Clinical trial NCT01511913: A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma
Official title: A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Cutaneous Melanoma
Keywords: Unresectable or metastatic cutaneous melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2012-01-19
Enrollment: 1411
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients will be selected from approximately 200 medical practice sites (e.g. community-based, office-based, hospital-based, academic setting) in several European Union countries, Central America, North America, and South America, as well as Australia and Israel.

Brief summary: The purpose of this study is to examine the safety of Ipilimumab and patterns of use in the treatment of unresectable or metastatic melanoma in the post-approval setting

Detailed description: Time Perspective: this study does have a retrospective component involving a subset of patients

Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Diagnosis of unresectable or metastatic melanoma
* 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 or pending participation in a clinical trial examining therapy for the treatment of any cancer (including unresectable or metastatic melanoma)
* Current use of therapy to treat a primary cancer other than melanoma

Primary outcomes:
measure: Incidence and severity of adverse reactions in patients treated with Ipilimumab in the post-approval setting
timeFrame: Every 12 months up to 5 years
measure: Incidence rate with person-year-exposure and frequency estimate of adverse events/serious adverse events
timeFrame: Every 12 months up to 5 years
measure: Frequency at which immunosuppressive therapy was administered to patients to manage treatment-related adverse events associated with Ipilimumab
timeFrame: Every 12 months up to 5 years
measure: Patterns of disease monitoring as observed in a real-world setting
timeFrame: Every 12 months up to 5 years
Secondary outcomes:
measure: Quality of life (QoL), impact on work productivity, and overall satisfaction among patients receiving any therapy for unresectable or metastatic melanoma
timeFrame: Every 12 months up to 5 years
measure: Resource utilization associated with advanced melanoma treatment
timeFrame: Every 12 months up to 5 years
measure: Overall survival (OS) in patients receiving Ipilimumab or other therapies for unresectable or metastatic melanoma
timeFrame: Every 12 months up to 5 years
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Local Institution
state: Arizona
city: Hot Springs
country: United States
facility: Local Institution
state: Arkansas
city: Encinitas
country: United States
facility: Local Institution
state: California
city: La Jolla
country: United States
facility: Local Institution
state: California
city: Long Beach
country: United States
facility: Local Institution
state: California
city: Los Angeles
country: United States
facility: Local Institution
state: California
city: Denver
country: United States
facility: Local Institution
state: Colorado
city: Washington
country: United States
facility: Local Institution
state: District of Columbia
city: Lakeland
country: United States
facility: Local Institution
state: Florida
city: Miami Beach
country: United States
facility: Local Institution
state: Florida
city: Orange Park
country: United States
facility: Local Institution
state: Florida
city: Chicago
country: United States
facility: Local Institution
state: Illinois
city: Niles
country: United States
facility: Local Institution
state: Illinois
city: Detroit
country: United States
facility: Local Institution
state: Michigan
city: Hattiesburg
country: United States
facility: Local Institution
state: Mississippi
city: Lincoln
country: United States
facility: Local Institution
state: Nebraska
city: Morristown
country: United States
facility: Local Institution
state: New Jersey
city: Canton
country: United States
facility: Local Institution
state: Ohio
city: Columbus
country: United States
facility: Mid Ohio Onc/Hem, Inc
state: Ohio
city: Columbus
country: United States
facility: Local Institution
state: Ohio
city: Middletown
country: United States
facility: Local Institution
state: Ohio
city: Portland
country: United States
facility: Local Institution
state: Oregon
city: Knoxville
country: United States
facility: Local Institution
state: Tennessee
city: Everett
country: United States
facility: Local Institution
state: Washington
city: Caba
country: Argentina
facility: Local Institution
city: Caba
country: Argentina
facility: Local Institution
city: Caba
country: Argentina
facility: Local Institution
city: Cordoba
country: Argentina
facility: Local Institution
city: Rosario- Santa Fe
country: Argentina
facility: Local Institution
city: Tucuman
country: Argentina
facility: Local Institution
city: Canberra
country: Australia
facility: Local Institution
state: Australian Capital Territory
city: Corrimal
country: Australia
facility: Local Institution
state: New South Wales
city: Lismore
country: Australia
facility: Local Institution
state: New South Wales
city: Port Macquarie
country: Australia
facility: Local Institution
state: New South Wales
city: Tamworth
country: Australia
facility: Local Institution
state: New South Wales
city: Tweeds Head
country: Australia
facility: Local Institution
state: New South Wales
city: Wagga Wagga
country: Australia
facility: Local Institution
state: New South Wales
city: Waratah
country: Australia
facility: Local Institution
state: New South Wales
city: Cairns
country: Australia
facility: Local Institution
state: Queensland
city: Douglas
country: Australia
facility: Local Institution
state: Queensland
city: Greenslopes
country: Australia
facility: Local Institution
state: Queensland
city: Adelaide
country: Australia
facility: Local Institution
state: South Australia
city: Bedford Park
country: Australia
facility: Local Institution
state: South Australia
city: Kurralta Park
country: Australia
facility: Local Institution
state: South Australia
city: Frankston
country: Australia
facility: Local Institution
state: Victoria
city: Malvern
country: Australia
facility: Local Institution
state: Victoria
city: Feldkirch
country: Austria
facility: Local Institution
city: Graz
country: Austria
facility: Local Institution
city: Linz
country: Austria
facility: Local Institution
city: Salzburg
country: Austria
facility: Local Institution
city: St Poelten
country: Austria
facility: Local Institution
city: Vienna
country: Austria
facility: Local Institution
city: Brasschaat
country: Belgium
facility: Local Institution
city: Brussels
country: Belgium
facility: Local Institution
city: Edegem
country: Belgium
facility: Local Institution
city: Haint Saint Paul
country: Belgium
facility: Local Institution
city: Hasselt
country: Belgium
facility: Local Institution
city: Kortrijk
country: Belgium
facility: Local Institution
city: Leuven
country: Belgium
facility: Local Institution
city: Moncton
country: Canada
facility: Local Institution
state: New Brunswick
city: London
country: Canada
facility: Local Institution
state: Ontario
city: Mississauga
country: Canada
facility: Local Institution
state: Ontario
city: Windsor
country: Canada
facility: Local Institution
state: Ontario
city: Saskatoon
country: Canada
facility: Local Institution
state: Saskatchewan
city: Quebec
country: Canada
facility: Local Institution
city: Québec
country: Canada
facility: Local Institution
city: Bayonne
country: France
facility: Local Institution
city: Besancon
country: France
facility: Local Institution
city: Boulogne sur Mer
country: France
facility: Local Institution
city: Boulogne
country: France
facility: Local Institution
city: Brest Cedex
country: France
facility: Local Institution
city: Clermont Ferrand Cédex 1
country: France
facility: Local Institution
city: Dijon
country: France
facility: Local Institution
city: Grenoble Cédex
country: France
facility: Local Institution
city: Lille Cedex
country: France
facility: Local Institution
city: Limoges Cedex
country: France
facility: Local Institution
city: Montauban
country: France
facility: Local Institution
city: Mougins
country: France
facility: Local Institution
city: Nouvelle Caledonie
country: France
facility: Local Institution
city: Paris Cedex 10
country: France
facility: Local Institution
city: Pierre Bénite
country: France
facility: Local Institution
city: Quimper Cedex
country: France
facility: Local Institution
city: Quimper
country: France
facility: Local Institution
city: Soissons cedex
country: France
facility: Local Institution
city: Strasbourg Cedex
country: France
facility: Local Institution
city: Vandoeuvre Les Nancy
country: France
facility: Local Institution
city: Augsburg
country: Germany
facility: Local Institution
city: Bochum
country: Germany
facility: Local Institution
city: Buxtehude
country: Germany
facility: Local Institution
city: Chemnitz
country: Germany
facility: Local Institution
city: Darmstadt
country: Germany
facility: Local Institution
city: Dessau-Roblau
country: Germany
facility: Local Institution
city: Dortmund
country: Germany
facility: Local Institution
city: Dresden
country: Germany
facility: Local Institution
city: Düsseldorf
country: Germany
facility: Local Institution
city: Frankfurt
country: Germany
facility: Local Institution
city: Gera
country: Germany
facility: Local Institution
city: Halle/Saale
country: Germany
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Hannover
country: Germany
facility: Local Institution
city: Jena
country: Germany
facility: Local Institution
city: Koblenz
country: Germany
facility: Local Institution
city: Lüdenscheid
country: Germany
facility: Local Institution
city: Magdeburg
country: Germany
facility: Local Institution
city: Mainz
country: Germany
facility: Local Institution
city: Mannheim
country: Germany
facility: Local Institution
city: Marburg
country: Germany
facility: Local Institution
city: Münster
country: Germany
facility: Local Institution
city: Plauen
country: Germany
facility: Local Institution
city: Quedlinburg
country: Germany
facility: Local Institution
city: Recklinghausen
country: Germany
facility: Local Institution
city: Rostock
country: Germany
facility: Local Institution
city: Schwäbisch Hall
country: Germany
facility: Local Institution
city: Stuttgart
country: Germany
facility: Local Institution
city: Tübingen
country: Germany
facility: Local Institution
city: Würzburg
country: Germany
facility: Local Institution
city: Cholargos
country: Greece
facility: Local Institution
state: Athens
city: Goudi
country: Greece
facility: Local institution
state: Athens
city: Neo Faliro
country: Greece
facility: Local Institution
state: Athens
city: Heraklion
country: Greece
facility: Local Institution
state: Crete
city: Neas Efkarpia
country: Greece
facility: Local Institution
state: Thessaloniki
city: Alexandroupolis
country: Greece
facility: Local Institutio
city: Athens
country: Greece
facility: Local Institution
city: Athens
country: Greece
facility: Local Institution
city: Mezourlo
country: Greece
facility: Local Institution
city: Neo Faliro
country: Greece
facility: Local Institution
city: Wilton
country: Ireland
facility: Local Institution
state: Cork
city: Cork
country: Ireland
facility: Local Institution
city: Dublin
country: Ireland
facility: Local Institution
city: Galway
country: Ireland
facility: Local Institution
city: Tullamore
country: Ireland
facility: Local Institution
city: Haifa
country: Israel
facility: Local Institution
city: Tel Aviv
country: Israel
facility: Local Institution
city: Tel Hashomer
country: Israel
facility: Local Institution
city: Bydgoszcz
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Wrocław
country: Poland
facility: Local Institution
city: Łódź
country: Poland
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Donostia
country: Spain
facility: Local Institution
city: Las Palmas de Gran Canaria
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Palma de Mallorca
country: Spain
facility: Local Institution
city: Palma
country: Spain
facility: Local Institution
city: Pamplona
country: Spain
facility: Local Institution
city: Santa Cruz de Tenerife
country: Spain
facility: Local Institution
city: Santander
country: Spain
facility: Local Institution
city: Santiago De Compostela; A Coruña
country: Spain
facility: Local Institution
city: Sevilla
country: Spain
facility: Local Institution
city: Sta Cruz de Tenerife
country: Spain
facility: Local Institution
city: Terrassa
country: Spain
facility: Local Institution
city: Valladolid
country: Spain
facility: Local Institution
city: Zaragoza
country: Spain
facility: Local Institution
city: Baden
country: Switzerland
facility: Local Institution
city: Lugano
country: Switzerland
facility: Local Institution
city: Zurich
country: Switzerland
facility: Local Institution
city: Zürich
country: Switzerland
facility: Local Institution
city: Rhyl
country: United Kingdom
facility: Local Institution
state: Denbigshire
city: London
country: United Kingdom
facility: Local Institution
state: England
city: Chelmsford, Essex
country: United Kingdom
facility: Local Institution
state: Essex
city: Southend
country: United Kingdom
facility: Local Institution
state: Essex
city: Belfast
country: United Kingdom
facility: Local Institution
state: Ireland
city: Cardiff
country: United Kingdom
facility: Local Institution
state: South Glamorgan
city: Birmingham
country: United Kingdom
facility: Local Institution
city: Bristol
country: United Kingdom
facility: Local Institution
city: Exeter
country: United Kingdom
facility: Local Institution
city: Hull
country: United Kingdom
facility: Local Institution
city: Leeds
country: United Kingdom
facility: Local Institution
city: Lincoln
country: United Kingdom
facility: Local Institution
city: London
country: United Kingdom
facility: Local Institution
city: London
country: United Kingdom
facility: Local Institution
city: London
country: United Kingdom
facility: Local Institution
city: Oxfordshire
country: United Kingdom
facility: Local Institution
city: Plymouth
country: United Kingdom
facility: Local Institution
city: Poole
country: United Kingdom
facility: Local Institution
city: Preston
country: United Kingdom
facility: Local Institution
city: Staffordshire
country: United Kingdom
facility: Local Institution
city: Taunton, Somerset
country: United Kingdom
facility: Local Institution
city: Truro, Cornwall
country: United Kingdom
facility: Local Institution
city: Wirral
country: United Kingdom
facility: Local Institution
city: Wolverhampton
country: United Kingdom
facility: Local Institution
city: Yeovil, Somerset
country: United Kingdom
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.