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

December 13, 2023 updated by: Pfizer

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

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.

Study Overview

Status

Active, not recruiting

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.

Study Type

Interventional

Enrollment (Actual)

1070

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New South Wales
      • Bowral, New South Wales, Australia, 2756
        • Southern Highlands Cancer Centre
      • Campbelltown, New South Wales, Australia, 2560
        • Campbelltown Hospital
      • Campbelltown, New South Wales, Australia, 2560
        • Campbelltown Private Hospital
      • Camperdown, New South Wales, Australia, 2050
        • Chris O'Brien Lifehouse
      • Camperdown, New South Wales, Australia, 2050
        • Chris O'Brien Lifehouse Hospital
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
      • Box Hill, Victoria, Australia, 3128
        • Eastern Clinical Research Unit
      • Lilydale, Victoria, Australia, 3140
        • Yarra Ranges Health
      • Gent, Belgium, 9000
        • UZ Gent
      • Quebec, Canada, G1R 2J6
        • Hotel-Dieu de Quebec - CHU de Quebec - Universite Laval
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver Prostate Centre at the Vancouver General Hospital
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • Hamilton Regional Laboratory Medicine Program
      • Hamilton, Ontario, Canada, L8N 4A6
        • McMaster Institute of Urology/St Joseph's Healthcare Hamilton
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston Health Sciences Centre - Kingston General Hospital
      • Kingston, Ontario, Canada, K7L 3J7
        • Centre for Applied Urological Research
      • Kingston, Ontario, Canada, K7L 5G2
        • Kingston Health Sciences Centre -- Hotel Dieu Hospital
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network - Princess Margaret Cancer Centre
      • Toronto, Ontario, Canada, M5G2C4
        • University Health Network - Toronto General Hospital
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Centre Integre Universitaire de Sante et de Services Sociaux du Saguenay-Lac-Saint-Jean
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre
      • Chongqing, China, 400030
        • Chongqing University Cancer Hospital
      • Shanghai, China, 200032
        • Fudan University Cancer Hospital
      • Shanghai, China, 201321
        • Fudan University Shanghai Cancer Center
      • Tianjin, China, 300211
        • The Second Hospital of Tianjin Medical University
    • Anhui
      • Hefei, Anhui, China, 230022
        • The First Affiliated Hospital of Anhui Medical University
    • Beijing
      • Beijing, Beijing, China, 100034
        • Peking University First Hospital
      • Beijing, Beijing, China, 100142
        • Beijing Cancer Hospital
      • Beijing, Beijing, China, 100730
        • Peking Union Medical College Hospital
      • Beijing, Beijing, China, 100020
        • Beijing Chao-Yang Hospital
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • Fujian Medical University Affiliated First Hospital
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    • Hunan
      • Changsha, Hunan, China, 410013
        • Hunan Cancer Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Nanjing Drum Tower Hospital
      • Nantong, Jiangsu, China, 226000
        • Nantong Tumor Hospital
      • Suzhou, Jiangsu, China, 215004
        • Second Affiliated Hospital of Suzhou University
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • First Affiliated Hospital of Xi 'an Jiaotong University
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital of Sichuan University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310014
        • Zhejiang Provincial People's Hospital
      • Ningbo, Zhejiang, China, 315010
        • Ningbo First Hospital
      • Wenzhou, Zhejiang, China, 325000
        • The First Affiliated Hospital of Wenzhou Medical University
      • Wenzhou, Zhejiang, China, 325035
        • The First Affiliated Hospital of Wenzhou Medical University
      • Antony, France, 92160
        • Hôpital privé Antony (Pharmacy)
      • Antony, France, 92160
        • Hopital Prive d'Antony
      • BORDEAUX Cedex, France, 33074
        • Clinique Saint-Augustin
      • Bayonne, France, 64100
        • Clinique Belharra
      • Bordeaux, France, 33000
        • CHU de Bordeaux Hôpital Pellegrin
      • Bordeaux Cedex, France, 33076
        • Institut Bergonie
      • Brest, France, 29200
        • Cabinet Privé d'urologie
      • Brest, France, 29200
        • CHPB Keraudren
      • Brest Cedex 2, France, 29229
        • Groupe Vivalto Sante - Clinique Pasteur-Lanroze- CFRO
      • Limoges, France, 87000
        • Polyclinique de Limoges Site Chenieux
      • Limoges Cedex 1, France, 87038
        • Polyclinique de Limoges Site Emailleurs-Colombier
      • Nancy, France, 54100
        • Polyclinique de Gentilly
      • Paris, France, 75877
        • Hôpital Bichat - Claude-Bernard
      • Strasbourg, France, 67000
        • Clinique Sainte Anne
      • Duisburg, Germany, 47179
        • Urologicum Duisburg
      • Frankfurt, Germany, 60590
        • Klinikum der Goethe-Universitaet Frankfurt
      • Muenster, Germany, 48149
        • Universitaetsklinikum Muenster, Urologie
      • Nuertingen, Germany, 72622
        • Studienpraxis Urologie
      • Tuebingen, Germany, 72076
        • Universitaetsklinikum Tuebingen
      • Arezzo, Italy, 52100
        • Ospedale Area Aretina Nord - UOC Oncologia Medica
      • Bari, Italy, 70124
        • UO Oncologia Medica IRCCS Istituto Tumori "Giovanni Paolo II"
      • Genova, Italy, 16132
        • IRCCS Azienda Ospedaliera Universitaria Policlinico San Martino Urologia
      • Macerata, Italy, 62100
        • Ospedale Generale Provinciale di Macerata - UOC Oncologia
      • Messina, Italy, 98158
        • Medical Oncology Unit, AO Papardo
      • Milan, Italy, 20132
        • IRCCS Ospedale San Raffaele, URI (Urological Research Institute)
      • Reggio Emilia, Italy, 42123
        • AUSL/IRCCS di Reggio Emilia
      • Varese, Italy, 21100
        • ASST Sette Laghi Ospedale di Circolo Fondazione Macchi
    • CR
      • Cremona, CR, Italy, 26100
        • UO Oncologia, ASST di Cremona - Istituti Ospitalieri - Ospedale di Cremona
    • Catania
      • Misterobianco (CT), Catania, Italy, 95045
        • Humanitas Istituto Clinico Catanese S.p.A - U.O. Oncologia Medica
    • Milano
      • Rozzano, Milano, Italy, 20089
        • IRCSS Istituto Clinico Humanitas - U.O. Oncologia Medica
    • Turin
      • Torino, Turin, Italy, 10128
        • AO Azienda Ospedaliera Ordine Mauriziano Di Torino
      • Kagoshima, Japan, 890-8520
        • Kagoshima University Hospital
      • Kumamoto, Japan, 860-0008
        • National Hospital Organization Kumamoto Medical Center
      • Okayama, Japan, 701-1192
        • Okayama Medical Center
      • Yamagata, Japan, 990-9585
        • Yamagata University Hospital
    • Ehime
      • Matsuyama, Ehime, Japan, 791-0280
        • National Hospital Organization Shikoku Cancer Center
      • Toon, Ehime, Japan, 791-0295
        • Ehime University Hospital
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 811-1395
        • National Hospital Organization Kyushu Cancer Center
    • Gunma
      • Ota, Gunma, Japan, 373-8550
        • Gunma Prefectural Cancer Center
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 003-0804
        • National Hospital Organization Hokkaido Cancer Center
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 241-8515
        • Kanagawa Cancer Center
    • Osaka
      • Osaka-shi, Osaka, Japan, 541-8567
        • Osaka International Cancer Institute
      • Osakasayama, Osaka, Japan, 589-8511
        • Kindai University Hospital
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 431-3192
        • Hamamatsu University Hospital
    • Tokyo
      • Shinjuku-ku, Tokyo, Japan, 160-8582
        • Keio University Hospital
      • Daegu, Korea, Republic of, 41404
        • Kyungpook National University Chilgok Hospital
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
        • National Cancer Center
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
      • Belchatow, Poland, 97-400
        • Szpital Wojewodzki im Jana Pawla II
      • Gliwice, Poland, 44-100
        • NZOZ AKMED Andrzej Kupilas
      • Grudziadz, Poland, 86-300
        • Regionalny Szpital Specjalistyczny im. Dr. Wladyslawa Bieganskiego
      • Mysłowice, Poland, 41-400
        • Niepubliczny Zaklad Opieki Zdrowotnej Centrum Urologiczne Sp. z o.o.
      • Piotrkow Trybunalski, Poland, 97-300
        • Provita Profamilia
      • Poznan, Poland, 61-731
        • Clinical Research Center Spolka z ograniczona odpowiedzialnoscia MEDIC-R Spolka Komandytowa
      • Skierniewice, Poland, 96-100
        • ETG Skierniewice
      • Warszawa, Poland, 02-647
        • Provita 001
      • Warszawa, Poland, 02-798
        • Medical Concierge Centrum Medyczne
      • Wroclaw, Poland, 53-114
        • LexMedica
      • Chelyabinsk, Russian Federation, 454048
        • Evimed LLC
      • Ivanovo, Russian Federation, 153040
        • Regional Budgetary Healthcare Institution "Ivanovo Regional Oncology Dispensary"
      • Kaliningrad, Russian Federation, 236006
        • Ars Medika Center, LLC
      • Kaluga, Russian Federation, 248007
        • Kaluga Regional Clinical Oncology Center
      • Moscow, Russian Federation, 125284
        • P.A. Hertsen Moscow Oncology Research Center- branch of the National Medical Research
      • Nizhny Novgorod, Russian Federation, 603074
        • Federal Budgetary Institution of Healthcare "Privolzhsky District Medical Center of the Federal
      • Omsk, Russian Federation, 644013
        • BHI of Omsk region "Clinical oncological dispensary"
      • Ryazan, Russian Federation, 390011
        • State Budgetary Institution of Ryazan Region "Regional Clinical Oncology Center"
      • Saint Petersburg, Russian Federation, 194355
        • Joint-Stock Company "North-Western Centre of Evidence-Based Medicine" ("NWCoEBM" JSC)
      • Saint-Petersburg, Russian Federation, 194017
        • Federal State Budgetary Healthcare Institution Saint - Petersburg
      • Saint-Petersburg, Russian Federation, 198095
        • Joint-Stock Company "North-Western Centre of Evidence-Based Medicine" ("NWCoEBM" JSC)
      • Saint-Petersburg, Russian Federation, 199178
        • Hospital Orkli LLC
      • Saint-Petersburg, Russian Federation, 194291
        • Leningrad Regional Clinical Hospital
      • Ufa, Russian Federation, 450054
        • Republican Clinical Oncology Dispensary of the Ministry of Health of Bashkortostan Republic
      • Vologda, Russian Federation, 160022
        • Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"
      • Yaroslavl, Russian Federation, 150054
        • SBHI YaR Regional clinical oncology hospital
    • Kaluzhskaya OBL.
      • Obninsk, Kaluzhskaya OBL., Russian Federation, 249036
        • A.Tsyb Medical Research Radiological Center of the Ministry of Health of the Russian Federation
    • Other
      • Leningrad Region, Other, Russian Federation, 188663
        • Leningrad Regional Clinical Hospital
    • Republic OF Mordovia
      • Saransk, Republic OF Mordovia, Russian Federation, 430032
        • State Budgetary Institution of Healthcare of the Republic of Mordovia
    • Saint-petersburg
      • Pushkin, Saint-petersburg, Russian Federation, 196603
        • Private medical institution "Euromedservice"
    • Stavropolskiy KRAI
      • Pyatigorsk, Stavropolskiy KRAI, Russian Federation, 357502
        • Klinika UZI 4D, LLC
    • Vsevolozhskiy District
      • Kuzmolovskiy Settlement, Vsevolozhskiy District, Russian Federation
        • Leningrad Regional Clinical Hospital
    • Vsevolozhsky District
      • Kuzmolovskiy Settlement, Vsevolozhsky District, Russian Federation
        • Leningrad Regional Clinical Hospital
      • Kuzmolovsky Settlement, Vsevolozhsky District, Russian Federation, 188663
        • State Budgetary Healthcare Institution "Leningrad Regional Clinical Oncology Dispensary"
      • A Coruna, Spain, 15006
        • Complejo Hospitalario Universitario A Coruna
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08041
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain, 08025
        • Fundacio Puigvert
      • Caceres, Spain, 10003
        • Hospital San Pedro de Alcántara
      • Girona, Spain, 17007
        • Hospital Universitari de Girona Doctor Josep Trueta
      • Lugo, Spain, 27003
        • Hospital Universitario Lucus Augusti
      • Madrid, Spain, 28006
        • Hospital Universitario La Princesa
      • Madrid, Spain, 28040
        • Hospital Clínico San Carlos
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28006
        • Hospital Universitario de La Princesa
      • Valencia, Spain, 46009
        • Fundación Instituto Valenciano de Oncología
      • Valencia, Spain, 46015
        • Hospital Arnau de Vilanova
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol
      • Granollers, Barcelona, Spain, 08402
        • Hospital General de Granollers
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitari de Bellvitge
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Hospital Duran i Reynals- ICO L'Hospitalet
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro Majadahonda
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Complejo Hospitalario de Navarra
    • Tarragona
      • Reus, Tarragona, Spain, 43204
        • Salut Sant Joan de Reus-Baix Camp
      • London, United Kingdom, W6 8RF
        • Charing Cross Hospital
      • London, United Kingdom, EC1A 7BE
        • Barts Health NHS Trust, St Bartholomew's Hospital
    • Arizona
      • Tucson, Arizona, United States, 85715
        • Urological Associates of Southern Arizona, P.C .
      • Tucson, Arizona, United States, 85741
        • Urological Associates of Southern Arizona P.C.
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Arkansas Urology
      • Little Rock, Arkansas, United States, 72211
        • Centerview Surgery Center
    • California
      • La Jolla, California, United States, 92093
        • UC San Diego Moores Cancer Center
      • La Jolla, California, United States, 92037
        • Koman Family Outpatient Pavilion
      • La Jolla, California, United States, 92037
        • Sulpizio Cardiovascular Center at UC San Diego Health
      • La Jolla, California, United States, 92037
        • UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
      • Orange, California, United States, 92868
        • University of California Irvine Medical Center
      • San Diego, California, United States, 92103
        • UC San Diego Medical Center - Hillcrest
    • Colorado
      • Denver, Colorado, United States, 80211
        • The Urology Center of Colorado
    • Florida
      • Hialeah, Florida, United States, 33016
        • Urological Research Network CORP
      • Jacksonville, Florida, United States, 32209
        • UF Health Jacksonville
      • Jacksonville, Florida, United States, 32218
        • UF Health North
    • Illinois
      • Chicago, Illinois, United States, 60612
        • John H. Stroger, Jr. Hospital of Cook County
      • Chicago, Illinois, United States, 60612
        • John H. Stroger, Jr. Hospital of Cook County/IND Pharmacy
      • Lisle, Illinois, United States, 60532
        • DuPage Medical Group
      • Lombard, Illinois, United States, 60148
        • DuPage Medical Group Ambulatory Surgery Center
      • Lombard, Illinois, United States, 60148
        • DuPage Medical Group
      • Naperville, Illinois, United States, 60540
        • Edward Hospital
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • Regional Urology, LLC
      • Shreveport, Louisiana, United States, 71106
        • Regional Urology Oncology & Radiation Center
      • Shreveport, Louisiana, United States, 71106
        • Ochsner LSU Health Shreveport - Regional Urology
    • Maryland
      • Hanover, Maryland, United States, 21076
        • Chesapeake Urology Research Associates
    • Michigan
      • Troy, Michigan, United States, 48084
        • Michigan Institute of Urology, PC
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center - Montefiore Medical Park
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center - Oncology Investigational Services
      • New Windsor, New York, United States, 12553
        • Premier Medical Group of the Hudson Valley PC
      • New York, New York, United States, 10016
        • Bellevue Hospital
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10029
        • Mount Sinai Hospital
      • New York, New York, United States, 10016
        • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
      • New York, New York, United States, 10016
        • NYU Langone Medical Center (Tisch Hospital)
      • New York, New York, United States, 10017
        • NYU Langone Health Urology Associates
      • Poughkeepsie, New York, United States, 12601
        • Dutchess Ambulatory Surgery Center
      • Poughkeepsie, New York, United States, 12603
        • Premier Medical Group of the Hudson Valley PC
      • Syracuse, New York, United States, 13210
        • Associated Medical Professionals of New York, PLLC
    • Oregon
      • Portland, Oregon, United States, 97239
        • VA Portland Healthcare System
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Urologic Research Center
      • Myrtle Beach, South Carolina, United States, 29572
        • Parkway Surgery Center
    • Texas
      • Dallas, Texas, United States, 75231
        • Urology Clinics of North Texas
      • Dallas, Texas, United States, 75246
        • Urology Clinics of North Texas
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital
      • Houston, Texas, United States, 77027
        • Houston Metro Urology
      • San Antonio, Texas, United States, 78229
        • Urology San Antonio PA
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk General Hospital
      • Virginia Beach, Virginia, United States, 23462
        • Urology Of Virginia, Pllc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PF-06801591 + BCG induction and maintenance
PF-06801591 in combination with Bacillus Calmette Guerin(induction+maintenance).
A monoclonal antibody (mAb) that blocks the interaction between PD-1 and PD-L1/PD-L2.
Other Names:
  • Sasanlimab
Immunotherapy treatment approved by FDA for patients with high-risk non-muscle invasive bladder cancer
Other Names:
  • BCG
Experimental: PF-06801591 + BCG induction only
PF-06801591 in combination with Bacillus Calmette Guerin (induction only).
A monoclonal antibody (mAb) that blocks the interaction between PD-1 and PD-L1/PD-L2.
Other Names:
  • Sasanlimab
Immunotherapy treatment approved by FDA for patients with high-risk non-muscle invasive bladder cancer
Other Names:
  • BCG
Active Comparator: BCG induction and maintenance
Bacillus Calmette Guerin (induction and maintenance).
Immunotherapy treatment approved by FDA for patients with high-risk non-muscle invasive bladder cancer
Other Names:
  • BCG
Experimental: BCG Unresponsive CIS
PF-06801591
A monoclonal antibody (mAb) that blocks the interaction between PD-1 and PD-L1/PD-L2.
Other Names:
  • Sasanlimab
Experimental: BCG Unresponsive NMIBC
PF-06801591
A monoclonal antibody (mAb) that blocks the interaction between PD-1 and PD-L1/PD-L2.
Other Names:
  • Sasanlimab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event free survival (Cohort A: Arm A compared to Arm C)
Time Frame: 55 months after first participant randomized
Event free survival is defined as the time from randomization to date of EFS event.
55 months after first participant randomized
Event free survival (Cohort A: Arm B compared to Arm C)
Time Frame: 55 months after first participant randomized
Event free survival is defined as the time from randomization to date of EFS event.
55 months after first participant randomized
Complete response rate (Cohort B1) (Obsolete after stopping enrollment in Cohort B)
Time Frame: Registration to 12 months after last participant initially assessed
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
Event free survival (Cohort B2) (Obsolete after stopping enrollment in Cohort B)
Time Frame: Registration to 12 months after last participant initially assessed
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (Cohort A: Arm A compared to Arm C)
Time Frame: Randomization up to 60 months from last participant randomized
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
Overall Survival (Cohort A: Arm B compared to Arm C)
Time Frame: Randomization up to 60 months from last participant randomized
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
Complete response rate in participants with CIS at randomization (Cohort A: Arm A, B, C)
Time Frame: Randomization up to 60 months from last participant randomized
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
Disease-specific survival (Cohort A: Arm A, B, C)
Time Frame: Randomization up to 60 months from last participant randomized
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
ctrough of PF-06801591 when in combination with BCG (induction and maintenance or induction). Cohort A: Arms A and B only.
Time Frame: Randomization up to 24 months
Ctrough will be summarized in Cohort A Arms A and B only.
Randomization up to 24 months
Incidence of ADA/Nab of PF-06801591 when in combination with BCG (induction and maintenance or induction). Cohort A: Arms A and B only.
Time Frame: Randomization up to 24 months
Immunogenicity will be evaluated for Cohort A Arms A and B only.
Randomization up to 24 months
Time to recurrence of low grade disease (Cohort A: Arm A, B, C)
Time Frame: Randomization up to 60 months from last participant randomized
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
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)
Time Frame: Randomization up to 60 months from last participant randomized
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
Tumor sample biomarker status based on PD-L1 expression (high or low) (Obsolete for Cohort B after stopping enrollment)
Time Frame: Baseline
Evaluate PD-L1 expression.
Baseline
Duration of CR for participants with CIS at randomization (Obsolete for Cohort B after stopping enrollment)
Time Frame: Randomization/registration up to 60 months from last participant randomized
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
Time to cystectomy (Obsolete for Cohort B after stopping enrollment)
Time Frame: Randomization/registration to date of cystectomy (up to 5 years after last participant is randomized)
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)
Health-related quality of life as measured by PTAB (Patient Treatment Administration Burden Questionnaire) (Obsolete for Cohort B after stopping enrollment)
Time Frame: Randomization/registration up to 24 months
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
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)
Time Frame: Baseline up to 60 months from the last participant randomized
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
Percentage of Participants With Laboratory Abnormalities (Obsolete for Cohort B after stopping enrollment)
Time Frame: Baseline up to 60 months from last participant randomized
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
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)
Time Frame: Randomization/registration up to 60 months from the last participant randomized
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
Complete response rate at 12 months (Cohort B1) (Obsolete after stopping enrollment in Cohort B)
Time Frame: 12 months after last participant's initial assessment
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
Event Free Survival (Cohort B1) (Obsolete after stopping enrollment in Cohort B)
Time Frame: Registration to 5 years after last participant randomized.
Time from first dose to date of EFS event.
Registration to 5 years after last participant randomized.
Overall Survival (Cohorts B1 and B2) (Obsolete after stopping enrollment in Cohort B)
Time Frame: Registration to 5 years after last participant randomized.
Time from the date of first dose to the date of death due to any cause.
Registration to 5 years after last participant randomized.
ctrough of PF-06801591 (Cohorts B1 and B2) (Obsolete after stopping enrollment in Cohort B)
Time Frame: Registration up to 24 months
Ctrough will be summarized
Registration up to 24 months
Incidence of ADA/Nab of PF-06801591 (Cohorts B1 and B2) (Obsolete after stopping enrollment in Cohort B)
Time Frame: Registration up to 24 months
Immunogenicity will be evaluated for participants with BCG unresponsive NMIBC, including those with CIS.
Registration up to 24 months
cmax of PF-06801591 (Cohort B2 only) (Obsolete after stopping enrollment in Cohort B)
Time Frame: Registration up to 24 months
Cmax will be summarized in Cohort B2 only.
Registration up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2019

Primary Completion (Estimated)

June 3, 2024

Study Completion (Estimated)

December 2, 2026

Study Registration Dates

First Submitted

November 13, 2019

First Submitted That Met QC Criteria

November 13, 2019

First Posted (Actual)

November 15, 2019

Study Record Updates

Last Update Posted (Estimated)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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