Phase II Study to Determine Predictive Markers of Response to BMS-734016 (MDX-010) - Tabular View

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Phase II Study to Determine Predictive Markers of Response to BMS-734016 (MDX-010)

This study has been completed.
Information provided by Bristol-Myers Squibb

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

Descriptive Information Fields

Brief Title ^†

Phase II Study to Determine Predictive Markers of Response to BMS-734016 (MDX-010)

Official Title ^†

An Exploratory Study to Determine Potential Predictive Markers of Response and/or Toxicity in Patients With Unresectable Stage III or IV Malignant Melanoma Randomized and Treated With Ipilimumab (MDX-010/BMS-734016) at Two Dose Levels

Brief Summary

The purpose of this study is to identify candidate markers predictive of response and/or serious toxicity to BMS-734016 (MDX-010).

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Factorial Assignment

Primary Outcome Measure ^†

Purpose - to identify candidate markers predictive of response and/or serious toxicity to MDX-101 (BMS-734016) [ Time Frame: on a continuous & ongoing basis ] [ Designated as safety issue: No ]

Secondary Outcome Measure ^†

Safety & tumor response are important secondary objectives. Safety evaluated [ Time Frame: on a continuous & ongoing basis ] [ Designated as safety issue: Yes ]
Tumor response measured [ Time Frame: starting @ wk 12 through wk 24. Those continuing on therapy after wk 24 have tumor responses evaluated every 3 months ] [ Designated as safety issue: No ]

Condition ^†

Unresectable Stage III or IV Malignant 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 www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

November 2005

Completion Date

October 2007

Eligibility Criteria ^†

Inclusion Criteria:

Histologic or cytologic diagnosis of unresectable State III or IV malignant melanoma (excluding ocular melanoma); A pre- and post-treatment fresh core or excision tumor biopsy must be provided.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Denmark, Israel, Italy, Norway, Peru, Sweden

Administrative Information Fields

NCT ID ^†

NCT00261365

Organization ID

CA184-004

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 ^†

December 1, 2005

Last Updated Date

August 19, 2008

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