Clinical trial NCT00261365: Phase II Study to Determine Predictive Markers of Response to BMS-734016 (MDX-010)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Unresectable Stage III or IV Malignant Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2005-12-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Purpose - to identify candidate markers predictive of response and/or serious toxicity to MDX-101 (BMS-734016)
timeFrame: on a continuous & ongoing basis
Secondary outcomes:
measure: Safety & tumor response are important secondary objectives. Safety evaluated
timeFrame: on a continuous & ongoing basis
measure: Tumor response measured
timeFrame: starting @ wk 12 through wk 24. Those continuing on therapy after wk 24 have tumor responses evaluated every 3 months
Other outcomes:
Locations:
city: Palm Springs
country: United States
facility: Comprehensive Cancer Center
state: California
city: Santa Monica
country: United States
facility: The Angeles Clinic And Research Institution
state: California
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Aarhus C
country: Denmark
facility: Local Institution
city: Odense C
country: Denmark
facility: Local Institution
city: Jerusalem
country: Israel
facility: Local Institution
city: Bari
country: Italy
facility: Local Institution
city: Forli'
country: Italy
facility: Local Institution
city: Ravenna
country: Italy
facility: Local Institution
city: Rimini
country: Italy
facility: Local Institution
city: Oslo
country: Norway
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Gothenberg
country: Sweden
facility: Local Institution
city: Stockholm
country: Sweden
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, Patt D, Chen TT, Berman DM, Wolchok JD. Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. J Clin Oncol. 2015 Jun 10;33(17):1889-94. doi: 10.1200/JCO.2014.56.2736. Epub 2015 Feb 9.
citation: Hamid O, Schmidt H, Nissan A, Ridolfi L, Aamdal S, Hansson J, Guida M, Hyams DM, Gomez H, Bastholt L, Chasalow SD, Berman D. A prospective phase II trial exploring the association between tumor microenvironment biomarkers and clinical activity of ipilimumab in advanced melanoma. J Transl Med. 2011 Nov 28;9:204. doi: 10.1186/1479-5876-9-204.