Clinical trial NCT06356129: Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants With Previously Untreated High-risk Large B-cell Lymphoma
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Comparing the Efficacy and Safety of Golcadomide Plus R-CHOP Chemotherapy vs Placebo Plus R-CHOP Chemotherapy in Participants With Previously Untreated High-risk Large B-cell Lymphoma (GOLSEEK-1)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Large B-cell Lymphoma
Keywords: Lymphoma, Large B-Cell
Lymphoma
BMS-986369
CC-99282
DLBCL
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2024-04-10
Enrollment: 850
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 compare the effectiveness and safety of golcadomide in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy vs placebo in combination with R-CHOP chemotherapy in participants with previously untreated high-risk large B-cell lymphoma (LBCL).


Eligibility criteria: Inclusion Criteria:

- Histologically confirmed (per local evaluation) diagnosis of de novo, previously untreated large B-cell lymphoma (LBCL) according to 2022 world health organization (WHO) classification including:

i) Diffuse large B-cell lymphoma (DLBCL), not otherwise specified \[including germinal center B-cell (GCB) and activated B-cell (ABC) types\]

ii) High-grade B-cell lymphoma, with MYC and BCL2 rearrangements (HGBL-MYC/BCL2 double-hit lymphomas)

iii) High-grade B-cell lymphoma, not otherwise specified

iv) T-cell/histiocyte/rich large B-cell lymphoma (THRLBCL)

v) Epstein-Barr virus + DLBCL

* International Prognostic Index (IPI) score 1 or 2 with lactate dehydrogenase (LDH) \> 1.3 x upper limit of normal (ULN) and/or bulky disease defined as single lesion of ≥ 7 cm OR IPI ≥ 3.
* Measurable disease defined by at least 1 fluorodeoxyglucose (FDG)-avid lesion for FDG-avid subtype and 1 bi-dimensionally measurable (\> 1.5 cm in longest diameter) disease by computed tomography (CT) or magnetic resonance imaging (MRI), as defined by the Lugano classification.
* Must have Ann Arbor Stage II-IV disease.

Exclusion Criteria:

* Any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
* Any other subtype of lymphoma. Cases of primary mediastinal (thymic) large B-cell lymphoma (PMBCL), primary cutaneous DLBCL-leg type, Grade 3b FL, indolent lymphoma transformed to large B-cell lymphoma (LBCL), Anaplastic lymphoma kinase (ALK) positive large B-cell lymphoma, primary effusion lymphoma, and Burkitt lymphoma.
* Documented or suspected central nervous system (CNS) involvement by lymphoma.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcomes:
measure: Progression-free survival (PFS) assessed by the Investigator
timeFrame: Up to approximately 67 months
Secondary outcomes:
measure: PFS assessed by the Investigator
timeFrame: Up to approximately 67 months
measure: Overall survival (OS)
timeFrame: Up to approximately 67 months
measure: Event-free survival (EFS)
timeFrame: Up to approximately 67 months
measure: Complete Metabolic Response assessed by the Independent Response Adjudication Committee (IRAC)
timeFrame: Up to approximately 18 weeks
measure: Minimal residual disease (MRD) negativity rate
timeFrame: Up to approximately 18 weeks
measure: Progression-free survival (PFS) assessed by the IRAC
timeFrame: Up to approximately 47 months
measure: Objective response (OR) assessed by the Investigator
timeFrame: Up to approximately 18 weeks
measure: Complete metabolic response (CMR) assessed by the Investigator
timeFrame: Up to approximately 18 weeks
measure: PFS24 assessed by the Investigator 24 months after randomization
timeFrame: Up to 24 months
measure: Duration of response (DoR)
timeFrame: Up to approximately 67 months
measure: Second progression-free survival (PFS2) assessed by the Investigator
timeFrame: Up to approximately 67 months
measure: Relative dose intensity (%)
timeFrame: Up to 18 weeks
measure: Time from randomization to meaningful improvement in primary domains of interest in the European Organization for Research and Treatment of Cancer - Quality of Life C30 (EORTC QLQ-C30) Questionnaire
timeFrame: Up to approximately 67 months
measure: Time from randomization to meaningful improvement in primary domains of interest in the Functional Assessment of Cancer Treatment-Lymphoma (FACT-LymS) Questionnaire
timeFrame: Up to approximately 67 months
measure: Mean change from baseline in the EORTC QLQ-C30
timeFrame: Up to approximately 67 months
measure: Mean change from baseline in the FACT-LymS
timeFrame: Up to approximately 67 months
measure: Number of participants with Adverse Events (AEs)
timeFrame: Up to approximately 20 weeks
measure: Number of participants with treatment-emergent adverse events (TEAEs)
timeFrame: Up to approximately 20 weeks
measure: Number of participants with laboratory abnormalities
timeFrame: Up to approximately 20 weeks
measure: Number of participants with vital sign abnormalities
timeFrame: Up to approximately 20 weeks
Other outcomes:
Locations:
city: Mobile
country: United States
facility: USA Mitchell Cancer Institute
state: Alabama
city: Anchorage
country: United States
facility: Alaska Oncology and Hematology
state: Alaska
city: Phoenix
country: United States
facility: Mayo Clinic in Arizona - Phoenix
state: Arizona
city: San Francisco
country: United States
facility: Local Institution - 0342
state: California
city: Fort Myers
country: United States
facility: Florida Cancer Specialists - South
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Margate
country: United States
facility: D&H Cancer Research Center LLC
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Cancer Center
state: Florida
city: Pensacola
country: United States
facility: Sacred Heart Medical Oncology Group
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists - North
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists - East
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine- Grady Campus
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute, Emory University
state: Georgia
city: Chicago
country: United States
facility: Local Institution - 0182
state: Illinois
city: Skokie
country: United States
facility: Orchard Healthcare Research Inc.
state: Illinois
city: Waukee
country: United States
facility: Mission Cancer + Blood
state: Iowa
city: Westwood
country: United States
facility: The University of Kansas Cancer Center - Westwood
state: Kansas
city: Edgewood
country: United States
facility: Local Institution - 0436
state: Kentucky
city: Baton Rouge
country: United States
facility: Mary Bird Perkins Cancer Center Baton Rouge
state: Louisiana
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Allina Health Cancer Institute - Abbott Northwestern Hospital
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic in Rochester, Minnesota
state: Minnesota
city: Kansas City
country: United States
facility: Local Institution - 0437
state: Missouri
city: Reno
country: United States
facility: Cancer Care Specialists
state: Nevada
city: East Brunswick
country: United States
facility: Astera Cancer Care
state: New Jersey
city: Hackensack
country: United States
facility: Local Institution - 0480
state: New Jersey
city: Morristown
country: United States
facility: Atlantic Health System Morristown Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Buffalo
country: United States
facility: Local Institution - 0190
state: New York
city: East Syracuse
country: United States
facility: Hematology-Oncology Associates of Central New York, PC
state: New York
city: New York
country: United States
facility: Local Institution - 0484
state: New York
city: New York
country: United States
facility: Local Institution - 0369
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Chapel Hill
country: United States
facility: Local Institution - 0174
state: North Carolina
city: Massillon
country: United States
facility: Local Institution - 0066
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
city: York
country: United States
facility: WellSpan Oncology Research
state: Pennsylvania
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital - Texas Medical Center
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University (VCU) Medical Center
state: Virginia
city: Tacoma
country: United States
facility: Local Institution - 0465
state: Washington
city: Buenos Aires
country: Argentina
facility: Hospital Aleman
state: Ciudad Autónoma De Buenos Aires
city: Buenos Aires
country: Argentina
facility: Local Institution - 0421
state: Ciudad Autónoma De Buenos Aires
city: Buenos Aires
country: Argentina
facility: Clínica Zabala
city: Buenos Aires
country: Argentina
facility: Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC)
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Instituto Alexander Fleming
city: Córdoba
country: Argentina
facility: Hospital Privado Universitario de Córdoba
city: Gosford
country: Australia
facility: Gosford Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Campbelltown Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Tiwi
country: Australia
facility: Royal Darwin Hospital
state: Northern Territory
city: Birtinya
country: Australia
facility: Sunshine Coast University Hospital
state: Queensland
city: Southport
country: Australia
facility: Gold Coast University Hospital
state: Queensland
city: Frankston
country: Australia
facility: Peninsula Private Hospital
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: St Albans
country: Australia
facility: Western Health-Sunshine & Footscray Hospitals
state: Victoria
city: Warrnambool
country: Australia
facility: South West Healthcare
state: Victoria
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH
state: Oberösterreich
city: Linz
country: Austria
facility: Kepler Universitätsklinikum
city: Vienna
country: Austria
facility: Local Institution - 0386
city: Fortaleza
country: Brazil
facility: Núcleo de Oncologia e Hematologia do Ceará
state: Ceara
city: Lago sul
country: Brazil
facility: Hospital Brasilia
state: Distrito Federal
city: Goiania
country: Brazil
facility: Universidade Federal de Goias
state: Goias
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner
state: Paraná
city: Niteroi
country: Brazil
facility: CHN - Complexo Hospitalar de Niterói
state: Rio De Janeiro
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra o Câncer
state: Rio Grande Do Norte
city: Porto Alegre
country: Brazil
facility: Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa
state: Rio Grande Do Sul
city: Chapecó
country: Brazil
facility: Clínica Supera
state: Santa Catarina
city: Joinville
country: Brazil
facility: Instituto Joinvilense de Hematologia e Oncologia
state: Santa Catarina
city: São Paulo
country: Brazil
facility: Hospital 9 De Julho
state: SAO Paulo
city: Barretos
country: Brazil
facility: Fundação Pio XII - Hospital de Câncer de Barretos
state: São Paulo
city: Jaú
country: Brazil
facility: Hospital Amaral Carvalho
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Hospital Alemao Oswaldo Cruz
state: São Paulo
city: Sao Paulo
country: Brazil
facility: A. C. Camargo Cancer Center
state: São Paulo
city: São José do Rio Preto
country: Brazil
facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Hospital São Lucas de Copacabana
city: Sao Paulo
country: Brazil
facility: Instituto D'Or de Pesquisa e Ensino (IDOR)
city: São Paulo
country: Brazil
facility: Hospital das Clinicas FMUSP
city: São Paulo
country: Brazil
facility: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
city: Plovdiv
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD
city: Sofia
country: Bulgaria
facility: Local Institution - 0392
city: Sofia
country: Bulgaria
facility: UMHAT 'Sveti Ivan Rilsky'
city: Edmonton
country: Canada
facility: Local Institution - 0492
state: Alberta
city: Victoria
country: Canada
facility: BC Cancer Victoria
state: British Columbia
city: Montreal
country: Canada
facility: St. Marys Hospital Center
state: Quebec
city: Montreal
country: Canada
facility: Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSSS NÎM) - Hôpital du Sacré-Coeur
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUS
state: Quebec
city: Chile
country: Chile
facility: Local Institution - 0109
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Fundacion Arturo Lopez Perez (FALP)
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Clínica Inmunocel
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Clínica UC San Carlos de Apoquindo
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Clínica Alemana de Santiago
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Bradfordhill
state: Región Metropolitana De Santiago
city: Viña del Mar
country: Chile
facility: Centro de Investigaciones
state: Valparaíso
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated hospital of Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Nanning
country: China
facility: Guangxi Medical University Affiliated Tumor Hospital
state: Guangxi
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical,Science & Technology
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: Jiangxi Provincial Cancer Hospital
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: 沈阳市
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
city: Cheng Du
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Local Institution - 0289
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjin
city: Urumchi
country: China
facility: Local Institution - 0155
state: Xinjiang
city: Urumqi
country: China
facility: Xinjiang Medical University Cancer Hospital - Urumqi
state: Xinjiang
city: Hangzhou
country: China
facility: The first Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated hospital of Zhejiang University school of medicine
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Bogota
country: Colombia
facility: Local Institution - 0130
state: Cundinamarca
city: Bogotá
country: Colombia
facility: Local Institution - 0129
state: Distrito Capital De Bogotá
city: Zagreb
country: Croatia
facility: Local Institution - 0390
state: Grad Zagreb
city: Osijek
country: Croatia
facility: Local Institution - 0440
city: Brno
country: Czechia
facility: Fakultní nemocnice Brno Bohunice
state: Brno-město
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
state: Hradec Králové
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
state: Olomoucký Kraj
city: Pilsen
country: Czechia
facility: Fakultni Nemocnice Plzen
state: Plzeňský Kraj
city: PRague
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
state: Praha 10
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital, Skejby
state: Midtjylland
city: Odense
country: Denmark
facility: Odense Universitetshospital
state: Syddanmark
city: Oulu
country: Finland
facility: Oulun yliopistollinen sairaala
state: Pohjois-Pohjanmaa
city: Kuopio
country: Finland
facility: Kuopion Yliopistollinen Sairaala
state: Pohjois-Savo
city: Turku
country: Finland
facility: Turku University Hospital
state: Varsinais-Suomi
city: Helsinki
country: Finland
facility: Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
state: Alpes-Maritimes
city: Strasbourg
country: France
facility: Institut de cancérologie Strasbourg Europe (ICANS)
state: Alsace
city: Bordeaux
country: France
facility: Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
state: Aquitaine
city: Pessac
country: France
facility: Local Institution - 0324
state: Aquitaine
city: Marseille
country: France
facility: Institut Paoli-Calmettes
state: Bouches-du-Rhône
city: Dijon
country: France
facility: Local Institution - 0292
state: Côte-d'Or
city: Besançon
country: France
facility: Chu Jean Minjoz
state: Doubs
city: Brest
country: France
facility: CHRU de Brest
state: Finistère
city: Saint-Cloud
country: France
facility: Institut Curie - site Saint-Cloud
state: Hauts-de-Seine
city: Tours
country: France
facility: Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau
state: Indre-et-Loire
city: La Tronche
country: France
facility: Chu Grenoble Alpes
state: Isère
city: Saint-Pierre
country: France
facility: Centre Hospitalier Sud Réunion
state: La Réunion
city: Montpellier
country: France
facility: Chu Saint Eloi
state: Languedoc-Roussillon
city: Saint Priest en Jarez
country: France
facility: CHU de Saint-Etienne
state: Loire
city: Lille
country: France
facility: Hôpital Saint Vincent-de-Paul
state: Nord-Pas-de-Calais
city: Lille
country: France
facility: Hopital Claude Huriez - CHU de Lille
state: Nord
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
state: Pays-de-la-Loire
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
state: Rhône
city: Creteil
country: France
facility: Henri Mondor Hospital
state: Val-de-Marne
city: Villejuif
country: France
facility: Gustave Roussy
state: Val-de-Marne
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire de Poitiers
state: Vienne
city: Bayonne
country: France
facility: Centre Hospitalier de la Côte Basque
city: Caen
country: France
facility: Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Ulm
country: Germany
facility: Bundeswehrkrankenhaus Ulm
state: Baden-Württemberg
city: Augsburg
country: Germany
facility: Klinikum Augsburg
state: Bayern
city: Bayreuth
country: Germany
facility: Klinikum Bayreuth
state: Bayern
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen
state: Bayern
city: Langen
country: Germany
facility: Gemeinschaftspraxis für Hämatologie und Onkologie
state: Hessen
city: Hannover
country: Germany
facility: KRH Klinikum Siloah-Oststadt-Heidehaus-Pneumology
state: Niedersachsen
city: Koblenz
country: Germany
facility: InVO Institut für Versorgungsforschung in der Onkologie
state: Rheinland-Pfalz
city: Halle
country: Germany
facility: Universitätsklinikum Halle
state: Sachsen-Anhalt
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Local Institution - 0508
city: Cottbus
country: Germany
facility: Medizinische Universität Lausitz- Carl Thiem
city: Dresden
country: Germany
facility: Gemeinschaftspraxis Hämatologie - Onkologie Freiberg-Richter, Jacobasch, Illmer, Wolf
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Athens
country: Greece
facility: Evangelismos General Hospital of Athens
state: Attikí
city: Athens
country: Greece
facility: General Hospital of Athens "Laiko"
state: Attikí
city: Chaidari
country: Greece
facility: Attikon General University Hospital
state: Attikí
city: Alexandroupolis
country: Greece
facility: University Hospital of Alexandroupolis
city: Ioannina
country: Greece
facility: University Hospital of Ioannina
state: Ípeiros
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
state: Hajdú-Bihar
city: Kaposvár
country: Hungary
facility: Somogy Vármegyei Kaposi Mór Oktató Kórház
state: Somogy
city: Nyíregyháza
country: Hungary
facility: Szabolcs Szatmár Bereg Vármegyei Oktatókórház
state: Szabolcs-Szatmár-Bereg
city: Szombathely
country: Hungary
facility: Markusovszky Egyetemi Oktatokorhaz
state: Vas
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Országos Onkológiai Intézet
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
state: Delhi
city: New Delhi
country: India
facility: Rajiv Gandhi Cancer Institute And Research Centre
state: Delhi
city: Srinagar
country: India
facility: Local Institution - 0429
state: Jammu And Kashmir
city: Belagavi
country: India
facility: KLES Dr. Prabhakar Kore Hospital & M.R.C
state: Karnataka
city: Kochi
country: India
facility: Aster Medcity
state: Kerala
city: Mumbai
country: India
facility: Local Institution - 0154
state: Maharashtra
city: Howrah
country: India
facility: Narayana Superspecialty Hospital
state: West Bengal
city: New Town
country: India
facility: Tata Medical Center
state: West Bengal
city: Ravenna
country: Italy
facility: Ospedale Santa Maria delle Croci
state: Emilia-Romagna
city: Roma
country: Italy
facility: Local Institution - 0493
state: Lazio
city: Palermo
country: Italy
facility: Local Institution - 0494
state: Sicilia
city: Novara
country: Italy
facility: Local Institution - 0496
city: Anjo
country: Japan
facility: Local Institution - 0276
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Eiheiji-cho,Yoshida-gun
country: Japan
facility: University of Fukui Hospital
state: Fukui
city: Ogaki
country: Japan
facility: Ogaki Municipal Hospital
state: Gifu
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Aiiku Hospital
state: Hokkaido
city: Amagasaki
country: Japan
facility: Hyogo Prefectural Amagasaki General Medical Center
state: Hyogo
city: Himeji
country: Japan
facility: Japanease Red Cross Society Himeji Hospital
state: Hyogo
city: Kanazawa
country: Japan
facility: Ishikawa Prefectural Central Hospital
state: Ishikawa
city: Morioka
country: Japan
facility: Iwate Prefectural Central Hospital
state: Iwate
city: Isehara
country: Japan
facility: Tokai University Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama Municipal Citizens Hospital
state: Kanagawa
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Osaka-sayama
country: Japan
facility: Kindai University Hospital- Osakasayama Campus
state: Osaka
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center
state: Saitama
city: Nagaizumi-cho,Sunto-gun
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Itabashiku
country: Japan
facility: Nihon University Itabashi Hospital
state: Tokyo
city: Chuo
country: Japan
facility: University of Yamanashi Hospital
state: Yamanashi
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Kumamoto
country: Japan
facility: National Hospital Organization Kumamoto Medical Center
city: Kyoto
country: Japan
facility: Local Institution - 0215
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Osaka
country: Japan
facility: Osaka Red Cross Hospital
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital
city: Yamagata
country: Japan
facility: Yamagata University Hospital
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Kyǒnggi-do
city: Seongnam
country: Korea, Republic of
facility: Local Institution - 0117
state: Kyǒnggi-do
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyǒnggi-do
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital
state: Kyǒnggi-do
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
state: Pusan-Kwangyǒkshi
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
state: Pusan-Kwangyǒkshi
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
state: Pusan-Kwangyǒkshi
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0100
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0070
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Yeouido St. Mary's Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Daegu
country: Korea, Republic of
facility: Local Institution - 0442
state: Taegu-Kwangyǒkshi
city: Deagu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
state: Taegu-Kwangyǒkshi
city: Deagu
country: Korea, Republic of
facility: Local Institution - 0116
state: Taegu-Kwangyǒkshi
city: Seongnam
country: Korea, Republic of
facility: Local Institution - 0455
city: George Town
country: Malaysia
facility: Hospital Pulau Pinang
state: Pulau Pinang
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
state: Sarawak
city: Ampang
country: Malaysia
facility: Hospital Ampang
state: Selangor
city: Lembah Pantai
country: Malaysia
facility: Local Institution - 0453
state: Wilayah Persekutuan Kuala Lumpur
city: Ciudad de México
country: Mexico
facility: Health Pharma Professional Research S.A. de C.V:
state: DIF
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
state: DIF
city: Cdmx
country: Mexico
facility: Local Institution - 0126
state: Distrito Federal
city: México
country: Mexico
facility: Local Institution - 0128
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Local Institution - 0448
state: Jalisco
city: Morelia
country: Mexico
facility: Centro de Investigacion Clinica Chapultepec
state: Michoacán
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
state: Nuevo León
city: Oaxaca de Juarez
country: Mexico
facility: Centro de Investigacion Clinica de Oaxaca
state: Oaxaca
city: Hermosillo
country: Mexico
facility: Local Institution - 0444
state: Sonora
city: Hermosillo
country: Mexico
facility: Local Institution - 0463
state: Sonora
city: Huixquilucan
country: Mexico
facility: Local Institution - 0123
city: Puebla
country: Mexico
facility: Unidad Médica Onco-hematológica
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum
state: Zuid-Holland
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
state: Otago
city: Hamilton
country: New Zealand
facility: Local Institution - 0366
state: Waikato
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Oslo
country: Norway
facility: Oslo universitetssykehus, Radiumhospitalet
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy
state: Kujawsko-pomorskie
city: Lublin
country: Poland
facility: Centrum Onkologii Ziemi Lubelskiej
state: Lubelskie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
state: Mazowieckie
city: Kraków
country: Poland
facility: Pratia MCM Krakow
state: Małopolskie
city: Skorzewo
country: Poland
facility: Aidport
state: Wielkopolskie
city: Katowice
country: Poland
facility: Local Institution - 0330
state: Śląskie
city: Lisboa
country: Portugal
facility: Hospital da Luz Lisboa
city: Porto
country: Portugal
facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE
city: San Juan
country: Puerto Rico
facility: Pan American Center for Oncology Trials - Ciudadela
city: Bucuresti
country: Romania
facility: Fundeni Clinical Institute
state: București
city: Bucuresti
country: Romania
facility: Local Institution - 0375
state: București
city: Tg.Mures
country: Romania
facility: Spital Clinic Judetean de Urgenta Tg.Mures
state: Mureș
city: Brasov
country: Romania
facility: Sc Onco Card Srl
city: București
country: Romania
facility: Affidea Fundeni
city: București
country: Romania
facility: Spitalul Clinic Colțea
city: București
country: Romania
facility: Spitalul Clinic Colțea
city: București
country: Romania
facility: Spitalul Universitar de Urgență București
city: Cluj
country: Romania
facility: Institutul Oncologic Cluj
city: Iași
country: Romania
facility: Institutul Regional de Oncologie
city: Sibiu
country: Romania
facility: Spitalul Clinic Județean de Urgență Sibiu
city: Riyadh
country: Saudi Arabia
facility: Local Institution - 0445
state: Ar Riyāḑ
city: Dammam
country: Saudi Arabia
facility: King Fahad Specialist Hospital - Dammam
state: Ash Sharqīyah
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz Medical City
city: Riyadh
country: Saudi Arabia
facility: Local Institution - 0416
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
state: Central Singapore
city: Banska Bystrica
country: Slovakia
facility: Local Institution - 0355
state: Banskobystrický Kraj
city: Bratislava
country: Slovakia
facility: Local Institution - 0204
city: A Coruña
country: Spain
facility: CHUAC-Complejo Hospitalario Universitario A Coruña
state: A Coruña [La Coruña]
city: Badalona
country: Spain
facility: Institut Catalan d Oncologia (ICO) - Badalona
state: Barcelona [Barcelona]
city: L'Hospitalet Del Llobregat
country: Spain
facility: Institut Català d'Oncologia - L'Hospitalet
state: Barcelona [Barcelona]
city: Barakaldo
country: Spain
facility: OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces
state: Bizkaia
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario Nuestra Señora de Candelaria
state: Canarias
city: San Sebastian
country: Spain
facility: Hospital Universitario Donostia
state: Gipuzkoa
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid, Comunidad De
city: El Palmar, Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
state: Murcia, Región De
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
state: Málaga
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcantara
city: Madrid
country: Spain
facility: Hospital La Princesa
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Lund
country: Sweden
facility: Skånes Universitetssjukhus Lund
state: Skåne Län [se-12]
city: Solna
country: Sweden
facility: Karolinska Universitetssjukhuset Solna
state: Stockholms Län [se-01]
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset
state: Uppsala Län [se-03]
city: Linköping
country: Sweden
facility: Local Institution - 0278
state: Östergötlands Län [se-05]
city: Chiayi City
country: Taiwan
facility: Chang Gung Memorial Hospital- Chiayi
state: Chiayi
city: Tainan City
country: Taiwan
facility: Chi Mei Medical Center
state: Tainan
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital at Kaohsiung
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch
city: Bangkok
country: Thailand
facility: Chulalongkorn University
state: Krung Thep Maha Nakhon
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
state: Krung Thep Maha Nakhon
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital
state: Krung Thep Maha Nakhon
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital
city: Ankara
country: Turkey
facility: Ankara University Health Practice and Research Hospitals
city: Ankara
country: Turkey
facility: Gazi University Health Research and Application Center Gazi Hospital
city: Ankara
country: Turkey
facility: Local Institution - 0422
city: Ankara
country: Turkey
facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi
city: İzmir
country: Turkey
facility: Ege Universitesi Hastanesi
city: Mersin
country: Turkey
facility: VM Medical Park Mersin Hastanesi
city: Samsun
country: Turkey
facility: Ondokuz Mayıs Universitesi
city: Trabzon
country: Turkey
facility: Karadeniz Teknik Universitesi Tip Fakultesi
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: