A Companion Study for Patients Enrolled in Prior/Parent Ipilimumab Studies - Tabular View

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

November 4, 2009

Start Date ^ICMJE

May 2006

Estimated Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To monitor safety of ipilimumab by evaluating the frequency of adverse events and laboratory abnormalities with corresponding severity. [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

To monitor the safety and time to progression or remission in patients receiving re-induction or maintenance therapy

Change History

Complete list of historical versions of study NCT00162123 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Estimate overall survival from the first dose [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]
Estimate survival rate from the first dose [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Monitor Immune Breakthrough Events [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Best obj. response rate,major durable response,disease control rate,&progression free survival for pts receiving re-induction. For pts receiving maintenance/followup; measure progression free survival from 1st dose of the study drug. Overall survival.

Descriptive Information

Brief Title ^ICMJE

A Companion Study for Patients Enrolled in Prior/Parent Ipilimumab Studies

Official Title ^ICMJE

A Multi-Center, Open-Label, Phase II Study of Ipilimumab (MDX-010 Extended-Treatment Monotherapy or Follow-up for Patients Previously Enrolled in Ipilimumab (MDX-010) Protocols.

Brief Summary

The purpose of this study is to evaluate the continued use of ipilimumab in patients who had clinical benefit in a prior/parent study and are now eligible to receive either Re-Induction at the time of disease progression or to continue Maintenance treatment. In addition, this study will also continue to follow patients that have had ipilimumab but who are not eligible for Maintenance or Re-Induction therapy.

Detailed Description

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study

Condition ^ICMJE

Melanoma

Intervention ^ICMJE

Drug: Ipilimumab

Study Arms / Comparison Groups

No Intervention: Until withdrawal of consent or study closure

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

Active, not recruiting

Estimated Enrollment ^ICMJE

207

Estimated Completion Date

March 2011

Estimated Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosis of advanced melanoma
Prior treatment in a prior/parent ipilimumab study
Men and women >=18 years of age (or, >=16, if allowable per local regulatory authority)

Exclusion Criteria:

Prior treatment with a CD137 agonist or CTLA-4 inhibitor or agonist, except for ipilimumab
Primary ocular or mucosal melanoma

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Denmark, France, Germany, Israel, Italy, Norway, Peru, Poland, Russian Federation, South Africa, Spain, Ukraine

Administrative Information

NCT ID ^ICMJE

NCT00162123

Responsible Party

Study Director, Bristol-Myers Squibb

Study ID Numbers ^ICMJE

CA184-025

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

November 2009

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