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Brief Title: Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma
Official Title: A Randomized Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Treatment With OncoVEX^GM-CSF Compared to Subcutaneously Administered GM-CSF in Melanoma Patients With Unresectable Stage IIIb, IIIc and IV Disease
Study ID: NCT00769704
Brief Summary: The objective of this study is to evaluate the efficacy and safety of treatment with talimogene laherparepvec compared to subcutaneously administered GM-CSF in patients with unresectable Stage IIIb, IIIc and Stage IV melanoma. The efficacy endpoints of the study aim to demonstrate overall clinical benefit for patients treated with talimogene laherparepvec as compared to GM-CSF.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Arizona Cancer Center, Tucson, Arizona, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
University of California San Diego, Moores Cancer Center, La Jolla, California, United States
UCLA Medical Center, Los Angeles, California, United States
San Francisco Oncology Associates, San Francisco, California, United States
Northern California Melanoma Center, St. Mary's Medical Center, San Francisco, California, United States
John Wayne Cancer Institute, Santa Monica, California, United States
Redwood Regional Medical Group Inc, North Bay Melanoma Program, Sebastopol, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
Baptist Cancer Institute, Jacksonville, Florida, United States
Lakeland Regional Cancer Center, Lakeland, Florida, United States
Mount Sinai Medical Center CCOP, Miami Beach, Florida, United States
University of Miami, Miami, Florida, United States
MD Anderson Cancer Center Orlando, Orlando, Florida, United States
H. Lee Moffitt Cancer Center, Tampa, Florida, United States
Palm Beach Cancer Institute, West Palm Beach, Florida, United States
Emory University, Atlanta, Georgia, United States
Rush University Medical Center, Chicago, Illinois, United States
Cancer Care Center at Lutheran General Hospital, Park Ridge, Illinois, United States
Indiana University, Indianapolis, Indiana, United States
Investigative Clinical Research of Indiana, Indianapolis, Indiana, United States
University of Iowa Hospitals & Clinics, Iowa City, Iowa, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
James Graham Brown Cancer Center, Louisville, Kentucky, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Hubert H Humphrey Cancer Center, Robbinsdale, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
Kansas City Cancer Center, Kansas City, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
St. Louis University Hospital, St. Louis, Missouri, United States
Methodist Estabrook Cancer Center, Omaha, Nebraska, United States
Mountainside Hospital, Morristown, New Jersey, United States
New Mexico Cancer Care Alliance, Albuquerque, New Mexico, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Columbia Medical University, New York, New York, United States
Mount Sinai School of Medicine, New York, New York, United States
University of North Carolina At Chapel Hill School of Medicine, Chapel Hill, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Wake Forest University School of Medicine, Winston Salem, North Carolina, United States
Gabrail Cancer Center, Canton, Ohio, United States
Barrett Cancer Center, Cincinnati, Ohio, United States
Cleveland Clinic Foundation, Taussig Cancer Center, Cleveland, Ohio, United States
Earle A Chiles Research Institute, Providence Cancer Center, Portland, Oregon, United States
St Luke's Hospital & Health Network, Bethlehem, Pennsylvania, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Rhode Island Hospital, Providence, Rhode Island, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Institute for Translational Oncology Research, Greenville, South Carolina, United States
Vanderbilt Ingram Cancer Center, Nashville, Tennessee, United States
Texas Cancer Center, Abilene, Abilene, Texas, United States
Mary Crowley Medical Research Center, Dallas, Texas, United States
University of Texas - MD Anderson, Houston, Texas, United States
Texas Oncology, Allison Cancer Center, Midland, Texas, United States
Intermountain Medical Center, Murray, Utah, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Oncology and Hematology Associates of Southwest Virginia, Inc., Salem, Virginia, United States
Aurora/St. Luke's Medical Center, Milwaukee, Wisconsin, United States
Cross Cancer Institute, Edmonton, Alberta, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Jewish General Hospital, Montreal, Quebec, Canada
GVI Oncology, Port Elizabeth, Eastern Cape, South Africa
Dr. Fourie & Bonnet, Bloemfontein, Free State, South Africa
Medical Oncology Centre of Rosebank, Johannesburg, Gauteng, South Africa
Wits Donald Gordon Clinical Trial Site, Parktown, Guateng, South Africa
University of Pretoria, Pretoria, Guateng, South Africa
Mary Potter Oncology Centre, Pretoria, Guateng, South Africa
Hopelands Cancer Centre, Pietermaritzburg, Kwa-Zulu Natal, South Africa
Wilgers Oncology Center, Hatfield, Pretoria, South Africa
GVI Onocology Clinical Trials Unit, Cape Town, Western Cape, South Africa
GVI Oncology Centre, Cape Town, Western Cape, South Africa
University of Birmingham, Birmingham, , United Kingdom
Addenbrookes Hospital, Cambridge, , United Kingdom
Broomfield Hospital, Chelmsford, , United Kingdom
St. James's University Hospital, Leeds, , United Kingdom
Leicester Royal Infirmary, Leicester, , United Kingdom
Royal Free Hospital, London, , United Kingdom
St. George's University of London, London, , United Kingdom
Royal Marsden Hospital, London, , United Kingdom
Freeman Hospital, Newcastle upon Tyne, , United Kingdom
Nottingham City Hospital, Nottingham, , United Kingdom
Churchill Hospital, Oxford, , United Kingdom
Southampton General Hospital, Southampton, , United Kingdom
Clatterbridge Centre for Oncology, Wirral, , United Kingdom
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR