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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:
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

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 130)

Klinikum der Goethe-Universitaet Frankfurt
60590 Frankfurt
(Hessen)
GermanyNoch nicht rekrutierend» Google-Maps
Universitaetsklinikum Tuebingen
72076 Tuebingen
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Urological 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-Maps
University of California Irvine Medical Center
92868 Orange
United StatesRekrutierend» Google-Maps
Urological Research Network Corp
33016 Hialeah
United StatesRekrutierend» Google-Maps
UF Health Jacksonville
32209 Jacksonville
United StatesRekrutierend» 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 Ambulatory Surgery Center
60148 Lombard
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 StatesNoch nicht rekrutierend» Google-Maps
Michigan Institute of Urology, PC
48084 Troy
United StatesRekrutierend» Google-Maps
Montefiore Medical Center - Montefiore Medical Park
10461 Bronx
United StatesNoch nicht rekrutierend» Google-Maps
Montefiore Medical Center - Oncology Investigational Services
10461 Bronx
United StatesNoch nicht rekrutierend» Google-Maps
Bellevue Hospital
10016 New York
United StatesNoch nicht rekrutierend» Google-Maps
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
10016 New York
United StatesNoch nicht rekrutierend» Google-Maps
NYU Langone Medical Center (Tisch Hospital)
10016 New York
United StatesNoch nicht rekrutierend» Google-Maps
NYU Langone Health Urology Associates
10017 New York
United StatesNoch nicht rekrutierend» Google-Maps
Icahn School of Medicine at Mount Sinai
10029 New York
United StatesNoch nicht rekrutierend» Google-Maps
Mount Sinai Hospital
10029 New York
United StatesNoch nicht rekrutierend» 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 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 StatesNoch nicht rekrutierend» Google-Maps
Urology Clinics of North Texas
75246 Dallas
United StatesNoch nicht rekrutierend» 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
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
University Health Network - Princess Margaret Cancer Centre
M5G 2M9 Toronto
CanadaRekrutierend» Google-Maps
University Health Network - Toronto General Hospital
M5G2C4 Toronto
CanadaRekrutierend» Google-Maps
Beijing Cancer Hospital
100142 Beijing
ChinaNoch nicht rekrutierend» Google-Maps
Nantong Tumor Hospital
226000 Nantong
ChinaNoch nicht rekrutierend» Google-Maps
Hôpital privé Antony (Pharmacy)
92160 Antony
FranceNoch nicht rekrutierend» Google-Maps
Hôpital Privé d'Antony
92160 Antony
FranceNoch nicht rekrutierend» Google-Maps
Clinique Saint-Augustin
33074 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
FranceNoch nicht rekrutierend» Google-Maps
Cabinet Privé d'urologie
29200 Brest
FranceNoch nicht rekrutierend» Google-Maps
Polyclinique de Limoges Site Chenieux
87000 Limoges
FranceRekrutierend» Google-Maps
Polyclinique de Gentilly
54100 Nancy
FranceNoch nicht rekrutierend» Google-Maps
Hôpital Bichat - Claude-Bernard
75877 Paris
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
ItalyNoch nicht rekrutierend» Google-Maps
IRCSS Istituto Clinico Humanitas - U.O. Oncologia Medica
20089 Rozzano
ItalyRekrutierend» Google-Maps
AO Azienda Ospedaliera Ordine Mauriziano Di Torino
10128 Torino
ItalyNoch nicht rekrutierend» Google-Maps
UO Oncologia Medica IRCCS Istituto Tumori "Giovanni Paolo II"
70124 Bari
ItalyRekrutierend» Google-Maps
Ospedale Generale Provinciale di Macerata - UOC Oncologia
62100 Macerata
ItalyRekrutierend» Google-Maps
IRCCS Ospedale San Raffaele, URI (Urological Research Institute)
20132 Milan
ItalyNoch nicht rekrutierend» Google-Maps
ASST Sette Laghi Ospedale di Circolo Fondazione Macchi
21100 Varese
ItalyRekrutierend» Google-Maps
National Hospital Organization Shikoku Cancer Center
791-0280 Matsuyama
JapanNoch nicht rekrutierend» Google-Maps
Ehime University Hospital
791-0295 Toon
JapanNoch nicht rekrutierend» Google-Maps
National Hospital Organization Kyushu Cancer Center
811-1395 Fukuoka-shi
JapanRekrutierend» Google-Maps
Gunma Prefectural Cancer Center
373-8550 Ota
JapanNoch nicht rekrutierend» Google-Maps
National Hospital Organization Hokkaido Cancer Center
003-0804 Sapporo
JapanNoch nicht rekrutierend» Google-Maps
Niigata University Medical & Dental Hospital
951-8520 Niigata-shi
JapanNoch nicht rekrutierend» Google-Maps
Hamamatsu University Hospital
431-3192 Hamamatsu
JapanNoch nicht rekrutierend» 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
Yamagata University Hospital
990-9585 Yamagata
JapanNoch nicht rekrutierend» 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
Regionalny Szpital Specjalistyczny im. Dr. Wladyslawa Bieganskiego
86-300 Grudziadz
PolandNoch nicht rekrutierend» 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 Sp.k.
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
PolandNoch nicht rekrutierend» Google-Maps
Medical Concierge Centrum Medyczne
02-798 Warszawa
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
Regional Budgetary Healthcare Institution "Ivanovo Regional Oncology Dispensary"
153040 Ivanovo
Russian FederationRekrutierend» Google-Maps
Ars Medika Center, LLC
236006 Kaliningrad
Russian FederationNoch nicht rekrutierend» 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 FederationNoch nicht rekrutierend» Google-Maps
Federal State Budgetary Healthcare Institution Saint - Petersburg
194017 Saint-Petersburg
Russian FederationNoch nicht rekrutierend» 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
Complejo Hospitalario de Navarra
31008 Pamplona
SpainRekrutierend» Google-Maps
Hospital Universitari Sant Joan de Reus
43204 Reus
SpainNoch nicht rekrutierend» Google-Maps
Complejo Hospitalario Universitario A Coruna
15006 A Coruna
SpainNoch nicht rekrutierend» Google-Maps
Hospital Universitari de Girona Doctor Josep Trueta
17007 Girona
SpainNoch nicht rekrutierend» Google-Maps
Hospital Universitario Lucus Augusti
27003 Lugo
SpainRekrutierend» Google-Maps
Hospital Universitario de La Princesa
28006 Madrid
SpainNoch nicht rekrutierend» Google-Maps
Fundacion Instituto Valenciano de Oncologia
46009 Valencia
SpainNoch nicht rekrutierend» Google-Maps
Barts Health NHS Trust, St Bartholomew's Hospital
EC1A 7BE London
United KingdomRekrutierend» Google-Maps
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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