CMTTdb

An integrated database for cancer molecular targeted thearpies

Entry Detail


General information
Database:DB00005
Objective:Nivolumab was associated with higher rates of objective response than chemotherapy in a phase 3 study involving patients with ipilimumabrefractory metastatic melanoma. The use of nivolumab in previously untreated patients with advanced melanoma has not been tested in a phase 3 controlled study
Authors:Robert C, et al
Title:Nivolumab in previously untreated melanoma without BRAF mutation.
Journal:N Engl J Med
Year:2015
PMID:25399552
Trial Design
Clinical Trial Id:NCT01721772
Agent:nivolumab
Target:PD1
Cancer Type:melanoma
Cancer Subtype:advanced melanoma
Therapy Type:mono
Therapeutic Combination Type:NA
Therapeutic Combination Content:NA
Study Type:a phase III controlled study
Key Patients Feature:previously untreated patients who had metastatic melanoma without a BRAF mutation
Biomarker:BRAF mutation
Biomark Analysis:as in the conclusion
Control Group Info:dacarbazine
Treatment Info: receive nivolumab (at a dose of 3 mg per kilogram of body weight every 2 weeks and dacarbazinematched placebo every 3 weeks) or dacarbazine (at a dose of 1000 mg per square meter of bodysurface area every 3 weeks and nivolumabmatched placebo every 2 weeks).
Primary End Point:overall survival
Secondary End Point:NA
Patients Number:418
Trial Results
DLT_MTD:NA
Objective Response Rate:At 1 year, the overall rate of survival was 72.9% (95% confidence interval [CI], 65.5 to 78.9) in the nivolumab group, as compared with 42.1% (95% CI, 33.0 to 50.9) in the dacarbazine group (hazard ratio for death, 0.42; 99.79% CI, 0.25 to 0.73; P<0.001).
Disease Control Rate:NA
Median Time to Progression:NA
Median PFS A vs. C:The median progression free survival was 5.1 months in the nivolumab group versus 2.2 months in the dacarbazine group (hazard ratio for death or progression of disease, 0.43; 95% CI, 0.34 to 0.56; P<0.001). The
Median OS A vs. C:At 1 year, the overall rate of survival was 72.9% (95% confidence interval [CI], 65.5 to 78.9) in the nivolumab group, as compared with 42.1% (95% CI, 33.0 to 50.9) in the dacarbazine group (hazard ratio for death, 0.42; 99.79% CI, 0.25 to 0.73; P<0.001).
Adverse Event(agent arm):Common adverse events associated with nivolumab included fatigue, pruritus, and nausea. Drugrelated adverse events of grade 3 or 4 occurred in 11.7% of the patients treated with nivolumab and 17.6% of those treated with dacarbazine.
Conclusions:Nivolumab was associated with significant improvements in overall survival and progression free survival, as compared with dacarbazine, among previously untreated patients who had metastatic melanoma without a BRAF mutation.