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

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

Study Overview

• Status: Completed
• Conditions: Advanced Cutaneous Melanoma

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 1411

Contacts and Locations

Study Locations

• Argentina
  • Caba, Argentina, 1426
    • Local Institution
  • Caba, Argentina, C1417DNT
    • Local Institution
  • Caba, Argentina, C1426ANZ
    • Local Institution
  • Cordoba, Argentina, X5006HBF
    • Local Institution
  • Rosario- Santa Fe, Argentina, S2000KZE
    • Local Institution
  • Tucuman, Argentina, T4000GTB
    • Local Institution
• Australia
  • Australian Capital Territory
    • Canberra, Australian Capital Territory, Australia, 02605
      • Local Institution
  • New South Wales
    • Corrimal, New South Wales, Australia, 02518
      • Local Institution
    • Lismore, New South Wales, Australia, 02480
      • Local Institution
    • Port Macquarie, New South Wales, Australia, 02444
      • Local Institution
    • Tamworth, New South Wales, Australia, 02340
      • Local Institution
    • Tweeds Head, New South Wales, Australia, 02485
      • Local Institution
    • Wagga Wagga, New South Wales, Australia, 2650
      • Local Institution
    • Waratah, New South Wales, Australia, 02298
      • Local Institution
  • Queensland
    • Cairns, Queensland, Australia, 4870
      • Local Institution
    • Douglas, Queensland, Australia, 04810
      • Local Institution
    • Greenslopes, Queensland, Australia, 4120
      • Local Institution
  • South Australia
    • Adelaide, South Australia, Australia, 05000
      • Local Institution
    • Bedford Park, South Australia, Australia, 05042
      • Local Institution
    • Kurralta Park, South Australia, Australia, 5037
      • Local Institution
  • Victoria
    • Frankston, Victoria, Australia, 03199
      • Local Institution
    • Malvern, Victoria, Australia, 03144
      • Local Institution
• Austria
  • Feldkirch, Austria, 6800
    • Local Institution
  • Graz, Austria, A-8036
    • Local Institution
  • Linz, Austria, A-4020
    • Local Institution
  • Salzburg, Austria, A-5020
    • Local Institution
  • St Poelten, Austria, A-3100
    • Local Institution
  • Vienna, Austria, A-1090
    • Local Institution
• Belgium
  • Brasschaat, Belgium, 2930
    • Local Institution
  • Brussels, Belgium, 1200
    • Local Institution
  • Edegem, Belgium, 2650
    • Local Institution
  • Haint Saint Paul, Belgium, 7100
    • Local Institution
  • Hasselt, Belgium, 3500
    • Local Institution
  • Kortrijk, Belgium, 8500
    • Local Institution
  • Leuven, Belgium, 3000
    • Local Institution
• Canada
  • Quebec, Canada, G1V 4G2
    • Local Institution
  • Québec, Canada, G1R 2J6
    • Local Institution
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 6Z8
      • Local Institution
  • Ontario
    • London, Ontario, Canada, N6C 6B5
      • Local Institution
    • Mississauga, Ontario, Canada, L5M 2N1
      • Local Institution
    • Windsor, Ontario, Canada, N8W 2X3
      • Local Institution
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
      • Local Institution
• France
  • Bayonne, France, 64100
    • Local Institution
  • Besancon, France, 25000
    • Local Institution
  • Boulogne, France, 92104
    • Local Institution
  • Boulogne sur Mer, France, 62200
    • Local Institution
  • Brest Cedex, France, 29609
    • Local Institution
  • Clermont Ferrand Cédex 1, France, 63003
    • Local Institution
  • Dijon, France, 21079
    • Local Institution
  • Grenoble Cédex, France, 38043
    • Local Institution
  • Lille Cedex, France, 59037
    • Local Institution
  • Limoges Cedex, France, 87042
    • Local Institution
  • Montauban, France, 82000
    • Local Institution
  • Mougins, France, 06250
    • Local Institution
  • Nouvelle Caledonie, France, 98849
    • Local Institution
  • Paris Cedex 10, France, 75475
    • Local Institution
  • Pierre Bénite, France, 69495
    • Local Institution
  • Quimper, France, 29107
    • Local Institution
  • Quimper Cedex, France, 29107
    • Local Institution
  • Soissons cedex, France, 02209
    • Local Institution
  • Strasbourg Cedex, France, 67065
    • Local Institution
  • Vandoeuvre Les Nancy, France, 54500
    • Local Institution
• Germany
  • Augsburg, Germany, 86156
    • Local Institution
  • Bochum, Germany, 44791
    • Local Institution
  • Buxtehude, Germany, 21614
    • Local Institution
  • Chemnitz, Germany, 09117
    • Local Institution
  • Darmstadt, Germany, 64297
    • Local Institution
  • Dessau-Roblau, Germany, 06847
    • Local Institution
  • Dortmund, Germany, 44137
    • Local Institution
  • Dresden, Germany, 01307
    • Local Institution
  • Düsseldorf, Germany, 40225
    • Local Institution
  • Frankfurt, Germany, 60590
    • Local Institution
  • Gera, Germany, 07548
    • Local Institution
  • Halle/Saale, Germany, 06120
    • Local Institution
  • Hamburg, Germany, 20246
    • Local Institution
  • Hamburg, Germany, 20253
    • Local Institution
  • Hamburg, Germany, 20099
    • Local Institution
  • Hannover, Germany, 30625
    • Local Institution
  • Jena, Germany, 07743
    • Local Institution
  • Koblenz, Germany, 56068
    • Local Institution
  • Lüdenscheid, Germany, 58515
    • Local Institution
  • Magdeburg, Germany, 39120
    • Local Institution
  • Mainz, Germany, 55131
    • Local Institution
  • Mannheim, Germany, 68167
    • Local Institution
  • Marburg, Germany, 35043
    • Local Institution
  • Münster, Germany, 48149
    • Local Institution
  • Plauen, Germany, 08529
    • Local Institution
  • Quedlinburg, Germany, 06484
    • Local Institution
  • Recklinghausen, Germany, 45657
    • Local Institution
  • Rostock, Germany, 18055
    • Local Institution
  • Schwäbisch Hall, Germany, 74523
    • Local Institution
  • Stuttgart, Germany, 70374
    • Local Institution
  • Tübingen, Germany, 72076
    • Local Institution
  • Würzburg, Germany, 97080
    • Local Institution
• Greece
  • Alexandroupolis, Greece, 68100
    • Local Institutio
  • Athens, Greece, 11528
    • Local Institution
  • Athens, Greece, 15233
    • Local Institution
  • Mezourlo, Greece, 41334
    • Local Institution
  • Neo Faliro, Greece, 18547
    • Local Institution
  • Athens
    • Cholargos, Athens, Greece, 15562
      • Local Institution
    • Goudi, Athens, Greece, 11527
      • Local Institution
    • Neo Faliro, Athens, Greece, 18547
      • Local Institution
  • Crete
    • Heraklion, Crete, Greece, 71100
      • Local Institution
  • Thessaloniki
    • Neas Efkarpia, Thessaloniki, Greece, 56429
      • Local Institution
• Ireland
  • Cork, Ireland
    • Local Institution
  • Dublin, Ireland
    • Local Institution
  • Galway, Ireland
    • Local Institution
  • Tullamore, Ireland
    • Local Institution
  • Cork
    • Wilton, Cork, Ireland, T12 DC4A
      • Local Institution
• Israel
  • Haifa, Israel, 31096
    • Local Institution
  • Tel Aviv, Israel, 64239
    • Local Institution
  • Tel Hashomer, Israel, 52621
    • Local Institution
• Poland
  • Bydgoszcz, Poland, 85-796
    • Local Institution
  • Warszawa, Poland, 02-781
    • Local Institution
  • Wrocław, Poland, 51-124
    • Local Institution
  • Łódź, Poland, 93-510
    • Local Institution
• Spain
  • Barcelona, Spain, 08036
    • Local Institution
  • Donostia, Spain, 20014
    • Local Institution
  • Las Palmas de Gran Canaria, Spain, 35016
    • Local Institution
  • Madrid, Spain, 28041
    • Local Institution
  • Madrid, Spain, 28034
    • Local Institution
  • Madrid, Spain, 28033
    • Local Institution
  • Madrid, Spain, 28007
    • Local Institution
  • Palma, Spain, 07198
    • Local Institution
  • Palma de Mallorca, Spain, 07198
    • Local Institution
  • Pamplona, Spain, 31008
    • Local Institution
  • Santa Cruz de Tenerife, Spain, 38010
    • Local Institution
  • Santander, Spain, 39008
    • Local Institution
  • Santiago De Compostela; A Coruña, Spain, 15706
    • Local Institution
  • Sevilla, Spain, 41013
    • Local Institution
  • Sta Cruz de Tenerife, Spain, 35320
    • Local Institution
  • Terrassa, Spain, 08027
    • Local Institution
  • Valladolid, Spain, 47012
    • Local Institution
  • Zaragoza, Spain, 50009
    • Local Institution
• Switzerland
  • Baden, Switzerland, CH-5404
    • Local Institution
  • Lugano, Switzerland, CH-6900
    • Local Institution
  • Zurich, Switzerland, 8091
    • Local Institution
  • Zürich, Switzerland, CH-8091
    • Local Institution
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • Local Institution
  • Bristol, United Kingdom, BS2 8ED
    • Local Institution
  • Exeter, United Kingdom, EX2 5DW
    • Local Institution
  • Hull, United Kingdom, HU16 5JQ
    • Local Institution
  • Leeds, United Kingdom, LS9 7TF
    • Local Institution
  • Lincoln, United Kingdom, LN2 5QY
    • Local Institution
  • London, United Kingdom, SE1 9RT
    • Local Institution
  • London, United Kingdom, SW3 6JJ
    • Local Institution
  • London, United Kingdom
    • Local Institution
  • Oxfordshire, United Kingdom, OX3 7LE
    • Local Institution
  • Plymouth, United Kingdom, PL6 8DH
    • Local Institution
  • Poole, United Kingdom, BH15 2JB
    • Local Institution
  • Preston, United Kingdom, PR2 9HT
    • Local Institution
  • Staffordshire, United Kingdom, ST46QG
    • Local Institution
  • Taunton, Somerset, United Kingdom, TA1 5DA
    • Local Institution
  • Truro, Cornwall, United Kingdom, TR1 3LJ
    • Local Institution
  • Wirral, United Kingdom, CH63 4JY
    • Local Institution
  • Wolverhampton, United Kingdom, WS13 6NH
    • Local Institution
  • Yeovil, Somerset, United Kingdom, BA21 4AT
    • Local Institution
  • Denbigshire
    • Rhyl, Denbigshire, United Kingdom, LL18 5UJ
      • Local Institution
  • England
    • London, England, United Kingdom, NW3 2QG
      • Local Institution
  • Essex
    • Chelmsford, Essex, Essex, United Kingdom, CM1 7ET
      • Local Institution
    • Southend, Essex, United Kingdom, SS0 0RY
      • Local Institution
  • Ireland
    • Belfast, Ireland, United Kingdom, BT9 7AB
      • Local Institution
  • South Glamorgan
    • Cardiff, South Glamorgan, United Kingdom, CF14 2TL
      • Local Institution
• United States
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Local Institution
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Local Institution
  • California
    • Encinitas, California, United States, 92024
      • Local Institution
    • La Jolla, California, United States, 92093
      • Local Institution
    • Long Beach, California, United States, 90813
      • Local Institution
    • Los Angeles, California, United States, 90025
      • Local Institution
  • Colorado
    • Denver, Colorado, United States, 80218
      • Local Institution
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Local Institution
  • Florida
    • Lakeland, Florida, United States, 33085
      • Local Institution
    • Miami Beach, Florida, United States, 33140
      • Local Institution
    • Orange Park, Florida, United States, 32073
      • Local Institution
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Local Institution
    • Niles, Illinois, United States, 60714
      • Local Institution
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Local Institution
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Local Institution
  • Nebraska
    • Lincoln, Nebraska, United States, 18015
      • Local Institution
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Local Institution
  • Ohio
    • Canton, Ohio, United States, 44178
      • Local Institution
    • Columbus, Ohio, United States, 43206
      • Mid Ohio Onc/Hem, Inc
    • Columbus, Ohio, United States, 43219
      • Local Institution
    • Middletown, Ohio, United States, 45042
      • Local Institution
  • Oregon
    • Portland, Oregon, United States, 97213
      • Local Institution
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Local Institution
  • Washington
    • Everett, Washington, United States, 98201
      • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Ipilimumab treatment cohort of 1106 prospective participants
Non-Ipilimumab treatment cohort of 305 prospective participants
Retrospective cohort of 177 participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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
Overall survival (OS) in patients receiving Ipilimumab or other therapies for unresectable or metastatic melanoma		Every 12 months up to 5 years

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2012
• Primary Completion (Actual): March 30, 2018
• Study Completion (Actual): December 12, 2019

Study Registration Dates

• First Submitted: November 15, 2011
• First Submitted That Met QC Criteria: January 18, 2012
• First Posted (Estimate): January 19, 2012

Study Record Updates

• Last Update Posted (Actual): December 28, 2021
• Last Update Submitted That Met QC Criteria: December 22, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Unresectable or metastatic cutaneous melanoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: CA184-143; ENCEPP/SDPP/2723 (Other Identifier: Euro. Ntwk. of Ctrs. for Pharmacoepidemiology and Pharmacovigilance)