Clinical trial NCT04165317: A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Non-muscle Invasive Bladder Cancer
Keywords: CREST
Sasanlimab
PF-06801591
Bacillus Calmette Guerin
BCG
Bladder cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-11-15
Enrollment: 1070
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Event free survival (Cohort A: Arm A compared to Arm C)
timeFrame: 55 months after first participant randomized
measure: Complete response rate (Cohort B1) (Obsolete after stopping enrollment in Cohort B)
timeFrame: Registration to 12 months after last participant initially assessed
measure: Event free survival (Cohort B2) (Obsolete after stopping enrollment in Cohort B)
timeFrame: Registration to 12 months after last participant initially assessed
Secondary outcomes:
measure: Event free survival (Cohort A: Arm B compared to Arm C)
timeFrame: 55 months after first participant randomized
measure: Overall Survival (Cohort A: Arm A compared to Arm C)
timeFrame: Randomization up to 60 months from last participant randomized
measure: Overall Survival (Cohort A: Arm B compared to Arm C)
timeFrame: Randomization up to 60 months from last participant randomized
measure: Complete response rate in participants with CIS at randomization (Cohort A: Arm A, B, C)
timeFrame: Randomization up to 60 months from last participant randomized
measure: Disease-specific survival (Cohort A: Arm A, B, C)
timeFrame: Randomization up to 60 months from last participant randomized
measure: 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)
timeFrame: Randomization up to 60 months from last participant randomized
measure: ctrough of PF-06801591 when in combination with BCG (induction and maintenance or induction). Cohort A: Arms A and B only.
timeFrame: Randomization up to 24 months
measure: Incidence of ADA/Nab of PF-06801591 when in combination with BCG (induction and maintenance or induction). Cohort A: Arms A and B only.
timeFrame: Randomization up to 24 months
measure: Tumor sample biomarker status based on PD-L1 expression (high or low) (Obsolete for Cohort B after stopping enrollment)
timeFrame: Baseline
measure: Duration of CR for participants with CIS at randomization (Obsolete for Cohort B after stopping enrollment)
timeFrame: Randomization/registration up to 60 months from last participant randomized
measure: Time to recurrence of low grade disease (Cohort A: Arm A, B, C)
timeFrame: Randomization up to 60 months from last participant randomized
measure: Time to cystectomy (Obsolete for Cohort B after stopping enrollment)
timeFrame: Randomization/registration to date of cystectomy (up to 5 years after last participant is randomized)
measure: Health-related quality of life as measured by PTAB (Patient Treatment Administration Burden Questionnaire) (Obsolete for Cohort B after stopping enrollment)
timeFrame: Randomization/registration up to 24 months
measure: 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)
timeFrame: Baseline up to 60 months from the last participant randomized
measure: Percentage of Participants With Laboratory Abnormalities (Obsolete for Cohort B after stopping enrollment)
timeFrame: Baseline up to 60 months from last participant randomized
measure: 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)
timeFrame: Randomization/registration up to 60 months from the last participant randomized
measure: Complete response rate at 12 months (Cohort B1) (Obsolete after stopping enrollment in Cohort B)
timeFrame: 12 months after last participant's initial assessment
measure: Event Free Survival (Cohort B1) (Obsolete after stopping enrollment in Cohort B)
timeFrame: Registration to 5 years after last participant randomized.
measure: Overall Survival (Cohorts B1 and B2) (Obsolete after stopping enrollment in Cohort B)
timeFrame: Registration to 5 years after last participant randomized.
measure: ctrough of PF-06801591 (Cohorts B1 and B2) (Obsolete after stopping enrollment in Cohort B)
timeFrame: Registration up to 24 months
measure: Incidence of ADA/Nab of PF-06801591 (Cohorts B1 and B2) (Obsolete after stopping enrollment in Cohort B)
timeFrame: Registration up to 24 months
measure: cmax of PF-06801591 (Cohort B2 only) (Obsolete after stopping enrollment in Cohort B)
timeFrame: Registration up to 24 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Urological Associates of Southern Arizona, P.C .
state: Arizona
city: Tucson
country: United States
facility: Urological Associates of Southern Arizona P.C.
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Urology
state: Arkansas
city: La Jolla
country: United States
facility: Koman Family Outpatient Pavilion
state: California
city: La Jolla
country: United States
facility: Sulpizio Cardiovascular Center at UC San Diego Health
state: California
city: La Jolla
country: United States
facility: UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
state: California
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Center
state: California
city: Orange
country: United States
facility: University of California Irvine Medical Center
state: California
city: San Diego
country: United States
facility: UC San Diego Medical Center - Hillcrest
state: California
city: Denver
country: United States
facility: The Urology Center of Colorado
state: Colorado
city: Hialeah
country: United States
facility: Urological Research Network Corp
state: Florida
city: Jacksonville
country: United States
facility: UF Health Jacksonville
state: Florida
city: Jacksonville
country: United States
facility: UF Health North
state: Florida
city: Chicago
country: United States
facility: John H. Stroger, Jr. Hospital of Cook County
state: Illinois
city: Lisle
country: United States
facility: DuPage Medical Group
state: Illinois
city: Lombard
country: United States
facility: DuPage Medical Group Ambulatory Surgery Center
state: Illinois
city: Lombard
country: United States
facility: DuPage Medical Group
state: Illinois
city: Naperville
country: United States
facility: Edward Hospital
state: Illinois
city: Shreveport
country: United States
facility: Ochsner LSU Health Shreveport - Regional Urology
state: Louisiana
city: Hanover
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Troy
country: United States
facility: Michigan Institute of Urology, PC
state: Michigan
city: Bronx
country: United States
facility: Montefiore Medical Center - Montefiore Medical Park
state: New York
city: New York
country: United States
facility: Bellevue Hospital
state: New York
city: New York
country: United States
facility: Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center (Tisch Hospital)
state: New York
city: New York
country: United States
facility: NYU Langone Health Urology Associates
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley PC
state: New York
city: Syracuse
country: United States
facility: Associated Medical Professionals of New York, PLLC
state: New York
city: Portland
country: United States
facility: VA Portland Healthcare System
state: Oregon
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Myrtle Beach
country: United States
facility: Parkway Surgery Center
state: South Carolina
city: Myrtle Beach
country: United States
facility: Atlantic Urology Clinics South Strand Office
state: South Carolina
city: Dallas
country: United States
facility: Urology Clinics of North Texas
state: Texas
city: Dallas
country: United States
facility: Urology Clinics of North Texas
state: Texas
city: Houston
country: United States
facility: Houston Metro Urology
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio PA
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Virginia Beach
country: United States
facility: Chesapeake Regional Surgery Center - Virginia Beach
state: Virginia
city: Virginia Beach
country: United States
facility: Urology of Virginia, PLLC
state: Virginia
city: Bowral
country: Australia
facility: Southern Highlands Cancer Centre
state: New South Wales
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse Hospital
state: New South Wales
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Box Hill
country: Australia
facility: Eastern Clinical Research Unit
state: Victoria
city: Lilydale
country: Australia
facility: Yarra Ranges Health
state: Victoria
city: Gent
country: Belgium
facility: UZ Gent
city: Vancouver
country: Canada
facility: Vancouver Prostate Centre at the Vancouver General Hospital
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton Regional Laboratory Medicine Program
state: Ontario
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre - Kingston General Hospital
state: Ontario
city: Kingston
country: Canada
facility: Centre for Applied Urological Research
state: Ontario
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre -- Hotel Dieu Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network - Princess Margaret Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network - Toronto General Hospital
state: Ontario
city: Chicoutimi
country: Canada
facility: Centre intégré universitaire de santé et de services sociaux du Saguenay-Lac-Saint-Jean
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Quebec
country: Canada
facility: Hotel-Dieu de Quebec - CHU de Quebec - Universite Laval
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing Chao-yang Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Medical University Affiliated First Hospital
state: Fujian
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Nantong
country: China
facility: Nantong Tumor Hospital
state: Jiangsu
city: Suzhou
country: China
facility: Second Affiliated Hospital of Suzhou University
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi 'an Jiaotong University
state: Shaanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Tianjin
country: China
facility: The Second Hospital of Tianjin Medical University
city: Antony
country: France
facility: Hôpital privé Antony (Pharmacy)
city: Bayonne
country: France
facility: Clinique Belharra
city: BORDEAUX Cedex
country: France
facility: Clinique Saint-Augustin
city: Bordeaux Cedex
country: France
facility: Institut Bergonié
city: Bordeaux
country: France
facility: CHU de Bordeaux Hôpital Pellegrin
city: Brest Cedex 2
country: France
facility: Groupe Vivalto Sante - Clinique Pasteur-Lanroze- CFRO
city: Brest
country: France
facility: Cabinet Privé d'urologie
city: Brest
country: France
facility: CHPB Keraudren
city: Limoges
country: France
facility: Polyclinique de Limoges Site Chenieux
city: Nancy
country: France
facility: Polyclinique de Gentilly
city: Paris
country: France
facility: Hôpital Bichat - Claude-Bernard
city: Strasbourg
country: France
facility: Clinique Sainte Anne
city: Duisburg
country: Germany
facility: Urologicum Duisburg
city: Frankfurt
country: Germany
facility: Klinikum der Goethe-Universitaet Frankfurt
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster, Urologie
city: Nuertingen
country: Germany
facility: Studienpraxis Urologie
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
city: Misterobianco (CT)
country: Italy
facility: Humanitas Istituto Clinico Catanese S.p.A - U.O. Oncologia Medica
state: Catania
city: Cremona
country: Italy
facility: UO Oncologia, ASST di Cremona - Istituti Ospitalieri - Ospedale di Cremona
state: CR
city: Rozzano
country: Italy
facility: IRCSS Istituto Clinico Humanitas - U.O. Oncologia Medica
state: Milano
city: Arezzo
country: Italy
facility: Ospedale Area Aretina Nord - UOC Oncologia Medica
city: Bari
country: Italy
facility: UO Oncologia Medica IRCCS Istituto Tumori "Giovanni Paolo II"
city: Genova
country: Italy
facility: IRCCS Azienda Ospedaliera Universitaria Policlinico San Martino Urologia
city: Macerata
country: Italy
facility: Ospedale Generale Provinciale di Macerata - UOC Oncologia
city: Messina
country: Italy
facility: Medical Oncology Unit, AO Papardo
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele, URI (Urological Research Institute)
city: Reggio Emilia
country: Italy
facility: AUSL/IRCCS di Reggio Emilia
city: Turin
country: Italy
facility: AO Azienda Ospedaliera Ordine Mauriziano Di Torino
city: Varese
country: Italy
facility: ASST Sette Laghi Ospedale di Circolo Fondazione Macchi
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Toon
country: Japan
facility: Ehime University Hospital
state: Ehime
city: Fukuoka-shi
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
state: Fukuoka
city: Ota
country: Japan
facility: Gunma Prefectural Cancer Center
state: Gunma
city: Sapporo
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
state: Hokkaido
city: Yokohama
country: Japan
facility: Kanagawa cancer center
state: Kanagawa
city: Osaka-shi
country: Japan
facility: Osaka International Cancer Institute
state: Osaka
city: Osakasayama
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
state: Shizuoka
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Kumamoto
country: Japan
facility: National Hospital Organization Kumamoto Medical Center
city: Okayama
country: Japan
facility: Okayama Medical Center
city: Yamagata
country: Japan
facility: Yamagata University Hospital
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Gliwice
country: Poland
facility: NZOZ AKMED Andrzej Kupilas
city: Grudziadz
country: Poland
facility: Regionalny Szpital Specjalistyczny im. Dr. Wladyslawa Bieganskiego
city: Mysłowice
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej Centrum Urologiczne Sp. z o.o.
city: Piotrkow Trybunalski
country: Poland
facility: Provita Profamilia
city: Poznan
country: Poland
facility: Clinical Research Center Spolka z ograniczona odpowiedzialnoscia MEDIC-R Spolka Komandytowa
city: Skierniewice
country: Poland
facility: ETG Skierniewice
city: Warszawa
country: Poland
facility: Provita 001
city: Warszawa
country: Poland
facility: Medical Concierge Centrum Medyczne
city: Wroclaw
country: Poland
facility: Lexmedica
city: Obninsk
country: Russian Federation
facility: A.Tsyb Medical Research Radiological Center of the Ministry of Health of the Russian Federation
state: Kaluzhskaya OBL.
city: Saransk
country: Russian Federation
facility: State Budgetary Institution of Healthcare of the Republic of Mordovia
state: Republic OF Mordovia
city: Pushkin
country: Russian Federation
facility: Private Medical Institution "Euromedservice"
state: Saint-petersburg
city: Pyatigorsk
country: Russian Federation
facility: Klinika UZI 4D, LLC
state: Stavropolskiy KRAI
city: Kuzmolovskiy Settlement
country: Russian Federation
facility: Leningrad Regional Clinical Hospital
state: Vsevolozhsky District
city: Chelyabinsk
country: Russian Federation
facility: Evimed Llc
city: Ivanovo
country: Russian Federation
facility: Regional Budgetary Healthcare Institution "Ivanovo Regional Oncology Dispensary"
city: Kaliningrad
country: Russian Federation
facility: Ars Medika Center, LLC
city: Kaluga
country: Russian Federation
facility: Kaluga Regional Clinical Oncology Center
city: Moscow
country: Russian Federation
facility: P.A. Hertsen Moscow Oncology Research Center- branch of the National Medical Research
city: Nizhny Novgorod
country: Russian Federation
facility: Federal Budgetary Institution of Healthcare "Privolzhsky District Medical Center of the Federal
city: Omsk
country: Russian Federation
facility: BHI of Omsk region "Clinical Oncological Dispensary"
city: Ryazan
country: Russian Federation
facility: State Budgetary Institution of Ryazan Region "Regional Clinical Oncology Center"
city: Saint Petersburg
country: Russian Federation
facility: Joint-Stock Company "North-Western Centre of Evidence-Based Medicine" ("NWCoEBM" JSC)
city: Saint Petersburg
country: Russian Federation
facility: Limited Liability Company "North-Western Medical Center"
city: Saint-Petersburg
country: Russian Federation
facility: Federal State Budgetary Healthcare Institution Saint - Petersburg
city: Saint-Petersburg
country: Russian Federation
facility: Hospital OrKli LLC
city: Ufa
country: Russian Federation
facility: Republican Clinical Oncology Dispensary of the Ministry of Health of Bashkortostan Republic
city: Vologda
country: Russian Federation
facility: Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"
city: Yaroslavl
country: Russian Federation
facility: SBHI YaR Regional clinical oncology hospital
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Granollers
country: Spain
facility: Hospital General de Granollers
state: Barcelona
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
city: Reus
country: Spain
facility: Salut Sant Joan de Reus-Baix Camp
state: Tarragona
city: A Coruna
country: Spain
facility: Complejo Hospitalario Universitario A Coruna
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Fundacio Puigvert
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Caceres
country: Spain
facility: Hospital San Pedro de Alcantara
city: Girona
country: Spain
facility: Hospital Universitari de Girona Doctor Josep Trueta
city: Llíria
country: Spain
facility: Hospital de Llíria
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Valencia
country: Spain
facility: Fundacion Instituto Valenciano de Oncologia
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
city: London
country: United Kingdom
facility: Barts Health NHS Trust, St Bartholomew's Hospital
city: London
country: United Kingdom
facility: Charing Cross Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: