Back to resultsStudy of CP-675,206 in Refractory Melanoma
Primary Purpose
Refractory Melanoma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CP-675,206
Sponsored by
About this trial
This is an interventional treatment trial for Refractory Melanoma focused on measuring refractory melanoma, malignant melanoma
Eligibility Criteria
Inclusion Criteria: Surgically incurable Stage III or IV melanoma One prior systemic treatment for metastatic melanoma Measurable disease Eastern Cooperative Oncology Group (ECOG) PS = 0 or 1 Exclusion Criteria: Melanoma of ocular origin Received prior vaccine Received prior CTLA4-inhibiting agent History of, or significant risk for, chronic inflammatory or autoimmune disease Potential requirement for systemic corticosteroids
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Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
15 mg/kg CP-675,206
Arm Description
Outcomes
Primary Outcome Measures
To assess the anti-tumor efficacy, as determined by objective response rate, of intravenous CP-675,206 administered at a dose of 15 mg/kg every 90 days to patients with relapsed or refractory advanced melanoma
Secondary Outcome Measures
Safety
Pharmaco Kinetic
Survival
Health-related QoL
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00254579
Brief Title
Study of CP-675,206 in Refractory Melanoma
Official Title
A Phase 2, Open Label, Single Arm Study To Evaluate The Efficacy, Safety, Tolerability And Pharmacokinetics Of CP-675,206 In Patients With Advanced Refractory And/Or Relapsed Melanoma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
CP-675,206 is a fully human monoclonal antibody (mAb). It binds to the CTLA4 molecule, which is expressed on the surface of activated T lymphocytes. CP-675,206 is thought to stimulate patients' immune systems to attack their tumors. CP-675,206 is not expected to have a direct effect on tumor cells. CP-675,206 been shown to induce durable tumor responses in patients with metastatic melanoma in Phase 1 and Phase 2 clinical studies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Melanoma
Keywords
refractory melanoma, malignant melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
251 (Actual)
8. Arms, Groups, and Interventions
Arm Title
15 mg/kg CP-675,206
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CP-675,206
Intervention Description
15 mg/kg Q12W dosing regimen
Primary Outcome Measure Information:
Title
To assess the anti-tumor efficacy, as determined by objective response rate, of intravenous CP-675,206 administered at a dose of 15 mg/kg every 90 days to patients with relapsed or refractory advanced melanoma
Time Frame
Tumor response is assessed every 2-3 months until disease progression
Secondary Outcome Measure Information:
Title
Safety
Time Frame
At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
Title
Pharmaco Kinetic
Time Frame
At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
Title
Survival
Time Frame
At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
Title
Health-related QoL
Time Frame
At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Surgically incurable Stage III or IV melanoma
One prior systemic treatment for metastatic melanoma
Measurable disease
Eastern Cooperative Oncology Group (ECOG) PS = 0 or 1
Exclusion Criteria:
Melanoma of ocular origin
Received prior vaccine
Received prior CTLA4-inhibiting agent
History of, or significant risk for, chronic inflammatory or autoimmune disease
Potential requirement for systemic corticosteroids
Facility Information:
Facility Name
Research Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
Research Site
City
Bentonville
State/Province
Arkansas
ZIP/Postal Code
72712
Country
United States
Facility Name
Research Site
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Research Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-6970
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Research Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Research Site
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902-3628
Country
United States
Facility Name
Research Site
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Research Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Research Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Research Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Research Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237-3998
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Research Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0946
Country
United States
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Research Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Research Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7600
Country
United States
Facility Name
Research Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Pfizer Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Research Site
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Research Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Research Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6307
Country
United States
Facility Name
Research Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Research Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Research Site
City
Federal Way
State/Province
Washington
ZIP/Postal Code
98003
Country
United States
Facility Name
Research Site
City
Lakewood
State/Province
Washington
ZIP/Postal Code
98499
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Research Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
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Research Site
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Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
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Research Site
City
Ciudad de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1280AEA
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Argentina
Facility Name
Research Site
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
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Australia
Facility Name
Research Site
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
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Australia
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Research Site
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Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
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Australia
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Research Site
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
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Australia
Facility Name
Research Site
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
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Australia
Facility Name
Research Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Research Site
City
Lille
State/Province
Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Research Site
City
Paris Cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
Research Site
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Research Site
City
Frankfurt
ZIP/Postal Code
60488
Country
Germany
Facility Name
Research Site
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Research Site
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Research Site
City
Meldola, FC
ZIP/Postal Code
47014
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Research Site
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
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Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Research Site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Research Site
City
Truro
State/Province
Cornwall
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Facility Name
Research Site
City
Northwood
State/Province
Middlesex
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Research Site
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Research Site
City
Newcastle upon Tyne
State/Province
Tyne and Wear
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Research Site
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Research Site
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
12. IPD Sharing Statement
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Study of CP-675,206 in Refractory Melanoma
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