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

Tracking Information

First Received Date ^ICMJE

December 1, 2005

Last Updated Date

August 19, 2008

Start Date ^ICMJE

November 2005

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Purpose - to identify candidate markers predictive of response and/or serious toxicity to MDX-010 (BMS734016)

Change History

Complete list of historical versions of study NCT00261365 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Safety & tumor response are important secondary objectives. Safety evaluated on a continuous & ongoing basis. Tumor response measured starting @ wk 12 through wk 24. Those continuing on therapy after wk 24 have tumor responses evaluated every 3 months

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Unresectable Stage III or IV Malignant Melanoma

Intervention ^ICMJE

Drug: Ipilimumab

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

Completed

Estimated Enrollment ^ICMJE

Completion Date

October 2007

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

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

Administrative Information

NCT ID ^ICMJE

NCT00261365

Responsible Party

Study Director, Bristol-Myers Squibb

Study ID Numbers ^ICMJE

CA184-004

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

August 2008

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