A Single Arm Study of Ipilimumab Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma
Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT00289627
Collaborator
Medarex (Industry)
155
54
1
15
2.9
0.2
Study Details
Study Description
Brief Summary
The purpose of this clinical research study is to evaluate the Best Overall Response Rate (BORR), (as per modified WHO criteria) in patients with previously treated melanoma-Stage III (unresectable) or Stage IV melanoma receiving 10 mg/kg of ipilimumab. The safety of this product will also be evaluated.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
155 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multi-Center Single Arm Phase II Study of MDX-010 (BMS-734016) 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: ipilimumab (MDX-010, BMS-734016)
|
Drug: ipilimumab (MDX-010, BMS-734016)
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
- Evaluate BORR in patients with previously treated Stage III (unresectable) or Stage IV melanoma receiving ipilimumab. []
Secondary Outcome Measures
- estimate disease control rate []
- estimate progression free survival rate at Week 12 []
- estimate PFS []
- estimate overall survival []
- estimate survival rate at one year []
- estimate duration of BOR []
- evaluate proportion of patients whose duration of response is >=24 weeks []
- estimate time to BOR []
- evaluate safety profile of ipilimumab during the induction and maintenance phases []
- evaluate health-related quality of life []
- obtain PK sample for population PK analysis []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients with previously treated Stage III (unresectable)or Stage IV melanoma
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Little Rock | Arkansas | United States | ||
| 2 | San Francisco | California | United States | ||
| 3 | Santa Monica | California | United States | ||
| 4 | Chicago | Illinois | United States | ||
| 5 | Park Ridge | Illinois | United States | ||
| 6 | Goshen | Indiana | United States | ||
| 7 | Hazard | Kentucky | United States | ||
| 8 | Alburquerque | New Mexico | United States | ||
| 9 | New York | New York | United States | ||
| 10 | Portland | Oregon | United States | ||
| 11 | Greenville | South Carolina | United States | ||
| 12 | Knoxville | Tennessee | United States | ||
| 13 | Dallas | Texas | United States | ||
| 14 | Charlottesvillle | Virginia | United States | ||
| 15 | Local Institution | Salzburg | Austria | ||
| 16 | Local Institution | Wels | Austria | ||
| 17 | Local Institution | Wien | Austria | ||
| 18 | Local Institution | Turku | Finland | ||
| 19 | Local Institution | Genova | Italy | ||
| 20 | Local Institution | Meldola | Italy | ||
| 21 | Local Institution | Milano | Italy | ||
| 22 | Local Institution | Napoli | Italy | ||
| 23 | Local Institution | Padova | Italy | ||
| 24 | Local Institution | Siena | Italy | ||
| 25 | Local Institution | Torino | Italy | ||
| 26 | Local Institution | Oslo | Norway | ||
| 27 | Local Institution | Lodz | Poland | ||
| 28 | Local Institution | Poznan | Poland | ||
| 29 | Local Institution | Wroclaw | Poland | ||
| 30 | Local Institution | Barnaul | Russian Federation | ||
| 31 | Local Institution | Moscow | Russian Federation | ||
| 32 | Local Institution | Murmansk | Russian Federation | ||
| 33 | Local Institution | Ryazan | Russian Federation | ||
| 34 | Local Institution | Samara | Russian Federation | ||
| 35 | Local Institution | St Petersburg | Russian Federation | ||
| 36 | Local Institution | St. Petersburg | Russian Federation | ||
| 37 | Local Institution | Stavropol | Russian Federation | ||
| 38 | Local Institution | Velikiy Novgorod | Russian Federation | ||
| 39 | Local Institution | Voronezh | Russian Federation | ||
| 40 | Local Institution | Barcelona | Spain | ||
| 41 | Local Institution | Madrid | Spain | ||
| 42 | Local Institution | Malaga | Spain | ||
| 43 | Local Institution | Tenerife | Spain | ||
| 44 | Local Institution | Valencia | Spain | ||
| 45 | Local Institution | Goteborg | Sweden | ||
| 46 | Local Institution | Lund | Sweden | ||
| 47 | Local Institution | Stockholm | Sweden | ||
| 48 | Local Institution | Uppsala | Sweden | ||
| 49 | Local Institution | Cherkassy | Ukraine | ||
| 50 | Local Institution | Dnipropetrovsk | Ukraine | ||
| 51 | Local Institution | Kiev | Ukraine | ||
| 52 | Local Institution | Lvov | Ukraine | ||
| 53 | Local Institution | Sumy | Ukraine | ||
| 54 | Local Institution | Uzhgorod | Ukraine |
Sponsors and Collaborators
- Bristol-Myers Squibb
- Medarex
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00289627
Other Study ID Numbers:
- CA184-008
First Posted:
Feb 10, 2006
Last Update Posted:
Sep 28, 2016
Last Verified:
Sep 1, 2016
Keywords provided by ,
,
Additional relevant MeSH terms: