Efficacy Study of Ipilimumab Versus Placebo to Prevent Recurrence After Complete Resection of High Risk Stage III Melanoma - Full Text View

Sponsored by:	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

MedlinePlus related topics: Melanoma

Drug Information available for: Immunoglobulins Globulin, Immune Ipilimumab Cytotoxic T-lymphocyte antigen 4

U.S. FDA Resources

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

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:	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

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.

Show 88 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure 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

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

Study placed in the following topic categories:

Antibodies, Monoclonal
Neuroectodermal Tumors
Antibodies
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Nevus
Cytotoxic T-lymphocyte antigen 4
Recurrence
Immunoglobulins
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on January 16, 2009