search
Back to results

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

Primary Purpose

Non-muscle Invasive Bladder Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PF-06801591
Bacillus Calmette-Guerin
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-muscle Invasive Bladder Cancer focused on measuring CREST, Sasanlimab, PF-06801591, Bacillus Calmette Guerin, BCG, Bladder cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Urological Associates of Southern Arizona, P.C .
  • Urological Associates of Southern Arizona P.C.
  • Arkansas Urology
  • Centerview Surgery Center
  • Koman Family Outpatient Pavilion
  • Sulpizio Cardiovascular Center at UC San Diego Health
  • UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
  • UC San Diego Moores Cancer Center
  • University of California Irvine Medical Center
  • UC San Diego Medical Center - Hillcrest
  • The Urology Center of Colorado
  • Urological Research Network Corp
  • UF Health Jacksonville
  • UF Health North
  • John H. Stroger, Jr. Hospital of Cook County/IND Pharmacy
  • John H. Stroger, Jr. Hospital of Cook County
  • DuPage Medical Group
  • DuPage Medical Group Ambulatory Surgery Center
  • DuPage Medical Group
  • Edward Hospital
  • Ochsner LSU Health Shreveport - Regional Urology
  • Regional Urology Oncology & Radiation Center
  • Regional Urology, LLC
  • Chesapeake Urology Research Associates
  • Michigan Institute of Urology, PC
  • Montefiore Medical Center - Montefiore Medical Park
  • Montefiore Medical Center - Oncology Investigational Services
  • Premier Medical Group of the Hudson Valley PC
  • Bellevue Hospital
  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
  • NYU Langone Medical Center (Tisch Hospital)
  • NYU Langone Health Urology Associates
  • Icahn School of Medicine at Mount Sinai
  • Mount Sinai Hospital
  • Dutchess Ambulatory Surgery Center
  • Premier Medical Group of the Hudson Valley PC
  • Associated Medical Professionals of New York, PLLC
  • VA Portland Healthcare System
  • Carolina Urologic Research Center
  • Parkway Surgery Center
  • Urology Clinics of North Texas
  • Urology Clinics of North Texas
  • Houston Metro Urology
  • Houston Methodist Hospital
  • Urology San Antonio PA
  • Sentara Norfolk General Hospital
  • Urology of Virginia, PLLC
  • Southern Highlands Cancer Centre
  • Campbelltown Hospital
  • Campbelltown Private Hospital
  • Chris O'Brien Lifehouse Hospital
  • Chris O'Brien Lifehouse
  • Box Hill Hospital
  • Eastern Clinical Research Unit
  • Yarra Ranges Health
  • UZ Gent
  • Vancouver Prostate Centre at the Vancouver General Hospital
  • Hamilton Regional Laboratory Medicine Program
  • McMaster Institute of Urology/St Joseph's Healthcare Hamilton
  • Kingston Health Sciences Centre - Kingston General Hospital
  • Centre for Applied Urological Research
  • Kingston Health Sciences Centre -- Hotel Dieu Hospital
  • University Health Network - Princess Margaret Cancer Centre
  • University Health Network - Toronto General Hospital
  • Centre intégré universitaire de santé et de services sociaux du Saguenay-Lac-Saint-Jean
  • McGill University Health Centre
  • Hotel-Dieu de Quebec - CHU de Quebec - Universite Laval
  • The First Affiliated Hospital of Anhui Medical University
  • Beijing Chao-yang Hospital
  • Peking University First Hospital
  • Beijing Cancer Hospital
  • Peking Union Medical College Hospital
  • Fujian Medical University Affiliated First Hospital
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Hunan Cancer Hospital
  • Nanjing Drum Tower Hospital
  • Nantong Tumor Hospital
  • Second Affiliated Hospital of Suzhou University
  • The First Affiliated Hospital of Nanchang University
  • First Affiliated Hospital of Xi 'an Jiaotong University
  • West China Hospital of Sichuan University
  • Zhejiang Provincial People's Hospital
  • Ningbo First Hospital
  • The First Affiliated Hospital of Wenzhou Medical University
  • The First Affiliated Hospital of Wenzhou Medical University
  • Chongqing University Cancer Hospital
  • Fudan University Cancer Hospital
  • The Second Hospital of Tianjin Medical University
  • Hôpital privé Antony (Pharmacy)
  • Hôpital Privé d'Antony
  • Clinique Belharra
  • Clinique Saint-Augustin
  • Institut Bergonié
  • CHU de Bordeaux Hôpital Pellegrin
  • Groupe Vivalto Sante - Clinique Pasteur-Lanroze- CFRO
  • Cabinet Privé d'urologie
  • CHPB Keraudren
  • Polyclinique de Limoges Site Emailleurs-Colombier
  • Polyclinique de Limoges Site Chenieux
  • Polyclinique de Gentilly
  • Hôpital Bichat - Claude-Bernard
  • Clinique Sainte Anne
  • Urologicum Duisburg
  • Klinikum der Goethe-Universitaet Frankfurt
  • Universitaetsklinikum Muenster, Urologie
  • Studienpraxis Urologie
  • Universitaetsklinikum Tuebingen
  • Humanitas Istituto Clinico Catanese S.p.A - U.O. Oncologia Medica
  • UO Oncologia, ASST di Cremona - Istituti Ospitalieri - Ospedale di Cremona
  • IRCSS Istituto Clinico Humanitas - U.O. Oncologia Medica
  • AO Azienda Ospedaliera Ordine Mauriziano Di Torino
  • Ospedale Area Aretina Nord - UOC Oncologia Medica
  • UO Oncologia Medica IRCCS Istituto Tumori "Giovanni Paolo II"
  • IRCCS Azienda Ospedaliera Universitaria Policlinico San Martino Urologia
  • Ospedale Generale Provinciale di Macerata - UOC Oncologia
  • Medical Oncology Unit, AO Papardo
  • IRCCS Ospedale San Raffaele, URI (Urological Research Institute)
  • AUSL/IRCCS di Reggio Emilia
  • ASST Sette Laghi Ospedale di Circolo Fondazione Macchi
  • National Hospital Organization Shikoku Cancer Center
  • Ehime University Hospital
  • National Hospital Organization Kyushu Cancer Center
  • Gunma Prefectural Cancer Center
  • National Hospital Organization Hokkaido Cancer Center
  • Kanagawa cancer center
  • Osaka International Cancer Institute
  • Kindai University Hospital
  • Hamamatsu University Hospital
  • Keio University Hospital
  • Kagoshima University Hospital
  • National Hospital Organization Kumamoto Medical Center
  • Okayama Medical Center
  • Yamagata University Hospital
  • National Cancer Center
  • Seoul National University Bundang Hospital
  • Kyungpook National University Chilgok Hospital
  • Korea University Anam Hospital
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Samsung Medical Center
  • Szpital Wojewodzki im Jana Pawla II
  • NZOZ AKMED Andrzej Kupilas
  • Regionalny Szpital Specjalistyczny im. Dr. Wladyslawa Bieganskiego
  • Niepubliczny Zaklad Opieki Zdrowotnej Centrum Urologiczne Sp. z o.o.
  • Provita Profamilia
  • Clinical Research Center Spolka z ograniczona odpowiedzialnoscia MEDIC-R Spolka Komandytowa
  • ETG Skierniewice
  • Provita 001
  • Medical Concierge Centrum Medyczne
  • Lexmedica
  • A.Tsyb Medical Research Radiological Center of the Ministry of Health of the Russian Federation
  • Leningrad Regional Clinical Hospital
  • State Budgetary Institution of Healthcare of the Republic of Mordovia
  • Private Medical Institution "Euromedservice"
  • Klinika UZI 4D, LLC
  • Leningrad Regional Clinical Hospital
  • Leningrad Regional Clinical Hospital
  • State Budgetary Healthcare Institution "Leningrad Regional Clinical Oncology Dispensary"
  • Evimed Llc
  • Regional Budgetary Healthcare Institution "Ivanovo Regional Oncology Dispensary"
  • Ars Medika Center, LLC
  • Kaluga Regional Clinical Oncology Center
  • P.A. Hertsen Moscow Oncology Research Center- branch of the National Medical Research
  • Federal Budgetary Institution of Healthcare "Privolzhsky District Medical Center of the Federal
  • BHI of Omsk region "Clinical Oncological Dispensary"
  • State Budgetary Institution of Ryazan Region "Regional Clinical Oncology Center"
  • Joint-Stock Company "North-Western Centre of Evidence-Based Medicine" ("NWCoEBM" JSC)
  • Federal State Budgetary Healthcare Institution Saint - Petersburg
  • Leningrad Regional Clinical Hospital
  • Joint-Stock Company "North-Western Centre of Evidence-Based Medicine" ("NWCoEBM" JSC)
  • Hospital OrKli LLC
  • Republican Clinical Oncology Dispensary of the Ministry of Health of Bashkortostan Republic
  • Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"
  • SBHI YaR Regional clinical oncology hospital
  • Hospital Universitari Germans Trias i Pujol
  • Hospital General de Granollers
  • Hospital Universitari de Bellvitge
  • Hospital Duran i Reynals- ICO L'Hospitalet
  • Hospital Universitario Puerta de Hierro Majadahonda
  • Complejo Hospitalario de Navarra
  • Salut Sant Joan de Reus-Baix Camp
  • Complejo Hospitalario Universitario A Coruna
  • Hospital del Mar
  • Fundacio Puigvert
  • Hospital de la Santa Creu i Sant Pau
  • Hospital San Pedro de Alcantara
  • Hospital Universitari de Girona Doctor Josep Trueta
  • Hospital Universitario Lucus Augusti
  • Hospital Universitario de La Princesa
  • Hospital Universitario La Princesa
  • Hospital Clínico San Carlos
  • Hospital Universitario 12 de Octubre
  • Fundacion Instituto Valenciano de Oncologia
  • Hospital Arnau de Vilanova
  • Barts Health NHS Trust, St Bartholomew's Hospital
  • Charing Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Active Comparator

Experimental

Experimental

Arm Label

PF-06801591 + BCG induction and maintenance

PF-06801591 + BCG induction only

BCG induction and maintenance

BCG Unresponsive CIS

BCG Unresponsive NMIBC

Arm Description

PF-06801591 in combination with Bacillus Calmette Guerin(induction+maintenance).

PF-06801591 in combination with Bacillus Calmette Guerin (induction only).

Bacillus Calmette Guerin (induction and maintenance).

PF-06801591

PF-06801591

Outcomes

Primary Outcome Measures

Event free survival (Cohort A: Arm A compared to Arm C)
Event free survival is defined as the time from randomization to date of EFS event.
Event free survival (Cohort A: Arm B compared to Arm C)
Event free survival is defined as the time from randomization to date of EFS event.
Complete response rate (Cohort B1) (Obsolete after stopping enrollment in Cohort B)
Complete response (CR) rate defined as the proportion of participants in the analysis population with CR.
Event free survival (Cohort B2) (Obsolete after stopping enrollment in Cohort B)
Event free survival is defined as the time from first dose to date of EFS event.

Secondary Outcome Measures

Overall Survival (Cohort A: Arm A compared to Arm C)
Overall survival is defined as the time from the date of randomization to the date of death due to any cause.
Overall Survival (Cohort A: Arm B compared to Arm C)
Overall survival is defined as the time from the date of randomization to the date of death due to any cause.
Complete response rate in participants with CIS at randomization (Cohort A: Arm A, B, C)
Complete response (CR) rate defined as the proportion of participants in the analysis population with CR.
Disease-specific survival (Cohort A: Arm A, B, C)
Disease specific survival (DSS) is defined as the time from randomization to death resulting from bladder cancer.
Health-related quality of life as measured by EORTC QLQ-C30 (European Organization for Treatment of Cancer Quality of Life Questionnaire for cancer patients) (Obsolete for Cohort B after stopping enrollment)
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties).
ctrough of PF-06801591 when in combination with BCG (induction and maintenance or induction). Cohort A: Arms A and B only.
Ctrough will be summarized in Cohort A Arms A and B only.
Incidence of ADA/Nab of PF-06801591 when in combination with BCG (induction and maintenance or induction). Cohort A: Arms A and B only.
Immunogenicity will be evaluated for Cohort A Arms A and B only.
Tumor sample biomarker status based on PD-L1 expression (high or low) (Obsolete for Cohort B after stopping enrollment)
Evaluate PD-L1 expression.
Duration of CR for participants with CIS at randomization (Obsolete for Cohort B after stopping enrollment)
Duration of CR is defined as time from first CR to first recurrence or death due to any cause, whichever occurs first.
Time to recurrence of low grade disease (Cohort A: Arm A, B, C)
Time to recurrence defined as time from randomization to the date of first documentation of recurrence of low grade disease or death due to any cause, whichever occurs first.
Time to cystectomy (Obsolete for Cohort B after stopping enrollment)
Time to cystectomy is defined as time from randomization/registration to cystectomy in participants with NMIBC
Health-related quality of life as measured by PTAB (Patient Treatment Administration Burden Questionnaire) (Obsolete for Cohort B after stopping enrollment)
PTAB is a 2-item PRO designed to assess, from the patient perspective, any pain associated with the treatment administration and the burden of the amount of time required to complete the treatment administration procedures (1 item each).
Percentage of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs (Obsolete for Cohort B after stopping enrollment)
An adverse event (AE) is any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. Causality assessment is made by the investigator. Grading is per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) version 3.0.
Percentage of Participants With Laboratory Abnormalities (Obsolete for Cohort B after stopping enrollment)
Percentage of participants with laboratory test abnormalities without regard to baseline abnormality. Grading is per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) version 3.0.
Health-related quality of life as measured by EORTC QLQ-NMIBC24 (European Organization for Treatment of Cancer in patients with non-muscle invasion bladder cancer) (Obsolete for Cohort B after stopping enrollment)
EORTC-QLQ-NMIBC24 has 24 items which can be grouped into 6 subscales: urinary symptoms (7 items), malaise (2 items), future worries (4 items), bloating/flatulence (2 items), sexual functioning (2 items), and male sexual issues (2 items). The NMIBC24 also assesses intravesical treatment, female sexual issues, sexual intimacy, risk of contaminating a partner, and sexual enjoyment (1 item each).
Complete response rate at 12 months (Cohort B1) (Obsolete after stopping enrollment in Cohort B)
Complete response (CR) rate defined as the proportion of participants in the analysis population with CR at 12 months.
Event Free Survival (Cohort B1) (Obsolete after stopping enrollment in Cohort B)
Time from first dose to date of EFS event.
Overall Survival (Cohorts B1 and B2) (Obsolete after stopping enrollment in Cohort B)
Time from the date of first dose to the date of death due to any cause.
ctrough of PF-06801591 (Cohorts B1 and B2) (Obsolete after stopping enrollment in Cohort B)
Ctrough will be summarized
Incidence of ADA/Nab of PF-06801591 (Cohorts B1 and B2) (Obsolete after stopping enrollment in Cohort B)
Immunogenicity will be evaluated for participants with BCG unresponsive NMIBC, including those with CIS.
cmax of PF-06801591 (Cohort B2 only) (Obsolete after stopping enrollment in Cohort B)
Cmax will be summarized in Cohort B2 only.

Full Information

First Posted
November 13, 2019
Last Updated
August 31, 2023
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT04165317
Brief Title
A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer
Acronym
CREST
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 30, 2019 (Actual)
Primary Completion Date
June 3, 2024 (Anticipated)
Study Completion Date
December 2, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-muscle Invasive Bladder Cancer
Keywords
CREST, Sasanlimab, PF-06801591, Bacillus Calmette Guerin, BCG, Bladder cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1070 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PF-06801591 + BCG induction and maintenance
Arm Type
Experimental
Arm Description
PF-06801591 in combination with Bacillus Calmette Guerin(induction+maintenance).
Arm Title
PF-06801591 + BCG induction only
Arm Type
Experimental
Arm Description
PF-06801591 in combination with Bacillus Calmette Guerin (induction only).
Arm Title
BCG induction and maintenance
Arm Type
Active Comparator
Arm Description
Bacillus Calmette Guerin (induction and maintenance).
Arm Title
BCG Unresponsive CIS
Arm Type
Experimental
Arm Description
PF-06801591
Arm Title
BCG Unresponsive NMIBC
Arm Type
Experimental
Arm Description
PF-06801591
Intervention Type
Drug
Intervention Name(s)
PF-06801591
Other Intervention Name(s)
Sasanlimab
Intervention Description
A monoclonal antibody (mAb) that blocks the interaction between PD-1 and PD-L1/PD-L2.
Intervention Type
Drug
Intervention Name(s)
Bacillus Calmette-Guerin
Other Intervention Name(s)
BCG
Intervention Description
Immunotherapy treatment approved by FDA for patients with high-risk non-muscle invasive bladder cancer
Primary Outcome Measure Information:
Title
Event free survival (Cohort A: Arm A compared to Arm C)
Description
Event free survival is defined as the time from randomization to date of EFS event.
Time Frame
55 months after first participant randomized
Title
Event free survival (Cohort A: Arm B compared to Arm C)
Description
Event free survival is defined as the time from randomization to date of EFS event.
Time Frame
55 months after first participant randomized
Title
Complete response rate (Cohort B1) (Obsolete after stopping enrollment in Cohort B)
Description
Complete response (CR) rate defined as the proportion of participants in the analysis population with CR.
Time Frame
Registration to 12 months after last participant initially assessed
Title
Event free survival (Cohort B2) (Obsolete after stopping enrollment in Cohort B)
Description
Event free survival is defined as the time from first dose to date of EFS event.
Time Frame
Registration to 12 months after last participant initially assessed
Secondary Outcome Measure Information:
Title
Overall Survival (Cohort A: Arm A compared to Arm C)
Description
Overall survival is defined as the time from the date of randomization to the date of death due to any cause.
Time Frame
Randomization up to 60 months from last participant randomized
Title
Overall Survival (Cohort A: Arm B compared to Arm C)
Description
Overall survival is defined as the time from the date of randomization to the date of death due to any cause.
Time Frame
Randomization up to 60 months from last participant randomized
Title
Complete response rate in participants with CIS at randomization (Cohort A: Arm A, B, C)
Description
Complete response (CR) rate defined as the proportion of participants in the analysis population with CR.
Time Frame
Randomization up to 60 months from last participant randomized
Title
Disease-specific survival (Cohort A: Arm A, B, C)
Description
Disease specific survival (DSS) is defined as the time from randomization to death resulting from bladder cancer.
Time Frame
Randomization up to 60 months from last participant randomized
Title
Health-related quality of life as measured by EORTC QLQ-C30 (European Organization for Treatment of Cancer Quality of Life Questionnaire for cancer patients) (Obsolete for Cohort B after stopping enrollment)
Description
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties).
Time Frame
Randomization up to 60 months from last participant randomized
Title
ctrough of PF-06801591 when in combination with BCG (induction and maintenance or induction). Cohort A: Arms A and B only.
Description
Ctrough will be summarized in Cohort A Arms A and B only.
Time Frame
Randomization up to 24 months
Title
Incidence of ADA/Nab of PF-06801591 when in combination with BCG (induction and maintenance or induction). Cohort A: Arms A and B only.
Description
Immunogenicity will be evaluated for Cohort A Arms A and B only.
Time Frame
Randomization up to 24 months
Title
Tumor sample biomarker status based on PD-L1 expression (high or low) (Obsolete for Cohort B after stopping enrollment)
Description
Evaluate PD-L1 expression.
Time Frame
Baseline
Title
Duration of CR for participants with CIS at randomization (Obsolete for Cohort B after stopping enrollment)
Description
Duration of CR is defined as time from first CR to first recurrence or death due to any cause, whichever occurs first.
Time Frame
Randomization/registration up to 60 months from last participant randomized
Title
Time to recurrence of low grade disease (Cohort A: Arm A, B, C)
Description
Time to recurrence defined as time from randomization to the date of first documentation of recurrence of low grade disease or death due to any cause, whichever occurs first.
Time Frame
Randomization up to 60 months from last participant randomized
Title
Time to cystectomy (Obsolete for Cohort B after stopping enrollment)
Description
Time to cystectomy is defined as time from randomization/registration to cystectomy in participants with NMIBC
Time Frame
Randomization/registration to date of cystectomy (up to 5 years after last participant is randomized)
Title
Health-related quality of life as measured by PTAB (Patient Treatment Administration Burden Questionnaire) (Obsolete for Cohort B after stopping enrollment)
Description
PTAB is a 2-item PRO designed to assess, from the patient perspective, any pain associated with the treatment administration and the burden of the amount of time required to complete the treatment administration procedures (1 item each).
Time Frame
Randomization/registration up to 24 months
Title
Percentage of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs (Obsolete for Cohort B after stopping enrollment)
Description
An adverse event (AE) is any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. Causality assessment is made by the investigator. Grading is per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) version 3.0.
Time Frame
Baseline up to 60 months from the last participant randomized
Title
Percentage of Participants With Laboratory Abnormalities (Obsolete for Cohort B after stopping enrollment)
Description
Percentage of participants with laboratory test abnormalities without regard to baseline abnormality. Grading is per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) version 3.0.
Time Frame
Baseline up to 60 months from last participant randomized
Title
Health-related quality of life as measured by EORTC QLQ-NMIBC24 (European Organization for Treatment of Cancer in patients with non-muscle invasion bladder cancer) (Obsolete for Cohort B after stopping enrollment)
Description
EORTC-QLQ-NMIBC24 has 24 items which can be grouped into 6 subscales: urinary symptoms (7 items), malaise (2 items), future worries (4 items), bloating/flatulence (2 items), sexual functioning (2 items), and male sexual issues (2 items). The NMIBC24 also assesses intravesical treatment, female sexual issues, sexual intimacy, risk of contaminating a partner, and sexual enjoyment (1 item each).
Time Frame
Randomization/registration up to 60 months from the last participant randomized
Title
Complete response rate at 12 months (Cohort B1) (Obsolete after stopping enrollment in Cohort B)
Description
Complete response (CR) rate defined as the proportion of participants in the analysis population with CR at 12 months.
Time Frame
12 months after last participant's initial assessment
Title
Event Free Survival (Cohort B1) (Obsolete after stopping enrollment in Cohort B)
Description
Time from first dose to date of EFS event.
Time Frame
Registration to 5 years after last participant randomized.
Title
Overall Survival (Cohorts B1 and B2) (Obsolete after stopping enrollment in Cohort B)
Description
Time from the date of first dose to the date of death due to any cause.
Time Frame
Registration to 5 years after last participant randomized.
Title
ctrough of PF-06801591 (Cohorts B1 and B2) (Obsolete after stopping enrollment in Cohort B)
Description
Ctrough will be summarized
Time Frame
Registration up to 24 months
Title
Incidence of ADA/Nab of PF-06801591 (Cohorts B1 and B2) (Obsolete after stopping enrollment in Cohort B)
Description
Immunogenicity will be evaluated for participants with BCG unresponsive NMIBC, including those with CIS.
Time Frame
Registration up to 24 months
Title
cmax of PF-06801591 (Cohort B2 only) (Obsolete after stopping enrollment in Cohort B)
Description
Cmax will be summarized in Cohort B2 only.
Time Frame
Registration up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Urological Associates of Southern Arizona, P.C .
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Urological Associates of Southern Arizona P.C.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Arkansas Urology
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Centerview Surgery Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Koman Family Outpatient Pavilion
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Sulpizio Cardiovascular Center at UC San Diego Health
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
University of California Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
UC San Diego Medical Center - Hillcrest
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
The Urology Center of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80211
Country
United States
Facility Name
Urological Research Network Corp
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
UF Health Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
UF Health North
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32218
Country
United States
Facility Name
John H. Stroger, Jr. Hospital of Cook County/IND Pharmacy
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
John H. Stroger, Jr. Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
DuPage Medical Group
City
Lisle
State/Province
Illinois
ZIP/Postal Code
60532
Country
United States
Facility Name
DuPage Medical Group Ambulatory Surgery Center
City
Lombard
State/Province
Illinois
ZIP/Postal Code
60148
Country
United States
Facility Name
DuPage Medical Group
City
Lombard
State/Province
Illinois
ZIP/Postal Code
60148
Country
United States
Facility Name
Edward Hospital
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
Facility Name
Ochsner LSU Health Shreveport - Regional Urology
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Regional Urology Oncology & Radiation Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Regional Urology, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Chesapeake Urology Research Associates
City
Hanover
State/Province
Maryland
ZIP/Postal Code
21076
Country
United States
Facility Name
Michigan Institute of Urology, PC
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Montefiore Medical Center - Montefiore Medical Park
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Montefiore Medical Center - Oncology Investigational Services
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Premier Medical Group of the Hudson Valley PC
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Facility Name
Bellevue Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
NYU Langone Medical Center (Tisch Hospital)
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
NYU Langone Health Urology Associates
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Dutchess Ambulatory Surgery Center
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Premier Medical Group of the Hudson Valley PC
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12603
Country
United States
Facility Name
Associated Medical Professionals of New York, PLLC
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
VA Portland Healthcare System
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Parkway Surgery Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Urology Clinics of North Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Urology Clinics of North Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Houston Metro Urology
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Urology San Antonio PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Urology of Virginia, PLLC
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Facility Name
Southern Highlands Cancer Centre
City
Bowral
State/Province
New South Wales
ZIP/Postal Code
2756
Country
Australia
Facility Name
Campbelltown Hospital
City
Campbelltown
State/Province
New South Wales
ZIP/Postal Code
2560
Country
Australia
Facility Name
Campbelltown Private Hospital
City
Campbelltown
State/Province
New South Wales
ZIP/Postal Code
2560
Country
Australia
Facility Name
Chris O'Brien Lifehouse Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Chris O'Brien Lifehouse
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Eastern Clinical Research Unit
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Yarra Ranges Health
City
Lilydale
State/Province
Victoria
ZIP/Postal Code
3140
Country
Australia
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Vancouver Prostate Centre at the Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Hamilton Regional Laboratory Medicine Program
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
McMaster Institute of Urology/St Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Kingston Health Sciences Centre - Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
Centre for Applied Urological Research
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3J7
Country
Canada
Facility Name
Kingston Health Sciences Centre -- Hotel Dieu Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5G2
Country
Canada
Facility Name
University Health Network - Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
University Health Network - Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2C4
Country
Canada
Facility Name
Centre intégré universitaire de santé et de services sociaux du Saguenay-Lac-Saint-Jean
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 5H6
Country
Canada
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Hotel-Dieu de Quebec - CHU de Quebec - Universite Laval
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Facility Name
Beijing Chao-yang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Fujian Medical University Affiliated First Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350005
Country
China
Facility Name
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Name
Nantong Tumor Hospital
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226000
Country
China
Facility Name
Second Affiliated Hospital of Suzhou University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215004
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
First Affiliated Hospital of Xi 'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Facility Name
Ningbo First Hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315010
Country
China
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325035
Country
China
Facility Name
Chongqing University Cancer Hospital
City
Chongqing
ZIP/Postal Code
400030
Country
China
Facility Name
Fudan University Cancer Hospital
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
The Second Hospital of Tianjin Medical University
City
Tianjin
ZIP/Postal Code
300211
Country
China
Facility Name
Hôpital privé Antony (Pharmacy)
City
Antony
ZIP/Postal Code
92160
Country
France
Facility Name
Hôpital Privé d'Antony
City
Antony
ZIP/Postal Code
92160
Country
France
Facility Name
Clinique Belharra
City
Bayonne
ZIP/Postal Code
64100
Country
France
Facility Name
Clinique Saint-Augustin
City
BORDEAUX Cedex
ZIP/Postal Code
33074
Country
France
Facility Name
Institut Bergonié
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
Facility Name
CHU de Bordeaux Hôpital Pellegrin
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Groupe Vivalto Sante - Clinique Pasteur-Lanroze- CFRO
City
Brest Cedex 2
ZIP/Postal Code
29229
Country
France
Facility Name
Cabinet Privé d'urologie
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
CHPB Keraudren
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Polyclinique de Limoges Site Emailleurs-Colombier
City
Limoges Cedex 1
ZIP/Postal Code
87038
Country
France
Facility Name
Polyclinique de Limoges Site Chenieux
City
Limoges
ZIP/Postal Code
87000
Country
France
Facility Name
Polyclinique de Gentilly
City
Nancy
ZIP/Postal Code
54100
Country
France
Facility Name
Hôpital Bichat - Claude-Bernard
City
Paris
ZIP/Postal Code
75877
Country
France
Facility Name
Clinique Sainte Anne
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Urologicum Duisburg
City
Duisburg
ZIP/Postal Code
47179
Country
Germany
Facility Name
Klinikum der Goethe-Universitaet Frankfurt
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitaetsklinikum Muenster, Urologie
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Studienpraxis Urologie
City
Nuertingen
ZIP/Postal Code
72622
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Humanitas Istituto Clinico Catanese S.p.A - U.O. Oncologia Medica
City
Misterobianco (CT)
State/Province
Catania
ZIP/Postal Code
95045
Country
Italy
Facility Name
UO Oncologia, ASST di Cremona - Istituti Ospitalieri - Ospedale di Cremona
City
Cremona
State/Province
CR
ZIP/Postal Code
26100
Country
Italy
Facility Name
IRCSS Istituto Clinico Humanitas - U.O. Oncologia Medica
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
AO Azienda Ospedaliera Ordine Mauriziano Di Torino
City
Torino
State/Province
Turin
ZIP/Postal Code
10128
Country
Italy
Facility Name
Ospedale Area Aretina Nord - UOC Oncologia Medica
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Facility Name
UO Oncologia Medica IRCCS Istituto Tumori "Giovanni Paolo II"
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
IRCCS Azienda Ospedaliera Universitaria Policlinico San Martino Urologia
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Ospedale Generale Provinciale di Macerata - UOC Oncologia
City
Macerata
ZIP/Postal Code
62100
Country
Italy
Facility Name
Medical Oncology Unit, AO Papardo
City
Messina
ZIP/Postal Code
98158
Country
Italy
Facility Name
IRCCS Ospedale San Raffaele, URI (Urological Research Institute)
City
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
AUSL/IRCCS di Reggio Emilia
City
Reggio Emilia
ZIP/Postal Code
42123
Country
Italy
Facility Name
ASST Sette Laghi Ospedale di Circolo Fondazione Macchi
City
Varese
ZIP/Postal Code
21100
Country
Italy
Facility Name
National Hospital Organization Shikoku Cancer Center
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
Ehime University Hospital
City
Toon
State/Province
Ehime
ZIP/Postal Code
791-0295
Country
Japan
Facility Name
National Hospital Organization Kyushu Cancer Center
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Gunma Prefectural Cancer Center
City
Ota
State/Province
Gunma
ZIP/Postal Code
373-8550
Country
Japan
Facility Name
National Hospital Organization Hokkaido Cancer Center
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
Facility Name
Kanagawa cancer center
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Osaka International Cancer Institute
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Kindai University Hospital
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Hamamatsu University Hospital
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Keio University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Kagoshima University Hospital
City
Kagoshima
ZIP/Postal Code
890-8520
Country
Japan
Facility Name
National Hospital Organization Kumamoto Medical Center
City
Kumamoto
ZIP/Postal Code
860-0008
Country
Japan
Facility Name
Okayama Medical Center
City
Okayama
ZIP/Postal Code
701-1192
Country
Japan
Facility Name
Yamagata University Hospital
City
Yamagata
ZIP/Postal Code
990-9585
Country
Japan
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Szpital Wojewodzki im Jana Pawla II
City
Belchatow
ZIP/Postal Code
97-400
Country
Poland
Facility Name
NZOZ AKMED Andrzej Kupilas
City
Gliwice
ZIP/Postal Code
44-100
Country
Poland
Facility Name
Regionalny Szpital Specjalistyczny im. Dr. Wladyslawa Bieganskiego
City
Grudziadz
ZIP/Postal Code
86-300
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Urologiczne Sp. z o.o.
City
Mysłowice
ZIP/Postal Code
41-400
Country
Poland
Facility Name
Provita Profamilia
City
Piotrkow Trybunalski
ZIP/Postal Code
97-300
Country
Poland
Facility Name
Clinical Research Center Spolka z ograniczona odpowiedzialnoscia MEDIC-R Spolka Komandytowa
City
Poznan
ZIP/Postal Code
61-731
Country
Poland
Facility Name
ETG Skierniewice
City
Skierniewice
ZIP/Postal Code
96-100
Country
Poland
Facility Name
Provita 001
City
Warszawa
ZIP/Postal Code
02-647
Country
Poland
Facility Name
Medical Concierge Centrum Medyczne
City
Warszawa
ZIP/Postal Code
02-798
Country
Poland
Facility Name
Lexmedica
City
Wroclaw
ZIP/Postal Code
53-114
Country
Poland
Facility Name
A.Tsyb Medical Research Radiological Center of the Ministry of Health of the Russian Federation
City
Obninsk
State/Province
Kaluzhskaya OBL.
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
Leningrad Regional Clinical Hospital
City
Leningrad Region
State/Province
Other
ZIP/Postal Code
188663
Country
Russian Federation
Facility Name
State Budgetary Institution of Healthcare of the Republic of Mordovia
City
Saransk
State/Province
Republic OF Mordovia
ZIP/Postal Code
430032
Country
Russian Federation
Facility Name
Private Medical Institution "Euromedservice"
City
Pushkin
State/Province
Saint-petersburg
ZIP/Postal Code
196603
Country
Russian Federation
Facility Name
Klinika UZI 4D, LLC
City
Pyatigorsk
State/Province
Stavropolskiy KRAI
ZIP/Postal Code
357502
Country
Russian Federation
Facility Name
Leningrad Regional Clinical Hospital
City
Kuzmolovskiy Settlement
State/Province
Vsevolozhskiy District
Country
Russian Federation
Facility Name
Leningrad Regional Clinical Hospital
City
Kuzmolovskiy Settlement
State/Province
Vsevolozhsky District
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution "Leningrad Regional Clinical Oncology Dispensary"
City
Kuzmolovsky Settlement
State/Province
Vsevolozhsky District
ZIP/Postal Code
188663
Country
Russian Federation
Facility Name
Evimed Llc
City
Chelyabinsk
ZIP/Postal Code
454048
Country
Russian Federation
Facility Name
Regional Budgetary Healthcare Institution "Ivanovo Regional Oncology Dispensary"
City
Ivanovo
ZIP/Postal Code
153040
Country
Russian Federation
Facility Name
Ars Medika Center, LLC
City
Kaliningrad
ZIP/Postal Code
236006
Country
Russian Federation
Facility Name
Kaluga Regional Clinical Oncology Center
City
Kaluga
ZIP/Postal Code
248007
Country
Russian Federation
Facility Name
P.A. Hertsen Moscow Oncology Research Center- branch of the National Medical Research
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Federal Budgetary Institution of Healthcare "Privolzhsky District Medical Center of the Federal
City
Nizhny Novgorod
ZIP/Postal Code
603074
Country
Russian Federation
Facility Name
BHI of Omsk region "Clinical Oncological Dispensary"
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
State Budgetary Institution of Ryazan Region "Regional Clinical Oncology Center"
City
Ryazan
ZIP/Postal Code
390011
Country
Russian Federation
Facility Name
Joint-Stock Company "North-Western Centre of Evidence-Based Medicine" ("NWCoEBM" JSC)
City
Saint Petersburg
ZIP/Postal Code
194355
Country
Russian Federation
Facility Name
Federal State Budgetary Healthcare Institution Saint - Petersburg
City
Saint-Petersburg
ZIP/Postal Code
194017
Country
Russian Federation
Facility Name
Leningrad Regional Clinical Hospital
City
Saint-Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Joint-Stock Company "North-Western Centre of Evidence-Based Medicine" ("NWCoEBM" JSC)
City
Saint-Petersburg
ZIP/Postal Code
198095
Country
Russian Federation
Facility Name
Hospital OrKli LLC
City
Saint-Petersburg
ZIP/Postal Code
199178
Country
Russian Federation
Facility Name
Republican Clinical Oncology Dispensary of the Ministry of Health of Bashkortostan Republic
City
Ufa
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"
City
Vologda
ZIP/Postal Code
160022
Country
Russian Federation
Facility Name
SBHI YaR Regional clinical oncology hospital
City
Yaroslavl
ZIP/Postal Code
150054
Country
Russian Federation
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital General de Granollers
City
Granollers
State/Province
Barcelona
ZIP/Postal Code
08402
Country
Spain
Facility Name
Hospital Universitari de Bellvitge
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Duran i Reynals- ICO L'Hospitalet
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Complejo Hospitalario de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Salut Sant Joan de Reus-Baix Camp
City
Reus
State/Province
Tarragona
ZIP/Postal Code
43204
Country
Spain
Facility Name
Complejo Hospitalario Universitario A Coruna
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Fundacio Puigvert
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital San Pedro de Alcantara
City
Caceres
ZIP/Postal Code
10003
Country
Spain
Facility Name
Hospital Universitari de Girona Doctor Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Universitario Lucus Augusti
City
Lugo
ZIP/Postal Code
27003
Country
Spain
Facility Name
Hospital Universitario de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Fundacion Instituto Valenciano de Oncologia
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital Arnau de Vilanova
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Facility Name
Barts Health NHS Trust, St Bartholomew's Hospital
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Charing Cross Hospital
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B8011006
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

We'll reach out to this number within 24 hrs