Advanced Unresectable Melanoma
Conditions
Brief summary
The purpose of this study is to provide access to CP-675,206 for patients with advanced unresectable melanoma and who have the potential to gain benefit from this treatment and who are not eligible for participation in other CP-675,206 studies.
Detailed description
This is an expanded access trial that canceled prior to enrolling patients.
Interventions
DRUGCP-675,206
This is a single arm study. Patients will receive intravenous administration of CP-675,206 at a dose of 15 mg/kg on Day 1 of every 90-day cycle for up to 4 cycles. For purposes of treatment visits and scheduling, each cycle is defined as a 90 (± 4 day) period. Patients who discontinue treatment after 4 doses of CP-675,206 without disease progression and who subsequently experience disease progression more than 3 months after the last dose may receive 2 additional doses of CP-675,206 provided that they have not received other systemic therapy for their melanoma Survival in this study will be monitored on all patients for up to 5 years from the date of first dose of CP-675,206.
Sponsors
Pfizer
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Advanced melanoma with life expectancy of at least 6 months. * Melanoma must be considered unresectable. * Patients with stable, treated brain mets must be stable clinically and radiographically and off steroids for at least one month.
Exclusion criteria
* Patients must not be eligible for participation in any ongoing CP-675,206 clinical studies currently open for enrollment. * History of chronic inflammatory or autoimmune disease. * History of inflammatory bowel disease, celiac disease, or other chronic gastrointestinal conditions associated with diarrhea, active colitis, history of diverticulitis.
Outcome results
None listed