Bladder Cancer Clinical Trial

A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer

Summary

The purpose of this study is to learn about the safety and effects of the study medicine (sasanlimab) in people with non-muscle invasive bladder cancer. This study is seeking participants whose bladder cancer is still in early stages, has not spread outside of the bladder, has been removed with surgery, and is high risk (Part A) or was previously treated with BCG (Bacillus Calmette Guerin), a standard treatment for bladder cancer (Part B).

In Part A (enrollment closed), each participant was assigned to one of three study treatment groups.

One group is given sasanlimab and BCG at the study clinic.
The second group is given sasanlimab and BCG at the study clinic. This group will receive BCG for the first six weeks only.
The third group is given BCG only and will not receive sasanlimab.

In Part B of the study, each new participant will be assigned to a study treatment group based on the type of their bladder tumor.

- Both groups will be given sasanlimab at the study clinic.

View Full Description

Full Description

CREST: Combination of sasanlimab and alternative BCG Regimens to Evaluate outcomes with Subcutaneous anti-PD-1 Treatment

Phase 3 Design with two Cohorts. Cohort A consists of 3 study Arms (A, B and C) of BCG naive participants. Arms A and B consist of two study drugs, PF-06801591 plus BCG. Arm C consists of one study drug, BCG. Cohort B consists of B1 and B2, which test PF-06801591 and include participants who have BCG unresponsive CIS (B1) or BCG unresponsive papillary only disease (B2).

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. The study is also designed to estimate the CR rate of PF-06801591 alone in participants with BCG unresponsive CIS and to evaluate the EFS of PF-06801591 alone in participants with BCG unresponsive NMIBC.

View Eligibility Criteria

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 positive TURBT occurring within 12 weeks prior to randomization or study intervention. A second TURBT must have been performed if indicated according to the current locally applicable guidelines, ie, American Urological Association, European Association of Urology
(Cohorts B1 and B2 only): Histological confirmed diagnosis of BCG-unresponsive high-risk, non-muscle invasive TCC of the urothelium within 12 months (CIS only) or 6 months (recurrent Ta/T1 disease) of completion of adequate BCG therapy.
Have refused or are ineligible for radical cystectomy

Exclusion Criteria:

Evidence of muscle-invasive, locally advanced or metastatic urothelial cancer or concurrent extravesical, non-muscle invasive TCC of the urothelium
(Cohort A only): Intravesical BCG therapy within 2 years prior to randomization. Prior intravesical chemotherapy for NMIBC is allowed.

(Cohorts B1 and B2 only): Any systemic or intravesical chemotherapy or immunotherapy from the time of most recent positive TURBT to initiation of study intervention.

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
(Cohorts B1 and B2 only): Prior participation in Cohort A of this study.

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

1160

Study ID:

NCT04165317

Recruitment Status:

Active, not recruiting

Sponsor:

Pfizer

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There are 169 Locations for this study

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Urological Associates of Southern Arizona, P.C .
Tucson Arizona, 85715, United States
Urological Associates of Southern Arizona P.C.
Tucson Arizona, 85741, United States
Arkansas Urology
Little Rock Arkansas, 72211, United States
Centerview Surgery Center
Little Rock Arkansas, 72211, United States
Koman Family Outpatient Pavilion
La Jolla California, 92037, United States
Sulpizio Cardiovascular Center at UC San Diego Health
La Jolla California, 92037, United States
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
La Jolla California, 92037, United States
UC San Diego Moores Cancer Center
La Jolla California, 92093, United States
University of California Irvine Medical Center
Orange California, 92868, United States
UC San Diego Medical Center - Hillcrest
San Diego California, 92103, United States
The Urology Center of Colorado
Denver Colorado, 80211, United States
Urological Research Network Corp
Hialeah Florida, 33016, United States
UF Health Jacksonville
Jacksonville Florida, 32209, United States
UF Health North
Jacksonville Florida, 32218, United States
John H. Stroger, Jr. Hospital of Cook County/IND Pharmacy
Chicago Illinois, 60612, United States
John H. Stroger, Jr. Hospital of Cook County
Chicago Illinois, 60612, United States
DuPage Medical Group
Lisle Illinois, 60532, United States
DuPage Medical Group Ambulatory Surgery Center
Lombard Illinois, 60148, United States
DuPage Medical Group
Lombard Illinois, 60148, United States
Edward Hospital
Naperville Illinois, 60540, United States
Regional Urology Oncology & Radiation Center
Shreveport Louisiana, 71106, United States
Regional Urology, LLC
Shreveport Louisiana, 71106, United States
Chesapeake Urology Research Associates
Hanover Maryland, 21076, United States
Michigan Institute of Urology, PC
Troy Michigan, 48084, United States
Montefiore Medical Center - Montefiore Medical Park
Bronx New York, 10461, United States
Montefiore Medical Center - Oncology Investigational Services
Bronx New York, 10461, United States
Premier Medical Group of the Hudson Valley PC
New Windsor New York, 12553, United States
Bellevue Hospital
New York New York, 10016, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York New York, 10016, United States
NYU Langone Medical Center (Tisch Hospital)
New York New York, 10016, United States
NYU Langone Health Urology Associates
New York New York, 10017, United States
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States
Mount Sinai Hospital
New York New York, 10029, United States
Dutchess Ambulatory Surgery Center
Poughkeepsie New York, 12601, United States
Premier Medical Group of the Hudson Valley PC
Poughkeepsie New York, 12603, United States
Associated Medical Professionals of New York, PLLC
Syracuse New York, 13210, United States
VA Portland Healthcare System
Portland Oregon, 97239, United States
Carolina Urologic Research Center
Myrtle Beach South Carolina, 29572, United States
Parkway Surgery Center
Myrtle Beach South Carolina, 29572, United States
Urology Clinics of North Texas
Dallas Texas, 75231, United States
Urology Clinics of North Texas
Dallas Texas, 75246, United States
Houston Metro Urology
Houston Texas, 77027, United States
Houston Methodist Hospital
Houston Texas, 77030, United States
Urology San Antonio PA
San Antonio Texas, 78229, United States
Sentara Norfolk General Hospital
Norfolk Virginia, 23507, United States
Urology of Virginia, PLLC
Virginia Beach Virginia, 23462, United States
Southern Highlands Cancer Centre
Bowral New South Wales, 2756, Australia
Campbelltown Hospital
Campbelltown New South Wales, 2560, Australia
Campbelltown Private Hospital
Campbelltown New South Wales, 2560, Australia
Chris O'Brien Lifehouse
Camperdown New South Wales, 2050, Australia
Box Hill Hospital
Box Hill Victoria, 3128, Australia
Eastern Clinical Research Unit
Box Hill Victoria, 3128, Australia
Yarra Ranges Health
Lilydale Victoria, 3140, Australia
UZ Gent
Gent , 9000, Belgium
Vancouver Prostate Centre at the Vancouver General Hospital
Vancouver British Columbia, V5Z 1, Canada
Hamilton Regional Laboratory Medicine Program
Hamilton Ontario, L8N 4, Canada
McMaster Institute of Urology/St Joseph's Healthcare Hamilton
Hamilton Ontario, L8N 4, Canada
Kingston Health Sciences Centre - Kingston General Hospital
Kingston Ontario, K7L 2, Canada
Centre for Applied Urological Research
Kingston Ontario, K7L 3, Canada
Kingston Health Sciences Centre -- Hotel Dieu Hospital
Kingston Ontario, K7L 5, Canada
University Health Network - Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
University Health Network - Toronto General Hospital
Toronto Ontario, M5G2C, Canada
Centre intégré universitaire de santé et de services sociaux du Saguenay-Lac-Saint-Jean
Chicoutimi Quebec, G7H 5, Canada
McGill University Health Centre
Montreal Quebec, H4A 3, Canada
Hotel-Dieu de Quebec - CHU de Quebec - Universite Laval
Quebec , G1R 2, Canada
The First Affiliated Hospital of Anhui Medical University
Hefei Anhui, 23002, China
Beijing Chao-yang Hospital
Beijing Beijing, 10002, China
Peking University First Hospital
Beijing Beijing, 10003, China
Beijing Cancer Hospital
Beijing Beijing, 10014, China
Peking Union Medical College Hospital
Beijing Beijing, 10073, China
Fujian Medical University Affiliated First Hospital
Fuzhou Fujian, 35000, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan Hubei, 43002, China
Hunan Cancer Hospital
Changsha Hunan, 41001, China
Nanjing Drum Tower Hospital
Nanjing Jiangsu, 21000, China
Nantong Tumor Hospital
Nantong Jiangsu, 22600, China
Second Affiliated Hospital of Suzhou University
Suzhou Jiangsu, 21500, China
The First Affiliated Hospital of Nanchang University
Nanchang Jiangxi, 33000, China
First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an Shaanxi, 71006, China
West China Hospital of Sichuan University
Chengdu Sichuan, 61004, China
Zhejiang Provincial People's Hospital
Hangzhou Zhejiang, 31001, China
Ningbo First Hospital
Ningbo Zhejiang, 31501, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou Zhejiang, 32500, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou Zhejiang, 32503, China
Chongqing University Cancer Hospital
Chongqing , 40003, China
Fudan University Cancer Hospital
Shanghai , 20003, China
The Second Hospital of Tianjin Medical University
Tianjin , 30021, China
Hôpital privé Antony (Pharmacy)
Antony , 92160, France
Hôpital Privé d'Antony
Antony , 92160, France
Clinique Belharra
Bayonne , 64100, France
Clinique Saint-Augustin
BORDEAUX Cedex , 33074, France
Institut Bergonié
Bordeaux Cedex , 33076, France
CHU de Bordeaux Hôpital Pellegrin
Bordeaux , 33000, France
Groupe Vivalto Sante - Clinique Pasteur-Lanroze- CFRO
Brest Cedex 2 , 29229, France
Cabinet Privé d'urologie
Brest , 29200, France
CHPB Keraudren
Brest , 29200, France
Polyclinique de Limoges Site Emailleurs-Colombier
Limoges Cedex 1 , 87038, France
Polyclinique de Limoges Site Chenieux
Limoges , 87000, France
Polyclinique de Gentilly
Nancy , 54100, France
Hôpital Bichat - Claude-Bernard
Paris , 75877, France
Clinique Sainte Anne
Strasbourg , 67000, France
Urologicum Duisburg
Duisburg , 47179, Germany
Klinikum der Goethe-Universitaet Frankfurt
Frankfurt , 60590, Germany
Universitaetsklinikum Muenster, Urologie
Muenster , 48149, Germany
Studienpraxis Urologie
Nuertingen , 72622, Germany
Universitaetsklinikum Tuebingen
Tuebingen , 72076, Germany
Humanitas Istituto Clinico Catanese S.p.A - U.O. Oncologia Medica
Misterobianco (CT) Catania, 95045, Italy
UO Oncologia, ASST di Cremona - Istituti Ospitalieri - Ospedale di Cremona
Cremona CR, 26100, Italy
IRCSS Istituto Clinico Humanitas - U.O. Oncologia Medica
Rozzano Milano, 20089, Italy
AO Azienda Ospedaliera Ordine Mauriziano Di Torino
Torino Turin, 10128, Italy
Ospedale Area Aretina Nord - UOC Oncologia Medica
Arezzo , 52100, Italy
UO Oncologia Medica IRCCS Istituto Tumori "Giovanni Paolo II"
Bari , 70124, Italy
IRCCS Azienda Ospedaliera Universitaria Policlinico San Martino Urologia
Genova , 16132, Italy
Ospedale Generale Provinciale di Macerata - UOC Oncologia
Macerata , 62100, Italy
Medical Oncology Unit, AO Papardo
Messina , 98158, Italy
IRCCS Ospedale San Raffaele, URI (Urological Research Institute)
Milan , 20132, Italy
AUSL/IRCCS di Reggio Emilia
Reggio Emilia , 42123, Italy
ASST Sette Laghi Ospedale di Circolo Fondazione Macchi
Varese , 21100, Italy
National Hospital Organization Shikoku Cancer Center
Matsuyama Ehime, 791-0, Japan
Ehime University Hospital
Toon Ehime, 791-0, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka-shi Fukuoka, 811-1, Japan
Gunma Prefectural Cancer Center
Ota Gunma, 373-8, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo Hokkaido, 003-0, Japan
Kanagawa cancer center
Yokohama Kanagawa, 241-8, Japan
Osaka International Cancer Institute
Osaka-shi Osaka, 541-8, Japan
Kindai University Hospital
Osakasayama Osaka, 589-8, Japan
Hamamatsu University Hospital
Hamamatsu Shizuoka, 431-3, Japan
Keio University Hospital
Shinjuku-ku Tokyo, 160-8, Japan
Kagoshima University Hospital
Kagoshima , 890-8, Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto , 860-0, Japan
Okayama Medical Center
Okayama , 701-1, Japan
Yamagata University Hospital
Yamagata , 990-9, Japan
National Cancer Center
Goyang-si Gyeonggi-do, 10408, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si Gyeonggi-do, 13620, Korea, Republic of
Kyungpook National University Chilgok Hospital
Daegu , 41404, Korea, Republic of
Korea University Anam Hospital
Seoul , 02841, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Szpital Wojewodzki im Jana Pawla II
Belchatow , 97-40, Poland
NZOZ AKMED Andrzej Kupilas
Gliwice , 44-10, Poland
Regionalny Szpital Specjalistyczny im. Dr. Wladyslawa Bieganskiego
Grudziadz , 86-30, Poland
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Urologiczne Sp. z o.o.
Mysłowice , 41-40, Poland
Provita Profamilia
Piotrkow Trybunalski , 97-30, Poland
Clinical Research Center Spolka z ograniczona odpowiedzialnoscia MEDIC-R Spolka Komandytowa
Poznan , 61-73, Poland
ETG Skierniewice
Skierniewice , 96-10, Poland
Provita 001
Warszawa , 02-64, Poland
Medical Concierge Centrum Medyczne
Warszawa , 02-79, Poland
Lexmedica
Wroclaw , 53-11, Poland
A.Tsyb Medical Research Radiological Center of the Ministry of Health of the Russian Federation
Obninsk Kaluzhskaya OBL., 24903, Russian Federation
State Budgetary Institution of Healthcare of the Republic of Mordovia
Saransk Republic OF Mordovia, 43003, Russian Federation
Private Medical Institution "Euromedservice"
Pushkin Saint-petersburg, 19660, Russian Federation
Klinika UZI 4D, LLC
Pyatigorsk Stavropolskiy KRAI, 35750, Russian Federation
State Budgetary Healthcare Institution "Leningrad Regional Clinical Oncology Dispensary"
Kuzmolovsky Settlement Vsevolozhsky District, 18866, Russian Federation
Evimed Llc
Chelyabinsk , 45404, Russian Federation
Regional Budgetary Healthcare Institution "Ivanovo Regional Oncology Dispensary"
Ivanovo , 15304, Russian Federation
Ars Medika Center, LLC
Kaliningrad , 23600, Russian Federation
Kaluga Regional Clinical Oncology Center
Kaluga , 24800, Russian Federation
P.A. Hertsen Moscow Oncology Research Center- branch of the National Medical Research
Moscow , 12528, Russian Federation
Federal Budgetary Institution of Healthcare "Privolzhsky District Medical Center of the Federal
Nizhny Novgorod , 60307, Russian Federation
BHI of Omsk region "Clinical Oncological Dispensary"
Omsk , 64401, Russian Federation
State Budgetary Institution of Ryazan Region "Regional Clinical Oncology Center"
Ryazan , 39001, Russian Federation
Federal State Budgetary Healthcare Institution Saint - Petersburg
Saint-Petersburg , 19401, Russian Federation
Joint-Stock Company "North-Western Centre of Evidence-Based Medicine" ("NWCoEBM" JSC)
Saint-Petersburg , 19809, Russian Federation
Hospital OrKli LLC
Saint-Petersburg , 19917, Russian Federation
Republican Clinical Oncology Dispensary of the Ministry of Health of Bashkortostan Republic
Ufa , 45005, Russian Federation
Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"
Vologda , 16002, Russian Federation
SBHI YaR Regional clinical oncology hospital
Yaroslavl , 15005, Russian Federation
Hospital Universitari Germans Trias i Pujol
Badalona Barcelona, 08916, Spain
Hospital General de Granollers
Granollers Barcelona, 08402, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat Barcelona, 08907, Spain
Hospital Duran i Reynals- ICO L'Hospitalet
L'Hospitalet de Llobregat Barcelona, 08908, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda Madrid, 28222, Spain
Complejo Hospitalario de Navarra
Pamplona Navarra, 31008, Spain
Salut Sant Joan de Reus-Baix Camp
Reus Tarragona, 43204, Spain
Complejo Hospitalario Universitario A Coruna
A Coruna , 15006, Spain
Hospital del Mar
Barcelona , 08003, Spain
Fundacio Puigvert
Barcelona , 08025, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona , 08041, Spain
Hospital San Pedro de Alcantara
Caceres , 10003, Spain
Hospital Universitari de Girona Doctor Josep Trueta
Girona , 17007, Spain
Hospital Universitario Lucus Augusti
Lugo , 27003, Spain
Hospital Universitario de La Princesa
Madrid , 28006, Spain
Hospital Universitario La Princesa
Madrid , 28006, Spain
Hospital Clínico San Carlos
Madrid , 28040, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Fundacion Instituto Valenciano de Oncologia
Valencia , 46009, Spain
Hospital Arnau de Vilanova
Valencia , 46015, Spain
Barts Health NHS Trust, St Bartholomew's Hospital
London , EC1A , United Kingdom
Charing Cross Hospital
London , W6 8R, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

1160

Study ID:

NCT04165317

Recruitment Status:

Active, not recruiting

Sponsor:


Pfizer

How clear is this clinincal trial information?

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