Treatment Use Study for Advanced Melanoma.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Study Start Date

2008-05-31

Brief Summary

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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

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This is an expanded access trial that canceled prior to enrolling patients.

Conditions

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Advanced Unresectable Melanoma

Interventions

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CP-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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Pfizer Inc

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Other Identifiers

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A3671028

Identifier Type: -

Identifier Source: org_study_id