Study to Compare Two Formulations of CP-675,206 Monoclonal Antibody

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, 2-arm study in which patients are randomized to receive either the formulation that is being used in clinical trials or the formulation that will be used when if the drug becomes commercially available. The purpose of this study is to compare the pharmacokinetics of the two formulations.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Antibodies; Antibodies, Monoclonal; Ipilimumab; Tremelimumab

Criteria

Inclusion Criteria:

• Stage III or Stage IV melanoma

• No evidence of disease following resection of melanoma lesions

• Recovered from all prior surgical or adjuvant treatment-related toxicities

Exclusion Criteria:

• History of chronic inflammatory or autoimmune disease

• History of inflammatory bowel disease