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.
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.
On August 31, 2022, the Sponsor announced the discontinuation of enrollment to Part B, which enrolled participants with BCG unresponsive NMIBC. The decision to discontinue enrollment to Part B was not made for safety reasons.
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.
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There are 171 Locations for this study
Tucson Arizona, 85715, United States
Tucson Arizona, 85741, United States
Little Rock Arkansas, 72211, United States
Little Rock Arkansas, 72211, United States
La Jolla California, 92037, United States
La Jolla California, 92037, United States
La Jolla California, 92037, United States
La Jolla California, 92093, United States
Orange California, 92868, United States
San Diego California, 92103, United States
Denver Colorado, 80211, United States
Hialeah Florida, 33016, United States
Jacksonville Florida, 32209, United States
Jacksonville Florida, 32218, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60612, United States
Lisle Illinois, 60532, United States
Lombard Illinois, 60148, United States
Lombard Illinois, 60148, United States
Naperville Illinois, 60540, United States
Shreveport Louisiana, 71106, United States
Shreveport Louisiana, 71106, United States
Hanover Maryland, 21076, United States
Troy Michigan, 48084, United States
Bronx New York, 10461, United States
Bronx New York, 10461, United States
New Windsor New York, 12553, United States
New York New York, 10016, United States
New York New York, 10016, United States
New York New York, 10016, United States
New York New York, 10017, United States
New York New York, 10029, United States
New York New York, 10029, United States
Poughkeepsie New York, 12601, United States
Poughkeepsie New York, 12603, United States
Syracuse New York, 13210, United States
Portland Oregon, 97239, United States
Myrtle Beach South Carolina, 29572, United States
Myrtle Beach South Carolina, 29572, United States
Dallas Texas, 75231, United States
Dallas Texas, 75246, United States
Houston Texas, 77027, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
Norfolk Virginia, 23507, United States
Virginia Beach Virginia, 23462, United States
Bowral New South Wales, 2756, Australia
Campbelltown New South Wales, 2560, Australia
Campbelltown New South Wales, 2560, Australia
Camperdown New South Wales, 2050, Australia
Camperdown New South Wales, 2050, Australia
Box Hill Victoria, 3128, Australia
Box Hill Victoria, 3128, Australia
Lilydale Victoria, 3140, Australia
Gent , 9000, Belgium
Vancouver British Columbia, V5Z 1, Canada
Hamilton Ontario, L8N 4, Canada
Hamilton Ontario, L8N 4, Canada
Kingston Ontario, K7L 2, Canada
Kingston Ontario, K7L 3, Canada
Kingston Ontario, K7L 5, Canada
Toronto Ontario, M5G 2, Canada
Toronto Ontario, M5G2C, Canada
Chicoutimi Quebec, G7H 5, Canada
Montreal Quebec, H4A 3, Canada
Quebec , G1R 2, Canada
Hefei Anhui, 23002, China
Beijing Beijing, 10002, China
Beijing Beijing, 10003, China
Beijing Beijing, 10014, China
Beijing Beijing, 10073, China
Fuzhou Fujian, 35000, China
Wuhan Hubei, 43002, China
Changsha Hunan, 41001, China
Nanjing Jiangsu, 21000, China
Nantong Jiangsu, 22600, China
Suzhou Jiangsu, 21500, China
Nanchang Jiangxi, 33000, China
Xi'an Shaanxi, 71006, China
Chengdu Sichuan, 61004, China
Hangzhou Zhejiang, 31001, China
Ningbo Zhejiang, 31501, China
Wenzhou Zhejiang, 32500, China
Wenzhou Zhejiang, 32503, China
Chongqing , 40003, China
Shanghai , 20003, China
Tianjin , 30021, China
Antony , 92160, France
Antony , 92160, France
Bayonne , 64100, France
BORDEAUX Cedex , 33074, France
Bordeaux Cedex , 33076, France
Bordeaux , 33000, France
Brest Cedex 2 , 29229, France
Brest , 29200, France
Brest , 29200, France
Limoges Cedex 1 , 87038, France
Limoges , 87000, France
Nancy , 54100, France
Paris , 75877, France
Strasbourg , 67000, France
Duisburg , 47179, Germany
Frankfurt , 60590, Germany
Muenster , 48149, Germany
Nuertingen , 72622, Germany
Tuebingen , 72076, Germany
Misterobianco (CT) Catania, 95045, Italy
Cremona CR, 26100, Italy
Rozzano Milano, 20089, Italy
Torino Turin, 10128, Italy
Arezzo , 52100, Italy
Bari , 70124, Italy
Genova , 16132, Italy
Macerata , 62100, Italy
Messina , 98158, Italy
Milan , 20132, Italy
Reggio Emilia , 42123, Italy
Varese , 21100, Italy
Matsuyama Ehime, 791-0, Japan
Toon Ehime, 791-0, Japan
Fukuoka-shi Fukuoka, 811-1, Japan
Ota Gunma, 373-8, Japan
Sapporo Hokkaido, 003-0, Japan
Yokohama Kanagawa, 241-8, Japan
Osaka-shi Osaka, 541-8, Japan
Osakasayama Osaka, 589-8, Japan
Hamamatsu Shizuoka, 431-3, Japan
Shinjuku-ku Tokyo, 160-8, Japan
Kagoshima , 890-8, Japan
Kumamoto , 860-0, Japan
Okayama , 701-1, Japan
Yamagata , 990-9, Japan
Goyang-si Gyeonggi-do, 10408, Korea, Republic of
Seongnam-si Gyeonggi-do, 13620, Korea, Republic of
Daegu , 41404, Korea, Republic of
Seoul , 02841, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 06351, Korea, Republic of
Belchatow , 97-40, Poland
Gliwice , 44-10, Poland
Grudziadz , 86-30, Poland
Mysłowice , 41-40, Poland
Piotrkow Trybunalski , 97-30, Poland
Poznan , 61-73, Poland
Skierniewice , 96-10, Poland
Warszawa , 02-64, Poland
Warszawa , 02-79, Poland
Wroclaw , 53-11, Poland
Obninsk Kaluzhskaya OBL., 24903, Russian Federation
Leningrad Region Other, 18866, Russian Federation
Saransk Republic OF Mordovia, 43003, Russian Federation
Pushkin Saint-petersburg, 19660, Russian Federation
Pyatigorsk Stavropolskiy KRAI, 35750, Russian Federation
Kuzmolovsky Settlement Vsevolozhsky District, 18866, Russian Federation
Chelyabinsk , 45404, Russian Federation
Ivanovo , 15304, Russian Federation
Kaliningrad , 23600, Russian Federation
Kaluga , 24800, Russian Federation
Moscow , 12528, Russian Federation
Nizhny Novgorod , 60307, Russian Federation
Omsk , 64401, Russian Federation
Ryazan , 39001, Russian Federation
Saint Petersburg , 19435, Russian Federation
Saint-Petersburg , 19401, Russian Federation
Saint-Petersburg , 19429, Russian Federation
Saint-Petersburg , 19809, Russian Federation
Saint-Petersburg , 19917, Russian Federation
Ufa , 45005, Russian Federation
Vologda , 16002, Russian Federation
Yaroslavl , 15005, Russian Federation
Badalona Barcelona, 08916, Spain
Granollers Barcelona, 08402, Spain
L'Hospitalet de Llobregat Barcelona, 08907, Spain
L'Hospitalet de Llobregat Barcelona, 08908, Spain
Majadahonda Madrid, 28222, Spain
Pamplona Navarra, 31008, Spain
Reus Tarragona, 43204, Spain
A Coruna , 15006, Spain
Barcelona , 08003, Spain
Barcelona , 08025, Spain
Barcelona , 08041, Spain
Caceres , 10003, Spain
Girona , 17007, Spain
Lugo , 27003, Spain
Madrid , 28006, Spain
Madrid , 28006, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Valencia , 46009, Spain
Valencia , 46015, Spain
London , EC1A , United Kingdom
London , W6 8R, United Kingdom
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