Clinical trial NCT05730036: A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma
Official title: An Open-label, Randomized, Phase 3 Study of Linvoseltamab (REGN5458; Anti- BCMA x Anti-CD3 Bispecific Antibody) Versus the Combination of Elotuzumab, Pomalidomide, and Dexamethasone (EPd), in Patients With Relapsed/Refractory Multiple Myeloma (LINKER-MM3)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Relapsed Refractory Multiple Myeloma (RRMM)
Keywords: BCMA X CD3 Bispecific Monoclonal Antibody
CD38 antibody
Proteasome inhibitor
Lenalidomide
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-02-15
Enrollment: 380
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: This study is researching an experimental drug called linvoseltamab, also called REGN5458.

Linvoseltamab has previously been studied by itself (without other cancer drugs) in participants who had advanced multiple myeloma that returned and needed to be treated again after many other therapies had failed. These participants were no longer benefiting from standard medications and had no good treatment options. In that study, some participants who were treated with linvoseltamab had improvement of their myeloma (shrinkage of their tumors), including some participants who had complete responses (that is, the treatment got rid of all evidence of myeloma in their bodies).

This study is focused on participants who have multiple myeloma that has returned or needs to be treated again after one to four prior treatments and have standard cancer treatment options available to them. The aim of this study is to see how safe and effective linvoseltamab is compared to a combination of three cancer drugs: elotuzumab, pomalidomide and dexamethasone, (called EPd) in participants who have returned after having received prior treatment that included lenalidomide, a proteosome inhibitor, and (for participants in some countries) a cluster of differentiation 38 (CD38) antibody. Half of the participants in this study will get linvoseltamab, and the other half will get EPd.

This study is looking at several other research questions, including:

* How long participants benefit from receiving linvoseltamab compared with EPd
* How many participants treated with linvoseltamab or EPd have improvement of their multiple myeloma and by how much
* What side effects happen from taking linvoseltamab compared to EPd
* How long participants live while receiving treatment or after treatment with linvoseltamab compared to EPd
* If there is any improvement in pain after treatment with linvoseltamab compared to EPd


Eligibility criteria: Key Inclusion Criteria:

1. Age 18 years or older (or legal adult age in the country) at the time of the screening visit.
2. Eastern Cooperative Oncology Group (ECOG) performance status ≤1. Patients with ECOG 2 solely due to local symptoms of myeloma (eg. pain) may be allowed after discussion with the Medical Monitor.
3. Received at least 1 and no more than 4 prior lines of anti-neoplastic MM therapies, including lenalidomide and a proteasome inhibitor and demonstrated disease progression on or after the last therapy as defined by the 2016 IMWG criteria. Participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory, as described in the protocol.

   Note: Participants in Israel also must have previously received a CD38 antibody. Participants in the EU and the UK must have previously received 2 to 4 prior lines of therapy, including a CD38 antibody.
4. Patients must have measurable disease for response assessment as per the 2016 IMWG response assessment criteria, as described in the protocol
5. Adequate hematologic function and hepatic function within 7 days of randomization, as well as adequate renal and cardiac function and corrected calcium
6. Life expectancy of at least 6 months

Key Exclusion Criteria:

1. Diagnosis of plasma cell leukemia, amyloidosis, Waldenström macroglobulinemia, or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
2. Prior treatment with elotuzumab and/or pomalidomide
3. Participants with known MM brain lesions or meningeal involvement
4. Treatment with any systemic anti-cancer therapy within 5 half-lives or within 28 days before first administration of study drug, whichever is shorter
5. History of allogeneic stem cell transplantation within 6 months, or autologous stem cell transplantation within 12 weeks of the start of study treatment. Participants who have received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease. Steroids at doses equivalent to suppletion doses may be acceptable.
6. Prior treatment with B-cell maturation antigen (BCMA) directed immunotherapies Note: BCMA antibody-drug conjugates are allowed.
7. History of progressive multifocal leukoencephalopathy (PML), known or suspected PML, or history of a neurocognitive condition or central nervous system (CNS) movement disorder (Parkinson's disease or Parkinsonism).
8. Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first administration of study drug
9. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); or another uncontrolled infection, as defined in the protocol 10 Cardiac ejection fraction \<40%.

NOTE: Other protocol defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Progression Free Survival (PFS) per International Myeloma Working Group (IMWG) response criteria determined by Independent Review Committee (IRC) in CD38 antibody exposed participants
timeFrame: Up to approximatively 5 years
Secondary outcomes:
measure: PFS per IMWG response criteria determined by IRC in all participants
timeFrame: Up to approximatively 5 years
measure: Objective Response (OR) of Complete Response (CR) or better per IMWG response criteria as determined by IRC in CD38 antibody exposed participants
timeFrame: Up to approximatively 5 years
measure: OR of CR or better per IMWG response criteria as determined by IRC in all participants
timeFrame: Up to approximatively 5 years
measure: Overall Survival (OS) in participants previously exposed to CD38 antibodies
timeFrame: Up to approximatively 5 years
measure: OS in all participants
timeFrame: Up to approximatively 5 years
measure: Incidence of minimal residual disease (MRD) negative status in participants previously exposed to CD38 antibodies
timeFrame: Up to approximatively 5 years
measure: Incidence of MRD negative status in all participants
timeFrame: Up to approximatively 5 years
measure: Mean change in the worst pain score measured by Brief Pain Inventory-Short Form (BPI-SF) Item 3 in participants previously exposed to CD38 antibodies
timeFrame: Baseline to week 12
measure: Mean change in the worst pain score measured by BPI-SF Item 3 in all participants
timeFrame: Baseline to week 12
measure: Incidence of treatment emergent adverse events (TEAEs) in participants previously exposed to CD38 antibodies
timeFrame: Up to approximatively 5 years
measure: Incidence TEAEs in all participants
timeFrame: Up to approximatively 5 years
measure: Severity of TEAEs in participants previously exposed to CD38 antibodies
timeFrame: Up to approximatively 5 years
measure: Severity of TEAEs in all participants
timeFrame: Up to approximatively 5 years
measure: Incidence of adverse events of special interest (AESI) in participants previously exposed to CD38 antibodies
timeFrame: Up to approximatively 5 years
measure: Incidence of AESI in all participants
timeFrame: Up to approximatively 5 years
measure: Severity of AESI in participants previously exposed to CD38 antibodies
timeFrame: Up to approximatively 5 years
measure: Severity AESI in all participants
timeFrame: Up to approximatively 5 years
measure: Incidence of Serious Adverse Events (SAE) in participants previously exposed to CD38 antibodies
timeFrame: Up to approximatively 5 years
measure: Incidence of SAE in all participants
timeFrame: Up to approximatively 5 years
measure: Severity of SAE in participants previously exposed to CD38 antibodies
timeFrame: Up to approximatively 5 years
measure: Severity of SAE in all participants
timeFrame: Up to approximatively 5 years
measure: PFS per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies
timeFrame: Up to approximatively 5 years
measure: PFS per IMWG response criteria as determined by the investigator in all participants
timeFrame: Up to approximatively 5 years
measure: OR of Partial Response (PR) or better per IMWG response criteria as determined by the IRC in CD38 antibody exposed participants
timeFrame: Up to approximatively 5 years
measure: OR of PR or better per IMWG response criteria as determined by the IRC in all participants
timeFrame: Up to approximatively 5 years
measure: OR of Very Good Partial Response (VGPR) or better per IMWG response criteria as determined by IRC in CD38 antibody exposed participants
timeFrame: Up to approximatively 5 years
measure: OR of VGPR or better per IMWG response criteria as determined by IRC in all participants
timeFrame: Up to approximatively 5 years
measure: OR of PR or better per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies
timeFrame: Up to approximatively 5 years
measure: OR of PR or better per IMWG response criteria as determined by the investigator in all participants
timeFrame: Up to approximatively 5 years
measure: OR of VGPR or better per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies
timeFrame: Up to approximatively 5 years
measure: OR of VGPR or better per IMWG response criteria as determined by the investigator in all participants
timeFrame: Up to approximatively 5 years
measure: OR of CR or better per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies
timeFrame: Up to approximatively 5 years
measure: OR of CR or better per IMWG response criteria as determined by the investigator in all participants
timeFrame: Up to approximatively 5 years
measure: Duration of Response (DoR) as per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies
timeFrame: Up to approximatively 5 years
measure: DoR as per IMWG response criteria as determined by the investigator in all participants
timeFrame: Up to approximatively 5 years
measure: DoR as per IMWG response criteria as determined by the IRC in participants previously exposed to CD38 antibodies
timeFrame: Up to approximatively 5 years
measure: DoR as per IMWG response criteria as determined by the IRC in all participants
timeFrame: Up to approximatively 5 years
measure: Duration of MRD negative status in the bone marrow in participants previously exposed to CD38 antibodies
timeFrame: Up to approximatively 5 years
measure: Duration of MRD negative status in the bone marrow in all participants
timeFrame: Up to approximatively 5 years
measure: Time from randomization to objective response (≥PR) as per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies
timeFrame: Up to approximatively 5 years
measure: Time from randomization to objective response (≥PR) as per IMWG response criteria as determined by the investigator in all participants
timeFrame: Up to approximatively 5 years
measure: Time from randomization to objective response (≥PR) as per IMWG response criteria as determined by the IRC in participants previously exposed to CD38 antibodies
timeFrame: Up to approximatively 5 years
measure: Time from randomization to objective response (≥PR) as per IMWG response criteria as determined by the IRC in all participants
timeFrame: Up to approximatively 5 years
measure: Concentration of linvoseltamab in the serum over time in participants previously exposed to CD38 antibodies
timeFrame: Up to approximatively 5 years
measure: Concentration of linvoseltamab in the serum over time in all participants
timeFrame: Up to approximatively 5 years
measure: Incidence of antidrug antibodies (ADAs) in participants previously exposed to CD38 antibodies
timeFrame: Up to approximatively 5 years
measure: Incidence of ADAs in all participants
timeFrame: Up to approximatively 5 years
measure: Titer of ADAs in participants previously exposed to CD38 antibodies
timeFrame: Up to approximatively 5 years
measure: Titer of ADAs in all participants
timeFrame: Up to approximatively 5 years
measure: Incidence of neutralizing antibodies (Nabs) to linvoseltamab over time in participants previously exposed to CD38 antibodies
timeFrame: Up to approximatively 5 years
measure: Incidence of Nabs to linvoseltamab over time in all participants
timeFrame: Up to approximatively 5 years
measure: Proportion of Pain Responders in participants previously exposed to CD38 antibodies
timeFrame: At week 12
measure: Proportion of Pain Responders in all participants
timeFrame: At week 12
measure: Change in patient-reported global health status/quality of life (QoL), per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in participants previously exposed to CD38 antibodies
timeFrame: Baseline to week 12
measure: Change in patient-reported QoL, per EORTC QLQ-C30 in all participants
timeFrame: Baseline to week 12
measure: Change in patient reported disease symptoms per EORTC Quality of Life Questionnaire-Multiple Myeloma (MM) module 20 [QLQ-MY20]) in participants previously exposed to CD38 antibodies
timeFrame: Baseline to week 12
measure: Change in patient reported disease symptoms per EORTC QLQ-MY20 in all participants
timeFrame: Baseline to week 12
measure: Patient-Reported Outcomes in Patient Global Impression of Symptom Severity (PGIS) in participants previously exposed to CD38 antibodies
timeFrame: Baseline to week 12
measure: Patient-Reported Outcomes in PGIS in all participants
timeFrame: Baseline to week 12
measure: Patient-Reported Outcomes in Patient Global Impression of Change (PGIC) in participants previously exposed to CD38 antibodies
timeFrame: Baseline to week 12
measure: Patient-Reported Outcomes in PGIC in all participants
timeFrame: Baseline to week 12
measure: Change in patient-reported general health status per EuroQoL-5 Dimension-5 Level Scale [EQ-5D-5L]) in participants previously exposed to CD38 antibodies
timeFrame: Baseline to week 12
measure: Change in patient-reported general health status per EQ-5D-5L in all participants
timeFrame: Baseline to week 12
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles (UCLA)
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Lexington
country: United States
facility: University of Kentucky, Markey Cancer Center Clinical Research Organization
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Portland
country: United States
facility: Kaiser Permanente Northwest
state: Oregon
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Auchenflower
country: Australia
facility: Icon Cancer Centre - Wesley
state: Queensland
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Launceston
country: Australia
facility: Launceston General Hospital
state: Tasmania
city: Fitzroy
country: Australia
facility: St Vincent's Hospital
state: Victoria
city: Geelong
country: Australia
facility: University Hospital Geelong
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Hospital
state: Victoria
city: Nedlands
country: Australia
facility: One Clinical Research at Hollywood Private Hospital
state: Western Australia
city: Roeselare
country: Belgium
facility: AZ Delta Algemeen Ziekenhuis Delta
state: West-Vlaanderen
city: Antwerp
country: Belgium
facility: Ziekenhuis Netwerk Antwerpen Stuivenberg
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Yvoir
country: Belgium
facility: Clinique Universitaire de Mont Godinne
city: Salvador
country: Brazil
facility: IDOR - Sao Rafael Salvador Bahia
state: Bahia
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner
state: Parana
city: Bento Goncalves
country: Brazil
facility: Associacao Dr Bartholomeu Tacchini
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Centro Gaucho Integrado
state: Rio Grande Do Sul
city: Centro
country: Brazil
facility: Animi Unidade de Tratamento Oncologico
city: Rio de Janeiro
country: Brazil
facility: Instituto Americas de Ensino e Pesquisa
city: Sao Paulo
country: Brazil
facility: Hospital A Beneficencia Portuguesa de Sao Paulo
city: Sao Paulo
country: Brazil
facility: Instituto DOr de Pesquisa e Ensino
city: Sao Paulo
country: Brazil
facility: AC Camargo Cancer Center
city: Sao Paulo
country: Brazil
facility: Clinica Medica Sao Germano
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network-Princess Margaret Cancer Center
state: Ontario
city: Santiago
country: Chile
facility: Hospital Clinico Universidad de Los Andes
state: Las Condes
city: Santiago
country: Chile
facility: Clinica Alemana de Santiago
state: Region Metropolitana
city: Santiago
country: Chile
facility: Fundacion Arturo Lopez Perez
state: Region Metropolitana
city: Santiago
country: Chile
facility: Clinica UC San Carlos de Apoquindo
state: Region Metropolitana
city: Santiago
country: Chile
facility: Centro Oncologia de Precision Universidad Mayor
state: Region Metropolitana
city: Vina del Mar
country: Chile
facility: Centro de Investigaciones Clinicas Vina del Mar
state: Valparaiso
city: Lyon
country: France
facility: Centre Leon Berard (CLB) - Centre de Recherche en Cancerologie Lyon-Est (CRCL)
state: Auvergne-Rhone
city: Pessac
country: France
facility: Centre Francois Magendie
state: Gironde
city: Lille
country: France
facility: Centre Hospitalier Universitaire de Lille
state: Hauts De France
city: Villejuif
country: France
facility: Gustave Roussy
state: Ile De France
city: Paris
country: France
facility: Hopital Necker
state: Ile-de-France
city: Paris
country: France
facility: Hopital Saint Louis, APHP
city: Paris
country: France
facility: Hopital Saint Antoine
city: Saint-Cloud
country: France
facility: Institut Curie
city: Tuebingen
country: Germany
facility: Medical Clinic II
state: Baden-Wuerttemberg
city: Luebeck
country: Germany
facility: Universitat zu Lubeck Neuromuskulares Zentrum
state: Ratzeburger
city: Hamburg
country: Germany
facility: University Hospital Hamburg Eppendorf
city: Leipzig
country: Germany
facility: University Hospital Leipzig - Hematology and Cellular Therapy
city: Haifa
country: Israel
facility: Rambam Health Care Campus
state: North
city: Haifa
country: Israel
facility: Lady Davis Carmel Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Tel Aviv
country: Israel
facility: The Tel Aviv Sourasky Medical Center
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Casa Sollievo della Sofferenza
state: Foggia
city: Meldola
country: Italy
facility: Istituto Romagnolo per lo Studio Dei Tumori Dino Amadori
state: Forli Cesena
city: Torino
country: Italy
facility: A.O.U. Citta della Salute e della Scienza di Torino
state: Piemonte
city: Candiolo
country: Italy
facility: IRCCS Fondazione Piemontese Oncologica Candiolo
state: Torino
city: Alessandria
country: Italy
facility: Azienda Ospedaliera Nazionale SS - Antonio e Biagio e Cesare Arrigo
city: Ancona
country: Italy
facility: AOU Ospedali Riuniti di Ancona
city: Bologna
country: Italy
facility: Policlinico S. Orsola- Malpighi
city: Catania
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco"
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino IRCCS
city: Pavia
country: Italy
facility: Universita degli Studi di Pavia - Fondazione IRCCS Policlini
city: Ravenna
country: Italy
facility: Ospedale Santa Maria delle Croci
city: Reggio Emilia
country: Italy
facility: AUSL IRCCS OF Reggio Emilia - Clinical Study Location -
city: Varese
country: Italy
facility: Ospedale di Circolo e Fondazione Macchi Varese
city: Kamogawa
country: Japan
facility: Kameda General Hospital
state: Chiba
city: Kurume
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Ogaki
country: Japan
facility: Ogaki Municipal Hospital
state: Gifu
city: Maebashi
country: Japan
facility: Gunma University Hospital
state: Gunma
city: Shibukawa
country: Japan
facility: NHO Shibukawa Medical Center
state: Gunma
city: Sapporo
country: Japan
facility: Sapporo Hokuyu Hospital
state: Hokkaido
city: Morioka
country: Japan
facility: Iwate Medical University Hospital
state: Iwate
city: Kita-ku
country: Japan
facility: National Hospital Organization Okayama Medical Center
state: Okayama
city: Suita-shi
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Iruma-gun
country: Japan
facility: Saitama Medical University Hospital
state: Saitama
city: Chiba-shi
country: Japan
facility: Chiba Cancer Center
state: Tiba
city: Tokushima-shi
country: Japan
facility: Tokushima Prefectural Central Hospital
state: Tokushima
city: Shibuya-ku
country: Japan
facility: Japanese Red Cross Medical Center
state: Tokyo
city: Kofu
country: Japan
facility: Yamanashi Prefectural Central Hospital
state: Yamanashi
city: Fukushima
country: Japan
facility: Fukushima Medical University
city: Kumamoto
country: Japan
facility: National Hospital Organization Kumamoto Medical Center
city: Sendai
country: Japan
facility: National Hospital Organization Sendai Medical Center
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
state: Gyeonggi
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk National University Hospital
state: Jeollabuk-do
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: South Jeolla
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul St Marys Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Hospital
state: Zuid-Holland
city: Lodz
country: Poland
facility: Wielospecjalistyczne Centrum Onkologii i Traumatologii
state: Lodzkie
city: Gdansk
country: Poland
facility: University Clinical Center / Medical University of Gdansk
state: Pomorskie
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki Nr2 Bydgoszcz
city: Katowice
country: Poland
facility: Pratia Onkologia Katowice
city: Lublin
country: Poland
facility: Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario Santiago de Compostela
state: A Coruna
city: Vitoria Gasteiz
country: Spain
facility: Hospital Universitario Araba
state: Alava
city: Gijon
country: Spain
facility: University Hospital of Cabuenes
state: Asturias
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Palma Mallorca
country: Spain
facility: Hospital Universitari Son Llatzer
state: Baleares
city: Palma
country: Spain
facility: Hospital Universitari Son Espases
state: Balearic Islands
city: Badalona
country: Spain
facility: Institut Catala d'Oncologia
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Universitari Mutua Terrassa
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Leon
country: Spain
facility: Complejo Asistencial Universitario de Leon
state: Castilla Y Leon
city: Alicante
country: Spain
facility: Hospital General Universitario Doctor Balmis Alicante
state: Comunidad Valenciana
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Universitario Quironsalud Madrid
state: Madrid
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra
state: Navarra
city: Madrid
country: Spain
facility: Universitary Hospital La Princesa
state: Salamanca
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Sant Pau
city: Barcelona
country: Spain
facility: Catalan Institute of Oncology (ICO) Hospitalet
city: Girona
country: Spain
facility: Instituto Catalan Oncologia
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra - Madrid
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Malaga
country: Spain
facility: Hospital Virgen de la Victoria
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de Valme
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Zaragoza
country: Spain
facility: Hospital Clinico Lozano Blesa
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital - Linkou Branch
state: Hunan Province
city: Changhua City
country: Taiwan
facility: Changhua Christian Hospital
city: Hualien City
country: Taiwan
facility: Hualien Tzu Chi Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan City
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: Wanfang Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
state: Cambrigeshire
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
state: Scotland
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital Birmingham
state: West Midlands
city: London
country: United Kingdom
facility: Barts Health NHS Trust
city: London
country: United Kingdom
facility: Guy's & St Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: Royal Marsden Hospital
city: London
country: United Kingdom
facility: Hammersmith Hospital
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: