Advanced Cutaneous Melanoma Clinical Trial
— IMAGEOfficial title:
A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma
| Verified date | December 2021 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Completed |
| Enrollment | 1411 |
| Est. completion date | December 12, 2019 |
| Est. primary completion date | March 30, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Local Institution | Caba | |
| Argentina | Local Institution | Caba | |
| Argentina | Local Institution | Caba | |
| Argentina | Local Institution | Cordoba | |
| Argentina | Local Institution | Rosario- Santa Fe | |
| Argentina | Local Institution | Tucuman | |
| Australia | Local Institution | Adelaide | South Australia |
| Australia | Local Institution | Bedford Park | South Australia |
| Australia | Local Institution | Cairns | Queensland |
| Australia | Local Institution | Canberra | Australian Capital Territory |
| Australia | Local Institution | Corrimal | New South Wales |
| Australia | Local Institution | Douglas | Queensland |
| Australia | Local Institution | Frankston | Victoria |
| Australia | Local Institution | Greenslopes | Queensland |
| Australia | Local Institution | Kurralta Park | South Australia |
| Australia | Local Institution | Lismore | New South Wales |
| Australia | Local Institution | Malvern | Victoria |
| Australia | Local Institution | Port Macquarie | New South Wales |
| Australia | Local Institution | Tamworth | New South Wales |
| Australia | Local Institution | Tweeds Head | New South Wales |
| Australia | Local Institution | Wagga Wagga | New South Wales |
| Australia | Local Institution | Waratah | New South Wales |
| Austria | Local Institution | Feldkirch | |
| Austria | Local Institution | Graz | |
| Austria | Local Institution | Linz | |
| Austria | Local Institution | Salzburg | |
| Austria | Local Institution | St Poelten | |
| Austria | Local Institution | Vienna | |
| Belgium | Local Institution | Brasschaat | |
| Belgium | Local Institution | Brussels | |
| Belgium | Local Institution | Edegem | |
| Belgium | Local Institution | Haint Saint Paul | |
| Belgium | Local Institution | Hasselt | |
| Belgium | Local Institution | Kortrijk | |
| Belgium | Local Institution | Leuven | |
| Canada | Local Institution | London | Ontario |
| Canada | Local Institution | Mississauga | Ontario |
| Canada | Local Institution | Moncton | New Brunswick |
| Canada | Local Institution | Quebec | |
| Canada | Local Institution | Québec | |
| Canada | Local Institution | Saskatoon | Saskatchewan |
| Canada | Local Institution | Windsor | Ontario |
| France | Local Institution | Bayonne | |
| France | Local Institution | Besancon | |
| France | Local Institution | Boulogne | |
| France | Local Institution | Boulogne sur Mer | |
| France | Local Institution | Brest Cedex | |
| France | Local Institution | Clermont Ferrand Cédex 1 | |
| France | Local Institution | Dijon | |
| France | Local Institution | Grenoble Cédex | |
| France | Local Institution | Lille Cedex | |
| France | Local Institution | Limoges Cedex | |
| France | Local Institution | Montauban | |
| France | Local Institution | Mougins | |
| France | Local Institution | Nouvelle Caledonie | |
| France | Local Institution | Paris Cedex 10 | |
| France | Local Institution | Pierre Bénite | |
| France | Local Institution | Quimper | |
| France | Local Institution | Quimper Cedex | |
| France | Local Institution | Soissons cedex | |
| France | Local Institution | Strasbourg Cedex | |
| France | Local Institution | Vandoeuvre Les Nancy | |
| Germany | Local Institution | Augsburg | |
| Germany | Local Institution | Bochum | |
| Germany | Local Institution | Buxtehude | |
| Germany | Local Institution | Chemnitz | |
| Germany | Local Institution | Darmstadt | |
| Germany | Local Institution | Dessau-Roblau | |
| Germany | Local Institution | Dortmund | |
| Germany | Local Institution | Dresden | |
| Germany | Local Institution | Düsseldorf | |
| Germany | Local Institution | Frankfurt | |
| Germany | Local Institution | Gera | |
| Germany | Local Institution | Halle/Saale | |
| Germany | Local Institution | Hamburg | |
| Germany | Local Institution | Hamburg | |
| Germany | Local Institution | Hamburg | |
| Germany | Local Institution | Hannover | |
| Germany | Local Institution | Jena | |
| Germany | Local Institution | Koblenz | |
| Germany | Local Institution | Lüdenscheid | |
| Germany | Local Institution | Magdeburg | |
| Germany | Local Institution | Mainz | |
| Germany | Local Institution | Mannheim | |
| Germany | Local Institution | Marburg | |
| Germany | Local Institution | Münster | |
| Germany | Local Institution | Plauen | |
| Germany | Local Institution | Quedlinburg | |
| Germany | Local Institution | Recklinghausen | |
| Germany | Local Institution | Rostock | |
| Germany | Local Institution | Schwäbisch Hall | |
| Germany | Local Institution | Stuttgart | |
| Germany | Local Institution | Tübingen | |
| Germany | Local Institution | Würzburg | |
| Greece | Local Institutio | Alexandroupolis | |
| Greece | Local Institution | Athens | |
| Greece | Local Institution | Athens | |
| Greece | Local Institution | Cholargos | Athens |
| Greece | Local institution | Goudi | Athens |
| Greece | Local Institution | Heraklion | Crete |
| Greece | Local Institution | Mezourlo | |
| Greece | Local Institution | Neas Efkarpia | Thessaloniki |
| Greece | Local Institution | Neo Faliro | |
| Greece | Local Institution | Neo Faliro | Athens |
| Ireland | Local Institution | Cork | |
| Ireland | Local Institution | Dublin | |
| Ireland | Local Institution | Galway | |
| Ireland | Local Institution | Tullamore | |
| Ireland | Local Institution | Wilton | Cork |
| Israel | Local Institution | Haifa | |
| Israel | Local Institution | Tel Aviv | |
| Israel | Local Institution | Tel Hashomer | |
| Poland | Local Institution | Bydgoszcz | |
| Poland | Local Institution | Lódz | |
| Poland | Local Institution | Warszawa | |
| Poland | Local Institution | Wroclaw | |
| Spain | Local Institution | Barcelona | |
| Spain | Local Institution | Donostia | |
| Spain | Local Institution | Las Palmas de Gran Canaria | |
| Spain | Local Institution | Madrid | |
| Spain | Local Institution | Madrid | |
| Spain | Local Institution | Madrid | |
| Spain | Local Institution | Madrid | |
| Spain | Local Institution | Palma | |
| Spain | Local Institution | Palma de Mallorca | |
| Spain | Local Institution | Pamplona | |
| Spain | Local Institution | Santa Cruz de Tenerife | |
| Spain | Local Institution | Santander | |
| Spain | Local Institution | Santiago De Compostela; A Coruña | |
| Spain | Local Institution | Sevilla | |
| Spain | Local Institution | Sta Cruz de Tenerife | |
| Spain | Local Institution | Terrassa | |
| Spain | Local Institution | Valladolid | |
| Spain | Local Institution | Zaragoza | |
| Switzerland | Local Institution | Baden | |
| Switzerland | Local Institution | Lugano | |
| Switzerland | Local Institution | Zurich | |
| Switzerland | Local Institution | Zürich | |
| United Kingdom | Local Institution | Belfast | Ireland |
| United Kingdom | Local Institution | Birmingham | |
| United Kingdom | Local Institution | Bristol | |
| United Kingdom | Local Institution | Cardiff | South Glamorgan |
| United Kingdom | Local Institution | Chelmsford, Essex | Essex |
| United Kingdom | Local Institution | Exeter | |
| United Kingdom | Local Institution | Hull | |
| United Kingdom | Local Institution | Leeds | |
| United Kingdom | Local Institution | Lincoln | |
| United Kingdom | Local Institution | London | |
| United Kingdom | Local Institution | London | |
| United Kingdom | Local Institution | London | |
| United Kingdom | Local Institution | London | England |
| United Kingdom | Local Institution | Oxfordshire | |
| United Kingdom | Local Institution | Plymouth | |
| United Kingdom | Local Institution | Poole | |
| United Kingdom | Local Institution | Preston | |
| United Kingdom | Local Institution | Rhyl | Denbigshire |
| United Kingdom | Local Institution | Southend | Essex |
| United Kingdom | Local Institution | Staffordshire | |
| United Kingdom | Local Institution | Taunton, Somerset | |
| United Kingdom | Local Institution | Truro, Cornwall | |
| United Kingdom | Local Institution | Wirral | |
| United Kingdom | Local Institution | Wolverhampton | |
| United Kingdom | Local Institution | Yeovil, Somerset | |
| United States | Local Institution | Canton | Ohio |
| United States | Local Institution | Chicago | Illinois |
| United States | Local Institution | Columbus | Ohio |
| United States | Mid Ohio Onc/Hem, Inc | Columbus | Ohio |
| United States | Local Institution | Denver | Colorado |
| United States | Local Institution | Detroit | Michigan |
| United States | Local Institution | Encinitas | California |
| United States | Local Institution | Everett | Washington |
| United States | Local Institution | Gilbert | Arizona |
| United States | Local Institution | Hattiesburg | Mississippi |
| United States | Local Institution | Hot Springs | Arkansas |
| United States | Local Institution | Knoxville | Tennessee |
| United States | Local Institution | La Jolla | California |
| United States | Local Institution | Lakeland | Florida |
| United States | Local Institution | Lincoln | Nebraska |
| United States | Local Institution | Long Beach | California |
| United States | Local Institution | Los Angeles | California |
| United States | Local Institution | Miami Beach | Florida |
| United States | Local Institution | Middletown | Ohio |
| United States | Local Institution | Morristown | New Jersey |
| United States | Local Institution | Niles | Illinois |
| United States | Local Institution | Orange Park | Florida |
| United States | Local Institution | Portland | Oregon |
| United States | Local Institution | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Argentina, Australia, Austria, Belgium, Canada, France, Germany, Greece, Ireland, Israel, Poland, Spain, Switzerland, United Kingdom,
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-i — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence and severity of adverse reactions in patients treated with Ipilimumab in the post-approval setting | Every 12 months up to 5 years | ||
| Primary | Incidence rate with person-year-exposure and frequency estimate of adverse events/serious adverse events | Every 12 months up to 5 years | ||
| Primary | Frequency at which immunosuppressive therapy was administered to patients to manage treatment-related adverse events associated with Ipilimumab | Every 12 months up to 5 years | ||
| Primary | Patterns of disease monitoring as observed in a real-world setting | To evaluate patterns of care, descriptive statistics will describe treatment, dosing, regimen, indication, treatment rationales, management of treatment-related adverse events, reasons for treatment termination | Every 12 months up to 5 years | |
| Secondary | Quality of life (QoL), impact on work productivity, and overall satisfaction among patients receiving any therapy for unresectable or metastatic melanoma | Every 12 months up to 5 years | ||
| Secondary | Resource utilization associated with advanced melanoma treatment | Descriptive statistics will be reported for healthcare utilization (inpatient, outpatient, emergency department and other ancillary services) and imputed costs | Every 12 months up to 5 years | |
| Secondary | Overall survival (OS) in patients receiving Ipilimumab or other therapies for unresectable or metastatic melanoma | Every 12 months up to 5 years |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT05050006 -
ITIL-168 in Advanced Melanoma
|
Phase 2 |