Phase II Study to Determine Predictive Markers of Response to BMS-734016 (MDX-010)
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00261365
First received: December 1, 2005
Last updated: February 27, 2010
Last verified: August 2008
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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:
|
| Active Comparator: A2 |
Drug: Ipilimumab
Solution, Intravenous, 10 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.
Other Names:
|
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
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 Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
ClinicalTrials.gov processed this record on May 21, 2013