A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer
CREST
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 or PF-06801591 as a Single Agent in Participants With BCG-Unresponsive NMIBC
3 other identifiers
interventional
1,068
14 countries
194
Brief 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. On August 31, 2022, the Sponsor announced the discontinuation of enrollment to Part B. The decision to discontinue enrollment to Part B was not made for safety reasons.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2019
Longer than P75 for phase_3
194 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2019
CompletedFirst Posted
Study publicly available on registry
November 15, 2019
CompletedStudy Start
First participant enrolled
December 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 2, 2024
CompletedResults Posted
Study results publicly available
January 22, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 2, 2026
ExpectedJanuary 22, 2026
January 1, 2026
4.9 years
November 13, 2019
November 24, 2025
January 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cohort A: Event Free Survival (EFS) as Assessed by the Investigator: Arm A Versus Arm C
EFS: time from randomization till recurrence of high-grade disease, progression of disease, persistence of carcinoma in situ (CIS), death due to any cause, whichever occurred first. Recurrence of high-grade disease: re-appearance of high-grade disease after randomization/study intervention initiation, re-appearance of high-grade disease after complete response (CR) for CIS participants or re-appearance of high-grade disease before CR for CIS participants and concurrent papillary disease at baseline. Progression of disease defined as any of following: Lamina propria invasion, muscle invasive disease, lymph node positive disease, metastatic disease, high-grade stage of bladder cancer (non-invasive papillary carcinoma \[Ta\] or invasion into the lamina propria without invasion into the muscularis propria \[T1\]) in participants with CIS only at baseline before achieving CR. Persistence of CIS: persistent CIS after induction, re-induction. EFS estimated using Kaplan-Meier analysis.
From randomization (Day 1) to first documentation of high-grade disease, progression of disease, persistence of CIS or death due to any cause, whichever occurred first (maximum follow up duration was up to 257.1 weeks)
Secondary Outcomes (19)
Cohort A: EFS as Assessed by the Investigator: Arm B Versus Arm C
From randomization (Day 1) to the first documentation of high-grade disease, progression of disease, persistence of CIS or death due to any cause, whichever occurred first (maximum follow up duration was up to 257.1 weeks)
Cohort A: Overall Survival (OS) for Participants: Arm A Versus Arm C
From randomization (Day 1) until date of death due to any cause or censoring date
Cohort A: OS of Participants: Arm B Versus Arm C
From randomization (Day 1) until date of death due to any cause or censoring date
Cohort A: Percentage of Participants With Complete Response (CR)as Assessed by Investigator: Participants With CIS at Baseline in Full Analysis Set
From randomization (Day 1) to the first documented CR (maximum follow up duration was up to 257.1 weeks)
Cohort A: Duration of CR as Assessed by the Investigator: Participants With CIS at Baseline in Full Analysis Set
From date of first documentation of CR to date of an EFS event (maximum follow up duration was up to 257.1 weeks)
- +14 more secondary outcomes
Study Arms (5)
PF-06801591 + BCG induction and maintenance
EXPERIMENTALPF-06801591 in combination with Bacillus Calmette Guerin(induction+maintenance).
PF-06801591 + BCG induction only
EXPERIMENTALPF-06801591 in combination with Bacillus Calmette Guerin (induction only).
BCG induction and maintenance
ACTIVE COMPARATORBacillus Calmette Guerin (induction and maintenance).
BCG Unresponsive CIS
EXPERIMENTALPF-06801591
BCG Unresponsive NMIBC
EXPERIMENTALPF-06801591
Interventions
A monoclonal antibody (mAb) that blocks the interaction between PD-1 and PD-L1/PD-L2.
Immunotherapy treatment approved by FDA for patients with high-risk non-muscle invasive bladder cancer
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (194)
Arizona Urology Specialists
Tucson, Arizona, 85741, United States
Arkansas Urology
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
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
Ochsner LSU Health Shreveport - Regional Urology
Shreveport, Louisiana, 71106, United States
Chesapeake Urology Research Associates
Hanover, Maryland, 21076, United States
Michigan Institute of Urology, PC
Troy, Michigan, 48084, 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
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
Montefiore Medical Center - Montefiore Medical Park
The Bronx, New York, 10461, United States
Montefiore Medical Center - Oncology Investigational Services
The Bronx, New York, 10461, United States
VA Portland Healthcare System
Portland, Oregon, 97239, United States
AUC Urologists LLC
Murrells Inlet, South Carolina, 29576, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
Parkway Surgery Center
Myrtle Beach, South Carolina, 29572, United States
Atlantic Urology Clinics South Strand Office
Myrtle Beach, South Carolina, 29588., United States
Urology Clinics of North Texas
Dallas, Texas, 75231, United States
Baylor University Medical Center
Dallas, Texas, 75246, 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
Chesapeake Regional Surgery Center - Virginia Beach
Virginia Beach, Virginia, 23462, United States
Urology of Virginia, PLLC
Virginia Beach, Virginia, 23462, United States
Southern Highlands Cancer Centre
Bowral, New South Wales, 2576, Australia
Chris O'Brien Lifehouse Hospital
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
Ghent, 9000, Belgium
Vancouver Prostate Centre at the Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
Hamilton Regional Laboratory Medicine Program
Hamilton, Ontario, L8N 4A6, Canada
Kingston Health Sciences Center - Queen's University
Kingston, Ontario, K7L 2V7, Canada
Centre for Applied Urological Research
Kingston, Ontario, K7L 3J7, Canada
Kingston Health Sciences Centre -- Hotel Dieu Hospital
Kingston, Ontario, K7L 5G2, Canada
University Health Network , Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
University Health Network
Toronto, Ontario, M5G 2C4, Canada
University Health Network - Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Centre integre universitaire de sante et de services sociaux (CIUSSS) du Saguenay-Lac-Saint-Jean
Chicoutimi, Quebec, G7H 5H6, Canada
Centre intégré universitaire de santé et de services sociaux (CIUSSS) du Saguenay-Lac-Saint-Jean
Chicoutimi, Quebec, G7H 7K9, Canada
The Research Institute of the McGill University Health Centre
Montreal, Quebec, H3H 2R9, Canada
McGill University Health Centre
Montreal, Quebec, H4A 3J1, Canada
Hotel-Dieu de Quebec - CHU de Quebec - Universite Laval
Québec, Quebec, G1R 2J6, Canada
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022, China
Beijing Chao-yang Hospital
Beijing, Beijing Municipality, 100020, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Fujian Medical University Affiliated First Hospital
Fuzhou, Fujian, 350005, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008, China
Nantong Tumor Hospital
Nantong, Jiangsu, 226000, China
Second Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, 215004, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi, 710061, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014, China
Ningbo First Hospital
Ningbo, Zhejiang, 315010, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325035, China
Chongqing University Cancer Hospital
Chongqing, 400030, China
Fudan University Cancer Hospital
Shanghai, 200032, China
Fudan University Shanghai Cancer Center
Shanghai, 201321, China
The Second Hospital of Tianjin Medical University
Tianjin, 300211, China
Hôpital privé Antony (Pharmacy)
Antony, 92160, France
Clinique Belharra
Bayonne, 64100, France
CHU de Bordeaux Hôpital Pellegrin
Bordeaux, 33000, France
Clinique Saint-Augustin
Bordeaux, 33074, France
Institut Bergonié
Bordeaux, 33076, France
Cabinet Privé d'urologie
Brest, 29200, France
CHPB Keraudren
Brest, 29200, France
Groupe Vivalto Sante - Clinique Pasteur-Lanroze- CFRO
Brest, 29229, 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, 47169, Germany
Klinikum der Goethe-Universitaet Frankfurt
Frankfurt, 60590, Germany
Universitaetsklinikum Muenster, Urologie
Münster, 48149, Germany
Studienpraxis Urologie
Nürtingen, 72622, Germany
Universitaetsklinikum Tuebingen
Tübingen, 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
Ordine Mauriziano Umberto I Hospital,
Turin, Other, 10128, Italy
Azienda USL IRCCS di Reggio Emilia
Reggio Emilia, RE, 42122, Italy
Azienda Unita Sanitaria Locale Toscana Sud-Est
Arezzo, 52100, Italy
Ospedale Area Aretina Nord - UOC Oncologia Medica
Arezzo, 52100, Italy
Ospedale San Donato
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
AO Azienda Ospedaliera Ordine Mauriziano Di Torino
Turin, 10128, Italy
ASST Sette Laghi Ospedale di Circolo Fondazione Macchi
Varese, 21100, Italy
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 791-0280, Japan
Ehime University Hospital
Tōon, Ehime, 791-0295, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka, 811-1395, Japan
Gunma Prefectural Cancer Center
Ōta, Gunma, 373-8550, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804, Japan
Kanagawa cancer center
Yokohama, Kanagawa, 241-8515, Japan
Osaka International Cancer Institute
Osaka, Osaka, 541-8567, Japan
Kindai University Hospital
Sayama, Osaka, 589-8511, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582, Japan
Kagoshima University Hospital
Kagoshima, 890-8520, Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, 860-0008, Japan
Okayama Medical Center
Okayama, 701-1192, Japan
Yamagata University Hospital
Yamagata, 990-9585, Japan
NZOZ AKMED Andrzej Kupilas
Gliwice, 44-100, Poland
Regionalny Szpital Specjalistyczny im. Dr. Wladyslawa Bieganskiego
Grudziądz, 86-300, Poland
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Urologiczne Sp. z o.o.
Mysłowice, 41-400, Poland
Provita Profamilia
Piotrkow Trybunalski, 97-300, Poland
Clinical Research Center Spolka z ograniczona odpowiedzialnoscia MEDIC-R Spolka Komandytowa
Poznan, 60-848, Poland
Clinical Research Center Spolka z ograniczona odpowiedzialnoscia MEDIC-R Spolka Komandytowa
Poznan, 61-731, Poland
ETG Skierniewice
Skierniewice, 96-100, Poland
Provita 001
Warsaw, 02-647, Poland
Medical Concierge Centrum Medyczne
Warsaw, 02-798, Poland
Lexmedica
Wroclaw, 53-114, Poland
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
Łódż, Łódź Voivodeship, 93-513, Poland
A.Tsyb Medical Research Radiological Center of the Ministry of Health of the Russian Federation
Obninsk, Kaluzhskaya OBL., 249036, Russia
State Budgetary Institution of Healthcare of the Republic of Mordovia
Saransk, Respublika Mordoviya, 430032, Russia
Private Medical Institution "Euromedservice"
Pushkin, Sankt-Peterburg, 196603, Russia
Klinika UZI 4D, LLC
Pyatigorsk, Stavropolskiy KRAI, 357502, Russia
Evimed Llc
Chelyabinsk, 454048, Russia
Regional Budgetary Healthcare Institution "Ivanovo Regional Oncology Dispensary"
Ivanovo, 153040, Russia
Ars Medika Center, LLC
Kaliningrad, 236006, Russia
Kaluga Regional Clinical Oncology Center
Kaluga, 248007, Russia
P.A. Hertsen Moscow Oncology Research Center- branch of the National Medical Research
Moscow, 125284, Russia
Federal Budgetary Institution of Healthcare "Privolzhsky District Medical Center of the Federal
Nizhny Novgorod, 603074, Russia
National Medical Research Radiological Centre of the MoH of the Russian Federation
Obninsk, 249036, Russia
BHI of Omsk region "Clinical Oncological Dispensary"
Omsk, 644013, Russia
State Budgetary Institution of Ryazan Region "Regional Clinical Oncology Center"
Ryazan, 390011, Russia
Federal State Budgetary Healthcare Institution Saint - Petersburg
Saint Petersburg, 194017, Russia
Limited Liability Company "North-Western Medical Center"
Saint Petersburg, 194355, Russia
Hospital OrKli LLC
Saint Petersburg, 199178, Russia
Federal State Budgetary Educational Institution of Higher Education
Saransk, 4з0032, Russia
Republican Clinical Oncology Dispensary of the Ministry of Health of Bashkortostan Republic
Ufa, 450054, Russia
Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"
Vologda, 160002, Russia
Leningrad Regional Clinical Hospital
Vsevolozhskiy District, 188663, Russia
SBHI YaR Regional clinical oncology hospital
Yaroslavl, 150054, Russia
National Cancer Center
Goyang-si, Gyeonggi-do, 10408, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], 03080, South Korea
Kyungpook National University Chilgok Hospital
Daegu, 41404, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
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 Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, 31008, Spain
Salut Sant Joan de Reus-Baix Camp
Reus, Tarragona, 43204, Spain
Complejo Hospitalario Universitario A Coruna
A Coruña, 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
Cáceres, 10003, Spain
Hospital Universitari de Girona Doctor Josep Trueta
Girona, 17007, Spain
Hospital de Llíria
Llíria, 46160, Spain
Hospital Universitario Lucus Augusti
Lugo, 27003, Spain
Hospital Universitario de 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, CITY of London, EC1A 7BE, United Kingdom
Barts Health NHS Trust, of Royal London Hospital
London, E1 1FR, United Kingdom
Imperial College Healthcare NHS Trust, of The Bays, St. Mary's Hospital
London, W2 1NY, United Kingdom
Charing Cross Hospital
London, W6 8RF, United Kingdom
Related Publications (2)
Shore ND, Powles TB, Bedke J, Galsky MD, Palou Redorta J, Ku JH, Kretkowski M, Xylinas E, Alekseev B, Ye D, Guerrero-Ramos F, Briganti A, Kulkarni GS, Brinkmann J, Calella AM, Cesari R, Eccleston A, Michelon E, Vermette J, Wei C, Steinberg GD. Sasanlimab plus BCG in BCG-naive, high-risk non-muscle invasive bladder cancer: the randomized phase 3 CREST trial. Nat Med. 2025 Aug;31(8):2806-2814. doi: 10.1038/s41591-025-03738-z. Epub 2025 May 31.
PMID: 40450141DERIVEDSteinberg GD, Shore ND, Redorta JP, Galsky MD, Bedke J, Ku JH, Kretkowski M, Hu H, Penkov K, Vermette JJ, Tarazi JC, Randall AE, Pierce KJ, Saltzstein D, Powles TB. CREST: phase III study of sasanlimab and Bacillus Calmette-Guerin for patients with Bacillus Calmette-Guerin-naive high-risk non-muscle-invasive bladder cancer. Future Oncol. 2024 May;20(14):891-901. doi: 10.2217/fon-2023-0271. Epub 2024 Jan 8.
PMID: 38189180DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Enrollment in Cohort B was closed based on sponsors decision; hence, the study objectives for Cohorts B1 and B2 were no longer required as pre-specified in the protocol; outcome measures for Cohorts B based on the data collected will be summarized and reported at the time of final analysis.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2019
First Posted
November 15, 2019
Study Start
December 30, 2019
Primary Completion
December 2, 2024
Study Completion (Estimated)
December 2, 2026
Last Updated
January 22, 2026
Results First Posted
January 22, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.