Spots Global Cancer Trial Database for Phase 3 Trial of Autologous Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma
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Trial Identification
Brief Title: Phase 3 Trial of Autologous Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma
Official Title: An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT)
Study ID: NCT01582672
Study Description
Brief Summary: This is a trial of AGS-003, which is being studied as a possible treatment for Advanced Renal Cell Carcinoma. The purpose of this study is to determine whether there is an overall survival (OS) benefit between subjects treated with AGS-003 in combination with standard treatment versus subjects treated with standard treatment alone.
Detailed Description: This study will investigate the combination of an autologous ribonucleic acid (RNA) electroporated dendritic cell (DC) based immunotherapy, AGS-003, plus standard treatment (initiating with sunitinib). The primary objective in this study is to determine the median OS achieved by this combination compared to the OS resulting from use of active control (standard treatment), in a population of adults with advanced renal cell carcinoma (RCC), with nephrectomy indicated, and with remaining metastatic disease.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Scottsdale, Arizona, United States
, Little Rock, Arkansas, United States
, La Jolla, California, United States
, Los Angeles, California, United States
, Los Angeles, California, United States
, San Francisco, California, United States
, Aurora, Colorado, United States
, Colorado Springs, Colorado, United States
, Denver, Colorado, United States
, Miami, Florida, United States
, Tampa, Florida, United States
, Atlanta, Georgia, United States
, Augusta, Georgia, United States
, Marietta, Georgia, United States
, Boise, Idaho, United States
, Meridian, Idaho, United States
, Chicago, Illinois, United States
, Maywood, Illinois, United States
, Springfield, Illinois, United States
, Greenwood, Indiana, United States
, Indianapolis, Indiana, United States
, Indianapolis, Indiana, United States
, Iowa City, Iowa, United States
, Kansas City, Kansas, United States
, Wichita, Kansas, United States
, Metairie, Louisiana, United States
, New Orleans, Louisiana, United States
, New Orleans, Louisiana, United States
, Baltimore, Maryland, United States
, Baltimore, Maryland, United States
, Boston, Massachusetts, United States
, Burlington, Massachusetts, United States
, Detroit, Michigan, United States
, Detroit, Michigan, United States
, Grand Rapids, Michigan, United States
, Lansing, Michigan, United States
, Minneapolis, Minnesota, United States
, Rochester, Minnesota, United States
, Saint Louis, Missouri, United States
, Omaha, Nebraska, United States
, Omaha, Nebraska, United States
, Omaha, Nebraska, United States
, Lebanon, New Hampshire, United States
, Hackensack, New Jersey, United States
, Albuquerque, New Mexico, United States
, Albany, New York, United States
, East Syracuse, New York, United States
, New Hyde Park, New York, United States
, New York, New York, United States
, New York, New York, United States
, Stony Brook, New York, United States
, Syracuse, New York, United States
, Charlotte, North Carolina, United States
, Durham, North Carolina, United States
, Raleigh, North Carolina, United States
, Winston-Salem, North Carolina, United States
, Cincinnati, Ohio, United States
, Middletown, Ohio, United States
, Toledo, Ohio, United States
, Oklahoma City, Oklahoma, United States
, Portland, Oregon, United States
, Portland, Oregon, United States
, Springfield, Oregon, United States
, Allentown, Pennsylvania, United States
, Danville, Pennsylvania, United States
, Easton, Pennsylvania, United States
, Hershey, Pennsylvania, United States
, Philadelphia, Pennsylvania, United States
, Philadelphia, Pennsylvania, United States
, Pittsburgh, Pennsylvania, United States
, Pittsburgh, Pennsylvania, United States
, Providence, Rhode Island, United States
, Charleston, South Carolina, United States
, Greenville, South Carolina, United States
, Myrtle Beach, South Carolina, United States
, Sioux Falls, South Dakota, United States
, Nashville, Tennessee, United States
, Dallas, Texas, United States
, Houston, Texas, United States
, San Antonio, Texas, United States
, San Antonio, Texas, United States
, Salt Lake City, Utah, United States
, Charlottesville, Virginia, United States
, Virginia Beach, Virginia, United States
, Seattle, Washington, United States
, Seattle, Washington, United States
, Milwaukee, Wisconsin, United States
, Milwaukee, Wisconsin, United States
, Winnipeg, Manitoba, Canada
, Hamilton, Ontario, Canada
, London, Ontario, Canada
, Oshawa, Ontario, Canada
, Ottawa, Ontario, Canada
, Greenfield Park, Quebec, Canada
, Montreal, Quebec, Canada
, Montreal, Quebec, Canada
, Quebec, , Canada
, Hradec Kralove, , Czechia
, Liberec, , Czechia
, Olomouc, , Czechia
, Prague, , Czechia
, Praha 8, , Czechia
, Budapest, , Hungary
, Budapest, , Hungary
, Debrecen, , Hungary
, Haifa, , Israel
, Jerusalem, , Israel
, Kfar Saba, , Israel
, Rehovot, , Israel
, Tel Hashomer, , Israel
, Zerifin, , Israel
, Roma, , Italy
, Rome, , Italy
, Badalona, , Spain
, Barcelona, , Spain
, Barcelona, , Spain
, Madrid, , Spain
, Madrid, , Spain
, Madrid, , Spain
, Sevilla, , Spain
, Valencia, , Spain
, Vigo, , Spain
, Cambridge, , United Kingdom
, Norwich, , United Kingdom
, Preston, , United Kingdom
Contact Details
Name: Robert Figlin, MD, FACP
Affiliation: Cedars-Sinai Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Christopher G Wood, MD, FACP
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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