Study of CP-675,206 in Refractory Melanoma

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00254579
• Date of registration: 14/11/2005
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: Study of CP-675,206 in Refractory Melanoma
• Scientific 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
• Date of first enrolment: December 2005
• Target sample size: 251
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00254579
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Argentina, Australia, Canada, France, Germany, Italy, Spain, United Kingdom, United States

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Refractory Melanoma

Intervention(s)

Drug: CP-675,206

Primary Outcome(s)

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(s)

Safety [Time Frame: At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug]

Pharmaco Kinetic [Time Frame: At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug]

Survival [Time Frame: At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug]

Health-related QoL [Time Frame: At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug]

Secondary ID(s)

A3671008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors