JOURNAL ONKOLOGIE – STUDIE
CREST
Pfizer CT.gov Call Center
Study Director
Pfizer
Pfizer CT.gov Call Center
Kontakt:
Phone: 1-800-718-1021
E-Mail: ClinicalTrials.gov_Inquiries@pfizer.com» Kontaktdaten anzeigen
Studienlocations
Urologicum Duisburg
47179 Duisburg
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps Klinikum der Goethe-Universitaet Frankfurt
60590 Frankfurt
(Hessen)
GermanyRekrutierend» Google-Maps Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
55131 Mainz
(Rheinland-Pfalz)
GermanyNoch nicht rekrutierend» Google-Maps Universitaetsklinikum Muenster, Urologie
48149 Muenster
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps Studienpraxis Urologie
72622 Nuertingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps Universitaetsklinikum Tuebingen
72076 Tuebingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps Urological Associates of Southern Arizona, P.C .
85715 Tucson
United StatesRekrutierend» Google-Maps Urological Associates of Southern Arizona P.C.
85741 Tucson
United StatesRekrutierend» Google-Maps Arkansas Urology
72211 Little Rock
United StatesRekrutierend» Google-Maps Centerview Surgery Center
72211 Little Rock
United StatesRekrutierend» Google-Maps Koman Family Outpatient Pavilion
92037 La Jolla
United StatesRekrutierend» Google-Maps Sulpizio Cardiovascular Center at UC San Diego Health
92037 La Jolla
United StatesRekrutierend» Google-Maps UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
92037 La Jolla
United StatesRekrutierend» Google-Maps UC San Diego Moores Cancer Center
92093 La Jolla
United StatesRekrutierend» Google-Maps University of California Irvine Medical Center
92868 Orange
United StatesRekrutierend» Google-Maps UC San Diego Medical Center - Hillcrest
92103 San Diego
United StatesRekrutierend» Google-Maps The Urology Center of Colorado
80211 Denver
United StatesRekrutierend» Google-Maps Urological Research Network Corp
33016 Hialeah
United StatesRekrutierend» Google-Maps UF Health Jacksonville
32209 Jacksonville
United StatesRekrutierend» Google-Maps UF Health North
32218 Jacksonville
United StatesRekrutierend» Google-Maps Florida Urology Partners, LLP
33578 Riverview
United StatesNoch nicht rekrutierend» Google-Maps Florida Urology Partners, LLP
33606 Tampa
United StatesNoch nicht rekrutierend» Google-Maps John H. Stroger, Jr. Hospital of Cook County/IND Pharmacy
60612 Chicago
United StatesRekrutierend» Google-Maps John H. Stroger, Jr. Hospital of Cook County
60612 Chicago
United StatesRekrutierend» Google-Maps DuPage Medical Group
60532 Lisle
United StatesRekrutierend» Google-Maps DuPage Medical Group Ambulatory Surgery Center
60148 Lombard
United StatesRekrutierend» Google-Maps DuPage Medical Group
60148 Lombard
United StatesRekrutierend» Google-Maps Edward Hospital
60540 Naperville
United StatesRekrutierend» Google-Maps Regional Urology Oncology & Radiation Center
71106 Shreveport
United StatesRekrutierend» Google-Maps Regional Urology, LLC
71106 Shreveport
United StatesRekrutierend» Google-Maps Chesapeake Urology Research Associates
21076 Hanover
United StatesRekrutierend» Google-Maps Michigan Institute of Urology, PC
48084 Troy
United StatesRekrutierend» Google-Maps Pharmacy Address: University of Minnesota Medical Center, Fairview IDS Pharmacy
55455 Minneapolis
United StatesNoch nicht rekrutierend» Google-Maps University of Minnesota Health: Clinics and Surgery Center
55455 Minneapolis
United StatesNoch nicht rekrutierend» Google-Maps University of Minnesota Medical Center, Fairview
55455 Minneapolis
United StatesNoch nicht rekrutierend» Google-Maps University of Missouri - Ellis Fischel Cancer Center
65212 Columbia
United StatesNoch nicht rekrutierend» Google-Maps Montefiore Medical Center - Montefiore Medical Park
10461 Bronx
United StatesRekrutierend» Google-Maps Montefiore Medical Center - Oncology Investigational Services
10461 Bronx
United StatesRekrutierend» Google-Maps Premier Medical Group of the Hudson Valley PC
12553 New Windsor
United StatesRekrutierend» Google-Maps Bellevue Hospital
10016 New York
United StatesRekrutierend» Google-Maps Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
10016 New York
United StatesRekrutierend» Google-Maps NYU Langone Medical Center (Tisch Hospital)
10016 New York
United StatesRekrutierend» Google-Maps NYU Langone Health Urology Associates
10017 New York
United StatesRekrutierend» Google-Maps Icahn School of Medicine at Mount Sinai
10029 New York
United StatesRekrutierend» Google-Maps Mount Sinai Hospital
10029 New York
United StatesRekrutierend» Google-Maps Dutchess Ambulatory Surgery Center
12601 Poughkeepsie
United StatesRekrutierend» Google-Maps Premier Medical Group of the Hudson Valley PC
12603 Poughkeepsie
United StatesRekrutierend» Google-Maps Associated Medical Professionals of New York, PLLC
13210 Syracuse
United StatesRekrutierend» Google-Maps Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
44195 Cleveland
United StatesNoch nicht rekrutierend» Google-Maps Cleveland Clinic
44195 Cleveland
United StatesNoch nicht rekrutierend» Google-Maps VA Portland Healthcare System
97239 Portland
United StatesNoch nicht rekrutierend» Google-Maps UPMC Urology
15232 Pittsburgh
United StatesNoch nicht rekrutierend» Google-Maps Carolina Urologic Research Center
29572 Myrtle Beach
United StatesRekrutierend» Google-Maps Parkway Surgery Center
29572 Myrtle Beach
United StatesRekrutierend» Google-Maps Urology Clinics of North Texas
75231 Dallas
United StatesRekrutierend» Google-Maps Urology Clinics of North Texas
75246 Dallas
United StatesRekrutierend» Google-Maps Houston Metro Urology
77027 Houston
United StatesRekrutierend» Google-Maps Houston Methodist Hospital
77030 Houston
United StatesRekrutierend» Google-Maps Urology San Antonio PA
78229 San Antonio
United StatesRekrutierend» Google-Maps Sentara Norfolk General Hospital
23507 Norfolk
United StatesRekrutierend» Google-Maps Urology of Virginia, PLLC
23462 Virginia Beach
United StatesRekrutierend» Google-Maps Southern Highlands Cancer Centre
2756 Bowral
AustraliaRekrutierend» Google-Maps Campbelltown Hospital
2560 Campbelltown
AustraliaRekrutierend» Google-Maps Campbelltown Private Hospital
2560 Campbelltown
AustraliaRekrutierend» Google-Maps Chris O'Brien Lifehouse
2050 Camperdown
AustraliaRekrutierend» Google-Maps Box Hill Hospital
3128 Box Hill
AustraliaNoch nicht rekrutierend» Google-Maps Eastern Clinical Research Unit
3128 Box Hill
AustraliaNoch nicht rekrutierend» Google-Maps Yarra Ranges Health
3140 Lilydale
AustraliaNoch nicht rekrutierend» Google-Maps UZ Gent
9000 Gent
BelgiumRekrutierend» Google-Maps Hamilton Regional Laboratory Medicine Program
L8N 4A6 Hamilton
CanadaNoch nicht rekrutierend» Google-Maps McMaster Institute of Urology/St Joseph's Healthcare Hamilton
L8N 4A6 Hamilton
CanadaNoch nicht rekrutierend» Google-Maps Kingston Health Sciences Centre - Kingston General Hospital
K7L 2V7 Kingston
CanadaRekrutierend» Google-Maps Centre for Applied Urological Research
K7L 3J7 Kingston
CanadaRekrutierend» Google-Maps Kingston Health Sciences Centre -- Hotel Dieu Hospital
K7L 5G2 Kingston
CanadaRekrutierend» Google-Maps University Health Network - Princess Margaret Cancer Centre
M5G 2M9 Toronto
CanadaRekrutierend» Google-Maps University Health Network - Toronto General Hospital
M5G2C4 Toronto
CanadaRekrutierend» Google-Maps Centre intégré universitaire de santé et de services sociaux du Saguenay-Lac-Saint-Jean
G7H 5H6 Chicoutimi
CanadaRekrutierend» Google-Maps Jewish General Hospital
H3T 1E2 Montreal
CanadaNoch nicht rekrutierend» Google-Maps McGill University Health Centre
H4A 3J1 Montreal
CanadaNoch nicht rekrutierend» Google-Maps Hotel-Dieu de Quebec - CHU de Quebec - Universite Laval
G1R 2J6 Quebec
CanadaRekrutierend» Google-Maps Centre de recherche clinique et evaluative en oncologie (CRCEO)
G1R 3S1 Quebec
CanadaRekrutierend» Google-Maps The First Affiliated Hospital of Anhui Medical University
230022 Hefei
ChinaNoch nicht rekrutierend» Google-Maps Beijing Chao-yang Hospital
100020 Beijing
ChinaRekrutierend» Google-Maps Peking University First Hospital
100034 Beijing
ChinaRekrutierend» Google-Maps Beijing Cancer Hospital
100142 Beijing
ChinaRekrutierend» Google-Maps Peking University Third Hospital
100191 Beijing
ChinaNoch nicht rekrutierend» Google-Maps Peking Union Medical College Hospital
100730 Beijing
ChinaNoch nicht rekrutierend» Google-Maps Fujian Medical University Affiliated First Hospital
350005 Fuzhou
ChinaRekrutierend» Google-Maps Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
430022 Wuhan
ChinaRekrutierend» Google-Maps Hunan Cancer Hospital
410013 Changsha
ChinaRekrutierend» Google-Maps Nanjing Drum Tower Hospital
210008 Nanjing
ChinaRekrutierend» Google-Maps Nantong Tumor Hospital
226000 Nantong
ChinaRekrutierend» Google-Maps Second Affiliated Hospital of Suzhou University
215004 Suzhou
ChinaRekrutierend» Google-Maps The First Affiliated Hospital of Nanchang University
330006 Nanchang
ChinaNoch nicht rekrutierend» Google-Maps First Affiliated Hospital of Xi 'an Jiaotong University
710061 Xi'an
ChinaRekrutierend» Google-Maps Yantai Yu Huang Ding Hospital
264000 Yantai
ChinaNoch nicht rekrutierend» Google-Maps West China Hospital of Sichuan University
610041 Chengdu
ChinaRekrutierend» Google-Maps Zhejiang Provincial People's Hospital
310014 Hangzhou
ChinaRekrutierend» Google-Maps Ningbo First Hospital
315010 Ningbo
ChinaRekrutierend» Google-Maps The First Affiliated Hospital of Wenzhou Medical University
325000 Wenzhou
ChinaRekrutierend» Google-Maps The First Affiliated Hospital of Wenzhou Medical University
325035 Wenzhou
ChinaRekrutierend» Google-Maps Chongqing University Cancer Hospital
400030 Chongqing
ChinaRekrutierend» Google-Maps Fudan University Cancer Hospital
200032 Shanghai
ChinaRekrutierend» Google-Maps The Second Hospital of Tianjin Medical University
300211 Tianjin
ChinaRekrutierend» Google-Maps Hôpital privé Antony (Pharmacy)
92160 Antony
FranceRekrutierend» Google-Maps Hôpital Privé d'Antony
92160 Antony
FranceRekrutierend» Google-Maps Clinique Belharra
64100 Bayonne
FranceRekrutierend» Google-Maps Clinique Saint-Augustin
33074 BORDEAUX Cedex
FranceRekrutierend» Google-Maps Institut Bergonié
33076 Bordeaux Cedex
FranceRekrutierend» Google-Maps CHU de Bordeaux Hôpital Pellegrin
33000 Bordeaux
FranceRekrutierend» Google-Maps Groupe Vivalto Sante - Clinique Pasteur-Lanroze- CFRO
29229 Brest Cedex 2
FranceRekrutierend» Google-Maps Cabinet Privé d'urologie
29200 Brest
FranceRekrutierend» Google-Maps CHPB Keraudren
29200 Brest
FranceRekrutierend» Google-Maps Pôle Santé République
63100 Clermont-Ferrand
FranceNoch nicht rekrutierend» Google-Maps Centre d'oncologie Bourgogne
59000 Lille
FranceNoch nicht rekrutierend» Google-Maps Polyclinique de Limoges Site Emailleurs-Colombier
87038 Limoges Cedex 1
FranceRekrutierend» Google-Maps Polyclinique de Limoges Site Chenieux
87000 Limoges
FranceRekrutierend» Google-Maps Polyclinique de Gentilly
54100 Nancy
FranceRekrutierend» Google-Maps Hôpital Bichat - Claude-Bernard
75877 Paris
FranceRekrutierend» Google-Maps Clinique Sainte Anne
67000 Strasbourg
FranceRekrutierend» Google-Maps Humanitas Istituto Clinico Catanese S.p.A - U.O. Oncologia Medica
95045 Misterobianco (CT)
ItalyRekrutierend» Google-Maps UO Oncologia, ASST di Cremona - Istituti Ospitalieri - Ospedale di Cremona
26100 Cremona
ItalyRekrutierend» Google-Maps IRCSS Istituto Clinico Humanitas - U.O. Oncologia Medica
20089 Rozzano
ItalyRekrutierend» Google-Maps AO Azienda Ospedaliera Ordine Mauriziano Di Torino
10128 Torino
ItalyRekrutierend» Google-Maps Ospedale Area Aretina Nord - UOC Oncologia Medica
52100 Arezzo
ItalyRekrutierend» Google-Maps UO Oncologia Medica IRCCS Istituto Tumori "Giovanni Paolo II"
70124 Bari
ItalyRekrutierend» Google-Maps IRCCS Azienda Ospedaliera Universitaria Policlinico San Martino Urologia
16132 Genova
ItalyRekrutierend» Google-Maps Ospedale Generale Provinciale di Macerata - UOC Oncologia
62100 Macerata
ItalyRekrutierend» Google-Maps Medical Oncology Unit, AO Papardo
98158 Messina
ItalyNoch nicht rekrutierend» Google-Maps IRCCS Ospedale San Raffaele, URI (Urological Research Institute)
20132 Milan
ItalyRekrutierend» Google-Maps AUSL/IRCCS di Reggio Emilia
42123 Reggio Emilia
ItalyRekrutierend» Google-Maps ASST Sette Laghi Ospedale di Circolo Fondazione Macchi
21100 Varese
ItalyRekrutierend» Google-Maps National Hospital Organization Shikoku Cancer Center
791-0280 Matsuyama
JapanRekrutierend» Google-Maps Ehime University Hospital
791-0295 Toon
JapanRekrutierend» Google-Maps National Hospital Organization Kyushu Cancer Center
811-1395 Fukuoka-shi
JapanRekrutierend» Google-Maps Gunma Prefectural Cancer Center
373-8550 Ota
JapanRekrutierend» Google-Maps National Hospital Organization Hokkaido Cancer Center
003-0804 Sapporo
JapanRekrutierend» Google-Maps Kanagawa cancer center
241-8515 Yokohama
JapanRekrutierend» Google-Maps Niigata University Medical & Dental Hospital
951-8520 Niigata-shi
JapanNoch nicht rekrutierend» Google-Maps Osaka International Cancer Institute
541-8567 Osaka-shi
JapanRekrutierend» Google-Maps Kindai University Hospital
589-8511 Osakasayama
JapanRekrutierend» Google-Maps Hamamatsu University Hospital
431-3192 Hamamatsu
JapanRekrutierend» Google-Maps Keio University Hospital
160-8582 Shinjuku-ku
JapanRekrutierend» Google-Maps Kagoshima University Hospital
890-8520 Kagoshima
JapanNoch nicht rekrutierend» Google-Maps National Hospital Organization Kumamoto Medical Center
860-0008 Kumamoto
JapanRekrutierend» Google-Maps Okayama Medical Center
701-1192 Okayama
JapanRekrutierend» Google-Maps Yamagata University Hospital
990-9585 Yamagata
JapanRekrutierend» Google-Maps National Cancer Center
10408 Goyang-si
Korea, Republic ofRekrutierend» Google-Maps Seoul National University Bundang Hospital
13620 Seongnam-si
Korea, Republic ofRekrutierend» Google-Maps Kyungpook National University Chilgok Hospital
41404 Daegu
Korea, Republic ofRekrutierend» Google-Maps Korea University Anam Hospital
02841 Seoul
Korea, Republic ofRekrutierend» Google-Maps Seoul National University Hospital
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps Severance Hospital, Yonsei University Health System
03722 Seoul
Korea, Republic ofRekrutierend» Google-Maps Samsung Medical Center
06351 Seoul
Korea, Republic ofRekrutierend» Google-Maps NZOZ AKMED Andrzej Kupilas
44-100 Gliwice
PolandRekrutierend» Google-Maps Regionalny Szpital Specjalistyczny im. Dr. Wladyslawa Bieganskiego
86-300 Grudziadz
PolandRekrutierend» Google-Maps Niepubliczny Zaklad Opieki Zdrowotnej Centrum Urologiczne Sp. z o.o.
41-400 Mysłowice
PolandRekrutierend» Google-Maps Provita Profamilia
97-300 Piotrkow Trybunalski
PolandRekrutierend» Google-Maps Clinical Research Center Spolka z ograniczona odpowiedzialnoscia MEDIC-R Spolka Komandytowa
60-848 Poznan
PolandRekrutierend» Google-Maps Niepubliczny Zakład Opieki Zdrowotnej Nr 1
84-230 Rumia
PolandNoch nicht rekrutierend» Google-Maps ETG Skierniewice
96-100 Skierniewice
PolandRekrutierend» Google-Maps Provita 001
02-647 Warszawa
PolandRekrutierend» Google-Maps Medical Concierge Centrum Medyczne
02-798 Warszawa
PolandRekrutierend» Google-Maps Lexmedica
53-114 Wroclaw
PolandNoch nicht rekrutierend» Google-Maps A.Tsyb Medical Research Radiological Center of the Ministry of Health of the Russian Federation
249036 Obninsk
Russian FederationRekrutierend» Google-Maps State Budgetary Institution of Healthcare of the Republic of Mordovia
430032 Saransk
Russian FederationRekrutierend» Google-Maps Private Medical Institution "Euromedservice"
196603 Pushkin
Russian FederationRekrutierend» Google-Maps 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 Evimed Llc
454048 Chelyabinsk
Russian FederationRekrutierend» Google-Maps Regional Budgetary Healthcare Institution "Ivanovo Regional Oncology Dispensary"
153040 Ivanovo
Russian FederationRekrutierend» Google-Maps Ars Medika Center, LLC
236006 Kaliningrad
Russian FederationRekrutierend» Google-Maps Kaluga Regional Clinical Oncology Center
248007 Kaluga
Russian FederationRekrutierend» Google-Maps P.A. Hertsen Moscow Oncology Research Center- branch of the National Medical Research
125284 Moscow
Russian FederationRekrutierend» Google-Maps Federal Budgetary Institution of Healthcare "Privolzhsky District Medical Center of the Federal
603074 Nizhny Novgorod
Russian FederationRekrutierend» Google-Maps BHI of Omsk region "Clinical Oncological Dispensary"
644013 Omsk
Russian FederationRekrutierend» Google-Maps State Budgetary Institution of Ryazan Region "Regional Clinical Oncology Center"
390011 Ryazan
Russian FederationRekrutierend» Google-Maps 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
Russian FederationRekrutierend» Google-Maps Republican Clinical Oncology Dispensary of the Ministry of Health of Bashkortostan Republic
450054 Ufa
Russian FederationRekrutierend» Google-Maps Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"
160022 Vologda
Russian FederationRekrutierend» Google-Maps SBHI YaR Regional clinical oncology hospital
150054 Yaroslavl
Russian FederationRekrutierend» Google-Maps Hospital Universitari Germans Trias i Pujol
08916 Badalona
SpainRekrutierend» Google-Maps Hospital General de Granollers
08402 Granollers
SpainRekrutierend» Google-Maps Hospital Universitari de Bellvitge
08907 L'Hospitalet de Llobregat
SpainRekrutierend» Google-Maps Hospital Duran i Reynals- ICO L'Hospitalet
08908 L'Hospitalet de Llobregat
SpainRekrutierend» Google-Maps Hospital Universitario Puerta de Hierro Majadahonda
28222 Majadahonda
SpainRekrutierend» Google-Maps Complejo Hospitalario de Navarra
31008 Pamplona
SpainRekrutierend» Google-Maps Hospital Universitari Sant Joan de Reus
43204 Reus
SpainRekrutierend» Google-Maps Complejo Hospitalario Universitario A Coruna
15006 A Coruna
SpainRekrutierend» Google-Maps Hospital del Mar
08003 Barcelona
SpainRekrutierend» Google-Maps Fundacio Puigvert
08025 Barcelona
SpainRekrutierend» Google-Maps Hospital de la Santa Creu i Sant Pau
08041 Barcelona
SpainRekrutierend» Google-Maps Hospital San Pedro de Alcantara
10003 Caceres
SpainRekrutierend» Google-Maps Hospital Universitari de Girona Doctor Josep Trueta
17007 Girona
SpainRekrutierend» Google-Maps Hospital Universitario Lucus Augusti
27003 Lugo
SpainRekrutierend» Google-Maps Hospital Universitario de La Princesa
28006 Madrid
SpainRekrutierend» Google-Maps Hospital Universitario La Princesa
28006 Madrid
SpainRekrutierend» Google-Maps Hospital Clínico San Carlos
28040 Madrid
SpainRekrutierend» Google-Maps Hospital Universitario 12 de Octubre
28041 Madrid
SpainRekrutierend» Google-Maps Fundacion Instituto Valenciano de Oncologia
46009 Valencia
SpainRekrutierend» Google-Maps Hospital Arnau de Vilanova
46015 Valencia
SpainRekrutierend» Google-Maps Barts Health NHS Trust, St Bartholomew's Hospital
EC1A 7BE London
United KingdomRekrutierend» Google-Maps Charing Cross Hospital
W6 8RF London
United KingdomRekrutierend» Google-Maps Alle anzeigen
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.
- 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
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).
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
Study Director
Pfizer
Kontakt
Kontakt:
Phone: 1-800-718-1021
E-Mail: ClinicalTrials.gov_Inquiries@pfizer.com» Kontaktdaten anzeigen
Studienlocations
(3 von 205)
47179 Duisburg
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
60590 Frankfurt
(Hessen)
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55131 Mainz
(Rheinland-Pfalz)
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48149 Muenster
(Nordrhein-Westfalen)
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72622 Nuertingen
(Baden-Württemberg)
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72076 Tuebingen
(Baden-Württemberg)
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85715 Tucson
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85741 Tucson
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72211 Little Rock
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72211 Little Rock
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92037 La Jolla
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92037 La Jolla
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92037 La Jolla
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92093 La Jolla
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92868 Orange
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92103 San Diego
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80211 Denver
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33016 Hialeah
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32209 Jacksonville
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32218 Jacksonville
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33578 Riverview
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33606 Tampa
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60612 Chicago
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60612 Chicago
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60532 Lisle
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60148 Lombard
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60148 Lombard
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60540 Naperville
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71106 Shreveport
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71106 Shreveport
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21076 Hanover
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48084 Troy
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55455 Minneapolis
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55455 Minneapolis
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55455 Minneapolis
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65212 Columbia
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10461 Bronx
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10461 Bronx
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12553 New Windsor
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10016 New York
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10016 New York
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10016 New York
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10017 New York
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10029 New York
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10029 New York
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12601 Poughkeepsie
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12603 Poughkeepsie
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13210 Syracuse
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44195 Cleveland
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44195 Cleveland
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97239 Portland
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15232 Pittsburgh
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29572 Myrtle Beach
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29572 Myrtle Beach
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75231 Dallas
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75246 Dallas
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77027 Houston
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77030 Houston
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78229 San Antonio
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23507 Norfolk
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23462 Virginia Beach
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2756 Bowral
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2560 Campbelltown
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2560 Campbelltown
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2050 Camperdown
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3128 Box Hill
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3128 Box Hill
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3140 Lilydale
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9000 Gent
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L8N 4A6 Hamilton
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L8N 4A6 Hamilton
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K7L 2V7 Kingston
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K7L 3J7 Kingston
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K7L 5G2 Kingston
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M5G 2M9 Toronto
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G7H 5H6 Chicoutimi
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H3T 1E2 Montreal
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G1R 2J6 Quebec
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230022 Hefei
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100020 Beijing
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100034 Beijing
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100142 Beijing
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100191 Beijing
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100730 Beijing
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350005 Fuzhou
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430022 Wuhan
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410013 Changsha
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210008 Nanjing
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226000 Nantong
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215004 Suzhou
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330006 Nanchang
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710061 Xi'an
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264000 Yantai
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610041 Chengdu
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310014 Hangzhou
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315010 Ningbo
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325000 Wenzhou
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325035 Wenzhou
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400030 Chongqing
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200032 Shanghai
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300211 Tianjin
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92160 Antony
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92160 Antony
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64100 Bayonne
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33074 BORDEAUX Cedex
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33076 Bordeaux Cedex
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33000 Bordeaux
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29229 Brest Cedex 2
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29200 Brest
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29200 Brest
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63100 Clermont-Ferrand
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59000 Lille
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87038 Limoges Cedex 1
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87000 Limoges
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54100 Nancy
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75877 Paris
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67000 Strasbourg
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95045 Misterobianco (CT)
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26100 Cremona
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20089 Rozzano
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10128 Torino
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52100 Arezzo
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70124 Bari
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16132 Genova
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62100 Macerata
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98158 Messina
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20132 Milan
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42123 Reggio Emilia
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21100 Varese
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791-0280 Matsuyama
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791-0295 Toon
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811-1395 Fukuoka-shi
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373-8550 Ota
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003-0804 Sapporo
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241-8515 Yokohama
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951-8520 Niigata-shi
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541-8567 Osaka-shi
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589-8511 Osakasayama
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431-3192 Hamamatsu
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160-8582 Shinjuku-ku
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890-8520 Kagoshima
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860-0008 Kumamoto
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701-1192 Okayama
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990-9585 Yamagata
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10408 Goyang-si
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13620 Seongnam-si
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41404 Daegu
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02841 Seoul
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03080 Seoul
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03722 Seoul
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06351 Seoul
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44-100 Gliwice
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86-300 Grudziadz
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41-400 Mysłowice
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97-300 Piotrkow Trybunalski
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60-848 Poznan
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84-230 Rumia
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96-100 Skierniewice
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02-647 Warszawa
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02-798 Warszawa
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53-114 Wroclaw
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249036 Obninsk
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430032 Saransk
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196603 Pushkin
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357502 Pyatigorsk
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188663 Kuzmolovsky Settlement
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454048 Chelyabinsk
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153040 Ivanovo
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236006 Kaliningrad
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248007 Kaluga
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125284 Moscow
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603074 Nizhny Novgorod
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644013 Omsk
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390011 Ryazan
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194355 Saint Petersburg
Russian FederationRekrutierend» Google-Maps
194017 Saint-Petersburg
Russian FederationRekrutierend» Google-Maps
199178 Saint-Petersburg
Russian FederationRekrutierend» Google-Maps
450054 Ufa
Russian FederationRekrutierend» Google-Maps
160022 Vologda
Russian FederationRekrutierend» Google-Maps
150054 Yaroslavl
Russian FederationRekrutierend» Google-Maps
08916 Badalona
SpainRekrutierend» Google-Maps
08402 Granollers
SpainRekrutierend» Google-Maps
08907 L'Hospitalet de Llobregat
SpainRekrutierend» Google-Maps
08908 L'Hospitalet de Llobregat
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28222 Majadahonda
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31008 Pamplona
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43204 Reus
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15006 A Coruna
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08003 Barcelona
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08025 Barcelona
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08041 Barcelona
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10003 Caceres
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17007 Girona
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27003 Lugo
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28006 Madrid
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28006 Madrid
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28040 Madrid
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28041 Madrid
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46009 Valencia
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46015 Valencia
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EC1A 7BE London
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W6 8RF London
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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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