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Brief Title: A Study of Tilsotolimod in Combo With Ipilimumab vs Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma
Official Title: A Randomized Phase 3 Comparison of IMO-2125 With Ipilimumab Versus Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma (ILLUMINATE-301)
Study ID: NCT03445533
Brief Summary: A Phase 3 comparison of ipilimumab with and without IMO-2125 in advanced melanoma
Detailed Description: A Phase 3 global, multi-center, open-label comparison of ipilimumab with and without intratumoral IMO-2125 in subjects with advanced melanoma who had confirmed disease progression while on anti-PD-1
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham (UAB), Birmingham, Alabama, United States
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
Cancer Treatment Centers of America (CTCA) - Western Regional Medical Center, Scottsdale, Arizona, United States
University of Southern California, Los Angeles, California, United States
University of California, Los Angeles (UCLA), Los Angeles, California, United States
Sutter Health Sacramento, Sacramento, California, United States
University of California, San Diego (UCSD) - Moores Cancer Center, San Diego, California, United States
Stanford Cancer Center, Stanford, California, United States
Mount Sinai Medical Center of Florida, Inc., Miami Beach, Florida, United States
University of Florida Health Cancer Center - Orlando Health, Orlando, Florida, United States
The Valley Hospital, Ridgewood, New Jersey, United States
University of Cincinnati Health, Cincinnati, Ohio, United States
The Cleveland Clinic Foundation, Cleveland, Ohio, United States
The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James), Columbus, Ohio, United States
MD Anderson Cancer Center, Houston, Texas, United States
Inova Health Care Services, Falls Church, Virginia, United States
Greenslopes Private Hospital, Greenslopes, Queensland, Australia
Icon Cancer Center, South Brisbane, Queensland, Australia
Gold Coast University Hospital, Southport, Queensland, Australia
Queen Elizabeth Hospital, Woodville South, South Australia, Australia
University Hospital Geelong, Geelong, Victoria, Australia
Fiona Stanley Hospital, Murdoch, Western Australia, Australia
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Alberta Health Services Cross Cancer Institute, Edmonton, Alberta, Canada
Princess Margaret Hopsital, Toronto, Ontario, Canada
Fakultni nemocnice Olomouc - Oncology clinic, Olomouc, , Czechia
Dermatovenerologika Klinika, Praha, , Czechia
Vseobecna fakultni nemocnice v Praze, Praha, , Czechia
CHU - Clermont Ferrand, Clermont-Ferrand, Cedex, France
CHRU Besançon - Jean Minjoz, Rouen, Cedex, France
CHU Amiens Picardie - Hopital Sud, Amiens, , France
CHU Dijon - Hôpital Mitterrand, Dijon, , France
CHU de Grenoble, La Tronche, , France
CHRU de Lille - Hôpital Claude Huriez, Lille, , France
Centre Leon Berard, Lyon Cedex 08, , France
CHU de Marseille - Hopital de la Timone, Marseille, , France
Hopital Saint Louis, Paris, , France
Centre Hospitalier Lyon Sud, Pierre-Bénite, , France
CHU Hopitaux de Rouen, Rouen, , France
Institut Gustave Roussy, Villejuif, , France
Klinikum Augsburg, Augsburg, , Germany
Charite Universitaetsmedizin Berlin, Berlin, , Germany
Elbe Kliniken, Buxtehude, , Germany
Medizinische Hochschule Hannover - Klinik for Dermatologie, Allergologie und Venerologie, Hannöver, , Germany
Universitaetsklinikum Heidelberg Universitaets-Hautklinik, Heidelberg, , Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz, Mainz, , Germany
Universitatsklinikum Regensburg, Regensburg, , Germany
Universität Tübingen, Tübingen, , Germany
Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie, Universität Würzburg, Würzburg, , Germany
Azienda Ospedale Policlinico di Bari, Bari, , Italy
Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari, Bari, , Italy
ASST degli Spedali Civili di Brescia, Brescia, , Italy
IRCCS Azienda Ospedaliera Universitaria San Martino IST, Genova, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, , Italy
Istituto Europeo di Oncologia, Milano, , Italy
Azienda Ospedaliero-Universitaria di Modena, Modena, , Italy
Istituto Nazionale di Tumori IRCCS "Fondazione Sen. G. Pascale", Napoli, , Italy
Istituto Oncologico Veneto-I.R.C.C.S., Padova, , Italy
Azienda Ospedaliero Universitaria Pisana, Pisa, , Italy
Fondazione Policlinico Universitario A. Gemelli - Universita Cattolica del Sacro Cuore, Rome, , Italy
Azienda Ospedaliero Universitaria Senese, Siena, , Italy
Universita di Torino, Torino, , Italy
Leids Universitair Medisch Centrum, Leiden, , Netherlands
Universitair Medisch Centrum Utrecht, Utrecht, , Netherlands
Hospital Universitario A Coruna, A Coruña, , Spain
Hospital Germans Trias i Pujol, Badalona, , Spain
Hospital Universitari Quiron Dexeus Barcelona, Barcelona, , Spain
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Hospital Clinic Barcelona, Barcelona, , Spain
Onkologikoa, Donostia, , Spain
Hospital General Universitario Gregorio Maranon, Madrid, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
Consorci Hospital General Universitari de Valencia, Valencia, , Spain
Skånes Universitetssjukhus i Lund, Lund, , Sweden
Karolinska Universitetssjukhuset, Solna, , Sweden
Centrallasarettet i Växjö, Växjö, , Sweden
Bristol Haematology and Oncology Centre, Bristol, , United Kingdom
Guy's Hospital, London, , United Kingdom
Royal Marsden Foundation Trust, London, , United Kingdom
Name: Idera Medical Director
Affiliation: Idera Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR