Study of CP-675,206 in Refractory Melanoma

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Refractory Melanoma

Treatments: Drug: CP-675,206

Study type: Interventional

Funder types: Industry

Identifiers

NCT00254579

A3671008

Details and patient eligibility

About

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.

Enrollment: 251 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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251 participants in 1 patient group

15 mg/kg CP-675,206

Experimental group

Treatment:

Drug: CP-675,206