A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma

NCT01511913 | Completed

• 2 other identifiers: CA184-143ENCEPP/SDPP/2723
• Study Type: observational
• Target: 1,411
• Locations: 14 countries
• Sites: 180

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

Conditions

Advanced Cutaneous Melanoma

Keywords

Unresectable or metastatic cutaneous melanoma

Outcome Measures

Primary Outcomes (4)

• Incidence and severity of adverse reactions in patients treated with Ipilimumab in the post-approval setting

  Every 12 months up to 5 years

• Incidence rate with person-year-exposure and frequency estimate of adverse events/serious adverse events

  Every 12 months up to 5 years

• 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

• 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 Outcomes (3)

• 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

• Resource utilization associated with advanced melanoma treatment

  Every 12 months up to 5 years

• Overall survival (OS) in patients receiving Ipilimumab or other therapies for unresectable or metastatic melanoma

  Every 12 months up to 5 years

Study Arms (3)

Ipilimumab treatment cohort of 1106 prospective participants

Non-Ipilimumab treatment cohort of 305 prospective participants

Retrospective cohort of 177 participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (186)

Local Institution

Gilbert, Arizona, 85234, United States

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Hot Springs, Arkansas, 71913, United States

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Encinitas, California, 92024, United States

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La Jolla, California, 92093, United States

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Long Beach, California, 90813, United States

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Los Angeles, California, 90025, United States

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Denver, Colorado, 80218, United States

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Washington D.C., District of Columbia, 20010, United States

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Lakeland, Florida, 33085, United States

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Miami Beach, Florida, 33140, United States

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Orange Park, Florida, 32073, United States

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Chicago, Illinois, 60612, United States

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Niles, Illinois, 60714, United States

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Detroit, Michigan, 48201, United States

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Hattiesburg, Mississippi, 39401, United States

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Lincoln, Nebraska, 18015, United States

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Morristown, New Jersey, 07960, United States

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Canton, Ohio, 44178, United States

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Mid Ohio Onc/Hem, Inc

Columbus, Ohio, 43206, United States

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Columbus, Ohio, 43219, United States

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Middletown, Ohio, 45042, United States

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Portland, Oregon, 97213, United States

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Knoxville, Tennessee, 37920, United States

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Everett, Washington, 98201, United States

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CABA, 1426, Argentina

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CABA, C1417DNT, Argentina

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CABA, C1426ANZ, Argentina

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Córdoba, X5006HBF, Argentina

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Rosario- Santa Fe, S2000KZE, Argentina

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San Miguel de Tucumán, T4000GTB, Argentina

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Canberra, Australian Capital Territory, 02605, Australia

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Corrimal, New South Wales, 02518, Australia

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Lismore, New South Wales, 02480, Australia

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Port Macquarie, New South Wales, 02444, Australia

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Tamworth, New South Wales, 02340, Australia

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Tweeds Head, New South Wales, 02485, Australia

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Wagga Wagga, New South Wales, 2650, Australia

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Waratah, New South Wales, 02298, Australia

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Cairns, Queensland, 4870, Australia

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Douglas, Queensland, 04810, Australia

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Greenslopes, Queensland, 4120, Australia

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Adelaide, South Australia, 05000, Australia

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Bedford Park, South Australia, 05042, Australia

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Kurralta Park, South Australia, 5037, Australia

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Frankston, Victoria, 03199, Australia

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Malvern, Victoria, 03144, Australia

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Feldkirch, 6800, Austria

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Graz, A-8036, Austria

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Linz, A-4020, Austria

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Salzburg, A-5020, Austria

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Sankt Pölten, A-3100, Austria

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Vienna, A-1090, Austria

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Brasschaat, 2930, Belgium

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Brussels, 1200, Belgium

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Edegem, 2650, Belgium

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Haint Saint Paul, 7100, Belgium

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Hasselt, 3500, Belgium

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Kortrijk, 8500, Belgium

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Leuven, 3000, Belgium

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Moncton, New Brunswick, E1C 6Z8, Canada

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London, Ontario, N6C 6B5, Canada

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Mississauga, Ontario, L5M 2N1, Canada

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Windsor, Ontario, N8W 2X3, Canada

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Québec, Quebec, G1V 4G2, Canada

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Saskatoon, Saskatchewan, S7N 4H4, Canada

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Québec, G1R 2J6, Canada

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Bayonne, 64100, France

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Besançon, 25000, France

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Boulogne, 92104, France

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Boulogne-sur-Mer, 62200, France

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Brest, 29609, France

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Clermont Ferrand Cédex 1, 63003, France

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Dijon, 21079, France

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Grenoble Cédex, 38043, France

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Lille, 59037, France

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Limoges, 87042, France

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Montauban, 82000, France

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Mougins, 06250, France

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Nouvelle Caledonie, 98849, France

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Paris, 75475, France

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Pierre-Bénite, 69495, France

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Quimper, 29107, France

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Soissons, 02209, France

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Strasbourg, 67065, France

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Vandœuvre-lès-Nancy, 54500, France

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Augsburg, 86156, Germany

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Bochum, 44791, Germany

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Buxtehude, 21614, Germany

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Chemnitz, 09117, Germany

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Darmstadt, 64297, Germany

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Dessau-Roblau, 06847, Germany

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Dortmund, 44137, Germany

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Dresden, 01307, Germany

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Düsseldorf, 40225, Germany

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Frankfurt, 60590, Germany

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Gera, 07548, Germany

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Halle, 06120, Germany

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Hamburg, 20099, Germany

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Hamburg, 20246, Germany

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Hamburg, 20253, Germany

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Hanover, 30625, Germany

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Jena, 07743, Germany

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Koblenz, 56068, Germany

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Lüdenscheid, 58515, Germany

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Magdeburg, 39120, Germany

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Mainz, 55131, Germany

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Mannheim, 68167, Germany

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Marburg, 35043, Germany

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Münster, 48149, Germany

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Plauen, 08529, Germany

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Quedlinburg, 06484, Germany

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Recklinghausen, 45657, Germany

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Rostock, 18055, Germany

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Schwäbisch Hall, 74523, Germany

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Stuttgart, 70374, Germany

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Tübingen, 72076, Germany

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Würzburg, 97080, Germany

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Cholargós, Athens, 15562, Greece

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Goudi, Athens, 11527, Greece

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Neo Faliro, Athens, 18547, Greece

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Heraklion, Crete, 71100, Greece

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Neas Efkarpia, Thessaloniki, 56429, Greece

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Alexandroupoli, 68100, Greece

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Athens, 11528, Greece

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Athens, 15233, Greece

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Mezourlo, 41334, Greece

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Neo Faliro, 18547, Greece

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Wilton, CORK, T12 DC4A, 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, 31096, Israel

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Tel Aviv, 64239, Israel

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Tel Litwinsky, 52621, Israel

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Bydgoszcz, 85-796, Poland

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Lodz, 93-510, Poland

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Warsaw, 02-781, Poland

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Wroclaw, 51-124, Poland

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Barcelona, 08036, Spain

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Donostia / San Sebastian, 20014, Spain

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Las Palmas de Gran Canaria, 35016, Spain

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Madrid, 28007, Spain

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Madrid, 28033, Spain

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Madrid, 28034, Spain

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Madrid, 28041, Spain

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Palma, 07198, Spain

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Palma de Mallorca, 07198, Spain

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Pamplona, 31008, Spain

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Santa Cruz de Tenerife, 35320, Spain

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Santa Cruz de Tenerife, 38010, Spain

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Santander, 39008, Spain

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Santiago de Compostela; A Coruña, 15706, Spain

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Seville, 41013, Spain

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Terrassa, 08027, Spain

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Valladolid, 47012, Spain

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Zaragoza, 50009, Spain

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Baden, CH-5404, Switzerland

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Lugano, CH-6900, Switzerland

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Zurich, 8091, Switzerland

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Zurich, CH-8091, Switzerland

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Rhyl, Denbigshire, LL18 5UJ, United Kingdom

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London, England, NW3 2QG, United Kingdom

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Chelmsford, Essex, Essex, CM1 7ET, United Kingdom

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Southend, Essex, SS0 0RY, United Kingdom

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Belfast, Ireland, BT9 7AB, United Kingdom

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Cardiff, South Glamorgan, CF14 2TL, United Kingdom

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Birmingham, B15 2TH, United Kingdom

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Bristol, BS2 8ED, United Kingdom

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Exeter, EX2 5DW, United Kingdom

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Hull, HU16 5JQ, United Kingdom

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Leeds, LS9 7TF, United Kingdom

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Lincoln, LN2 5QY, United Kingdom

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London, SE1 9RT, United Kingdom

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London, SW3 6JJ, United Kingdom

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London, United Kingdom

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Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

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Oxfordshire, OX3 7LE, United Kingdom

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Plymouth, PL6 8DH, United Kingdom

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Poole, BH15 2JB, United Kingdom

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Preston, PR2 9HT, United Kingdom

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Staffordshire, ST46QG, United Kingdom

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Taunton, Somerset, TA1 5DA, United Kingdom

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Truro, Cornwall, TR1 3LJ, United Kingdom

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Wolverhampton, WS13 6NH, United Kingdom

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Yeovil, Somerset, BA21 4AT, United Kingdom

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Related Publications (2)

• 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.

  PMID: 34051732 RESULT

• 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.

  PMID: 27118102 RESULT

Related Links

• BMS Clinical Trials Disclosure
• Investigator Inquiry form
• FDA Safety Alerts and Recalls
• BMS clinical trial educational resource

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2011
• First Posted: January 19, 2012
• Study Start: June 3, 2012
• Primary Completion: March 30, 2018
• Study Completion: December 12, 2019
• Last Updated: December 28, 2021

Record last verified: 2021-12

Locations

CA (7); GR (10); AR (6); PL (4); CH (4); AU (16); ES (18); IL (3); BE (7); FR (19); IE (5); GB (25); DE (32); US (24)