drugset / Trial / NCT02713867

A Dose Frequency Optimization,Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer Who Received Up to 12 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks

NCT02713867 ↗

Phase 3 Completed 363 enrolled Bristol-Myers Squibb
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this study is to compare PFS (progression-free survival) rate at 6 months and at 1 year after randomization, of Nivolumab 480 mg every 4 weeks with nivolumab 240 mg every 2 weeks in subjects with advanced/metastatic (Stage IIIb/IV) NSCLC (non-Sq and Sq).

Timeline

Start
2016-05-24
Primary completion
2019-07-15
Completion
2022-01-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Nivolumab Monoclonal antibody 240 mg —
Subject Nivolumab Monoclonal antibody 480 mg —

Indications