| General information |
| Database: | DB00935 |
| Objective: | To evaluate the efficacy and safety of ramucirumab (IMC1121B; LY3009806), a fully human monoclonal antibody targeting the vascular endothelial growth factor receptor2, alone and in combination with dacarbazine in chemotherapyna ve patients with metastatic melanoma (MM). |
| Authors: | Carvajal RD, et al |
| Title: | a phase 2 randomised study of ramucirumab (IMC1121B) with or without dacarbazine in patients with metastatic melanoma. |
| Journal: | Eur J Cancer. |
| Year: | 2014 |
| PMID: | 24930625 |
| Trial Design |
| Clinical Trial Id: | NCT00533702 |
| Agent: | ramucirumab
|
| Target: | Vascular endothelial growth factor receptor 2
|
| Cancer Type: | melanoma |
| Cancer Subtype: | advanced melanoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | ramucirumab (IMC1121B) with dacarbazine |
| Study Type: | a phase II randomised study |
| Key Patients Feature: | chemotherapyna ve patients with metastatic melanoma (MM). |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | ramucirumab (IMC1121B) versus ramucirumab (IMC1121B) with dacarbazine |
| Treatment Info: | Eligible patients received ramucirumab (10mg/kg) + dacarbazine (1000 mg/m(2)) (Arm A) or ramucirumab only (10mg/kg) (Arm B) every 3 weeks. |
| Primary End Point: | progression free survival (PFS); |
| Secondary End Point: | overall survival (OS), overall response and safety. |
| Patients Number: | 106 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 17.3% in arm A; 4.0% in arm B |
| Disease Control Rate: | 36.5% in arm A; 42.0% in arm B |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 2.6 months (Arm A) and 1.7 months (Arm B) |
| Median OS A vs. C: | 8.7 months in Arm A and 11.1 months in Arm B. |
| Adverse Event(agent arm): | Overall AE rates were similar in both treatment arms (100.0% in Arm A, 98.0% in Arm B). A slightly higher proportion of patients in Arm A experienced AEs Grade 3 (30 patients, 57.7%) compared with Arm B (24 patients, 48.0%). Fatigue was the most common AE in both treatment groups (63.5% in Arm A and 56.0% in Arm B). In Arm A, the other most common AEs were thrombocytopenia (38.5%), neutropenia (34.6%) and hypertension (23.1%). In Arm B, the other most common AEs were headache (32.0%), hypertension (26.0%) and back pain (20.0%). |
| Conclusions: | Ramucirumab alone or in combination with dacarbazine was associated with an acceptable safety profile in patients with MM. Although the study was not pothey wered for comparison bettheyen treatment arms, PFS appeared greater with combination therapy. Sustained disease control was observed on both study arm. |