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Sponsored by: |
Bristol-Myers Squibb |
---|---|
Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00636168 |
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 |
Estimated Enrollment: | 950 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | July 2014 |
Estimated Primary Completion Date: | June 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
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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. |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | CA184-029, EORTC 18071 |
Study First Received: | March 7, 2008 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00636168 |
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 |
Antibodies, Monoclonal Neuroectodermal Tumors Antibodies Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Cytotoxic T-lymphocyte antigen 4 Recurrence Immunoglobulins Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas |