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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00261365
First received: December 1, 2005
Last updated: February 27, 2010
Last verified: August 2008
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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:


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
Active Comparator: A1 Drug: Ipilimumab
Solution, Intravenous, 3 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.
Other Names:
  • BMS-734016
  • (MDX-010)
Active Comparator: A2 Drug: Ipilimumab
Solution, Intravenous, 10 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.
Other Names:
  • BMS-734016
  • (MDX-010)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Aarhus C, Denmark, 8000
Local Institution
Odense C, Denmark, 5000
Israel
Local Institution
Jerusalem, Israel, 72080
Italy
Local Institution
Bari, Italy, 70126
Local Institution
Forli', Italy, 47100
Local Institution
Ravenna, Italy, 48100
Local Institution
Rimini, Italy, 47900
Norway
Local Institution
Oslo, Norway, 0310
Peru
Local Institution
Lima, Peru, LIMA 11
Local Institution
Lima, Peru, 43
Sweden
Local Institution
Gothenberg, Sweden, 413 45
Local Institution
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00261365     History of Changes
Other Study ID Numbers: CA184-004
Study First Received: December 1, 2005
Last Updated: February 27, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on October 30, 2014