Full Text View
Tabular View
No Study Results Posted
Related Studies
Efficacy Study of Ipilimumab Versus Placebo to Prevent Recurrence After Complete Resection of High Risk Stage III Melanoma
This study is currently recruiting participants.
Verified by Bristol-Myers Squibb, July 2009
First Received: March 7, 2008   Last Updated: November 16, 2009   History of Changes
Sponsor: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00636168
  Purpose

The purpose of the study is to determine if ipilimumab is effective in preventing or delaying recurrence and prolongs survival after complete resection of high risk stage III melanoma


Condition Intervention Phase
High Risk Stage III Melanoma
 Drug: ipilimumab
Drug: Placebo
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Adjuvant Immunotherapy With Anti-CTLA-4 Monoclonal Antibody (Ipilimumab) Versus Placebo After Complete Resection of High Risk Stage III Melanoma: A Randomized, Double-blind Phase 3 Trial of the EORTC Melanoma Group

Resource links provided by NLM:

MedlinePlus related topics: Melanoma
Drug Information available for: Ipilimumab
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • To determine whether post-operative adjuvant therapy with ipilimumab improves recurrence-free survival (RFS) as compared to placebo [ Time Frame: Upon occurrence ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine whether post-operative adjuvant therapy with ipilimumab improves overall survival (OS) as compared to placebo [ Time Frame: Upon occurrence ] [ Designated as safety issue: No ]
  • To determine whether post-operative adjuvant therapy with ipilimumab improves distant metastases-free survival (DMFS) as compared to placebo [ Time Frame: Upon occurrence ] [ Designated as safety issue: No ]
  • To compare adverse event profiles between patients receiving ipilimumab versus patients receiving placebo [ Time Frame: Upon occurrence ] [ Designated as safety issue: No ]
  • To compare quality of life and quality-of-life-adjusted survival between the two treatment groups (ipilimumab versus placebo) [ Time Frame: Upon occurrence ] [ Designated as safety issue: No ]

Estimated Enrollment: 950
Study Start Date: June 2008
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Active Comparator Drug: ipilimumab
IV solution, IV, 10 mg/kg, 4x every 21 days, then starting from Week 24 every 12 weeks until Week 156 or progression, 3 years
B: Placebo Comparator Drug: Placebo
IV solution, IV, 10 mg/kg, 4x every 21 days then starting from Week 24 every 12 weeks until Week 156 or progression, 3 years

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Complete and adequate resection of Stage III melanoma with histologically confirmed melanoma metastatic to lymph node
  • Disease-free
  • ECOG PS 0 or 1
  • Randomization within 12 weeks of surgery

Exclusion Criteria:

  • No prior therapy for melanoma except surgery
  • No auto-immune disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00636168

Contacts
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

  Hide Study Locations
Locations
United States, California
San Francisco Oncology Associates Recruiting
San Francisco, California, United States, 94115
Contact: David R. Minor, Site 002     415-885-8600        
Saint Mary'S Medical Center Recruiting
San Francisco, California, United States, 94117
Contact: Lynn Spitler, Site 004            
The Angeles Clinic And Research Institute Recruiting
Santa Monica, California, United States, 90404
Contact: Steven O'Day, Site 009     310-582-7900        
Sharp Memorial Hospital Recruiting
San Diego, California, United States, 92123
Contact: Nayyar Siddique, Site 089            
United States, Connecticut
Yale University Cancer Center Recruiting
New Haven, Connecticut, United States, 06520
Contact: Mario Sznol, Site 005            
United States, Florida
H Lee Moffit Cancer Cnt And Res Inst Recruiting
Tampa, Florida, United States, 33612
Contact: Jeffrey Weber, Site 006     813-745-2007        
Local Institution Not yet recruiting
Boca Raton, Florida, United States, 33428
Contact: Site 116            
United States, Illinois
Oncology Specialists, S.C. Recruiting
Park Ridge, Illinois, United States, 60068
Contact: Jon Richards, Site 003            
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: F. Stephen Hodi, Site 110            
United States, Missouri
Washington University School Of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Gerald Linette, Site 053            
United States, Nevada
Nevada Cancer Center Recruiting
Las Vegas, Nevada, United States, 89135
Contact: Wolfram Samlowski, Site 088            
United States, New Jersey
Atlantic Melanoma Center Recruiting
Morristown, New Jersey, United States, 07960
Contact: Eric Whitman, Site 007            
United States, New Mexico
Cancer Research And Treatment Center Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Claire Verschraegen, Site 099            
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Jedd D. Wolchok, Site 008     646-888-2395        
United States, North Carolina
Blumenthal Cancer Center, Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Asim Amin, Site 087            
United States, Pennsylvania
St Luke'S Hospital And Health Network Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Sanjiv Agarwala, Site 001            
United States, Tennessee
Vanderbilt Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Jeffrey A. Sosman, Site 010     615-322-4967        
United States, Texas
Center For Oncology Research & Treatment, P.A. Recruiting
Dallas, Texas, United States, 75230
Contact: Barry C. Mirtsching, Site 083     972-566-5588        
United States, Utah
Huntsman Cancer Institute At The Univ. Of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Wallace Akerley Iii, Site 098            
United States, Washington
Seattle Can Care Alliance Recruiting
Seattle, Washington, United States, 98109
Contact: Kim Margolin, Site 111            
Australia, New South Wales
Local Institution Recruiting
Waratah, New South Wales, Australia, 2298
Contact: Site 055            
Local Institution Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Site 071            
Australia, Queensland
Local Institution Recruiting
Greenslopes, Queensland, Australia, 4120
Contact: Site 066            
Local Institution Recruiting
Woolloongabba, Queensland, Australia, 4102
Contact: Site 076            
Australia, Victoria
Local Institution Recruiting
Box Hill, Victoria, Australia, 3128
Contact: Site 056            
Local Institution Recruiting
Malvern, Victoria, Australia, 3144
Contact: Site 105            
Australia, Western Australia
Local Institution Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Site 073            
Austria
Local Institution Recruiting
Wien, Austria, 1090
Contact: Site 107            
Local Institution Not yet recruiting
Graz, Austria, 8010
Contact: Site 108            
Belgium
Local Institution Recruiting
Bruxelles, Belgium, 1000
Contact: Site 013            
Local Institution Recruiting
Gent, Belgium, 9000
Contact: Site 036            
Local Institution Not yet recruiting
Leuven, Belgium, 3000
Contact: Site 109            
Canada, Alberta
Local Institution Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Site 012            
Local Institution Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Site 080            
Canada, Nova Scotia
Local Institution Recruiting
Halifax, Nova Scotia, Canada, B3H 1V7
Contact: Site 049            
Canada, Ontario
Local Institution Recruiting
London, Ontario, Canada, N6A 4L6
Contact: Site 085            
Local Institution Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Site 090            
Canada, Quebec
Local Institution Recruiting
Montreal, Quebec, Canada, H2W 1S6
Contact: Site 051            
Czech Republic
Local Institution Recruiting
Praha 2, Czech Republic, 128 08
Contact: Site 058            
Local Institution Recruiting
Brno, Czech Republic, 656 53
Contact: Site 074            
Denmark
Local Institution Recruiting
Odense, Denmark, DK-5000
Contact: Site 014            
Local Institution Recruiting
Aarhus C, Denmark, 8000
Contact: Site 015            
Local Institution Recruiting
Herlev, Denmark, 2730
Contact: Site 070            
Finland
Local Institution Recruiting
Helsinki, Finland, 00290
Contact: Site 017            
Local Institution Recruiting
Turku, Finland, 20520
Contact: Site 045            
France
Local Institution Recruiting
Vandoeuvre Les Nancy, France, 54511
Contact: Site 059            
Local Institution Recruiting
Montpellier, France, 34295
Contact: Site 060            
Local Institution Recruiting
Villejuif, France, 94805
Contact: Site 061            
Local Institution Recruiting
Boulogne-Billancourt, France, 92104
Contact: Site 062            
Local Institution Recruiting
Paris, France, 75010
Contact: Site 069            
Local Institution Recruiting
Lille, France, 59037
Contact: Site 072            
Local Institution Recruiting
Marseille, France, 13009
Contact: Site 101            
Local Institution Recruiting
Paris, France, 75018
Contact: Site 102            
Local Institution Recruiting
Pierre Benite, France, 69495
Contact: Site 103            
Germany
Local Institution Recruiting
Heidelberg, Germany, 69115
Contact: Site 018            
Local Institution Suspended
Berlin, Germany, 10117
Local Institution Recruiting
Luebeck, Germany, 23538
Contact: Site 039            
Local Institution Recruiting
Kiel, Germany, 24105
Contact: Site 091            
Local Institution Recruiting
Goettingen, Germany, 37075
Contact: Site 092            
Local Institution Recruiting
Koln, Germany, 50937
Contact: Site 093            
Local Institution Recruiting
Tuebingen, Germany, 72076
Contact: Site 094            
Local Institution Recruiting
Essen, Germany, 45122
Contact: Site 097            
Local Institution Recruiting
Wuerzburg, Germany, D-97080
Contact: Site 113            
Local Institution Not yet recruiting
Heidelberg, Germany, 69120
Contact: Site 117            
Italy
Local Institution Recruiting
Genova, Italy, 16132
Contact: Site 019            
Local Institution Recruiting
Siena, Italy, 53100
Contact: Site 023            
Local Institution Recruiting
Milano, Italy, 20141
Contact: Site 024            
Local Institution Recruiting
Padova, Italy, 35128
Contact: Site 046            
Local Institution Recruiting
Napoli, Italy, 80131
Contact: Site 064            
Local Institution Recruiting
Roma, Italy, 00144
Contact: Site 065            
Netherlands
Local Institution Not yet recruiting
Utrecht, Netherlands, 3584 CX
Contact: Site 020            
Local Institution Not yet recruiting
Amsterdam, Netherlands, 1066 CX
Contact: Site 025            
Local Institution Not yet recruiting
Rotterdam, Netherlands, 3008 AE
Contact: Site 027            
Local Institution Not yet recruiting
Utrecht, Netherlands, 6500 HB
Contact: Site 028            
Local Institution Not yet recruiting
Mb Amsterdam, Netherlands, 1007MB
Contact: Site 029            
Local Institution Not yet recruiting
Leiden, Netherlands, 2300
Contact: Site 079            
Norway
Local Institution Recruiting
Oslo, Norway, 0310
Contact: Site 063            
Poland
Local Institution Recruiting
Warsaw, Poland, 02-781
Contact: Site 047            
Local Institution Recruiting
Poznan, Poland, 61-866
Contact: Site 054            
Spain
Local Institution Recruiting
Valencia, Spain, 46014
Contact: Site 030            
Local Institution Recruiting
Madrid, Spain, 28041
Contact: Site 041            
Local Institution Recruiting
Barcelona, Spain, 08036
Contact: Site 084            
Local Institution Suspended
Zaragoza, Spain, 50009
Sweden
Local Institution Recruiting
Stockholm, Sweden, 171 76
Contact: Site 037            
Switzerland
Local Institution Recruiting
Zurich, Switzerland, 8091
Contact: Site 038            
United Kingdom, Essex
Local Institution Recruiting
Chelmsford, Essex, United Kingdom, CM1 7ET
Contact: Site 043            
United Kingdom, Greater London
Local Institution Recruiting
London, Greater London, United Kingdom, SW17 0QT
Contact: Site 042            
United Kingdom, Hampshire
Local Institution Not yet recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
Contact: Site 114            
United Kingdom, Nottinghamshire
Local Institution Recruiting
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Contact: Site 068            
United Kingdom, Yorkshire
Local Institution Recruiting
Leeds, Yorkshire, United Kingdom, LS9 7TF
Contact: Site 034            
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb ( Study Director )
Study ID Numbers: CA184-029, EORTC 18071
Study First Received: March 7, 2008
Last Updated: November 16, 2009
ClinicalTrials.gov Identifier: NCT00636168     History of Changes
Health Authority: United States: Food and Drug Administration;   United States: Institutional Review Board;   European Union: European Medicines Agency;   Australia: Department of Health and Ageing Therapeutic Goods Administration;   Belgium: Federal Agency for Medicinal Products and Health Products;   Czech Republic: State Institute for Drug Control;   Denmark: Laegmiddeistyrelsen;   Finland: Laakelaitos;   France: Afssaps - French Health Products Safety Agency;   Italy: Isituto Supiore di Sanita Commissione per l'accertamento dei requisti dei prodotti farmaceuticidi nuova istituzione;   Netherlands: The Central Committee on Research Involving Human Subjects (CCMO);   Norway: Statens legemiddelverk;   Poland: Urzad Rejestracji Produktow Leczniczych Wyrobow Medycznych i Produktow Biobojczych;   Spain: AEMPS - Agencia Espanola der Medicamento y Productos Sanitarios;   Sweden: Ladenmedeisverket;   Switzerland: Swissmedic;   United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
 Neoplasms, Nerve Tissue
Nevi and Melanomas
Neuroendocrine Tumors
Melanoma

ClinicalTrials.gov processed this record on November 27, 2009



Contact Help Desk
Lister Hill National Center for Biomedical Communications,  U.S. National Library of Medicine,
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services