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

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

This study is currently recruiting participants.
Information provided by Bristol-Myers Squibb

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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 ]

Secondary Outcome Measure ^†

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 ]

Condition ^†

Melanoma

Intervention ^†

Drug: Ipilimumab

MEDLINE PMIDs

Links

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

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

207

Start Date ^†

May 2006

Completion Date

March 2011

Eligibility Criteria ^†

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 ^††

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 ^†

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

Administrative Information Fields

NCT ID ^†

NCT00162123

Organization ID

CA184-025

Secondary IDs ^††

Study Sponsor ^†

Bristol-Myers Squibb

Collaborators ^††

Investigators ^†

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

August 2008

First Received Date ^†

September 9, 2005

Last Updated Date

September 4, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.