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

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.

Show 89 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

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:	February 3, 2010
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 February 08, 2010