Clinical Trial: A Study of Nivolumab in Adult Participants With Recurrent High-Grade Meningioma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Single Arm, Open-Label Phase II Study of Nivolumab in Adult Participants With Recurrent High-Grade Meningioma

Brief Summary: This research study is studying a targeted immunotherapy as a possible treatment for Recurrent Meningioma. The name of the study intervention involved in this study is Nivolumab.

Detailed Summary:

This research is a Phase II clinical trial, which means it will test the safety and effectiveness of Nivolumab. Nivolumab is an antibody (type of human protein) that works to stop tumor cells from growing and multiplying by immunotherapy. Immunotherapy is trying to have the body's own immune system work against tumor cells.

Nivolumab has been used in other research studies and information from those other research studies suggests that this intervention may help to stop Meningioma cells from growing. Nivolumab is FDA approved to treat other types of cancers, but the FDA (the U.S. Food and Drug Administration) has not yet approved this intervention for this type of cancer.


Sponsor: Dana-Farber Cancer Institute

Current Primary Outcome: Progression-Free Survival At Six Months Following Initiation Of Study Therapy [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Median Progression-Free Survival [ Time Frame: 2 years ]
  • Median Overall Survival [ Time Frame: 2 years ]
  • Objective Radiologic Response Rate [ Time Frame: 2 years ]
  • Number of participants with treatment related adverse events as assessed by CTCAE v4.0. [ Time Frame: 2 years ]


Original Secondary Outcome:

  • Median Overall Survival [ Time Frame: 2 years ]
  • Objective Radiologic Response Rate [ Time Frame: 2 years ]
  • Number of participants with treatment related adverse events as assessed by CTCAE v4.0. [ Time Frame: 2 years ]


Information By: Dana-Farber Cancer Institute

Dates:
Date Received: January 5, 2016
Date Started: March 2016
Date Completion: July 2023
Last Updated: April 20, 2017
Last Verified: April 2017