A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma
NCT ID: NCT01511913
Last Updated: 2021-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1411 participants
OBSERVATIONAL
2012-06-03
2019-12-12
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Ipilimumab treatment cohort of 1106 prospective participants
No interventions assigned to this group
Non-Ipilimumab treatment cohort of 305 prospective participants
No interventions assigned to this group
Retrospective cohort of 177 participants
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age of 18 years or older at time of entry into the study
* Patients who have initiated treatment for unresectable or metastatic melanoma at medical practice (e.g. community-based, office-based, hospital-based, academic setting)within 21 days before informed consent for this study OR in the case where treatment has not yet been initiated, documentation that the treatment strategy was determined before informed consent for this study, and treatment must be initiated within 28 days after informed consent
* Ipilimumab-treated patients must be receiving treatment for the indication(s) approved in their country of residence or where they are receiving treatment
Exclusion Criteria
* Current use of therapy to treat a primary cancer other than melanoma
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Gilbert, Arizona, United States
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Hot Springs, Arkansas, United States
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Encinitas, California, United States
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La Jolla, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Denver, Colorado, United States
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Washington D.C., District of Columbia, United States
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Lakeland, Florida, United States
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Miami Beach, Florida, United States
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Orange Park, Florida, United States
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Chicago, Illinois, United States
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Niles, Illinois, United States
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Detroit, Michigan, United States
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Hattiesburg, Mississippi, United States
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Lincoln, Nebraska, United States
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Morristown, New Jersey, United States
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Canton, Ohio, United States
Mid Ohio Onc/Hem, Inc
Columbus, Ohio, United States
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Columbus, Ohio, United States
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Middletown, Ohio, United States
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Portland, Oregon, United States
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Knoxville, Tennessee, United States
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Everett, Washington, United States
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CABA, , Argentina
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CABA, , Argentina
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CABA, , Argentina
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Córdoba, , Argentina
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Rosario- Santa Fe, , Argentina
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San Miguel de Tucumán, , Argentina
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Canberra, Australian Capital Territory, Australia
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Corrimal, New South Wales, Australia
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Lismore, New South Wales, Australia
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Port Macquarie, New South Wales, Australia
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Tamworth, New South Wales, Australia
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Tweeds Head, New South Wales, Australia
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Wagga Wagga, New South Wales, Australia
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Waratah, New South Wales, Australia
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Cairns, Queensland, Australia
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Douglas, Queensland, Australia
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Greenslopes, Queensland, Australia
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Adelaide, South Australia, Australia
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Bedford Park, South Australia, Australia
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Kurralta Park, South Australia, Australia
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Frankston, Victoria, Australia
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Malvern, Victoria, Australia
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Feldkirch, , Austria
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Graz, , Austria
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Linz, , Austria
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Salzburg, , Austria
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Sankt Pölten, , Austria
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Vienna, , Austria
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Brasschaat, , Belgium
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Brussels, , Belgium
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Edegem, , Belgium
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Haint Saint Paul, , Belgium
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Hasselt, , Belgium
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Kortrijk, , Belgium
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Leuven, , Belgium
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Moncton, New Brunswick, Canada
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London, Ontario, Canada
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Mississauga, Ontario, Canada
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Windsor, Ontario, Canada
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Québec, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Québec, , Canada
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Bayonne, , France
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Besançon, , France
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Boulogne, , France
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Boulogne-sur-Mer, , France
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Brest, , France
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Clermont Ferrand Cédex 1, , France
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Dijon, , France
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Grenoble Cédex, , France
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Lille, , France
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Limoges, , France
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Montauban, , France
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Mougins, , France
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Nouvelle Caledonie, , France
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Paris, , France
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Pierre-Bénite, , France
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Quimper, , France
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Soissons, , France
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Strasbourg, , France
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Vandœuvre-lès-Nancy, , France
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Augsburg, , Germany
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Bochum, , Germany
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Buxtehude, , Germany
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Chemnitz, , Germany
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Darmstadt, , Germany
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Dessau-Roblau, , Germany
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Dortmund, , Germany
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Dresden, , Germany
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Düsseldorf, , Germany
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Frankfurt, , Germany
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Gera, , Germany
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Halle, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Jena, , Germany
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Koblenz, , Germany
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Lüdenscheid, , Germany
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Magdeburg, , Germany
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Mainz, , Germany
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Mannheim, , Germany
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Marburg, , Germany
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Münster, , Germany
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Plauen, , Germany
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Quedlinburg, , Germany
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Recklinghausen, , Germany
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Rostock, , Germany
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Schwäbisch Hall, , Germany
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Stuttgart, , Germany
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Tübingen, , Germany
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Würzburg, , Germany
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Cholargós, Athens, Greece
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Goudi, Athens, Greece
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Neo Faliro, Athens, Greece
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Heraklion, Crete, Greece
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Neas Efkarpia, Thessaloniki, Greece
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Alexandroupoli, , Greece
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Athens, , Greece
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Athens, , Greece
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Mezourlo, , Greece
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Neo Faliro, , Greece
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Wilton, CORK, Ireland
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Cork, , Ireland
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Dublin, , Ireland
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Galway, , Ireland
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Tullamore, , Ireland
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Haifa, , Israel
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Tel Aviv, , Israel
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Tel Litwinsky, , Israel
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Bydgoszcz, , Poland
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Lodz, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Barcelona, , Spain
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Donostia / San Sebastian, , Spain
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Las Palmas de Gran Canaria, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Palma, , Spain
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Palma de Mallorca, , Spain
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Pamplona, , Spain
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Santa Cruz de Tenerife, , Spain
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Santa Cruz de Tenerife, , Spain
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Santander, , Spain
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Santiago de Compostela; A Coruña, , Spain
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Seville, , Spain
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Terrassa, , Spain
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Valladolid, , Spain
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Zaragoza, , Spain
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Baden, , Switzerland
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Lugano, , Switzerland
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Zurich, , Switzerland
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Zurich, , Switzerland
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Rhyl, Denbigshire, United Kingdom
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London, England, United Kingdom
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Chelmsford, Essex, Essex, United Kingdom
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Southend, Essex, United Kingdom
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Belfast, Ireland, United Kingdom
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Cardiff, South Glamorgan, United Kingdom
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Birmingham, , United Kingdom
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Bristol, , United Kingdom
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Exeter, , United Kingdom
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Hull, , United Kingdom
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Leeds, , United Kingdom
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Lincoln, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Metropolitan Borough of Wirral, , United Kingdom
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Oxfordshire, , United Kingdom
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Plymouth, , United Kingdom
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Poole, , United Kingdom
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Preston, , United Kingdom
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Staffordshire, , United Kingdom
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Taunton, Somerset, , United Kingdom
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Truro, Cornwall, , United Kingdom
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Wolverhampton, , United Kingdom
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Yeovil, Somerset, , United Kingdom
Countries
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References
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Dalle S, Mortier L, Corrie P, Lotem M, Board R, Arance AM, Meiss F, Terheyden P, Gutzmer R, Buysse B, Oh K, Brokaw J, Le TK, Mathias SD, Scotto J, Lord-Bessen J, Moshyk A, Kotapati S, Middleton MR. Long-term real-world experience with ipilimumab and non-ipilimumab therapies in advanced melanoma: the IMAGE study. BMC Cancer. 2021 May 29;21(1):642. doi: 10.1186/s12885-021-08032-y.
Middleton MR, Dalle S, Claveau J, Mut P, Hallmeyer S, Plantin P, Highley M, Kotapati S, Le TK, Brokaw J, Abernethy AP. Real-world treatment practice in patients with advanced melanoma in the era before ipilimumab: results from the IMAGE study. Cancer Med. 2016 Jul;5(7):1436-43. doi: 10.1002/cam4.717. Epub 2016 Apr 26.
Related Links
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BMS Clinical Trials Disclosure
Investigator Inquiry form
FDA Safety Alerts and Recalls
BMS clinical trial educational resource
Other Identifiers
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ENCEPP/SDPP/2723
Identifier Type: OTHER
Identifier Source: secondary_id
CA184-143
Identifier Type: -
Identifier Source: org_study_id