Spots Global Cancer Trial Database for Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
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Trial Identification
Brief Title: 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 ID: NCT03906071
Study Description
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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Alabama Oncology - Grandview, Birmingham, Alabama, United States
Clearview Cancer Institute, Huntsville, Alabama, United States
Palo Verde Cancer Specialists - Glendale, Glendale, Arizona, United States
The Oncology Institute of Hope and Innovation - Tucson, Tucson, Arizona, United States
Yuma Regional Medical Center, Yuma, Arizona, United States
NEA Baptist Fowler Family Center for Cancer Care, Jonesboro, Arkansas, United States
Saint Bernards Medical Center, Jonesboro, Arkansas, United States
Highlands Oncology Group - Springdale, Springdale, Arkansas, United States
Comprehensive Blood and Cancer Center - Bakersfield, Bakersfield, California, United States
Beverly Hills Cancer Center, Beverly Hills, California, United States
The Oncology Institute of Hope and Innovation - Corona, Corona, California, United States
Saint Joseph Heritage Healthcare - Virginia K. Crosson Cancer Center, Fullerton, California, United States
Pacific Shores Medical Group, Long Beach, California, United States
Cancer and Blood Specialty Clinic, Los Alamitos, California, United States
Los Angeles Hematology Oncology Medical Group, Los Angeles, California, United States
University of California Los Angeles - Jonsson Comprehensive Cancer Center, Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States
Redlands Hematology Oncology, Redlands, California, United States
University of California San Francisco, San Francisco, California, United States
California Cancer Associates for Research and Excellence - San Marcos, San Marcos, California, United States
The Oncology Institute of Hope and Innovation - Thousand Oaks, Thousand Oaks, California, United States
Torrance Memorial Physician Network - Cancer Care and Infusion Center, Torrance, California, United States
Brian J. LeBerthon M.D., West Covina, California, United States
The Oncology Institute of Hope and Innovation - Whittier, Whittier, California, United States
Sisters of Charity of Leavenworth Health St. Mary's, Grand Junction, Colorado, United States
Good Samaritan Medical Center, Lafayette, Colorado, United States
Eastern Connecticut Hematology and Oncology Associates, Norwich, Connecticut, United States
Michael and Dianne Bienes Comprehensive Cancer Center, Fort Lauderdale, Florida, United States
Florida Cancer Specialists & Research Institute, Fort Myers, Florida, United States
Memorial Regional Hospital, Hollywood, Florida, United States
Watson Clinic Cancer & Research Center, Lakeland, Florida, United States
Mount Sinai Medical Center, Miami Beach, Florida, United States
Florida Cancer Affiliates - Ocala - Main, Ocala, Florida, United States
Cancer Institute of Florida - Orlando, Orlando, Florida, United States
BRCR Medical Center Inc, Plantation, Florida, United States
SCRI - Florida Cancer Specialists - North Region Research Office, Sarasota, Florida, United States
SCRI - Florida Cancer Specialists - Panhandle Research Office, Tallahassee, Florida, United States
SCRI - Florida Cancer Specialists - West Palm Beach, West Palm Beach, Florida, United States
University Cancer and Blood Center - LLC - Athens, Athens, Georgia, United States
Piedmont Cancer Institute, Atlanta, Georgia, United States
John B. Amos Cancer Center Research, Columbus, Georgia, United States
Northwest Georgia Oncology Centers - Marietta, Marietta, Georgia, United States
Straub Medical Center, Honolulu, Hawaii, United States
Beacon Cancer Care, Coeur d'Alene, Idaho, United States
Evanston Hospital, Evanston, Illinois, United States
Illinois Cancer Specialists - Niles, Niles, Illinois, United States
Orchard Healthcare Research Inc., Skokie, Illinois, United States
Fort Wayne Medical Oncology and Hematology - Fort Wayne South Office, Fort Wayne, Indiana, United States
Goshen Center for Cancer Care, Goshen, Indiana, United States
Franciscan Health Indianapolis, Indianapolis, Indiana, United States
Indiana University Health Arnett Cancer Care, Lafayette, Indiana, United States
The Richard and Annette Bloch Cancer Care Pavilion and Westwood Medical Pavilion, Westwood, Kansas, United States
Cancer Center of Kansas, Wichita, Kansas, United States
Commonwealth Cancer Center, Danville, Kentucky, United States
Norton Cancer Institute - Broadway, Louisville, Kentucky, United States
Pontchartrain Cancer Center - Covington Office, Covington, Louisiana, United States
New England Cancer Specialists, Scarborough, Maine, United States
Maryland Oncology Hematology - Rockville Aquilino Cancer Center, Rockville, Maryland, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Henry Ford Hospital, Detroit, Michigan, United States
Park Nicollet - Frauenshuh Cancer Center, Saint Louis Park, Minnesota, United States
Jackson Oncology Associates, Jackson, Mississippi, United States
Central Care Cancer Center - Bolivar, Bolivar, Missouri, United States
Kansas City Care Health Center - Research Medical Campus, Kansas City, Missouri, United States
St. Vincent Frontier Cancer Center, Billings, Montana, United States
Methodist Hospital - Omaha, Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada, Henderson, Nevada, United States
Summit Medical Group - Florham Park Campus, Florham Park, New Jersey, United States
Regional Cancer Care Associates - Little Silver, Little Silver, New Jersey, United States
Broome Oncology, Johnson City, New York, United States
Monter Cancer Center, Lake Success, New York, United States
New York Cancer & Blood Specialists, Port Jefferson Station, New York, United States
Stony Brook University Cancer Center, Stony Brook, New York, United States
Mercy Hematology & Oncology Associates, Canton, Ohio, United States
Oncology Hematology Care - Blue Ash, Cincinnati, Ohio, United States
The Ohio State University College of Medicine, Columbus, Ohio, United States
Tricounty Hematology and Oncology- Massillon, Massillon, Ohio, United States
Toledo Clinic Cancer Center, Toledo, Ohio, United States
Mercy Clinic Oncology and Hematology - Coletta, Oklahoma City, Oklahoma, United States
Providence Cancer Institute Franz Clinic, Portland, Oregon, United States
Oregon Health and Science University Knight Cancer Institute, Portland, Oregon, United States
USOR - Consultants in Medical Oncology and Hematology PC - Abington Hematology/Oncology Associates, Horsham, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Baptist Cancer Center - Memphis, Memphis, Tennessee, United States
SCRI - Tennessee Oncology - Nashville - Centennial, Nashville, Tennessee, United States
Texas Oncology - South Austin, Austin, Texas, United States
Texas Oncology - Beaumont Mamie Mcfaddin Ward Cancer Center, Beaumont, Texas, United States
Texas Oncology - Methodist Dallas Cancer Center, Dallas, Texas, United States
Texas Oncology - Dallas Presbyterian Hospital, Dallas, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Texas Oncology - Denton South, Denton, Texas, United States
The Center for Cancer & Blood Disorders - Fort Worth, Fort Worth, Texas, United States
Texas Oncology - Houston Willowbrook, Houston, Texas, United States
Millennium Physicians - North Houston, Houston, Texas, United States
Texas Oncology - McKinney, McKinney, Texas, United States
Texas Oncology - San Antonio, San Antonio, Texas, United States
Texas Oncology - Sherman, Sherman, Texas, United States
Texas Oncology - Sugar Land, Sugar Land, Texas, United States
Texas Oncology - Tyler, Tyler, Texas, United States
University of Virginia Cancer Center, Charlottesville, Virginia, United States
Hematology Oncology Associates of Fredericksburg, Fredericksburg, Virginia, United States
Virginia Cancer Institute - Reynolds Crossing, Richmond, Virginia, United States
Providence Regional Center Partnership, Everett, Washington, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Cancer Care Northwest - North Spokane, Spokane, Washington, United States
MultiCare Institute for Research & Innovation, Tacoma, Washington, United States
Northwest Medical Specialties, PLLC, Tacoma, Washington, United States
Northwest Cancer Specialists, Vancouver, Washington, United States
ThedaCare Regional Cancer Center, Appleton, Wisconsin, United States
University Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States
Froedtert Hospital - Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Algemeen Ziekenhuis Klina, Brasschaat, Antwerp, Belgium
Algemeen Ziekenhuis Glorieux Ronse, Ronse, East Flanders, Belgium
Grand Hôpital de Charleroi - Notre Dame, Charleroi, Henegouwen, Belgium
Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne, Yvoir, Namur, Belgium
Algemeen Ziekenhuis Maria Middelares, Gent, Oost-Vlaaderen, Belgium
Algemeen Ziekenhuis Delta, Roeselare, West-Vlaanderen, Belgium
Universitair Ziekenhuis Antwerpen, Edegem, , Belgium
Universitair Ziekenhuis Gent, Gent, , Belgium
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Horizon Health Network - The Moncton Hospital, Moncton, New Brunswick, Canada
Saint John Regional Hospital, Saint John, New Brunswick, Canada
Juravinski Cancer Centre, Hamilton, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Windsor Regional Hospital Cancer Program, Windsor, Ontario, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec-Universite Laval, Québec, , Canada
Saskatoon Cancer Center, Saskatoon, , Canada
Hôpital Morvan, Brest, , France
Hôpital Louis Pradel, Bron, , France
Centre Hospitalier Intercommunal de Créteil, Créteil, , France
Centre Georges François Leclerc, Dijon Cedex, , France
Centre Hospitalier Le Mans, Le Mans Cedex 9, , France
Centre Hospitalier Universitaire Limoges, Limoges Cedex, , France
Centre Léon Bérard, Lyon, , France
Hôpital Nord de Marseille, Marseille cedex 20, , France
Institut Paoli-Calmettes, Marseille, , France
Institut Régional du Cancer de Montpellier - Val d'Aurelle, Montpellier, , France
Hôpital Bichat-Claude-Bernard, Paris Cedex 18, , France
Rouen University Hôpital Charles-Nicolle, Rouen, , France
Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec, Saint-Herblain, , France
Institut de Cancérologie Strasbourg Europe, Strasbourg, , France
Institut Gustave Roussy, Villejuif Cedex, , France
Klinik Löwenstein gGmbH, Heilbronn, Baden-Württemberg, Germany
Klinikverbund Kempten-Oberallgäu - Klinik Immenstadt - Klinikverbund Allgäu gGmbH, Immenstadt, Bayern, Germany
LungenClinic Grosshansdorf GmbH, Großhansdorf, Schleswig-Holstein, Germany
Evangelische Lungenklinik Berlin, Berlin, , Germany
Universitätsklinikum Bonn, Bonn, , Germany
KEM. Evang.Kliniken Essen-Mitte gGmbh, Essen, , Germany
Asklepios Fachkliniken München-Gauting, Gauting, , Germany
Martha-Maria Krankenhaus Halle-Dölau gGmbH, Studiensekretariat, Halle, , Germany
Klinikum Kassel, Kassel, , Germany
Kliniken der Stadt Köln, Köln, , Germany
Universitatsklinikum Schleswig-Holstein-Campus Lubeck, Lübeck, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz - III. Medizinischen Klinik und Poliklinik, Mainz, , Germany
Klinikum rechts der Isar der Technischen Universität München, München, , Germany
Munchen Klinik Bogenhausen, München, , Germany
Petz Aladár Megyei Oktató Kórház, Győr, Gyor-Moson-Sopron, Hungary
Szent Borbála Kórház, Tatabánya, Komárom-Esztergom, Hungary
Intézeti Gyógyszertár, Szombathely, Vas, Hungary
Semmelweis Egyetem - Pulmonológiai Klinika, Budapest, , Hungary
Országos Korányi Tbc És Pulmonológiai Intézet, Budapest, , Hungary
Országos Onkológiai Intézet, Budapest, , Hungary
Törökbálinti Tüdőgyógyintézet, Törökbálint, , Hungary
Emek Medical Center, Afula, , Israel
Soroka Medical Center, Be'er Sheva, , Israel
Shamir Medical Center (Assaf Harofeh), Be'er Ya'aqov, , Israel
Shaare Zedek Medical Center, Jerusalem, , Israel
Chaim Sheba Medical Center, Ramat Gan, , Israel
Ziv Medical Center, Safed, , Israel
The Edith Wolfson Medical Center, Tel Aviv, , Israel
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Forlì-Cesena, Italy
Istituto Europeo di Oncologia, Milano, Lombardia, Italy
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli, Naples, Italy
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo, Alessandria, , Italy
IRCCS Istituto Tumori "Giovanni Paolo II", Bari, , Italy
Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco", Catania, , Italy
Ospedale di Cremona, Cremona, , Italy
ASL Lecce - Ospedale Vito Fazzi, Lecce, , Italy
S.C Oncologia Medica, ASST Monza - Ospedale San Gerardo, Monza, , Italy
Azienda Ospedaliero-Universitaria di Parma, Parma, , Italy
Ospedale Guglielmo da Saliceto, Piacenza, , Italy
Azienda Ospedaliero - Universitaria Pisana, Pisa, , Italy
Istituto Nazionale Tumori Regina Elena, Roma, , Italy
ASST-SETTE LAGHI, Ospedale di Circolo e Fondazione Macchi, Varese, , Italy
Maastricht Universitair Medisch Centrum, Maastricht, Limburg, Netherlands
The Netherlands Cancer Institute, Amsterdam, Noord-Holland, Netherlands
Jeroen Bosch Ziekenhuis, s-Hertogenbosch, North Brabant, Netherlands
Isala, Zwolle, Overijssel, Netherlands
Franciscus Vlietland & Gasthuis, Schiedam, South Holland, Netherlands
Ziekenhuis Nieuwegein, Nieuwegein, Utrecht, Netherlands
Hagaziekenhuis Van Den Haag - Leyweg, Den Haag, Zuid-Holland, Netherlands
Erasmus Medisch Centrum, Rotterdam, Zuid-Holland, Netherlands
Amsterdam Universitair Medische Centra - Vrije Universiteit Medisch Centrum, Amsterdam, , Netherlands
Amphia Ziekenhuis - Breda Molengracht, Breda, , Netherlands
Albert Schweitzer Ziekenhuis, Dordrecht, , Netherlands
Martini Ziekenhuis, Groningen, , Netherlands
Radboud University Medical Center, Nijmegen, , Netherlands
UMC Utrecht, Utrecht, , Netherlands
Hospital Clínico Universitario de Santiago de Compostela, Santiago De Compostela, A Coruña, Spain
Institut Català d'Oncologia Badalona, Hospital Universitari Germans Trias i Puj, Badalona, Barcelona, Spain
Complejo Hospitalario Universitario A Coruña, A Coruña, La Coruña, Spain
Hospital Universitario Puerta de Hierro - Majadahonda, Majadahonda, Madrid, Spain
Hospital Regional Universitario de Málaga - Hospital Civil, Málaga, Malaga, Spain
Hospital del Mar - Parc de Salut Mar, Barcelona, , Spain
Hospital Universitari Dexeus, Barcelona, , Spain
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Complejo Hospitalario de Jaén, Jaén, , Spain
Hospital Universitario Insular de Gran Canaria, Las Palmas De Gran Canaria, , Spain
Hospital de León, León, , Spain
Hospital Universitario Lucus Augusti, Lugo, , Spain
Complejo Hospitalario Ruber Juan Bravo, Madrid, , Spain
Hospital Universitario La Princesa, Madrid, , Spain
Clinica Universidad de Navarra - Madrid, Madrid, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Universitario Central de Asturias, Oviedo, , Spain
Fundacion Instituto Valenciano de Oncologia, Valencia, , Spain
Hospital Universitari i Politècnic La Fe, Valencia, , Spain
Hospital Alvaro Cunqueiro - Clinico Universitario Vigo, Vigo, , Spain
HUG: hopitaux universitaires de genève, Genève, , Switzerland
Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland
Kantonsspital Winterthur, Winterthur, , Switzerland
Royal Cornwall Hospital NHS Trust, Truro, Cornwall, United Kingdom
The Christie NHS Foundation Trust, Withington, Manchester, United Kingdom
East and North Hertfordshire NHS Trust, Northwood, Middlesex, United Kingdom
Velindre University NHS Trust, Cardiff, , United Kingdom
University Hospitals of Leicester NHS Trust, Leicester, , United Kingdom
Barts Health NHS Trust, London, , United Kingdom
Royal Free London NHS Foundation Trust, London, , United Kingdom
The Royal Marsden NHS Foundation Trust, London, , United Kingdom
The Royal Marsden NHS Foundation Trust, Sutton, , United Kingdom
Contact Details
Name: Ronald L. Shazer, MD, MBA
Affiliation: Mirati Therapeutics Inc.
Role: STUDY_DIRECTOR
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