Clinical trial NCT04994717: Study Comparing Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care Chemotherapy for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia
Official title: Phase 3 Randomized, Controlled Study of Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia With Safety Run-in (Golden Gate Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Newly Diagnosed Philadelphia (Ph)-Negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL)
Keywords: Newly Diagnosed Philadelphia (Ph)-negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL)
Blinatumomab
Low-intensity Chemotherapy
GMALL HyperCVAD
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2021-08-06
Enrollment: 284
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The safety run-in part of the study aims to evaluate the safety and tolerability of blinatumomab alternating with low-intensity chemotherapy. The phase 3 part of the study aims to compare event-free survival (EFS) and overall survival (OS) of participants receiving blinatumomab alternating with low-intensity chemotherapy to EFS and (OS) of participants receiving standard of care (SOC) chemotherapy.


Eligibility criteria: Inclusion Criteria:

- Age ≥ 55 years at the time of informed consent. OR

Age 40 to \< 55 years of age if at least 1 of the following comorbidities at the time of informed consent:

* history of grades 3 and 4 pancreatitis
* diabetes mellitus with end-organ damage
* severe liver disease such as cirrhosis stage 2 with portal hypertension or history of esophageal variceal bleeding and aspartate transaminase (AST)/alanine aminotransferase (ALT) \> 10 x upper limit of normal (ULN) (liver cirrhosis must be confirmed by biopsy)
* body mass index (BMI) ≥ 40 combined with relevant comorbidities such as metabolic syndrome
* Any further combination of documented severe comorbidities that the investigator judges to be incompatible with administering an intensive pediatric based, adult adapted standard chemotherapy regimen but still compatible with the suggested protocol for older participants in both the experimental and the SOC arm. The participant history will be reviewed by the medical monitor during screening to determine enrollment acceptability based on a standard list with types of comorbidities allowed.

  * Participants with newly diagnosed Philadelphia (Ph)-negative B-cell precursor acute lymphoblastic leukemia (ALL)
  * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, higher ECOG score allowed if due to underlying leukemia
  * All participants must have adequate organ function as defined below:
* renal: estimated glomerular filtration rate based on MDRD calculation ≥ 50 mL/min/1.73 m\^2
* liver function: total bilirubin ≤ 2x upper limit of normal (ULN; unless Gilbert's Disease or if liver involvement with leukemia); exception for participants 40 to \< 55 years of age if they have a comorbidity listed above: severe liver disease such as cirrhosis stage 2 with portal hypertension or history of esophageal variceal bleeding and AST/ALT \> 10 x ULN (liver cirrhosis must be confirmed by biopsy)
* cardiac: left ventricular ejection fraction (LVEF) ≥ 50% and no clinically significant, uncontrolled, or active cardiovascular disease (eg, myocardial infarction or stroke within 3 months). Consult with medical monitor as needed.

Exclusion Criteria:

* Active central nervous system (CNS) leukemia (i.e., CNS 3 leukemia, confirmed by lumbar puncture) not resolved with IT chemotherapy during screening.
* History of other malignancy within the past 3 years, with the following exceptions:

  * Malignancy treated with curative intent and with no known active disease present for ≥ 3 years before enrollment and felt to be at low risk for recurrence by the treating physician
  * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
  * Adequately treated cervical carcinoma in situ without evidence of disease
  * Adequately treated breast ductal carcinoma in situ without evidence of disease
  * Prostatic intraepithelial neoplasia without evidence of prostate cancer
  * Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ
* Clinically relevant CNS pathology or event such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychiatric conditions that preclude the use of high dose of corticosteroids
* Current autoimmune disease or history of autoimmune disease with potential CNS involvement
* Known infection with human immunodeficiency virus (HIV)
* Known infection with chronic or active infection with hepatitis B (eg, hepatitis b surface \[HBs\] antigen reactive or quantifiable hepatitis b virus \[HBV\] viral load) or hepatitis C virus (HCV) (eg, HCV RNA \[qualitative\] is detected).

Active hepatitis B and C based on the following results:

* positive for hepatitis B surface antigen (HepBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B)
* negative HepBsAg and positive for hepatitis B core antibody: negative HBV DNA by PCR result is necessary to enroll.
* positive Hepatitis C virus antibody (HepCAb): negative hepatitis C virus RNA by PCR result is necessary to enroll.

  * Participant with symptoms and/or clinical signs and/or radiographic and/or sonographic signs that indicate an acute or uncontrolled chronic infection.
  * Cancer chemotherapy for this newly diagnosed B cell ALL before the start of protocol-required therapy with the exception of IT chemotherapy or optional pre-phase (debulking) chemotherapy. Radiation to a spot lesion such as chloroma or lytic lesion of bone or vertebrae for pain or vertebral stabilization is allowed.

Primary outcomes:
measure: Safety run-in: Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to approximately 5 years
measure: Phase 3: Event-free Survival (EFS)
timeFrame: Up to approximately 5 years
measure: Phase 3: Overall Survival (OS)
timeFrame: Up to approximately 5 years
Secondary outcomes:
measure: Safety run-in: Complete Remission (CR) Rate by the End of Initial Disease Assessment Period
timeFrame: Baseline to Week 14
measure: Safety run-in: Minimal Residual Disease (MRD) Response by the End of Initial Disease Assessment Period
timeFrame: Baseline to Week 14
measure: Safety run-in: Relapse-free Survival (RFS)
timeFrame: Up to approximately 5 years
measure: Safety run-in: Minimal Residual Disease (MRD) Relapse Free Survival (RFS)
timeFrame: Up to approximately 5 years
measure: Safety run-in: Steady State Concentration (Css) of Blinatumomab
timeFrame: Up to approximately 34 weeks
measure: Safety run-in: Clearance (CL) of Blinatumomab
timeFrame: Up to approximately 34 weeks
measure: Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Fatigue Score
timeFrame: Baseline to Week 14
measure: Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Pain Score
timeFrame: Baseline to Week 14
measure: Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Global Health Status
timeFrame: Baseline to Week 14
measure: Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Physical Function
timeFrame: Baseline to Week 14
measure: Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Nausea and Vomiting
timeFrame: Baseline to Week 14
measure: Phase 3: Complete Remission (CR) Rate by the End of Initial Disease Assessment Period
timeFrame: Baseline to Week 14
measure: Phase 3: Minimal Residual Disease (MRD) Response by the End of Initial Disease Assessment Period
timeFrame: Baseline to Week 14
measure: Phase 3: Relapse-free Survival (RFS)
timeFrame: Up to approximately 5 years
measure: Phase 3: Minimal Residual Disease (MRD) Relapse Free Survival (RFS)
timeFrame: Up to approximately 5 years
measure: Phase 3: Minimal Residual Disease (MRD) Over Time
timeFrame: Up to approximately 5 years
measure: Phase 3: Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to approximately 5 years
measure: Phase 3: Number of Participants who Experience Cluster of Differentiation (CD) 19 Positive and Negative Relapse by Flow Cytometry for Bone Marrow
timeFrame: Up to approximately 5 years
measure: Phase 3: Number of Participants who Experience Cluster of Differentiation (CD) 19 Positive and Negative Relapse Identified by Immunohistochemistry or Flow Cytometry for Cerebrospinal Fluid
timeFrame: Up to end of safety follow up (approximately 44 months)
measure: Phase 3: Number of Participants who Experience Cluster of Differentiation (CD) 19 Positive and Negative Relapse for Extramedullary Sites other than Cerebrospinal Fluid
timeFrame: Up to end of safety follow up (approximately 44 months)
measure: Phase 3: Rate of Lineage Switch to Acute Myeloid Leukemia (AML)
timeFrame: Up to end of safety follow up (approximately 44 months)
measure: Phase 3: Localization of Relapse by Clinical Assessment
timeFrame: Up to end of safety follow up (approximately 44 months)
measure: Phase 3: Mortality Rate in Participants who Experience Complete Remission (CR)
timeFrame: Up to approximately 5 years
measure: Phase 3: Number of Participants who have Allogeneic Hematopoietic Stem Cell Transplant (alloHSCT) in Participants who Experience Continuous First Complete Remission (CR)
timeFrame: Up to approximately 5 years
measure: Phase 3: Mortality Rate in Participants who Experience Complete Remission (CR) after Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT)
timeFrame: Up to approximately 5 years
measure: Phase 3: Relapse Rate Following Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT)
timeFrame: Up to approximately 5 years
measure: Phase 3: Time to Deterioration using the Fatigue Score
timeFrame: Up to approximately 5 years
measure: Phase 3: Time to Improvements using the Fatigue Score
timeFrame: Up to approximately 5 years
measure: Phase 3: Time to Deterioration using the Pain Score
timeFrame: Up to approximately 5 years
measure: Phase 3: Time to Improvements using the Pain Score
timeFrame: Up to approximately 5 years
measure: Phase 3: Change from Baseline in Global Health Status, Physical Function, Nausea/Vomiting, and All Other Subscales of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
timeFrame: Baseline to end of study (up to approximately 5 years)
measure: Phase 3: Time to Deterioration for Global Health Status, Physical Function, Nausea/Vomiting, and All Other Subscales of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
timeFrame: Up to approximately 5 years
measure: Phase 3: Time to Improvements for Global Health Status, Physical Function, Nausea/Vomiting, and All Other Subscales of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
timeFrame: Up to approximately 5 years
measure: Steady State Concentration of Blinatumomab
timeFrame: Up to approximately Day 36
measure: Clearance of Blinatumomab
timeFrame: Up to approximately Day 36
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Orange
country: United States
facility: University of California Irvine
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Orlando
country: United States
facility: Adventist Health System/Sunbelt, Inc d/b/a AdventHealth Orlando
state: Florida
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Greenville
country: United States
facility: Saint Francis Hospital, Inc
state: South Carolina
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Garran
country: Australia
facility: Canberra Hospital
state: Australian Capital Territory
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Womens Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health, Austin Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Graz
country: Austria
facility: Medizinische Universitaet Graz
city: Innsbruck
country: Austria
facility: Medizinische Universitaet Innsbruck
city: Linz
country: Austria
facility: Ordensklinikum Linz Elisabethinen
city: Wien
country: Austria
facility: Hanusch Krankenhaus
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge-Oostende AV
city: Bruxelles
country: Belgium
facility: Universite Catholique de Louvain Cliniques Universitaires Saint Luc
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Ghent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis - Campus Virga Jesse
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire de Liege - Sart Tilman
city: Roeselare
country: Belgium
facility: AZ Delta Campus Rumbeke
city: Yvoir
country: Belgium
facility: Centre Hospitalier Universitaire Dinant Godinne - Universite Catholique de Louvain Namur
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas de Porto Alegre
state: Rio Grande Do Sul
city: Jau
country: Brazil
facility: Fundacao Amaral Carvalho
state: São Paulo
city: São Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira Icesp
city: Plovdiv
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
city: Sofia
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Hematology Diseases EAD
city: Calgary
country: Canada
facility: Arthur J E Child Comprehensive Cancer Centre
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital, Gordon and Leslie Diamond Health Care Centre
state: British Columbia
city: Winnipeg
country: Canada
facility: Cancer Care Manitoba
state: Manitoba
city: Halifax
country: Canada
facility: Queen Elizabeth II, Health Sciences Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - Juravinski Hospital and Cancer Centre
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: CEMTL Hopital Maisonneuve Rosemont
state: Quebec
city: Santiago
country: Chile
facility: Fundacion Arturo Lopez Perez
city: Santiago
country: Chile
facility: Inmunocel
city: Santiago
country: Chile
facility: Clinica Alemana de Santiago
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital
city: København Ø
country: Denmark
facility: Rigshospitalet
city: Odense
country: Denmark
facility: Odense Universitetshospital
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
city: Creteil
country: France
facility: Hopital Henri Mondor
city: Dijon
country: France
facility: Centre Hospitalier Universitaire de Dijon - Hopital du Bocage
city: Le Chesnay Cedex
country: France
facility: Centre Hospitalier de Versailles - Hopital Andre Mignot
city: Lille
country: France
facility: Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes - Hopital Hotel Dieu
city: Nice cedex 3
country: France
facility: Centre Hospitalier Universitaire Archet 2
city: Paris
country: France
facility: Hopital Saint Louis
city: Paris
country: France
facility: Hopital Saint Antoine
city: Pessac Cedex
country: France
facility: Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque
city: Pierre Benite
country: France
facility: Hopital Lyon Sud
city: Rennes Cedex 9
country: France
facility: Centre Hospitalier Universitaire de Rennes
city: Toulouse cedex 9
country: France
facility: Institut Universitaire du Cancer Toulouse Oncopole
city: Vandoeuvre les Nancy Cedex
country: France
facility: Centre Hospitalier Universitaire de Nancy - Hopital de Brabois
city: Augsburg
country: Germany
facility: Universitaetsklinikum Augsburg
city: Berlin
country: Germany
facility: Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin
city: Dresden
country: Germany
facility: Universitaetsklinikum Dresden
city: Duesseldorf
country: Germany
facility: Universitaetsklinikum Duesseldorf
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Jena
country: Germany
facility: Universitaetsklinikum Jena
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein
city: Muenchen
country: Germany
facility: Klinikum der LMU Muenchen
city: Athens
country: Greece
facility: Evangelismos Hospital
city: Athens
country: Greece
facility: Laiko General Hospital of Athens
city: Athens
country: Greece
facility: Attiko General University Hospital
city: Heraklion
country: Greece
facility: University Hospital of Heraklion
city: Ioannina
country: Greece
facility: University Hospital of Ioannina
city: Larissa
country: Greece
facility: University Hospital of Larissa
city: Patras
country: Greece
facility: University Hospital of Patras
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki Georgios Papanikolaou
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital, The University of Hong Kong
city: Kowloon
country: Hong Kong
facility: Princess Margaret Hospital
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Eger
country: Hungary
facility: Heves Varmegyei Markhot Ferenc Oktatokorhaz es Rendelointezet
city: Nyiregyhaza
country: Hungary
facility: Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz
city: Bari
country: Italy
facility: Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari
city: Bergamo
country: Italy
facility: Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino IRCCS
city: Lecce
country: Italy
facility: Azienda Unita Sanitaria Locale LE Presidio Ospedaliero Vito Fazzi Polo Oncologico Giovanni Paolo II
city: Mestre (VE)
country: Italy
facility: Azienda Unità Locale Socio Sanitaria 3 Ospedale Dell Angelo
city: Milano
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
city: Napoli
country: Italy
facility: Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
city: Pescara
country: Italy
facility: Azienda Unita Sanitaria Locale Pescara Ospedale Civile Santo Spirito
city: Roma
country: Italy
facility: Azienda Ospedaliera Policlinico Umberto I
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata di Verona Ospedale G B Rossi Borgo Roma
city: Nagoya-shi
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Akita-shi
country: Japan
facility: Akita University Hospital
state: Akita
city: Kamogawa-shi
country: Japan
facility: Tesshokai Kameda General Hospital
state: Chiba
city: Yoshida-gun
country: Japan
facility: University of Fukui Hospital
state: Fukui
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Fukushima-shi
country: Japan
facility: Fukushima Medical University Hospital
state: Fukushima
city: Maebashi-shi
country: Japan
facility: Gunma Saiseikai Maebashi Hospital
state: Gunma
city: Sapporo-shi
country: Japan
facility: Sapporo Hokuyu Hospital
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
city: Kanazawa-shi
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Isehara-shi
country: Japan
facility: Tokai University Hospital
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Yokohama City University Medical Center
state: Kanagawa
city: Kyoto-shi
country: Japan
facility: Kyoto University Hospital
state: Kyoto
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Nagasaki-shi
country: Japan
facility: Nagasaki University Hospital
state: Nagasaki
city: Okayama-shi
country: Japan
facility: National Hospital Organization Okayama Medical Center
state: Okayama
city: Osaka-shi
country: Japan
facility: Osaka Metropolitan University Hospital
state: Osaka
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Shimotsuke-shi
country: Japan
facility: Jichi Medical University Hospital
state: Tochigi
city: Itabashi-ku
country: Japan
facility: Nihon University Itabashi Hospital
state: Tokyo
city: Yamagata-shi
country: Japan
facility: Yamagata University Hospital
state: Yamagata
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun 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: The Catholic University of Korea Seoul St Marys Hospital
city: Ciudad de Mexico
country: Mexico
facility: Boca Clinical Trials Mexico SC
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Centro Oncologico Internacional
state: Distrito Federal
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr Jose Eleuterio Gonzalez
state: Nuevo León
city: Huixquilucan
country: Mexico
facility: Hematologica Alta Especialidad
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Coimbra
country: Portugal
facility: Unidade Local de Saude de Coimbra, EPE
city: Lisboa
country: Portugal
facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil, EPE
city: Lisboa
country: Portugal
facility: Unidade Local de Saude de Sao Jose, EPE - Hospital de Santo Antonio dos Capuchos
city: Lisboa
country: Portugal
facility: Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
city: Porto
country: Portugal
facility: Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
city: Bucharest
country: Romania
facility: Institutul Clinic Fundeni
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic Prof Dr Ion Chiricuta
city: Iasi
country: Romania
facility: Institutul Regional de Oncologie Iasi
city: Sibiu
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Sibiu
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
state: Andalucía
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
state: Andalucía
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Salamanca
country: Spain
facility: Complejo Asistencial Universitario de Salamanca Hospital Universitario de Salamanca
state: Castilla León
city: Badalona
country: Spain
facility: Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d Hebron
state: Cataluña
city: Hospitalet de Llobregat
country: Spain
facility: Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
state: Cataluña
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
state: Comunidad Valenciana
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Goteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi Hastanesi
city: Ankara
country: Turkey
facility: Ankara Bilkent Sehir Hastanesi
city: Antalya
country: Turkey
facility: Memorial Antalya Hastanesi
city: Istanbul
country: Turkey
facility: Bagcilar Medipol Mega Universite Hastanesi
city: Izmir
country: Turkey
facility: Dokuz Eylul Universitesi Tip Fakultesi Hastanesi
city: Samsun
country: Turkey
facility: Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
city: London
country: United Kingdom
facility: University College London
city: London
country: United Kingdom
facility: Kings College Hospital
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: