Study of CP-675,206 in Refractory Melanoma

Phase 2

Completed

• Conditions: Refractory Melanoma
• Interventions: Drug: CP-675,206

• Registration Number: NCT00254579
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-11-14
• Study First Submitted QC: 2005-11-14
• Study First Posted: 2005-11-16
• Study Start: 2005-12
• Disposition First Submitted: 2009-05-09
• Disposition First Submitted QC: 2009-05-13
• Disposition First Posted: 2009-09-28
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-05
• Last Update Posted: 2012-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 251

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
15 mg/kg CP-675,206	CP-675,206	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Survival	At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
Safety	At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
Pharmaco Kinetic	At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
Health-related QoL	At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug

Trial Locations

Locations (2)

Research Site; 🇬🇧 Newcastle Upon Tyne, United Kingdom

Pfizer Investigational Site; 🇺🇸 Columbus, Ohio, United States