| General information |
| Database: | DB00001 |
| Objective: | Ipilimumab monotherapy (at a dose of 3 mg per kilogram of body weight), as compared with glycoprotein 100, improved overall survival in a phase 3 study involving patients with previously treated metastatic melanoma. They conducted a phase 3 study of ipilimumab (10 mg per kilogram) plus dacarbazine in patients with previously untreated metastatic melanoma. |
| Authors: | Robert C, et al |
| Title: | Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. |
| Journal: | N Engl J Med. |
| Year: | 2011 |
| PMID: | 21639810 |
| Trial Design |
| Clinical Trial Id: | NCT00324155 |
| Agent: | ipilimumab
|
| Target: | Cytotoxic Tlymphocyte antigen 4 (CTLA4)
|
| Cancer Type: | melanoma |
| Cancer Subtype: | advanced melanoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 8 |
| Therapeutic Combination Content: | ipilimumab (10 mg per kilogram)+ dacarbazine |
| Study Type: | A multinational, randomized, doubleblind, phase III study |
| Key Patients Feature: | Eligible patients were at least 18 years of age and had previously untreated stage III (unresectable) or stage IV melanoma with measurable lesions |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | dacarbazine and placebo |
| Treatment Info: | randomly assigned patients with previously untreated metastatic melanoma, in a 1:1 ratio, to ipilimumab (10 mg per kilogram) plus dacarbazine (850 mg per square meter of bodysurface area) or dacarbazine (850 mg per square meter) plus placebo, given at weeks 1, 4, 7, and 10, followed by dacarbazine alone every 3 weeks through week 22. |
| Primary End Point: | overall survival. |
| Secondary End Point: | NA |
| Patients Number: | 502 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | OS was significantly longer in the group receiving ipilimumab plus dacarbazine than in the group receiving dacarbazine plus placebo (11.2 months vs. 9.1 months, with higher survival rates in the ipilimumabdacarbazine group at 1 year (47.3% vs. 36.3%), 2 years (28.5% vs. 17.9%), and 3 years (20.8% vs. 12.2%) (hazard ratio for death, 0.72; P<0.001). |
| Adverse Event(agent arm): | Grade 3 or 4 adverse events occurred in 56.3% of patients treated with ipilimumab plus dacarbazine, as compared with 27.5% treated with dacarbazine and placebo (P<0.001). No drugrelated deaths or gastrointestinal perforations occurred in the ipilimumabdacarbazine group. |
| Conclusions: | Ipilimumab (at a dose of 10 mg per kilogram) in combination with dacarbazine, as compared with dacarbazine plus placebo, improved overall survival in patients with previously untreated metastatic melanoma. The types of adverse events they were consistent with those seen in prior studies of ipilimumab; hotheyver, the rates of elevated liverfunction values they were higher and the rates of gastrointestinal events they were lotheyr than expected on the basis of prior studies. |