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NCT00261365 Clinical Trial

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

Unresectable Stage III or IV Malignant Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00261365
Other study ID # CA184-004
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received December 1, 2005
Last updated September 27, 2016
Start date November 2005
Est. completion date October 2007

Study information
Verified date August 2008
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date October 2007
Est. primary completion date October 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

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

Related Conditions & MeSH terms

  • Melanoma
  • Unresectable Stage III or IV Malignant Melanoma

Intervention

Drug:
• Ipilimumab
Solution, Intravenous, 3 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.
• Ipilimumab
Solution, Intravenous, 10 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.

Locations
Country Name City State
Denmark Local Institution Aarhus C
Denmark Local Institution Odense C
Israel Local Institution Jerusalem
Italy Local Institution Bari
Italy Local Institution Forli'
Italy Local Institution Ravenna
Italy Local Institution Rimini
Norway Local Institution Oslo
Peru Local Institution Lima
Peru Local Institution Lima
Sweden Local Institution Gothenberg
Sweden Local Institution Stockholm
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Comprehensive Cancer Center Palm Springs California
United States The Angeles Clinic And Research Institution Santa Monica California

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

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

Outcome
Type Measure Description Time frame Safety issue
Primary Purpose - to identify candidate markers predictive of response and/or serious toxicity to MDX-101 (BMS-734016) on a continuous & ongoing basis No
Secondary Safety & tumor response are important secondary objectives. Safety evaluated on a continuous & ongoing basis Yes
Secondary Tumor response measured starting @ wk 12 through wk 24. Those continuing on therapy after wk 24 have tumor responses evaluated every 3 months No

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