Study of Nivolumab Given Sequentially With Ipilimumab in Subjects With Advanced or Metastatic Melanoma (CheckMate 064)

Advanced or Metastatic Melanoma Clinical Trial

Official title: An Open-Label, Randomized, Phase 2 Study of Nivolumab Given Sequentially With Ipilimumab in Subjects With Advanced or Metastatic Melanoma

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of a sequential combination therapy of Nivolumab and Ipilimumab

Clinical Trial Description

In order to evaluate the potential synergistic activity of nivolumab and ipilimumab and also because there may be differences in biology between tumors which are stable or responding to therapy and those that are clinically progressing, this study, CA209064, looked at two sequential combination regimens in which the second agent is administered immediately after a pre-specified duration of therapy with the first agent and not delayed until the time of progression after the first agent. This sequential study design looked at pharmacodynamic changes during treatment with one agent which may predict clinical activity to subsequent treatment with the alternate agent. This was done because it has not been scientifically proven whether or not the order in which nivolumab and ipilimumab are given is clinically important. ;

Related Conditions & MeSH terms

• Advanced or Metastatic Melanoma
• Melanoma

• NCT number: NCT01783938
• Study type: Interventional
• Source: Bristol-Myers Squibb
• Status: Completed
• Phase: Phase 2
• Start date: April 30, 2013
• Completion date: August 12, 2020