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

Purpose

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

Condition	Intervention	Phase
Unresectable Stage III or IV Malignant Melanoma	Drug: Ipilimumab	Phase I Phase II

MedlinePlus related topics:

Cancer Melanoma

ChemIDplus related topics:

Ipilimumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Factorial Assignment

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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

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 Measures:

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 ]

Estimated Enrollment:	80
Study Start Date:	November 2005
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A1: Active Comparator	Drug: Ipilimumab Solution, Intravenous, 3 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.
A2: Active Comparator	Drug: Ipilimumab Solution, Intravenous, 10 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00261365

Locations


United States, California
	Comprehensive Cancer Center
	Palm Springs, California, United States, 92262
	The Angeles Clinic And Research Institution
	Santa Monica, California, United States, 90404

United States, Massachusetts
	Beth Israel Deaconess Medical Center
	Boston, Massachusetts, United States, 02215

Denmark
	Local Institution
	Odense C, Denmark, 5000
	Local Institution
	Aarhus C, Denmark, 8000

Israel
	Local Institution
	Jerusalem, Israel, 72080

Italy
	Local Institution
	Forli', Italy, 47100
	Local Institution
	Ravenna, Italy, 48100
	Local Institution
	Rimini, Italy, 47900
	Local Institution
	Bari, Italy, 70126

Norway
	Local Institution
	Oslo, Norway, 0310

Peru
	Local Institution
	Lima, Peru, LIMA 11
	Local Institution
	Lima, Peru, 43

Sweden
	Local Institution
	Stockholm, Sweden, 171 76
	Local Institution
	Gothenberg, Sweden, 413 45

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators


Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA184-004
First Received:	December 1, 2005
Last Updated:	August 19, 2008
ClinicalTrials.gov Identifier:	NCT00261365
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neuroectodermal Tumors

Nevus, Pigmented

Neoplasms, Germ Cell and Embryonal

Neuroepithelioma

Nevus

Neuroendocrine Tumors

Melanoma

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevi and Melanomas

ClinicalTrials.gov processed this record on September 04, 2008

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00261365