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

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Ipilimumab

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

More Information

Additional Information:

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

No publications provided

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

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue
Nevi and Melanomas
Neuroendocrine Tumors
Melanoma

ClinicalTrials.gov processed this record on November 27, 2009