Clinical trial NCT03906071: Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
Official title: A Randomized Phase 3 Study of Sitravatinib in Combination With Nivolumab Versus Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer With Disease Progression On or After Platinum-Based Chemotherapy and Checkpoint Inhibitor Therapy SAPPHIRE
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Metastatic Non-Squamous Non-Small Cell Lung Cancer
Keywords: Sitravatinib
Nivolumab
Docetaxel
Checkpoint inhibitor
MGCD516
NSCLC
SAPPHIRE
Lead sponsor: Mirati Therapeutics Inc.
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2019-04-08
Enrollment: 577
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 will compare the efficacy of the investigational agent sitravatinib in combination with nivolumab versus docetaxel in patients with advanced non-squamous NSCLC who have previously experienced disease progression on or after platinum-based chemotherapy and checkpoint inhibitor therapy.

Detailed description: Sitravatinib (MGCD516) is an orally-available, small molecule inhibitor of a closely related spectrum of receptor tyrosine kinases (RTKs) including MET, TAM (Tyro3, AXL, MERTK) family, VEGFR family, PDGFR family, KIT, FLT3, TRK family, RET, DDR2, and selected EPH family members. Nivolumab is a human IgG monoclonal antibody that binds to the PD-1 receptor and selectively blocks the interaction with its ligands PD-L1 and PD-L2, thereby releasing PD-1 pathway mediated inhibition of the immune response, including anti-tumor immune response. RTKs have been implicated in mediating an immunosuppressive tumor microenvironment, which has emerged as a potential resistance mechanism to checkpoint inhibitor therapy. Inhibition of these RTKs by sitravatinib may augment anti-tumor immune response and improve outcomes by overcoming resistance to checkpoint inhibitor therapy.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Non-Squamous Non-Small Cell Lung Cancer
* Receipt of at least one but not more than two prior treatment regimens in the advanced setting
* Prior treatment with PD-1/PD-L1 checkpoint inhibitor therapy and platinum-based chemotherapy in combination or in sequence (i.e., platinum-based chemotheraphy followed by checkpoint inhibitor therapy)
* Most recent treatment regimen must have included a checkpoint inhibitor therapy with radiographic disease progression on or after treatment
* Candidate to receive docetaxel as second or third line therapy

Exclusion Criteria:

* Uncontrolled brain metastases
* Tumors that have tested positive for EGFR, ROS1, ALK mutations, or ALK fusions
* Unacceptable toxicity with prior checkpoint inhibitor therapy
* Receipt of systemic anti-cancer therapy post checkpoint inhibitor therapy, other than maintenance chemotherapy
* Impaired heart function

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: From randomization date to date of death due to any cause (Up to approximately 44 months)
Secondary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Event (TEAEs)
timeFrame: From first dose up to 28 days post last dose, and up to 100 days post last dose of nivolumab for immune-related AEs (Up to maximum of 38 months)
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAE) Leading to Study Drug Discontinuation
timeFrame: From first dose up to 28 days post last dose, and up to 100 days post last dose of nivolumab for immune-related AEs (Up to maximum of 38 months)
measure: Number of Participants With Maximum Post Baseline Hematology Grade Results
timeFrame: From first dose up to 28 days post last dose (Up to an average of 7.5 months and maximum of 36 months)
measure: Number of Participants With Maximum Post Baseline Chemistry Grade Results
timeFrame: From first dose up to 28 days post last dose (Up to an average of 7.5 months and maximum of 36 months)
measure: Objective Response Rate (ORR) Per Central Radiographic Assessment
timeFrame: From randomization until disease progression or start of new anti-cancer therapy (Up to approximately 44 months)
measure: Duration of Response (DOR) Per Central Radiographic Assessment
timeFrame: From randomization to the first documentation of disease progression (PD) or to death due to any cause in the absence of documented PD (Up to approximately 44 months)
measure: Clinical Benefit Rate Per Central Radiographic Assessment
timeFrame: From randomization until disease progression or start of new anti-cancer therapy (Up to approximately 44 months)
measure: Progression-Free Survival (PFS) Per Central Radiographic Assessment
timeFrame: From randomization to the date of the first documentation of objective disease progression or death due to any cause (Up to approximately 44 months)
measure: 1-Year Survival Rate
timeFrame: At 12 months from first dose
measure: Change From Baseline in the Lung Cancer Symptom Scale (LCSS) Average Total Score
timeFrame: Clinic visit closest to the disease evaluation on weeks 9, 17, 25, 33, 41, 49.
measure: Change From Baseline in the European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) - Health Utility Index (HUI)
timeFrame: Clinic visit closest to the disease evaluation on weeks 9, 17, 25, 33, 41, 49.
measure: Change From Baseline in the European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) - Visual Analogue Score (VAS)
timeFrame: Clinic visit closest to the disease evaluation on weeks 9, 17, 25, 33, 41, 49.
measure: Sitravatinib Plasma Concentration by Time Point
timeFrame: 0.5 hours post dose on cycle 1 (day 1) and 5 hours post dose on cycle 1 (day 1 and 15), and pre-dose on cycle 1 (day 15), and cycle 2, 3, and 5 (day 1)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution - 005-164
state: Alabama
city: Huntsville
country: United States
facility: Clearview Cancer Institute - Huntsville
state: Alabama
city: Glendale
country: United States
facility: Palo Verde Cancer Specialists - Glendale
state: Arizona
city: Tucson
country: United States
facility: The Oncology Institute of Hope & Innovation - Tucson
state: Arizona
city: Yuma
country: United States
facility: Yuma Regional Medical Center
state: Arizona
city: Jonesboro
country: United States
facility: Local Institution - 005-174
state: Arkansas
city: Jonesboro
country: United States
facility: NEA Baptist Fowler Family Center for Cancer Care
state: Arkansas
city: Springdale
country: United States
facility: Highlands Oncology Group - Springdale
state: Arkansas
city: Bakersfield
country: United States
facility: Comprehensive Blood and Cancer Center - Bakersfield
state: California
city: Beverly Hills
country: United States
facility: Local Institution - 005-118
state: California
city: Fresno
country: United States
facility: Local Institution - 005-171
state: California
city: Fullerton
country: United States
facility: Providence Medical Foundation - Virginia K. Crosson Cancer Center - Fullerton
state: California
city: Long Beach
country: United States
facility: Local Institution - 005-096
state: California
city: Los Alamitos
country: United States
facility: Cancer and Blood Specialty Clinic
state: California
city: Los Angeles
country: United States
facility: Los Angeles Hematology Oncology Medical Group
state: California
city: Los Angeles
country: United States
facility: Local Institution - 005-185
state: California
city: Newport Beach
country: United States
facility: Local Institution - 005-072
state: California
city: Northridge
country: United States
facility: Local Institution - 005-109
state: California
city: Redlands
country: United States
facility: Local Institution - 005-177
state: California
city: Riverside
country: United States
facility: Local Institution - 005-112
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: San Marcos
country: United States
facility: Local Institution - 005-176
state: California
city: Torrance
country: United States
facility: Local Institution - 005-192
state: California
city: West Covina
country: United States
facility: Local Institution - 005-090
state: California
city: Whittier
country: United States
facility: Local Institution - 005-105
state: California
city: Lafayette
country: United States
facility: Local Institution - 005-097
state: Colorado
city: Norwich
country: United States
facility: Eastern Connecticut Hematology and Oncology Associates
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Michael and Dianne Bienes Comprehensive Cancer Center
state: Florida
city: Fort Myers
country: United States
facility: Local Institution - 005-120
state: Florida
city: Hollywood
country: United States
facility: Memorial Regional Hospital
state: Florida
city: Lakeland
country: United States
facility: Watson Clinic Cancer and Research Center
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Health System
state: Florida
city: Naples
country: United States
facility: Local Institution - 005-120E
state: Florida
city: Ocala
country: United States
facility: Local Institution - 005-079
state: Florida
city: Orlando
country: United States
facility: Local Institution - 005-104
state: Florida
city: Saint Petersburg
country: United States
facility: SCRI - Florida Cancer Specialists - North Region Research Office
state: Florida
city: Tallahassee
country: United States
facility: SCRI - Florida Cancer Specialists - Panhandle Research Office
state: Florida
city: West Palm Beach
country: United States
facility: Local Institution - 005-154
state: Florida
city: Athens
country: United States
facility: University Cancer & Blood Center (UCBC) - Athens
state: Georgia
city: Atlanta
country: United States
facility: Local Institution - 005-146
state: Georgia
city: Columbus
country: United States
facility: John B. Amos Cancer Center Research
state: Georgia
city: Marietta
country: United States
facility: Local Institution - 005-119
state: Georgia
city: Honolulu
country: United States
facility: Straub Medical Center
state: Hawaii
city: Coeur d'Alene
country: United States
facility: Local Institution - 005-191
state: Idaho
city: Chicago
country: United States
facility: Local Institution - 005-151
state: Illinois
city: Evanston
country: United States
facility: Local Institution - 005-110
state: Illinois
city: Niles
country: United States
facility: Local Institution - 005-198
state: Illinois
city: Skokie
country: United States
facility: Orchard Healthcare Research
state: Illinois
city: Tinley Park
country: United States
facility: Healthcare Research Network - Tinley Park
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology - Fort Wayne South Office
state: Indiana
city: Goshen
country: United States
facility: Local Institution - 005-122
state: Indiana
city: Indianapolis
country: United States
facility: Franciscan Health Cancer Center Indianapolis
state: Indiana
city: Lafayette
country: United States
facility: Local Institution - 005-150
state: Indiana
city: Westwood
country: United States
facility: Local Institution - 005-169
state: Kansas
city: Wichita
country: United States
facility: Local Institution - 005-098
state: Kansas
city: Danville
country: United States
facility: Commonwealth Cancer Center - Frankfort
state: Kentucky
city: Louisville
country: United States
facility: Local Institution - 005-153
state: Kentucky
city: Scarborough
country: United States
facility: New England Cancer Specialists - Scarborough
state: Maine
city: Rockville
country: United States
facility: Local Institution - 005-178
state: Maryland
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Local Institution - 005-127
state: Minnesota
city: Saint Louis Park
country: United States
facility: Local Institution - 005-159
state: Minnesota
city: Jackson
country: United States
facility: Jackson Oncology Associates - The Hederman Cancer Center
state: Mississippi
city: Bolivar
country: United States
facility: Central Care Cancer Center - Bolivar
state: Missouri
city: Kansas City
country: United States
facility: Kansas City Care Health Center - Research Medical Campus
state: Missouri
city: Billings
country: United States
facility: Sisters of Charity of Leavenworth Health St. Marys
state: Montana
city: Grand Island
country: United States
facility: Saint Francis Cancer Treatment Center
state: Nebraska
city: Omaha
country: United States
facility: Methodist Hospital - Omaha
state: Nebraska
city: Henderson
country: United States
facility: The Oncology Institute of Hope & Innovation - Henderson
state: Nevada
city: Henderson
country: United States
facility: Local Institution - 005-152
state: Nevada
city: Florham Park
country: United States
facility: Local Institution - 005-142
state: New Jersey
city: Little Silver
country: United States
facility: Local Institution - 005-163
state: New Jersey
city: Livingston
country: United States
facility: Cooperman Barnabas Medical Center
state: New Jersey
city: Sparta
country: United States
facility: Regional Cancer Care Associates - Sparta
state: New Jersey
city: Johnson City
country: United States
facility: Local Institution - 005-123
state: New York
city: Lake Success
country: United States
facility: Local Institution - 005-182
state: New York
city: Port Jefferson Station
country: United States
facility: New York Cancer & Blood Specialists - Port Jefferson Medical Oncology
state: New York
city: Stony Brook
country: United States
facility: Local Institution - 005-107
state: New York
city: Canton
country: United States
facility: Local Institution - 005-196
state: Ohio
city: Cincinnati
country: United States
facility: USOR - Oncology Hematology Care - Blue Ash
state: Ohio
city: Columbus
country: United States
facility: Local Institution - 005-181
state: Ohio
city: Massillon
country: United States
facility: Tricounty Hematology and Oncology - Massillon
state: Ohio
city: Toledo
country: United States
facility: Local Institution - 005-103
state: Ohio
city: Oklahoma City
country: United States
facility: Local Institution - 005-088
state: Oklahoma
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Portland
country: United States
facility: Local Institution - 005-073
state: Oregon
city: Horsham
country: United States
facility: USOR - Alliance Cancer Specialists - Horsham (Abington Hematology Oncology Associates)
state: Pennsylvania
city: Philadelphia
country: United States
facility: Local Institution - 005-186
state: Pennsylvania
city: Dickson
country: United States
facility: Local Institution - 005-137A
state: Tennessee
city: Dickson
country: United States
facility: Local Institution - 005-137B
state: Tennessee
city: Dickson
country: United States
facility: Local Institution - 005-137C
state: Tennessee
city: Dickson
country: United States
facility: Local Institution - 005-137D
state: Tennessee
city: Dickson
country: United States
facility: Local Institution - 005-137E
state: Tennessee
city: Dickson
country: United States
facility: Local Institution - 005-137F
state: Tennessee
city: Dickson
country: United States
facility: Local Institution - 005-137G
state: Tennessee
city: Dickson
country: United States
facility: Local Institution - 005-137H
state: Tennessee
city: Dickson
country: United States
facility: Local Institution - 005-137I
state: Tennessee
city: Dickson
country: United States
facility: Local Institution - 005-137J
state: Tennessee
city: Dickson
country: United States
facility: Local Institution - 005-137K
state: Tennessee
city: Dickson
country: United States
facility: Local Institution - 005-137L
state: Tennessee
city: Hendersonville
country: United States
facility: Local Institution - 005-137M
state: Tennessee
city: Memphis
country: United States
facility: Local Institution - 005-195
state: Tennessee
city: Nashville
country: United States
facility: Local Institution - 005-137
state: Tennessee
city: Austin
country: United States
facility: Local Institution - 005-134
state: Texas
city: Beaumont
country: United States
facility: Local Institution - 005-075
state: Texas
city: Dallas
country: United States
facility: Local Institution - 005-128
state: Texas
city: Dallas
country: United States
facility: Local Institution - 005-129
state: Texas
city: Dallas
country: United States
facility: Local Institution - 005-126
state: Texas
city: Denison
country: United States
facility: USOR - Texas Oncology Northeast Texas - Denison
state: Texas
city: Denton
country: United States
facility: Local Institution - 005-124
state: Texas
city: Fort Worth
country: United States
facility: The Center for Cancer & Blood Disorders - Fort Worth
state: Texas
city: Houston
country: United States
facility: Oncology Consultants - Texas Medical Center
state: Texas
city: Houston
country: United States
facility: Local Institution - 005-076
state: Texas
city: Houston
country: United States
facility: Millennium Research and Clinical Development
state: Texas
city: Irving
country: United States
facility: USOR - US Oncology Investigational Products Center
state: Texas
city: McKinney
country: United States
facility: Local Institution - 005-125
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology - San Antonio Medical Center
state: Texas
city: Sugar Land
country: United States
facility: USOR - Texas Oncology - Sugar Land
state: Texas
city: Tyler
country: United States
facility: USOR - Texas Oncology Northeast Texas - Cancer and Research Institute - Tyler
state: Texas
city: Charlottesville
country: United States
facility: Local Institution - 005-144
state: Virginia
city: Fredericksburg
country: United States
facility: Hematology Oncology Associates of Fredericksburg
state: Virginia
city: Richmond
country: United States
facility: Virginia Cancer Institute - West End
state: Virginia
city: Bellevue
country: United States
facility: Overlake Medical Center and Clinics
state: Washington
city: Everett
country: United States
facility: Local Institution - 005-082
state: Washington
city: Seattle
country: United States
facility: Local Institution - 005-111
state: Washington
city: Spokane
country: United States
facility: Local Institution - 005-187
state: Washington
city: Tacoma
country: United States
facility: Local Institution - 005-081
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties - Tacoma
state: Washington
city: Vancouver
country: United States
facility: Local Institution - 005-136
state: Washington
city: Appleton
country: United States
facility: ThedaCare Regional Cancer Center
state: Wisconsin
city: Madison
country: United States
facility: Local Institution - 005-116
state: Wisconsin
city: Milwaukee
country: United States
facility: Froedtert Hospital
state: Wisconsin
city: Brasschaat
country: Belgium
facility: Local Institution - 005-201
city: Charleroi
country: Belgium
facility: Local Institution - 005-200
city: Edegem
country: Belgium
facility: Local Institution - 005-206
city: Gent
country: Belgium
facility: Local Institution - 005-202
city: Gent
country: Belgium
facility: Local Institution - 005-207
city: Roeselare
country: Belgium
facility: Local Institution - 005-205
city: Ronse
country: Belgium
facility: Local Institution - 005-204
city: Yvoir
country: Belgium
facility: Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne
city: Calgary
country: Canada
facility: Local Institution - 005-259
state: Alberta
city: Moncton
country: Canada
facility: Local Institution - 005-250
state: New Brunswick
city: Saint John
country: Canada
facility: Saint John Regional Hospital
state: New Brunswick
city: Hamilton
country: Canada
facility: Local Institution - 005-252
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 005-251
state: Ontario
city: Windsor
country: Canada
facility: Local Institution - 005-257
state: Ontario
city: Montreal
country: Canada
facility: Local Institution - 005-255
state: Quebec
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre
state: Saskatchewan
city: Quebec
country: Canada
facility: Local Institution - 005-258
city: Brest
country: France
facility: Local Institution - 005-307
city: Bron
country: France
facility: Local Institution - 005-310
city: Creteil
country: France
facility: Local Institution - 005-311
city: Dijon cedex
country: France
facility: Local Institution - 005-303
city: Le Mans Cedex 9
country: France
facility: Local Institution - 005-309
city: Limoges cedex
country: France
facility: Local Institution - 005-308
city: Lyon
country: France
facility: Local Institution - 005-317
city: Marseille
country: France
facility: Local Institution - 005-301
city: Marseille
country: France
facility: Local Institution - 005-312
city: Montpellier Cedex 5
country: France
facility: Local Institution - 005-313
city: Mulhouse
country: France
facility: Local Institution - 005-306
city: Paris
country: France
facility: Local Institution - 005-302
city: Rouen cedex
country: France
facility: Local Institution - 005-314
city: Saint Herblain
country: France
facility: Local Institution - 005-316
city: Strasbourg
country: France
facility: Local Institution - 005-305
city: Villejuif
country: France
facility: Local Institution - 005-304
city: Bad Berka
country: Germany
facility: Local Institution - 005-400
city: Berlin
country: Germany
facility: Local Institution - 005-418
city: Bonn
country: Germany
facility: Local Institution - 005-401
city: Essen
country: Germany
facility: Local Institution - 005-419
city: Esslingen
country: Germany
facility: Local Institution - 005-406
city: Gauting
country: Germany
facility: Local Institution - 005-403
city: Grohansdorf
country: Germany
facility: Local Institution - 005-417
city: Halle
country: Germany
facility: Local Institution - 005-408
city: Immenstadt
country: Germany
facility: Local Institution - 005-411
city: Kassel
country: Germany
facility: Local Institution - 005-416
city: Koln
country: Germany
facility: Local Institution - 005-412
city: Lowenstein
country: Germany
facility: Local Institution - 005-410
city: Lubeck
country: Germany
facility: Local Institution - 005-405
city: Mainz
country: Germany
facility: Local Institution - 005-414
city: Munchen
country: Germany
facility: Local Institution - 005-413
city: Munchen
country: Germany
facility: Local Institution - 005-402
city: Budapest
country: Hungary
facility: Local Institution - 005-454
city: Budapest
country: Hungary
facility: Local Institution - 005-457
city: Budapest
country: Hungary
facility: Local Institution - 005-455
city: Farkasgyepu
country: Hungary
facility: Local Institution - 005-453
city: Gyor
country: Hungary
facility: Local Institution - 005-452
city: Szombathely
country: Hungary
facility: Local Institution - 005-451
city: Tatabanya
country: Hungary
facility: Local Institution - 005-450
city: Torokbalint
country: Hungary
facility: Local Institution - 005-456
city: Afula
country: Israel
facility: Local Institution - 005-500
city: Beer Sheva
country: Israel
facility: Local Institution - 005-504
city: Beer Yaakov
country: Israel
facility: Local Institution - 005-501
city: Holon
country: Israel
facility: Local Institution - 005-502
city: Jerusalem
country: Israel
facility: Local Institution - 005-507
city: Ramat Gan
country: Israel
facility: Local Institution - 005-506
city: Zsfat
country: Israel
facility: Local Institution - 005-505
city: Alessandria
country: Italy
facility: Local Institution - 005-612
city: Bari
country: Italy
facility: Local Institution - 005-602
city: Catania
country: Italy
facility: Local Institution - 005-603
city: Cremona
country: Italy
facility: Local Institution - 005-611
city: Lecce
country: Italy
facility: Local Institution - 005-608
city: Meldola
country: Italy
facility: Local Institution - 005-610
city: Milan
country: Italy
facility: Local Institution - 005-606
city: Monza
country: Italy
facility: Local Institution - 005-605
city: Napoli
country: Italy
facility: Local Institution - 005-604
city: Parma
country: Italy
facility: Local Institution - 005-600
city: Piacenza
country: Italy
facility: Local Institution - 005-607
city: Pisa
country: Italy
facility: Local Institution - 005-609
city: Roma
country: Italy
facility: Local Institution - 005-614
city: Varese
country: Italy
facility: Ospedale di Circolo e Fondazione Macchi
city: Amsterdam
country: Netherlands
facility: Local Institution - 005-703
city: Amsterdam
country: Netherlands
facility: Local Institution - 005-711
city: Breda
country: Netherlands
facility: Local Institution - 005-707
city: Den Haag
country: Netherlands
facility: Local Institution - 005-709
city: Dordrecht
country: Netherlands
facility: Local Institution - 005-713
city: Groningen
country: Netherlands
facility: Local Institution - 005-702
city: Maastricht
country: Netherlands
facility: Local Institution - 005-712
city: Nijmegen
country: Netherlands
facility: Local Institution - 005-714
city: Rotterdam
country: Netherlands
facility: Local Institution - 005-710
city: Rotterdam
country: Netherlands
facility: Local Institution - 005-705
city: s-Hertogenbosch
country: Netherlands
facility: Local Institution - 005-700
city: Utrecht
country: Netherlands
facility: Local Institution - 005-701
city: Utrecht
country: Netherlands
facility: Local Institution - 005-708
city: Zwolle
country: Netherlands
facility: Local Institution - 005-706
city: A Coruna
country: Spain
facility: Local Institution - 005-807
city: Badalona
country: Spain
facility: Local Institution - 005-800
city: Barcelona
country: Spain
facility: Local Institution - 005-822
city: Barcelona
country: Spain
facility: Local Institution - 005-811
city: Barcelona
country: Spain
facility: Local Institution - 005-810
city: Jaen
country: Spain
facility: Local Institution - 005-805
city: Las Palmas de Gran Canaria
country: Spain
facility: Local Institution - 005-816
city: Leon
country: Spain
facility: Local Institution - 005-817
city: Lugo
country: Spain
facility: Local Institution - 005-812
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Local Institution - 005-808
city: Madrid
country: Spain
facility: Local Institution - 005-819
city: Madrid
country: Spain
facility: Local Institution - 005-821
city: Madrid
country: Spain
facility: Local Institution - 005-813
city: Madrid
country: Spain
facility: Local Institution - 005-815
city: Madrid
country: Spain
facility: Local Institution - 005-809
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Majadahonda
country: Spain
facility: Local Institution - 005-806
city: Malaga
country: Spain
facility: Local Institution - 005-801
city: Oviedo
country: Spain
facility: Local Institution - 005-803
city: Santiago de Compostela
country: Spain
facility: Local Institution - 005-823
city: Valencia
country: Spain
facility: IVO - Fundacion Instituto Valenciano de Oncologia
city: Valencia
country: Spain
facility: Local Institution - 005-804
city: Vigo
country: Spain
facility: Local Institution - 005-818
city: Bern
country: Switzerland
facility: Inselspital Universitatsspital Bern
city: Geneve
country: Switzerland
facility: Hopitaux Universitaires de Geneve
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois Lausanne
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
city: Cardiff
country: United Kingdom
facility: Velindre University NHS Trust
city: Cornwall
country: United Kingdom
facility: Local Institution - 005-904
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
city: London
country: United Kingdom
facility: Local Institution - 005-908
city: London
country: United Kingdom
facility: Local Institution - 005-900
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Middlesex
country: United Kingdom
facility: Local Institution - 005-903
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: