| General information |
| Database: | DB00966 |
| Objective: | Ipilimumab improves survival in advanced melanoma and can induce immunemediated tumor vasculopathy. Besides promoting angiogenesis, vascular endothelial growth factor (VEGF) suppresses dendritic cell maturation and modulates lymphocyte endothelial trafficking. This study investigated the combination of CTLA4 blockade with ipilimumab and VEGF inhibition with bevacizumab. |
| Authors: | Hodi FS, et al |
| Title: | Bevacizumab plus ipilimumab in patients with metastatic melanoma. |
| Journal: | Cancer Immunol Res. |
| Year: | 2014 |
| PMID: | 24838938 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | Bevacizumab, ipilimumab
|
| Target: | NA
|
| Cancer Type: | melanoma |
| Cancer Subtype: | advanced melanoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 1 |
| Therapeutic Combination Content: | Bevacizumab+ ipilimumab |
| Study Type: | Patient eligibility included measureable unresectable stage III or stage IV melanoma, Eastern Cooperative Oncology Group (ECOG) performance status of 0 or I, adequate endorgan function |
| Key Patients Feature: | patients with metastatic melanoma |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients with metastatic melanoma were treated in four dosing cohorts of ipilimumab (3 or 10 mg/kg) with four doses at 3week intervals and then every 12 weeks, and bevacizumab (7.5 or 15 mg/kg) every 3 weeks. |
| Primary End Point: | efficacy and safety |
| Secondary End Point: | NA |
| Patients Number: | 46 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 10.90% |
| Disease Control Rate: | 67.40% |
| Median Time to Progression: | 9.0 months (95% CI 5.5 to 14.5 months) (longest cohort 2: 14.5 months (95% CI 3.8 to ¡Þ) |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | 25.1 months (95% CI: 12.7 to ¡Þ) (cohort 2: 25.1 months (95% CI: 9.6 to ¡Þ). |
| Adverse Event(agent arm): | No doselimiting toxicities occurred in cohorts 1 or 2. There were no treatmentrelated deaths. All 46 patients reported adverse events. The most commonly reported adverse events (any grade) were: fatigue, rash/desquamation, headache, and cough. |
| Conclusions: | These findings provide a basis for further investigating the dual roles of angiogenic factors in blood vessel formation and immune regulation, as well as future combinations of antiangiogenesis agents and immune checkpoint blockade |