Compassionate Use Trial for Unresectable Melanoma With Ipilimumab (anti-CTLA4 Monoclonal Antibody MDX 010)

MDX-010 is a monoclonal antibody against CTLA-4 on the surface of activated T-cells. Interaction of the antibody with the CTLA-4 results in enhanced T cell responses and can lead to tumor rejection in animal models..

Since this is a compassionate use protocol, there are no primary or secondary outcome measures.

Inclusion Criteria (conditions the patient must meet)

1. At least 18 years old
2. Stage III or IV unresectable melanoma
3. Must have failed at least one systemic therapy or be intolerant to at least one prior systemic therapy

Exclusion Criteria
Patients who exhibit any of the following conditions at screening will not be eligible for admission into the study:

1. Women of child-bearing potential must use adequate contraception
2. Active autoimmune disease
3. Positive test for hepatitis B or C
4. Subjects taking other systemic therapy
5. Prior treatment with anti-CTLA-4 antibody if treatment failure was due to immune related AEs

Treatment Regimen