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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
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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