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Study of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma

Primary Purpose

Melanoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ipilimumab (MDX-010, BMS-734016)
Ipilimumab
Ipilimumab
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Stage III (unresectable), Stage IV melanoma

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with previously treated, therapy-refractory or -intolerant, Stage III (unresectable) or Stage IV melanoma

Sites / Locations

  • Arizona Cancer Center
  • Wilshire Oncology Medical Group Inc
  • Scripps Cancer Center
  • The Angeles Clinic And Research Institution
  • Yale University School Of Medicine
  • Baptist Cancer Institute
  • Mount Sinai Comprehensive Cancer Center
  • Md Anderson Cancer Center Orlando
  • Palm Beach Cancer Institute
  • Oncology Specialists, Sc
  • American Health Network
  • University Of Louisville
  • Harry And Jeanette Weinberg Cancer Inst At Franklin Square
  • Hubert H. Humphrey Cancer Center
  • Ellis Fischel Cancer Center
  • St Joseph Oncology Inc
  • Washington University School Of Medicine
  • Memorial Sloan Kettering Cancer Center
  • Presbyterian Hospital
  • The Christ Hospital Cancer Center Research
  • Cleveland Clinic
  • Providence Portland Medical Center
  • Cancer Centers Of The Carolinas
  • Center For Oncology Research & Treatment, P.A.
  • Mary Crowley Medical Research Center
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

1

2

3

Arm Description

Outcomes

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

Full Information

First Posted
February 9, 2006
Last Updated
February 27, 2010
Sponsor
Bristol-Myers Squibb
Collaborators
Medarex
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1. Study Identification

Unique Protocol Identification Number
NCT00289640
Brief Title
Study of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma
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 Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Medarex

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Stage III (unresectable), Stage IV melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ipilimumab (MDX-010, BMS-734016)
Intervention Description
IV solution, IV, 0.3mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
Intervention Type
Drug
Intervention Name(s)
Ipilimumab
Intervention Description
IV solution, IV, 3 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
Intervention Type
Drug
Intervention Name(s)
Ipilimumab
Intervention Description
IV solution, IV, 10 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
estimate progression free survival rate at Week 12 assessment and other timepoints
Title
estimate disease control rate at various time points
Title
estimate overall survival
Title
estimate survival rate at one year
Title
evaluate health-related quality of life
Title
obtain pharmacokinetic samples for population PK analysis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with previously treated, therapy-refractory or -intolerant, Stage III (unresectable) or Stage IV melanoma
Facility Information:
Facility Name
Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Wilshire Oncology Medical Group Inc
City
Laverne
State/Province
California
ZIP/Postal Code
91750
Country
United States
Facility Name
Scripps Cancer Center
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
The Angeles Clinic And Research Institution
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Yale University School Of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Baptist Cancer Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Mount Sinai Comprehensive Cancer Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Md Anderson Cancer Center Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Palm Beach Cancer Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Oncology Specialists, Sc
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
American Health Network
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University Of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Harry And Jeanette Weinberg Cancer Inst At Franklin Square
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Hubert H. Humphrey Cancer Center
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Ellis Fischel Cancer Center
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
St Joseph Oncology Inc
City
St Joseph
State/Province
Missouri
ZIP/Postal Code
64507
Country
United States
Facility Name
Washington University School Of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Presbyterian Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
The Christ Hospital Cancer Center Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Cancer Centers Of The Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Center For Oncology Research & Treatment, P.A.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Mary Crowley Medical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Local Institution
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2300
Country
Australia
Facility Name
Local Institution
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Local Institution
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Local Institution
City
Wodonga
State/Province
Victoria
ZIP/Postal Code
3690
Country
Australia
Facility Name
Local Institution
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Local Institution
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Local Institution
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Local Institution
City
Centro-Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90020
Country
Brazil
Facility Name
Local Institution
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610
Country
Brazil
Facility Name
Local Institution
City
Jau
State/Province
Sao Paulo
ZIP/Postal Code
17210
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
01509
Country
Brazil
Facility Name
Local Institution
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Local Institution
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Local Institution
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5P9
Country
Canada
Facility Name
Local Institution
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
Facility Name
Local Institution
City
Praha
ZIP/Postal Code
128 08
Country
Czech Republic
Facility Name
Local Institution
City
Brest
State/Province
Cedex
ZIP/Postal Code
29200
Country
France
Facility Name
Local Institution
City
Clermont Ferrand
ZIP/Postal Code
63058
Country
France
Facility Name
Local Institution
City
Lyon Cedex 08
ZIP/Postal Code
69373
Country
France
Facility Name
Local Institution
City
Lyon
ZIP/Postal Code
69288
Country
France
Facility Name
Local Institution
City
Marseille Cedex 09
ZIP/Postal Code
13009
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Local Institution
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Local Institution
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Local Institution
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Local Institution
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Local Institution
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Local Institution
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
Local Institution
City
Jena
ZIP/Postal Code
07740
Country
Germany
Facility Name
Local Institution
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Local Institution
City
Mannheim
ZIP/Postal Code
68169
Country
Germany
Facility Name
Local Institution
City
Wurzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Local Institution
City
Pécs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Local Institution
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2199
Country
South Africa
Facility Name
Local Institution
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0041
Country
South Africa
Facility Name
Local Institution
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0181
Country
South Africa
Facility Name
Local Institution
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7506
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
25667295
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.
Results Reference
derived
PubMed Identifier
20004617
Citation
Wolchok JD, Neyns B, Linette G, Negrier S, Lutzky J, Thomas L, Waterfield W, Schadendorf D, Smylie M, Guthrie T Jr, Grob JJ, Chesney J, Chin K, Chen K, Hoos A, O'Day SJ, Lebbe C. Ipilimumab monotherapy in patients with pretreated advanced melanoma: a randomised, double-blind, multicentre, phase 2, dose-ranging study. Lancet Oncol. 2010 Feb;11(2):155-64. doi: 10.1016/S1470-2045(09)70334-1. Epub 2009 Dec 8.
Results Reference
derived

Learn more about this trial

Study of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma

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