Clinical trial NCT05352672: Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma
Official title: A Phase 3 Trial of Fianlimab (REGN3767, Anti-LAG-3) + Cemiplimab Versus Pembrolizumab in Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Melanoma
Keywords: Unresectable
Metastatic
Stage III
Stage IV
Anti-Lymphocyte-activation gene 3 Pathway (LAG-3)
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-04-29
Enrollment: 1535
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
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 REGN3767, also known as fianlimab (R3767), when combined with another medication called REGN2810, also known as cemiplimab (each individually called a "study drug" or called "study drugs" when combined).

The study is focused on patients with a type of skin cancer known as melanoma. The aims of the study are to see how effective the combination of fianlimab and cemiplimab are in treating the melanoma skin cancer, in comparison with a medication, pembrolizumab, approved for the treatment of melanoma skin cancer in adults, and to observe any similarities, or differences, in how the study drugs work in adolescent participants compared with adult participants.

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

* What side effects may happen from receiving the study drugs
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects). Antibodies are proteins that are naturally found in the blood stream that fight infections.
* How administering the study drugs might improve quality of life


Eligibility criteria: Key Inclusion Criteria:

1. Age ≥12 years on the date of providing informed consent
2. Patients with histologically confirmed unresectable Stage III and Stage IV (metastatic) melanoma (AJCC, 8th revised edition) who have not received prior systemic therapy for advanced unresectable disease

   1. Patients who received adjuvant and/or neoadjuvant systemic therapies are eligible if they did not have evidence of progression or recurrence of disease and/or discontinued due to occurrence of unmanageable imAEs ≥ grade 3 (with the exclusion of endocrinopathies which are fully controlled by hormone replacement) while on such therapies. Also, patients must have had a treatment-free and disease-free interval of \>6 months. Accrual of these patients is limited to approximately 10% of the total population enrolled.
   2. Patients with acral and mucosal melanomas are eligible. Accrual will be limited to 10% of the total population.
3. Measurable disease per RECIST v1.1

   1. Previously irradiated lesions can only be counted as target lesions if they have been demonstrated to progress and no other target lesion is available
   2. Cutaneous lesions should be evaluated as non-target lesions
4. Performance status:

   1. For adult patients: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
   2. For pediatric patients: Karnofsky performance status ≥70 (patients ≥16 years) or Lansky performance status ≥70 (patients ≤16 years)
5. Anticipated life expectancy of at least 3 months

Key Exclusion Criteria:

1. Uveal melanoma
2. Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment.
3. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C virus (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection
4. Unknown BRAF V600 mutation status as described in the protocol
5. Systemic immune suppression:

   1. Use of immunosuppressive doses of corticosteroids (\>10mg of prednisone per day or equivalent) within 14 days of the first dose of study medication. Physiologic replacement doses are allowed up to and including 10mg of prednisone/day or equivalent. Inhaled or topical steroids are permitted, if they are not for treatment of an autoimmune disorder.
   2. Other clinically relevant forms of systemic immune suppression
6. Treatment with other anti-cancer therapy including immuno- therapy, chemotherapy, major surgery or biological therapy within 21 days prior to the first dose of trial treatment. Adjuvant hormonotherapy used for breast cancer or other hormone-sensitive cancers in long term remission is allowed.
7. History or current evidence of significant (CTCAE Grade ≥2) local or systemic infection (e. g., cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 14 days prior to the first dose of trial medication.
8. Active or untreated brain metastases or spinal cord compression. Patients with leptomeningeal disease are excluded. Patients with known brain metastases are eligible if they:

   1. Received radiotherapy or another appropriate standard therapy for the brain metastases,
   2. Have neurologically returned to baseline (except for residual signs and symptoms related to the CNS treatment) for at least 14 days prior to enrollment
   3. Did not require immunosuppressive doses of corticosteroids therapy (\>10mg of prednisone per day or equivalent) in the 14 days prior to enrollment
   4. Are asymptomatic with a single untreated brain metastasis \<10 mm in size
9. Participants with a history of myocarditis.

Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Approximately 27 months
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Up to 96 months
measure: Objective response rate (ORR)
timeFrame: Up to 27 months
measure: Disease control rate (DCR)
timeFrame: Up to 27 months
measure: Duration of response (DoR)
timeFrame: Up to 27 months
measure: PFS
timeFrame: Up to 27 months
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 90 days post last dose, approximately 6 years
measure: Occurrence of interruption and discontinuation of study drug(s) due to AEs
timeFrame: Up to 90 days post last dose, approximately 6 years
measure: TEAEs leading to death
timeFrame: Up to 6 years
measure: Incidence of laboratory abnormalities
timeFrame: Up to 90 days post last dose, approximately 6 years
measure: Concentrations of cemiplimab in serum
timeFrame: Up to 90 days post last dose, approximately 6 years
measure: Concentrations of fianlimab in serum
timeFrame: Up to 90 days post last dose, approximately 6 years
measure: Incidence of anti-drug antibodies (ADA) to fianlimab over time
timeFrame: Up to 30 days post last dose, approximately 6 years
measure: Titer of anti-drug antibodies (ADA) to fianlimab over time
timeFrame: Up to 30 days post last dose, approximately 6 years
measure: Incidence of ADA to cemiplimab over time
timeFrame: Up to 30 days post last dose, approximately 6 years
measure: Titer of ADA to cemiplimab over time
timeFrame: Up to 30 days post last dose, approximately 6 years
measure: Incidence of neutralizing antibodies (NAb) to fianlimab over time
timeFrame: Up to 30 days post last dose, approximately 6 years
measure: Incidence of NAb to cemiplimab over time
timeFrame: Up to 30 days post last dose, approximately 6 years
measure: Patient-reported outcomes (PROs) as measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30)
timeFrame: Up to 90 days post last dose, approximately 6 years
measure: PROs as measured by EQ-5D-5L
timeFrame: Up to 90 days post last dose, approximately 6 years
measure: PROs as measured by Functional Assessment of Cancer Therapy melanoma (FACTM) (melanoma subscale only)
timeFrame: Up to 90 days post last dose, approximately 6 years
measure: PROs as measured by Patient Global Impression of Severity (PGIS)
timeFrame: Up to 21 days post last dose, approximately 6 years
measure: PROs as measured by Patient Global Impression of Change (PGIC)
timeFrame: Up to 21 days post last dose, approximately 6 years
measure: Change in physical functioning per EORTC QLQ-C30
timeFrame: Baseline to Week 25
measure: Change in role functioning per EORTC QLQ-C30
timeFrame: Baseline to Week 25
measure: Change in global health status/quality of life (GHS/QoL) per EORTC QLQ-C30
timeFrame: Baseline to Week 25
measure: Change in physical functioning per EORTC QLQ-C30
timeFrame: Baseline to end of study, approximately 6 years
measure: Change in role functioning per EORTC QLQ-C30
timeFrame: Baseline to end of study, approximately 6 years
measure: Change in GHS/QoL per EORTC QLQ-C30
timeFrame: Baseline to end of study, approximately 6 years
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Los Angeles
country: United States
facility: The Angeles Clinic and Research Institute
state: California
city: Miami
country: United States
facility: Miami Cancer Institute
state: Florida
city: Orlando
country: United States
facility: Orlando Health, Inc
state: Florida
city: Morristown
country: United States
facility: Atlantic Health System - Morristown Medical Center
state: New Jersey
city: Cleveland
country: United States
facility: University Hospitals Seidmand Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Buenos Aires
country: Argentina
facility: Fundacion Cenit para la Investigacion en Neurociencias
city: Buenos Aires
country: Argentina
facility: DIABAID - Instituto de Asistencia Integral en Diabetes
city: Caba
country: Argentina
facility: Clinica Adventista Belgrano
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Fundacion CENIT Centro Medico de Neurociencias
city: Rosario
country: Argentina
facility: Instituto de Oncologia de Rosario
city: San Miguel de Tucuman
country: Argentina
facility: Centro Medico San Roque
city: Adelaide
country: Australia
facility: Calvary North Adelaide Hospital
city: Geelong
country: Australia
facility: Barwon Health Andrew Love Cancer Centre, University Hospital Geelong
city: Hobart
country: Australia
facility: Icon Cancer Centre Hobart
city: Melbourne
country: Australia
facility: The Alfred Hospital
city: Southport
country: Australia
facility: Gold Coast University Hospital
city: Townsville
country: Australia
facility: The Townsville Hospital and Health Service
city: Wendouree
country: Australia
facility: Ballarat Oncology and Haematology Clinical Trials Unit
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
state: Tyrol
city: Graz
country: Austria
facility: Medical University of Graz
city: St. Poelten
country: Austria
facility: University Hospital St. Poelten
city: Vienna
country: Austria
facility: Medical University Of Vienna
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Kortrijk
country: Belgium
facility: AZ Groeninge, Campus Kennedylaan
city: Namur
country: Belgium
facility: Clinique et Maternite Sainte-Elisabeth (CMSE)
city: Sint Niklaas
country: Belgium
facility: AZ Nikolaas
city: Barretos
country: Brazil
facility: Fundacao Pio XII - Hospital de Amor de Barretos
city: Belo Horizonte
country: Brazil
facility: Centro Avancado de Tratamento Oncologico (CENANTRON)
city: Curitiba
country: Brazil
facility: Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner
city: Ijui
country: Brazil
facility: Oncosite Centro De Pesquisa Clinica Em Oncologia
city: Itajai
country: Brazil
facility: Clinica de Neoplasias Litoral/atarina Pesquisa Clínica
city: Joinville
country: Brazil
facility: Instituto Joinvilense De Hematologia E Oncologia
city: Lages
country: Brazil
facility: Animi Unidade de Tratamento Oncologico Ltda
city: Lajeado
country: Brazil
facility: Hospital Bruno Born
city: Passo Fundo
country: Brazil
facility: Hospital Sao Vicente de Paulo (HSVP) Instituto do Cancer
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre (HCPA)
city: Porto Alegre
country: Brazil
facility: CPO - Centro de Pesquisas em Oncologia
city: Porto Velho
country: Brazil
facility: Fundacao PIO XII - Hospital de Amor Amazonia
city: Rio de Janeiro
country: Brazil
facility: Instituto COI
city: Salvador
country: Brazil
facility: Hospital Sao Rafael
city: Santo Cristo
country: Brazil
facility: INCA - Brazilian National Cancer Institute
city: Sao Jose do Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
city: Sao paulo
country: Brazil
facility: Hemomed
city: Sao Paulo
country: Brazil
facility: Hospital Sirio Libanes (HSL)
city: Sao Paulo
country: Brazil
facility: Sao Camilo Oncologia
city: Toronto
country: Canada
facility: Sunnybrook Research Institute
state: Ontario
city: Barrie
country: Canada
facility: Royal Victoria Regional Health Centre
city: Edmonton
country: Canada
facility: Cross Cancer Institute (CCI)
city: Fredericton
country: Canada
facility: Dr. Everett Chalmers Hospital
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre (SCC)
city: Toronto
country: Canada
facility: University Health Network, Princess Margaret Cancer Centre
city: Recoleta
country: Chile
facility: Centro De Investigacion Clinica Bradford Hill
state: Chi
city: Santiago
country: Chile
facility: Oncovida
state: Region Metropolitana De Santiago
city: Antofagasta
country: Chile
facility: Centro Oncologico Antofagasta Bradford Hill Norte
city: Santiago
country: Chile
facility: Universidad Mayor - Centro Oncologia de Precision
city: Santiago
country: Chile
facility: Hospital Clinico Universidad de Chile
city: Vina del Mar
country: Chile
facility: Oncocentro
city: Hradec Kralove
country: Czechia
facility: Fakultni Nemocnice Hradec Kralove
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
city: Prague 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady, Dermatovenerologicka klinika
city: Besancon Cedex
country: France
facility: CHU Jean MINJOZ
city: Bobigny
country: France
facility: Hopital Avicenne Service de Dermatologie du Pr Caux
city: Bordeaux Cedex
country: France
facility: HOPITAL SAINT ANDRE Chu De Bordeaux
city: Boulogne Billancourt
country: France
facility: Hopital Ambroise Pare
city: Clermont-Ferrand
country: France
facility: CHU Estaing, Service de Dermatologie
city: Creteil
country: France
facility: Hopitaux Universitaires Henri-Mondor
city: Dijon
country: France
facility: CHU de DIJON - Service de Dermatologie
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire De Grenoble Alpes Service Dermatologie
city: Le Mans
country: France
facility: CH Le Mans - Plateforme de recherche clinique
city: Lille Cedex
country: France
facility: Chru De Lille
city: Lyon cedex 08
country: France
facility: Centre Leon Berard
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes (CHU de Nantes) Hotel Dieu
city: Paris
country: France
facility: Hopital Cochin APHP
city: Pierre Benite Cedex
country: France
facility: Hospices Civils de Lyon
city: Poitiers Cedex
country: France
facility: Hopital de la Miletrie Centre Hospitalier Universitaire de Poitiers
city: Rouen
country: France
facility: CHU Charles Nicolle Dermatologie
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne - Hopital Nord
city: Strasbourg
country: France
facility: Clinique Sainte Anne/Strasbourg Oncologie Liberale
city: Villejuif Cedex
country: France
facility: Institut Gustave Roussy Cancer Center DITEP
city: Batumi
country: Georgia
facility: LTD High Technology Hospital Medcenter
city: Tbilisi
country: Georgia
facility: Israeli Georgian medical research clinic Helsicore
city: Tbilisi
country: Georgia
facility: LTD New Hospitals
city: Tbilisi
country: Georgia
facility: LTD Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
city: Tbilisi
country: Georgia
facility: JSC K. Eristavi National Center of Experimental and Clinical Surgery
city: Tbilisi
country: Georgia
facility: TIM -Tbilisi Institute of Medicine
city: Tbilisi
country: Georgia
facility: Medulla - Clinics And Medical Centers
city: Tbilisi
country: Georgia
facility: LLC Todua Clinic
city: Augsburg
country: Germany
facility: Universitatsklinikum Augsburg Klinik fur Dermatologie und Allergologie Campus Sud
city: Berlin
country: Germany
facility: Charite - Universitaetsmedizin Berlin
city: Bochum
country: Germany
facility: Universitaetsklinikum der Ruhr Universitaet Bochum (UKRUB) St Josef Hospital
city: Buxtehude
country: Germany
facility: Elbekliniken Buxtehude
city: Dessau
country: Germany
facility: Staedtisches Klinikum Dessau
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet
city: Erfurt
country: Germany
facility: Helios Klinikum Erfurt Klinik fur Hautkrankheiten und Allergologie
city: Frankfurt
country: Germany
facility: Universitatsklinik Frankfurt
city: Giessen
country: Germany
facility: University Hospital Giessen
city: Göttingen
country: Germany
facility: Universitatsmedizin Gottingen Klinik fur Dermatologie
city: Kiel
country: Germany
facility: University of Kiel
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig
city: Luebeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein Campus Luebeck
city: Mainz
country: Germany
facility: Universitatsmedizin der Johanned Gutenberg-Universitat Mainz
city: Mannheim
country: Germany
facility: University Medical Center Mannheim
city: Muenster
country: Germany
facility: Fachklinik Hornheide
city: Munchen
country: Germany
facility: Klinikum der Universitat Munchen - LMU Klinik und Poliklinik fur Dermatologie und Allergologie Hautt
city: Nuremberg
country: Germany
facility: Universitätsklinik der Paracelsus Medizinischen Privatuniversität
city: Quedlinburg
country: Germany
facility: Harzklinikum, Klinik fur Dermatologie und Allergologie
city: Regensburg
country: Germany
facility: University Clinic Regensburg
city: Schwerin
country: Germany
facility: Helios Klinik Schwerin
city: Tuebingen
country: Germany
facility: Universitaetsapotheke Tuebingen
city: Debrecen
country: Hungary
facility: University of Debrecen
city: Nyíregyhaza
country: Hungary
facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktato Korhazak
city: Pecs
country: Hungary
facility: University of Pecs Medical School
city: Szeged
country: Hungary
facility: University of Szeged
city: Cork
country: Ireland
facility: Cork University Hospital
city: Dublin 4
country: Ireland
facility: St. Vincents University Hospital
city: Dublin
country: Ireland
facility: St. James Hospital
city: Galway
country: Ireland
facility: University College Hospital Galway
city: Bari
country: Italy
facility: Istituto dei Tumori
city: Brescia
country: Italy
facility: ASST Spedali Civili Brescia
city: Candiolo
country: Italy
facility: Istituto di Candiolo, FPO IRCCS
city: Cuneo
country: Italy
facility: Azienda Sanitaria Ospedaliera Santa Croce E Carle - Cuneo
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino - IRCCS
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo dei Tintori
city: Napoli
country: Italy
facility: Università della Campania Luigi Vanvitella
city: Napoli
country: Italy
facility: IRCCS Istituto Nazionale dei Tumori di Napoli Fondazione G. Pascale
city: Novara
country: Italy
facility: SCDU di Oncologia AOU Maggiore Della Carita
city: Padova
country: Italy
facility: IOV - Istituto Oncologico Veneto - IRCCS
city: Pisa
country: Italy
facility: U.O. Oncologia Medica Universitaria - Istituto Toscano Tumori Polo Oncologico
city: Roma
country: Italy
facility: Istituti Fisioterapici Ospitalieri (IFO)
city: Rome
country: Italy
facility: Campus Bio-Medico di Roma
city: Rome
country: Italy
facility: Istituto Dermopatico Dell'Immacolata Irccs
city: Rozzano
country: Italy
facility: IRCCS Istituto Clinico Humanitas
city: San Giovanni Rotondo
country: Italy
facility: Fondazione IRCSS Casa Sollievo Della Sofferenza
city: Terni
country: Italy
facility: Azienda Ospedaliera S. Maria
city: Trento
country: Italy
facility: Santa Chiara Regional Hospital
city: Turin
country: Italy
facility: AOU Citta della Salute e della Scienza di Torino
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - Ospedale Udine
city: Chihuahua
country: Mexico
facility: Centro Estatal de Cancerologia de Chihuahua
city: Culiacan
country: Mexico
facility: Neurociencias Estudios Clinicos SC
city: Guadalajara
country: Mexico
facility: Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
city: Leon
country: Mexico
facility: Preparaciones Oncologicas SC
city: Merida
country: Mexico
facility: Centro De Atencion E Investigacion Clinica En Oncologia Scp
city: Monterrey
country: Mexico
facility: iCan Oncology Center
city: Tuxtla Gutierrez
country: Mexico
facility: Centro De Estudios Y Prevencion Del Cancer A. C.
city: Veracruz
country: Mexico
facility: FAICIC S. de R.L. de C.V.
city: Zapopan
country: Mexico
facility: Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
city: Amsterdam
country: Netherlands
facility: The Netherlands Cancer Institute (NKI) - Antoni van Leeuwenhoek Hospital
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Arequipa
country: Peru
facility: Hospital Goyeneche
city: Arequipa
country: Peru
facility: Centro Medico Monte Carmelo
city: Bellavista
country: Peru
facility: Hospital Nacional Daniel Alcides Carrion
city: Concepcion
country: Peru
facility: Instituto Regional de Enfermedades Neoplasicas del Centro - IREN CENTRO
city: Lima
country: Peru
facility: Instituto Peruano de Oncologia and Radioterapia
city: Lima
country: Peru
facility: Instituto Nacional de Enfermedades Neoplasicas
city: San Borja
country: Peru
facility: Clinica Internacional San Borja
city: Trujillo
country: Peru
facility: Clinica Peruano Americana
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne (UCK)
city: Krakow
country: Poland
facility: Narodowego Instytutu Onkologii im Maria Sklodowska Curie
city: Poznan
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Poznaniu
city: Siedlce
country: Poland
facility: Mazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii
city: Slupsk
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka
city: Warszawa
country: Poland
facility: Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow
city: Bucharest
country: Romania
facility: Institute of Oncology Bucharest
city: Cluj Napoca
country: Romania
facility: Medisprof
city: Cluj-Napoca
country: Romania
facility: Cardiomed SRL
city: Cluj
country: Romania
facility: SC Radiotherapy Center Cluj SRL
city: Craiova
country: Romania
facility: Centrul de Oncologie Sf. Nectarie S.R.L
city: Iasi
country: Romania
facility: SC Centrul de Oncologie Euroclinic SRL
city: Iasi
country: Romania
facility: Regional Institute of Oncology
city: Otopeni
country: Romania
facility: RTC Radiology Therapeutic Center SRL
city: Timisoara
country: Romania
facility: Oncocenter Oncologie Clinica S.R.L
city: Timisoara
country: Romania
facility: Oncomed
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
city: Johannesburg
country: South Africa
facility: The Medical Oncology Centre of Rosebank
city: Kraaifontein
country: South Africa
facility: Cape Town Oncology Trials
city: A Coruna
country: Spain
facility: Hospital Teresa Herrera-Chuac (CHUAC)
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol (HUGTP)
city: Barcelona
country: Spain
facility: Instituto Oncologico Dr Rosel
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Catalan Institute of Oncology (ICO) Hospitalet
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Girona
country: Spain
facility: Catalan Institute Of Oncology - Girona
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Centro integral Oncologico HM Clara Campal
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga
city: Múrcia
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: San Sebastian
country: Spain
facility: Onkologikoa
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncologia
city: Valencia
country: Spain
facility: INCLIVA-Instituto de Investigacion Sanitaria
city: Adana
country: Turkey
facility: Adana Baskent Hospital
city: Ankara
country: Turkey
facility: Gulhane Training and Research Hospital
city: Ankara
country: Turkey
facility: Memorial Ankara Hospital
city: Ankara
country: Turkey
facility: Ozel Liv Hospital
city: Diyarbakir
country: Turkey
facility: Dicle University Medical Faculty
city: Edirne
country: Turkey
facility: Trakya University
city: Gaziantep
country: Turkey
facility: Gaziantep University Medical Faculty
city: Istanbul
country: Turkey
facility: Bezmialem University
city: Istanbul
country: Turkey
facility: Cerrahpasa Medical Hospital
city: Istanbul
country: Turkey
facility: Bakirkoy Sadi Konuk Training Hospital
city: Istanbul
country: Turkey
facility: Prof. Dr. Suleyman Yalcin Sehir Hospital
city: Izmir
country: Turkey
facility: Ege University hospital
city: Kocaeli
country: Turkey
facility: Kocaeli Universitesi
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital NHS Trust
state: Devon
city: Guildford
country: United Kingdom
facility: Royal Surrey NHS Foundation Trust
city: Hull
country: United Kingdom
facility: Hull University Teaching Hospitals NHS Trust
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
city: London
country: United Kingdom
facility: Guy's Hospital
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: