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

Non-muscle Invasive Bladder Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04165317
• Other study ID #: B8011006
• Secondary ID: 2019-003375-19CR
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 30, 2019
• Est. completion date: December 2, 2026

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1070
• Est. completion date: December 2, 2026
• Est. primary completion date: June 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Non-muscle Invasive Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• PF-06801591
A monoclonal antibody (mAb) that blocks the interaction between PD-1 and PD-L1/PD-L2.
• Bacillus Calmette-Guerin
Immunotherapy treatment approved by FDA for patients with high-risk non-muscle invasive bladder cancer

Locations

Country	Name	City	State
Australia	Southern Highlands Cancer Centre	Bowral	New South Wales
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	Eastern Clinical Research Unit	Box Hill	Victoria
Australia	Campbelltown Hospital	Campbelltown	New South Wales
Australia	Campbelltown Private Hospital	Campbelltown	New South Wales
Australia	Chris O'Brien Lifehouse	Camperdown	New South Wales
Australia	Chris O'Brien Lifehouse Hospital	Camperdown	New South Wales
Australia	Yarra Ranges Health	Lilydale	Victoria
Belgium	UZ Gent	Gent
Canada	Centre intégré universitaire de santé et de services sociaux du Saguenay-Lac-Saint-Jean	Chicoutimi	Quebec
Canada	Hamilton Regional Laboratory Medicine Program	Hamilton	Ontario
Canada	McMaster Institute of Urology/St Joseph's Healthcare Hamilton	Hamilton	Ontario
Canada	Centre for Applied Urological Research	Kingston	Ontario
Canada	Kingston Health Sciences Centre - Kingston General Hospital	Kingston	Ontario
Canada	Kingston Health Sciences Centre -- Hotel Dieu Hospital	Kingston	Ontario
Canada	McGill University Health Centre	Montreal	Quebec
Canada	Hotel-Dieu de Quebec - CHU de Quebec - Universite Laval	Quebec
Canada	University Health Network - Princess Margaret Cancer Centre	Toronto	Ontario
Canada	University Health Network - Toronto General Hospital	Toronto	Ontario
Canada	Vancouver Prostate Centre at the Vancouver General Hospital	Vancouver	British Columbia
China	Beijing Cancer Hospital	Beijing	Beijing
China	Beijing Chao-yang Hospital	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Hunan Cancer Hospital	Changsha	Hunan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Chongqing University Cancer Hospital	Chongqing
China	Fujian Medical University Affiliated First Hospital	Fuzhou	Fujian
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu
China	Nantong Tumor Hospital	Nantong	Jiangsu
China	Ningbo First Hospital	Ningbo	Zhejiang
China	Fudan University Cancer Hospital	Shanghai
China	Fudan University Shanghai Cancer Center	Shanghai
China	Second Affiliated Hospital of Suzhou University	Suzhou	Jiangsu
China	The Second Hospital of Tianjin Medical University	Tianjin
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	First Affiliated Hospital of Xi 'an Jiaotong University	Xi'an	Shaanxi
France	Hôpital privé Antony (Pharmacy)	Antony
France	Hôpital Privé d'Antony	Antony
France	Clinique Belharra	Bayonne
France	CHU de Bordeaux Hôpital Pellegrin	Bordeaux
France	Clinique Saint-Augustin	BORDEAUX Cedex
France	Institut Bergonié	Bordeaux Cedex
France	Cabinet Privé d'urologie	Brest
France	CHPB Keraudren	Brest
France	Groupe Vivalto Sante - Clinique Pasteur-Lanroze- CFRO	Brest Cedex 2
France	Polyclinique de Limoges Site Chenieux	Limoges
France	Polyclinique de Limoges Site Emailleurs-Colombier	Limoges Cedex 1
France	Polyclinique de Gentilly	Nancy
France	Hôpital Bichat - Claude-Bernard	Paris
France	Clinique Sainte Anne	Strasbourg
Germany	Urologicum Duisburg	Duisburg
Germany	Klinikum der Goethe-Universitaet Frankfurt	Frankfurt
Germany	Universitaetsklinikum Muenster, Urologie	Muenster
Germany	Studienpraxis Urologie	Nuertingen
Germany	Universitaetsklinikum Tuebingen	Tuebingen
Italy	Ospedale Area Aretina Nord - UOC Oncologia Medica	Arezzo
Italy	UO Oncologia Medica IRCCS Istituto Tumori "Giovanni Paolo II"	Bari
Italy	UO Oncologia, ASST di Cremona - Istituti Ospitalieri - Ospedale di Cremona	Cremona	CR
Italy	IRCCS Azienda Ospedaliera Universitaria Policlinico San Martino Urologia	Genova
Italy	Ospedale Generale Provinciale di Macerata - UOC Oncologia	Macerata
Italy	Medical Oncology Unit, AO Papardo	Messina
Italy	IRCCS Ospedale San Raffaele, URI (Urological Research Institute)	Milan
Italy	Humanitas Istituto Clinico Catanese S.p.A - U.O. Oncologia Medica	Misterobianco (CT)	Catania
Italy	AUSL/IRCCS di Reggio Emilia	Reggio Emilia
Italy	IRCSS Istituto Clinico Humanitas - U.O. Oncologia Medica	Rozzano	Milano
Italy	AO Azienda Ospedaliera Ordine Mauriziano Di Torino	Torino	Turin
Italy	AO Azienda Ospedaliera Ordine Mauriziano Di Torino	Turin
Italy	ASST Sette Laghi Ospedale di Circolo Fondazione Macchi	Varese
Japan	National Hospital Organization Kyushu Cancer Center	Fukuoka-shi	Fukuoka
Japan	Hamamatsu University Hospital	Hamamatsu	Shizuoka
Japan	Kagoshima University Hospital	Kagoshima
Japan	National Hospital Organization Kumamoto Medical Center	Kumamoto
Japan	National Hospital Organization Shikoku Cancer Center	Matsuyama	Ehime
Japan	Okayama Medical Center	Okayama
Japan	Osaka International Cancer Institute	Osaka-shi	Osaka
Japan	Kindai University Hospital	Osakasayama	Osaka
Japan	Gunma Prefectural Cancer Center	Ota	Gunma
Japan	National Hospital Organization Hokkaido Cancer Center	Sapporo	Hokkaido
Japan	Keio University Hospital	Shinjuku-ku	Tokyo
Japan	Ehime University Hospital	Toon	Ehime
Japan	Yamagata University Hospital	Yamagata
Japan	Kanagawa cancer center	Yokohama	Kanagawa
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu
Korea, Republic of	National Cancer Center	Goyang-si	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Poland	Szpital Wojewodzki im Jana Pawla II	Belchatow
Poland	NZOZ AKMED Andrzej Kupilas	Gliwice
Poland	Regionalny Szpital Specjalistyczny im. Dr. Wladyslawa Bieganskiego	Grudziadz
Poland	Niepubliczny Zaklad Opieki Zdrowotnej Centrum Urologiczne Sp. z o.o.	Myslowice
Poland	Provita Profamilia	Piotrkow Trybunalski
Poland	Clinical Research Center Spolka z ograniczona odpowiedzialnoscia MEDIC-R Spolka Komandytowa	Poznan
Poland	ETG Skierniewice	Skierniewice
Poland	Medical Concierge Centrum Medyczne	Warszawa
Poland	Provita 001	Warszawa
Poland	Lexmedica	Wroclaw
Russian Federation	Evimed Llc	Chelyabinsk
Russian Federation	Regional Budgetary Healthcare Institution "Ivanovo Regional Oncology Dispensary"	Ivanovo
Russian Federation	Ars Medika Center, LLC	Kaliningrad
Russian Federation	Kaluga Regional Clinical Oncology Center	Kaluga
Russian Federation	Leningrad Regional Clinical Hospital	Kuzmolovskiy Settlement	Vsevolozhskiy District
Russian Federation	Leningrad Regional Clinical Hospital	Kuzmolovskiy Settlement	Vsevolozhsky District
Russian Federation	State Budgetary Healthcare Institution "Leningrad Regional Clinical Oncology Dispensary"	Kuzmolovsky Settlement	Vsevolozhsky District
Russian Federation	Leningrad Regional Clinical Hospital	Leningrad Region	Other
Russian Federation	P.A. Hertsen Moscow Oncology Research Center- branch of the National Medical Research	Moscow
Russian Federation	Federal Budgetary Institution of Healthcare "Privolzhsky District Medical Center of the Federal	Nizhny Novgorod
Russian Federation	A.Tsyb Medical Research Radiological Center of the Ministry of Health of the Russian Federation	Obninsk	Kaluzhskaya OBL.
Russian Federation	BHI of Omsk region "Clinical Oncological Dispensary"	Omsk
Russian Federation	Private Medical Institution "Euromedservice"	Pushkin	Saint-petersburg
Russian Federation	Klinika UZI 4D, LLC	Pyatigorsk	Stavropolskiy KRAI
Russian Federation	State Budgetary Institution of Ryazan Region "Regional Clinical Oncology Center"	Ryazan
Russian Federation	Joint-Stock Company "North-Western Centre of Evidence-Based Medicine" ("NWCoEBM" JSC)	Saint Petersburg
Russian Federation	Federal State Budgetary Healthcare Institution Saint - Petersburg	Saint-Petersburg
Russian Federation	Hospital OrKli LLC	Saint-Petersburg
Russian Federation	Joint-Stock Company "North-Western Centre of Evidence-Based Medicine" ("NWCoEBM" JSC)	Saint-Petersburg
Russian Federation	Leningrad Regional Clinical Hospital	Saint-Petersburg
Russian Federation	State Budgetary Institution of Healthcare of the Republic of Mordovia	Saransk	Republic OF Mordovia
Russian Federation	Republican Clinical Oncology Dispensary of the Ministry of Health of Bashkortostan Republic	Ufa
Russian Federation	Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"	Vologda
Russian Federation	SBHI YaR Regional clinical oncology hospital	Yaroslavl
Spain	Complejo Hospitalario Universitario A Coruna	A Coruna
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	Fundacio Puigvert	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital San Pedro de Alcantara	Caceres
Spain	Hospital Universitari de Girona Doctor Josep Trueta	Girona
Spain	Hospital General de Granollers	Granollers	Barcelona
Spain	Hospital Duran i Reynals- ICO L'Hospitalet	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Universitari de Bellvitge	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Universitario Lucus Augusti	Lugo
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Hospital Universitario La Princesa	Madrid
Spain	Hospital Universitario Puerta de Hierro Majadahonda	Majadahonda	Madrid
Spain	Complejo Hospitalario de Navarra	Pamplona	Navarra
Spain	Salut Sant Joan de Reus-Baix Camp	Reus	Tarragona
Spain	Fundacion Instituto Valenciano de Oncologia	Valencia
Spain	Hospital Arnau de Vilanova	Valencia
United Kingdom	Barts Health NHS Trust, St Bartholomew's Hospital	London
United Kingdom	Charing Cross Hospital	London
United States	Montefiore Medical Center - Montefiore Medical Park	Bronx	New York
United States	Montefiore Medical Center - Oncology Investigational Services	Bronx	New York
United States	John H. Stroger, Jr. Hospital of Cook County	Chicago	Illinois
United States	John H. Stroger, Jr. Hospital of Cook County/IND Pharmacy	Chicago	Illinois
United States	Urology Clinics of North Texas	Dallas	Texas
United States	Urology Clinics of North Texas	Dallas	Texas
United States	The Urology Center of Colorado	Denver	Colorado
United States	Chesapeake Urology Research Associates	Hanover	Maryland
United States	Urological Research Network Corp	Hialeah	Florida
United States	Houston Methodist Hospital	Houston	Texas
United States	Houston Metro Urology	Houston	Texas
United States	UF Health Jacksonville	Jacksonville	Florida
United States	UF Health North	Jacksonville	Florida
United States	Koman Family Outpatient Pavilion	La Jolla	California
United States	Sulpizio Cardiovascular Center at UC San Diego Health	La Jolla	California
United States	UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)	La Jolla	California
United States	UC San Diego Moores Cancer Center	La Jolla	California
United States	DuPage Medical Group	Lisle	Illinois
United States	Arkansas Urology	Little Rock	Arkansas
United States	Centerview Surgery Center	Little Rock	Arkansas
United States	DuPage Medical Group	Lombard	Illinois
United States	DuPage Medical Group Ambulatory Surgery Center	Lombard	Illinois
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Parkway Surgery Center	Myrtle Beach	South Carolina
United States	Edward Hospital	Naperville	Illinois
United States	Premier Medical Group of the Hudson Valley PC	New Windsor	New York
United States	Bellevue Hospital	New York	New York
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Laura & Isaac Perlmutter Cancer Center at NYU Langone Health	New York	New York
United States	Mount Sinai Hospital	New York	New York
United States	NYU Langone Health Urology Associates	New York	New York
United States	NYU Langone Medical Center (Tisch Hospital)	New York	New York
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	University of California Irvine Medical Center	Orange	California
United States	VA Portland Healthcare System	Portland	Oregon
United States	Dutchess Ambulatory Surgery Center	Poughkeepsie	New York
United States	Premier Medical Group of the Hudson Valley PC	Poughkeepsie	New York
United States	Urology San Antonio PA	San Antonio	Texas
United States	UC San Diego Medical Center - Hillcrest	San Diego	California
United States	Ochsner LSU Health Shreveport - Regional Urology	Shreveport	Louisiana
United States	Regional Urology Oncology & Radiation Center	Shreveport	Louisiana
United States	Regional Urology, LLC	Shreveport	Louisiana
United States	Associated Medical Professionals of New York, PLLC	Syracuse	New York
United States	Michigan Institute of Urology, PC	Troy	Michigan
United States	Urological Associates of Southern Arizona P.C.	Tucson	Arizona
United States	Urological Associates of Southern Arizona, P.C .	Tucson	Arizona
United States	Urology of Virginia, PLLC	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  China,  France,  Germany,  Italy,  Japan,  Korea, Republic of,  Poland,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	55 months after first participant randomized
Primary	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.	55 months after first participant randomized
Primary	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.	Registration to 12 months after last participant initially assessed
Primary	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.	Registration to 12 months after last participant initially assessed
Secondary	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.	Randomization up to 60 months from last participant randomized
Secondary	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.	Randomization up to 60 months from last participant randomized
Secondary	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.	Randomization up to 60 months from last participant randomized
Secondary	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.	Randomization up to 60 months from last participant randomized
Secondary	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).	Randomization up to 60 months from last participant randomized
Secondary	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.	Randomization up to 24 months
Secondary	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.	Randomization up to 24 months
Secondary	Tumor sample biomarker status based on PD-L1 expression (high or low) (Obsolete for Cohort B after stopping enrollment)	Evaluate PD-L1 expression.	Baseline
Secondary	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.	Randomization/registration up to 60 months from last participant randomized
Secondary	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.	Randomization up to 60 months from last participant randomized
Secondary	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	Randomization/registration to date of cystectomy (up to 5 years after last participant is randomized)
Secondary	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).	Randomization/registration up to 24 months
Secondary	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.	Baseline up to 60 months from the last participant randomized
Secondary	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.	Baseline up to 60 months from last participant randomized
Secondary	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).	Randomization/registration up to 60 months from the last participant randomized
Secondary	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.	12 months after last participant's initial assessment
Secondary	Event Free Survival (Cohort B1) (Obsolete after stopping enrollment in Cohort B)	Time from first dose to date of EFS event.	Registration to 5 years after last participant randomized.
Secondary	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.	Registration to 5 years after last participant randomized.
Secondary	ctrough of PF-06801591 (Cohorts B1 and B2) (Obsolete after stopping enrollment in Cohort B)	Ctrough will be summarized	Registration up to 24 months
Secondary	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.	Registration up to 24 months
Secondary	cmax of PF-06801591 (Cohort B2 only) (Obsolete after stopping enrollment in Cohort B)	Cmax will be summarized in Cohort B2 only.	Registration up to 24 months

External Links

•   To obtain contact information for a study center near you, click here.