Spots Global Cancer Trial Database for Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009)
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Trial Identification
Brief Title: Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009)
Official Title: A Phase 2, Randomized, Open-label Three-arm Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) That Have Progressed After Platinum Therapy and Immunotherapy (PD-1/PD-L1 Inhibitors) (LEAP-009)
Study ID: NCT04428151
Conditions
Study Description
Brief Summary: This study is designed to assess the safety and efficacy of lenvatinib in combination with pembrolizumab versus standard of care (SOC) chemotherapy, and to also assess the safety and efficacy of lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and a programmed cell death protein 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) inhibitor. The primary hypothesis is that lenvatinib + pembrolizumab is superior to SOC chemotherapy with respect to ORR per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope ( Site 1519), Duarte, California, United States
UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1568), Los Angeles, California, United States
Yale-New Haven Hospital-Yale Cancer Center ( Site 1505), New Haven, Connecticut, United States
Georgetown University Medical Center ( Site 1520), Washington, District of Columbia, United States
UF Health ( Site 1554), Gainesville, Florida, United States
Mid Florida Hematology and Oncology Center ( Site 1606), Orange City, Florida, United States
Cleveland Clinic Florida ( Site 1596), Weston, Florida, United States
Georgia Cancer Center at Augusta University ( Site 1575), Augusta, Georgia, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1521), Marietta, Georgia, United States
Memorial Health University Medical Center ( Site 1626), Savannah, Georgia, United States
Beacon Cancer Care ( Site 1599), Post Falls, Idaho, United States
Rush University Medical Center ( Site 1560), Chicago, Illinois, United States
NorthShore University HealthSystem - Evanston Hospital ( Site 1614), Evanston, Illinois, United States
IU Health Ball Memorial Hospital, Inc.-IU Health Ball Memorial Cancer Center ( Site 1612), Muncie, Indiana, United States
University of Iowa ( Site 1572), Iowa City, Iowa, United States
University of Kansas Cancer Center ( Site 1538), Westwood, Kansas, United States
Norton Hospital-Norton Cancer Institute - Downtown ( Site 1601), Louisville, Kentucky, United States
Mercy Health-Paducah Medical Oncology and Hematology ( Site 1623), Paducah, Kentucky, United States
Our Lady of the Lake RMC-Clinical Research ( Site 1624), Baton Rouge, Louisiana, United States
Mary Bird Perkins Cancer Center Baton Rouge ( Site 1622), Baton Rouge, Louisiana, United States
University of Maryland Greenebaum Cancer Center ( Site 1522), Baltimore, Maryland, United States
Boston Medical Center ( Site 1605), Boston, Massachusetts, United States
University of Massachusetts Chan Medical School ( Site 1616), Worcester, Massachusetts, United States
VA Ann Arbor Healthcare System ( Site 1584), Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute ( Site 1566), Detroit, Michigan, United States
Henry Ford Health System ( Site 1544), Detroit, Michigan, United States
Hattiesburg Clinic ( Site 1515), Hattiesburg, Mississippi, United States
Jackson Oncology Associates, PLLC-Clinical Trials ( Site 1625), Jackson, Mississippi, United States
Washington University School of Medicine ( Site 1500), Saint Louis, Missouri, United States
St. Vincent Frontier Cancer Center ( Site 1507), Billings, Montana, United States
University Of Nebraska Medical Center ( Site 1570), Omaha, Nebraska, United States
Oncology Hematology West P.C. dba Nebraska Cancer Specialists ( Site 1627), Omaha, Nebraska, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 1555), Hackensack, New Jersey, United States
Rutgers Cancer Institute of New Jersey ( Site 1523), New Brunswick, New Jersey, United States
Perlmutter Cancer Center at Winthrop Oncology Hematology Associates NYU Langone Health ( Site 1597), Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center ( Site 1582), New York, New York, United States
Levine Cancer Institute ( Site 1590), Charlotte, North Carolina, United States
Duke Cancer Institute ( Site 1541), Durham, North Carolina, United States
University of Cincinnati Medical Center ( Site 1567), Cincinnati, Ohio, United States
University Hospital Cleveland ( Site 1578), Cleveland, Ohio, United States
Cleveland Clinic Main ( Site 1598), Cleveland, Ohio, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C, Columbus, Ohio, United States
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1508), Tulsa, Oklahoma, United States
Gettysburg Cancer Center ( Site 1594), Gettysburg, Pennsylvania, United States
Penn State Hershey Medical Center ( Site 1561), Hershey, Pennsylvania, United States
Fox Chase Cancer Center ( Site 1502), Philadelphia, Pennsylvania, United States
Medical University of South Carolina ( Site 1579), Charleston, South Carolina, United States
St Francis Cancer Center-Research Office ( Site 1607), Greenville, South Carolina, United States
The Center For Cancer And Blood Disorders ( Site 1569), Fort Worth, Texas, United States
Utah Cancer Specialists ( Site 1621), Salt Lake City, Utah, United States
Huntsman Cancer Institute ( Site 1532), Salt Lake City, Utah, United States
Inova Schar Cancer Institute ( Site 1550), Fairfax, Virginia, United States
Hematology Oncology Associates of Fredericksburg ( Site 1537), Fredericksburg, Virginia, United States
MultiCare Health System-MultiCare Oncology - Puget Sound ( Site 1609), Tacoma, Washington, United States
Medical College of Wisconsin Clinical Cancer Center ( Site 1574), Milwaukee, Wisconsin, United States
Blacktown Hospital ( Site 0101), Blacktown, New South Wales, Australia
Mid North Coast Cancer Institute ( Site 0109), Port Macquarie, New South Wales, Australia
The Townsville Hospital ( Site 0107), Douglas, Queensland, Australia
Gallipoli Medical Research Ltd-GMRF CTU ( Site 0105), Greenslopes, Queensland, Australia
Royal Adelaide Hospital ( Site 0110), Adelaide, South Australia, Australia
Monash Health ( Site 0102), Clayton, Victoria, Australia
Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0806), Porto Alegre, Rio Grande Do Sul, Brazil
A. C. Camargo Cancer Center ( Site 0809), Sao Paulo, , Brazil
Tom Baker Cancer Centre ( Site 0304), Calgary, Alberta, Canada
BC Cancer-Vancouver Center ( Site 0306), Vancouver, British Columbia, Canada
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0307), Hamilton, Ontario, Canada
Sunnybrook Research Institute ( Site 0308), Toronto, Ontario, Canada
Instituto de Cancerología ( Site 0408), Medellin, Antioquia, Colombia
Sociedad De Oncologia Y Hematologia Del Cesar ( Site 0404), Valledupar, Cesar, Colombia
Oncomédica S.A.S ( Site 0409), Montería, Cordoba, Colombia
Administradora Country S.A.S - Clínica del Country ( Site 0407), Bogotá, Cundinamarca, Colombia
Rigshospitalet University Hospital Copenhagen ( Site 1000), Copenhagen, Hovedstaden, Denmark
Hopital La Timone ( Site 0503), Marseille, Bouches-du-Rhone, France
Centre de Cancerologie du Grand Montpellier ( Site 0508), Montpellier, Herault, France
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne-ONCOLOGY ( Site 0510), Clermont-Ferrand, Puy-de-Dome, France
Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen ( Site 0509), Rouen, Seine-Maritime, France
Institut Gustave Roussy ( Site 0505), Villejuif, Val-de-Marne, France
Institut Curie ( Site 0500), Paris, , France
Soroka Medical Center-Oncology ( Site 0604), Be'er Sheva, , Israel
Rambam Health Care Campus-Oncology Division ( Site 0602), Haifa, , Israel
Hadassah Medical Center. Ein Kerem ( Site 0601), Jerusalem, , Israel
Chaim Sheba Medical Center ( Site 0600), Ramat Gan, , Israel
Seoul National University Bundang Hospital ( Site 1801), Seongnam, Kyonggi-do, Korea, Republic of
Ajou University Hospital ( Site 1802), Suwon, Kyonggi-do, Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 1800), Seoul, , Korea, Republic of
Samsung Medical Center ( Site 1803), Seoul, , Korea, Republic of
Oslo universitetssykehus, Radiumhospitalet ( Site 1102), Oslo, , Norway
Centro Hospitalar Vila Nova de Gaia. Espinho EPE ( Site 1401), Vila Nova de Gaia, Porto, Portugal
Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 1400), Porto, , Portugal
Spitalul Clinic Colțea ( Site 1708), București, Bucuresti, Romania
Cardiomed SRL Cluj-Napoca ( Site 1701), Cluj Napoca, Cluj, Romania
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1702), Cluj Napoca, Cluj, Romania
S.C. Radiotherapy Center Cluj S.R.L ( Site 1706), Floresti, Cluj, Romania
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1704), Craiova, Dolj, Romania
Cabinet Medical Oncomed ( Site 1707), Timișoara, Timis, Romania
S.C.Focus Lab Plus S.R.L ( Site 1703), Bucuresti, , Romania
Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 0700), Hospitalet de Llobregat, Barcelona, Spain
HOSPITAL CLÍNIC DE BARCELONA ( Site 0707), Barcelona, Cataluna, Spain
Centro Oncologico de Galicia ( Site 0706), A Coruna, Galicia, Spain
Hospital General de Valencia ( Site 0703), Valencia, Valenciana, Comunitat, Spain
Hospital Universitari Vall d Hebron ( Site 0701), Barcelona, , Spain
Hospital Ramon y Cajal ( Site 0705), Madrid, , Spain
Hospital Virgen de la Victoria ( Site 0702), Malaga, , Spain
Chang Gung Memorial Hospital - Linkou Branch ( Site 1203), Taoyuan County, Taoyuan, Taiwan
Chang Gung Medical Foundation - Kaohsiung ( Site 1204), Kaohsiung, , Taiwan
China Medical University Hospital ( Site 1205), Taichung, , Taiwan
Taichung Veterans General Hospital ( Site 1206), Taichung, , Taiwan
National Cheng Kung University Hospital ( Site 1202), Tainan, , Taiwan
National Taiwan University Hospital ( Site 1200), Taipei, , Taiwan
Taipei Veterans General Hospital ( Site 1201), Taipei, , Taiwan
Aberdeen Royal Infirmary ( Site 0911), Aberdeen, Aberdeen City, United Kingdom
Castle Hill Hospital ( Site 0910), Cottingham, East Riding Of Yorkshire, United Kingdom
The Beatson West of Scotland Cancer Centre ( Site 0909), Glasgow, Glasgow City, United Kingdom
Guy s and St Thomas Hospital NHS Foundation Trust ( Site 0903), London, Great Britain, United Kingdom
University Hospital Southampton NHS Foundation Trust ( Site 0905), Southampton, Hampshire, United Kingdom
Royal Marsden Hospital ( Site 0902), London, London, City Of, United Kingdom
Charing Cross Hospital ( Site 0908), London, London, City Of, United Kingdom
Musgrove Park Hospital ( Site 0904), Taunton, Somerset, United Kingdom
Royal Marsden Hospital. ( Site 0901), Sutton, Surrey, United Kingdom
The Christie NHS Foundation Trust ( Site 0907), Manchester, , United Kingdom
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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