| General information |
| Database: | DB00976 |
| Objective: | Ipilimumab improves survival of patients with metastatic melanoma, many of whom develop brain metastases. Chemotherapyinduced release of tumour antigens might amplify ipilimumab's antitumour activity. they aimed to investigate the efficacy and safety of ipilimumab plus fotemustine in patients with metastatic melanoma with or without asymptomatic brain metastases |
| Authors: | Di Giacomo AM, et al |
| Title: | Ipilimumab and fotemustine in patients with advanced melanoma (NIBITM1): an openlabel, singlearmphase 2 trial. |
| Journal: | Lancet Oncol. |
| Year: | 2012 |
| PMID: | 22894884 |
| Trial Design |
| Clinical Trial Id: | NCT01654692 |
| Agent: | ipilimumab
|
| Target: | Cytotoxic Tlymphocyte antigen 4 (CTLA4)
|
| Cancer Type: | melanoma |
| Cancer Subtype: | advanced melanoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | Ipilimumab + fotemustine |
| Study Type: | an openlabel, singlearmphase II trial |
| Key Patients Feature: | patients 18 years or older with measurable, locally advanced, unresectable stage III or stage IV melanoma;Eligible patients had a life expectancy of 16 weeks or more and an Eastern Cooperative Oncology Group performance status of 1 or less, and could have received a maximum of one previous line of chemotherapy |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Participants received induction treatment of 10 mg/kg intravenous ipilimumab every 3 weeks to a total of four doses, and 100 mg/m(2) intravenous fotemustine weekly for 3 weeks and then every 3 weeks from week 9 to week 24. Patients with a confirmed clinical response were eligible for maintenance treatment from week 24, with ipilimumab every 12 weeks and fotemustine every 3 weeks. |
| Primary End Point: | the proportion of patients with immunerelated disease control as established with immunerelated response criteria. Analyses were done per protocol |
| Secondary End Point: | NA |
| Patients Number: | 86 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | 46.50% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 8.6 months, 3.6-13.6 in the whole study population |
| Median OS A vs. C: | 13.3 months (95% CI 8.9-19.9) in the whole study population |
| Adverse Event(agent arm): | The most common adverse events were immunerelated adverse reactions (table 4), the most common of which were skin and liver related. No cases of gastrointestinal perforations or hypophysitis were reported after treatment. however, myelotoxicity, nausea, and vomiting related to fotemustine were recorded (table 4). |
| Conclusions: | The combination of ipilimumab plus fotemustine has clinical activity in patients with metastatic melanoma, including those with brain metastases. |