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


Phase 2
18 Years
N/A
Not Enrolling
Both
Refractory Melanoma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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

Outcome Time Frame:

Tumor response is assessed every 2-3 months until disease progression

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

A3671008

NCT ID:

NCT00254579

Start Date:

December 2005

Completion Date:

December 2009

Related Keywords:

  • Refractory Melanoma
  • refractory melanoma
  • malignant melanoma
  • Melanoma

Name

Location
Pfizer Investigational Site Cincinnait, Ohio  45236
Research Site Mesa, Arizona  
Research Site Bentonville, Arkansas  
Research Site Anaheim, California  
Research Site Boulder, Colorado  
Research Site Danbury, Connecticut  
Research Site Boca Raton, Florida  
Research Site Arlington Heights, Illinois  
Research Site Bloomington, Indiana  
Research Site Ashland, Kentucky  
Research Site Baltimore, Maryland  
Research Site Beverly, Massachusetts  
Research Site Battle Kreek, Michigan  
Research Site Albany, New York  
Research Site Asheville, North Carolina  
Research Site Akron, Ohio  
Research Site Allentown, Pennsylvania  
Research Site Chattanooga, Tennessee  
Research Site Ivins, Utah  
Research Site Auburn, Washington  
Research Site Appleton, Wisconsin