulatory Surgery Center
12601 Poughkeepsie
United StatesRekrutierend» Google-MapsPremier Medical Group of the Hudson Valley PC
12603 Poughkeepsie
United StatesRekrutierend» Google-MapsAssociated Medical Professionals of New York, PLLC
13210 Syracuse
United StatesNoch nicht rekrutierend» Google-MapsCarolina Urologic Research Center
29572 Myrtle Beach
United StatesRekrutierend» Google-MapsParkway Surgery Center
29572 Myrtle Beach
United StatesRekrutierend» Google-MapsUrology Clinics of North Texas
75231 Dallas
United StatesNoch nicht rekrutierend» Google-MapsUrology Clinics of North Texas
75246 Dallas
United StatesNoch nicht rekrutierend» Google-MapsHouston Metro Urology
77027 Houston
United StatesRekrutierend» Google-MapsHouston Methodist Hospital
77030 Houston
United StatesRekrutierend» Google-MapsUrology San Antonio PA
78229 San Antonio
United StatesRekrutierend» Google-MapsSentara Norfolk General Hospital
23507 Norfolk
United StatesRekrutierend» Google-MapsUrology of Virginia, PLLC
23462 Virginia Beach
United StatesRekrutierend» Google-MapsSouthern Highlands Cancer Centre
2756 Bowral
AustraliaRekrutierend» Google-MapsBox Hill Hospital
3128 Box Hill
AustraliaNoch nicht rekrutierend» Google-MapsEastern Clinical Research Unit
3128 Box Hill
AustraliaNoch nicht rekrutierend» Google-MapsMonash Health
3168 Clayton
AustraliaNoch nicht rekrutierend» Google-MapsYarra Ranges Health
3140 Lilydale
AustraliaNoch nicht rekrutierend» Google-MapsUZ Gent
9000 Gent
BelgiumRekrutierend» Google-MapsAZ Groeninge
8500 Kortrijk
BelgiumNoch nicht rekrutierend» Google-MapsMount Sinai Hospital
M5G 1X5 Toronto
CanadaRekrutierend» Google-MapsUniversity Health Network - Princess Margaret Cancer Centre
M5G 2M9 Toronto
CanadaRekrutierend» Google-MapsUniversity Health Network - Toronto General Hospital
M5G2C4 Toronto
CanadaRekrutierend» Google-MapsBeijing Cancer Hospital
100142 Beijing
ChinaNoch nicht rekrutierend» Google-MapsNantong Tumor Hospital
226000 Nantong
ChinaNoch nicht rekrutierend» Google-MapsHôpital privé Antony (Pharmacy)
92160 Antony
FranceNoch nicht rekrutierend» Google-MapsHôpital Privé d'Antony
92160 Antony
FranceNoch nicht rekrutierend» Google-MapsClinique Belharra
64100 Bayonne
FranceRekrutierend» Google-MapsClinique Saint-Augustin
33074 BORDEAUX Cedex
FranceRekrutierend» Google-MapsInstitut Bergonié
33076 Bordeaux Cedex
FranceRekrutierend» Google-MapsCHU de Bordeaux Hôpital Pellegrin
33000 Bordeaux
FranceRekrutierend» Google-MapsGroupe Vivalto Sante - Clinique Pasteur-Lanroze- CFRO
29229 Brest Cedex 2
FranceNoch nicht rekrutierend» Google-MapsCabinet Privé d'urologie
29200 Brest
FranceNoch nicht rekrutierend» Google-MapsCHPB Keraudren
29200 Brest
FranceNoch nicht rekrutierend» Google-MapsPolyclinique de Limoges Site Chenieux
87000 Limoges
FranceRekrutierend» Google-MapsPolyclinique de Gentilly
54100 Nancy
FranceNoch nicht rekrutierend» Google-MapsHôpital Bichat - Claude-Bernard
75877 Paris
FranceRekrutierend» Google-MapsClinique Sainte Anne
67000 Strasbourg
FranceRekrutierend» Google-MapsHumanitas Istituto Clinico Catanese S.p.A - U.O. Oncologia Medica
95045 Misterobianco (CT)
ItalyRekrutierend» Google-MapsUO Oncologia, ASST di Cremona - Istituti Ospitalieri - Ospedale di Cremona
26100 Cremona
ItalyNoch nicht rekrutierend» Google-MapsIRCSS Istituto Clinico Humanitas - U.O. Oncologia Medica
20089 Rozzano
ItalyRekrutierend» Google-MapsAO Azienda Ospedaliera Ordine Mauriziano Di Torino
10128 Torino
ItalyNoch nicht rekrutierend» Google-MapsUO Oncologia Medica IRCCS Istituto Tumori "Giovanni Paolo II"
70124 Bari
ItalyRekrutierend» Google-MapsOspedale Generale Provinciale di Macerata - UOC Oncologia
62100 Macerata
ItalyRekrutierend» Google-MapsIRCCS Ospedale San Raffaele, URI (Urological Research Institute)
20132 Milan
ItalyNoch nicht rekrutierend» Google-MapsASST Sette Laghi Ospedale di Circolo Fondazione Macchi
21100 Varese
ItalyRekrutierend» Google-MapsNational Hospital Organization Shikoku Cancer Center
791-0280 Matsuyama
JapanNoch nicht rekrutierend» Google-MapsEhime University Hospital
791-0295 Toon
JapanNoch nicht rekrutierend» Google-MapsNational Hospital Organization Kyushu Cancer Center
811-1395 Fukuoka-shi
JapanRekrutierend» Google-MapsGunma Prefectural Cancer Center
373-8550 Ota
JapanNoch nicht rekrutierend» Google-MapsNational Hospital Organization Hokkaido Cancer Center
003-0804 Sapporo
JapanNoch nicht rekrutierend» Google-MapsNiigata University Medical & Dental Hospital
951-8520 Niigata-shi
JapanNoch nicht rekrutierend» Google-MapsHamamatsu University Hospital
431-3192 Hamamatsu
JapanNoch nicht rekrutierend» Google-MapsKeio University Hospital
160-8582 Shinjuku-ku
JapanRekrutierend» Google-MapsKagoshima University Hospital
890-8520 Kagoshima
JapanNoch nicht rekrutierend» Google-MapsNational Hospital Organization Kumamoto Medical Center
860-0008 Kumamoto
JapanRekrutierend» Google-MapsOkayama Medical Center
701-1192 Okayama
JapanRekrutierend» Google-MapsYamagata University Hospital
990-9585 Yamagata
JapanNoch nicht rekrutierend» Google-MapsNational Cancer Center
10408 Goyang-si
Korea, Republic ofRekrutierend» Google-MapsSeoul National University Bundang Hospital
13620 Seongnam-si
Korea, Republic ofRekrutierend» Google-MapsKyungpook National University Chilgok Hospital
41404 Daegu
Korea, Republic ofRekrutierend» Google-MapsKorea University Anam Hospital
02841 Seoul
Korea, Republic ofRekrutierend» Google-MapsSeoul National University Hospital
03080 Seoul
Korea, Republic ofRekrutierend» Google-MapsSeverance Hospital, Yonsei University Health System
03722 Seoul
Korea, Republic ofRekrutierend» Google-MapsSamsung Medical Center
06351 Seoul
Korea, Republic ofRekrutierend» Google-MapsNZOZ AKMED Andrzej Kupilas
44-100 Gliwice
PolandRekrutierend» Google-MapsRegionalny Szpital Specjalistyczny im. Dr. Wladyslawa Bieganskiego
86-300 Grudziadz
PolandNoch nicht rekrutierend» Google-MapsNiepubliczny Zaklad Opieki Zdrowotnej Centrum Urologiczne Sp. z o.o.
41-400 Mysłowice
PolandRekrutierend» Google-MapsProvita Profamilia
97-300 Piotrkow Trybunalski
PolandRekrutierend» Google-MapsClinical Research Center Spolka z ograniczona odpowiedzialnoscia MEDIC-R Sp.k.
60-848 Poznan
PolandRekrutierend» Google-MapsNiepubliczny Zakład Opieki Zdrowotnej Nr 1
84-230 Rumia
PolandNoch nicht rekrutierend» Google-MapsETG Skierniewice
96-100 Skierniewice
PolandNoch nicht rekrutierend» Google-MapsProvita 001
02-647 Warszawa
PolandRekrutierend» Google-MapsMedical Concierge Centrum Medyczne
02-798 Warszawa
PolandNoch nicht rekrutierend» Google-MapsLexmedica
53-114 Wroclaw
PolandNoch nicht rekrutierend» Google-MapsA.Tsyb Medical Research Radiological Center of the Ministry of Health of the Russian Federation
249036 Obninsk
Russian FederationRekrutierend» Google-MapsState Budgetary Institution of Healthcare of the Republic of Mordovia
430032 Saransk
Russian FederationRekrutierend» Google-MapsPrivate Medical Institution "Euromedservice"
196603 Pushkin
Russian FederationRekrutierend» Google-MapsKlinika UZI 4D, LLC
357502 Pyatigorsk
Russian FederationRekrutierend» Google-MapsState Budgetary Healthcare Institution "Leningrad Regional Clinical Oncology Dispensary"
188663 Kuzmolovsky Settlement
Russian FederationRekrutierend» Google-MapsEvimed Llc
454048 Chelyabinsk
Russian FederationRekrutierend» Google-MapsRegional Budgetary Healthcare Institution "Ivanovo Regional Oncology Dispensary"
153040 Ivanovo
Russian FederationRekrutierend» Google-MapsArs Medika Center, LLC
236006 Kaliningrad
Russian FederationNoch nicht rekrutierend» Google-MapsKaluga Regional Clinical Oncology Center
248007 Kaluga
Russian FederationRekrutierend» Google-MapsP.A. Hertsen Moscow Oncology Research Center- branch of the National Medical Research
125284 Moscow
Russian FederationRekrutierend» Google-MapsFederal Budgetary Institution of Healthcare "Privolzhsky District Medical Center of the Federal
603074 Nizhny Novgorod
Russian FederationRekrutierend» Google-MapsBHI of Omsk region "Clinical Oncological Dispensary"
644013 Omsk
Russian FederationRekrutierend» Google-MapsState Budgetary Institution of Ryazan Region "Regional Clinical Oncology Center"
390011 Ryazan
Russian FederationNoch nicht rekrutierend» Google-MapsFederal State Budgetary Healthcare Institution Saint - Petersburg
194017 Saint-Petersburg
Russian FederationNoch nicht rekrutierend» Google-MapsHospital OrKli LLC
199178 Saint-Petersburg
Russian FederationRekrutierend» Google-MapsRepublican Clinical Oncology Dispensary of the Ministry of Health of Bashkortostan Republic
450054 Ufa
Russian FederationRekrutierend» Google-MapsBudgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"
160022 Vologda
Russian FederationRekrutierend» Google-MapsSBHI YaR Regional clinical oncology hospital
150054 Yaroslavl
Russian FederationRekrutierend» Google-MapsHospital Universitari Germans Trias i Pujol
08916 Badalona
SpainRekrutierend» Google-MapsHospital General de Granollers
08402 Granollers
SpainRekrutierend» Google-MapsComplejo Hospitalario de Navarra
31008 Pamplona
SpainRekrutierend» Google-MapsHospital Universitari Sant Joan de Reus
43204 Reus
SpainNoch nicht rekrutierend» Google-MapsComplejo Hospitalario Universitario A Coruna
15006 A Coruna
SpainNoch nicht rekrutierend» Google-MapsHospital del Mar
08003 Barcelona
SpainRekrutierend» Google-MapsHospital Universitari de Girona Doctor Josep Trueta
17007 Girona
SpainNoch nicht rekrutierend» Google-MapsHospital Universitario Lucus Augusti
27003 Lugo
SpainRekrutierend» Google-MapsHospital Universitario de La Princesa
28006 Madrid
SpainNoch nicht rekrutierend» Google-MapsHospital Clínico San Carlos
28040 Madrid
SpainRekrutierend» Google-MapsFundacion Instituto Valenciano de Oncologia
46009 Valencia
SpainNoch nicht rekrutierend» Google-MapsHospital Arnau de Vilanova
46015 Valencia
SpainRekrutierend» Google-MapsBarts Health NHS Trust, St Bartholomew's Hospital
EC1A 7BE London
United KingdomRekrutierend» Google-Maps
Alle anzeigen 85741 Tucson
United StatesNoch nicht rekrutierend» Google-MapsUniversity of California Irvine Medical Center
92868 Orange
United StatesRekrutierend» Google-MapsUrological Research Network Corp
33016 Hialeah
United StatesRekrutierend» Google-MapsUF Health Jacksonville
32209 Jacksonville
United StatesRekrutierend» Google-MapsUF Health North
32218 Jacksonville
United StatesRekrutierend» Google-MapsJohn H. Stroger, Jr. Hospital of Cook County/IND Pharmacy
60612 Chicago
United StatesRekrutierend» Google-MapsJohn H. Stroger, Jr. Hospital of Cook County
60612 Chicago
United StatesRekrutierend» Google-MapsDuPage Medical Group
60532 Lisle
United StatesRekrutierend» Google-MapsDuPage Medical Group Ambulatory Surgery Center
60148 Lombard
United StatesRekrutierend» Google-MapsEdward Hospital
60540 Naperville
United StatesRekrutierend» Google-MapsRegional Urology Oncology & Radiation Center
71106 Shreveport
United StatesRekrutierend» Google-MapsRegional Urology, LLC
71106 Shreveport
United StatesRekrutierend» Google-MapsChesapeake Urology Research Associates
21076 Hanover
United StatesNoch nicht rekrutierend» Google-MapsMichigan Institute of Urology, PC
48084 Troy
United StatesRekrutierend» Google-MapsMontefiore Medical Center - Montefiore Medical Park
10461 Bronx
United StatesNoch nicht rekrutierend» Google-MapsMontefiore Medical Center - Oncology Investigational Services
10461 Bronx
United StatesNoch nicht rekrutierend» Google-MapsBellevue Hospital
10016 New York
United StatesNoch nicht rekrutierend» Google-MapsLaura & Isaac Perlmutter Cancer Center at NYU Langone Health
10016 New York
United StatesNoch nicht rekrutierend» Google-MapsNYU Langone Medical Center (Tisch Hospital)
10016 New York
United StatesNoch nicht rekrutierend» Google-MapsNYU Langone Health Urology Associates
10017 New York
United StatesNoch nicht rekrutierend» Google-MapsIcahn School of Medicine at Mount Sinai
10029 New York
United StatesNoch nicht rekrutierend» Google-MapsMount Sinai Hospital
10029 New York
United StatesNoch nicht rekrutierend» Google-MapsDutchess Ambulatory Surgery Center
12601 Poughkeepsie
United StatesRekrutierend» Google-MapsPremier Medical Group of the Hudson Valley PC
12603 Poughkeepsie
United StatesRekrutierend» Google-MapsAssociated Medical Professionals of New York, PLLC
13210 Syracuse
United StatesNoch nicht rekrutierend» Google-MapsCarolina Urologic Research Center
29572 Myrtle Beach
United StatesRekrutierend» Google-MapsParkway Surgery Center
29572 Myrtle Beach
United StatesRekrutierend» Google-MapsUrology Clinics of North Texas
75231 Dallas
United StatesNoch nicht rekrutierend» Google-MapsUrology Clinics of North Texas
75246 Dallas
United StatesNoch nicht rekrutierend» Google-MapsHouston Metro Urology
77027 Houston
United StatesRekrutierend» Google-MapsHouston Methodist Hospital
77030 Houston
United StatesRekrutierend» Google-MapsUrology San Antonio PA
78229 San Antonio
United StatesRekrutierend» Google-MapsSentara Norfolk General Hospital
23507 Norfolk
United StatesRekrutierend» Google-MapsUrology of Virginia, PLLC
23462 Virginia Beach
United StatesRekrutierend» Google-MapsSouthern Highlands Cancer Centre
2756 Bowral
AustraliaRekrutierend» Google-MapsBox Hill Hospital
3128 Box Hill
AustraliaNoch nicht rekrutierend» Google-MapsEastern Clinical Research Unit
3128 Box Hill
AustraliaNoch nicht rekrutierend» Google-MapsMonash Health
3168 Clayton
AustraliaNoch nicht rekrutierend» Google-MapsYarra Ranges Health
3140 Lilydale
AustraliaNoch nicht rekrutierend» Google-MapsUZ Gent
9000 Gent
BelgiumRekrutierend» Google-MapsAZ Groeninge
8500 Kortrijk
BelgiumNoch nicht rekrutierend» Google-MapsMount Sinai Hospital
M5G 1X5 Toronto
CanadaRekrutierend» Google-MapsUniversity Health Network - Princess Margaret Cancer Centre
M5G 2M9 Toronto
CanadaRekrutierend» Google-MapsUniversity Health Network - Toronto General Hospital
M5G2C4 Toronto
CanadaRekrutierend» Google-MapsBeijing Cancer Hospital
100142 Beijing
ChinaNoch nicht rekrutierend» Google-MapsNantong Tumor Hospital
226000 Nantong
ChinaNoch nicht rekrutierend» Google-MapsHôpital privé Antony (Pharmacy)
92160 Antony
FranceNoch nicht rekrutierend» Google-MapsHôpital Privé d'Antony
92160 Antony
FranceNoch nicht rekrutierend» Google-MapsClinique Belharra
64100 Bayonne
FranceRekrutierend» Google-MapsClinique Saint-Augustin
33074 BORDEAUX Cedex
FranceRekrutierend» Google-MapsInstitut Bergonié
33076 Bordeaux Cedex
FranceRekrutierend» Google-MapsCHU de Bordeaux Hôpital Pellegrin
33000 Bordeaux
FranceRekrutierend» Google-MapsGroupe Vivalto Sante - Clinique Pasteur-Lanroze- CFRO
29229 Brest Cedex 2
FranceNoch nicht rekrutierend» Google-MapsCabinet Privé d'urologie
29200 Brest
FranceNoch nicht rekrutierend» Google-MapsCHPB Keraudren
29200 Brest
FranceNoch nicht rekrutierend» Google-MapsPolyclinique de Limoges Site Chenieux
87000 Limoges
FranceRekrutierend» Google-MapsPolyclinique de Gentilly
54100 Nancy
FranceNoch nicht rekrutierend» Google-MapsHôpital Bichat - Claude-Bernard
75877 Paris
FranceRekrutierend» Google-MapsClinique Sainte Anne
67000 Strasbourg
FranceRekrutierend» Google-MapsHumanitas Istituto Clinico Catanese S.p.A - U.O. Oncologia Medica
95045 Misterobianco (CT)
ItalyRekrutierend» Google-MapsUO Oncologia, ASST di Cremona - Istituti Ospitalieri - Ospedale di Cremona
26100 Cremona
ItalyNoch nicht rekrutierend» Google-MapsIRCSS Istituto Clinico Humanitas - U.O. Oncologia Medica
20089 Rozzano
ItalyRekrutierend» Google-MapsAO Azienda Ospedaliera Ordine Mauriziano Di Torino
10128 Torino
ItalyNoch nicht rekrutierend» Google-MapsUO Oncologia Medica IRCCS Istituto Tumori "Giovanni Paolo II"
70124 Bari
ItalyRekrutierend» Google-MapsOspedale Generale Provinciale di Macerata - UOC Oncologia
62100 Macerata
ItalyRekrutierend» Google-MapsIRCCS Ospedale San Raffaele, URI (Urological Research Institute)
20132 Milan
ItalyNoch nicht rekrutierend» Google-MapsASST Sette Laghi Ospedale di Circolo Fondazione Macchi
21100 Varese
ItalyRekrutierend» Google-MapsNational Hospital Organization Shikoku Cancer Center
791-0280 Matsuyama
JapanNoch nicht rekrutierend» Google-MapsEhime University Hospital
791-0295 Toon
JapanNoch nicht rekrutierend» Google-MapsNational Hospital Organization Kyushu Cancer Center
811-1395 Fukuoka-shi
JapanRekrutierend» Google-MapsGunma Prefectural Cancer Center
373-8550 Ota
JapanNoch nicht rekrutierend» Google-MapsNational Hospital Organization Hokkaido Cancer Center
003-0804 Sapporo
JapanNoch nicht rekrutierend» Google-MapsNiigata University Medical & Dental Hospital
951-8520 Niigata-shi
JapanNoch nicht rekrutierend» Google-MapsHamamatsu University Hospital
431-3192 Hamamatsu
JapanNoch nicht rekrutierend» Google-MapsKeio University Hospital
160-8582 Shinjuku-ku
JapanRekrutierend» Google-MapsKagoshima University Hospital
890-8520 Kagoshima
JapanNoch nicht rekrutierend» Google-MapsNational Hospital Organization Kumamoto Medical Center
860-0008 Kumamoto
JapanRekrutierend» Google-MapsOkayama Medical Center
701-1192 Okayama
JapanRekrutierend» Google-MapsYamagata University Hospital
990-9585 Yamagata
JapanNoch nicht rekrutierend» Google-MapsNational Cancer Center
10408 Goyang-si
Korea, Republic ofRekrutierend» Google-MapsSeoul National University Bundang Hospital
13620 Seongnam-si
Korea, Republic ofRekrutierend» Google-MapsKyungpook National University Chilgok Hospital
41404 Daegu
Korea, Republic ofRekrutierend» Google-MapsKorea University Anam Hospital
02841 Seoul
Korea, Republic ofRekrutierend» Google-MapsSeoul National University Hospital
03080 Seoul
Korea, Republic ofRekrutierend» Google-MapsSeverance Hospital, Yonsei University Health System
03722 Seoul
Korea, Republic ofRekrutierend» Google-MapsSamsung Medical Center
06351 Seoul
Korea, Republic ofRekrutierend» Google-MapsNZOZ AKMED Andrzej Kupilas
44-100 Gliwice
PolandRekrutierend» Google-MapsRegionalny Szpital Specjalistyczny im. Dr. Wladyslawa Bieganskiego
86-300 Grudziadz
PolandNoch nicht rekrutierend» Google-MapsNiepubliczny Zaklad Opieki Zdrowotnej Centrum Urologiczne Sp. z o.o.
41-400 Mysłowice
PolandRekrutierend» Google-MapsProvita Profamilia
97-300 Piotrkow Trybunalski
PolandRekrutierend» Google-MapsClinical Research Center Spolka z ograniczona odpowiedzialnoscia MEDIC-R Sp.k.
60-848 Poznan
PolandRekrutierend» Google-MapsNiepubliczny Zakład Opieki Zdrowotnej Nr 1
84-230 Rumia
PolandNoch nicht rekrutierend» Google-MapsETG Skierniewice
96-100 Skierniewice
PolandNoch nicht rekrutierend» Google-MapsProvita 001
02-647 Warszawa
PolandRekrutierend» Google-MapsMedical Concierge Centrum Medyczne
02-798 Warszawa
PolandNoch nicht rekrutierend» Google-MapsLexmedica
53-114 Wroclaw
PolandNoch nicht rekrutierend» Google-MapsA.Tsyb Medical Research Radiological Center of the Ministry of Health of the Russian Federation
249036 Obninsk
Russian FederationRekrutierend» Google-MapsState Budgetary Institution of Healthcare of the Republic of Mordovia
430032 Saransk
Russian FederationRekrutierend» Google-MapsPrivate Medical Institution "Euromedservice"
196603 Pushkin
Russian FederationRekrutierend» Google-MapsKlinika UZI 4D, LLC
357502 Pyatigorsk
Russian FederationRekrutierend» Google-MapsState Budgetary Healthcare Institution "Leningrad Regional Clinical Oncology Dispensary"
188663 Kuzmolovsky Settlement
Russian FederationRekrutierend» Google-MapsEvimed Llc
454048 Chelyabinsk
Russian FederationRekrutierend» Google-MapsRegional Budgetary Healthcare Institution "Ivanovo Regional Oncology Dispensary"
153040 Ivanovo
Russian FederationRekrutierend» Google-MapsArs Medika Center, LLC
236006 Kaliningrad
Russian FederationNoch nicht rekrutierend» Google-MapsKaluga Regional Clinical Oncology Center
248007 Kaluga
Russian FederationRekrutierend» Google-MapsP.A. Hertsen Moscow Oncology Research Center- branch of the National Medical Research
125284 Moscow
Russian FederationRekrutierend» Google-MapsFederal Budgetary Institution of Healthcare "Privolzhsky District Medical Center of the Federal
603074 Nizhny Novgorod
Russian FederationRekrutierend» Google-MapsBHI of Omsk region "Clinical Oncological Dispensary"
644013 Omsk
Russian FederationRekrutierend» Google-MapsState Budgetary Institution of Ryazan Region "Regional Clinical Oncology Center"
390011 Ryazan
Russian FederationNoch nicht rekrutierend» Google-MapsFederal State Budgetary Healthcare Institution Saint - Petersburg
194017 Saint-Petersburg
Russian FederationNoch nicht rekrutierend» Google-MapsHospital OrKli LLC
199178 Saint-Petersburg
Russian FederationRekrutierend» Google-MapsRepublican Clinical Oncology Dispensary of the Ministry of Health of Bashkortostan Republic
450054 Ufa
Russian FederationRekrutierend» Google-MapsBudgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"
160022 Vologda
Russian FederationRekrutierend» Google-MapsSBHI YaR Regional clinical oncology hospital
150054 Yaroslavl
Russian FederationRekrutierend» Google-MapsHospital Universitari Germans Trias i Pujol
08916 Badalona
SpainRekrutierend» Google-MapsHospital General de Granollers
08402 Granollers
SpainRekrutierend» Google-MapsComplejo Hospitalario de Navarra
31008 Pamplona
SpainRekrutierend» Google-MapsHospital Universitari Sant Joan de Reus
43204 Reus
SpainNoch nicht rekrutierend» Google-MapsComplejo Hospitalario Universitario A Coruna
15006 A Coruna
SpainNoch nicht rekrutierend» Google-MapsHospital del Mar
08003 Barcelona
SpainRekrutierend» Google-MapsHospital Universitari de Girona Doctor Josep Trueta
17007 Girona
SpainNoch nicht rekrutierend» Google-MapsHospital Universitario Lucus Augusti
27003 Lugo
SpainRekrutierend» Google-MapsHospital Universitario de La Princesa
28006 Madrid
SpainNoch nicht rekrutierend» Google-MapsHospital Clínico San Carlos
28040 Madrid
SpainRekrutierend» Google-MapsFundacion Instituto Valenciano de Oncologia
46009 Valencia
SpainNoch nicht rekrutierend» Google-MapsHospital Arnau de Vilanova
46015 Valencia
SpainRekrutierend» Google-MapsBarts Health NHS Trust, St Bartholomew's Hospital
EC1A 7BE London
United KingdomRekrutierend» Google-Maps
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