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JOURNAL ONKOLOGIE – STUDIE
SAPPHIRE

Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer

Rekrutierend

NCT-Nummer:
NCT03906071

Studienbeginn:
Juli 2019

Letztes Update:
01.06.2021

Wirkstoff:
Nivolumab, Sitravatinib, Docetaxel

Indikation (Clinical Trials):
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Mirati Therapeutics Inc.

Collaborator:
Bristol-Myers Squibb

Studienleiter

Ronald L. Shazer, MD, MBA
Study Director
Mirati Therapeutics Inc.

Kontakt

Mirati Therapeutics Study Locator Services
Kontakt:
Phone: 1-844-893-5530 (toll free)
E-Mail: miratistudylocator@emergingmed.com
» Kontaktdaten anzeigen

Studienlocations
(3 von 180)

Klinik Löwenstein gGmbH
74078 Heilbronn
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Klinikverbund Kempten-Oberallgäu - Klinik Immenstadt - Klinikverbund Allgäu gGmbH
87509 Immenstadt
(Bayern)
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LungenClinic Grosshansdorf GmbH
22927 Großhansdorf
(Schleswig-Holstein)
GermanyRekrutierend» Google-Maps
Asklepios Fachkliniken München-Gauting
82131 Gauting
(Bayern)
GermanyRekrutierend» Google-Maps
Martha-Maria Krankenhaus Halle-Dölau gGmbH, Studiensekretariat
06120 Halle
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
Universitätsmedizin der Johannes Gutenberg-Universität Mainz - III. Medizinischen Klinik und Poliklinik
55131 Mainz
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
Alabama Oncology - Grandview
35243 Birmingham
United StatesRekrutierend» Google-Maps
Clearview Cancer Institute
35805 Huntsville
United StatesRekrutierend» Google-Maps
Palo Verde Cancer Specialists - Glendale
85304 Glendale
United StatesRekrutierend» Google-Maps
The Oncology Institute of Hope and Innovation - Tucson
85745 Tucson
United StatesRekrutierend» Google-Maps
Yuma Regional Medical Center
85364 Yuma
United StatesRekrutierend» Google-Maps
NEA Baptist Fowler Family Center for Cancer Care
72401 Jonesboro
United StatesRekrutierend» Google-Maps
Saint Bernards Medical Center
72401 Jonesboro
United StatesRekrutierend» Google-Maps
Highlands Oncology Group - Springdale
72762 Springdale
United StatesRekrutierend» Google-Maps
Comprehensive Blood and Cancer Center - Bakersfield
93309 Bakersfield
United StatesRekrutierend» Google-Maps
Beverly Hills Cancer Center
90211 Beverly Hills
United StatesRekrutierend» Google-Maps
The Oncology Institute of Hope and Innovation - Corona
92882 Corona
United StatesRekrutierend» Google-Maps
California Cancer Associates for Research and Excellence - Fresno Cancer Center
93720 Fresno
United StatesRekrutierend» Google-Maps
Saint Joseph Heritage Healthcare - Virginia K. Crosson Cancer Center
92835 Fullerton
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Pacific Shores Medical Group
90813 Long Beach
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Cancer and Blood Specialty Clinic
90720 Los Alamitos
United StatesRekrutierend» Google-Maps
Los Angeles Hematology Oncology Medical Group
90017 Los Angeles
United StatesRekrutierend» Google-Maps
University of California Los Angeles - Jonsson Comprehensive Cancer Center
90024 Los Angeles
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Redlands Hematology Oncology
92373 Redlands
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University of California San Francisco
94518 San Francisco
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California Cancer Associates for Research and Excellence - San Marcos
92069 San Marcos
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The Oncology Institute of Hope and Innovation - Thousand Oaks
91361 Thousand Oaks
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Torrance Memorial Physician Network - Cancer Care and Infusion Center
90505 Torrance
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Brian J. LeBerthon M.D.
91790 West Covina
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The Oncology Institute of Hope and Innovation - Whittier
90603 Whittier
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Sisters of Charity of Leavenworth Health St. Mary's
81501 Grand Junction
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Good Samaritan Medical Center
80026 Lafayette
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Eastern Connecticut Hematology and Oncology Associates
06360 Norwich
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Michael and Dianne Bienes Comprehensive Cancer Center
33308 Fort Lauderdale
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Florida Cancer Specialists & Research Institute
33901 Fort Myers
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Memorial Regional Hospital
33021 Hollywood
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Watson Clinic Cancer & Research Center
33805 Lakeland
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Mount Sinai Medical Center
33140 Miami Beach
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Florida Cancer Affiliates - Ocala - Main
34474 Ocala
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Cancer Institute of Florida - Orlando
32804 Orlando
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BRCR Medical Center Inc
33322 Plantation
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SCRI - Florida Cancer Specialists - North Region Research Office
34232 Sarasota
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SCRI - Florida Cancer Specialists - Panhandle Research Office
32308 Tallahassee
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SCRI - Florida Cancer Specialists - West Palm Beach
33401 West Palm Beach
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University Cancer and Blood Center - LLC - Athens
30607 Athens
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Piedmont Cancer Institute
30318 Atlanta
United StatesRekrutierend» Google-Maps
John B. Amos Cancer Center Research
31904 Columbus
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Northwest Georgia Oncology Centers - Marietta
30060 Marietta
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Straub Medical Center
96813 Honolulu
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Beacon Cancer Care
83814 Coeur d'Alene
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Swedish Covenant Hospital
60625 Chicago
United StatesRekrutierend» Google-Maps
Illinois Cancer Specialists - Niles
60714 Niles
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Orchard Healthcare Research Inc.
60077 Skokie
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Fort Wayne Medical Oncology and Hematology - Fort Wayne South Office
46804 Fort Wayne
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Goshen Center for Cancer Care
46526 Goshen
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Franciscan Health Indianapolis
46237 Indianapolis
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Indiana University Health Arnett Cancer Care
47904 Lafayette
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The Richard and Annette Bloch Cancer Care Pavilion and Westwood Medical Pavilion
66205 Westwood
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Cancer Center of Kansas
67214 Wichita
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Commonwealth Cancer Center
40422 Danville
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Norton Cancer Institute - Broadway
40241 Louisville
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Pontchartrain Cancer Center - Covington Office
70433 Covington
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New England Cancer Specialists
04074 Scarborough
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Maryland Oncology Hematology - Rockville Aquilino Cancer Center
20850 Rockville
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Barbara Ann Karmanos Cancer Institute
48201 Detroit
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Park Nicollet - Frauenshuh Cancer Center
55426 Saint Louis Park
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Jackson Oncology Associates
39202 Jackson
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Central Care Cancer Center - Bolivar
65613 Bolivar
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Kansas City Care Health Center - Research Medical Campus
64132 Kansas City
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St. Vincent Frontier Cancer Center
59102 Billings
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Saint Francis Cancer Treatment Center
68803 Grand Island
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Methodist Hospital - Omaha
68114 Omaha
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The Oncology Institute of Hope and Innovation - Henderson
89052 Henderson
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Comprehensive Cancer Centers of Nevada
89074 Henderson
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Summit Medical Group - Florham Park Campus
07932 Florham Park
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Regional Cancer Care Associates - Little Silver
07739 Little Silver
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Saint Barnabas Medical Center
07039 Livingston
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Monter Cancer Center
11042 Lake Success
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New York Cancer & Blood Specialists
11776 Port Jefferson Station
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Stony Brook University Cancer Center
11794 Stony Brook
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Mercy Hematology & Oncology Associates
44708 Canton
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Oncology Hematology Care - Blue Ash
45242 Cincinnati
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The Ohio State University College of Medicine
43210 Columbus
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Tricounty Hematology and Oncology- Massillon
44646 Massillon
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Toledo Clinic Cancer Center
43623 Toledo
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Mercy Clinic Oncology and Hematology - Coletta
73120 Oklahoma City
United StatesRekrutierend» Google-Maps
USOR - Consultants in Medical Oncology and Hematology PC - Abington Hematology/Oncology Associates
19044 Horsham
United StatesRekrutierend» Google-Maps
Fox Chase Cancer Center
19111 Philadelphia
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Baptist Cancer Center - Memphis
38120 Memphis
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SCRI - Tennessee Oncology - Nashville - Centennial
37203 Nashville
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Texas Oncology - South Austin
78745 Austin
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Texas Oncology - Beaumont Mamie Mcfaddin Ward Cancer Center
77702 Beaumont
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Texas Oncology - Methodist Dallas Cancer Center
75203 Dallas
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Texas Oncology - Dallas Presbyterian Hospital
75231 Dallas
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Texas Oncology - Baylor Charles A. Sammons Cancer Center
75246 Dallas
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Texas Oncology - Denton South
76210 Denton
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The Center for Cancer & Blood Disorders - Fort Worth
76104 Fort Worth
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Oncology Consultants - Texas Medical Center
77030 Houston
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Texas Oncology - Houston Willowbrook
77070 Houston
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Millennium Physicians - North Houston
77090 Houston
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Texas Oncology - McKinney
75071 McKinney
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Texas Oncology - San Antonio
78240 San Antonio
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Texas Oncology - Sherman
75090 Sherman
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Texas Oncology - Sugar Land
77479 Sugar Land
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University of Virginia Cancer Center
22908 Charlottesville
United StatesRekrutierend» Google-Maps
Hematology Oncology Associates of Fredericksburg
22408 Fredericksburg
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Virginia Cancer Institute - Reynolds Crossing
23230 Richmond
United StatesRekrutierend» Google-Maps
Seattle Cancer Care Alliance
98109 Seattle
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Cancer Care Northwest - North Spokane
99216 Spokane
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MultiCare Institute for Research & Innovation
98405 Tacoma
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Northwest Medical Specialties, PLLC
98405 Tacoma
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Northwest Cancer Specialists
98684 Vancouver
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University Wisconsin Carbone Cancer Center
53705 Madison
United StatesRekrutierend» Google-Maps
Froedtert Hospital - Medical College of Wisconsin
53226 Milwaukee
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Algemeen Ziekenhuis Glorieux Ronse
9600 Ronse
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Grand Hôpital de Charleroi - Notre Dame
6000 Charleroi
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Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne
B-5530 Yvoir
BelgiumRekrutierend» Google-Maps
Algemeen Ziekenhuis Maria Middelares
9000 Gent
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Horizon Health Network - The Moncton Hospital
E1C 6Z8 Moncton
CanadaRekrutierend» Google-Maps
Saint John Regional Hospital
E2L 4L2 Saint John
CanadaRekrutierend» Google-Maps
Princess Margaret Cancer Centre
M5G 2M9 Toronto
CanadaRekrutierend» Google-Maps
Windsor Regional Hospital Cancer Program
N8W 3X3 Windsor
CanadaRekrutierend» Google-Maps
Centre Georges François Leclerc
21079 Dijon Cedex
FranceRekrutierend» Google-Maps
Centre Hospitalier Le Mans
72037 Le Mans Cedex 9
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Centre Hospitalier Universitaire Limoges
87042 Limoges Cedex
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Hôpital Bichat-Claude-Bernard
75877 Paris Cedex 18
FranceRekrutierend» Google-Maps
Institut de Cancérologie Strasbourg Europe
67200 Strasbourg
FranceRekrutierend» Google-Maps
Institut Gustave Roussy
94802 Villejuif Cedex
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Petz Aladár Megyei Oktató Kórház
9024 Győr
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Semmelweis Egyetem - Pulmonológiai Klinika
1083 Budapest
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Országos Korányi Tbc És Pulmonológiai Intézet
1121 Budapest
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Országos Onkológiai Intézet
1122 Budapest
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Veszprém Megyei Tüdőgyógyintézet
8582 Farkasgyepű
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Törökbálinti Tüdőgyógyintézet
2045 Törökbálint
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Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
47014 Meldola
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Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
80100 Napoli
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IRCCS Istituto Tumori "Giovanni Paolo II"
70124 Bari
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Azienda Ospedaliero - Universitaria Pisana
56126 Pisa
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The Netherlands Cancer Institute
1066 CX Amsterdam
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Ziekenhuis Nieuwegein
3435 CM Nieuwegein
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Hagaziekenhuis Van Den Haag - Leyweg
2545 AA Den Haag
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Erasmus Medisch Centrum
3015 GD Rotterdam
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Institut Català d'Oncologia Badalona, Hospital Universitari Germans Trias i Puj
8916 Badalona
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Complejo Hospitalario Universitario A Coruña
15006 A Coruña
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Hospital Universitario Puerta de Hierro - Majadahonda
28222 Majadahonda
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Hospital Universitari Dexeus
08028 Barcelona
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Hospital Universitario Vall d'Hebron
8035 Barcelona
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Hospital Universitario Insular de Gran Canaria
35016 Las Palmas De Gran Canaria
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Hospital Universitario Lucus Augusti
27003 Lugo
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Complejo Hospitalario Ruber Juan Bravo
28006 Madrid
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Hospital Universitario La Princesa
28006 Madrid
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Hospital Universitario Fundación Jiménez Díaz
28040 Madrid
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Hospital Universitario 12 de Octubre
28041 Madrid
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Hospital Universitario Central de Asturias
15006 Oviedo
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Hospital Universitari i Politècnic La Fe
46026 Valencia
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HUG: hopitaux universitaires de genève
CH - 1211 Genève
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Royal Cornwall Hospital NHS Trust
TR1 3LI Truro
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Barts Health NHS Trust
EC1A 7BE London
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The Royal Marsden NHS Foundation Trust
SW3 6JJ London
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The Royal Marsden NHS Foundation Trust
SM2 5PT Sutton
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Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Overall Survival (OS) (Time Frame - 36 Months):
OS is defined as time from date of randomization to date of death due to any cause



Secondary outcome:

1. Adverse Events (AEs) (Time Frame - 36 Months):
Frequency of patients experiencing treatment-emergent AEs

2. Objective Response Rate (ORR) (Time Frame - 36 Months):
ORR defined as complete response (CR) or partial response (PR) per RECIST version 1.1 recorded from randomization until disease progression or start of new anti-cancer therapy

3. Progression-Free Survival (PFS) (Time Frame - 36 months):
PFS is defined as the time from randomization to the date of the first documentation of objective disease progression or death due to any cause

Studien-Arme

  • Experimental: Nivolumab and Sitravatinib
    Nivolumab will be administered by intravenous infusion over 30 minutes at 240 mg every 2 weeks or at 480 mg every 4 weeks. Sitravatinib capsules will be administered orally, once daily.
  • Active Comparator: Docetaxel
    Docetaxel will be administered by intravenous infusion at 75 mg/m2 over 1 hour every 3 weeks.

Geprüfte Regime

  • Nivolumab (Opdivo):
    Nivolumab is an antibody directed at the programmed death receptor-1 (PD-1), blocking its interaction with PD-L1 and PD-L2.
  • Sitravatinib (MGCD516):
    Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.
  • Docetaxel (Taxotere):
    Docetaxel is an anti-neoplastic agent that acts by disrupting the microtubular network in cells.

Quelle: ClinicalTrials.gov


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