The CREST study aims to build on the well-established efficacy of BCG therapy by investigating whether a potential new treatment, when used alongside BCG, could deliver improved results.
Study participants can expect to receive 25 cycles of study treatment (a cycle = 4 weeks) with the investigational drug and/or BCG depending on the study group allocation. Study participants’ high-risk NMIBC will be continually monitored using health assessments such as medical questionnaires, physical examinations, ECG, chest X-ray, CT or MRI scans, cystoscopy, blood and urine tests.
Study participants will be followed up regularly by telephone every 12 weeks for up to 5 years from when the last participant is randomized.
Approximately 150 research centers in 15 countries will be participating in the CREST study.
Get more information by visiting www.TheCrestStudy.com
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 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
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
Name: Pfizer CT.gov Call Center
Role: Study Director
Affiliation: Pfizer
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.
Facility | Status | Contact |
---|---|---|
Urological Associates of Southern Arizona, P.C . Tucson, Arizona 85715 United States |
Recruiting | |
Urological Associates of Southern Arizona P.C. Tucson, Arizona 85741 United States |
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 |
Recruiting | |
UF Health North Jacksonville, Florida 32218 United States |
Recruiting | |
John H. Stroger, Jr. Hospital of Cook County/IND Pharmacy Chicago, Illinois 60612 United States |
Recruiting | |
John H. Stroger, Jr. Hospital of Cook County Chicago, Illinois 60612 United States |
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 |
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 | |
Bellevue Hospital New York, New York 10016 United States |
Recruiting | |
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health New York, New York 10016 United States |
Recruiting | |
NYU Langone Medical Center (Tisch Hospital) New York, New York 10016 United States |
Recruiting | |
NYU Langone Health Urology Associates New York, New York 10017 United States |
Recruiting | |
Icahn School of Medicine at Mount Sinai New York, New York 10029 United States |
Recruiting | |
Mount Sinai Hospital New York, New York 10029 United States |
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 | |
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 | |
Chris O'Brien Lifehouse Camperdown, New South Wales 2050 Australia |
Not yet 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 |
Recruiting | |
AZ Groeninge Kortrijk, 8500 Belgium |
Not yet recruiting | |
Kingston Health Sciences Centre - Kingston General Hospital Kingston, Ontario K7L 2V7 Canada |
Not yet recruiting | |
Centre for Applied Urological Research Kingston, Ontario K7L 3J7 Canada |
Not yet recruiting | |
Kingston Health Sciences Centre -- Hotel Dieu Hospital Kingston, Ontario K7L 5G2 Canada |
Not yet recruiting | |
Mount Sinai Hospital Toronto, Ontario M5G 1X5 Canada |
Recruiting | |
University Health Network - Princess Margaret Cancer Centre Toronto, Ontario M5G 2M9 Canada |
Recruiting | |
University Health Network - Toronto General Hospital Toronto, Ontario M5G2C4 Canada |
Recruiting | |
McGill University Health Centre Montreal, Quebec H4A 3J1 Canada |
Not yet recruiting | |
Hotel-Dieu de Quebec - CHU de Quebec - Universite Laval Quebec, G1R 2J6 Canada |
Not yet recruiting | |
Centre de recherche clinique et evaluative en oncologie (CRCEO) Quebec, G1R 3S1 Canada |
Not yet recruiting | |
Beijing Chao-yang Hospital Beijing, Beijing 100020 China |
Not yet recruiting | |
Beijing Cancer Hospital Beijing, Beijing 100142 China |
Recruiting | |
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan, Hubei 430022 China |
Not yet recruiting | |
Nantong Tumor Hospital Nantong, Jiangsu 226000 China |
Not yet recruiting | |
Second Affiliated Hospital of Suzhou University Suzhou, Jiangsu 215004 China |
Recruiting | |
Zhejiang Provincial People's Hospital Hangzhou, Zhejiang 310014 China |
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 |
Recruiting | |
Clinique Saint-Augustin BORDEAUX Cedex, 33074 France |
Recruiting | |
Institut Bergonié Bordeaux Cedex, 33076 France |
Recruiting | |
CHU de Bordeaux Hôpital Pellegrin Bordeaux, 33000 France |
Recruiting | |
Groupe Vivalto Sante - Clinique Pasteur-Lanroze- CFRO Brest Cedex 2, 29229 France |
Not yet recruiting | |
Cabinet Privé d'urologie Brest, 29200 France |
Not yet recruiting | |
CHPB Keraudren Brest, 29200 France |
Not yet recruiting | |
Centre d'oncologie Bourgogne Lille, 59000 France |
Not yet recruiting | |
Polyclinique de Limoges Site Emailleurs-Colombier Limoges Cedex 1, 87038 France |
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 | |
Klinikum der Goethe-Universitaet Frankfurt Frankfurt, 60590 Germany |
Not yet recruiting | |
Universitaetsklinikum Muenster, Urologie Muenster, 48149 Germany |
Not yet recruiting | |
Studienpraxis Urologie Nuertingen, 72622 Germany |
Not yet recruiting | |
Universitaetsklinikum Tuebingen Tuebingen, 72076 Germany |
Recruiting | |
Humanitas Istituto Clinico Catanese S.p.A - U.O. Oncologia Medica Misterobianco (CT), Catania 95045 Italy |
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 |
Recruiting | |
AO Azienda Ospedaliera Ordine Mauriziano Di Torino Torino, Turin 10128 Italy |
Recruiting | |
Ospedale Area Aretina Nord - UOC Oncologia Medica Arezzo, 52100 Italy |
Not yet recruiting | |
UO Oncologia Medica IRCCS Istituto Tumori "Giovanni Paolo II" Bari, 70124 Italy |
Recruiting | |
Ospedale Generale Provinciale di Macerata - UOC Oncologia Macerata, 62100 Italy |
Recruiting | |
IRCCS Ospedale San Raffaele, URI (Urological Research Institute) Milan, 20132 Italy |
Recruiting | |
ASST Sette Laghi Ospedale di Circolo Fondazione Macchi Varese, 21100 Italy |
Recruiting | |
National Hospital Organization Shikoku Cancer Center Matsuyama, Ehime 791-0280 Japan |
Not yet recruiting | |
Ehime University Hospital Toon, Ehime 791-0295 Japan |
Not yet recruiting | |
National Hospital Organization Kyushu Cancer Center Fukuoka-shi, Fukuoka 811-1395 Japan |
Recruiting | |
Gunma Prefectural Cancer Center Ota, Gunma 373-8550 Japan |
Recruiting | |
National Hospital Organization Hokkaido Cancer Center Sapporo, Hokkaido 003-0804 Japan |
Not yet recruiting | |
Kanagawa Cancer Center Yokohama, Kanagawa 241-8515 Japan |
Not yet recruiting | |
Niigata University Medical & Dental Hospital Niigata-shi, Niigata 951-8520 Japan |
Not yet recruiting | |
Osaka International Cancer Institute Osaka-shi, Osaka 541-8567 Japan |
Not yet recruiting | |
Hamamatsu University Hospital Hamamatsu, Shizuoka 431-3192 Japan |
Recruiting | |
Keio University Hospital Shinjuku-ku, Tokyo 160-8582 Japan |
Recruiting | |
Kagoshima University Hospital Kagoshima, 890-8520 Japan |
Not yet recruiting | |
National Hospital Organization Kumamoto Medical Center Kumamoto, 860-0008 Japan |
Recruiting | |
Okayama Medical Center Okayama, 701-1192 Japan |
Recruiting | |
Yamagata University Hospital Yamagata, 990-9585 Japan |
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 |
Recruiting | |
Provita Profamilia Piotrkow Trybunalski, 97-300 Poland |
Recruiting | |
Clinical Research Center Spolka z ograniczona odpowiedzialnoscia MEDIC-R Spolka Komandytowa Poznan, 60-848 Poland |
Recruiting | |
Niepubliczny Zakład Opieki Zdrowotnej Nr 1 Rumia, 84-230 Poland |
Not yet recruiting | |
ETG Skierniewice Skierniewice, 96-100 Poland |
Not yet recruiting | |
Provita 001 Warszawa, 02-647 Poland |
Recruiting | |
Medical Concierge Centrum Medyczne Warszawa, 02-798 Poland |
Not yet recruiting | |
Lexmedica Wroclaw, 53-114 Poland |
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 |
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 |
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 |
Recruiting | |
Federal Budgetary Institution of Healthcare "Privolzhsky District Medical Center of the Federal Nizhny Novgorod, 603074 Russian Federation |
Recruiting | |
BHI of Omsk region "Clinical Oncological Dispensary" Omsk, 644013 Russian Federation |
Recruiting | |
State Budgetary Institution of Ryazan Region "Regional Clinical Oncology Center" Ryazan, 390011 Russian Federation |
Not yet recruiting | |
Federal State Budgetary Healthcare Institution Saint - Petersburg Saint-Petersburg, 194017 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 | |
Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital" Vologda, 160022 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 | |
Hospital Universitari de Bellvitge L'Hospitalet de Llobregat, Barcelona 08907 Spain |
Not yet recruiting | |
Hospital Duran i Reynals- ICO L'Hospitalet L'Hospitalet de Llobregat, Barcelona 08908 Spain |
Not yet recruiting | |
Complejo Hospitalario de Navarra Pamplona, Navarra 31008 Spain |
Recruiting | |
Hospital Universitari Sant Joan de Reus Reus, Tarragona 43204 Spain |
Not yet recruiting | |
Complejo Hospitalario Universitario A Coruna A Coruna, 15006 Spain |
Recruiting | |
Hospital del Mar Barcelona, 08003 Spain |
Recruiting | |
Hospital San Pedro de Alcantara Caceres, 10003 Spain |
Not yet recruiting | |
Hospital Universitari de Girona Doctor Josep Trueta Girona, 17007 Spain |
Not yet recruiting | |
Hospital Universitario Lucus Augusti Lugo, 27003 Spain |
Recruiting | |
Hospital Universitario de La Princesa Madrid, 28006 Spain |
Recruiting | |
Hospital Universitario La Princesa Madrid, 28006 Spain |
Recruiting | |
Hospital Clínico San Carlos Madrid, 28040 Spain |
Recruiting | |
Fundacion Instituto Valenciano de Oncologia Valencia, 46009 Spain |
Not yet recruiting | |
Hospital Arnau de Vilanova Valencia, 46015 Spain |
Recruiting | |
Barts Health NHS Trust, St Bartholomew's Hospital London, EC1A 7BE United Kingdom |
Recruiting |