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

Enrollment

Locations

Arms

Duration (Months)

3.4

Patients Per Site

0.2

Patients Per Site Per Month

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
Melanoma	Drug: ipilimumab (MDX-010, BMS-734016) Drug: Ipilimumab Drug: Ipilimumab	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.

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:

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 , ,

Stage III (unresectable)

Stage IV melanoma

Additional relevant MeSH terms:

Melanoma

Ipilimumab

Study Results

No Results Posted as of Mar 2, 2010