A Multicenter Treatment Protocol for Expanded Access Use of Ipilimumab (BMS-734016) Monotherapy in Subjects With Unresectable Stage III or Stage IV Melanoma
The primary objective of the study is to provide treatment with Ipilimumab to subjects who have serious or immediately life-threatening unresectable Stage III or Stage IV melanoma, who have no alternative treatment options, and whose physicians believe, based upon available data on benefit and risk, that it is appropriate to administer Ipilimumab at a dose of 3 mg/kg induction (with re-induction, if eligible), or for eligible subjects previously enrolled in Ipilimumab studies CA184-042, CA184-078, CA184-087, MDX010-16, or MDX010-20.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Ipilimumab
Ages Eligible For Study:
- Signed Written Informed Consent - Histologically confirmed Stage III (unresectable) or Stage IV melanoma - Must have failed at least one systemic therapy for malignant melanoma or be intolerant to at least one prior systemic treatment. Note: Enrollees must not be eligible for a clinical study with Ipilimumab - Subjects with asymptomatic brain metastases are eligible - Primary ocular and mucosal melanomas are allowed - Must be at least 28 days since treatment with chemotherapy, biochemotherapy, or immunotherapy, and recovered from any clinically significant toxicity experienced during treatment. Must have recovered from prior surgery or radiation. Systemic corticosteroids should be eliminated or weaned to the minimum dose before starting Ipilimumab treatment. Consult with the Medical Monitor for individual subjects - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0- 2 - Life expectancy ? 16 weeks - Subjects must have the complete set of baseline (screening/baseline) radiographic images, including but not limited to brain, chest, abdomen, and pelvis. Bone scans should be completed if clinically indicated. The images can be accepted if obtained 6 weeks before initiation of Ipilimumab - Required values for initial laboratory tests: 1. White Blood Cells (WBC): ? 2000/uL (? 2 x 10*9*/L) 2. Antigen Neutrophil Count (ANC): ? 1000/uL (? 1 x 10*9*/L) 3. Platelets: ? 75 x 103/uL (? 75 x 10*9*/L) 4. Hemoglobin: ? 9 g/dL (? 80 g/L; may be transfused) 5. Creatinine: ? 2.0 x ULN - Aspartate Aminotransferase (AST)/Alanine Aminotransferase (ALT):? 2.5 x Upper Limit of Normal (ULN) for subjects without liver metastasis ? 5 times for liver metastases - Bilirubin: ? 2.0 x ULN (except for subjects with Gilbert's Syndrome, who must have a total bilirubin of less than 3.0 mg/dL) - Men and women, at least 16 years of age - Prior treatment with an anti-Cytotoxic T-lymphocyte Associated Protein 4 (CTLA-4) drug is allowed provided therapy was not discontinued to to drug-related toxicity - Women of childbearing potential (WOCBP) and their partners must use highly effective methods of birth control (double barrier, e.g, condom or diaphragm or cervical cap associated with spermicide or intrauterine device combined with another form of birth control) for up to 12 weeks after the last dose of study drug to minimize the risk of pregnancy - WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) at Screening and within 24 hours prior to the start of investigational product - Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile - Men of fathering potential must be using an adequate method of contraception to avoid conception throughout the study and for up to 12 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized