Clinical trial NCT00254579: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Refractory Melanoma
Keywords: refractory melanoma
malignant melanoma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-16
Enrollment: 251
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: Tumor response is assessed every 2-3 months until disease progression
Secondary outcomes:
measure: Safety
timeFrame: At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
measure: Pharmaco Kinetic
timeFrame: At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
measure: Survival
timeFrame: At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
measure: Health-related QoL
timeFrame: At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
city: Bentonville
country: United States
facility: Research Site
state: Arkansas
city: Fayetteville
country: United States
facility: Research Site
state: Arkansas
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Stamford
country: United States
facility: Research Site
state: Connecticut
city: Ocoee
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Louisville
country: United States
facility: Research Site
state: Kentucky
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: Buffalo
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Chapel Hill
country: United States
facility: Research Site
state: North Carolina
city: Durham
country: United States
facility: Research Site
state: North Carolina
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Bethlehem
country: United States
facility: Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Federal Way
country: United States
facility: Research Site
state: Washington
city: Lakewood
country: United States
facility: Research Site
state: Washington
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Tacoma
country: United States
facility: Research Site
state: Washington
city: Madison
country: United States
facility: Research Site
state: Wisconsin
city: Ciudad de Buenos Aires
country: Argentina
facility: Research Site
state: Buenos Aires
city: Waratah
country: Australia
facility: Research Site
state: New South Wales
city: Westmead
country: Australia
facility: Research Site
state: New South Wales
city: Woolloongabba
country: Australia
facility: Research Site
state: Queensland
city: East Melbourne
country: Australia
facility: Research Site
state: Victoria
city: Nedlands
country: Australia
facility: Research Site
state: Western Australia
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: Lille
country: France
facility: Research Site
state: Cedex
city: Paris Cedex 13
country: France
facility: Research Site
city: Villejuif
country: France
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Kiel
country: Germany
facility: Research Site
city: Tuebingen
country: Germany
facility: Research Site
city: Meldola, FC
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Pamplona
country: Spain
facility: Research Site
state: Navarra
city: Barcelona
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
city: Truro
country: United Kingdom
facility: Research Site
state: Cornwall
city: Northwood
country: United Kingdom
facility: Research Site
state: Middlesex
city: Sutton
country: United Kingdom
facility: Research Site
state: Surrey
city: Newcastle upon Tyne
country: United Kingdom
facility: Research Site
state: Tyne and Wear
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Newcastle Upon Tyne
country: United Kingdom
facility: Research Site
Study officials:
References: