SUPPORT HOTLINE (888) 901-2226
Donate Now

BRIEF TITLE: Study of PF-06801591, an Anti-PD-1 Antibody, in Combination With Bacillus Calmette-Guerin (BCG Induction With or Without BCG Maintenance) Versus BCG (Induction and Maintenance) in Participants With High-Risk, BCG-Naïve Non-Muscle Invasive Bladder Cancer

A Phase 3, Multinational, Randomized, Open-Label, Three Parallel-Arm Study of PF-06801591, an Anti-PD-1 Antibody, in Combination With Bacillus Calmette-Guerin (BCG Induction With or Without BCG Maintenance) Versus BCG (Induction and Maintenance) in Participants With High-Risk, BCG-Naïve Non-Muscle Invasive Bladder Cancer


  • Org Study ID: B8011006
  • Secondary ID: 2019-003375-19
  • NCT ID: NCT04165317
  • NCT Alias:
  • Sponsor: Pfizer - Industry
  • Source: Pfizer

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.

Overal Status Start Date Phase Study Type
Recruiting December 30, 2019 Phase 3 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Event free survival (Arm A compared to Arm C)

Primary Outcome 1 - Time Frame: Randomization up to 55 months

Primary Outcome 2 - Measure: Event free survival (Arm B compared to Arm C)

Primary Outcome 2 - Time Frame: Randomization up to 55 months

Condition:

  • Non-muscle Invasive Bladder Cancer

Eligibility

Criteria:
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
Show More

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Pfizer CT.gov Call Center

Role: Study Director

Affiliation: Pfizer

Overall Contact

Name: Pfizer CT.gov Call Center

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Link: To obtain contact information for a study center near you, click here.

Locations

Facility Status Contact
Urological Associates of Southern Arizona, P.C .
Tucson, Arizona 85715
United States
Not yet recruiting
Urological Associates of Southern Arizona P.C.
Tucson, Arizona 85741
United States
Not yet recruiting
University of California Irvine Medical Center
Orange, California 92868
United States
Recruiting
Urological Research Network Corp
Hialeah, Florida 33016
United States
Recruiting
UF Health Jacksonville
Jacksonville, Florida 32209
United States
Not yet recruiting
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois 60612
United States
Not yet recruiting
DuPage Medical Group
Lisle, Illinois 60532
United States
Recruiting
DuPage Medical Group Ambulatory Surgery Center
Lombard, Illinois 60148
United States
Recruiting
Edward Hospital
Naperville, Illinois 60540
United States
Recruiting
Regional Urology Oncology & Radiation Center
Shreveport, Louisiana 71106
United States
Recruiting
Regional Urology, LLC
Shreveport, Louisiana 71106
United States
Recruiting
Chesapeake Urology Research Associates
Hanover, Maryland 21076
United States
Not yet recruiting
Michigan Institute of Urology, PC
Troy, Michigan 48084
United States
Recruiting
Montefiore Medical Center - Montefiore Medical Park
Bronx, New York 10461
United States
Not yet recruiting
Montefiore Medical Center - Oncology Investigational Services
Bronx, New York 10461
United States
Not yet recruiting
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
Not yet recruiting
Mount Sinai Hospital
New York, New York 10029
United States
Not yet recruiting
Dutchess Ambulatory Surgery Center
Poughkeepsie, New York 12601
United States
Recruiting
Premier Medical Group of the Hudson Valley PC
Poughkeepsie, New York 12603
United States
Recruiting
Associated Medical Professionals of New York, PLLC
Syracuse, New York 13210
United States
Not yet recruiting
Keystone Urology Specialists
Lancaster, Pennsylvania 17604
United States
Not yet recruiting
Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
United States
Recruiting
Parkway Surgery Center
Myrtle Beach, South Carolina 29572
United States
Recruiting
Urology Clinics of North Texas
Dallas, Texas 75231
United States
Not yet recruiting
Urology Clinics of North Texas
Dallas, Texas 75246
United States
Not yet recruiting
Houston Metro Urology
Houston, Texas 77027
United States
Recruiting
Houston Methodist Hospital
Houston, Texas 77030
United States
Recruiting
Urology San Antonio PA
San Antonio, Texas 78229
United States
Recruiting
Sentara Norfolk General Hospital
Norfolk, Virginia 23507
United States
Recruiting
Urology of Virginia, PLLC
Virginia Beach, Virginia 23462
United States
Recruiting
Southern Highlands Cancer Centre
Bowral, New South Wales 2756
Australia
Recruiting
Box Hill Hospital
Box Hill, Victoria 3128
Australia
Not yet recruiting
Eastern Clinical Research Unit
Box Hill, Victoria 3128
Australia
Not yet recruiting
Monash Health
Clayton, Victoria 3168
Australia
Not yet recruiting
Yarra Ranges Health
Lilydale, Victoria 3140
Australia
Not yet recruiting
UZ Gent
Gent, 9000
Belgium
Not yet recruiting
AZ Groeninge
Kortrijk, 8500
Belgium
Not yet recruiting
Mount Sinai Hospital
Toronto, Ontario M5G 1X5
Canada
Not yet recruiting
University Health Network - Princess Margaret Cancer Centre
Toronto, Ontario M5G 2M9
Canada
Not yet recruiting
University Health Network - Toronto General Hospital
Toronto, Ontario M5G2C4
Canada
Not yet recruiting
Hôpital privé Antony (Pharmacy)
Antony, 92160
France
Not yet recruiting
Hôpital Privé d'Antony
Antony, 92160
France
Not yet recruiting
Clinique Belharra
Bayonne, 64100
France
Not yet recruiting
Clinique Saint-Augustin
BORDEAUX Cedex, 33074
France
Not yet recruiting
Institut Bergonié
Bordeaux Cedex, 33076
France
Not yet recruiting
CHU de Bordeaux Hôpital Pellegrin
Bordeaux, 33000
France
Not yet recruiting
Polyclinique de Limoges Site Chenieux
Limoges, 87000
France
Recruiting
Polyclinique de Gentilly
Nancy, 54100
France
Not yet recruiting
Hôpital Bichat - Claude-Bernard
Paris, 75877
France
Recruiting
Clinique Sainte Anne
Strasbourg, 67000
France
Recruiting
Humanitas Istituto Clinico Catanese S.p.A - U.O. Oncologia Medica
Misterobianco (CT), Catania 95045
Italy
Not yet recruiting
UO Oncologia, ASST di Cremona - Istituti Ospitalieri - Ospedale di Cremona
Cremona, CR 26100
Italy
Not yet recruiting
IRCSS Istituto Clinico Humanitas - U.O. Oncologia Medica
Rozzano, Milano 20089
Italy
Not yet recruiting
UO Oncologia Medica IRCCS Istituto Tumori "Giovanni Paolo II"
Bari, 70124
Italy
Recruiting
IRCCS Ospedale San Raffaele, URI (Urological Research Institute)
Milan, 20132
Italy
Not yet recruiting
ASST Sette Laghi Ospedale di Circolo Fondazione Macchi
Varese, 21100
Italy
Recruiting
Hamamatsu University Hospital
Hamamatsu, Shizuoka 431-3192
Japan
Not yet recruiting
Keio University Hospital
Shinjuku-ku, Tokyo 160-8582
Japan
Not yet recruiting
National Hospital Organization Kumamoto Medical Center
Kumamoto, 860-0008
Japan
Not yet recruiting
Okayama Medical Center
Okayama, 701-1192
Japan
Not yet recruiting
National Cancer Center
Goyang-si, Gyeonggi-do 10408
Korea, Republic of
Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do 13620
Korea, Republic of
Recruiting
Kyungpook National University Chilgok Hospital
Daegu, 41404
Korea, Republic of
Recruiting
Korea University Anam Hospital
Seoul, 02841
Korea, Republic of
Recruiting
Seoul National University Hospital
Seoul, 03080
Korea, Republic of
Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
Korea, Republic of
Recruiting
Samsung Medical Center
Seoul, 06351
Korea, Republic of
Recruiting
NZOZ AKMED Andrzej Kupilas
Gliwice, 44-100
Poland
Recruiting
Regionalny Szpital Specjalistyczny im. Dr. Wladyslawa Bieganskiego
Grudziadz, 86-300
Poland
Not yet recruiting
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Urologiczne Sp. z o.o.
Mysłowice, 41-400
Poland
Not yet recruiting
Provita Profamilia
Piotrkow Trybunalski, 97-300
Poland
Not yet recruiting
ETG Skierniewice
Skierniewice, 96-100
Poland
Not yet recruiting
Provita 001
Warszawa, 02-647
Poland
Not yet recruiting
Lexmedica
Wroclaw, 53-114
Poland
Not yet recruiting
Hospital de Braga (Piso 1-Ala E)
Braga, 4710-243
Portugal
Not yet recruiting
Fundação Champalimaud
Lisboa, 1400-038
Portugal
Not yet recruiting
Hospital CUF Descobertas, SA
Lisboa, 1990-050
Portugal
Not yet recruiting
A.Tsyb Medical Research Radiological Center of the Ministry of Health of the Russian Federation
Obninsk, Kaluzhskaya OBL. 249036
Russian Federation
Recruiting
State Budgetary Institution of Healthcare of the Republic of Mordovia
Saransk, Republic OF Mordovia 430032
Russian Federation
Not yet recruiting
Private Medical Institution "Euromedservice"
Pushkin, Saint-petersburg 196603
Russian Federation
Recruiting
Klinika UZI 4D, LLC
Pyatigorsk, Stavropolskiy KRAI 357502
Russian Federation
Recruiting
State Budgetary Healthcare Institution "Leningrad Regional Clinical Oncology Dispensary"
Kuzmolovsky Settlement, Vsevolozhsky District 188663
Russian Federation
Recruiting
Evimed Llc
Chelyabinsk, 454048
Russian Federation
Recruiting
Regional Budgetary Healthcare Institution "Ivanovo Regional Oncology Dispensary"
Ivanovo, 153040
Russian Federation
Recruiting
Ars Medika Center, LLC
Kaliningrad, 236006
Russian Federation
Not yet recruiting
Kaluga Regional Clinical Oncology Center
Kaluga, 248007
Russian Federation
Recruiting
P.A. Hertsen Moscow Oncology Research Center- branch of the National Medical Research
Moscow, 125284
Russian Federation
Not yet recruiting
Federal Budgetary Institution of Healthcare "Privolzhsky District Medical Center of the Federal
Nizhny Novgorod, 603074
Russian Federation
Not yet recruiting
BHI of Omsk region "Clinical Oncological Dispensary"
Omsk, 644013
Russian Federation
Recruiting
Hospital OrKli LLC
Saint-Petersburg, 199178
Russian Federation
Recruiting
Republican Clinical Oncology Dispensary of the Ministry of Health of Bashkortostan Republic
Ufa, 450054
Russian Federation
Recruiting
SBHI YaR Regional clinical oncology hospital
Yaroslavl, 150054
Russian Federation
Recruiting
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona 08916
Spain
Recruiting
Hospital General de Granollers
Granollers, Barcelona 08402
Spain
Recruiting
Complejo Hospitalario de Navarra
Pamplona, Navarra 31008
Spain
Recruiting
Hospital Universitari Sant Joan de Reus
Reus, Tarragona 43204
Spain
Not yet recruiting
Hospital del Mar
Barcelona, 08003
Spain
Not yet recruiting
Hospital Universitari de Girona Doctor Josep Trueta
Girona, 17007
Spain
Not yet recruiting
Hospital Universitario Lucus Augusti
Lugo, 27003
Spain
Not yet recruiting
Hospital Universitario de La Princesa
Madrid, 28006
Spain
Not yet recruiting
Hospital Clínico San Carlos
Madrid, 28040
Spain
Recruiting
Hospital Arnau de Vilanova
Valencia, 46015
Spain
Recruiting
Barts Health NHS Trust, St Bartholomew's Hospital
London, EC1A 7BE
United Kingdom
Not yet recruiting