Study of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma
Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT00289640
Collaborator
Medarex (Industry)
210
62
3
15
3.4
0.2
Study Details
Study Description
Brief Summary
The purpose of this clinical research study is to compare the best overall response rate (BORR)(as per modified WHO criteria) in patients with previously treated, therapy-refractory, or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg. The safety of this product will also be evaluated.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
210 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Multi-center, Phase II Fixed Dose Study of Multiple Doses of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma
Study Start Date
:
Apr 1, 2006
Actual Primary Completion Date
:
Jul 1, 2007
Actual Study Completion Date
:
Jul 1, 2007
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 1
|
Drug: ipilimumab (MDX-010, BMS-734016)
IV solution, IV, 0.3mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
|
Experimental: 2
|
Drug: Ipilimumab
IV solution, IV, 3 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
|
Experimental: 3
|
Drug: Ipilimumab
IV solution, IV, 10 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
|
Outcome Measures
Primary Outcome Measures
- estimate BORR in patients with previously treated, therapy-refractory or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg. []
Secondary Outcome Measures
- estimate progression free survival rate at Week 12 assessment and other timepoints []
- estimate disease control rate at various time points []
- estimate overall survival []
- estimate survival rate at one year []
- evaluate health-related quality of life []
- obtain pharmacokinetic samples for population PK analysis []
Eligibility Criteria
Criteria
Ages Eligible for Study:
16 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients with previously treated, therapy-refractory or -intolerant, Stage III (unresectable) or Stage IV melanoma
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Arizona Cancer Center | Tucson | Arizona | United States | 85724 |
2 | Wilshire Oncology Medical Group Inc | Laverne | California | United States | 91750 |
3 | Scripps Cancer Center | San Diego | California | United States | 92121 |
4 | The Angeles Clinic And Research Institution | Santa Monica | California | United States | 90404 |
5 | Yale University School Of Medicine | New Haven | Connecticut | United States | 06520 |
6 | Baptist Cancer Institute | Jacksonville | Florida | United States | 32207 |
7 | Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida | United States | 33140 |
8 | Md Anderson Cancer Center Orlando | Orlando | Florida | United States | 32806 |
9 | Palm Beach Cancer Institute | West Palm Beach | Florida | United States | 33401 |
10 | Oncology Specialists, Sc | Park Ridge | Illinois | United States | 60068 |
11 | American Health Network | Indianapolis | Indiana | United States | 46202 |
12 | University Of Louisville | Louisville | Kentucky | United States | 40202 |
13 | Harry And Jeanette Weinberg Cancer Inst At Franklin Square | Baltimore | Maryland | United States | 21237 |
14 | Hubert H. Humphrey Cancer Center | Robbinsdale | Minnesota | United States | 55422 |
15 | Ellis Fischel Cancer Center | Columbia | Missouri | United States | 65203 |
16 | St Joseph Oncology Inc | St Joseph | Missouri | United States | 64507 |
17 | Washington University School Of Medicine | St. Louis | Missouri | United States | 63110 |
18 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10021 |
19 | Presbyterian Hospital | Charlotte | North Carolina | United States | 28204 |
20 | The Christ Hospital Cancer Center Research | Cincinnati | Ohio | United States | 45219 |
21 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
22 | Providence Portland Medical Center | Portland | Oregon | United States | 97213 |
23 | Cancer Centers Of The Carolinas | Greenville | South Carolina | United States | 29615 |
24 | Center For Oncology Research & Treatment, P.A. | Dallas | Texas | United States | 75230 |
25 | Mary Crowley Medical Research Center | Dallas | Texas | United States | 75246 |
26 | Local Institution | Newcastle | New South Wales | Australia | 2300 |
27 | Local Institution | Brisbane | Queensland | Australia | 4101 |
28 | Local Institution | Heidelberg | Victoria | Australia | 3084 |
29 | Local Institution | Wodonga | Victoria | Australia | 3690 |
30 | Local Institution | Brussels | Belgium | 1090 | |
31 | Local Institution | Bruxelles | Belgium | 1070 | |
32 | Local Institution | Bruxelles | Belgium | 1200 | |
33 | Local Institution | Centro-Porto Alegre | Rio Grande Do Sul | Brazil | 90020 |
34 | Local Institution | Porto Alegre | Rio Grande Do Sul | Brazil | 90610 |
35 | Local Institution | Jau | Sao Paulo | Brazil | 17210 |
36 | Local Institution | Sao Paulo | Brazil | 01509 | |
37 | Local Institution | Calgary | Alberta | Canada | T2N 4N2 |
38 | Local Institution | Edmonton | Alberta | Canada | T6G 1Z2 |
39 | Local Institution | Kingston | Ontario | Canada | K7L 5P9 |
40 | Local Institution | Olomouc | Czech Republic | 775 20 | |
41 | Local Institution | Praha | Czech Republic | 128 08 | |
42 | Local Institution | Brest | Cedex | France | 29200 |
43 | Local Institution | Clermont Ferrand | France | 63058 | |
44 | Local Institution | Lyon Cedex 08 | France | 69373 | |
45 | Local Institution | Lyon | France | 69288 | |
46 | Local Institution | Marseille Cedex 09 | France | 13009 | |
47 | Local Institution | Paris | France | 75010 | |
48 | Local Institution | Rennes | France | 35042 | |
49 | Local Institution | Toulouse | France | 31059 | |
50 | Local Institution | Vandoeuvre Les Nancy | France | 54511 | |
51 | Local Institution | Berlin | Germany | 12200 | |
52 | Local Institution | Essen | Germany | 45122 | |
53 | Local Institution | Heidelberg | Germany | 69115 | |
54 | Local Institution | Jena | Germany | 07740 | |
55 | Local Institution | Kiel | Germany | 24105 | |
56 | Local Institution | Mannheim | Germany | 68169 | |
57 | Local Institution | Wurzburg | Germany | 97080 | |
58 | Local Institution | Pécs | Hungary | 7624 | |
59 | Local Institution | Johannesburg | Gauteng | South Africa | 2199 |
60 | Local Institution | Pretoria | Gauteng | South Africa | 0041 |
61 | Local Institution | Pretoria | Gauteng | South Africa | 0181 |
62 | Local Institution | Cape Town | Western Cape | South Africa | 7506 |
Sponsors and Collaborators
- Bristol-Myers Squibb
- Medarex
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00289640
Other Study ID Numbers:
- CA184-022
First Posted:
Feb 10, 2006
Last Update Posted:
Mar 2, 2010
Last Verified:
Jan 1, 2009
Keywords provided by ,
,
Additional relevant MeSH terms: