Clinical trial NCT05949684: ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions
Official title: A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) vs Epoetin Alfa for the Treatment of Anemia Due to Revised International Prognostic Scoring System (IPSS-R) Very Low, Low, or Intermediate-Risk Myelodysplastic Syndrome (MDS) in Erythropoiesis-Stimulating Agent (ESA)-Naive Participants Who Are Non-Transfusion Dependent (NTD): The "ELEMENT-MDS" Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Myelodysplastic Syndromes
Keywords: Luspatercept
BMS-986346
ACE-536
Myelodysplastic Syndrome
Epoetin alfa
Erythropoietin stimulating agent (ESA)
Myelodysplastic Syndromes (MDS)
Anaemia
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-07-18
Enrollment: 360
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 the study is to compare the efficacy and safety of Luspatercept vs epoetin alfa in the treatment of anemia in adults due to IPSS-R very low, low, intermediate-risk MDS in ESA-naïve participants who are non-transfusion dependent (NTD).


Eligibility criteria: Inclusion Criteria

* Participant has documented diagnosis of MDS according to World Health Organization (WHO) 2016 that meet IPSS-R classification of very low, low, or intermediate-risk disease, (intermediate-risk of ≤ 3.5 IPSS-R score) confirmed via bone marrow aspirate and:.

  i) \< 5% blasts in bone marrow and \< 1% blasts in peripheral blood.
* Participant is not transfusion dependent (NTD) based on IWG2018 criteria.
* Participant is erythropoiesis-stimulating agent naive. Participants may be randomized at the investigator's discretion if the participant received no more than 2 prior doses of epoetin alfa, epoetin alfa biosimilar, or darbepoetin alfa, with the last dose at least 8 weeks prior to randomization.
* Participant has a baseline endogenous serum erythropoietin (sEPO) level of ≤ 500 U/L.
* Participant has symptoms of anemia:.

  i) Participant records a severity score of "moderate" or greater on at least 1 PGI-S item of fatigue, weakness, shortness of breath, or dizziness performed during the screening period.
* Participant has a baseline Hb concentration prior to randomization of ≤ 9.5 g/dL. The baseline Hb will be calculated using the mean of the two lowest available Hb measurements within 16 weeks prior to randomization and must include at least one central lab Hb reading done within the screening period (no more than 35 days before randomization). The two Hb measurements must have been performed at least seven days apart. Hb levels less than 21 days following RBC transfusion should not be used. Split samples for local assessments are not required.

Exclusion Criteria

* Participant with secondary MDS (that is, MDS that is known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases).
* Participant with known history of diagnosis of AML.
* Participant with history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (including proximal and distal), pulmonary or arterial embolism, arterial thrombosis, or other venous thrombosis within 6 months prior to randomization.
* Participant with a history of pure red cell aplasia and/or antibody against erythropoietin.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcomes:
measure: Number of participants with lower-risk non-transfusion dependent myelodysplastic syndromes (NTD-MDS) who converted to Transfusion Dependence (TD) during any continuous 16-week interval within the 96-week treatment period
timeFrame: Up to Week 96
Secondary outcomes:
measure: Number of participants with an increase from baseline in mean Hb values of ≥ 1.5 grams/deciliter (g/dL) in any continuous 16-week interval within the 48 week Treatment Period in the absence of transfusion
timeFrame: Up to Week 48
measure: Number of participants with an increase from baseline in mean Hb values of ≥ 1.5 g/dL in any continuous 24-week interval within the 48-week and 96-week treatment period in the absence of transfusion
timeFrame: Up to Week 48
measure: Number of participants with an increase from baseline in mean Hb values of ≥ 1.5 g/dL in any continuous 24-week interval within the 48-week and 96-week treatment period in the absence of transfusion
timeFrame: From Week 49 to Week 96
measure: Number of participants with an increase from baseline in mean Hb values of ≥ 1.5 g/dL in any continuous 24-week interval within the 48-week and 96-week treatment period in the absence of transfusion
timeFrame: Up to Week 96
measure: Number of participants with an increase from baseline in mean Hb values of ≥ 1.0 g/dL in any continuous 24-week interval within the 48-week and 96-week treatment period in the absence of transfusion
timeFrame: Up to Week 48
measure: Number of participants with an increase from baseline in mean Hb values of ≥ 1.0 g/dL in any continuous 24-week interval within the 48-week and 96-week treatment period in the absence of transfusion
timeFrame: From Week 49 to Week 96
measure: Number of participants with an increase from baseline in mean Hb values of ≥ 1.0 g/dL in any continuous 24-week interval within the 48-week and 96-week treatment period in the absence of transfusion
timeFrame: Up to Week 96
measure: Mean Hb change over fixed 24-week periods compared to the baseline Hb
timeFrame: Baseline, Week 24, Week 48, Week 72, Week 96
measure: Number of participants with an increase from baseline in mean Hb values of ≥ 1.5 g/dL in any continuous 16-week interval within the 96-week treatment period in the absence of transfusion
timeFrame: Up to Week 96
measure: Number of participants with TD by week 48
timeFrame: Up to Week 48
measure: Time to TD (IWG 2018 defined as ≥ 3 RBC units/16 weeks) during any continuous 16-week interval until the end of study
timeFrame: Up to 5 years
measure: Time from first Luspatercept dose to first RBC transfusion
timeFrame: Up to 5 years
measure: Duration of median hematologic improvement in erythroid response(mHI-E) in participants with an increase from baseline in mean Hb values of ≥1.5g/dL in any continuous 16-week interval within 48-week treatment period in absence of transfusion
timeFrame: Up to Week 48
measure: Duration of median hematologic improvement in erythroid response(mHI-E) in participants with an increase from baseline in mean Hb values of ≥1.5g/dL in any continuous 16-week interval within 96-week treatment period in absence of transfusion
timeFrame: Up to Week 96
measure: Time from first dose to first day of response (increase in mean Hb values of ≥ 1.5 g/dL in any continuous 16-week interval within the 48-week Treatment Period in the absence of transfusion)
timeFrame: Up to Week 48
measure: Time from first dose to first day of response (increase in mean Hb values of ≥ 1.5 g/dL in any continuous 16-week interval within the 96-week Treatment Period in the absence of transfusion)
timeFrame: Up to Week 96
measure: Number of participants with RBC transfusion independence over at least a consecutive 24-week period
timeFrame: Up to 5 years
measure: Number of transfusions
timeFrame: Up to 5 years
measure: Number of transfusions visits/units
timeFrame: Up to 5 years
measure: Change from baseline in subscales of self-reported health-related quality-of-life (HRQoL) assessed by the Functional Assessment of Cancer Therapy - Anemia (FACT-An)
timeFrame: Baseline, Up to 5 years
measure: Change from baseline in self-reported HRQoL assessed by the European quality of life questionnaire 5-dimension (EQ-5D-5L)
timeFrame: Baseline, Up to 5 years
measure: Number of participants with adverse events (AEs)
timeFrame: Up to Week 102
measure: Number of participants with antidrug antibody (ADA) (positive or negative)
timeFrame: Up to Week 102
measure: Pharmacokinetics (PK): Serum concentration
timeFrame: Up to Week 96
measure: PK: Area under the plasma concentration time curve (AUC)
timeFrame: Up to Week 96
measure: Number of participants with a platelet response at Week 24, Week 48 and Week 96
timeFrame: Up to Week 96
measure: Number of participants with a neutrophil response at Week 24, Week 48 and Week 96
timeFrame: Up to Week 96
measure: Number of participants with acute myeloid leukemia (AML) progression
timeFrame: Up to 5 years
measure: Time to AML progression
timeFrame: Up to 5 years
measure: Number of participants with high risk myelodysplastic syndromes (MDS) progression
timeFrame: Up to 5 years
measure: Time to high-risk MDS progression
timeFrame: Up to 5 years
measure: Time from date of randomization up to death due to any cause
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Clovis
country: United States
facility: Community Cancer Institute
state: California
city: Concord
country: United States
facility: John Muir Medical Center - Concord Campus
state: California
city: Fountain Valley
country: United States
facility: Compassionate Cancer Care Medical Group
state: California
city: Fresno
country: United States
facility: Local Institution - 0095
state: California
city: Los Alamitos
country: United States
facility: Cancer and Blood Specialty Clinic
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology - Westwood (Building 200 Suite 120)
state: California
city: Orange
country: United States
facility: St. Joseph Hospital
state: California
city: Oxnard
country: United States
facility: Ventura County Hematology Oncology Specialists
state: California
city: Fort Collins
country: United States
facility: Local Institution - 0098
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital (HH)
state: Connecticut
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
city: Daytona Beach
country: United States
facility: Halifax Health Medical Center
state: Florida
city: Daytona Beach
country: United States
facility: Local Institution - 0230
state: Florida
city: Fort Myers
country: United States
facility: Florida Cancer Specialists - South
state: Florida
city: Jacksonville
country: United States
facility: Baptist MD Anderson Cancer Center
state: Florida
city: Margate
country: United States
facility: D&H Cancer Research Center LLC
state: Florida
city: Plantation
country: United States
facility: BRCR Global
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists - North
state: Florida
city: Tamarac
country: United States
facility: Advanced Research
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Honolulu
country: United States
facility: Local Institution - 0240
state: Hawaii
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Skokie
country: United States
facility: Orchard Healthcare Research Inc.
state: Illinois
city: Dyer
country: United States
facility: Northwest Cancer Centers, P.C.
state: Indiana
city: Pikeville
country: United States
facility: Local Institution - 0232
state: Kentucky
city: Baton Rouge
country: United States
facility: Our Lady of the Lake RMC
state: Louisiana
city: Covington
country: United States
facility: Pontchartrain Cancer Center
state: Louisiana
city: New Orleans
country: United States
facility: Local Institution - 0097
state: Louisiana
city: Bethesda
country: United States
facility: American Oncology Partners of Maryland, PA
state: Maryland
city: Saint Louis Park
country: United States
facility: Metro-Minnesota Community Clinical Oncology
state: Minnesota
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic Hematology/Oncology
state: Mississippi
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center
state: New Jersey
city: Columbus
country: United States
facility: The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
state: Ohio
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Richmond
country: United States
facility: VCU Health Adult Outpatient Pavillion
state: Virginia
city: Roanoke
country: United States
facility: Blue Ridge Cancer Care
state: Virginia
city: Kennewick
country: United States
facility: Kadlec Clinic Hematology and Oncology
state: Washington
city: Seattle
country: United States
facility: Local Institution - 0213
state: Washington
city: Buenos Aires
country: Argentina
facility: Centro Mdico "Barrio Parque"
city: Buenos Aires
country: Argentina
facility: Hospital Británico de Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Instituto Alexander Fleming
city: Blacktown
country: Australia
facility: Blacktown Hospital
state: New South Wales
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Coffs Harbour
country: Australia
facility: Coffs Harbour Health Campus
state: New South Wales
city: Gold Coast
country: Australia
facility: Pindara Private Hospital
state: Queensland
city: Clayton
country: Australia
facility: Monash Health
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Fortaleza
country: Brazil
facility: Hospital Universitario Walter Cantidio
state: Ceará
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUCRS
state: Rio Grande Do Sul
city: Rio de Janeiro
country: Brazil
facility: HEMORIO
city: São Paulo
country: Brazil
facility: Hospital das Clinicas FMUSP
city: Calgary
country: Canada
facility: Arthur J.E. Child Comprehensive Cancer Centre
state: Alberta
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: London
country: Canada
facility: Victoria Hospital & Children's Hospital - London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Santiago
country: Chile
facility: Enroll SpA
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: FALP
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Clínica Inmunocel
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Bradfordhill
state: Región Metropolitana De Santiago
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Peking Union Medical College Hospital
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Fuzhou Fujian
country: China
facility: Local Institution - 0096
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated hospital of Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: Local Institution - 0031
state: Guangdong
city: Shijiazhuang
country: China
facility: The Second Afilliated Hospital of Hebei Medical University
state: Hebei
city: Harbin
country: China
facility: The First Hospital of Harbin
state: Heilongjiang
city: Zhengzhou
country: China
facility: People's Hospital of Henan Province
state: Henan
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
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: 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: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
state: Shanghai
city: Xi'an
country: China
facility: Shaanxi provincial people's hospital
state: Shanxi
city: Cheng Du
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Institute of hematology&blood disease hospital
state: Tianjin
city: Hangzhou
country: China
facility: The first Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Ningbo
country: China
facility: Local Institution - 0281
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe
state: Antioquia
city: Valledupar
country: Colombia
facility: Sociedad De Oncologia Y Hematologia Del Cesar
state: Cesar
city: Piedecuesta
country: Colombia
facility: Fundación Cardiovascular de Colombia
state: Santander
city: Montería
country: Colombia
facility: Oncomédica S.A.S
city: Brno
country: Czechia
facility: Fakultní nemocnice Brno Bohunice
state: Brno-město
city: Ostrava
country: Czechia
facility: Fakultni nemocnice Ostrava
state: Moravskoslezský Kraj
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
state: Alpes-Maritimes
city: Pessac
country: France
facility: CHU Bordeaux Haut-Leveque
state: Aquitaine
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: Vandoeuvre lès Nancy
country: France
facility: Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
state: Lorraine
city: Angers
country: France
facility: Centre Hospitalier Universitaire d'Angers
state: Maine-et-Loire
city: Villejuif
country: France
facility: Gustave Roussy
state: Val-de-Marne
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Toulouse
country: France
facility: Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
city: Erding
country: Germany
facility: Onkologie Erding
state: Bayern
city: Kempten
country: Germany
facility: Local Institution - 0250
state: Bayern
city: Münster
country: Germany
facility: Gemeinschaftspraxis für Hämatologie und Onkologie Münster
state: Nordrhein-Westfalen
city: Koblenz
country: Germany
facility: InVO Institut für Versorgungsforschung in der Onkologie
state: Rheinland-Pfalz
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
state: Sachsen
city: Jena
country: Germany
facility: Universitätsklinikum Jena
state: Thüringen
city: Berlin
country: Germany
facility: Praxis fur Hamatologie und Onkologie
city: Berlin
country: Germany
facility: Local Institution - 0028
city: Düsseldorf
country: Germany
facility: Universitaetsklinikum Duesseldorf
city: Lübeck
country: Germany
facility: Local Institution - 0255
city: Mutlangen
country: Germany
facility: Kliniken Ostalb, Stauferklinikum
city: Würzburg
country: Germany
facility: Gemeinschaftspraxis Dres. med. Björn Schöttker & Dominik Pretscher
city: Patras
country: Greece
facility: Local Institution - 0242
state: Achaḯa
city: Patras
country: Greece
facility: University Hospital of Patras
state: Achaḯa
city: Athens
country: Greece
facility: General Hospital of Athens "G. Gennimatas"
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: Hksar
country: Hong Kong
facility: Local Institution - 0034
city: Eger
country: Hungary
facility: Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet
state: Heves
city: Nyiregyhaza
country: Hungary
facility: Szabolcs Szatmár Bereg Vármegyei Oktatókórház
state: Szabolcs-Szatmár-Bereg
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
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: Ahmedabad
country: India
facility: Hemato Oncology Clinic
state: Gujarat
city: Ahmedabad
country: India
facility: Local Institution - 0273
state: Gujarat
city: Bengaluru
country: India
facility: Local Institution - 0177
state: Karnataka
city: Bhubaneswar
country: India
facility: Institute of Medical Sciences and Sum Hospital
state: Odisha
city: Hyderabad
country: India
facility: Local Institution - 0185
city: New Delhi
country: India
facility: Local Institution - 0186
city: Rome
country: Italy
facility: Fondazione Policlinico Tor Vergata
state: Lazio
city: Milano
country: Italy
facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
state: Lombardia
city: Milan
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
state: Milano
city: Rozzano
country: Italy
facility: Humanitas
state: Milano
city: Torino
country: Italy
facility: Azienda Ospedaliera Ordine Mauriziano di Torino
state: Piemonte
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
state: Toscana
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
city: Reggio Calabria
country: Italy
facility: Grande Ospedale Metropolitano - Presidio Morelli
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma
city: Kitakyushu-shi
country: Japan
facility: Local Institution - 0123
state: Fukuoka
city: Sapporo
country: Japan
facility: Local Institution - 0117
state: Hokkaido
city: Amagasaki
country: Japan
facility: Local Institution - 0126
state: Hyogo
city: Sagamihara
country: Japan
facility: Local Institution - 0120
state: Kanagawa
city: Sendai-shi
country: Japan
facility: Local Institution - 0118
state: Miyagi
city: Osaka-sayama
country: Japan
facility: Local Institution - 0125
state: Osaka
city: Shimotsuga
country: Japan
facility: Local Institution - 0121
state: Tochigi
city: Nagasaki
country: Japan
facility: Local Institution - 0124
city: Osaka
country: Japan
facility: Local Institution - 0122
city: Tokyo
country: Japan
facility: Local Institution - 0119
city: Huixquilucan
country: Mexico
facility: Hematológica Alta Especialidad SC, consultorio 830
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
city: Oaxaca
country: Mexico
facility: Local Institution - 0156
city: Puebla
country: Mexico
facility: Unidad Médica Onco-hematológica
city: Wałbrzych
country: Poland
facility: Specjalistyczny Szpital im. dra Alfreda Sokołowskiego w Wałbrzychu
state: Dolnośląskie
city: Gdańsk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Katowice
country: Poland
facility: Pratia Onkologia Katowice
city: Warsaw
country: Poland
facility: MTZ Clinical Research powered by Pratia
city: San Juan
country: Puerto Rico
facility: Auxilio Mutuo Cancer Center
city: San Juan
country: Puerto Rico
facility: Local Institution - 0237
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Barcelona [Barcelona]
city: L'Hospitalet de Llobregat
country: Spain
facility: Institut Català d'Oncologia - L'Hospitalet
state: Catalunya [Cataluña]
city: Valencia
country: Spain
facility: Hospital Clinico de Valencia
state: Valenciana, Comunitat
city: Granada
country: Spain
facility: Hospital Universitario Virgen Nieves
city: Madrid
country: Spain
facility: Hospital La Princesa
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: