| General information |
| Database: | DB00661 |
| Objective: | They conducted a retrospective analysis of data from a phase II study of ipilimumab in advanced melanoma patients. |
| Authors: | theyber JS, et al |
| Title: | Safety and clinical activity of ipilimumab in melanoma patients with brain metastases: retrospective analysis of data from a phase 2 trial. |
| Journal: | Melanoma Res. |
| Year: | 2011 |
| PMID: | 22051508 |
| Trial Design |
| Clinical Trial Id: | retrospective |
| Agent: | ipilimumab
|
| Target: | Cytotoxic Tlymphocyte antigen 4 (CTLA4)
|
| Cancer Type: | melanoma |
| Cancer Subtype: | advanced melanoma with brain metastases |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | retrospective analysisof data from a phase II trial |
| Key Patients Feature: | histologically or cytologically diagnosed unresectablestage III (3.5%) or IV (96.5%) melanoma |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | they conducted a retrospective analysis of data from a phase II study of ipilimumab in advanced melanoma patients. |
| Primary End Point: | safety and efficacy |
| Secondary End Point: | NA |
| Patients Number: | 115 |
| Trial Results |
| DLT_MTD: | Central nervous systemrelated adverse events of grade3-4, specifically cerebral edema and convulsion/seizure, occurred in two of 16 patients |
| Objective Response Rate: | Two of the 12patients achieved a partial response and three had stabledisease. Both patients with a partial response and one withstable disease were alive at the last followup, with survivaltime of more than 4 years |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | 14 months (range: 2.7-56.4+). |
| Adverse Event(agent arm): | Central nervous systemrelated adverse events of grade 3-4, specifically cerebral edema and convulsion/seizure, occurred in two of 16 patients. A |
| Conclusions: | Although the present study is limited by the fact that it is a retrospective analysis of a small number of patients, the results provide further evidence for the safety and efficacy of ipilimumab in melanoma patients with stable brain metastases. |