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

Tracking Information

First Received Date ^ICMJE

March 7, 2008

Last Updated Date

November 16, 2009

Start Date ^ICMJE

June 2008

Estimated Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

To determine whether post-operative adjuvant therapy with ipilimumab improves recurrence-free survival (RFS) as compared to placebo

Change History

Complete list of historical versions of study NCT00636168 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

To determine whether post-operative adjuvant therapy with ipilimumab improves overall survival (OS) as compared to placebo
To determine whether post-operative adjuvant therapy with ipilimumab improves distant metastases-free survival (DMFS) as compared to placebo
To compare adverse event profiles between patients receiving ipilimumab versus patients receiving placebo
To compare quality of life and quality-of-life-adjusted survival between the two treatment groups (ipilimumab versus placebo)

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

High Risk Stage III Melanoma

Intervention ^ICMJE

Drug: ipilimumab
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

950

Estimated Completion Date

September 2014

Estimated Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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.

Location Countries ^ICMJE

United States, Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00636168

Responsible Party

Study Director, Bristol-Myers Squibb

Study ID Numbers ^ICMJE

CA184-029, EORTC 18071

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP